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State Agency Letters (4/20/07)

01 SA Notice Of Inspection - Failure To Permit Inspection Results In Revocation


02 SA Failure To Cooperate With Survey - Refer To CMS
03 SA Failure To Schedule Survey - Last Chance Appointment
04 SA Failure To Schedule Survey - Refer To CMS
05 SA Terminate New Lab Not Ready For Survey or Lab Ceased Testing Prior To Recert.
06 SA No Deficiency
07 SA Standards Out - POC Request
08 SA Standards Out - POC Acceptable
09 SA Standards Out - No POC or POC Unacceptable
10 SA Conditions Out - AOC Request
11 SA Conditions Out - AOC Credible
12 SA Conditions Out - AOC Credible, Standards Remain
13 SA Conditions Out - AOC Not Credible
14 SA Conditions Out - No AOC
15 SA Conditions Out At Follow-Up Survey - Warning Letter
16 SA Conditions Out At Follow-Up Survey - Refer To CMS
17 SA IJ - AOC Request
18 SA PT Desk Review 1st Unsuccessful - AOC Request
19 SA PT Desk Review 1st Unsuccessful - AOC Credible
20 SA PT Desk Review 1st Unsuccessful - AOC Not Credible
21 SA PT Desk Review 1st Unsuccessful - AOC Not Credible Refer To CMS
22 SA PT - Survey Finds 1st Unsuccessful - AOC Request

RO Letters (5/16/07)

01 RO Terminate CLIA Certificate - Failed To Meet State Requirement


02 RO Terminate CLIA Certificate - Lab Not Operational
03 RO Denial Of CLIA Application
04 RO Loss Of Accreditation From AO
05 RO Cease & Desist Letter - Testing W/O Valid CLIA Certificate
06 RO Cease & Desist Letter - LBA
07 RO Federal Survey - Standards Out - POC Request
08 RO Federal Survey - Conditions Out - AOC Request
09A RO Sanction Proposal - Standards Out - POC Unacceptable
09B RO Sanction Proposal - Standards Out - POC Unacceptable
10A RO Sanction Proposal - Conditions Out - AOC Not Credible
10B RO Sanction Proposal - Conditions Out AOC Not Credible - Directed Plan Of Correction
11 RO Sanction Proposal - IJ
12 RO Sanction Proposal - Subsequent Unsuccessful PT
13 RO Sanction Proposal - Improper PT Referral
14 RO Sanction Imposition - Standards Out - POC Unacceptable
15 RO Sanction Imposition - Conditions Out - AOC Not Credible
16 RO Sanction Imposition - IJ
17 RO Sanction Imposition - Subsequent Unsuccessful PT
18 RO Sanction Imposition - Improper PT Referral
19 RO Sanctions Final - Standards Out - POC Unacceptable
20 RO Sanctions Final - IJ or Non IJ - Hearing or No Hearing
21 RO Sanctions Final - Subsequent Unsuccessful PT
22 RO Sanction - CMP Demand Letter
23 RO Sanction - Attestation For Director or Owner
24 RO Sanction - Public Notice & Cover Letter Request
25 RO Sanction - Client Notification
26 RO Sanction - Suspension Of Medicare Agreement
27 RO Referral To OIG Form
01 SA (4/20/07) – Notice of Inspection – notifies lab that failure to permit inspection results in
revocation of certificate

SA Letterhead

NOTICE OF INSPECTION

You are hereby notified that this representative of the [STATE AGENCY NAME] and the
federal Centers for Medicare & Medicaid Services (CMS) is present to perform an inspection of
your laboratory and its records.

This representative has been granted the authority to inspect your laboratory and its records
under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578.
Federal regulations require onsite surveys to determine whether or not a laboratory is in
compliance with the applicable CLIA regulations in section 353 of the Public Health Service
Act (42 U.S.C. § 263a) and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493).
Compliance with these regulations is a condition of certification for the CLIA program.

Failure to permit this inspection may result in the suspension or revocation of your laboratory’s
CLIA certificate and the cancellation of your laboratory’s participation in the Medicaid and
Medicare reimbursement programs, pursuant to 42 C.F.R. § 493.49(c) and 42 C.F.R. §
493.1773(g).

This document serves as official notice that CMS will take enforcement action against your
laboratory if this representative is refused entry or not permitted to inspect your laboratory to
determine continued compliance with all CLIA requirements, or if your laboratory refuses to
cooperate with the survey process.

Inspection Refused By: _______________________________ Date: __________________

Name of Laboratory: __________________________________ CLIA #: _______________

Address: ____________________________________________________________________

City: _______________________________ State: _________ Zip Code: _____________

Contact telephone number:______________________________________________________


02 SA (4/20/07) – Failure to cooperate with survey – refer to CMS for sanction action

IMPORTANT NOTICE – PLEASE READ CAREFULLY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: FAILURE TO ALLOW INSPECTION

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. §
263a) and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations
require onsite surveys to determine whether or not a laboratory is in compliance with the
applicable regulations. Compliance with these regulations is a condition of certification for the
CLIA program.

The [STATE AGENCY NAME] attempted to conduct [CHOOSE SURVEY TYPE: an


initial, a routine recertification, a complaint] survey of your laboratory during normal hours of
operation on [SURVEY DATES]. However, the surveyors were not able to complete the survey
due to the laboratory’s failure to cooperate with the survey process. [GIVE DETAILS OF
HOW LAB FAILED TO COOPERATE.] On [DATE], the surveyors advised your
laboratory that failure to cooperate in the survey process constitutes failure to permit inspection,
and your laboratory would be subject to CLIA sanctions.

As a result of the laboratory’s failure to allow survey, your laboratory is out of compliance with
the CLIA Condition of inspection:

42 C.F.R. § 493.1771 Inspection requirements applicable to all CLIA-certified and


CLIA-exempt laboratories.

A form CMS-2567, Statement of Deficiencies, documenting your laboratory’s non-compliance


is enclosed.
Laboratories that do not meet a CLIA Condition may not be certified to perform testing under
the CLIA program. Based on your laboratory’s failure to allow inspection, the [STATE
AGENCY NAME] is recommending to the [NAME OF RO] Regional Office of the Centers
for Medicare & Medicaid Services (CMS) that sanctions be taken against your laboratory's
CLIA certificate. These include alternative sanctions (Civil Money Penalty of $3,000 per day of
noncompliance per 42 C.F.R. § 493.1834) and principal sanctions (suspension and revocation of
your laboratory's CLIA certificate and cancellation of you laboratory's approval for Medicare
payments per 42 C.F.R. § 493.1814).

By this letter we are forwarding your file to the CMS Regional Office to initiate sanction
actions. The CMS Regional Office will be notifying you in writing regarding its determination
to impose sanction actions against your laboratory's CLIA certificate.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]

Enclosure: CMS-2567, Statement of Deficiencies

cc: CMS Regional Office


03 SA (4/20/07) – Failure to cooperate with scheduling of survey – last chance appointment

IMPORTANT NOTICE – PLEASE READ CAREFULLY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: FAILURE TO ALLOW INSPECTION – FINAL ATTEMPT TO SCHEDULE SURVEY

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. §
263a) and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations
require onsite surveys to determine whether or not a laboratory is in compliance with the
applicable regulations. Compliance with these regulations is a condition of certification for the
CLIA program.

The [STATE AGENCY NAME] has attempted to conduct [CHOOSE SURVEY TYPE: an
initial, a routine recertification, a complaint] survey of your laboratory to determine compliance
with CLIA requirements. Your laboratory was contacted on [GIVE HISTORY OF
ATTEMPT(S), I.E., DATES OF CONTACT AND RECORD OF WHAT TRANSPIRED]
to schedule the survey. However, your laboratory has continued to be uncooperative in
scheduling the survey.

By this letter, we are notifying you that we have scheduled the following date and time to
survey your laboratory: [10 DAYS FROM THE DATE OF LETTER OR THEREAFTER,
DEPENDING ON SURVEYOR SCHEDULE] at [TIME].

Failure to be present at the laboratory at the appointed time to allow access will constitute
failure to permit inspection and your laboratory will be subject to CLIA sanctions. The [STATE
AGENCY NAME] will recommend to the [NAME OF RO] Regional Office of the Centers for
Medicare & Medicaid Services (CMS) that sanctions be taken against your laboratory's CLIA
certificate. These will include alternative sanctions (Civil Money Penalty of $3,000 per day of
noncompliance per 42 C.F.R. § 493.1834) and principal sanctions (suspension and revocation of
your laboratory's CLIA certificate and cancellation of you laboratory's approval for Medicare
payments per 42 C.F.R. § 493.1814).
Please be advised that pursuant to 42 C.F.R. § 493.1001.1301, failure to allow immediate access
for inspection is basis for the Office of Inspector General (OIG) to exclude your laboratory from
participation in all Federal and State health care programs.

If you have questions regarding this letter, please feel free to contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]
04 SA (4/20/07) – Failure to cooperate with scheduling of survey – refer to CMS for sanction action

IMPORTANT NOTICE – PLEASE READ CAREFULLY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: FAILURE TO ALLOW INSPECTION – REFERRAL TO CMS FOR SANCTION


ACTION

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. §
263a) and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations
require onsite surveys to determine whether or not a laboratory is in compliance with the
applicable regulations. Compliance with these regulations is a condition of certification for the
CLIA program.

The [STATE AGENCY NAME] has attempted to conduct [CHOOSE SURVEY TYPE: an
initial, a routine recertification, or a complaint] survey of your laboratory to determine
compliance with CLIA requirements. Your laboratory was contacted on [GIVE HISTORY OF
ATTEMPT(S), I.E., DATES OF CONTACT AND RECORD OF WHAT TRANSPIRED]
to schedule the survey. However, your laboratory has continued to be uncooperative in
scheduling the survey.

As a result of your laboratory’s failure to allow survey, your laboratory is out of compliance
with the CLIA Condition of inspection:

42 C.F.R. § 493.1771 Inspection requirements applicable to all CLIA-certified and


CLIA-exempt laboratories.

A form CMS-2567, Statement of Deficiencies documenting your laboratory’s non-compliance is


enclosed.

Laboratories that do not meet a CLIA Condition may not be certified to perform testing under
the CLIA program. Based on your laboratory’s failure to allow inspection, the [STATE
AGENCY NAME] our is recommending to the [NAME OF RO] Regional Office of the
Centers for Medicare & Medicaid Services (CMS) that sanctions be taken against your
laboratory's CLIA certificate. These include alternative sanctions (Civil Money Penalty of
$3,000 per day of noncompliance per 42 C.F.R. § 493.1834) and principal sanctions (suspension
and revocation of your laboratory's CLIA certificate and cancellation of you laboratory's
approval for Medicare payments per 42 C.F.R. § 493.1814).

By this letter we are forwarding your file to the CMS Regional Office to initiate sanction
actions. The CMS Regional Office will be notifying you in writing regarding its determination
to impose sanction actions against your laboratory's CLIA certificate.

You are reminded that pursuant to 42 C.F.R. § 493.1001.1301, failure to allow immediate
access for inspection is basis for the Office of Inspector General (OIG) to exclude your
laboratory from participation in all Federal and State health care programs.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]

Enclosure: CMS-2567, Statement of Deficiencies

cc: CMS Regional Office


05 SA (4/20/07) – Terminate CLIA certificate – new lab not ready for survey or lab ceased testing
prior to recertification survey

IMPORTANT NOTICE – PLEASE READ CAREFULLY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: TERMINATION OF CLIA CERTIFICATE

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. §
263a) and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations
require onsite surveys to determine whether or not a laboratory is in compliance with the
applicable regulations. Compliance with these regulations is a condition of certification for the
CLIA program.

[FOR INITIAL LAB NOT READY FOR SURVEY, USE FOLLOWING 3


PARAGRAPHS:

Your laboratory applied for and was issued a CLIA number effective [APPLICATION DATE
ON 116 SCREEN 3.1]. The [STATE AGENCY NAME] has attempted to conduct an initial
survey of your laboratory to determine compliance with CLIA requirements. Your laboratory
was contacted on [GIVE HISTORY OF ATTEMPT(S), I.E., DATES OF CONTACT AND
RECORD OF WHAT TRANSPIRED] to schedule the survey. However, your laboratory has
indicated that it is not ready for survey.

By this letter, we are notifying you that we are terminating your laboratory's CLIA certificate
effective with the date of application. When your laboratory is fully operational, you may
contact our office again to reapply for CLIA certification and schedule the mandatory
compliance survey at that time after applicable fees have been paid.

You are also advised that until your laboratory is appropriately certified by CLIA, you are not
authorized to conduct any patient testing, including waived testing and provider performed
microscopy procedures, or to bill Medicare or Medicaid for any such testing. Any facility that
performs patient testing without proper CLIA certification shall be subject to imprisonment, or
fines, or both. See 42 U.S.C. 263(a)(l). ]

[FOR RECERTS – IF LAB HAS CEASED TESTING, USE THE FOLLOWING


PARAGRAPH:

In attempting to schedule a recertification survey to determine compliance with CLIA


requirements, we were informed that your laboratory has ceased testing effective [DATE].
Based on this information, we are terminating your laboratory's CLIA certificate effective
[DATE], the date testing ceased. If your laboratory wishes to resume testing in the future, you
may contact our office to reinstate your CLIA certificate or reapply for CLIA certification, as
appropriate. ]

If you have questions regarding this letter, please feel free to contact me at [PHONE #].

Sincerely,
[SURVEYOR NAME], [TITLE]
[STATE AGENCY NAME]
06 SA (4/20/07) – No deficiencies found

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA #[CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: CERTIFICATION OF COMPLIANCE

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. §
263a) and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations
require onsite surveys to determine whether or not a laboratory is in compliance with the
applicable regulations. Compliance with these regulations is a condition of certification for the
CLIA program.

The [STATE AGENCY] conducted [CHOOSE SURVEY TYPE: an initial, a routine


recertification, a complaint] survey of your laboratory on [SURVEY DATE]. The results of the
survey showed that all CLIA Condition-level requirements were met during the time of the
onsite survey. We are recommending to CMS that your laboratory be [CHOOSE ONE:
certified, recertified] in the CLIA program.

Please note that the routine survey takes an overview of the laboratory through random
sampling. By its nature, the routine survey may not find every instance of non-compliance that
may have occurred in the laboratory. It remains the responsibility of the laboratory and its
director to ensure that the laboratory is at all times following all CLIA requirements, to identify
any problems in the laboratory and take corrective action specific to the problems, and to
institute appropriate quality assessment measures to ensure that the deficient practices do not
recur.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]
Enclosure: CMS-2567
07 SA (4/20/07) – Standards out – POC request letter

IMPORTANT NOTICE – ACTION NECESSARY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA #[CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: STANDARD-LEVEL DEFICIENCIES

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. §
263a) and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations
require onsite surveys to determine whether or not a laboratory is in compliance with the
applicable regulations. Compliance with these regulations is a condition of certification for the
CLIA program.

The [STATE AGENCY NAME] (State agency) conducted [CHOOSE SURVEY TYPE: an
initial, a routine recertification, a complaint] survey of your laboratory that was completed on
[SURVEY DATE]. [ADD THE FOLLOWING SENTENCE WHEN APPROPRIATE:
Please note that this routine survey was expedited because your laboratory's CLIA certificate
has expired or is about to expire.] Enclosed is form CMS-2567, Statement of Deficiencies,
listing the deficiencies found during the survey. The deficiency statement references the CLIA
regulations at 42 C.F.R. § 493.

You are required to respond within 10 days of receipt of this notice. Please indicate your
corrective actions on the right side of the form CMS-2567 in the column labeled "Provider Plan
of Correction", keying your responses to the deficiencies on the left. Additionally, indicate your
anticipated completion dates in the column labeled "Completion Date."

Please return the completed form CMS-2567, dated and signed by the director, within 10 days
of receipt of this notice.

Regulations at 42 C.F.R. § 493.1816 state that if a laboratory has deficiencies that are not at the
Condition level, the laboratory must submit a plan of correction that is acceptable to CMS
(Centers for Medicare & Medicaid Services) in content and time frames. Further, regulations at
42 C.F.R. § 493.1816 require all deficiencies to be corrected within 12 months after the last day
of the survey. Please note that depending on the nature and seriousness of the deficiency, the
acceptable time frame for correction may be less than 12 months.

If your laboratory does not respond timely to this request, or if your laboratory submits a Plan of
Correction that is not acceptable in content and time frames, or if your laboratory does not
demonstrate compliance with all CLIA requirements by the specified completion date, we will
recommend to CMS imposition of principal sanctions, i.e., suspension, limitation and/or
revocation of your laboratory's CLIA certificate and concurrent cancellation of your laboratory's
approval for Medicare payments per 42 C.F.R. § 493.1816.

Your laboratory will also be required to provide acceptable evidence of correction for the cited
deficiencies. For your information, acceptable evidence of correction must include:

1) Documentation showing what corrective action(s) have been taken for patients
found to have been affected by the deficient practice;

2) How the laboratory has identified other patients having the potential to be affected
by the same deficient practice and what corrective action(s) has been taken;

3) What measure has been put into place or what systemic changes you have made to
ensure that the deficient practice does not recur, and

4) How the corrective action(s) are being monitored to ensure the deficient practice
does not recur.

Please note that the routine survey takes an overview of the laboratory through random
sampling. By its nature, the routine survey may not find every violation that the laboratory may
have committed. It remains the responsibility of the laboratory and its director to ensure that the
laboratory is at all times following all CLIA requirements, to identify any problems in the
laboratory and take corrective action specific to the problems, and to institute appropriate
quality assessment measures to ensure that the deficient practices do not recur.

In addition to the routine CLIA certification surveys, announced or unannounced investigations/


surveys may be conducted by the [STATE AGENCY NAME] at any time to address
complaints or other non-compliance issues. These investigations/surveys may well identify
violations that may not have surfaced during a routine survey using random sampling, but for
which the laboratory and its director will still be held responsible.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]

Enclosure: CMS-2567, Statement of Deficiencies


08 SA (4/20/07) – Standards only – POC acceptable

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA #[CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: PLAN OF CORRECTION AND EVIDENCE OF CORRECTION ACCEPTABLE

Dear Director/Owner(s):

By letter dated [LETTER DATE], we notified you that based on the onsite survey completed
on [SURVEY DATE], your facility was not in compliance with standard-level CLIA
requirements. In our letter we requested that you submit an acceptable plan of correction and
acceptance evidence of correction. We received your response on [SUBMISSION DATE], and
have determined that your plan of correction and evidence of correction are acceptable.

We encourage your laboratory to maintain compliance with all CLIA requirements. It is the
responsibility of the laboratory and its director to ensure that the laboratory is at all times
following all CLIA requirements, to identify any problems in the laboratory and take corrective
action specific to the problems, and to institute appropriate quality assessment measures to
ensure that the deficient practices do not recur.

If it is discovered that your plan of correction was not implemented or that compliance was not
maintained, the [STATE AGENCY NAME] will refer the case to the Regional Office of the
Centers for Medicare & Medicaid Services (CMS) for appropriate action, and recommend that
sanctions be taken against your laboratory's CLIA certificate.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]
09 SA (4/20/07) – Standards only – POC not received or unacceptable – second request for acceptable
POC

IMPORTANT NOTICE – ACTION NECESSARY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA #[CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: PLAN OF CORRECTION [CHOOSE AS APPROPRIATE: NOT RECEIVED OR


UNACCEPTABLE]

Dear Director/Owner(s):

[BEGIN WITH THE FOLLOWING 2 PARAGRAPHS IF POC NOT RECEIVED:

You were notified by our letter dated [DATE OF POC REQUEST LETTER] of deficiencies
found at the [SURVEY DATE] survey of your laboratory. We requested you submit an
acceptable plan of correction and evidence of correction for the deficiencies cited within ten
days of receipt of our notification letter. To date we have received no response from your
laboratory.

You are reminded that if you do not submit an acceptable plan of correction and acceptable
evidence of correction, or if you submit a plan of correction that is determined to be
unacceptable, the [STATE AGENCY NAME] will recommend to the [RO NAME] Regional
Office of the Centers for Medicare & Medicaid Services (CMS) that sanctions be taken against
your laboratory's CLIA certificate. As you were previously advised, these may include principal
sanctions of suspension, limitation and/or revocation of your laboratory's CLIA certificate and
cancellation of you laboratory's approval for Medicare payments per 42 C.F.R. § 493.1814.

[BEGIN WITH THE FOLLOWING 2 PARAGRAPHS IF POC UNACCEPTABLE:

You were notified by our letter dated [DATE OF POC REQUEST LETTER] of deficiencies
found at the [SURVEY DATE] survey of your laboratory. We requested you submit a plan of
correction for the deficiencies cited within ten days of receipt of our notification letter. You
were advised that the plan of correction must be acceptable in content and time frames.

We received your plan of correction on [DATE]. We have reviewed your submission and find
that it is unacceptable for the following reasons:
EXPLAIN WHY POC IS UNACCEPTABLE ]

[FOR BOTH SITUATIONS, USE THE FOLLOWING LANGUAGE FOR SECOND


REQUEST FOR ACCEPTABLE POC:

We are providing another opportunity for you to submit an acceptable plan of correction for
the cited deficiencies. You must respond WITHIN 10 DAYS OF RECEIPT of this notice and
provide a plan of correction that is acceptable in content and time frames.

You are reminded that your laboratory will also be required to provide acceptable evidence of
correction for the cited deficiencies by the specified completion date in your plan of correction
once it has been determined to be acceptable. We remind you that acceptable evidence of
correction must include:

1) Documentation showing what corrective action(s) have been taken for patients
found to have been affected by the deficient practice;

2) How the laboratory has identified other patients having the potential to be affected
by the same deficient practice and what corrective action(s) has been taken;

3) What measure has been put into place or what systemic changes you have made to
ensure that the deficient practice does not recur, and

4) How the corrective action(s) are being monitored to ensure the deficient practice
does not recur. ]

[END WITH THE FOLLOWING PARAGRAPH IF POC NOT RECEIVED:

If we do not hear from you, or if we do not receive from you an acceptable plan of correction
with acceptable evidence of correction WITHIN 10 DAYS from receipt of this notice, we will
forward your case to the CMS Regional Office with recommendations for sanction action
against your laboratory’s CLIA certificate. Once your case has been referred, the CMS
Regional Office has the final authority for any sanction actions to be imposed and will inform
you of its determination and the appeals procedures.]

[END WITH THE FOLLOWING PARAGRAPH IF POC UNACCEPTABLE:

Please note that if your laboratory does not provide a plan of correction that is acceptable in
content and time frames, or if your laboratory does not demonstrate compliance with all CLIA
requirements by the specified completion dates in your plan of correction, we will refer your
case to the Centers for Medicare & Medicaid Services (CMS) with recommendations that
sanctions be imposed against your laboratory's CLIA certificate.]
If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]
10 SA (4/20/07) – Conditions out - AOC request letter

IMPORTANT NOTICE – ACTION NECESSARY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA #[CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: CONDITION-LEVEL DEFICIENCIES

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. §
263a) and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations
require onsite surveys to determine whether or not a laboratory is in compliance with the
applicable regulations. Compliance with these regulations is a condition of certification for the
CLIA program.

The [STATE AGENCY NAME] (State agency) conducted [CHOOSE SURVEY TYPE: an
initial, a routine recertification, a complaint] survey of your laboratory that was completed on
[SURVEY DATE]. [ADD THE FOLLOWING SENTENCE WHEN APPROPRIATE:
Please note that this routine survey was expedited because your laboratory's CLIA certificate
has expired or is about to expire.] As a result of the survey, it was determined that your facility
is not in compliance with all of the Conditions required for certification in the CLIA program.
Specifically, the following Conditions were not met: [DELETE CONDITIONS THAT DO
NOT APPLY.]

D2000 - 42 C.F.R. § 493.801 Condition: Enrollment and testing of [proficiency testing]


samples;
D2016 - 42 C.F.R. § 493.803 Condition: Successful participation [proficiency testing]
D3000 - 42 C.F.R. § 493.1101 Condition: Facility Administration
D5002 - 42 C.F.R. § 493.1201 Condition: Bacteriology ;
D5004 - 42 C.F.R. § 493.1202 Condition: Mycobacteriology;
D5006 - 42 C.F.R. § 493.1203 Condition: Mycology;
D5008 - 42 C.F.R. § 493.1204 Condition: Parasitology;
D5010 - 42 C.F.R. § 493.1205 Condition: Virology;
D5012 - 42 C.F.R. § 493.1207 Condition: Syphilis serology;
D5014 - 42 C.F.R. § 493.1208 Condition: General immunology;
D5016 - 42 C.F.R. § 493.1210 Condition: Routine chemistry;
D5018 - 42 C.F.R. § 493.1211 Condition: Urinalysis;
D5020 - 42 C.F.R. § 493.1212 Condition: Endocrinology;
D5022 - 42 C.F.R. § 493.1213 Condition: Toxicology;
D5024 - 42 C.F.R. § 493.1215 Condition: Hematology;
D5026 - 42 C.F.R. § 493.1217 Condition: Immunohematology;
D5028 - 42 C.F.R. § 493.1219 Condition: Histopathology;
D5030 - 42 C.F.R. § 493.1220 Condition: Oral pathology;
D5032 - 42 C.F.R. § 493.1221 Condition: Cytology;
D5034 - 42 C.F.R. § 493.1225 Condition: Clinical cytogenetics;
D5040 - 42 C.F.R. § 493.1226 Condition: Radiobioassay;
D5042 - 42 C.F.R. § 493.1227 Condition: Histocompatibility;
D5200 - 42 C.F.R. § 493.1230 Condition: General laboratory systems;
D5300 - 42 C.F.R. § 493.1240 Condition: Preanalytic systems;
D5400 - 42 C.F.R. § 493.1250 Condition: Analytic systems;
D5800 - 42 C.F.R. § 493.1290 Condition: Postanalytic systems;
D5980 - 42 C.F.R. § 493.1355 Condition: Laboratories performing PPM procedures;
laboratory director;
D5990 - 42 C.F.R. § 493.1355 Condition: Laboratories performing PPM procedures;
testing personnel;
D6000 - 42 C.F.R. § 493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director;
D6033 - 42 C.F.R. § 493.1409 Condition: Laboratories performing moderate complexity
testing; technical consultant;
D6056 - 42 C.F.R. § 493.1415 Condition: Laboratories performing moderate complexity
testing; clinical consultant;
D6063 - 42 C.F.R. § 493.1421 Condition: Laboratories performing moderate complexity
testing; testing personnel;
D6076 - 42 C.F.R. § 493.1441 Condition: Laboratories performing high complexity testing;
laboratory director;
D6108 - 42 C.F.R. § 493.1447 Condition: Laboratories performing high complexity testing;
technical supervisor;
D6134 - 42 C.F.R. § 493.1453 Condition: Laboratories performing high complexity testing;
clinical consultant;
D6141 - 42 C.F.R. § 493.1459 Condition: Laboratories performing high complexity testing;
general supervisor;
D6153 - 42 C.F.R. § 493.1467 Condition: Laboratories performing high complexity testing;
cytology general supervisor
D6162 - 42 C.F.R. § 493.1481 Condition: Laboratories performing high complexity testing;
cytotechnologist;
D6168 - 42 C.F.R. § 493.1487 Condition: Laboratories performing high complexity testing;
testing personnel;
D8100 - 42 C.F.R. § 493.1771 Condition: Inspection requirements applicable to all CLIA-
certified and CLIA-exempt laboratories.

In addition, other standards were also found to be not met. Enclosed is Form CMS-2567,
Statement of Deficiencies, listing all the deficiencies found during the survey.
Laboratories that do not meet the Condition-level requirements of CLIA may not be certified to
perform laboratory testing under the CLIA program. You must take steps to bring any unmet
Conditions into compliance immediately.

You are directed to submit a credible allegation of compliance and acceptable evidence of
correction for the deficiencies cited. Please document your allegation of compliance using the
enclosed CMS-2567, Statement of Deficiencies, in the columns labeled “Provider Plan of
Correction” and “Completion Date” located on the right side of the form, keying your responses
to the deficiencies on the left. The laboratory director must sign, date and return the completed
CMS-2567 documented with a credible allegation of compliance to our office WITHIN 10
DAYS FROM RECEIPT of this notice. You must also submit documented evidence that
verifies that the corrections were made. We may conduct a follow-up onsite survey in
approximately 30-45 days to verify the corrections if we find your allegation of compliance to
be credible and the submitted evidence to be acceptable. If your laboratory does not submit a
credible allegation of compliance and acceptable evidence of correction, we will not conduct a
follow-up survey. (Your allegation of compliance will be included in the public record of the
inspection.)

A credible allegation of compliance is a statement or documentation that is:

1) Made by a representative of a laboratory with a history of having maintained a


commitment to compliance and taking corrective action when required;

2) Realistic in terms of the possibility of the corrective action being accomplished


between the date of the survey and the date of the allegation; and

3) Indicates resolution of the problems.

For your information, acceptable evidence of correction must include:

1) Documentation showing what corrective action(s) have been taken for patients
found to have been affected by the deficient practice;

2) How the laboratory has identified other patients having the potential to be affected
by the same deficient practice and what corrective action(s) has been taken;

3) What measure has been put into place or what systemic changes you have made to
ensure that the deficient practice does not recur, and

4) How the corrective action(s) are being monitored to ensure the deficient practice
does not recur.
If you do not submit a credible allegation of compliance and acceptable evidence of correction,
or if you submit an allegation of compliance that is determined to be credible but are found to
be still out of compliance with any CLIA Condition-level requirements at the time of the
follow-up visit, [STATE AGENCY NAME] will recommend to the [NAME OF RO]
Regional Office of the Centers for Medicare & Medicaid Services (CMS) that sanctions be
taken against your laboratory's CLIA certificate. These may include alternative sanctions (Civil
Money Penalty of up to $3,000 per day of noncompliance per 42 C.F.R. § 493.1834, Directed
Plan of Correction per 42 C.F.R. § 493.1832, State Onsite Monitoring per 42 C.F.R. §
493.1836) and principal sanctions (suspension, limitation and/or revocation of your laboratory's
CLIA certificate and cancellation of you laboratory's approval for Medicare payments per 42
C.F.R. § 493.1814).

Please note that the routine survey takes an overview of the laboratory through random
sampling. By its nature, the routine survey may not find every violation that the laboratory may
have committed. It remains the responsibility of the laboratory and its director to ensure that the
laboratory is at all times following all CLIA requirements, to identify any problems in the
laboratory and take corrective action specific to the problems, and to institute appropriate
quality assurance measures to ensure that the deficient practices do not recur.

In addition to the routine CLIA certification surveys, announced or unannounced investigations/


surveys may be conducted by the State agency at any time to address complaints or other non-
compliance issues. These investigations/surveys may well identify violations that may not have
surfaced during a routine survey using random sampling, but for which the laboratory and its
director will still be held responsible.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]

Enclosure: CMS-2567, Statement of Deficiencies


11 SA (4/20/07) – Condition(s) out – AOC credible

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: ALLEGATION OF COMPLIANCE CREDIBLE AND EVIDENCE OF CORRECTION


ACCEPTABLE

Dear Director/Owner(s):

By letter dated [LETTER DATE], we notified you that based on the onsite survey completed on
[SURVEY DATE], your facility was not in compliance with Condition-level CLIA
requirements. In our letter we requested that you submit a credible allegation of compliance and
acceptance evidence of correction. We received your response on [SUBMISSION DATE], and
have determined that your allegation of compliance is credible and evidence of correction is
acceptable.

We encourage your laboratory to maintain compliance with all CLIA requirements. It is the
responsibility of the laboratory and its director to ensure that the laboratory is at all times
following all CLIA requirements, to identify any problems in the laboratory and take corrective
action specific to the problems, and to institute appropriate quality assessment measures to
ensure that the deficient practices do not recur.

If it is discovered that the alleged corrective action was not implemented or that compliance was
not maintained, the [STATE AGENCY NAME] will refer the case to the Regional Office of the
Centers for Medicare & Medicaid Services (CMS) for appropriate action, and recommend that
sanctions be taken against your laboratory's CLIA certificate.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]
12 SA (4/20/07) – Conditions out– AOC credible – compliance with Conditions verified at F/U survey,
standards remain

IMPORTANT NOTICE – ACTION NECESSARY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: CONDITIONS CORRECTED, STANDARDS REMAIN

Dear Director/Owner(s):

A survey of your laboratory was completed on [INITIAL SURVEY DATE] which found your
laboratory to be out of compliance with Condition-level CLIA requirements. A follow-up survey
of your laboratory was conducted on [FOLLOW UP SURVEY DATE], following a submission
of a credible allegation of compliance and evidence of correction for the [INITIAL SURVEY
DATE] survey of your laboratory.

It was determined at the follow-up survey that all Conditions were met, but standard-level
deficiencies still remain. [ADD IF APPROPRIATE: These include deficiencies still
uncorrected from the [SURVEY DATE OF ORIGINAL SURVEY] survey as well as others
identified during the revisit survey.] Enclosed is form CMS-2567, Statement of Deficiencies,
listing the remaining deficiencies.

You are required to respond WITHIN 10 DAYS OF RECEIPT of this notice. Please indicate
your corrective actions on the right side of the form CMS-2567 in the column labeled "Provider
Plan of Correction", keying your responses to the deficiencies on the left. Additionally, indicate
your anticipated completion dates in the column labeled "Completion Date."

Please return the completed form CMS-2567, dated and signed by the director, within 10 days of
receipt of this notice.

Regulations at 42 C.F.R. § 493.1816 state that if a laboratory has deficiencies that are not at the
Condition level, the laboratory must submit a plan of correction that is acceptable to CMS
(Centers for Medicare & Medicaid Services) in content and time frames. Further, regulations at
42 C.F.R. § 493.1816 require all deficiencies be corrected within 12 months after the last day of
the survey. Please note that depending on the nature and seriousness of the deficiency, the
acceptable time frame for correction may be less than 12 months.

If your laboratory does not respond timely to this request, or if your laboratory submits a Plan of
Correction that is not acceptable in content and time frames, or if your laboratory does not
demonstrate compliance with all CLIA requirements by the specified completion date, we will
recommend to CMS imposition of principal sanctions, i.e., suspension, limitation and/or
revocation of your laboratory's CLIA certificate and concurrent cancellation of you laboratory's
approval for Medicare payments per 42 C.F.R. § 493.1816.

Your laboratory will also be required to provide acceptable evidence of correction for the cited
deficiencies. You are reminded that acceptable evidence of correction must include:

1) Documentation showing what corrective action(s) have been taken for patients
found to have been affected by the deficient practice;

2) How the laboratory has identified other patients having the potential to be affected by
the same deficient practice and what corrective action(s) has been taken;

3) What measure has been put into place or what systemic changes you have made to
ensure that the deficient practice does not recur, and

4) How the corrective action(s) are being monitored to ensure the deficient practice does
not recur.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]

Enclosure: CMS-2567, Statement of Deficiencies


13 SA (4/20/07) – Conditions out – AOC not credible, language for 1) no repeat deficiencies or 2) repeat
deficiencies

IMPORTANT NOTICE – ACTION NECESSARY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: ALLEGATION OF COMPLIANCE NOT CREDIBLE, EVIDENCE OF CORRECTION


UNACCEPTABLE

Dear Director/Owner(s):

You were notified by our letter dated [DATE OF AOC REQUEST LETTER] of deficiencies
found at the [SURVEY DATE] survey of your laboratory. We requested you submit a credible
allegation of compliance and acceptable evidence of correction for the deficiencies cited within
ten days of receipt of our notification letter. You were advised that a credible allegation of
compliance is a statement or documentation that is:

1) Made by a representative of a laboratory with a history of having maintained a


commitment to compliance and taking corrective action when required;

2) Realistic in terms of the possibility of the corrective action being accomplished


between the date of the survey and the date of the allegation; and

3) Indicates resolution of the problems.

You were also advised that acceptable evidence of correction must include:

1) Documentation showing what corrective action(s) have been taken for


patients found to have been affected by the deficient practice;

2) How the laboratory has identified other patients having the potential to be
affected by the same deficient practice and what corrective action(s) has been
taken;
3) What measure has been put into place or what systemic changes you have
made to ensure that the deficient practice does not recur, and

4) How the corrective action(s) are being monitored to ensure the deficient practice does
not recur.

We received your response on [DATE]. We have reviewed your submission and find that it
does not constitute a credible allegation of compliance and acceptable evidence of correction
for the following reasons):

[EXPLAIN WHY AOC/EVIDENCE OF CORRECTION UNACCEPTABLE]

[OPTION 1 – USE THE FOLLOWING 3 PARAGRAPHS IF NO REPEAT


DEFICIENCIES:

You are reminded that if you do not submit a credible allegation of compliance and acceptable
evidence of correction, or if you submit an allegation of compliance that is determined to be
credible but are found to be still out of compliance with any CLIA Condition-level requirements
at the time of the follow-up visit, the [STATE AGENCY NAME] will recommend to the [RO
NAME] Regional Office of the Centers for Medicare & Medicaid Services (CMS) that sanctions
be taken against your laboratory's CLIA certificate. As you were previously advised, these may
include alternative sanctions (Civil Money Penalty of up to $3,000 per day of noncompliance per
42 C.F.R. § 493.1834, Directed Plan of Correction per 42 C.F.R. § 493.1832, State Onsite
Monitoring per 42 C.F.R. § 493.1836) and principal sanctions (suspension, limitation and/or
revocation of your laboratory's CLIA certificate and cancellation of you laboratory's approval for
Medicare payments per 42 C.F.R. § 493.1814).

We are providing you another opportunity to submit a credible allegation of compliance and
acceptable evidence of correction for the cited deficiencies. You must respond WITHIN 10
DAYS from receipt of this notice. [IF REPEAT CONDITIONS OUT BASED ON SAME
DEFICIENCIES AND THE LAB HAS FAILED TO MAINTAIN COMPLIANCE, SA
MAY CHOOSE TO REFER CASE IMMEDIATELY TO RO FOR SANCTION. SEE
OPTION 2 BELOW.]

If we do not hear from you, or if we do not receive from you a credible allegation of compliance
and acceptable evidence of correction WITHIN 10 DAYS from receipt of this notice, we will
forward your case to the CMS Regional Office with recommendations for sanction action against
your laboratory’s CLIA certificate. Once your case has been referred, the CMS Regional Office
has the final authority for any sanction actions to be imposed and will inform you of its
determination and the appeals procedures. ]

[OPTION 2 – USE THE FOLLOWING 3 PARAGRAPHS IF REPEAT DEFICIENCIES


AND SA DETERMINES IT APPROPRIATE BASED ON AOC REVIEW TO REFER
CASE IMMEDIATELY TO RO FOR SANCTION:

We note that deficiencies cited at the [DATE OF SURVEY] survey of your laboratory are
repeat deficiencies from previous surveys. [GIVE DETAILS OF FINDINGS FROM PRIOR
SURVEYS.] You were notified in our letter dated [DATE OF AOC REQUEST LETTER]
that failure to come into Condition-level compliance would result in a referral to the Centers for
Medicare & Medicaid Services (CMS) for sanction action against your laboratory's CLIA
certificate.

Since your facility has not taken the necessary action to correct the deficiencies cited at the
current survey, and based on your laboratory’s history of non-compliance and failure to sustain
compliance with CLIA Condition-level requirements, we are recommending to the CMS
Regional Office that the following principal and/or alternative sanctions be imposed:

Civil Money Penalty of $3,000 per day for each day of non-compliance;
State On-site Monitoring; Directed Plan of Correction;
Suspension, Limitation and/or Revocation of your CLIA certificate;
Cancellation of all Medicare/Medicaid Payments.

The CMS Regional Office has the final authority for any sanction actions to be imposed and will
inform you of its determination and the appeals procedures. ]

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]
[FOR OPTION 2, CC RO:
cc: CMS Regional Office]
14 SA (4/20/07) – Conditions out – no AOC submitted, language for 1) no repeat deficiencies or 2)
repeat deficiencies

IMPORTANT NOTICE – ACTION NECESSARY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: ALLEGATION OF COMPLIANCE NOT RECEIVED

Dear Director/Owner(s):

You were notified by our letter dated [DATE OF AOC REQUEST LETTER] of deficiencies
found at the [SURVEY DATE] survey of your laboratory. We requested that you submit a
credible allegation of compliance and acceptable evidence of correction for the deficiencies cited
within ten days of receipt of our notification letter. To date we have received no response from
your laboratory.

[OPTION 1 – USE THE FOLLOWING 3 PARAGRAPHS IF NO REPEAT


DEFICIENCIES:

You are reminded that if you do not submit a credible allegation of compliance and acceptable
evidence of correction, or if you submit an allegation of compliance that is determined to be
credible but are found to be still out of compliance with any CLIA Condition-level requirements
at the time of the follow-up visit, the [STATE AGENCY NAME] will recommend to the [RO
NAME] Regional Office of the Centers for Medicare & Medicaid Services (CMS) that sanctions
be taken against your laboratory's CLIA certificate. As you were previously advised, these may
include alternative sanctions (Civil Money Penalty of up to $3,000 per day of noncompliance or
per violation per 42 C.F.R. § 493.1834, Directed Plan of Correction per 42 C.F.R. § 493.1832,
State Onsite Monitoring per 42 C.F.R. § 493.1836) and principal sanctions (suspension,
limitation and/or revocation of your laboratory's CLIA certificate and cancellation of you
laboratory's approval for Medicare payments per 42 C.F.R. § 493.1814).

We are giving you another opportunity to submit a credible allegation of compliance and
acceptable evidence of correction for the cited deficiencies. You must respond WITHIN 10
DAYS from receipt of this notice. [IF REPEAT CONDITIONS OUT AND THE LAB HAS
FAILED TO MAINTAIN COMPLIANCE, SA MAY CHOOSE TO REFER CASE
IMMEDIATELY TO RO FOR SANCTION. SEE OPTION 2 BELOW.]

If we do not hear from you, or if we do not receive from you a credible allegation of compliance
and acceptable evidence of correction WITHIN 10 DAYS from receipt of this notice, we will
forward your case to the CMS Regional Office with recommendations for sanction action against
your laboratory’s CLIA certificate. Once your case has been referred, the CMS Regional Office
has the final authority for any sanction actions to be imposed and will inform you of its
determination and the appeals procedures. ]

[OPTION 2 – USE THE FOLLOWING 3 PARAGRAPHS IF REPEAT DEFICIENCIES


AND SA DETERMINES IT APPROPRIATE BASED ON AOC REVIEW TO REFER
CASE IMMEDIATELY TO RO FOR SANCTION:

We note that deficiencies cited at the [DATE OF SURVEY] survey of your laboratory are
repeat deficiencies from previous surveys. [GIVE DETAILS OF FINDINGS FROM PRIOR
SURVEYS.] You were notified in our letter dated [DATE OF AOC REQUEST LETTER]
that failure to come into Condition-level compliance would result in a referral to the Centers for
Medicare & Medicaid Services (CMS) for sanction action against your laboratory's CLIA
certificate.

Since your facility has not taken the necessary action to correct the deficiencies cited at the
current survey, and based on your laboratory’s history of non-compliance and failure to sustain
compliance with CLIA Condition-level requirements, we are recommending to the CMS
Regional Office that the following principal and/or alternative sanctions be imposed:

Civil Money Penalty of $3,000 per day for each day of non-compliance;
State On-site Monitoring; Directed Plan of Correction;
Suspension, Limitation and/or Revocation of your CLIA certificate;
Cancellation of all Medicare/Medicaid Payments.

The CMS Regional Office has the final authority for any sanction actions to be imposed and will
inform you of its determination and the appeals procedures. ]

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]

[FOR OPTION 2, CC RO
cc: CMS Regional Office]
15 SA (4/20/07) – Conditions out – AOC credible, Conditions still out at FU survey

IMPORTANT NOTICE – ACTION NECESSARY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: CONDITIONS STILL OUT

Dear Director/Owner(s):

A survey of your laboratory was conducted on [INITIAL SURVEY DATE]. You were notified
by letter dated [NOTICE DATE] of the deficiencies found and that you must be in Condition-
level compliance to be certified in the CLIA program.

A revisit survey of your laboratory was conducted on [FOLLOW UP SURVEY DATE],


following a submission of a credible allegation of compliance and evidence that indicated
correction of the deficiencies cited at the [INITIAL SURVEY DATE] survey of your
laboratory. The follow-up survey resulted in the finding that your laboratory is still out of
compliance with the following Condition-level requirement(s):

[LIST CONDITIONS.]

Standard-level deficiencies cited at the [ORIGINAL SURVEY DATE] survey also remain
uncorrected. [DELETE FOLLOWING SENTENCE IF NOT APPLICABLE: Additional
standard-level deficiencies were also found at the follow-up survey.] Enclosed is form
CMS-2567, Statement of Deficiencies, detailing all deficiencies found at the time of the follow-
up survey.

You were notified in our letter dated [NOTICE DATE] that failure to come into Condition-level
compliance would result in a referral to the Centers for Medicare & Medicaid Services (CMS)
for sanction action against your laboratory's CLIA certificate. Since your facility has not taken
the necessary corrective action to come into Condition-level compliance with all CLIA
requirements, we are recommending to the CMS Regional Office that the following principal
and/or alternative sanctions be imposed:
Civil Money Penalty of $3,000 per day for each day of non-compliance; State On-site
Monitoring; Directed Plan of Correction; Suspension, Limitation and/or Revocation of
your CLIA certificate; Cancellation of all Medicare/Medicaid Payments.

If your laboratory has evidence of correction for the deficiencies, you should submit this
evidence no later than 10 days from the date of this notice. You are reminded that acceptable
evidence of correction must include:

1) Documentation showing what corrective action(s) have been taken for patients
found to have been affected by the deficient practice;

2) How the laboratory has identified other patients having the potential to be affected by
the same deficient practice and what corrective action(s) has been taken;

3) What measure has been put into place or what systemic changes you have made to
ensure that the deficient practice does not recur; and

4) How the corrective action(s) are being monitored to ensure the deficient practice does
not recur.

If we do not hear from you, or if we do not receive from you acceptable evidence of compliance
with all CLIA Condition-level requirements WITHIN 10 DAYS FROM RECEIPT OF THIS
NOTICE, we will forward your case to the CMS Regional Office to initiate the recommended
sanction actions. Once your case has been referred, the CMS Regional Office has the final
authority for any sanction actions to be imposed and will inform you of its determination and the
appeals procedures.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]

Enclosure: CMS-2567, Statement of Deficiencies


16 SA (4/20/07) – Conditions out at FU survey – compliance not achieved after warning letter, refer to
CMS for sanctions

IMPORTANT NOTICE – PLEASE READ CAREFULLY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: REFERRAL TO CMS FOR SANCTION ACTION

Dear Dr. [DIRECTOR NAME]:

You were notified by letter dated [NOTICE DATE] that Condition-level deficiencies remained
at the follow-up survey of your laboratory conducted on [FOLLOW UP SURVEY DATE].
You were notified in the same letter that our office would refer your case to the Regional Office
of the Centers for Medicare & Medicaid Services (CMS) with recommendations for sanction
actions. You were given 10 days in which to submit evidence verifying that all Condition-level
deficiencies had been corrected. The 10-day time frame has passed, and we have not received
such evidence of correction.

Accordingly, by this letter we are forwarding your file to the CMS Regional Office to initiate
sanction actions. The CMS Regional Office will be notifying you in writing regarding its
determination to impose sanction actions against your laboratory's CLIA certificate.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]

cc: CMS Regional Office


17 SA (4/20/07) – Immediate Jeopardy – AOC request letter

IMPORTANT NOTICE – ACTION NECESSARY

VIA FACSIMILE TO XXX XXX-XXXX AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA #[CLIA NUMBER]


[OPTIONAL] State I.D. # [STATE ID NUMBER]

RE: CONDITIONS OUT - IMMEDIATE JEOPARDY

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. § 263a)
and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations require
onsite surveys to determine whether or not a laboratory is in compliance with the applicable
regulations. Compliance with these regulations is a condition of certification for the CLIA
program.

The [STATE AGENCY NAME] (State agency) conducted [CHOOSE SURVEY TYPE: an
initial, a routine recertification, a complaint] survey of your laboratory that was completed on
[SURVEY DATE]. As a result of the survey, it was determined that your facility is not in
compliance with all of the Conditions required for certification in the CLIA program. In addition,
it was determined that the deficient practices of your laboratory pose immediate jeopardy to
patient health and safety. (Immediate jeopardy is defined by the CLIA regulations as a situation
in which immediate corrective action is necessary because the laboratory's non-compliance with
one or more Condition-level requirements has already caused, is causing, or is likely to cause, at
any time, serious injury or harm, or death, to individuals served by the laboratory or to the health
and safety of the general public.) Specifically, the following Conditions were not met:
[DELETE CONDITIONS THAT DO NOT APPLY.]

D2000 - 42 C.F.R. § 493.801 Condition: Enrollment and testing of [proficiency testing]


samples;
D2016 - 42 C.F.R. § 493.803 Condition: Successful participation [proficiency testing]
D3000 - 42 C.F.R. § 493.1101 Condition: Facility Administration
D5002 - 42 C.F.R. § 493.1201 Condition: Bacteriology ;
D5004 - 42 C.F.R. § 493.1202 Condition: Mycobacteriology;
D5006 - 42 C.F.R. § 493.1203 Condition: Mycology;
D5008 - 42 C.F.R. § 493.1204 Condition: Parasitology;
D5010 - 42 C.F.R. § 493.1205 Condition: Virology;
D5012 - 42 C.F.R. § 493.1207 Condition: Syphilis serology;
D5014 - 42 C.F.R. § 493.1208 Condition: General immunology;
D5016 - 42 C.F.R. § 493.1210 Condition: Routine chemistry;
D5018 - 42 C.F.R. § 493.1211 Condition: Urinalysis;
D5020 - 42 C.F.R. § 493.1212 Condition: Endocrinology;
D5022 - 42 C.F.R. § 493.1213 Condition: Toxicology;
D5024 - 42 C.F.R. § 493.1215 Condition: Hematology;
D5026 - 42 C.F.R. § 493.1217 Condition: Immunohematology;
D5028 - 42 C.F.R. § 493.1219 Condition: Histopathology;
D5030 - 42 C.F.R. § 493.1220 Condition: Oral pathology;
D5032 - 42 C.F.R. § 493.1221 Condition: Cytology;
D5034 - 42 C.F.R. § 493.1225 Condition: Clinical cytogenetics;
D5040 - 42 C.F.R. § 493.1226 Condition: Radiobioassay;
D5042 - 42 C.F.R. § 493.1227 Condition: Histocompatibility;
D5200 - 42 C.F.R. § 493.1230 Condition: General laboratory systems;
D5300 - 42 C.F.R. § 493.1240 Condition: Preanalytic systems;
D5400 - 42 C.F.R. § 493.1250 Condition: Analytic systems;
D5800 - 42 C.F.R. § 493.1290 Condition: Postanalytic systems;
D5980 - 42 C.F.R. § 493.1355 Condition: Laboratories performing PPM procedures;
laboratory director;
D5990 - 42 C.F.R. § 493.1355 Condition: Laboratories performing PPM procedures;
testing personnel;
D6000 - 42 C.F.R. § 493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director;
D6033 - 42 C.F.R. § 493.1409 Condition: Laboratories performing moderate complexity
testing; technical consultant;
D6056 - 42 C.F.R. § 493.1415 Condition: Laboratories performing moderate complexity
testing; clinical consultant;
D6063 - 42 C.F.R. § 493.1421 Condition: Laboratories performing moderate complexity
testing; testing personnel;
D6076 - 42 C.F.R. § 493.1441 Condition: Laboratories performing high complexity testing;
laboratory director;
D6108 - 42 C.F.R. § 493.1447 Condition: Laboratories performing high complexity testing;
technical supervisor;
D6134 - 42 C.F.R. § 493.1453 Condition: Laboratories performing high complexity testing;
clinical consultant;
D6141 - 42 C.F.R. § 493.1459 Condition: Laboratories performing high complexity testing;
general supervisor;
D6153 - 42 C.F.R. § 493.1467 Condition: Laboratories performing high complexity testing;
cytology general supervisor
D6162 - 42 C.F.R. § 493.1481 Condition: Laboratories performing high complexity testing;
cytotechnologist;
D6168 - 42 C.F.R. § 493.1487 Condition: Laboratories performing high complexity testing;
testing personnel;
D8100 - 42 C.F.R. § 493.1771 Condition: Inspection requirements applicable to all CLIA-
certified and CLIA-exempt laboratories.

In addition, other standards were also found to be not met. Enclosed is Form CMS-2567,
Statement of Deficiencies, listing all the deficiencies found during the survey.

Because of the seriousness of these deficiencies, your laboratory no longer meets the
requirements to perform testing under CLIA. Based on the finding of immediate jeopardy, this
office has contacted the Centers for Medicare & Medicaid Services (CMS), and has
recommended a determination of non-compliance and the following sanctions be imposed and/or
enforcement actions be taken if your laboratory does not remove jeopardy and come into
Condition-level compliance:

Principal sanction of suspension and revocation of your laboratory's CLIA


certificate 42 C.F.R. § 493.1806 and 493.1812);

Cancellation of all Medicare and Medicaid payments (42 C.F.R. § 493.1807 and
§ 493.1808);

and civil money penalties of $10,000 per day of violation (42 C.F.R.
§ 493.1806 and § 493.1834).

When a laboratory's deficiencies pose immediate jeopardy, CMS requires the laboratory to take
immediate action to remove the jeopardy and come into Condition-level compliance.
Laboratories that do not meet the Condition-level requirements of CLIA may not be certified to
perform laboratory testing under the CLIA program.

Please be advised that sanctions and/or enforcement actions can be rescinded only when
compliance is verified. Please also be advised that due to the potential significant hazard to the
public health and safety posed by the deficiencies identified, sanctions may become effective 23
calendar days from the survey date.

You have 10 CALENDAR DAYS from the date of this notice to provide this office, with a copy
to CMS (at the address shown at the end of this notice), with a credible allegation of compliance
and acceptable evidence documenting that the immediate jeopardy has been removed and that
action has been taken to correct all of the Condition-level deficiencies in question.

You are directed to document your allegation of compliance using the enclosed CMS-2567,
Statement of Deficiencies, in the columns labeled “Provider Plan of Correction” and
“Completion Date” located on the right side of the form, keying your responses to the
deficiencies on the left. The laboratory director must sign, date and return the completed CMS-
2567 documented with a credible allegation of compliance to our office WITHIN 10
CALENDAR DAYS from the date of this notice. You must also submit documented evidence
that verifies that the corrections were made.

For your information, a credible allegation of compliance is a statement or documentation that is:

1) Made by a representative of a laboratory with a history of having maintained a


commitment to compliance and taking corrective action when required;

2) Realistic in terms of the possibility of the corrective action being accomplished


between the date of the survey and the date of the allegation; and

3) Indicates resolution of the problems.

In addition, acceptable evidence of correction must include:

1) Documentation showing what corrective action(s) have been taken for patients
found to have been affected by the deficient practice;

2) How the laboratory has identified other patients having the potential to be affected by
the same deficient practice and what corrective action(s) has been taken;

3) What measure has been put into place or what systemic changes you have made to
ensure that the deficient practice does not recur, and

4) How the corrective action(s) are being monitored to ensure the deficient practice does
not recur.
If you submit by [DATE OF LETTER PLUS 10 DAYS] a credible allegation of compliance
and acceptable evidence that your laboratory has removed jeopardy and come into Condition-
level compliance, and we are able to verify compliance with all CLIA requirements through a
follow-up survey, sanctions will not be imposed. If your laboratory does not submit a credible
allegation of compliance and acceptable evidence of correction, we will not conduct a follow-up
survey. (Your allegation of compliance will be included in the public record of the inspection.)

If jeopardy is not removed and your laboratory does not come into Condition-level compliance,
we will refer your case to CMS for sanction action. CMS will make the final determination and
will advise you in writing of the sanction(s) to be imposed and/or enforcement action(s) that will
be taken. CMS will also notify you of your appeal rights at that time.

Please note that the routine survey takes an overview of the laboratory through random sampling.
By its nature, the routine survey may not find every violation that the laboratory may have
committed. It remains the responsibility of the laboratory and its director to ensure that the
laboratory is at all times following all CLIA requirements, to identify any problems in the
laboratory and take corrective action specific to the problems, and to institute appropriate quality
assurance measures to ensure that the deficient practices do not recur.

In addition to the routine CLIA certification surveys, announced or unannounced investigations/


surveys may be conducted by the State agency at any time to address complaints or other non-
compliance issues. These investigations/surveys may well identify violations that may not have
surfaced during a routine survey using random sampling, but for which the laboratory and its
director will still be held responsible.

If you have questions regarding this letter, please contact me at [PHONE #].
Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]

Enclosure: CMS-2567, Statement of Deficiencies

cc: CMS Regional Office


18 SA (4/20/07) – PT desk review finds 1st unsuccessful – request AOC

IMPORTANT NOTICE – ACTION NECESSARY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: CONDITIONS OUT – FIRST UNSUCCESSFUL PT PERFORMANCE

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. § 263a)
and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations require
onsite surveys to determine whether or not a laboratory is in compliance with the applicable
regulations. Compliance with these regulations is a condition of certification for the CLIA
program.

Subpart H of 42 C.F.R. § 493 requires each laboratory certified to test specimens under the CLIA
regulations to successfully participate in an approved proficiency testing (PT) program. The
[STATE AGENCY NAME] reviewed PT results submitted to CLIA by your PT provider and
found unsatisfactory performance in the events listed below:

PT Provider Testing Event Analyte/specialty/subspecialty Score

[LIST UNSATISFACTORY EVENTS.]

The CLIA regulations at 42 C.F.R. § 493.2 defines unsuccessful PT performance as failure to


attain the minimum satisfactory score for an analyte, test, subspecialty or specialty for two
consecutive or two out of three consecutive testing events. Based on the PT failures listed above,
your facility is not in compliance with the Conditions of successful participation in PT and
Laboratory Director. Enclosed is Form CMS-2567, Statement of Deficiencies, documenting your
laboratory’s failure to meet these requirements: [DELETE DIRECTOR CONDITION THAT
DOES NOT APPLY.]

D2016 - 42 C.F.R. § 493.803 Condition: Successful participation [proficiency testing]


D6000 - 42 C.F.R. § 493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director;
D6076 - 42 C.F.R. § 493.1441 Condition: Laboratories performing high complexity
testing; laboratory director;

Laboratories that do not meet the Condition-level requirements of CLIA may not be certified to
perform laboratory testing under the CLIA program. You must take steps to bring any unmet
Conditions into compliance immediately.

You are directed to submit a credible allegation of compliance and acceptable evidence of
correction for the deficiencies cited. Please document your allegation of compliance using the
enclosed CMS-2567, Statement of Deficiencies, in the columns labeled “Provider Plan of
Correction” and “Completion Date” located on the right side of the form, keying your responses
to the deficiencies on the left. The laboratory director must sign, date and return the completed
CMS-2567 documented with a credible allegation of compliance to our office WITHIN 10
DAYS FROM RECEIPT of this notice. You must also submit documented evidence that verifies
that the corrections were made. Your allegation of compliance will be subject to disclosure to the
public upon request.

A credible allegation of compliance is a statement or documentation that is:

1) Made by a representative of a laboratory with a history of having maintained a


commitment to compliance and taking corrective action when required;

2) Realistic in terms of the possibility of the corrective action being accomplished


between the date of the survey and the date of the allegation; and
3) Indicates resolution of the problems.
For your information, acceptable evidence of correction must include:

1) Documentation showing what corrective action(s) have been taken for patients
found to have been affected by the deficient practice;

2) How the laboratory has identified other patients having the potential to be affected by
the same deficient practice and what corrective action(s) has been taken;

3) What measure has been put into place or what systemic changes you have made to
ensure that the deficient practice does not recur, and

4) How the corrective action(s) are being monitored to ensure the deficient practice does
not recur.

CLIA regulations at 42 C.F.R. § 493.1838 allow a laboratory at the first occurrence of


unsuccessful PT performance to undertake training of its personnel, or obtain necessary technical
assistance, or both, if appropriate to the circumstances. If your laboratory determines that
training/technical assistance is the appropriate corrective action, evidence must be submitted to
document that the training and/or technical assistance have been undertaken and were effective
in correcting the problems that caused the unsuccessful PT performance. In particular, the
evidence must include documentation that your laboratory has taken action to correct actual or
potential patient outcome during the period of PT failure. See the requirements for acceptable
evidence of correction above.

If you do not submit a credible allegation of compliance and acceptable evidence of correction,
or if you submit an allegation of compliance that is determined to be credible but are found to be
out of compliance with the CLIA Condition of successful participation in PT at the time of the
next on-site survey, the [STATE AGENCY NAME] will recommend to the [RO NAME]
Regional Office of the Centers for Medicare & Medicaid Services (CMS) that sanctions be taken
against your laboratory's CLIA certificate. These may include alternative sanctions (Civil Money
Penalty of up to $3,000 per day of noncompliance or per violation per 42 C.F.R. § 493.1834,
Directed Plan of Correction per 42 C.F.R. § 493.1832, State Onsite Monitoring per 42 C.F.R. §
493.1836) and principal sanctions (suspension, limitation and/or revocation of your laboratory's
CLIA certificate and cancellation of you laboratory's approval for Medicare payments per 42
C.F.R. § 493.1814).

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[NAME, TITLE]
[STATE AGENCY NAME]

Enclosure: CMS-2567, Statement of Deficiencies


19 SA (4/20/07) – PT desk review 1st unsuccessful – AOC credible

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: ALLEGATION OF COMPLIANCE CREDIBLE AND EVIDENCE OF CORRECTION


ACCEPTABLE

Dear Director/Owner(s):

By letter dated [DATE OF LETTER], the [STATE AGENCY NAME] notified you that your
laboratory was not in compliance with the Conditions of successful participation in proficiency
testing (PT) and Laboratory Director based on unsatisfactory performance in PT for [NAME OF
ANALYET/SPECIALTY/SUBSPECIALTY] for the testing events [LIST PT EVENTS]. In
the letter, we requested that you submit a credible allegation of compliance and acceptance
evidence of correction. We received your response on [SUBMISSION DATE], and have
determined that your allegation of compliance is credible and evidence of correction is
acceptable.

We caution your laboratory to maintain compliance with all CLIA requirements for proficiency
testing. If it is discovered that your allegation of compliance was not implemented or that
compliance was not maintained, the [STATE AGENCY NAME] will refer the case to the
Regional Office of the Centers for Medicare & Medicaid Services (CMS) for appropriate action,
and recommend that sanctions be taken against your laboratory's CLIA certificate.

Any future proficiency testing failure that results in a subsequent occurrence of unsuccessful
participation in proficiency testing will be basis for such referral to the CMS Regional Office to
initiate sanction actions against your laboratory’s CLIA certificate. These sanctions may include
alternative sanctions of a Directed Plan of Correction, Civil Money Penalty and suspension of the
laboratory’s approval to receive Medicare payments as well as principal sanctions of suspension,
limitation or revocation of your laboratory’s CLIA certificate and cancellation of the laboratory’s
approval to receive Medicare payments.
If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[SURVEYOR NAME], [TITLE]


[STATE AGENCY NAME]
20 SA (4/20/07) – SA PT desk review 1st unsuccessful – AOC not credible, second chance to submit
credible AOC

IMPORTANT NOTICE – ACTION NECESSARY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: ALLEGATION OF COMPLIANCE NOT CREDIBLE/EVIDENCE OF CORRECTION


UNACCEPTABLE

Dear Director/Owner(s):

You were notified by our letter dated [DATE OF AOC REQUEST LETTER] of your
laboratory’s failure to meet the CLIA requirements for successful participation in PT and
Laboratory Director. We requested you submit a credible allegation of compliance and
acceptable evidence of correction within ten days of receipt of our notification letter and Form
CMS-2567, Statement of Deficiencies. You were advised that a credible allegation of
compliance is a statement or documentation that is:

1) Made by a representative of a laboratory with a history of having maintained a


commitment to compliance and taking corrective action when required;

2) Realistic in terms of the possibility of the corrective action being accomplished


between the date of the survey and the date of the allegation; and

3) Indicates resolution of the problems.

You were also advised that acceptable evidence of correction must include:

1) Documentation showing what corrective action(s) have been taken for patients
found to have been affected by the deficient practice;

2) How the laboratory has identified other patients having the potential to be affected by
the same deficient practice and what corrective action(s) has been taken;
3) What measure has been put into place or what systemic changes you have made to
ensure that the deficient practice does not recur, and

4) How the corrective action(s) are being monitored to ensure the deficient practice does
not recur.

We received your response on [DATE]. We have reviewed your submission and find that your
laboratory remains out of compliance with the CLIA Conditions of successful PT participation
and Laboratory Director. The submission does not constitute a credible allegation of
compliance and acceptable evidence of correction for the following reasons:

[EXPLAIN WHY AOC/EVIDENCE OF CORRECTION UNACCEPTABLE. FOR


EXAMPLE: Your laboratory did not submit evidence that it has corrected actual or potential
patient outcome during the period of PT failure.]

You are reminded that if you do not submit a credible allegation of compliance and acceptable
evidence of correction, or if you submit an allegation of compliance that is determined to be
credible but are found to be out of compliance with the requirement for successful participation
in PT at the time of the next on-site survey, the [STATE AGENCY NAME] will recommend to
the [RO NAME] Regional Office of the Centers for Medicare & Medicaid Services (CMS) that
sanctions be taken against your laboratory's CLIA certificate. As you were previously advised,
these may include alternative sanctions (Civil Money Penalty of up to $3,000 per day of non-
compliance or per violation per 42 C.F.R. § 493.1834, Directed Plan of Correction per 42 C.F.R.
§ 493.1832, State Onsite Monitoring per 42 C.F.R. § 493.1836) and principal sanctions
(suspension, limitation and/or revocation of your laboratory's CLIA certificate and cancellation
of you laboratory's approval for Medicare payments per 42 C.F.R. § 493.1814).

We are giving you another opportunity to submit a credible allegation of compliance and
acceptable evidence of correction for the cited deficiencies. You must respond WITHIN 10
DAYS from receipt of this notice.

If we do not hear from you, or if we do not receive from you a credible allegation of compliance
and acceptable evidence of correction WITHIN 10 DAYS from receipt of this notice, we will
forward your case to the CMS Regional Office with recommendations for sanction action against
your laboratory’s CLIA certificate. Once your case has been referred, the CMS Regional Office
has the final authority for any sanction actions to be imposed and will inform you of its
determination and the appeals procedures.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[NAME, TITLE]
[STATE AGENCY NAME]
21 SA – PT desk review 1st unsuccessful – no AOC or AOC not credible, refer to CMS RO for sanction
action

IMPORTANT NOTICE – PLEASE READ CAREFULLY

VIA FACSIMILE TO XXX XXX-XXXX AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: REFERRAL TO CMS FOR SANCTION ACTION

Dear Dr. [DIRECTOR NAME]:

[USE THE FOLLOWING PARAGRAPH IF NO AOC SUBMITTED:

On [DATE] a letter was sent to you from the [STATE AGENCY NAME] requesting that you
reply on Form CMS-2567, Statement of Deficiencies, in the “Provider Plan of Correction”
column with a credible allegation of compliance for unsuccessful proficiency testing and submit
evidence of corrective actions. Subsequent to that letter, the [STATE AGENCY NAME] sent
another notice via certified mail again requesting that your laboratory provide a credible
allegation of compliance and evidence of corrective actions for the unsuccessful proficiency
testing by no later than ten (10) calendar days after receipt. You were advised in the letters that
failure to come into compliance would result in our office referring your case to the Centers for
Medicare & Medicaid Services (CMS) with recommendations for sanction action. As of this
date, this office has not received any response from your laboratory to address your failure to
meet the CLIA Condition of successful participation in proficiency testing. ]

[USE THE FOLLOWING PARAGRAPH IF AOC CONTINUES TO BE NOT


CREDIBLE:

You were notified by letter dated [NOTICE DATE] that your laboratory’s allegation of
compliance was not credible and evidence of correction was not acceptable, and that your
laboratory remains out of compliance with the CLIA Conditions of successful participation in
proficiency testing and Laboratory Director. You were reminded in the same letter that failure to
come into compliance would result in our office referring your case to the Regional Office of the
Centers for Medicare & Medicaid Services (CMS) with recommendations for sanction action.
You were given another opportunity to submit a credible allegation of compliance and
acceptable evidence of correction within10 days. The 10-day time frame has passed, and we have
not received such evidence of correction. [OR: We received a second submission from your
laboratory and again found it to be unacceptable for the following reasons: GIVE REASONS. ]

Accordingly, we are forwarding your file to the CMS Regional Office to initiate sanction actions.
The CMS Regional Office will be notifying you in writing regarding its determination to impose
sanctions against your laboratory's CLIA certificate and will inform you of your laboratory’s
appeal rights.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[NAME, TITLE]
[STATE AGENCY NAME]

cc: CMS Regional Office


22 SA (4/20/07) – PT – survey finds 1st unsuccessful – AOC request, language for 1) unsuccessful
participation in PT only; and 2) other Condition(s) out in addition to unsuccessful participation in PT

IMPORTANT NOTICE – ACTION NECESSARY

VIA FACSIMILE TO [XXX XXX-XXXX] AND FIRST CLASS MAIL. (CONFIRMATION OF


SUCCESSFUL TRANSMISSION OF FACSIMILE CONSTITUTES PROOF OF RECEIPT)

[TODAY'S DATE]

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

CLIA # [CLIA NUMBER]


[OPTIONAL: State I.D. # [STATE ID NUMBER]

RE: CONDITIONS OUT – UNSUCCESSFUL PARTICIPATION IN PROFICIENCY


TESTING

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. § 263a)
and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations require
onsite surveys to determine whether or not a laboratory is in compliance with the applicable
regulations. Compliance with these regulations is a condition of certification for the CLIA
program.

[OPTION 1 – 1ST UNSUCCESSFUL ONLY ISSUE CAUSING CONDITIONS OUT:

The [STATE AGENCY NAME] conducted [CHOOSE SURVEY TYPE: an initial, a routine
recertification, a complaint] survey of your laboratory that was completed on [SURVEY
DATE]. [ADD THE FOLLOWING SENTENCE WHEN APPROPRIATE: Please note that
this routine survey was expedited because your laboratory's CLIA certificate has expired or is
about to expire.] As a result of the survey, it was determined that there was unsatisfactory
performance in proficiency testing (PT) for the events listed below:

PT Provider Testing Event Analyte/specialty/subspecialty Score

[LIST UNSATISFACTORY EVENTS]

The CLIA regulations at 493.2 defines unsuccessful PT performance as failure to attain the
minimum satisfactory score for an analyte, test, subspecialty or specialty for two consecutive or
two out of three consecutive testing events. Based on the PT failures listed above, your facility is
not in compliance with the Conditions of successful participation in PT and Laboratory Director:
[DELETE DIRECTOR CONDITION THAT DOES NOT APPLY.]

D2016 - 42 C.F.R. § 493.803 Condition: Successful participation [proficiency testing]


D6000 - 42 C.F.R. § 493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director;
D6076 - 42 C.F.R. § 493.1441 Condition: Laboratories performing high complexity testing;
laboratory director.

In addition, other standards were also found to be not met. Enclosed is Form CMS-2567,
Statement of Deficiencies, listing all the deficiencies found during the survey. ]

[OPTION 2 – OTHER CONDITIONS OUT IN ADDITION TO 1ST UNSUCCESSFUL:

The [STATE AGENCY NAME] conducted [CHOOSE SURVEY TYPE: an initial, a routine
recertification, a complaint] survey of your laboratory that was completed on [SURVEY
DATE]. [ADD THE FOLLOWING SENTENCE WHEN APPROPRIATE: Please note that
this routine survey was expedited because your laboratory's CLIA certificate has expired or is
about to expire.] As a result of the survey, it was determined that your facility is not in
compliance with all of the Conditions required for certification in the CLIA program, including
the Condition of successful participation in proficiency testing (PT). Specifically, the following
Conditions were not met: [DELETE CONDITIONS THAT DO NOT APPLY.]

D2000 - 42 C.F.R. § 493.801 Condition: Enrollment and testing of [proficiency testing]


samples;
D2016 - 42 C.F.R. § 493.803 Condition: Successful participation [proficiency testing]
D3000 - 42 C.F.R. § 493.1101 Condition: Facility Administration
D5002 - 42 C.F.R. § 493.1201 Condition: Bacteriology ;
D5004 - 42 C.F.R. § 493.1202 Condition: Mycobacteriology;
D5006 - 42 C.F.R. § 493.1203 Condition: Mycology;
D5008 - 42 C.F.R. § 493.1204 Condition: Parasitology;
D5010 - 42 C.F.R. § 493.1205 Condition: Virology;
D5012 - 42 C.F.R. § 493.1207 Condition: Syphilis serology;
D5014 - 42 C.F.R. § 493.1208 Condition: General immunology;
D5016 - 42 C.F.R. § 493.1210 Condition: Routine chemistry;
D5018 - 42 C.F.R. § 493.1211 Condition: Urinalysis;
D5020 - 42 C.F.R. § 493.1212 Condition: Endocrinology;
D5022 - 42 C.F.R. § 493.1213 Condition: Toxicology;
D5024 - 42 C.F.R. § 493.1215 Condition: Hematology;
D5026 - 42 C.F.R. § 493.1217 Condition: Immunohematology;
D5028 - 42 C.F.R. § 493.1219 Condition: Histopathology;
D5030 - 42 C.F.R. § 493.1220 Condition: Oral pathology;
D5032 - 42 C.F.R. § 493.1221 Condition: Cytology;
D5034 - 42 C.F.R. § 493.1225 Condition: Clinical cytogenetics;
D5040 - 42 C.F.R. § 493.1226 Condition: Radiobioassay;
D5042 - 42 C.F.R. § 493.1227 Condition: Histocompatibility;
D5200 - 42 C.F.R. § 493.1230 Condition: General laboratory systems;
D5300 - 42 C.F.R. § 493.1240 Condition: Preanalytic systems;
D5400 - 42 C.F.R. § 493.1250 Condition: Analytic systems;
D5800 - 42 C.F.R. § 493.1290 Condition: Postanalytic systems;
D5980 - 42 C.F.R. § 493.1355 Condition: Laboratories performing PPM procedures;
laboratory director;
D5990 - 42 C.F.R. § 493.1355 Condition: Laboratories performing PPM procedures;
testing personnel;
D6000 - 42 C.F.R. § 493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director;
D6033 - 42 C.F.R. § 493.1409 Condition: Laboratories performing moderate complexity
testing; technical consultant;
D6056 - 42 C.F.R. § 493.1415 Condition: Laboratories performing moderate complexity
testing; clinical consultant;
D6063 - 42 C.F.R. § 493.1421 Condition: Laboratories performing moderate complexity
testing; testing personnel;
D6076 - 42 C.F.R. § 493.1441 Condition: Laboratories performing high complexity testing;
laboratory director;
D6108 - 42 C.F.R. § 493.1447 Condition: Laboratories performing high complexity testing;
technical supervisor;
D6134 - 42 C.F.R. § 493.1453 Condition: Laboratories performing high complexity testing;
clinical consultant;
D6141 - 42 C.F.R. § 493.1459 Condition: Laboratories performing high complexity testing;
general supervisor;
D6153 - 42 C.F.R. § 493.1467 Condition: Laboratories performing high complexity testing;
cytology general supervisor
D6162 - 42 C.F.R. § 493.1481 Condition: Laboratories performing high complexity testing;
cytotechnologist;
D6168 - 42 C.F.R. § 493.1487 Condition: Laboratories performing high complexity testing;
testing personnel;
D8100 - 42 C.F.R. § 493.1771 Condition: Inspection requirements applicable to all CLIA-
certified and CLIA-exempt laboratories.

In addition, other standards were also found to be not met. Enclosed is Form CMS-2567,
Statement of Deficiencies, listing all the deficiencies found during the survey.

The CLIA regulations at 42 C.F.R. § 493.2 defines unsuccessful PT performance as failure to


attain the minimum satisfactory score for an analyte, test, subspecialty or specialty for two
consecutive or two out of three consecutive testing events. Based on the survey findings, your
laboratory is not in compliance with the Condition of successful participation in proficiency
testing (PT) based on unsatisfactory performance in proficiency testing (PT) for the events listed
below:

PT Provider Testing Event Analyte/specialty/subspecialty Score

[LIST UNSATISFACTORY EVENTS]

[USE THE FOLLOWING FOR BOTH OPTIONS:

Laboratories that do not meet the Condition-level requirements of CLIA may not be certified to
perform laboratory testing under the CLIA program. You must take steps to bring any unmet
Conditions into compliance immediately.
You are directed to submit a credible allegation of compliance and acceptable evidence of
correction for the deficiencies cited. Please document your allegation of compliance using the
enclosed CMS-2567, Statement of Deficiencies, in the columns labeled “Provider Plan of
Correction” and “Completion Date” located on the right side of the form, keying your responses
to the deficiencies on the left. The laboratory director must sign, date and return the completed
CMS-2567 documented with a credible allegation of compliance to our office WITHIN 10
DAYS FROM RECEIPT of this notice. You must also submit documented evidence that verifies
that the corrections were made. We may conduct a follow-up onsite survey in approximately 30-
45 days to verify the corrections if we find your allegation of compliance to be credible and the
submitted evidence to be acceptable. If your laboratory does not submit a credible allegation of
compliance and acceptable evidence of correction, we will not conduct a follow-up survey.
(Your allegation of compliance will be included in the public record of the inspection.)

A credible allegation of compliance is a statement or documentation that is:

1) Made by a representative of a laboratory with a history of having maintained a


commitment to compliance and taking corrective action when required;

2) Realistic in terms of the possibility of the corrective action being accomplished


between the date of the survey and the date of the allegation; and
3) Indicates resolution of the problems.

For your information, acceptable evidence of correction must include:

1) Documentation showing what corrective action(s) have been taken for patients
found to have been affected by the deficient practice;

2) How the laboratory has identified other patients having the potential to be affected by
the same deficient practice and what corrective action(s) has been taken;

3) What measure has been put into place or what systemic changes you have made to
ensure that the deficient practice does not recur, and

4) How the corrective action(s) are being monitored to ensure the deficient practice does
not recur.

CLIA regulations at 42 C.F.R. § 493.1838 allow a laboratory at the first occurrence of


unsuccessful PT performance to undertake training of its personnel, or obtain necessary technical
assistance, or both, if appropriate to the circumstances. If your laboratory determines that
training/technical assistance is the appropriate corrective action, evidence must be submitted to
document that the training and/or technical assistance have been undertaken and were effective
in correcting the problems that caused the unsuccessful PT performance. In particular, the
evidence must include documentation that your laboratory has taken action to correct actual or
potential patient outcome during the period of PT failure. See the requirements for acceptable
evidence of correction above.
If you do not submit a credible allegation of compliance and acceptable evidence of correction,
or if you submit an allegation of compliance that is determined to be credible but are found to be
still out of compliance with any CLIA Condition-level requirements at the time of the follow-up
visit, the [STATE AGENCY NAME] will recommend to the [RO NAME] Regional Office of
the Centers for Medicare & Medicaid Services (CMS) that sanctions be taken against your
laboratory's CLIA certificate. These may include alternative sanctions (Civil Money Penalty of
up to $3,000 per day of noncompliance or per violation per 42 C.F.R. § 493.1834, Directed Plan
of Correction per 42 C.F.R. § 493.1832, State Onsite Monitoring per 42 C.F.R. § 493.1836) and
principal sanctions (suspension, limitation and/or revocation of your laboratory's CLIA
certificate and cancellation of you laboratory's approval for Medicare payments per 42 C.F.R. §
493.1814).

Please note that the routine survey takes an overview of the laboratory through random sampling.
By its nature, the routine survey may not find every violation that the laboratory may have
committed. It remains the responsibility of the laboratory and its director to ensure that the
laboratory is at all times following all CLIA requirements, to identify any problems in the
laboratory and take corrective action specific to the problems, and to institute appropriate quality
assessment measures to ensure that the deficient practices do not recur.

In addition to the routine CLIA certification surveys, announced or unannounced investigations/


surveys may be conducted by the [STATE AGENCY NAME] at any time to address complaints
or other non-compliance issues. These investigations/surveys may well identify violations that
may not have surfaced during a routine survey using random sampling, but for which the
laboratory and its director will still be held responsible.

If you have questions regarding this letter, please contact me at [PHONE #].

Sincerely,

[NAME, TITLE]
[STATE AGENCY NAME]

Enclosure: CMS-2567, Statement of Deficiencies


01 RO (5/16/07) – Terminate CLIA certificate – failed to meet state requirements

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA number: [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: TERMINATION OF CLIA NUMBER – CEASE ALL PATIENT LABORATORY TESTING


IMMEDIATELY

Dear Director and Owner(s):

CLIA records show that the above CLIA number was issued to [LABORATORY NAME]
effective [DATE] based on a signed application dated [DATE]. We have determined this CLIA
number was issued to [LABORATORY NAME] in error as it has failed to meet all necessary
requirements.

CLIA regulations at 42 C.F.R. § 493.1101(c) require that a laboratory be in compliance with


applicable Federal, State and local laboratory requirements. [NAME OF STATE] law requires
that in order to legally perform any testing on [NAME OF STATE] patient specimens, a
laboratory must be licensed under the State’s laboratory licensure program.

Medicare records indicate that your laboratory is performing and billing for patient testing. We
have also been informed by the [STATE] State agency that [LABORATORY NAME] is not
licensed in [NAME OF STATE] to perform patient testing.

Accordingly, CMS is taking action to terminate your laboratory's CLIA certification.


[LABORATORY NAME] is directed to cease all patient laboratory testing immediately. You
are also directed to return to the [NAME] Regional Office at the address below the CLIA
certificate that was issued erroneously for the period [BEGIN DATE TO END DATE OF
CLIA CERTIFICATE].

In order to resume testing, your laboratory must reapply for a CLIA certificate when it can show
evidence that it has met the necessary State licensure requirements. Your laboratory must pay the
appropriate CLIA fees and be surveyed for compliance with all CLIA requirements prior to
resuming patient testing.

You are advised that under 42 U.S.C. § 263a(l), any person who intentionally violates the
requirements of CLIA or its regulations shall be imprisoned or fined, or both.
If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[PHONE NUMBER].
Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]
cc: [STATE AGENCY NAME]
02 RO (5/16/07) – Terminate CLIA certificate – lab not operational

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA number: [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: TERMINATION OF CLIA NUMBER – LABORATORY NOT OPERATIONAL

Dear Director and Owner(s):

CLIA records show that the above CLIA number was issued to [LABORATORY NAME]
effective [DATE] for the period [BEGIN DATE TO END DATE OF CLIA CERTIFICATE].

We have received information that [LABORATORY NAME] is no longer operating in the


location at [ADDRESS OF LABORATORY]. We called the telephone number of record and
were advised that it was not the number for [LABORATORY NAME]. Our records do not
indicate that your laboratory has reported a change of address.

As evidence indicates that your laboratory is no longer operational, this letter serves as advance
notice that we will take action on [DATE OF THIS NOTICE + 10 DAYS] to terminate
[LABORATORY NAME]’s CLIA certificate. If we do not hear from you by then, we will
terminate your laboratory’s CLIA certificate effective [DATE], [CHOOSE AS
APPROPRIATE: the date we were informed that the laboratory vacated the above location OR
the date of application (FOR LABORATORIES THAT HAVE NOT HAD AN INITIAL
SURVEY)]. You are also directed to return to the [NAME OF RO] Regional Office, at the
address below, the CLIA certificate of [CERTIFICATE TYPE] that was issued for the period
[BEGIN DATE TO END DATE OF CLIA CERTIFICATE].

Once your laboratory’s CLIA certificate is terminated, your laboratory may no longer perform
CLIA laboratory testing, including waived and provider performed microscopy testing. Please be
advised that no person may perform laboratory examinations or other procedures on materials
derived from the human body unless there is in effect a certificate issued by the Secretary of the
Health and Human Services applicable to the category of examinations or procedures which
includes such examination or procedure. See 42 U.S.C. § 263a(b). Please also be advised that any
person who intentionally violates the mandates of CLIA shall be subject to imprisonment, or fines,
or both. See 42 U.S.C. § 263(a)(l).
If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[PHONE NUMBER].
Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]
cc: [STATE AGENCY NAME]
03 RO (5/16/07) – Denial of CLIA Application – gives appeal rights of reconsideration for
prospective laboratory

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA number: [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: DENIAL OF APPLICATION FOR CLIA CERTIFICATION

Dear Director and Owner(s):

Our agent at the [STATE AGENCY NAME] (State agency) has referred your application for CLIA
certification to our office with recommendations to deny the application. [STATE REASON FOR
DENIAL. EXAMPLES:

The owner, operator or director previously owned, operated or directed another laboratory which
was revoked within the last two years.

The director does not meet the qualification requirements as specified in the CLIA regulations at
42 C.F.R. § 493._____ for [CHOOSE ONE: moderate, high] complexity testing.

The laboratory has not met the prerequisite state licensure requirements for the state of
__________.

The owner, operator or director has a prior history of non-compliance. [GIVE DETAILS.]

Your laboratory is located in the same location as [NAME OF REVOKED LABORATORY], a


laboratory whose CLIA certificate was revoked by the Centers for Medicare & Medicaid
Services (CMS) effective [REVOCATION DATE]. Evidence submitted indicates that this was
a change of ownership for the revoked laboratory.

.
We have reviewed the case and concur with the State agency’s recommendation to deny your CLIA
application. [ADD THE FOLOWING FOR THE LAST EXAMPLE: CLIA policy dictates that
when a change of ownership occurs, the existing CLIA number should be assigned automatically to
the new owner. In this instance, [NAME OF APPLICANT LABORATORY] must assume
[NAME OF REVOKED LABORATORY]'s CLIA number. However, as [NAME OF REVOKED
LABORATORY]'s CLIA certificate has been revoked, [NAME OF APPLICANT
LABORATORY] would not be able to operate under a CLIA number that has been revoked. We are
therefore denying your application for a CLIA certificate.]

[GIVE APPEAL RIGHTS FOR PROSPECTIVE LABORATORY AS FOLLOWS:]


If you do not believe this determination to deny your application for a CLIA certificate is correct,
you may request a reconsideration with CMS in accordance with 42 Code of Federal Regulations §
498.22. A written request for reconsideration must be filed no later than sixty days after the date this
letter is received. The date of receipt will be presumed to be 5 days after the date of this notice unless
there is showing that it was, in fact, received earlier or later. Such a request may be made to:

[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

The request for reconsideration must state the issues, or the findings of fact with which you disagree
and the reason for disagreement. You may submit any written evidence and statements that are
relevant and material to the matters at issue.

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[PHONE NUMBER].
Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]
cc: [STATE AGENCY NAME]
04 RO (5/16/07) – Loss of Accreditation – notifies lab of CLIA certificate status

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY’S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA number: [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: LOSS OF ACCREDITATION FROM [NAME OF AO]

Dear Director and Owner(s):

The [NAME OF AO] has advised us by letter dated [AO NOTICE DATE] that it has made the
determination to [CHOOSE ONE: deny, revoke, withdraw] accreditation for [NAME OF
LABORATORY] effective [LOSS OF ACCREDITATION DATE]. [NAME OF AO]’s
decision to [CHOOSE ONE: deny, revoke, withdraw] the laboratory’s accreditation was based
on [GIVE REASONS].

Laboratories with a CLIA certificate of accreditation, such as [NAME OF LABORATORY],


must be accredited by a CMS approved accrediting organization for all laboratory services
provided. As a result of the loss of accreditation from [NAME OF AO], [NAME OF
LABORATORY] is no longer deemed to meet the CLIA requirements. In addition, the CLIA
certificate of accreditation issued to the laboratory for the period [BEGIN DATE TO END
DATE OF CERTIFICATE] is no longer applicable.

CLIA regulations at 42 C.F.R. § 493.551(c) permit the laboratory to retain its certificate of
accreditation for 45 days after the laboratory receives notice of the withdrawal or revocation of
the accreditation, or the effective date of any action taken by the Centers for Medicare &
Medicaid Services (CMS), whichever is earlier. Accordingly, your laboratory may retain its
certificate of accreditation until no later than 45 days after [LOSS OF ACCREDITATION
DATE], or until [LOSS OF ACCREDITATION DATE + 45 CALENDAR DAYS].

Your laboratory is reminded that no person may perform laboratory examinations or other
procedures on materials derived from the human body unless there is in effect a certificate issued by
the Secretary of the Health and Human Services applicable to the category of examinations or
procedures which includes such examination or procedure. (See 42 U.S.C. § 263a (b)). Any person
who intentionally violates CLIA requirements is subject to sanctions, including imprisonment, fines,
or both. (42 U.S.C. § 263(a)(l)).

Based on the history of non-compliance with [NAME OF AO], it is necessary for our agents at
the [STATE AGENCY NAME] to conduct a survey of [NAME OF LABORATORY] to
determine whether your laboratory is in compliance with all CLIA requirements. To facilitate the
process and avoid any gap in certification, we recommend your laboratory apply for a certificate
of compliance and remit the applicable CLIA fees as soon as possible. To apply for a CLIA
certificate of compliance, please contact the State agency at:

[STATE AGENCY NAME


SA ADDRESS
SA PHONE NUMBER]

If compliance cannot be determined or an application for a CLIA certificate of compliance is not


received by [LOSS OF ACCREDITATION DATE + 45 CALENDAR DAYS], we may take
action to suspend and/or revoke your laboratory’s CLIA certificate of accreditation and, if
applicable, cancel Medicare payment for tests performed. (42 C.F.R. § 493.61(c)). [ADD THIS
SENTENCE IF A HOSPITAL LABORATORY: If the laboratory’s CLIA certificate is
revoked, [NAME OF HOSPITAL]’s eligibility to participate in the Medicare program as a
provider of hospital services may also be affected since the Condition of Participation related to
Laboratory Services at 42 C.F.R. § 482.27 will no longer be met.] Should this action be
necessary, we will notify you at the time of action and provide your laboratory with an
explanation of your appeal rights.

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[PHONE NUMBER].

Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

cc: [HOSPITAL ADMINISTRATIVE, IF APPLICABLE]

[NAME OF AO]

[STATE AGENCY NAME]

[CMS CO]
05 RO (5/16/07) – testing without a valid CLIA certificate – notice to cease/desist from testing

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY’S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[NAME]
[ADDRESS] CLIA number: NONE
[CITY], [STATE] [ZIP]

RE: TESTING WITHOUT A CLIA CERTIFICATE

Dear [NAME]:

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), it must comply with all CLIA requirements. These requirements
are found in section 353 of the Public Health Service Act (42 U.S.C. § 263a) and in Title 42
Code of Federal Regulations, Part 493 (42 C.F.R. Part 493). Compliance with these regulations
is a condition of certification for the CLIA program.

It has come to our attention that you have been performing laboratory testing without a valid
CLIA certificate.

Please be advised that no person may perform laboratory examinations or other procedures on
materials derived from the human body unless there is in effect a certificate issued by the Secretary
of the Health and Human Services applicable to the category of examinations or procedures which
includes such examination or procedure. See 42 U.S.C. § 263a(b). It is illegal for any facility to
perform patient testing, including waived and provider performed microscopy testing, without
appropriate CLIA certification. Please be advised that any person who intentionally violates the
mandates of CLIA shall be subject to imprisonment, or fines, or both. See 42 U.S.C. § 263(a)(l).

You are hereby directed to cease all patient laboratory testing including waived and provider
performed microscopy testing. In order to resume testing, you must first apply for and be issued a
valid CLIA certificate. To apply for CLIA certification, please contact our agents at

[STATE AGENCY NAME


SA ADDRESS
SA PHONE NUMBER]
If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[PHONE NUMBER].
Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]
cc: [STATE AGENCY NAME]
06 RO (5/16/07) – LBA Cease & Desist Letter – RO notifies facility to cease LBA testing till CLIA
certified

IMPORTANT NOTICE – ACTION NECESSARY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)

[NAME] CLIA number: NONE


[ADDRESS]
[CITY], [STATE] [ZIP]

RE: TESTING WITHOUT A CLIA CERTIFICATE

Dear [NAME]:

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), it must comply with all CLIA requirements. These requirements
are found in section 353 of the Public Health Service Act (42 U.S.C. § 263a) and in Title 42
Code of Federal Regulations, Part 493 (42 C.F.R. Part 493). Compliance with these regulations
is a condition of certification for the CLIA program.

It has come to our attention that your facility is performing [CHOOSE ONE: the laboratory test
“Live Blood Cell Analysis” OR an “Unestablished Laboratory Test”] without a CLIA certificate.

CLIA defines a laboratory as:

A facility for the biological, microbiological, serological, chemical, immuno-


hematological, hematological, biophysical, cytological, pathological, or other
examination of materials derived from the human body for the purpose of providing
information for the diagnosis, prevention, or treatment of any disease or impairment
of, or the assessment of health of, human beings. These examinations also include
procedures to determine, measure, or otherwise describe the presence or absence of
various substances or organisms in the body.

You are performing laboratory testing as defined by CLIA without the appropriate CLIA
certification. You are, therefore, in violation of CLIA and are performing laboratory testing
illegally.

Please be advised that no person may perform laboratory examinations or other procedures on
materials derived from the human body unless there is in effect a certificate issued by the
Secretary applicable to the category of examinations or procedures which includes such
examination or procedure. See 42 U.S.C. § 263a(b). Therefore, YOU ARE REQUIRED TO
CEASE ALL CLIA LABORATORY TESTING IMMEDIATELY. See 42 U.S.C. § 263a(l).
Please be advised that any person who intentionally violates this mandate of CLIA shall be
subject to imprisonment, or fines, or both. See 42 U.S.C. § 263a(l).
[CHOOSE ONE: Live Blood Cell Analysis OR The Unestablished Laboratory Test] is
categorized by default as a high complexity laboratory test. 42 C.F.R. 493 Subpart C identifies
the requirements for applying for and receiving a CLIA certificate of compliance. Please pay
particular attention to 42 C.F.R. § 493.43(c) for application requirements. If you elect to apply
for CLIA certification, a CLIA application may be obtained from:

[STATE AGENCY NAME


SA ADDRESS
SA PHONE NUMBER]

Unless an application is received and approved, and a CLIA registration certificate is issued to
your facility, you may not perform any laboratory testing. We reiterate that it is illegal for you to
perform any laboratory testing as you are not CLIA certified.

If you elect to permanently cease all patient laboratory testing, we are enclosing an attestation
for your completion and signature. Please complete, sign and return by [DATE OF NOTICE
+ 10 CALENDAR DAYS] to this office at:

Centers for Medicare & Medicaid Services


CLIA Program
[RO ADDRESS]
Attention: [STAFF NAME]

If we do not receive a notarized copy of the enclosed attestation or you fail to cease all laboratory
testing and fail to obtain appropriate CLIA certification, pursuant to 42 C.F.R. § 493.1840(a)(2)
and § 493.1840(a)(6), we will refer your case to the United States Department of Health and
Human Services’ Office of Inspector General for investigation and criminal prosecution. In the
future, if you are found to be in violation of CLIA, you may be subject to civil money penalties
of up to $3,000 per day of violation.

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[PHONE NUMBER].
Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

Enclosure: Attestation of Cease Testing

cc: [STATE AGENCY NAME]


Centers for Medicare & Medicaid Services
CLIA Program

ATTESTATION OF CEASE TESTING

By means of my signature on this attestation, I, [NAME], located at [ADDRESS], am attesting


to the fact that I have been notified by letter dated [NOTICE DATE] that since I do not possess
a valid CLIA certificate, it is illegal for me to perform any laboratory testing including Live
Blood Cell Analysis whether or not any fees are charged for the tests. I understand that any
person who intentionally violates this mandate of CLIA shall be subject to imprisonment,
or fines, or both. See 42 U.S.C. § 263a(l).

I am also attesting that all laboratory testing which includes microscopic examination of human
specimens ( [CHOOSE ONE: Live Blood Cell Analysis OR Unestablished Laboratory Test] )
has ceased as of the date of __________________________. I understand that if I am found
to be in violation of the above CLIA statute, I may be subject to a civil money penalty of up
to $3,000 per day of violation.

I understand that under section 353 of the Public Health Service Act, I may face imprisonment or
fines if convicted of intentionally violating CLIA requirements by conducting testing without a
valid CLIA certificate.

_________________________________________ ______________________________
Signature Date

___________________________________________
Name

___________________________________________
Name of Facility

___________________________________________
Address

___________________________________________
City, State, Zip

___________________________________________
Contact Telephone Number

NOTARIZATION REQUIRED
07 RO (5/16/07) – Federal survey – standards out - POC request

IMPORTANT NOTICE – ACTION NECESSARY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA number: [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: STANDARD-LEVEL DEFICIENCIES

Dear Director and Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. § 263a)
and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations require
onsite surveys to determine whether or not a laboratory is in compliance with the applicable
regulations. Compliance with these regulations is a condition of certification for the CLIA
program.

A representative from the Centers for Medicare & Medicaid Services (CMS), [RO NAME]
Regional Office conducted a [CHOOSE SURVEY TYPE: an initial, a routine recertification, a
complaint] survey of your laboratory that was completed on [SURVEY DATE]. Enclosed is
form CMS-2567, Statement of Deficiencies, listing the deficiencies found during the survey. The
deficiency statement references the CLIA regulations at 42 C.F.R. § 493.

You are required to respond within 10 days of receipt of this notice. Please indicate your
corrective actions on the right side of the form CMS-2567 in the column labeled "Provider Plan
of Correction", keying your responses to the deficiencies on the left. Additionally, indicate your
anticipated completion dates in the column labeled "Completion Date."

Please return the completed form CMS-2567, dated and signed by the director, within 10 days of
receipt of this notice.

Regulations at 42 C.F.R. § 493.1816 state that if a laboratory has deficiencies that are not at the
Condition level, the laboratory must submit a plan of correction that is acceptable to CMS in
content and time frames. Further, regulations at 42 C.F.R. § 493.1816 require all deficiencies to
be corrected within 12 months after the last day of the survey. Please note that depending on the
nature and seriousness of the deficiency, the acceptable time frame for correction may be less
than 12 months.

If your laboratory does not respond timely to this request, or if your laboratory submits a Plan of
Correction that is not acceptable in content and time frames, or if your laboratory does not
demonstrate compliance with all CLIA requirements by the specified completion date, we will
impose principal sanctions, i.e., suspension, limitation and/or revocation of your laboratory's CLIA
certificate and concurrent cancellation of your laboratory's approval for Medicare payments per 42
C.F.R. § 493.1816.

Your laboratory will also be required to provide acceptable evidence of correction for the cited
deficiencies. For your information, acceptable evidence of correction must include:

1) Documentation showing what corrective action(s) have been taken for patients
found to have been affected by the deficient practice;

2) How the laboratory has identified other patients having the potential to be affected by
the same deficient practice and what corrective action(s) has been taken;

3) What measure has been put into place or what systemic changes you have made to
ensure that the deficient practice does not recur, and

4) How the corrective action(s) are being monitored to ensure the deficient practice does
not recur.

Please note that the routine survey takes an overview of the laboratory through random sampling.
By its nature, the routine survey may not find every violation that the laboratory may have
committed. It remains the responsibility of the laboratory and its director to ensure that the
laboratory is at all times following all CLIA requirements, to identify any problems in the
laboratory and take corrective action specific to the problems, and to institute appropriate quality
assessment measures to ensure that the deficient practices do not recur.

In addition to the routine CLIA certification surveys, announced or unannounced investigations/


surveys may be conducted by CMS or its agent at any time to address complaints or other non-
compliance issues. These investigations/surveys may well identify violations that may not have
surfaced during a routine survey using random sampling, but for which the laboratory and its
director will still be held responsible.

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[PHONE NUMBER].
Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

Enclosure: CMS-2567, Statement of Deficiencies


08 RO (5/16/07) – Federal survey – Conditions out - AOC request

IMPORTANT NOTICE – ACTION NECESSARY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA number: [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: CONDITION-LEVEL DEFICIENCIES

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. § 263a)
and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations require
onsite surveys to determine whether or not a laboratory is in compliance with the applicable
regulations. Compliance with these regulations is a condition of certification for the CLIA
program.

A representative from the Centers for Medicare & Medicaid Services (CMS), [RO NAME]
Regional Office conducted [CHOOSE SURVEY TYPE: an initial, a routine recertification, a
complaint] survey of your laboratory that was completed on [SURVEY DATE]. As a result of
the survey, it was determined that your facility is not in compliance with all of the Conditions
required for certification in the CLIA program. Specifically, the following Conditions were not
met: [DELETE CONDITIONS THAT DO NOT APPLY.]

D2000 - 42 C.F.R. § 493.801 Condition: Enrollment and testing of [proficiency testing]


samples;
D2016 - 42 C.F.R. § 493.803 Condition: Successful participation [proficiency testing]
D3000 - 42 C.F.R. § 493.1101 Condition: Facility Administration
D5002 - 42 C.F.R. § 493.1201 Condition: Bacteriology ;
D5004 - 42 C.F.R. § 493.1202 Condition: Mycobacteriology;
D5006 - 42 C.F.R. § 493.1203 Condition: Mycology;
D5008 - 42 C.F.R. § 493.1204 Condition: Parasitology;
D5010 - 42 C.F.R. § 493.1205 Condition: Virology;
D5012 - 42 C.F.R. § 493.1207 Condition: Syphilis serology;
D5014 - 42 C.F.R. § 493.1208 Condition: General immunology;
D5016 - 42 C.F.R. § 493.1210 Condition: Routine chemistry;
D5018 - 42 C.F.R. § 493.1211 Condition: Urinalysis;
D5020 - 42 C.F.R. § 493.1212 Condition: Endocrinology;
D5022 - 42 C.F.R. § 493.1213 Condition: Toxicology;
D5024 - 42 C.F.R. § 493.1215 Condition: Hematology;
D5026 - 42 C.F.R. § 493.1217 Condition: Immunohematology;
D5028 - 42 C.F.R. § 493.1219 Condition: Histopathology;
D5030 - 42 C.F.R. § 493.1220 Condition: Oral pathology;
D5032 - 42 C.F.R. § 493.1221 Condition: Cytology;
D5034 - 42 C.F.R. § 493.1225 Condition: Clinical cytogenetics;
D5040 - 42 C.F.R. § 493.1226 Condition: Radiobioassay;
D5042 - 42 C.F.R. § 493.1227 Condition: Histocompatibility;
D5200 - 42 C.F.R. § 493.1230 Condition: General laboratory systems;
D5300 - 42 C.F.R. § 493.1240 Condition: Preanalytic systems;
D5400 - 42 C.F.R. § 493.1250 Condition: Analytic systems;
D5800 - 42 C.F.R. § 493.1290 Condition: Postanalytic systems;
D5980 - 42 C.F.R. § 493.1355 Condition: Laboratories performing PPM procedures;
laboratory director;
D5990 - 42 C.F.R. § 493.1355 Condition: Laboratories performing PPM procedures;
testing personnel;
D6000 - 42 C.F.R. § 493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director;
D6033 - 42 C.F.R. § 493.1409 Condition: Laboratories performing moderate complexity
testing; technical consultant;
D6056 - 42 C.F.R. § 493.1415 Condition: Laboratories performing moderate complexity
testing; clinical consultant;
D6063 - 42 C.F.R. § 493.1421 Condition: Laboratories performing moderate complexity
testing; testing personnel;
D6076 - 42 C.F.R. § 493.1441 Condition: Laboratories performing high complexity testing;
laboratory director;
D6108 - 42 C.F.R. § 493.1447 Condition: Laboratories performing high complexity testing;
technical supervisor;
D6134 - 42 C.F.R. § 493.1453 Condition: Laboratories performing high complexity testing;
clinical consultant;
D6141 - 42 C.F.R. § 493.1459 Condition: Laboratories performing high complexity testing;
general supervisor;
D6153 - 42 C.F.R. § 493.1467 Condition: Laboratories performing high complexity testing;
cytology general supervisor
D6162 - 42 C.F.R. § 493.1481 Condition: Laboratories performing high complexity testing;
cytotechnologist;
D6168 - 42 C.F.R. § 493.1487 Condition: Laboratories performing high complexity testing;
testing personnel;
D8100 - 42 C.F.R. § 493.1771 Condition: Inspection requirements applicable to all CLIA-
certified and CLIA-exempt laboratories.

In addition, other standards were also found to be not met. Enclosed is Form CMS-2567,
Statement of Deficiencies, listing all the deficiencies found during the survey.

Laboratories that do not meet the Condition-level requirements of CLIA may not be certified to
perform laboratory testing under the CLIA program. You must take steps to bring any unmet
Conditions into compliance immediately.

You are directed to submit a credible allegation of compliance and acceptable evidence of
correction for the deficiencies cited. Please document your allegation of compliance using the
enclosed CMS-2567, Statement of Deficiencies, in the columns labeled “Provider Plan of
Correction” and “Completion Date” located on the right side of the form, keying your responses
to the deficiencies on the left. The laboratory director must sign, date and return the completed
CMS-2567 documented with a credible allegation of compliance to our office WITHIN 10
DAYS FROM RECEIPT of this notice. You must also submit documented evidence that verifies
that the corrections were made. We may conduct a follow-up onsite survey in approximately 30-
45 days to verify the corrections if we find your allegation of compliance to be credible and the
submitted evidence to be acceptable. If your laboratory does not submit a credible allegation of
compliance and acceptable evidence of correction, we will not conduct a follow-up survey.
(Your allegation of compliance will be included in the public record of the inspection.)

A credible allegation of compliance is a statement or documentation that is:

1) Made by a representative of a laboratory with a history of having maintained a


commitment to compliance and taking corrective action when required;

2) Realistic in terms of the possibility of the corrective action being accomplished


between the date of the survey and the date of the allegation; and

3) Indicates resolution of the problems.

For your information, acceptable evidence of correction must include:

1) Documentation showing what corrective action(s) have been taken for patients
found to have been affected by the deficient practice;

2) How the laboratory has identified other patients having the potential to be affected by
the same deficient practice and what corrective action(s) has been taken;

3) What measure has been put into place or what systemic changes you have made to
ensure that the deficient practice does not recur, and

4) How the corrective action(s) are being monitored to ensure the deficient practice does
not recur.

If you do not submit a credible allegation of compliance and acceptable evidence of correction,
or if you submit an allegation of compliance that is determined to be credible but are found to be
still out of compliance with any CLIA Condition-level requirements at the time of the follow-up
visit, we will impose sanctions against your laboratory’s CLIA certificate. These may include
alternative sanctions (Civil Money Penalty of up to $3,000 per day of noncompliance per 42
C.F.R. § 493.1834, Directed Plan of Correction per 42 C.F.R. § 493.1832, State Onsite
Monitoring per 42 C.F.R. § 493.1836) and principal sanctions (suspension, limitation and/or
revocation of your laboratory's CLIA certificate and cancellation of you laboratory's approval for
Medicare payments per 42 C.F.R. § 493.1814).

Please note that the routine survey takes an overview of the laboratory through random sampling.
By its nature, the routine survey may not find every violation that the laboratory may have
committed. It remains the responsibility of the laboratory and its director to ensure that the
laboratory is at all times following all CLIA requirements, to identify any problems in the
laboratory and take corrective action specific to the problems, and to institute appropriate quality
assessment measures to ensure that the deficient practices do not recur.

In addition to the routine CLIA certification surveys, announced or unannounced investigations/


surveys may be conducted by CMS or its agent at any time to address complaints or other non-
compliance issues. These investigations/surveys may well identify violations that may not have
surfaced during a routine survey using random sampling, but for which the laboratory and its
director will still be held responsible.

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[PHONE NUMBER].
Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

Enclosure: CMS-2567, Statement of Deficiencies


09A RO (5/16/07) – sanction proposal – standards out – POC unacceptable, SA referred to RO
for sanction

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of
facsimile constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA number: [CLIA NUMBER]
[ADDRESS]
[CITY], [State] [ZIP]

RE: PROPOSED SANCTIONS – STANDARDS NOT MET

IMPOSITION NOTICE TO FOLLOW IF PROPOSED SANCTIONS ARE IMPOSED

Dear Director and Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. § 263a)
and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations require
onsite surveys to determine whether or not a laboratory is in compliance with the applicable
regulations. Compliance with these regulations is a condition of certification for the CLIA
program.

The [STATE AGENCY NAME] (State agency) conducted [CHOOSE SURVEY TYPE: an
initial, a routine recertification, a complaint] survey of your laboratory that was completed on
[SURVEY DATE]. Based on this survey, [NAME OF LABORATORY] was found to be out
of compliance with [NUMBER] CLIA standards. The State agency provided the laboratory a
listing of all deficiencies identified during the survey on Form CMS-2567, Statement of
Deficiencies, sent as an enclosure to its [DATE OF SA LETTER] letter.

In its [DATE OF SA LETTER] letter, the State agency notified the laboratory to take action to
correct the cited deficiencies. The State agency gave the laboratory ten days from the date of the
[DATE OF SA LETTER] letter to submit a plan of correction and supporting evidence to
document compliance with all CLIA requirements. Your laboratory submitted a plan of
correction dated [DATE OF SUBMISSION].

The State agency reviewed the [DATE OF SUBMISSION] submission and determined that it
did not constitute an acceptable plan of correction. The State agency notified your laboratory of
this determination by its letter dated [DATE OF SA POC REVIEW LETTER] and gave your
laboratory another opportunity to submit an amended plan of correction and additional evidence
of correction. Your laboratory sent in a second submission on [DATE OF SECOND
SUBMISSION] which the State agency reviewed and again determined to be not acceptable.
The State agency notified your laboratory by letter dated [DATE OF SA WARNING
LETTER] that it was referring the case to the CMS Regional Office with recommendations to
not [CHOOSE ONE: certify, recertify] [NAME OF LABORATORY] into the CLIA program.
We have reviewed the case and concur with the State agency in its findings and
recommendations.

Proposed Sanctions

Accordingly, pursuant to 42 C.F.R. §§ 493.1806 and 493.1840(a)(3), based on the laboratory’s


non-compliance with CLIA standard-level requirements and based on the failure by the owner(s)
and director of the laboratory to comply with the certificate requirements and performance
standards as evidenced by the deficiencies cited at the [DATE OF SURVEY] survey, we are
taking action to impose the following sanctions against [NAME OF LABORATORY]’s CLIA
certificate:

• 42 U.S.C. § 263a(i)(3), 42 C.F.R. §§ 493.1806, 493.1840(a)(3) and 493.1840(e) – Principal


Sanction: Revocation of the laboratory’s CLIA certificate. If imposed, the laboratory has 60
days to appeal the determination to revoke the laboratory’s CLIA certificate. If a timely
hearing request is received, revocation of the laboratory’s CLIA certificate will become
effective following the administrative hearing decision, if our determination of non-
compliance is upheld.

• 42 C.F.R. §§ 493.1807(a), 493.1808(a), 493.1842 and 493.1844(d)(3) – Principal Sanction:


Cancellation of the laboratory’s approval to receive Medicare payments for any
laboratory services performed on or after [DATE OF NOTICE + 15 CALENDAR DAYS].
If imposed, this sanction will be effectuated even if the laboratory files a timely appeal.

Moreover, in accordance with Section 1902(a)(9)(C) of the Social Security Act and 42 C.F.R. §
440.30(c), if the sanction of cancellation of the laboratory’s approval to receive Medicare
payments is imposed, payment under the Medicaid program, Title XIX of the Social Security
Act, will no longer be available to the laboratory for any laboratory services performed on or
after [DATE OF NOTICE + 15 CALENDAR DAYS]. See 42 C.F.R. § 440.2(b).

The laboratory is advised that the above sanctions cannot be avoided by the closure,
discontinuation of testing, voluntary withdrawal from the CLIA program, or changes in
certificate to a lower level of testing.

[USE THE FOLLOWING PARAGRAPH IF APPLICABLE:

As the current certificate of [NAME OF LABORATORY]’s CLIA certificate expired on


[EXPIRATION DATE], we will administratively extend the laboratory’s CLIA certificate
solely for the purpose of finalizing the current sanction action. The laboratory’s CLIA certificate
cannot be renewed for Medicare and Medicaid purposes as the laboratory has not shown itself to
be in compliance with CLIA requirements. (Compliance with all CLIA requirements and CLIA
certification is a requirement for Medicare and Medicaid payments.) ]

If the laboratory's CLIA certificate is revoked, 42 U.S.C. § 263a(i)(3) and 42 C.F.R. §


493.1840(a)(8) prohibit the owner(s) or operator(s) (including director – see 42 C.F.R. § 493.2)
from owning or operating (or directing) a laboratory for at least two years from the date of the
revocation. This prohibition applies to the owner(s) as well as the director at the time that the
deficiencies were found which led to the current sanction actions. If the sanctions become
effective as referenced above, in accordance with 42 C.F.R. § 493.1850(a)(2), information
regarding the actions against the laboratory’s CLIA certificate will appear in the Laboratory
Registry for the calendar year in which the actions are imposed. In addition, pursuant to 42
C.F.R. § 493.1844(g)(1), we will notify the general public by means of a notice published in a
local newspaper, if the above sanctions are imposed.

You have ten days from the date of this notice, or until [DATE OF NOTICE + 10
CALENDAR DAYS], to submit in writing any evidence or information as to why the
sanctions detailed above should not be imposed. If we do not receive a timely submission or if
we determine that the submission is unpersuasive, we will notify you in writing that we will
proceed to impose the above-referenced sanctions. We will provide you with the laboratory’s
appeal rights at that time.

Instructions for sending in Your Response

Your laboratory’s response should be sent to:

[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

A copy of any response the laboratory makes should also be sent to the State agency at the
following address:

[STATE AGENCY NAME AND ADDRESS]


Attention: [STAFF NAME]

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[PHONE NUMBER].

Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

cc: [DIRECTOR NAME] Via certified mail, return receipt # _________________________


[ADDRESS OTHER THAN LAB ADDRESS]
[CITY, STATE, ZIP]

[STATE AGENCY NAME]


09B RO (5/16/07) – sanction proposal – standards out – POC unacceptable, SA referred to RO for
sanction

IMPORTANT NOTICE – PLEASE READ CAREFULLY


[DATE]

[NAME OF LABORATORY] CLIA number: [CLIA NUMBER]


Attn: [NAME]
[ADDRESS]

Dear [NAME]:

In order for a laboratory to perform testing under the Clinical Laboratory Improvement Amendments of
1988 (CLIA), Public Law 100-578, and bill for services provided to Medicare beneficiaries or Medicaid
recipients under Titles XVIII and XIX of the Social Security Act, it must comply with all CLIA
Requirements [42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493].

The [NAME OF STATE AGENCY] (State agency) conducted [CHOOSE SURVEY TYPE:
an initial, a routine recertification, a complaint] survey of [NAME OF LABORATORY] on
[DATE]. The State agency requested a plan of correction on [DATE]. The plan of correction
was received by the State agency on [DATE] and was determined unacceptable. Since that time,
the State agency made several attempts at obtaining an acceptable plan of correction. The
following is a summary of those attempts:

[PROVIDE DETAILS]

If a laboratory fails to submit an acceptable plan of correction, and subsequent requests for an
acceptable plan of correction are unsuccessful, the Centers for Medicare & Medicaid Services
(CMS) may cancel the laboratory’s approval to receive Medicare payment for its services in
accordance with 42 C.F.R. § 493.1842(a)(2)(ii). In addition, CMS may consider the laboratory’s
failure to comply with reasonable requests for information pursuant to 42 C.F.R. §
493.1840(a)(4) and may initiate a principal sanction, i.e., suspension, limitation, or revocation of
the CLIA certificate, on the basis of this failure.

Based on the failure of [NAME OF LABORATORY] to submit an acceptable plan of


correction, CMS will impose the following sanctions:

[EXAMPLE:

• 42 C.F.R. § 493.1842(a)(2)(ii) - Principal sanction: cancellation of [Name of


Laboratory]'s approval to receive Medicare payments for laboratory services effective
[DATE]. In addition, under section 1902(a)(9)(C) of the Social Security Act and 42 C.F.R. §
440.30(c), payment under the Medicaid program, Title XIX of the Social Security Act, will
no longer be available to your laboratory for any laboratory services performed on or after
[DATE]. You may submit written evidence or other information against the cancellation of
the laboratory’s approval to receive Medicare and Medicaid payments in accordance with 42
C.F.R. § 493.1842(b). The information must be received within 10 days of receipt of this
notice.
• 42 C.F.R. § 493.1840(d)(2)(ii) - Principal sanction: suspension of your CLIA certificate,
effective [DATE]. Under suspension, your laboratory may not legally perform patient
laboratory testing. Your laboratory will be allowed to remain in operation, and may perform
other procedures (i.e., quality control, personnel recruitment, training, proficiency testing,
etc.).

• 42 C.F.R. § 493.1840(a)(4) - Principal sanction: revocation of your CLIA certificate,


pending a decision from an Administrative Law Judge, if an appeal is filed. Under
revocation, the laboratory will be required to cease all operations. Also, as required under 42
C.F.R. § 493.1840(a)(8), the present owner(s) and/or operator(s) of the [NAME OF
LABORATORY] will be prohibited from owning or operating a laboratory for at least two
years from the date of revocation. In accordance with 42 C.F.R. § 493.1850(a)(2),
information regarding the revocation of your CLIA certificate, should this sanction be
imposed, will appear in the Laboratory Registry for the calendar year of your revocation. ]

CMS is required to notify the general public when principal sanctions are imposed. In addition, if the
above mentioned sanctions are imposed and your laboratory continues testing, please be informed that
under 42 C.F.R. § 493.1806(e) and section 353(l) of the Public Health Service Act, any individual
who is convicted of intentionally violating any CLIA requirement may be imprisoned or fined.

If you believe this determination is not correct, you may request a hearing before an
administrative law judge of the Department of Health and Human Services, Departmental
Appeals Board. Procedures governing this process are set out in regulations at 42 C.F.R. §
493.1844. A written request for hearing must be filed no later than 60 days from the date of
receipt of this letter.

You may submit a hearing request directly (accompanied by a copy of this letter) to:

Departmental Appeals Board


Civil Remedies Division
Attention: Oliver Potts
Cohen Building, Room G-644
330 Independence Ave, SW
Washington, D.C. 20201

A copy of the hearing request should be sent to:

[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

A request for hearing should identify the specific issues, and the findings of fact and conclusions
of law with which you disagree. It should also specify the basis for contending that the findings
and conclusions are incorrect. You may be represented by counsel at a hearing at your own
expense. If no request for a hearing is received by [DATE], your CLIA certificate will be
revoked [DATE]. If a hearing is conducted and CMS’s determination is upheld, your laboratory
may be assessed a fee to cover the government’s costs related to the hearing, per 42 C.F.R. §
493.643(d)(2).

Please contact [NAME] at [PHONE/EMAIL] with any questions concerning this letter.

Sincerely,

[NAME/TITLE]
[OFFICE NAME]
cc: [LIST ALL CC’S]
10A RO (5/16/07) – sanction proposal – Conditions out – AOC not credible – SA referred to
RO for sanction

IMPORTANT NOTICE – ACTION NECESSARY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of
facsimile constitutes proof of receipt.)

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME] CLIA number: [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: PROPOSED SANCTIONS – CONDITIONS NOT MET

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. § 263a)
and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations require
onsite surveys to determine whether or not a laboratory is in compliance with the applicable
regulations. Compliance with these regulations is a condition of certification for the CLIA
program.

The [STATE AGENCY NAME] (State agency) conducted [CHOOSE SURVEY TYPE: an
initial, a routine recertification, a complaint] survey of your laboratory that was completed on
[SURVEY DATE]. Based on this survey, [NAME OF LABORATORY] was found to be out
of compliance with [NUMBER] CLIA Conditions:

[LIST CONDITIONS.]

In addition, other standards were also found to be not met. The State agency provided the
laboratory a listing of all deficiencies identified during the survey on Form CMS-2567,
Statement of Deficiencies, sent as an enclosure to its [DATE OF SA LETTER] letter.

In its [DATE OF SA LETTER] letter, the State agency notified the laboratory to take
immediate action to bring any unmet Condition-level requirements into compliance. The State
agency gave the laboratory ten days from receipt of the [DATE OF SA LETTER] letter to
submit a credible allegation of compliance and acceptable evidence of correction for the cited
deficiencies. Your laboratory submitted an allegation of compliance dated [DATE OF
SUBMISSION].

The State agency reviewed the [DATE OF SUBMISSION] submission and determined that it
did not constitute a credible allegation of compliance and acceptable evidence of correction. The
State agency notified your laboratory of this determination by its letter dated [DATE OF SA
AOC REVIEW LETTER] and that it was referring the case to the Regional Office of the
Centers for Medicare & Medicaid Services (CMS) with recommendations to not [CHOOSE
ONE: certify, recertify] [NAME OF LABORATORY] into the CLIA program. We have
reviewed the case and concur with the State agency in its findings and recommendations.

Proposed Sanctions

Accordingly, pursuant to 42 C.F.R. §§ 493.1806 and 493.1840(a)(3), based on the laboratory’s


failure to meet all CLIA Conditions, and based on the failure by the owner(s) and director of the
laboratory to comply with the certificate requirements and performance standards as evidenced
by the deficiencies cited at the [DATE OF SURVEY] survey, we are taking action to impose the
following sanctions against [NAME OF LABORATORY]’s CLIA certificate:

• 42 U.S.C. § 263a(i)(3), 42 C.F.R. §§ 493.1806, 493.1840(a)(3) and 493.1840(e) – Principal


Sanction: Revocation of the laboratory’s CLIA certificate. If imposed, the laboratory has 60
days to appeal the determination to revoke the laboratory’s CLIA certificate. If a timely
hearing request is received, revocation of the laboratory’s CLIA certificate will become
effective following the administrative hearing decision, if our determination of non-
compliance is upheld.

• 42 C.F.R. §§ 493.1806(c)(3), 493.1810(c)(2)(ii), 493.1810(d) and 493.1834 – Alternative


Sanction: Civil Money Penalty in the amount of $3,000 per day for each day of non-
compliance effective [DATE OF NOTICE + 15 CALENDAR DAYS]. If the laboratory
requests a hearing, the civil money penalty amount will not be collected until after the
hearing decision is rendered. However, if imposed, the $3,000/day will begin to accrue on
[DATE OF NOTICE + 15 CALENDAR DAYS] and will continue to accrue until it can be
verified that the laboratory is in compliance with all Condition-level requirements or the
laboratory’s CLIA certificate is revoked.

In determining the amount of the penalty, CMS has taken into account the following factors: (1)
the laboratory was found to be out of compliance with [NUMBER] CLIA Condition-level
requirements as well as numerous standard-level CLIA requirements at the survey completed on
[SURVEY DATE]; (2) the laboratory has failed to correct the deficiencies after being provided
an opportunity to do so; [EXAMPLES OF OTHER REASONS: (3) the laboratory failed to
meet the requirement for successful testing of proficiency testing samples; (4) the laboratory
failed to establish and verify performance specifications for each testing method prior to testing
and reporting patient results; (5) the laboratory director failed to establish and maintain quality
control and quality assessment programs to assure the accuracy of patient test results; and (6) the
laboratory has expressed no rational reason for its failure to achieve compliance with all
applicable Condition-level CLIA requirements.]

• 42 C.F.R. §§ 493.1806(c)(1), 493.1832, 493.1844(d)(1) and 493.1844(g)(1) – Alternative


Sanction: Directed Portion of a Plan of Correction effective [DATE OF NOTICE + 15
CALENDAR DAYS]. If imposed, the laboratory will be directed to submit to this office
within ten calendar days from the date of the imposition notice a list of the names and
addresses of all physicians and other clients who have used some or all of the laboratory’s
services since [DATE OF PRIOR SURVEY OR OTHER DATE AS APPROPRIATE].
This list may be used to advise the laboratory’s clients of the nature of its non-compliance
and the nature and effective date of any sanctions imposed against the laboratory.

• 42 C.F.R. §§ 493.1807(a), 493.1808(a), 493.1842 and 493.1844(d)(3) – Principal Sanction:


Cancellation of the laboratory’s approval to receive Medicare payments for any
laboratory services performed on or after [DATE OF NOTICE + 15 CALENDAR DAYS].
If imposed, this sanction will be effectuated even if the laboratory files a timely appeal.

Moreover, in accordance with Section 1902(a)(9)(C) of the Social Security Act and 42 C.F.R. §
440.30(c), if the sanction of cancellation of the laboratory’s approval to receive Medicare
payments is imposed, payment under the Medicaid program, Title XIX of the Social Security
Act, will no longer be available to the laboratory for any laboratory services performed on or
after [DATE OF NOTICE + 15 CALENDAR DAYS]. See 42 C.F.R. § 440.2(b).

The laboratory is advised that the above sanctions cannot be avoided by the closure,
discontinuation of testing, voluntary withdrawal from the CLIA program, or changes in
certificate to a lower level of testing.

[USE THE FOLLOWING PARAGRAPH IF APPLICABLE:

As the current certificate of [NAME OF LABORATORY]’s CLIA certificate expired on


[EXPIRATION DATE], we will administratively extend the laboratory’s CLIA certificate
solely for the purpose of finalizing the current sanction action. The laboratory’s CLIA certificate
cannot be renewed for Medicare and Medicaid purposes as the laboratory has not shown itself to
be in compliance with CLIA requirements. (Compliance with all CLIA requirements and CLIA
certification is a requirement for Medicare and Medicaid payments.)

If the laboratory's CLIA certificate is revoked, 42 U.S.C. § 263a(i)(3) and 42 C.F.R. §


493.1840(a)(8) prohibit the owner(s) or operator(s) (including director – see 42 C.F.R. § 493.2)
from owning or operating (or directing) a laboratory for at least two years from the date of the
revocation. This prohibition applies to the owner(s) as well as the director at the time that the
deficiencies were found which led to the current sanction actions.

If the sanctions become effective as referenced above, in accordance with 42 C.F.R. §


493.1850(a)(2), information regarding the actions against the laboratory’s CLIA certificate will
appear in the Laboratory Registry for the calendar year in which the actions are imposed. In
addition, pursuant to 42 C.F.R. § 493.1844(g)(1), we will notify the general public by means of a
notice published in a local newspaper, if the above sanctions are imposed.

You have ten days from the date of this notice, or until [DATE OF NOTICE + 10
CALENDAR DAYS], to submit in writing any evidence or information as to why the
sanctions detailed above should not be imposed. If we do not receive a timely submission or if
we determine that the submission is unpersuasive, we will notify you in writing that we will
proceed to impose the above-referenced sanctions. We will provide you with the laboratory’s
appeal rights at that time.

Instructions for sending in Your Response

Your laboratory’s response should be sent to:


[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

A copy of any response the laboratory makes should also be sent to the State agency at the
following address:

[STATE AGENCY NAME]


[STATE AGENCY ADDRESS]
Attention: [STAFF NAME]

If you have questions regarding this letter, please contact [STAFF NAME] at [PHONE
NUMBER].

Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

cc: [DIRECTOR NAME] Via certified mail, return receipt # _________________________


[ADDRESS OTHER THAN LAB ADDRESS]
[CITY, STATE, ZIP]
[STATE AGENCY NAME]
10B RO (5/16/07) – sanction proposal – Conditions out – AOC not credible – alternative sanctions of
Directed Plan of Correction and State Onsite Monitoring

[DATE]

[NAME OF LABORATORY] CLIA number: [CLIA NUMBER]


Attn: [NAME]
[ADDRESS]

Dear [NAME]:

In order for a laboratory to perform testing under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA), Public Law 100-578, and bill for services provided to Medicare beneficiaries or
Medicaid recipients under Title XVIII and XIX of the Social Security Act, it must comply with all
CLIA Requirements (42 C.F.R. § 493).

Federal regulations require surveys to determine whether or not a laboratory is in compliance


with the applicable regulations. [NAME OF STATE AGENCY] (State agency) conducted
[CHOOSE SURVEY TYPE: an initial, a routine recertification, a complaint] survey of
[NAME OF LABORATORY] on [DATE], resulting in the finding of Condition-level
noncompliance. On [DATE], the State agency requested your laboratory to correct the cited
deficiencies. Your laboratory submitted an allegation of compliance documented on the Provider
Plan of Correction column of the CMS-2567, Statement of Deficiencies. The State agency
reviewed your laboratory’s submission and informed you on [DATE] that the plan of correction
was not acceptable and did not constitute a credible allegation of compliance. Therefore, an on-
site revisit could not be performed.

The Centers for Medicare & Medicaid Services, (CMS) has reviewed the survey report and
determined that your laboratory is not in compliance with the CLIA Conditions. These
deficiencies have been found to be of such a serious nature as to substantially limit your
laboratory’s capability to render adequate services, and prevent it from being in compliance with
the CLIA Conditions. Specifically, your laboratory does not meet the following CLIA
Condition(s):

[EXAMPLE:

• 42 C.F.R. § 493.803 Condition: Successful Participation;


• 42 C.F.R. § 493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director; and
• 42 C.F.R. § 493.1409 Condition: Laboratories performing moderate complexity
testing; technical consultant. ]

Based on the serious nature of the deficiencies cited and the failure of [NAME OF
LABORATORY] to provide a credible allegation of compliance, CMS will impose the
following alternative sanctions by the authority of 42 C.F.R. § 493.1804(b)(2):

[EXAMPLE:
42 C.F.R. § 493.1832, Sanction: Directed Plan of Correction, effective [DATE]. When
CMS imposes a directed plan of correction, CMS directs the laboratory to take specific
corrective action within specific time frames in order to achieve compliance.

In order to correct the CLIA Condition 42 C.F.R. § 493.803 Successful Participation, your
laboratory must:

Cease patient testing in the failed specialty of hematology and demonstrate satisfactory
performance in two supplemental proficiency testing events. These testing events can be
requested from any approved proficiency testing company. Results of the supplemental
proficiency testing must be submitted to the state agency no later than [DATE].

In addition, in accordance with 42 C.F.R. § 493.1838, the laboratory must show


documentation of training and technical assistance for all personnel involved in patient testing
for the failed specialty. Documentation of training must be submitted to the state agency no
later than [DATE].

In order to achieve compliance for the CLIA Condition, Laboratories Performing Moderate
Complexity Testing, Technical Consultant at 42 C.F.R. § 493.1409, your laboratory must:

Obtain the services of a qualified Technical Consultant to assist and review the
laboratory's performance. Any prospective candidate must hold a bachelor's degree in a
chemical, physical or biological science or medical technology from an accredited
institution, and possess at least four (4) years of laboratory experience in the specialty of
Hematology.

Submit the name of the Technical Consultant to the State agency no later than [DATE]
and obtain that agency's approval prior to entering into any contractual arrangement with
such an individual.

The duties of the Technical Consultant will include:


a) The technical consultant must be accessible to the laboratory to provide on-site,
telephone, or electronic consultation;
b) Establish a quality control program appropriate for the testing performed; establish the
parameters for acceptable levels of analytic performance; and ensure that these levels
are maintained throughout the entire testing process from the initial receipt of the
specimen, through sample analysis and reporting of test results;
c) Document review of control material test results for the all laboratory testing on at
least a weekly basis;
d) Develop written protocols to monitor and verify test results for accuracy and
reliability;
e) Implement procedures for the review of proficiency testing to include documentation
of remedial actions for any unacceptable analyte and test event scores;
f) Resolve technical problems and ensuring that remedial actions are taken whenever
test systems deviate from the laboratory's established performance specifications;
g) Ensure that patient test results are not reported until all corrective actions have been
taken and the test system is functioning properly;
h) Identify training needs and assuring that each individual performing tests receives
regular in-service training and education appropriate for the type and complexity of
the laboratory services performed; document training of all individuals performing
patient testing with respect to the above requirements, including orientation to quality
control requirements, troubleshooting and record keeping;
i) Evaluate the competency of all testing personnel assuring that the staff maintain their
competency to perform test procedures and report test results promptly, accurately
and proficiently through:
(i) Direct observations of routine patient test performance, including patient
preparation, if applicable, specimen handling, processing and testing;
(ii) Monitoring the recording and reporting of test results;
(iii) Review of intermediate test results or worksheets, quality control records,
proficiency testing results, and preventive maintenance records;
(iv) Direct observation of performance of instrument maintenance and function
checks;
(v) Assessment of test performance through testing previously analyzed specimens,
internal blind testing samples or external proficiency testing samples; and
(vi) Assessment of problem solving skills.
j) Evaluate and document the performance of individuals responsible for moderate
complexity testing at least semiannually during the first year the individual tests patient
specimens. Thereafter, evaluations must be performed at least annually unless test
methodology or instrumentation changes, in which case, prior to reporting patient test
results, the individual's performance must be reevaluated to include the use of the new
test methodology or instrumentation.
k) Retain documentation of all corrective actions for review by CMS and/or the State
agency.

42 C.F.R. § 493.1836, Sanction: State onsite monitoring, effective [DATE]. CMS will
require the state agency to provide intermittent monitoring of the plan of correction to ensure
that the laboratory makes the improvements necessary to bring it into compliance. When CMS
imposes the sanction of onsite monitoring, the sanction continues until CMS determines that
the laboratory has the capability to ensure compliance with all Condition-level requirements.]

You may submit to CMS written evidence or other information against the imposition of
alternative sanctions in accordance with 42 C.F.R. § 493.1810(b). The information must be
received within 10 days of receipt of this notice.

The alternative sanction of a Directed Plan of Correction is intended to assist your laboratory to
come into compliance with CLIA requirements. However, it remains the responsibility of the
laboratory to provide a complete response to the cited deficiencies that would constitute a
credible allegation of compliance and acceptable evidence of correction.

Your laboratory must take action to correct all Condition-level deficiencies or, under the
authority of 42 C.F.R. § 493.1804(b)(2), CMS will take action to impose principal sanctions
against your laboratory’s CLIA certificate. In addition, failure to comply with the alternative
sanction of a Directed Plan of Correction is basis for suspension, limitation or revocation of your
laboratory’s CLIA certificate pursuant to 42 C.F.R. § 493.1840(a)(7).

Your laboratory is directed to document compliance with the Directed Plan of Correction and
indicate acceptable corrective action for each deficiency cited on the enclosed CMS-2567,
Statement of Deficiencies, using the Provider Plan of Correction column. Indicate the
appropriate completion dates on the right side of the form, keying your responses to the
deficiencies on the left. In addition, you must provide acceptable evidence that the corrective
actions have been implemented.

Acceptable evidence of correction must include:

• Documentation showing what corrective action(s) have been taken for patients found to
have been affected by the deficient practice;
• How the laboratory has identified other patients having the potential to be affected by the
same deficient practice and what corrective action(s) has been taken;
• What measure has been put into place or what systemic changes you have made to ensure
that the deficient practice does not recur, and
• How the corrective action(s) are being monitored to ensure the deficient practice does not
recur.

Please send the plan of correction and evidence of correction to: [STATE AGENCY
ADDRESS]. In addition, please forward a copy to this office. The State agency must receive
your response by [DATE].

If your plan of correction and evidence of correction is determined to constitute a credible


allegation of compliance and acceptable evidence of correction, CMS will determine if
compliance can be certified on the basis of the evidence presented, or if a revisit will be required
to verify whether the laboratory has, in fact, achieved compliance.

A credible allegation of compliance is a statement or documentation that is made by a


representative of a laboratory that has a history of having maintained a commitment to
compliance and of taking corrective action when required; is realistic in terms of its being
possible to accomplish the required corrective action between the date of the exit conference and
the date of the allegation; and indicates that the problem has been resolved.

If a revisit is conducted and the findings from the revisit indicate your laboratory is back in
compliance with all CLIA Conditions, principal sanctions will not be imposed. If on the revisit,
the laboratory is found out of compliance, CMS will impose the following principal sanctions:

42 C.F.R. § 493. 1807(a), Sanction: cancel your laboratory’s approval to receive


Medicare payments for laboratory services effective [DATE]. In addition, under section
1902(a)(9)(C) of the Social Security Act and 42 C.F.R. 440.30(c), payment under the
Medicaid program, Title XIX of the Social Security Act, will no longer be available to
your laboratory for any laboratory services performed on or after [DATE].

42 C.F.R. § 493.1840(a)(3) and (a)(7), Sanction: revocation of your CLIA certificate,


pending a decision from an Administrative Law Judge, if an appeal is filed. Under
revocation, the laboratory will be required to cease all patient testing. Also under
revocation, 42 C.F.R. § 493.1840(a)(8), will prohibit the present owner and operator from
owning or operating a laboratory for at least two years from the date of revocation. In
accordance with 42 C.F.R. § 493.1850(a)(2), information regarding the revocation of
your CLIA certificate, should this sanction be imposed, will appear in the Laboratory
Registry for the calendar year of your revocation.
CMS is required to notify the general public when principal sanctions are imposed. In addition, if
the above mentioned sanctions are imposed and your laboratory continues testing, please be
informed that under 42 C.F.R. § 493.1806(e), any individual who is convicted of intentionally
violating any CLIA requirement may be imprisoned or fined.

If you believe this determination is not correct, you may request a hearing before an
administrative law judge of the Department of Health and Human Services, Departmental
Appeals Board. Procedures governing this process are set out in regulations at 42 C.F.R. §
493.1844. A written request for hearing must be filed no later than 60 days from the date of
receipt of this letter.

You may submit a hearing request directly (accompanied by a copy of this letter) to:

Departmental Appeals Board


Civil Remedies Division
Attention: Oliver Potts
Cohen Building, Room G-644
330 Independence Avenue, S.W.
Washington, D.C. 20201

A copy of the hearing request should be sent to:

[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

A request for hearing should identify the specific issues, and the findings of fact and conclusions
of law with which you disagree. It should also specify the basis for contending that the findings
and conclusions are incorrect. You may be represented by counsel at a hearing at your own
expense. If the laboratory remains out of compliance on the revisit, and if no request for a
hearing is received by [DATE], your laboratory's CLIA certificate will be revoked [DATE]. If a
hearing is conducted and CMS’ determination is upheld, your laboratory may be assessed a fee
to cover the government’s costs related to the hearing, per 42 C.F.R. § 493.643(d)(2).
Please contact [STAFF NAME] at [PHONE/EMAIL] with any questions concerning this letter.

Sincerely,

[NAME/TITLE]
[OFFICE NAME]

cc: [DIRECTOR NAME] Via certified mail, return receipt # _________________________


[ADDRESS OTHER THAN LAB ADDRESS]
[CITY, STATE, ZIP]

[STATE AGENCY NAME]


11 RO (5/16/07) – sanction proposal – IJ – IJ not removed, SA referred to RO for sanction

IMPORTANT NOTICE – ACTION NECESSARY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA number: [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: PROPOSED SANCTIONS – CONDITIONS NOT MET – IMMEDIATE JEOPARDY

Dear Director/Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. § 263a)
and 42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations require
onsite surveys to determine whether or not a laboratory is in compliance with the applicable
regulations. Compliance with these regulations is a condition of certification for the CLIA
program.

The [STATE AGENCY NAME] (State agency) conducted [CHOOSE SURVEY TYPE: an
initial, a routine recertification, a complaint] survey of your laboratory that was completed on
[SURVEY DATE]. Based on this survey, [NAME OF LABORATORY] was found to be out
of compliance with [NUMBER] CLIA Conditions:

[LIST CONDITIONS.]

In addition, other standards were also found to be not met.

The serious nature of the deficiencies resulted in a determination of immediate jeopardy to


patient health and safety. The State agency notified [NAME OF LABORATORY] by letter
dated [DATE OF SA LETTER] that conditions within the laboratory pose an immediate
jeopardy situation. The State agency provided the laboratory a listing of all deficiencies
identified during the survey on Form CMS-2567, Statement of Deficiencies, sent as an enclosure
to its [DATE OF SA LETTER] letter.

In the [DATE OF SA LETTER] letter, the State agency notified the laboratory to take
immediate action to remove jeopardy and bring any unmet Condition-level requirements into
compliance. The State agency gave the laboratory ten days from the date of the [DATE OF SA
LETTER] letter to submit a credible allegation of compliance and acceptable evidence of
correction for the cited deficiencies. Your laboratory submitted an allegation of compliance
dated [DATE OF SUBMISSION].
The State agency reviewed the [DATE OF SUBMISSION] submission and determined that it
did not constitute a credible allegation of compliance and acceptable evidence of correction. The
State agency notified your laboratory of this determination by its letter dated [DATE OF SA
AOC REVIEW LETTER] and that it was referring the case to the CMS Regional Office with
recommendations to not [CHOOSE ONE: certify, recertify] [NAME OF LABORATORY]
into the CLIA program. We have reviewed the case and concur with the State agency in its
findings and recommendations.

Proposed Sanctions

Accordingly, pursuant to 42 C.F.R. §§ 493.1806 and 493.1840(a)(3), based on the laboratory’s


failure to meet all CLIA Conditions, and based on the failure by the owner(s) and director of the
laboratory to comply with the certificate requirements and performance standards as evidenced
by the deficiencies cited at the [DATE OF SURVEY] survey, we are taking action to impose the
following sanctions against [NAME OF LABORATORY]’s CLIA certificate:

• 42 U.S.C. § 263a(i)(3), 42 C.F.R. §§ 493.1806, 493.1840(a)(3) and 493.1840(e) – Principal


Sanction: Revocation of the laboratory’s CLIA certificate effective [DATE OF NOTICE +
60 CALENDAR DAYS]. The laboratory has 60 days to appeal the determination to revoke
the laboratory’s CLIA certificate. If a timely hearing request is received, revocation of the
laboratory’s CLIA certificate will become effective following the administrative hearing
decision, if our determination of non-compliance is upheld.

• 42 C.F.R. §§ 493.1806, 493.1812, 493.1840(a)(3) and 493.1840(d)(2)(i) – Principal Sanction:


Suspension of the laboratory’s CLIA certificate effective [DATE OF NOTICE + 8
CALENDAR DAYS] based on the finding of immediate jeopardy. The suspension will take
effect regardless of whether a hearing is filed and will remain in effect until the laboratory’s
CLIA certificate is revoked.

• 42 C.F.R. §§ 493.1806(c)(3), 493.1810(c)(2)(i), 493.1810(d) and 493.1834 – Alternative


Sanction: Civil Money Penalty in the amount of $10,000 per day for each day of non-
compliance effective [DATE OF NOTICE + 5 CALENDAR DAYS]. If the laboratory
requests a hearing, the civil money penalty amount will not be collected until after the hearing
decision is rendered. However, the $10,000/day will begin to accrue on [DATE OF NOTICE
+ 5 CALENDAR DAYS] and will continue to accrue until it can be verified that the
laboratory is in compliance with all Condition-level requirements or the laboratory’s CLIA
certificate is suspended.

In determining the amount of the penalty, CMS has taken into account the following
factors: (1) the laboratory was found to be out of compliance with [NUMBER] CLIA
Condition-level requirements as well as numerous standard-level CLIA requirements at
the survey completed on [SURVEY DATE]; (2) the deficiencies cited at the [SURVEY
DATE] survey were so serious as to result in the determination of immediate jeopardy to
patient health and safety; (3) the laboratory has failed to remove jeopardy after being
provided an opportunity to do so; [EXAMPLES OF OTHER REASONS: (4) the
laboratory failed to meet the requirement for successful testing of proficiency testing
samples; (5) the laboratory failed to establish and verify performance specifications for
each testing method prior to testing and reporting patient results; (6) the laboratory
accepted and tested patient specimens which were hemolyzed and serum samples having
had prolonged contact with red blood cells, i.e., the integrity of the patient specimens had
been compromised, yet the laboratory tested and reported panic values indicating life-
threatening conditions; (7) the laboratory director failed to establish and maintain quality
control and quality assessment programs to assure the accuracy of patient test results; and
(8) the laboratory has expressed no rational reason for its failure to achieve compliance
with all applicable Condition-level CLIA requirements.]

• 42 C.F.R. §§ 493.1806(c)(1), 493.1832, 493.1844(d)(1) and 493.1844(g)(1) – Alternative


Sanction: Directed Portion of a Plan of Correction effective [DATE OF NOTICE + 5
CALENDAR DAYS]. The laboratory will be directed to submit to this office within ten
calendar days from the date of the imposition notice a list of the names and addresses of all
physicians and other clients who have used some or all of the laboratory’s services since
[DATE OF PRIOR SURVEY OR OTHER DATE AS APPROPRIATE]. This list may
be used to advise the laboratory’s clients of the nature of its non-compliance and the nature
and effective date of any sanctions imposed against the laboratory.

• 42 C.F.R. §§ 493.1807(a), 493.1808(a), 493.1842 and 493.1844(d)(3) – Principal Sanction:


Cancellation of the laboratory’s approval to receive Medicare payments for any
laboratory services performed on or after [DATE OF NOTICE + 5 CALENDAR DAYS].
This sanction will be effectuated even if the laboratory files a timely appeal.

Moreover, in accordance with Section 1902(a)(9)(C) of the Social Security Act and 42 C.F.R. §
440.30(c), payment under the Medicaid program, Title XIX of the Social Security Act, will no
longer be available to the laboratory for any laboratory services performed on or after [DATE
OF NOTICE + 5 DAYS]. See 42 C.F.R. § 440.2(b).

The laboratory is advised that the above sanctions cannot be avoided by the closure,
discontinuation of testing, voluntary withdrawal from the CLIA program, or changes in
certificate to a lower level of testing.

When the laboratory's CLIA certificate is suspended, the laboratory will not be permitted
to perform any patient laboratory testing including waived and provider performed
microscopy testing and regardless of whether or not the laboratory charges for the testing.
(The laboratory may continue to perform parallel testing on patient specimens if needed to
implement corrective actions. However, the laboratory may not report any patient test results
during the period when its CLIA certificate is suspended.)

Also, under revocation, 42 U.S.C. § 263a(i)(3) and 42 C.F.R. § 493.1840(a)(8) prohibit the
owner(s) or operator(s) (including director – see 42 C.F.R. § 493.2) from owning or operating (or
directing) a laboratory for at least two years from the date of the revocation. This prohibition
applies to the owner(s) as well as the director at the time that the deficiencies were found which
led to the current sanction actions.

When the sanctions become effective as referenced above, in accordance with 42 C.F.R. §
493.1850(a)(2), information regarding the actions against the laboratory’s CLIA certificate will
appear in the Laboratory Registry for the calendar year in which the actions are imposed. In
addition, pursuant to 42 C.F.R. § 493.1844(g)(1), we will notify the general public by means of a
notice published in a local newspaper, when the above sanctions are imposed.
Appeal Rights

If [NAME OF LABORATORY] does not believe this determination to impose these actions
against its CLIA certificate is correct, the laboratory may request a hearing before an
administrative law judge (ALJ) of the Departmental Appeals Board in accordance with 42 C.F.R.
§ 493.1844(a)(1)-(2) and 42 C.F.R. §§ 498.40 through 498.78. A written request for hearing
must be filed no later than sixty days after the date of this letter is received (see 42 C.F.R. §
493.1844(f)). Such a request may be made directly (accompanied by a copy of this letter) to:

Departmental Appeals Board


Civil Remedies Division
Attention: Oliver Potts
Cohen Building, Room G-644
330 Independence Ave, SW
Washington, D.C. 20201

A copy of the hearing request should be sent to:

[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

The request for hearing must contain a statement as to the specific issues and findings of fact and
conclusions of law in this determination with which the laboratory disagrees and the basis for the
laboratory’s contention that the specific issues and/or findings and conclusions are incorrect.
Evidence and arguments may also be presented at the hearing, where counsel may represent the
laboratory at its own expense. If a hearing is conducted and CMS’ determination is upheld,
the laboratory will be assessed a fee to cover the government’s cost related to the hearing.
See 42 C.F.R. § 493.643(d)(2).

As noted above, if a timely request for hearing is filed, i.e., by [DATE OF NOTICE + 60
CALENDAR DAYS], CMS does not collect the Civil Money Penalty or revoke any type of
CLIA certificate until after an ALJ hearing that upholds CMS’ sanction determination. However,
suspension of the laboratory’s CLIA certificate will go into force effective [DATE OF NOTICE
+ 8 CALENDAR DAYS], and the Directed Portion of a Plan of Correction and cancellation of
all Medicare and Medicaid payment are effective [DATE OF NOTICE + 5 CALENDAR
DAYS], regardless of whether a hearing is requested. See 42 C.F.R. §§ 493.1844(d)(1)-(3) and
493.1844(h)(1).

Please be advised that the determination that a laboratory’s deficiencies pose immediate jeopardy
is not subject to appeal. Please also be advised that the determination as to which alternative
sanction or sanctions to impose, including the amount of a Civil Money Penalty to impose per
day or per violation, is not subject to appeal. See 42 C.F.R. § 493.1844(c)(4) and (c)(6).
Please note that in accordance with 42 U.S.C. § 263a(i)(2), CMS is authorized to suspend the
CLIA certificate of a laboratory before holding a hearing where the failure to comply with CLIA
requirements presents an imminent and serious risk to human health, as has been determined in
the case of [NAME OF LABORATORY]. As further provided under this section of the statute,
if the laboratory requests a hearing, it is entitled to have the hearing commence within 60 days of
the effective date of the suspension. The laboratory must specify in any request for a hearing to
challenge the suspension of its CLIA certificate whether it wishes the hearing to commence
within 60 days.

You have ten days from the date of this notice, or until [DATE OF NOTICE + 10
CALENDAR DAYS], to submit in writing any evidence and/or information as to why the
sanctions detailed above should not be imposed. Your laboratory’s response should be sent to:

[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

A copy of any response the laboratory makes should also be sent to the State agency at the
following address:
[STATE AGENCY NAME]
[STATE AGENCY ADDRESS]
Attention: [STAFF NAME]

If you have questions regarding this letter, please contact [STAFF NAME] at [PHONE
NUMBER].

Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

cc: [DIRECTOR NAME] Via certified mail, return receipt # _________________________


[ADDRESS OTHER THAN LAB ADDRESS]
[CITY, STATE, ZIP]

[STATE AGENCY NAME]


12 RO (5/16/07) – sanction proposal – subsequent unsuccessful PT – SA PT desk review finds
subsequent unsuccessful and referred immediately to RO for sanction

IMPORTANT NOTICE – ACTION NECESSARY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of
Facsimile constitutes proof of receipt.)

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME] CLIA number: [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: PROPOSED SANCTIONS DUE TO SUBSEQUENT OCCURRENCE OF


UNSUCCESSFUL PARTICIPATION IN PROFICIENCY TESTING – IMPOSITION
NOTICE TO FOLLOW IF PROPOSED SANCTIONS ARE IMPOSED

Dear Director and Owner(s):

In order for a laboratory to perform testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements.
These requirements are found in section 353 of the Public Health Service Act (42 U.S.C. § 263a)
and 42 Code of Federal Regulations, Part 493 (42 C.F.R. Part 493). Compliance with these
regulations is a requirement for certification for the CLIA program.

Subpart H of 42 C.F.R Part 493 requires each laboratory certified to test specimens under the
CLIA regulations to successfully participate in an approved proficiency testing program. The
CLIA regulations at 42 C.F.R. § 493.2 define, as set out in Subpart H, unsuccessful proficiency
testing performance as failure to attain the minimum satisfactory score for an analyte, test,
subspecialty, or specialty for two consecutive or two out of three consecutive testing events.

Determination of Non-Compliance: Finding of Unsuccessful Participation in Proficiency


Testing - Subsequent Occurrence

Evidence obtained by the [STATE AGENCY NAME] (the State agency) during a desk review
conducted on [DATE OF CMS-2567 FOR PT DESK REVIEW] of proficiency testing results
submitted to CLIA from your laboratory’s proficiency testing program shows your laboratory
has a repeat history of unsatisfactory proficiency testing performance for the tests and events
listed below which constitutes a subsequent occurrence of unsuccessful participation in
proficiency testing for these tests:

Testing Event PT Provider Test Score

[LIST UNSATISFACTORY EVENTS.]


Based on the repeat proficiency testing failures listed above, your laboratory is not in compliance
with [NUMBER] CLIA Conditions. The enclosed Form CMS-2567, Statement of Deficiencies,
specifically documents the laboratory’s failure to meet the Condition-level requirements at:
[DELETE DIRECTOR CONDITION THAT DOES NOT APPLY.]

D2016 - 42 C.F.R. § 493.803 Condition: Successful participation [proficiency testing]


D6000 - 42 C.F.R. § 493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director;
D6076 - 42 C.F.R. § 493.1441 Condition: Laboratories performing high complexity
testing; laboratory director;

In addition, other standards were found to be not met.

Proposed Sanctions Based on Unsuccessful Participation in Proficiency Testing –


Subsequent Occurrence

Pursuant to 42 C.F.R. §§ 493.1804(b)(1)(ii), 493.1806(a), and 493.1840(a)(3), we propose to


take sanction actions against the laboratory’s CLIA certificate based on Condition-level non-
compliance as evidenced by:

(1) The repeat history of proficiency testing failures in the [CHOOSE AS APPROPRIATE:
analyte, specialty, subspecialty] of [NAME OF ANALYTE, SPECIALTY,
SUBSPECIALTY], which constitutes a subsequent occurrence of unsuccessful participation in
proficiency testing; and

(2) The laboratory director’s failure to fulfill his responsibility for monitoring proficiency testing
to ensure that the laboratory is in compliance with the CLIA Condition of successful
participation in proficiency testing.

We propose to take the following sanction actions against the laboratory’s CLIA certificate:

• 42 C.F.R. §§ 493.803(b), 493.1804(b)(1)(ii), 493.1806, and 493.1840(a)(3) – Principal


Sanction: Limitation of the laboratory’s CLIA certificate for the [CHOOSE AS
APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE,
SPECIALTY, SUBSPECIALTY] for not less than six months effective [DATE OF
NOTICE + 15 CALENDAR DAYS (+ NUMBER OF OCCURRENCES OF
UNSUCCESSFUL PT IF IMPOSING A CMP)]. When a laboratory’s CLIA certificate is
limited in a specific [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty], the
laboratory will not be permitted to perform any patient testing in that [CHOOSE AS
APPROPRIATE: analyte, specialty, subspecialty.]

NOTE: The laboratory may continue to perform parallel testing on patient specimens in the
[CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF
ANALYTE, SPECIALTY, SUBSPECIALTY] if needed to implement corrective actions,
however, the laboratory may not report any patient test results in the [CHOOSE AS
APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE,
SPECIALTY, SUBSPECIALTY] during the period when its CLIA certificate is limited in
the [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF
ANALYTE, SPECIALTY, SUBSPECIALTY].

The laboratory has sixty (60) days in which to appeal the determination to limit its certificate
in the [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF
ANALYTE, SPECIALTY, SUBSPECIALTY]. If the laboratory chooses not to file an
appeal, limitation of its CLIA certificate in the [CHOOSE AS APPROPRIATE: analyte,
specialty, subspecialty] of [NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY] will
become effective [LIMITATION DATE]. If a timely hearing request is received, limitation
of the laboratory’s CLIA certificate in the [CHOOSE AS APPROPRIATE: analyte,
specialty, subspecialty] of [NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY] will
be effective with the date of the administrative hearing decision, if our determination of non-
compliance is upheld.

As noted below, pursuant to 42 C.F.R. §§ 493.1840(a)(4) and 493.1844(d)(2)(ii)(B),


limitation of the laboratory’s CLIA certificate will not be delayed even if a hearing is filed if
the laboratory fails to comply with the terms of the Directed Plan of Correction (see proposed
sanction of a Directed Plan of Correction below).

• 42 C.F.R. §§ 493.1804(b)(1)(ii), 493.1804(b)(2), 493.1806(c)(1), 493.1832, and


493.1844(h)(2) – Alternative Sanction: Directed Plan of Correction effective [DATE OF
NOTICE + 15 CALENDAR DAYS]. If this sanction is imposed, the laboratory is directed
to (1) address any actual or potential negative patient outcome during the period of
unsuccessful proficiency testing performance for the [CHOOSE AS APPROPRIATE:
analyte, specialty, subspecialty] of [NAME OF ANALYTE, SPECIALTY,
SUBSPECIALTY] and submit acceptable evidence that this has been done within ten (10)
calendar days from the date of the notice of imposition; (2) demonstrate that the laboratory
has established an effective oversight mechanism to prevent recurrences of proficiency
testing failure for all testing including testing in the [CHOOSE AS APPROPRIATE:
analyte, specialty, subspecialty] of [NAME OF ANALYTE, SPECIALTY,
SUBSPECIALTY] and submit acceptable evidence that such a mechanism has been
implemented within ten (10) calendar days from the date of the notice of imposition; and (3)
demonstrate satisfactory performance in two consecutive proficiency testing events for the
[CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF
ANALYTE, SPECIALTY, SUBSPECIALTY] before the limitation of the laboratory’s
certificate in the [CHOOSE AS APPROPRIATE: analyte, specialty or subspecialty] of
[NAME OF ANALYTE, SPECIALTY OR SUBSPECIALTY] can be lifted. The
laboratory may obtain the two consecutive proficiency testing events from any proficiency
testing program approved by CMS for the calendar year.

Acceptable evidence of correction to be submitted to meet the requirements of the Directed


Plan of Correction must include:

1) Documentation showing what corrective action(s) have been taken for patients found to
have been affected by the deficient practice;
2) How the laboratory has identified other patients having the potential to be affected by the
same deficient practice and what corrective action(s) have been taken;
3) What measure has been put into place or what systemic changes have been made to
ensure that the deficient practice does not recur; and,
4) How the corrective action(s) are being monitored to ensure the deficient practice does not
recur.

Please note that pursuant to 42 C.F.R. §§ 493.1840(a)(4) and 493.1844(d)(2)(ii)(B), if the


laboratory fails to comply with the terms of the Directed Plan of Correction above, it will
constitute failure to comply with a reasonable request from CMS for information and work
on materials necessary to determine continued eligibility for its CLIA certificate or continued
compliance with performance standards set by CMS, and will result in the limitation taking
effect [LIMITATION DATE], regardless of whether a hearing is filed. In addition, pursuant
to 42 C.F.R. § 493.1840(a)(7), failure to comply with alternative sanctions is a basis for
limitation, suspension, or revocation of any type of CLIA certificate.

• 42 C.F.R. §§ 493.1804(b)(1)(ii), 493.1804(b)(2), 493.1806(c)(3), 493.1810(d), 493.1814,


493.1834, and 493.1844(h)(2) – Alternative Sanction: Civil Money Penalty effective
[DATE OF NOTICE + 15 CALENDAR DAYS]. If this sanction is imposed, it will be in
the amount of $3,000 per day of non-compliance until compliance is met or until the
principal sanction of Limitation of the laboratory’s CLIA Certificate in the analyte
[ANALYTE NAME] (see proposed sanction of Limitation of the laboratory’s certificate
above) is imposed, whichever is earlier. If the laboratory does not appeal and the limitation is
effective on [LIMITATION EFFECTIVE DATE], the total Civil Money Penalty would
be [TOTAL CMP AMOUNT]. You are advised that if the laboratory requests a timely
hearing, the Civil Money Penalty amount will not be collected but will continue to run until
the hearing decision is rendered.

In determining the amount of the penalty, CMS has taken into account the following factors:
(1) the laboratory has a history of proficiency testing failures in the [CHOOSE AS
APPROPRIATE: analyte, specialty, subspecialty] OF [NAME OF ANALYTE,
SPECIALTY, SUBSPECIALTY] for [LIST PT TESTING EVENTS]*; (2) CLIA records
show that the laboratory also had proficiency testing failures for the analytes of [NAME OF
FAILED ANALYTES] for the [PT TESTING EVENTS]; (3) the laboratory director has
failed to fulfill his responsibility for monitoring proficiency testing to ensure that the
laboratory is in compliance with the CLIA Condition of successful participation in
proficiency testing; (4) the failure in proficiency testing indicates a high potential for
inaccurate patient test results as proficiency testing samples are tested in the same manner as
patient samples; and (5) the laboratory has failed to have an effective quality assessment
mechanism in place to ensure successful participation in proficiency testing and thereby to
ensure accurate and reliable patient test results.

* We note that on [DATE OF SA DESK REVIEW NOTICE OF 1ST UNSUCCESSFUL], the


State agency notified your laboratory of a first occurrence of unsuccessful participation in
proficiency testing for the [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of
[NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY], based on unsatisfactory results for
the [PT EVENTS]. Your laboratory submitted an allegation of compliance and evidence of
correction on [DATE OF AOC FOR 1ST UNSUCCESSFUL] which was deemed to be
acceptable. [LIST OTHER SA DESK REVIEW NOTIFICATIONS OF 1ST
UNSUCCESSFULS IF APPLICABLE.] The subsequent occurrence of unsuccessful participation
in PT indicates that the laboratory failed to either implement corrections as alleged or monitor for
the effectiveness of its corrective actions.
• 42 C.F.R. §§ 493.1804(b)(1)(ii), 493.1804(b)(2), 493.1807(b), 493.1808(b), 493.1826,
493.1844(d)(1), and 493.1844(h)(2) – Medicare Alternative Sanction: Suspension of the
laboratory’s approval to receive Medicare payments for any services performed in the
[CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF
ANALYTE, SPECIALTY, SUBSPECIALTY] effective [LIMITATION DATE].

[ADD THE FOLLOWING PARAGRAPH IF LIMITING AT THE ANALYTE


LEVEL:

The laboratory must agree in writing (in return for not having its Medicare approval
cancelled immediately) to not charge Medicare beneficiaries or their private insurance
carriers for the services for which Medicare payment is suspended, i.e., in the [CHOOSE AS
APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE,
SPECIALTY, SUBSPECIALTY]. Failure to provide this written agreement will result in
the cancellation of the laboratory’s approval to receive Medicare payment for all laboratory
services effective [LIMITATION DATE]. ]

As a consequence of the suspension of the approval to receive Medicare for services performed
in [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF
ANALYTE, SPECIALTY, SUBSPECIALTY], under section 1902(a)(9)(C) of the Social
Security Act and 42 C.F.R. § 440.30(c), payment under the Medicaid program, Title XIX of the
Social Security Act, will also no longer be available to the laboratory for all laboratory services
performed in the [CHOOSE as appropriate: analyte, specialty, subspecialty] of [NAME OF
ANALYTE, SPECIALTY, SUBSPECIALTY] effective [LIMITATION DATE]. See 42
C.F.R. § 440.2(b). Pursuant to 42 C.F.R. § 493.807, the suspension period for Medicare and
Medicaid approval for these services is for a period of not less than six months.

Please be advised that the imposition of sanctions cannot be avoided by closure of your
laboratory, discontinuation of testing, voluntary withdrawal from the CLIA program, or changes
in certificate to a lower level of testing.

Instructions for Sending in Your Response

The laboratory has ten (10) calendar days from the date of this notice, or until [NOTICE
DATE + 10 CALENDAR DAYS], to submit in writing any evidence or information as to
why the proposed sanctions for a subsequent occurrence of unsuccessful participation in
proficiency testing for the [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty]
of [NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY] and noncompliance with the
Conditions of successful participation in proficiency testing and laboratory director should
not be imposed. If we do not receive a timely submission or if we determine that the submission
is unpersuasive, we will notify you in writing that we will proceed to impose the above-
referenced sanctions. We will provide information regarding the laboratory’s appeal rights at that
time.

All responses, including written evidence as to why the proposed sanctions for a subsequent
occurrence of unsuccessful participation in proficiency testing for the [CHOOSE AS
APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE, SPECIALTY,
SUBSPECIALTY] should not be imposed should be sent to:

[Name of RO Manager]
[Name of Branch]
[Name of Division]
Centers for Medicare & Medicaid Services
[Street address]
[City, State, Zip]

If you have questions regarding this letter, please contact [STAFF NAME] at [PHONE
NUMBER].

Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

Enclosure: Form CMS-2567, Statement of Deficiencies

cc: [STATE AGENCY NAME]


13 RO (5/16/07) – sanction proposal – improper PT referral - SA survey finds improper PT
referral and referred to RO immediately for sanction

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA number: [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: PROPOSED SANCTIONS – IMPROPER PROFICIENCY TESTING REFERRAL

Dear Director/Owner(s):

For a laboratory to perform testing under the Clinical Laboratory Improvement Amendments of
1988 (CLIA), Public Law 100-578, it must comply with all CLIA requirements. These
requirements are found in section 353 of the Public Health Service Act (42 U.S.C. § 263a) and
42 Code of Federal Regulations, Part 493 (42 C.F.R. § 493). Federal regulations require onsite
surveys to determine whether or not a laboratory is in compliance with the applicable
regulations. Compliance with these regulations is a requirement for certification for the CLIA
program.

The [STATE AGENCY NAME] (State agency) conducted [CHOOSE SURVEY TYPE: an
initial, a routine recertification, a complaint] survey of your laboratory that was completed on
[SURVEY DATE]. Based on this survey, your laboratory was found to be out of compliance
with [NUMBER] CLIA Conditions: [DELETE DIRECTOR CONDITION THAT DOES
NOT APPLY]

D2000: 42 C.F.R. § 493.801 Enrollment and Testing of [Proficiency Testing]


Samples; and,
D6000: 42 C.F.R. § 493.1403 Laboratories performing moderate complexity
testing; laboratory director.
D6076: 42 C.F.R. § 493.1441 Condition: Laboratories performing high
complexity testing; laboratory director.

The Condition of proficiency testing is specifically supported by deficiency D2013 at 42 C.F.R.


§ 493.801(b)(4) for improper proficiency testing referral by reporting proficiency testing results
obtained from another laboratory. The Form CMS-2567, Statement of Deficiencies, which
details the cited deficiencies, is enclosed for your reference.

The State agency has referred your case to CMS for sanction action due to the improper
proficiency testing referral. CMS has reviewed your case and concurs with the State agency in its
findings and recommendations.
Accordingly, due to the improper referral of your laboratory’s proficiency testing samples
to another laboratory for analysis, and your laboratory’s failure to meet the Condition(s) of
laboratory director, [MODERATE AND/OR HIGH] complexity testing, CMS is proposing
to impose the following sanctions against your laboratory’s CLIA certificate:

• 42 U.S.C. § 263a(i)(3), 42 C.F.R. § 493.801(b)(4), § 493.1806(a) and (b), §


493.1840(a)(3) and (6), § 493.1840(b), and § 493.1840(e) – Principal Sanction:
Revocation of your laboratory’s CLIA certificate. The laboratory has 60 days in which to
appeal the determination to revoke its CLIA certificate. If the laboratory chooses not to
request an appeal, revocation of its CLIA certificate (if imposed) will become effective
[DATE OF THIS NOTICE + 60 CALENDAR DAYS]. If a timely hearing request is
received, revocation of the laboratory's CLIA certificate will become effective following
the administrative hearing decision, if our determination of non-compliance is upheld.

• 42 C.F.R. § 493.1804(b)(2), § 493.1806(c)(3), § 493.1834, and § 493.1840(b) –


Alternative Sanction: Civil Money Penalty effective [DATE OF NOTICE + 15
CALENDAR DAYS] in the amount of $3,000 per occurrence for each instance in which
your laboratory engaged in improper proficiency testing referral activities. The record
shows that [NUMBER] instances of improper proficiency testing referral occurred
[CITE THE INSTANCES, e.g., (API Q2/[Year] event chemistry proficiency testing
sample 6, API Q2/2000 event chemistry proficiency testing sample 7, API Q2/[Year]
event chemistry proficiency testing sample 8, API Q2/[Year] event chemistry proficiency
testing sample 9, and API Q2/[Year] event chemistry proficiency testing sample 10)]. At
$3,000 per occurrence, this amounts to a total Civil Money Penalty of [NUMBER x
$3,000]. (See Form CMS-2567 under D2013 for details regarding these occurrences.)

In determining the amount of the penalty, CMS has taken into account that the laboratory
was found to have engaged in improper proficiency testing referral activities in
[NUMBER] separate instances resulting in the determination by CMS that the laboratory
was out of compliance with [NUMBER] Condition-level requirements of CLIA.

• 42 C.F.R. § 493.1804(b)(2), § 493.1806(c)(1), § 493.1814, § 493.1832(b)(2), and §


493.1844(g)(1) – Alternative Sanction: Directed Portion of a Plan of Correction
effective [DATE OF NOTICE + 15 CALENDAR DAYS]. When this sanction is
imposed, you will be directed to submit to this office within ten calendar days from the
date of the notice of imposition a list of the names and addresses of all physicians and
other clients who have used some or all of your laboratory’s services from [DATE OF
PRIOR SURVEY OR OTHER DATE AS APPROPRIATE] to the present date. This
list may be used to advise your clients of the nature of your laboratory’s non-compliance
and the nature and effective date of any sanction actions imposed against your laboratory.

• 42 C.F.R. § 493.1807(a), § 493.1808(a), § 493.1842, and § 493.1844(d)(3) – Principal


Sanction: Cancellation of your laboratory’s approval to receive Medicare payments
for any services performed effective [DATE OF NOTICE + 15 CALENDAR DAYS].
When this sanction is imposed, under Section 1902(a)(9)(C) of the Social Security Act
and 42 C.F.R. § 440.30(c), payment under the Medicaid program, Title XIX of the Social
Security Act, will no longer be available to your laboratory for all services effective
[DATE OF NOTICE + 15 CALENDAR DAYS].
The laboratory is advised that the above sanctions cannot be avoided by the closure,
discontinuation of testing, voluntary withdrawal from the CLIA program, or changes in
certificate to a lower level of testing.

When your laboratory’s CLIA certificate is revoked, your laboratory will be required to cease all
patient laboratory testing, including waived testing or provider performed microscopy
procedures, regardless of whether the laboratory charges for such testing. Also, pursuant to 42
U.S.C. § 263a(i)(3) and 42 C.F.R. § 493.1840(a)(8), the owner(s) and operator (including the
director) of the laboratory will be prohibited from owning or operating (including directing) any
laboratory for at least two years from the date of the revocation. This prohibition applies to the
owner(s) as well as director at the time your laboratory was found to have been improperly
referring its proficiency testing specimens.

Appeal Rights

If [NAME OF LABORATORY] does not believe this determination to impose these additional
actions against its CLIA certificate is correct, the laboratory may request a hearing before an
administrative law judge (ALJ) of the Department Appeals Board in accordance with 42 C.F.R. §
493.1844(a)(1) - (2) and 42 C.F.R. Part 498. A written request for hearing must be filed no later
than sixty days after the date of this letter, or by [DATE OF THIS NOTICE + 60 CALENDAR
DAYS] (see 42 C.F.R. § 493.1844(f)). Such a request may be made directly (accompanied by a
copy of this letter) to:

Departmental Appeals Board


Civil Remedies Division
Attention: Oliver Potts
Cohen Building, Room G-644
330 Independence Ave, SW
Washington, D.C. 20201

A copy of the hearing request should be sent to:

[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

The request for hearing must contain a statement as to the specific issues and findings of fact and
conclusions of law in this determination with which the laboratory disagrees and the basis for the
laboratory’s contention that the specific issues and/or findings and conclusions are incorrect.
Evidence and arguments may also be presented at the hearing, where counsel may represent the
laboratory at its own expense. If a hearing is conducted and CMS’ determination is upheld,
the laboratory will be assessed a fee to cover the government’s cost related to the hearing.
See 42 C.F.R. § 493.643(d)(2).
If a timely request for hearing is filed, i.e., by [DATE OF THIS NOTICE + 60 CALENDAR
DAYS], CMS does not collect a Civil Money Penalty or revoke any type of CLIA certificate
until after an ALJ hearing that upholds CMS’ sanction determination. However, the Directed
Portion of a Plan of Correction to submit the laboratory’s client list and the cancellation of all
Medicare and Medicaid payment are effective [DATE OF THIS NOTICE + 15 CALENDAR
DAYS] regardless of whether a hearing is requested. See 42 C.F.R. §§ 493.1844(d)(1),
493.1844(d)(2)(i), 493.1844(d)(3), and 493.1844(h)(2).

Please be advised that the determination as to which alternative sanction or sanctions to impose,
including the amount of a Civil Money Penalty to impose per day or per violation, is not subject
to appeal. See 42 C.F.R. § 493.1844(c)(4) and (c)(7).

You have ten days from the date of this notice, or until [DATE OF NOTICE + 10
CALENDAR DAYS], to submit in writing any evidence or information as to why the
sanctions detailed above should not be imposed. If we do not receive a timely submission or if
we determine that the submission is unpersuasive, we will notify you in writing that we will
proceed to impose the above-referenced sanctions.

If you have questions regarding this letter, please contact [STAFF NAME] at [PHONE
NUMBER].

Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

Enclosure: Form CMS-2567, Statement of Deficiencies

cc: [DIRECTOR NAME] Via certified mail, return receipt # _________________________


[ADDRESS OTHER THAN LAB ADDRESS]
[CITY, STATE, ZIP]

[STATE AGENCY NAME]


14 RO (5/16/07) – sanction imposition – standards out – POC unacceptable – response to
sanction proposal notice not acceptable, sanctions imposed

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA number: [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: IMPOSITION OF SANCTIONS – STANDARDS NOT MET

Dear Director/Owner(s):

[NAME OF LABORATORY] was notified by our letter dated [DATE OF PROPOSED


SANCTION NOTICE] of proposed sanctions against the laboratory’s CLIA certificate based
on the laboratory’s failure to meet all CLIA standard-level requirements, and based on the failure
by the owner(s) and director of the laboratory to comply with the certificate requirements and
performance standards as evidenced by the deficiencies cited at the survey completed on
[SURVEY DATE]. The laboratory was given ten days from the date of the [DATE OF
PROPOSED SANCTION NOTICE] letter to submit information or written evidence as to why
these sanctions should not be imposed.

Your laboratory responded with a submission on [DATE]. The submission included [LIST
WHAT WAS INCLUDED IN THE SUBMISSION].

We have carefully reviewed the entire [DATE OF SUBMISSION] submission and determined
that your laboratory’s plan of correction is not acceptable. The evidence submitted shows that the
laboratory continues to be out of compliance with CLIA standard-level requirements as cited
during the [SURVEY DATE] survey.

As you were advised by the State agency in its [DATES OF SA LETTERS] letters, the
laboratory’s plan of correction must be substantiated by acceptable evidence of correction, which
must include:

1) Documentation showing what corrective action(s) have been taken for patients found to have
been affected by the deficient practice:
2) How the laboratory has identified other patients having the potential to be affected by the
same deficient practice and what corrective action(s) has been taken:
3) What measure has been put into place or what systemic changes the laboratory has made to
ensure that the deficient practice does not recur; and
4) How the corrective action(s) are being monitored to ensure the deficient practice does not
recur.
For your information, the following details by deficiency tag (D-tag) why [NAME OF
LABORATORY]’s [DATE OF SUBMISSION] submission does not constitute acceptable
evidence of correction.

[PROVIDE REVIEW OF SUBMISSION AND WHY NOT ACCEPTABLE.]

IMPOSED SANCTIONS

Accordingly, as the laboratory has failed to meet all CLIA standard-level requirements and based
on the failure the owner(s) and director of the laboratory to comply with the certificate
requirements and performance standards as evidenced by the deficiencies cited at the survey
completed on [SURVEY DATE], we are taking action to impose sanctions against [NAME OF
LABORATORY]’s CLIA certificate as proposed in our [DATE OF SANCTION PROPOSAL
NOTICE] letter, with effective dates as follows:

• Revocation of the laboratory’s CLIA certificate effective [DATE OF THIS NOTICE +


60 DAYS]. The laboratory has 60 days to appeal the determination to revoke the laboratory’s
CLIA certificate. If a timely hearing request is received, revocation of the laboratory’s CLIA
certificate will become effective following the administrative hearing decision, if our
determination of non-compliance is upheld.

• Cancellation of the laboratory's approval to receive Medicare payments for any


services performed on or after [DATE]. As a result, under section 1902 (a)(9)(C) of the
Social Security Act and 42 C.F.R. § 440.30(c), payment for all laboratory services under
the Medicaid program, Title XIX of the Social Security Act, is no longer available to the
laboratory for any laboratory services performed on or after [DATE]. See 42 C.F.R. §
440.2(b).

Appeal Rights

If [NAME OF LABORATORY] does not believe this determination to impose these actions
against its CLIA certificate is correct, the laboratory may request a hearing before an
administrative law judge (ALJ) of the Departmental Appeals Board in accordance with 42 C.F.R.
§ 493.1844(a)(1)-(2) and 42 C.F.R. §§ 498.40 through 498.78. A written request for hearing
must be filed no later than sixty days after the date of this letter is received (see 42 C.F.R. §
493.1844(f)). Such a request may be made directly (accompanied by a copy of this letter) to:

Departmental Appeals Board


Civil Remedies Division
Attention: Oliver Potts
Cohen Building, Room G-644
330 Independence Ave, SW
Washington, D.C. 20201

A copy of the hearing request should be sent to:

[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

The request for hearing must contain a statement as to the specific issues and findings of fact and
conclusions of law in this determination with which the laboratory disagrees and the basis for the
laboratory’s contention that the specific issues and/or findings and conclusions are incorrect.
Evidence and arguments may also be presented at the hearing, where counsel may represent the
laboratory at its own expense. If a hearing is conducted and CMS’ determination is upheld,
the laboratory will be assessed a fee to cover the government’s cost related to the hearing.
See 42 C.F.R. § 493.643(d)(2).

If a timely request for hearing is filed, i.e., by [DATE OF THIS NOTICE + 60 CALENDAR
DAYS], CMS does not revoke any type of CLIA certificate until after an ALJ hearing that
upholds CMS’ sanction determination. However, cancellation of all Medicare and Medicaid
payment is effective [DATE], regardless of whether a hearing is requested. See 42 C.F.R. §§
493.1844(d)(3) and 493.1844(h)(2).

The laboratory is reminded that the above sanctions cannot be avoided by the closure,
discontinuation of testing, voluntary withdrawal from the CLIA program, or changes in
certificate to a lower level of testing.

When a laboratory’s CLIA certificate is revoked, it is required to cease all patient laboratory
testing, including waived and provider performed microscopy testing and regardless of whether
or not the laboratory charges for the testing. Also, under revocation, 42 U.S.C. § 263a(i)(3) and
42 C.F.R. § 493.1840(a)(8) prohibit the owner(s) or operator(s) (including director – see 42
C.F.R. § 493.2) from owning or operating (or directing) a laboratory for at least two years from
the date of the revocation. This prohibition applies to the owner(s) as well as the director at the
time that the deficiencies were found which led to the current sanction actions.

In accordance with 42 C.F.R. § 493.1850(a)(2), information regarding the actions against the
laboratory’s CLIA certificate will appear in the Laboratory Registry for the calendar year in
which the actions are imposed. In addition, pursuant to 42 C.F.R. § 493.1844(g)(1), we will
notify the general public by means of a notice published in a local newspaper.
If you have questions regarding this letter, please contact [STAFF NAME] at [PHONE
NUMBER].
Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

Enclosure: Form CMS-2567, Statement of Deficiencies

cc: [DIRECTOR NAME] Via certified mail, return receipt # _________________________


[ADDRESS OTHER THAN LAB ADDRESS]
[CITY, STATE, ZIP]

[STATE AGENCY NAME]


15 RO (5/16/07) – sanction imposition – Conditions Out – AOC not credible, sanctions imposed

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA # [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: IMPOSITION OF SANCTIONS – CONDITIONS OUT

Dear Director/Owner(s):

[NAME OF LABORATORY] was notified by our letter dated [DATE OF PROPOSED


SANCTION NOTICE] of proposed sanctions against the laboratory’s CLIA certificate based
on the laboratory’s failure to meet all CLIA Conditions, and based on the failure by the owner(s)
and director of the laboratory to comply with the certificate requirements and performance
standards as evidenced by the deficiencies cited at the survey completed on [SURVEY DATE].
The laboratory was given ten days from the date of the [DATE OF PROPOSED SANCTION
NOTICE] letter to submit information or written evidence as to why these sanctions should not
be imposed.

Your laboratory responded with a submission on [DATE]. The submission included [LIST
WHAT WAS INCLUDED IN THE SUBMISSION].

We have carefully reviewed the entire [DATE OF SUBMISSION] submission and determined
that your laboratory’s allegation of compliance is not credible and evidence of correction is not
acceptable. The evidence submitted shows that the laboratory continues to be out of compliance
with CLIA Condition-level requirements as cited during the [SURVEY DATE] survey.

As you were advised by the State agency in its [DATES OF SA LETTERS] letters, a credible
allegation of compliance, as defined by the CLIA requirements at 42 C.F.R. § 493.2, is a
statement or document that is:

1) Made by a representative of a laboratory with a history of having maintained a commitment


to compliance and taking corrective action when required;
2) Realistic in terms of the possibility of the corrective action being accomplished between the
date of the survey and the date of the allegation; and
3) Indicates resolution of the problem.

It is important to note that for it to be credible, the allegation of compliance must be complete
and address each of the deficiencies. For each deficiency, the allegation of compliance must
include a corrective action date that is realistic in terms of the action being accomplished
between the date of the survey and the planned date of completion. In addition, the allegation of
compliance must contain information that indicates resolution of the problems.

As you were also advised by the State agency in its [DATES OF SA LETTERS] letters, the
laboratory’s allegation of compliance must be substantiated by acceptable evidence of correction,
which must include:

1) Documentation showing what corrective action(s) have been taken for patients found to
have been affected by the deficient practice:
2) How the laboratory has identified other patients having the potential to be affected by the
same deficient practice and what corrective action(s) has been taken:
3) What measure has been put into place or what systemic changes the laboratory has made
to ensure that the deficient practice does not recur; and,
4) How the corrective action(s) are being monitored to ensure the deficient practice does not
recur.

For your information, the following details by deficiency tag (D-tag) why [NAME OF
LABORATORY]’s [DATE OF SUBMISSION] submission does not constitute a credible
allegation of compliance and acceptable evidence of correction.

[PROVIDE REVIEW OF SUBMISSION AND WHY NOT ACCEPTABLE.]

IMPOSED SANCTIONS

Accordingly, as the laboratory has failed to meet all CLIA Conditions and based on the failure of
the owner(s) and director of the laboratory to comply with the certificate requirements and
performance standards as evidenced by the deficiencies cited at the survey completed on
[SURVEY DATE], we are taking action to impose sanctions against [NAME OF
LABORATORY]’s CLIA certificate as proposed in our [DATE OF SANCTION PROPOSAL
NOTICE] letter, with effective dates as follows:

• Revocation of the laboratory’s CLIA certificate effective [DATE OF THIS NOTICE +


60 CALENDAR DAYS]. The laboratory has 60 days to appeal the determination to revoke
the laboratory’s CLIA certificate. If a timely hearing request is received, revocation of the
laboratory’s CLIA certificate will become effective following the administrative hearing
decision, if our determination of non-compliance is upheld.

• Civil Money Penalty of $3,000 per day for each day of non-compliance effective
[BEGIN DATE] and will continue to accrue until it can be verified that the laboratory is in
compliance with all Condition-level requirements or the laboratory’s CLIA certificate is
revoked.

• Directed Portion of a Plan of Correction effective [Date] – The laboratory is directed


to submit to this office by [DATE OF NOTICE + 10 CALENDAR DAYS] a list of the
names and addresses of all physicians and other clients who have used some or all of the
laboratory’s services since [DATE OF PRIOR SURVEY OR OTHER DATE AS
APPROPRIATE]. We request that this list be provided as an electronic file, in an
EXCEL database format if possible. This list may be used to advise the laboratory's
clients of the nature of its non-compliance and the nature and effective date of sanction
actions imposed against the laboratory.

• Cancellation of the laboratory's approval to receive Medicare payments for any


services performed on or after [DATE]. As a result, under section 1902 (a)(9)(C) of the
Social Security Act and 42 C.F.R. § 440.30(c), payment for all laboratory services under
the Medicaid program, Title XIX of the Social Security Act, is no longer be available to
the laboratory for any laboratory services performed on or after [DATE]. See 42 C.F.R. §
440.2(b).

Appeal Rights

If [NAME OF LABORATORY] does not believe this determination to impose these actions
against its CLIA certificate is correct, the laboratory may request a hearing before an
administrative law judge (ALJ) of the Departmental Appeals Board in accordance with 42 C.F.R.
§ 493.1844(a)(1)-(2) and 42 C.F.R. §§ 498.40 through 498.78. A written request for hearing
must be filed no later than sixty days after the date of this letter is received (see 42 C.F.R. §
493.1844(f)). Such a request may be made directly (accompanied by a copy of this letter) to:

Departmental Appeals Board


Civil Remedies Division
Attention: Oliver Potts
Cohen Building, Room G-644
330 Independence Ave, SW
Washington, D.C. 20201

A copy of the hearing request should be sent to:

[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

The request for hearing must contain a statement as to the specific issues and findings of fact and
conclusions of law in this determination with which the laboratory disagrees and the basis for the
laboratory’s contention that the specific issues and/or findings and conclusions are incorrect.
Evidence and arguments may also be presented at the hearing, where counsel may represent the
laboratory at its own expense. If a hearing is conducted and CMS’ determination is upheld,
the laboratory will be assessed a fee to cover the government’s cost related to the hearing.
See 42 C.F.R. § 493.643(d)(2).

Please be advised that the determination as to which alternative sanction or sanctions to impose,
including the amount of a Civil Money Penalty to impose per day or per violation, is not subject
to appeal. See 42 C.F.R. § 493.1844(c)(4).

If a timely request for hearing is filed, i.e., by [DATE OF THIS NOTICE + 60 CALENDAR
DAYS], CMS does not collect the Civil Money Penalty or revoke any type of CLIA certificate
until after an ALJ hearing that upholds CMS’ sanction determination. However, the Directed
Portion of a Plan of Correction and cancellation of all Medicare and Medicaid payments are
effective [DATE], regardless of whether a hearing is requested. See 42 C.F.R. §§
493.1844(d)(1)-(3) and 493.1844(h)(2). Please be advised that failure to comply with an
alternative sanction is independent basis for suspension, limitation or revocation of any type of
CLIA certificate.

The laboratory is reminded that the above sanctions cannot be avoided by the closure,
discontinuation of testing, voluntary withdrawal from the CLIA program, or changes in
certificate to a lower level of testing.

When a laboratory’s CLIA certificate is revoked, it is required to cease all patient laboratory
testing, including waived and provider performed microscopy testing and regardless of whether
or not the laboratory charges for the testing. Also, under revocation, 42 U.S.C. § 263a(i)(3) and
42 C.F.R. § 493.1840(a)(8) prohibit the owner(s) or operator(s) (including director – see 42
C.F.R. § 493.2) from owning or operating (or directing) a laboratory for at least two years from
the date of the revocation. This prohibition applies to the owner(s) as well as the director at the
time that the deficiencies were found which led to the current sanction actions.

In accordance with 42 C.F.R. § 493.1850(a)(2), information regarding the actions against the
laboratory’s CLIA certificate will appear in the Laboratory Registry for the calendar year in
which the actions are imposed. In addition, pursuant to 42 C.F.R. § 493.1844(g)(1), we will
notify the general public by means of a notice published in a local newspaper.

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[TELEPHONE NUMBER].

Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

cc: [DIRECTOR NAME] Via certified mail, return receipt # _________________________


[ADDRESS OTHER THAN LAB ADDRESS]
[CITY, STATE, ZIP]

[STATE AGENCY NAME]


16 RO (5/16/07) – sanction imposition – IJ – IJ not removed – sanctions imposed

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA # [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: IMPOSITION OF SANCTIONS – CONDITIONS OUT – IMMEDIATE JEOPARDY

Dear Director/Owner(s):

[NAME OF LABORATORY] was notified by our letter dated [DATE OF SANCTION


PROPOSAL NOTICE] of proposed sanctions against the laboratory’s CLIA certificate based
on the findings of immediate jeopardy and the laboratory’s failure to meet all CLIA Conditions,
and based on the failure by the owners and director of the laboratory to comply with the
certificate requirements and performance standards as evidenced by the deficiencies cited at the
survey completed on [SURVEY DATE]. The laboratory was given ten days from the date of the
[DATE OF SANCTION PROPOSAL NOTICE] letter to submit information or written
evidence as to why these sanctions should not be imposed.

Your laboratory responded with a submission on [DATE]. The submission consisted of [LIST
WHAT WAS INCLUDED IN THE SUBMISSION].

We have carefully reviewed the entire [DATE OF SUBMISSION] submission and determined
that your laboratory’s allegation of compliance is not credible and evidence of correction is not
acceptable. The evidence submitted shows that the laboratory continues to be out of compliance
with CLIA requirements as cited during the [SURVEY DATE] survey and immediate jeopardy
continues to exist.

Your laboratory’s [DATE OF SUBMISSION] submission provides additional evidence of poor


laboratory practice beyond what was cited at the survey and leads us to question the
effectiveness of the laboratory’s oversight mechanisms and the competency of personnel. The
submission also fails to provide assurance of the laboratory’s ability to provide accurate and
reliable patient results.

As you were advised by the State agency in its [DATES OF SA LETTERS] letters, a credible
allegation of compliance, as defined by the CLIA requirements at 42 C.F.R. § 493.2, is a
statement or document that is:

1) Made by a representative of a laboratory with a history of having maintained a


commitment to compliance and taking corrective action when required;
2) Realistic in terms of the possibility of the corrective action being accomplished between
the date of the survey and the date of the allegation; and
3) Indicates resolution of the problem.

It is important to note that for it to be credible, the allegation of compliance must be complete
and address each of the deficiencies. For each deficiency, the allegation of compliance must
include a corrective action date that is realistic in terms of the action being accomplished
between the date of the survey and the planned date of completion. In addition, the allegation of
compliance must contain information that indicates resolution of the problems.

As you were also advised by the State agency in its [DATES OF SA LETTERS] letters, the
laboratory’s allegation of compliance must be substantiated by acceptable evidence of correction,
which must include:

1) Documentation showing what corrective action(s) have been taken for patients found to
have been affected by the deficient practice;
2) How the laboratory has identified other patients having the potential to be affected by the
same deficient practice and what corrective action(s) has been taken;
3) What measure has been put into place or what systemic changes the laboratory has made
to ensure that the deficient practice does not recur; and,
4) How the corrective action(s) are being monitored to ensure the deficient practice does not
recur.

For your information, the following details by deficiency tag (D-tag) why [NAME OF
LABORATORY]’s [DATE OF SUBMISSION] submission does not constitute a credible
allegation of compliance and acceptable evidence of correction.

[PROVIDE REVIEW OF SUBMISSION AND WHY NOT ACCEPTABLE.]

IMPOSED SANCTIONS

Accordingly, as the laboratory has failed to meet all CLIA Conditions and based on the failure of
the owners and director of the laboratory to comply with the certificate requirements and
performance standards as evidenced by the deficiencies cited at the survey completed on
[Survey date] which led to the determination of immediate jeopardy, we are taking action to
impose the following sanctions against [NAME OF LABORATORY]’s CLIA certificate as
proposed in our [DATE OF SANCTION PROPOSAL NOTICE] letter:

• Revocation of the laboratory’s CLIA certificate effective [DATE APPEAL PERIOD


EXPIRES].

• Suspension of the laboratory’s CLIA certificate effective [DATE].

• Civil Money Penalty of $10,000 per day for each day of non-compliance effective
[BEGIN DATE] until [END DATE], the date of suspension of the laboratory’s CLIA
certificate.

• Directed Portion of a Plan of Correction effective [DATE] – The laboratory is directed


to submit to this office by [DATE OF NOTICE + 10 CALENDAR DAYS] a list of the
names and addresses of all physicians and other clients who have used some or all of the
laboratory’s services since [DATE OF PRIOR SURVEY OR OTHER DATE AS
APPROPRIATE]. We request that this list be provided as an electronic file, in an
EXCEL database format if possible. This list may be used to advise the laboratory's
clients of the nature of its non-compliance and the nature and effective date of sanction
actions imposed against the laboratory.

• Cancellation of the laboratory's approval to receive Medicare payments for any


services performed on or after [DATE]. As a result, under section 1902 (a)(9)(C) of the
Social Security Act and 42 C.F.R. § 440.30(c), payment for all laboratory services under
the Medicaid program, Title XIX of the Social Security Act, is no longer be available to
the laboratory for any laboratory services performed on or after [DATE]. See 42 C.F.R. §
440.2(b).

Please refer to our [DATE OF SANCTION PROPOSAL NOTICE] letter for the laboratory’s
appeal rights and instructions on how to file an appeal. For an appeal request to be timely, it must
be requested by no later than [DATE APPEAL PERIOD EXPIRES] as noted in the [DATE
OF SANCTION PROPOSAL NOTICE] letter. If an appeal request is not filed, revocation of
[NAME OF LABORATORY]’s CLIA certificate will be effective [DATE APPEAL PERIOD
EXPIRES].

We remind the laboratory that the determination that a laboratory’s deficiencies pose immediate
jeopardy is not subject to appeal. In addition, the determination as to which alternative sanction
or sanctions to impose, including the amount of a Civil Money Penalty to impose per day or per
violation, is not subject to appeal. See 42 C.F.R. § 493.1844(c)(4), (c)(6) and (c)(7).

If a timely request for hearing is filed, revocation of the laboratory’s CLIA certificate will
become effective following the administrative hearing decision, if our determination of non-
compliance is upheld. However, suspension of the laboratory’s CLIA certificate remains
effective [DATE OF SUSPENSION], and the Directed Portion of a Plan of Correction and
cancellation of all Medicare and Medicaid payment remain effective [DATE], regardless of
whether a hearing is requested. See 42 C.F.R. 493.1844(d)(1)-(3) and 493.1844(h)(1). Please be
advised that failure to comply with an alternative sanction is independent basis for suspension,
limitation or revocation of any type of CLIA certificate.

In addition, if a timely hearing request is filed, the civil money penalty amount will not be
collected until after the hearing decision is rendered. However, the $10,000 per day accrues from
[CMP BEGIN DATE] until the suspension of the laboratory's CLIA certificate.

The laboratory is reminded that the above sanctions cannot be avoided by the closure,
discontinuation of testing, voluntary withdrawal from the CLIA program, or changes in
certificate to a lower level of testing.

We also remind the laboratory that as its CLIA certificate is suspended effective [Date], it
is not permitted to perform any patient laboratory testing, including waived testing and
regardless of whether or not the laboratory charges for the testing. (The laboratory may
continue to perform parallel testing on patient specimens if needed to implement corrective
actions. However, the laboratory may not report any patient test results during the period when
its CLIA certificate is suspended.)
The laboratory is also reminded that under revocation, 42 U.S.C. § 263a(i)(3) and 42 C.F.R. §
493.1840(a)(8) prohibit the owner(s) or operator(s) (including director – see 42 C.F.R. § 493.2)
from owning or operating (or directing) a laboratory for at least two years from the date of the
revocation. This prohibition applies to the owner(s) as well as the director at the time that the
deficiencies were found which led to the current sanction action.

In accordance with 42 C.F.R. § 493.1850(a)(2), information regarding the actions against the
laboratory’s CLIA certificate will appear in the Laboratory Registry for the calendar year in
which the actions are imposed. In addition, pursuant to 42 C.F.R. § 493.1844(g)(1), we will
notify the general public by means of a notice published in a local newspaper.

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[TELEPHONE NUMBER].

Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

cc: [DIRECTOR NAME] Via certified mail, return receipt # _________________________


[ADDRESS OTHER THAN LAB ADDRESS]
[CITY, STATE, ZIP]

[STATE AGENCY NAME]


17 RO (5/16/07) – sanction imposition – subsequent unsuccessful PT– evidence does not refute
subsequent unsuccessful, sanctions imposed

IMPORTANT NOTICE – ACTION NECESSARY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA # [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: IMPOSITION OF SANCTIONS – UNSUCCESSFUL PARTICIPATION IN


PROFICIENCY TESTING – SUBSEQUENT OCCURRENCE

Dear Director and Owner(s):

By letter dated [DATE OF SANCTION PROPOSAL NOTICE], we proposed sanctions


against [NAME OF LABORATORY] as a result of a subsequent occurrence of unsuccessful
participation in proficiency testing in the [CHOOSE AS APPROPRIATE: analyte, specialty,
subspecialty] of [NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY], which resulted in
the determination of noncompliance with the Condition-level requirements of successful
participation in proficiency testing and laboratory director. We provided the laboratory ten (10)
days to submit in writing any evidence or information as to why these proposed sanctions should
not be imposed.

In response, we received on [DATE SUBMISSION RECEIVED], the laboratory’s submission


under cover letter dated [SUBMISSION DATE]. The laboratory’s [SUBMISSION DATE]
submission consisted of [LIST WHAT WAS SUBMITTED].

Imposition of Sanctions Based on Unsuccessful Participation in Proficiency Testing –


Subsequent Occurrence

Based on careful review of the laboratory’s [SUBMISSION DATE] submission, we find no


evidence to refute the subsequent occurrence of unsuccessful participation in proficiency testing
in the [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF
ANALYTE, SPECIALTY, SUBSPECIALTY], which resulted in the determination of
noncompliance with the Condition-level requirements of successful participation in proficiency
testing and laboratory director.

As detailed on the form CMS-2567 under the Condition-level requirements at deficiency tags
[LIST D-TAGS: I.E., D2016, D6000, D6076] the laboratory has a repeat history of
unsatisfactory proficiency testing performance in the [CHOOSE AS APPROPRIATE: analyte,
specialty, subspecialty] of [NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY]
constituting a subsequent occurrence of unsuccessful participation in proficiency testing as
follows:
Proficiency Testing Event PT Provider Test Score

[LIST UNSATISFACTORY EVENTS.]

The laboratory’s [SUBMISSION DATE] submission provides no evidence to indicate that


unsatisfactory proficiency testing performance for [NAME OF ANALYTE, SPECIALTY,
SUBSPECIALTY] did not occur for the [LIST PT EVENTS]. Accordingly, we are imposing
the sanctions proposed in our [DATE OF SANCTION PROPOSAL NOTICE] letter against
the laboratory’s CLIA certificate, with effective dates as follows:

• 42 C.F.R. §§ 493.803(b), 493.807, 493.1804(b)(1)(ii), 493.1806, and 493.1840(a)(3) –


Principal Sanction: Limitation of the laboratory’s CLIA certificate for the [CHOOSE
AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE,
SPECIALTY, SUBSPECIALTY] for not less than six months effective [DATE]. When
a laboratory’s CLIA certificate is limited in a specific [CHOOSE AS APPROPRIATE:
analyte, specialty, subspecialty], the laboratory is not permitted to perform any patient
testing in that [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty].*

The laboratory has sixty (60) days from the date of this notice, or until [DATE OF THIS
NOTICE + 60 CALENDAR DAYS], in which to appeal the determination to limit its
certificate in the [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of
[NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY]. If the laboratory chooses
not to file an appeal, limitation of its CLIA certificate in the [CHOOSE AS
APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE,
SPECIALTY, SUBSPECIALTY] will become effective [DATE]. If a timely hearing
request is received, limitation of the laboratory’s CLIA certificate in the [CHOOSE AS
APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE,
SPECIALTY, SUBSPECIALTY] will be effective with the date of the administrative
hearing decision, if our determination of non-compliance is upheld.

[ADD THE FOLLOWING PARAGRAPH IF LIMITING AT ANALYTE LEVEL.]

Note: The laboratory must agree in writing to the limitation at the analyte level (i.e.,
[NAME OF ANALYTE] so that the limitation is not imposed at the [CHOOSE AS
APPROPRIATE: specialty, subspecialty] level (i.e., [NAME OF SPECIALTY OR
SUBSPECIALTY]). See agreement enclosed.

*The laboratory is reminded that it may continue to perform parallel testing on patient specimens in the [CHOOSE
AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE, SPECIALTY,
SUBSPECIALTY] if needed to implement corrective actions, however, the laboratory may not report any patient
test results in the [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE,
SPECIALTY, SUBSPECIALTY] during the period when its CLIA certificate is limited in the [CHOOSE AS
APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE, SPECIALTY,
SUBSPECIALTY].
• 42 C.F.R. §§ 493.1804(b)(1)(ii), 493.1804(b)(2), 493.1806(c)(1), 493.1832 and
493.1844(h)(2) – Alternative Sanction: Directed Plan of Correction effective [DATE]
as stated in our [DATE OF SANCTION PROPOSAL NOTICE] letter, and amended as
follows. The laboratory is directed to address any actual or potential negative patient
outcome during the period of unsuccessful proficiency testing performance for the
[CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF
ANALYTE, SPECIALTY, SUBSPECIALTY] and submit acceptable evidence that this
has been done within ten (10) calendar days from the date of this notice; (2) demonstrate
that the laboratory has established an effective oversight mechanism to prevent
recurrences of proficiency testing failure for all testing including testing in the
[CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF
ANALYTE, SPECIALTY, SUBSPECIALTY] and submit acceptable evidence that
such a mechanism has been implemented within ten (10) calendar days from this notice;
and (3) demonstrate satisfactory performance in two consecutive proficiency testing
events for the [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of
[NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY] before the limitation of the
laboratory’s certificate in the [CHOOSE AS APPROPRIATE: analyte, specialty,
subspecialty] of [NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY] can be
lifted. The laboratory may obtain the two consecutive proficiency testing events from any
proficiency testing program approved by CMS for the calendar year.

• 42 C.F.R. §§ 493.804(b)(1)(ii), 493.1804(b)(2), 493.1806(c)(3), 493.1810(d), 493.1814,


493.1834, and 493.1844(h)(2) – Alternative Sanction: Civil Money Penalty effective
[CMP EFFECTIVE DATE] (as stated in our notice dated [DATE OF SANCTION
PROPOSAL NOTICE]) in the amount of $3,000 per day of non-compliance until
compliance is met (i.e., compliance with the Directed Plan of Correction above) or until
the principal sanction of Limitation of the laboratory’s CLIA certificate in the [CHOOSE
AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE,
SPECIALTY, SUBSPECIALTY] is imposed (see imposed sanction of Limitation of the
laboratory’s certificate above). As you were advised in our [DATE OF SANCTION
PROPOSAL NOTICE] letter, if the laboratory requests a hearing, the Civil Money
Penalty amount will not be collected until after the hearing decision is rendered.

• 42 C.F.R. §§ 493.1804(b)(1)(ii), 493.1804(b)(2), 493.1807(b), 493.1808(b), 493.1826,


493.1844(d)(1), and 493.1844(h)(2) – Medicare Alternative Sanction: Suspension of the
laboratory’s approval to receive Medicare payments for any services performed in the
[CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF
ANALYTE, SPECIALTY, SUBSPECIALTY] effective [DATE].

The laboratory must agree in writing (in return for not having its Medicare approval
cancelled immediately) to not charge Medicare beneficiaries or their private insurance
carriers for the services for which Medicare payment is suspended, i.e., in the [CHOOSE
AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE,
SPECIALTY, SUBSPECIALTY]. For your convenience, we are enclosing a statement
to this effect for the laboratory’s owner(s) to sign to be returned within ten (10) days from
the date of this notice, or by [NOTICE DATE + 10 CALENDAR DAYS]. Failure to
provide this written agreement by [NOTICE DATE + 10 CALENDAR DAYS] will
result in the cancellation of the laboratory’s approval to receive Medicare payment for all
laboratory services effective [DATE].

As a consequence of the suspension of the approval to receive Medicare, under section


1902(a)(9)(C) of the Social Security Act and 42 C.F.R. § 440.30(c), payment under the
Medicaid program, Title XIX of the Social Security Act, will also no longer be available
to the laboratory for all laboratory services performed in the [CHOOSE AS
APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE,
SPECIALTY, SUBSPECIALTY] effective [DATE]. See 42 C.F.R. § 440.2(b).
Pursuant to 42 C.F.R. § 493.807, the suspension period for Medicare and Medicaid
approval is for a period of not less than six months.

The laboratory is reminded that pursuant to 42 C.F.R. § 493.1840(a)(7), failure to comply with
alternative sanctions is also a basis for limitation, suspension, or revocation of any type of CLIA
certificate.

If a laboratory’s CLIA certificate is revoked, it will be required to cease all patient laboratory
testing, including waived testing or provider performed microscopy procedures, regardless of
whether the laboratory charges for such testing. Also under revocation, 42 U.S.C. § 263a(i)(3)
and 42 C.F.R. § 1840(a)(8) prohibit the owners or operators (including the laboratory director –
see 42 C.F.R. § 493.2) from owning or operating (or directing) a laboratory for at least two years
from the date of the revocation. This prohibition applies to the owners and operators, as well as
the laboratory director at the time the deficiencies were found which lead to the current sanction
actions.

In accordance with 42 C.F.R. § 493.1850(a)(2), information regarding the above imposed


sanctions against the laboratory’s CLIA certificate will appear in the Laboratory Registry for the
calendar year in which the actions are imposed. In addition, pursuant to 42 C.F.R. §
493.1844(g)(1), we will notify the general public by means of a notice published in a local
newspaper.

Appeal Rights

If [NAME OF LABORATORY] does not believe this determination to impose these actions
against its CLIA certificate is correct, the laboratory may request a hearing before an
administrative law judge (ALJ) of the Department Appeals Board in accordance with 42 C.F.R. §
493.1844(a)(1)-(2) and 42 C.F.R. Part 498. A written request for hearing must be filed no later
than sixty (60) days from the date of this notice, or by [DATE OF THIS NOTICE + 60
CALENDAR DAYS] (see 42 C.F.R. § 493.1844(f)). Such a request may be made directly
(accompanied by a copy of this letter) to:

Departmental Appeals Board


Civil Remedies Division
Attention: Oliver Potts
Cohen Building, Room G-644
330 Independence Ave, SW
Washington, D.C. 20201

A copy of the hearing request should be sent to:


[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

The request for hearing must contain a statement as to the specific issues and findings of fact and
conclusions of law in this determination with which the laboratory disagrees and the basis for the
laboratory’s contention that the specific issues and/or findings and conclusions are incorrect.
Evidence and arguments may also be presented at the hearing, where counsel may represent the
laboratory at its own expense. If a hearing is conducted and CMS’ determination is upheld,
the laboratory will be assessed a fee to cover the government’s cost related to the hearing.
See 42 C.F.R. § 493. 643(d)(2).

As noted above, if a timely request for hearing is filed, i.e., by [DATE OF THIS NOTICE + 60
CALENDAR DAYS], CMS does not limit a laboratory’s CLIA certificate or collect the Civil
Money Penalty until after an ALJ hearing.

Please be advised that the determination as to which alternative sanction or sanctions to impose,
including the amount of a Civil Money Penalty imposed per day or per violation, is not subject to
appeal. See 42 C.F.R. § 493.1844(c)(4) and (c)(7). Pursuant to 42 C.F.R. § 1844(d)(1), the
effective date of an alternative sanction (other than a civil money penalty) is not delayed because
the laboratory has appealed and the hearing or the hearing decision is pending. As noted above,
failure to comply with alternative sanctions is basis for suspension, limitation, or revocation of
any type of CLIA certificate. See 42 C.F.R. § 493.1840(a)(7).

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[TELEPHONE NUMBER].

Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

Enclosure: Agreement

cc: [DIRECTOR NAME] Via certified mail, return receipt # _________________________


[ADDRESS OTHER THAN LAB ADDRESS]
[CITY, STATE, ZIP]

[STATE AGENCY NAME]


AGREEMENT

I am the [CHOOSE AS APPROPRIATE: owner, director] of [NAME OF LABORATORY]


located at [LABORATORY ADDRESS], CLIA number [CLIA NUMBER].

I understand and agree that the sanction of suspension of [NAME OF LABORATORY]’s approval
to receive Medicare payment for the analyte [NAME OF ANALYTE] is imposed effective
[LIMITATION DATE] for a period of six months.

By my signature below, [NAME OF LABORATORY] agrees (in return for not having its Medicare
approval cancelled immediately or its Medicare approval suspended on [LIMITATION DATE] for
the [CHOOSE AS APPROPRIATE: specialty, subspecialty] of [NAME OF SPECIALTY,
SUBSPECIALTY]) not to charge Medicare beneficiaries or their private insurance carriers for
laboratory services in the analyte of [NAME OF ANALYTE] for the duration of the six-month
suspension of Medicare for this analyte as stated above.

[NAME OF LABORATORY] also agrees to the limitation of its CLIA certification for the analyte
of [NAME OF ANALYTE], due to unsuccessful participation in proficiency testing, for the duration
of the six-month suspension of Medicare for this analyte as stated above in order that limitation is not
imposed for the [CHOOSE AS APPROPRIATE: specialty, subspecialty] of [NAME OF
SPECIALTY, SUBSPECIALTY]. This means [NAME OF LABORATORY] agrees to not
perform any patient testing (for both Medicare and non-Medicare patients) in the analyte of [NAME
OF ANALYTE] during this same six-month period. After the six-month period, [NAME OF
LABORATORY] agrees to notify CMS to apply for reinstatement and be granted CMS approval
prior to resuming testing in and receiving Medicare/Medicaid reimbursement for this analyte.

[NAME OF LABORATORY] understands and agrees that the alternative sanction of a Civil Money
Penalty in the amount of $3,000 per day of non-compliance until compliance is met or until the
principal sanction of Limitation of the laboratory’s CLIA certificate in the analyte of [NAME OF
ANALYTE] has been imposed effective [CMP EFFECTIVE DATE]. [NAME OF
LABORATORY] also understands that pursuant to 42 C.F.R. § 493.1840(a)(7), failure to pay the
Civil Money Penalty once it becomes final will be the basis for suspension or revocation of its CLIA
certificate.

I understand that failure to provide this written agreement by [NOTICE DATE + 10 DAYS] will
result in the automatic cancellation of the laboratory’s approval to receive Medicare payment for all
laboratory services effective [LIMITATION DATE]. I also understand that signing this agreement
does not affect the laboratory’s appeal rights in connection with this sanction action.

In addition, I understand that pursuant to 42 C.F.R. § 493.1840(a)(7) violation of this agreement will
result in the immediate revocation of [NAME OF LABORATORY]’s CLIA certificate under 42 C.F.
R. § 493.1840(a)(1) and pursuant to 42 C.F.R. § 493.1826(a)(1)(ii) in the immediate cancellation of
the laboratory’s approval to receive Medicare payments for all laboratory services.

___________________________________________ ___________________________
Signature Date

___________________________________________________________________________
Print Name and Title
____________________________________________________________________________
Contact address other than laboratory address

________________________________________ ________________________________
Contact telephone number Contact FAX number
18 RO (5/16/07) – sanction imposition – improper PT referral not refuted – sanctions imposed

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA # [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: IMPOSITION OF SANCTIONS – IMPROPER PROFICIENCY TESTING


REFERRAL

Dear Director and Owner(s):

You were notified by our letter dated [DATE OF SANCTION PROPOSAL NOTICE] of proposed
sanctions against your laboratory’s CLIA certificate. You were given ten days from the date of the
letter in which to submit information or written evidence as to why these proposed sanctions should
not be imposed.

On [DATE], we received your response dated [DATE]. We have carefully reviewed and considered
your response and find that your submission has no effect on our sanction determination, as it does not
remove the basis of our sanction action.

We remind you that the basis for our sanction determination against your laboratory’s CLIA
certificate is the improper referral of your laboratory’s proficiency testing samples to another
laboratory for analysis. Based on the CLIA requirements, the referral of your laboratory’s proficiency
testing samples alone, with or without the direct communication of the other laboratory’s test result to
your laboratory, requires CMS to take sanction actions as proposed. Your [DATE] submission does
not show that your laboratory did not engage in improper referral of your laboratory’s proficiency
testing samples to another laboratory for analysis. [ADD IF APPLICABLE: In fact, your submission
confirms the validity of the information we had already received from [NAME OF AO], your
laboratory’s former accrediting organization, and from the [NAME OF STATE AGENCY] (the
State agency). ]

[FOLLOWING 4 PARAGRAPHS ARE OPTIONAL:

A recent decision by the HHS Departmental Appeals Board (DAB) (Lackawanna Medical Group
Laboratory v. CMS, Decision No. CR957) underscores the special care a laboratory must take in
managing and overseeing its proficiency testing. In this case, the laboratory alleged that its quality
control program required that when it sent samples for parallel testing at another laboratory, it
included proficiency test samples with its regular patient workload. The laboratory only reported the
results of its own testing of proficiency testing samples to the proficiency testing program and not the
results of parallel testing by the other laboratory.
The DAB ruled that sending proficiency testing samples to another laboratory, either intentionally or
unintentionally, constitutes a violation of 42 C.F.R. § 493.801(b)(4) and the statute at 42 U.S.C. §
263a(i)(4). Because of this, the DAB concluded that CMS “is required to revoke” the laboratory’s
CLIA certificate. The DAB added that:

“The regulation establishes an absolute bar to sending proficiency test samples to another
laboratory for testing if the sending laboratory is certified to do the same testing. . .The statute
and regulations allow for no exceptions to the prohibition. Thus, the motives of the laboratory
that sends proficiency test samples to another laboratory for analysis that the sending
laboratory is certified to perform, are irrelevant.

The fact that the sending laboratory never reports the analysis of the proficiency samples to the
proficiency program is not mentioned by the statutes or regulations as an exception or defense
to the prohibition, and is also irrelevant.” ]

In the case of your laboratory, a review of the proficiency test results obtained from the other
laboratory indicates close agreement with those proficiency test results derived by your laboratory and
reported to the proficiency test provider. There is a strong possibility that if the test results had
differed significantly, knowledge of the other laboratory’s test results would have affected and,
perhaps, changed the proficiency testing results your laboratory reported. The close agreement
between the test results precluded any need for your testing person to immediately communicate the
other laboratory’s test results to your laboratory.

[INCLUDE HERE ANY FURTHER DETAILS]

Sanctions Imposed

Accordingly, we are taking action to impose sanctions as proposed in our [DATE OF SANCTION
PROPOSAL NOTICE] letter, with effective dates as follows:

• Revocation of the laboratory’s CLIA certificate effective [DATE APPEAL PERIOD


EXPIRES].

• Civil Money Penalty of $3,000 per occurrence for each instance in which the laboratory engaged
in improper proficiency testing referral activities for a total of [NUMBER OF OCCURRENCES
X $3,000.00].

• Directed Portion of a Plan of Correction effective [DATE] – The laboratory is directed to


submit to this office within ten calendar days from the date of this notice, or by [DATE OF
NOTICE + 10 CALENDAR DAYS], a list of the names and addresses of all physicians and other
clients who have used some or all of the laboratory’s services from [DATE OF PRIOR
SURVEY OR OTHER DATE AS APPROPRIATE] to the present date. This list may be used
to advise the laboratory’s clients of the nature of the laboratory’s non-compliance and the nature
and effective date of any sanction actions imposed against the laboratory.

• Cancellation of your laboratory’s approval to receive Medicare and Medicaid payments for
any services performed on or after [DATE].
Please refer to our [DATE OF SANCTION PROPOSAL NOTICE] letter for the laboratory’s
appeal rights and instructions on how to file an appeal. For an appeal request to be timely, it must be
requested by no later than [DATE APPEAL PERIOD EXPIRES] as noted in the [DATE OF
SANCTION PROPOSAL NOTICE] letter. If an appeal request is not filed, revocation of [NAME
OF LABORATORY]’s CLIA certificate will be effective [DATE APPEAL PERIOD EXPIRES].

As you were previously advised, if a timely request for hearing is filed, i.e., by [DATE APPEAL
PERIOD EXPIRES], CMS does not collect the Civil Money Penalty or revoke any type of CLIA
certificate until after an ALJ hearing that upholds the revocation. However, the cancellation of all
Medicare and Medicaid payment and the Directed Portion of a Plan of Correction are effective
[DATE], regardless of whether a hearing is requested. See 42 C.F.R. § 493.1844(d)(1), §
493.1844(d)(3), and § 493.1844(h)(2).

Please be reminded that pursuant to 42 C.R.R. § 493.1844(c)(4) and (c)(7), the determination as to
which alternative sanction(s) to impose, including the amount of a Civil Money Penalty to impose per
day or per violation, is not subject to appeal. Also, pursuant to 42 C.F.R. § 493.1840(a)(7), failure to
comply with alternative sanctions is an additional basis to suspend and/or revoke the laboratory’s
CLIA certificate.

When [NAME OF LABORATORY]'s CLIA certificate is revoked, it is required to cease all patient
laboratory testing, including waived testing or provider performed microscopy procedures, regardless
of whether the laboratory charges for such testing. Also, pursuant to 42 U.S.C. § 263a(i)(3) and 42
C.F.R. § 493.1840(a)(8), the owner and operator (including the director) of the laboratory will be
prohibited from owning or operating (including directing) any laboratory for at least two years from
the date of the revocation.

In accordance with the regulation at 42 C.F.R. § 493.1850(a)(4), information regarding the actions
against [NAME OF LABORATORY]’s CLIA certificate will appear in the Laboratory Registry for
the calendar year in which the action is imposed. Pursuant to 42 C.F.R. § 493.1844(g)(1), we will
notify the general public by means of a notice published in a local newspaper in your area when these
actions become effective as referenced above. In addition, we will notify the Office of Inspector
General that the laboratory referred its proficiency testing samples to another laboratory for analysis,
as required by the regulation at 42 C.F.R. § 493.1840(f).

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[PHONE NUMBER].
Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

cc: [DIRECTOR NAME] Via certified mail, return receipt # _________________________


[ADDRESS OTHER THAN LAB ADDRESS]
[CITY, STATE, ZIP]
[STATE AGENCY NAME]
19 RO (5/16/07) – sanctions final – standards out – POC unacceptable, no hearing request – sanctions final

IMPORTANT NOTICE – ACTION NECESSARY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[DIRECTOR NAME], M.D., Director
[OWNER NAME], Owner(s)
[LAB NAME] CLIA # [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: SANCTIONS FINAL

Dear Director and Owner(s):

You were notified by letter dated [DATE] of the imposition of sanctions against [NAME OF
LABORATORY]. You were advised that the laboratory had sixty (60) days to appeal CMS’
determination. The appeal period expired on [DATE] and we did not receive a request for appeal.

Accordingly, the sanction action against [NAME OF LABORATORY] is final. Cancellation of the
laboratory’s approval to receive Medicare and Medicaid payments effectuated [DATE] remains in
effect. The revocation of [NAME OF LABORATORY]’s CLIA certificate is effective [DATE], the
date the appeal period expired.

Since the laboratory’s CLIA certificate has been revoked, the laboratory is required to cease all patient
laboratory testing including waived and provided performed microscopy testing and regardless of
whether the laboratory charges for the testing. Please be advised that any person who intentionally
violates the mandates of CLIA shall be subject to imprisonment, or fines, or both. See 42 U.S.C. §
263a(l).

Due to the revocation of [NAME OF LABORATORY]’s CLIA certificate, you, as the owner(s)
and/or director of the laboratory at the time it was found to be in non-compliance, are barred from
owning, operating or directing any laboratory, in fact or by proxy, for a period of two years from the
date of the revocation, or until [REVOCATION DATE + 2 YEARS]. See U.S.C. § 263a(i)(3) and 42
C.F.R. § 1840(a)(8).

Before you can be reinstated into the CLIA program as an owner, operator, or director of any
laboratory, you must first apply for reinstatement [USE IF APPLICABLE: directly to the CMS
Regional Office] and the laboratory you seek to own, operate or direct must submit to a survey and be
found in compliance with all applicable CLIA requirements prior to being certified to perform any
testing. You must provide reasonable assurance that the deficient practices that resulted in the current
sanction action will not recur before we can reinstate you into the CLIA program as a laboratory
owner, operator or director.

You are directed to provide us with the names, addresses, and CLIA numbers of all laboratories of
which you are owner, operator or director as of the revocation date of [REVOCATION DATE]. In
addition, you must take action immediately to remove yourself from that position(s) and provide us
evidence that this has been accomplished. Please complete, sign, and date the enclosed attestation
and return it along with evidence as referenced above to our office within 15 days from the date of this
notice, or by [NOTICE DATE + 15 CALENDAR DAYS]. If you do not own, operate, or direct any
other laboratory, please so indicate on the attestation, and sign, date, and return to our office by
[NOTICE DATE + 15 CALENDAR DAYS].

As required by 42 U.S.C. § 263(a)(n) and 42 C.F.R. § 493.1850(a)(2), information regarding the


sanctions imposed against the laboratory’s CLIA certificate will appear in the Laboratory Registry for
the calendar year of its revocation. A notice of imposed sanctions will also be published in a local
newspaper in your area. See 42 C.F.R. § 493.1844(g)(1).

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[TELEPHONE NUMBER].

Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

Enclosures: Director Attestation


Owner Attestation(s)

cc: [DIRECTOR NAME] Via certified mail, return receipt # _________________________


[ADDRESS OTHER THAN LAB ADDRESS]
[CITY, STATE, ZIP]

[STATE AGENCY NAME]


20 RO (5/16/07) – sanctions final – Conditions out, IJ or non-IJ – hearing not requested, dismissed or
upheld – sanctions final, option 1) demand CMP – director is owner; and option 2) director is not
owner

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


(Confirmation of successful transmission of facsimile
[TODAY'S DATE] constitutes proof of receipt.)

[DIRECTOR NAME], M.D., Director


[OWNER NAME], Owner(s)
[LAB NAME]
[ADDRESS] CLIA # [CLIA NUMBER]
[CITY], [STATE] [ZIP]

RE: SANCTIONS FINAL [ADD IF DEMANDING CMP WITH THIS LETTER: – CMP
CASE NUMBER XXXX-XX-LAB-XXX]

Dear Director and Owner(s):

You were notified by letter dated [DATE] of the imposition of sanctions against [NAME OF
LABORATORY]. The sanction action was based on the finding of Condition-level non-compliance
[ADD IF APPLICABLE: that resulted in the determination of immediate jeopardy to patient health
and safety]. You were advised that the laboratory had sixty (60) days to appeal the sanction
determination.

[IF HEARING NOT REQUESTED, USE THE FOLLOWING PARAGRAPH:

The appeal period expired on [DATE] and we did not receive a request for appeal. With the expiration
of the appeal period, the sanction action against [NAME OF LABORATORY] is final. ]

[IF HEARING DISMISSED, USE FOLLOWING 2 PARAGRAPHS:

By letter dated [DATE], the laboratory requested a hearing. This request was forwarded to the
Departmental Appeals Board (DAB) on [DATE].

Subsequently, the laboratory [CHOOSE ONE OR STATE REASON FOR DISMISSAL:


withdrew, failed to pursue] the hearing request. Based on [CHOOSE ONE OR STATE REASON
FOR DISMISSAL: the withdrawal, failure to pursue], the Administrative Law Judge (ALJ) issued a
dismissal order on [DATE]. With the hearing dismissal, our sanction determination against the
laboratory is final.]

[IF HEARING UPHELD, USE FOLLOWING 2 PARAGRAPHS:

By letter dated [DATE], the laboratory requested a hearing. This request was forwarded to the
Departmental Appeals Board (DAB) on [DATE].
The administrative Law Judge (ALJ) issued a written decision on [DATE] upholding the sanction
determination against [NAME OF LABORATORY], including revocation of its CLIA certificate.
With the ALJ decision, our sanction determination against the laboratory is final.]

[CONTINUE FOR ALL SITUATIONS AND ADD OR DELETE SANCTIONS AS


APPLICABLE TO THE CASE.]

Accordingly, the Directed Portion of a Plan of Correction effectuated by our sanction imposition letter
dated [DATE] to submit to this office a list of names and addresses of all physicians, providers,
suppliers and other clients (including patients) who have used some or all of the laboratory’s services
from [DATE] to the present date remains in effect. Cancellation of the laboratory’s approval to
receive Medicare and Medicaid payments effectuated [DATE] also remains in effect. The Civil
Money Penalty totaling [CMP AMOUNT] as imposed by our letter dated [DATE] is now final. The
revocation of [NAME OF LABORATORY]’s CLIA certificate is effective [DATE], the date
[CHOOSE ONE: the appeal period expired, of the ALJ decision, the ALJ dismissed the case].

[INCLUDE FOLLOWING LANGUAGE IF APPLICABLE: We have yet to receive the


laboratory’s list as instructed by the Directed Portion of a Plan of Correction. We remind you that this
list may be used to advise the laboratory’s clients of the nature of the laboratory’s non-compliance and
the nature and effective dates of any sanction actions imposed against the laboratory.]

[OPTION 1 – USE THE FOLLOWING PARAGRAPH IF DIRECTOR IS NOT OWNER:

Please note that instructions for payment of the Civil Money Penalty will be sent to the owner(s) under
separate cover. [SEE LETTER 22 RO – CIVIL MONEY PENALTY DEMAND LETTER.] ]

[OPTION 2 – USE THE FOLLOWING 3 PARAGRAPHS IF DIRECTOR IS OWNER:

As noted above, the Civil Money Penalty due is [CMP AMOUNT]. The Civil Money Penalty is due
and payable on [NOTICE DATE + 15 DAYS]. Please note that interest is assessed, in accordance
with the regulation at 42 C.F.R. § 493.1834(i), on the unpaid balance of the penalty beginning on the
due date of [NOTICE DATE + 15 DAYS]. If the Civil Money Penalty is not received by [NOTICE
DATE + 15 DAYS], interest will be assessed at the rate of [CURRENT INTEREST RATE] on the
outstanding balance for every 30-day period for which it remains unpaid. If you are unable to pay the
entire amount at this time, please notify this office immediately and provide evidence of current income and
resources so that we may determine if you are eligible for installment payments.

Please remit the total due of [CMP AMOUNT] by [NOTICE DATE + 15 DAYS]. Your check
should be made out to “CMS Laboratory Program.” To assure proper crediting of the payment, please
be sure to include the Civil Money Penalty case number [XXXX-XX-LAB-XXX] on the face of the
check and remit to:

Centers for Medicare and Medicaid Services


Division of Premium Billing & Collections
Civil Money Penalty
P.O. Box 7520
Baltimore, MD 21207-0520

We are also requesting that a photocopy of the check be sent to:


[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP] ]

[CONTINUE FOR ALL SITUATIONS.]

Since the laboratory’s CLIA certificate has been revoked, the laboratory is required to cease all patient
laboratory testing, including waived and provided performed microscopy testing and regardless of
whether the laboratory charges for the testing. Please be advised that any person who intentionally
violates the mandates of CLIA shall be subject to imprisonment, or fines, or both. See 42 U.S.C. §
263a(l).

Due to the revocation of [NAME OF LABORATORY]’s CLIA certificate, you, as the owner(s)
and/or director of the laboratory at the time it was found to be in non-compliance, are barred from
owning, operating or directing any laboratory, in fact or by proxy, for a period of two years from the
date of the revocation, or until [DATE]. See U.S.C. § 263a(i)(3) and 42 C.F.R. § 1840(a)(8).

Before you can be reinstated into the CLIA program as an owner, operator, or director of any
laboratory, you must first apply for reinstatement [USE IF APPLICABLE: directly to the CMS
Regional Office] and the laboratory you seek to own, operate or direct must submit to a survey and be
found in compliance with all applicable CLIA requirements prior to being certified to perform any
testing. You must provide reasonable assurance that the deficient practices that resulted in the current
sanction action will not recur before we can reinstate you into the CLIA program as a laboratory
owner, operator or director.

You are directed to provide us with the names, addresses, and CLIA numbers of all laboratories of
which you are owner, operator or director as of the revocation date of [DATE]. In addition, you must
take action immediately to remove yourself from that position(s) and provide us evidence that this has
been accomplished. Please complete, sign, and date the enclosed attestation and return it along with
evidence as referenced above to our office within 15 calendar days from the date of this notice, or by
[NOTICE DATE + 15 CALENDAR DAYS]. If you do not own, operate, or direct any other
laboratory, please so indicate on the attestation, and sign, date, and return to our office by [NOTICE
DATE + 15 CALENDAR DAYS].

As required by 42 U.S.C. § 263(a)(n) and 42 C.F.R. § 493.1850(a)(2), information regarding the


sanctions imposed against the laboratory’s CLIA certificate will appear in the Laboratory Registry for
the calendar year of its revocation. A notice of imposed sanctions will also be published in a local
newspaper in your area. See 42 C.F.R. § 493.1844(g)(1). [ADD FOLLOWING SENTENCE IF
APPLICABLE: In addition, we will notify the Office of Inspector General that the laboratory
engaged in improper proficiency testing referral activities, as required by the regulation at 42 C.F.R. §
493.1840(f).]

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[TELEPHONE NUMBER].

Sincerely,
[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

Enclosures: Director Attestation


Owner Attestation (s)

cc: [IF DIRECTOR IS NOT OWNER, CC DIRECTOR AT ADDRESS OTHER


THAN LAB ADDRESS:

[DIRECTOR NAME] Via certified mail, return receipt # _________________________


[ADDRESS OTHER THAN LAB ADDRESS]
[CITY, STATE, ZIP] ]

[STATE AGENCY NAME]


21 RO (5/16/07) – sanctions final – subsequent unsuccessful PT – appeal period expired, lab does not file an
appeal, sanctions final

IMPORTANT NOTICE – PLEASE READ CAREFULLY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[NAME], M.D., Director/Owner
[LAB NAME] CLIA # [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: SANCTIONS FINAL – CMP CASE NUMBER [XXXX-XX-LAB-XXX]

Dear Director/Owner:

By letter dated [DATE OF SANCTION IMPOSITION NOTICE], we imposed sanctions against


[NAME OF LABORATORY] as a result of a subsequent occurrence of unsuccessful participation in
proficiency testing for the [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of
[NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY]. We notified your laboratory that it had
60 days, or until [DATE OF SANCTION IMPOSITION NOTICE + 60 CALENDAR DAYS], to
appeal the imposition of sanctions. The appeal period has ended and we did not receive an appeal
request from you.

Accordingly, the sanction action against [NAME OF LABORATORY] is final. The following
sanctions as imposed by our letter dated [DATE OF SANCTION IMPOSITION NOTICE] remain
in effect: Limitation of the laboratory’s CLIA certificate for the [CHOOSE AS APPROPRIATE:
analyte, specialty, subspecialty] of [NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY] for
not less than six months effective [LIMITATION DATE]; a Directed Plan of Correction effective
[LIMITATION DATE]; a Civil Money Penalty effective [CMP EFFECTIVE DATE] in the
amount of $3,000 per day of non-compliance (i.e., with the Directed Plan of Correction) or until the
principal sanction of Limitation of the laboratory’s CLIA certificate in the [CHOOSE AS
APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE, SPECIALTY,
SUBSPECIALTY] went into effect, for a total of [TOTAL CMP AMOUNT]; and Suspension of the
laboratory’s approval to receive Medicare and Medicaid payments for laboratory services performed
in the [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF
ANALYTE, SPECIALTY, SUBSPECIALTY] effective [DATE].

[IF APPLICABLE, INDICATE LAB’S COMPLIANCE STATUS WITH DPOC, FOR


EXAMPLE: Based on your laboratory’s submissions subsequent to our sanction proposal notice, we
have determined that your laboratory has complied with parts 1 and 2 of the Directed Plan of
Correction and has yet to comply with part 3, i.e., demonstrate satisfactory PT performance in two
consecutive proficiency testing events for the [CHOOSE AS APPROPRIATE: analyte, specialty,
subspecialty] of [NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY] before the laboratory
can resume testing for the [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of
[NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY].] [ADD THE FOLLOWING
SENTENCE IF APPROPRIATE: In addition, we acknowledge receipt of the signed agreement
from the laboratory that, in return for not having its Medicare approval cancelled immediately, it will
not charge Medicare beneficiaries or their private insurance carriers for the services for which
Medicare payment is suspended, i.e., in the [CHOOSE AS APPROPRIATE: analyte, specialty,
subspecialty] of [NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY].]

The Civil Money Penalty is due and payable on [NOTICE DATE + 15 CALENDAR DAYS]. Please
note that interest is assessed, in accordance with the regulation at 42 C.F.R. § 493.1834(i), on the
unpaid balance of the penalty beginning on the due date of [NOTICE DATE + 15 CALENDAR
DAYS]. If the Civil Money Penalty is not received by [NOTICE DATE + 15 CALENDAR DAYS],
interest will be assessed at the rate of [CURRENT INTEREST RATE] on the outstanding balance
for every 30-day period for which it remains unpaid. If you are unable to pay the entire amount at this
time, please notify this office immediately and provide evidence of current income and resources so that we
may determine if you are eligible for installment payments.

Please remit the total due of [CMP AMOUNT] by [NOTICE DATE + 15 CALENDAR DAYS].
Your check should be made out to “CMS Laboratory Program.” To assure proper crediting of the
payment, please be sure to include the Civil Money Penalty case number [XXXX-XX-LAB-XXX] on
the face of the check and remit to:

Centers for Medicare and Medicaid Services


Division of Premium Billing & Collections
Civil Money Penalty
P.O. Box 7520
Baltimore, MD 21207-0520

We are also requesting that a copy of the check be sent to:

[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

We caution the laboratory to maintain compliance with the CLIA requirements for successful
participation in proficiency testing. Any future repeat proficiency testing failures would be basis for
immediate sanction action to limit, suspend, or revoke the laboratory’s CLIA certificate.

After the limitation period of six months, i.e., after [LIMITATION DATE + 6 MONTHS], if the
laboratory wishes to resume testing for the [CHOOSE AS APPROPRIATE: analyte, specialty,
subspecialty] of [NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY], the laboratory must
contact CMS to apply for reinstatement. The laboratory will be requested to submit written evidence
that Part 3 of the directed plan of correction has been met and CMS will determine at that time
whether an on-site survey is needed to determine whether compliance was sustained prior to
reinstatement.

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[TELEPHONE NUMBER].

Sincerely,
[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

cc: [STATE AGENCY NAME]


22 RO (5/16/07) – sanction – CMP demand letter – sanctions final, demand payment of CMP

IMPORTANT NOTICE – ACTION NECESSARY

Via facsimile to [xxx xxx-xxxx] and first class mail.


[TODAY'S DATE] (Confirmation of successful transmission of facsimile
constitutes proof of receipt.)
[OWNER NAME], Owner(s)
[LAB NAME] CLIA # [CLIA NUMBER]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: CIVIL MONEY PENALTY PAYMENT DEMAND LETTER - CASE NUMBER [XXXX-XX-
LAB-XXX]

Dear Owner(s):

In accordance with the statutory provisions of section 353(h) of the U.S. Public Health Service Act and the
regulations at 42 C.F.R. § 493.1834, a Civil Money Penalty was imposed on [NAME OF
LABORATORY], [CLIA NUMBER] for not meeting CLIA requirements. Please refer to the enclosed
final sanction letter [ADD IF APPLICABLE: effectuating the ALJ decision of [ALJ DECISION
DATE].]

This is to inform you that the Civil Money Penalty imposed by letter dated [DATE OF SANCTION
IMPOSITION NOTICE] is due and payable on [NOTICE DATE + 15 CALENDAR DAYS]. The
total of the Civil Money Penalty is [CMP AMOUNT]. [USE FOLLOWING SENTENCE IF PER
DAY: This total represents the daily amount of [AMOUNT OF CMP PER DAY] for [NUMBER OF
DAYS ACCRUED] days of the penalty accrual from [CMP BEGIN DATE] through [CMP END
DATE]. [USE FOLLOWING SENTENCE IF PER VIOLATION: This total represents the per
violation amount of [AMOUNT] for the total number of [NUMBER] violations.]

The Civil Money Penalty is payable by check. Please note that interest is assessed in accordance with the
regulations at 42 C.F.R. § 493.1834(i), on the unpaid balance beginning on the due date of [NOTICE
DATE + 15 CALENDAR DAYS]. If the Civil Money Penalty is not received by [NOTICE DATE + 15
CALENDAR DAYS], interest will be assessed at the annual rate of [CURRENT INTEREST RATE] on
the outstanding principal balance for every 30-day period for which it remains unpaid. If you are unable to
pay the entire amount at this time, please notify this office immediately and provide evidence of current
income and resources so that we may determine if you are eligible for installment payments.

Please remit the total due of [CMP AMOUNT] by [NOTICE DATE + 15 CALENDAR DAYS].
Your check should be made out to “CMS Laboratory Program.” To assure proper crediting of the
payment, please be sure to include the Civil Money Penalty case number [XXXX-XX-LAB-XXX] on
the face of the check and remit to:

Centers for Medicare and Medicaid Services


Division of Premium Billing & Collections
Civil Money Penalty
P.O. Box 7520
Baltimore, MD 21207-0520
We are also requesting that a photocopy of the check be sent to:

[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
Centers for Medicare & Medicaid Services
[STREET ADDRESS]
[CITY, STATE ZIP]

You must pay all outstanding Civil Money Penalty amounts, including any applicable interest, before you
can be reinstated into the CLIA program in the capacity of owner, operator or director of any laboratory
after the prohibition period.

If you have any questions regarding this letter, please contact [STAFF NAME] of my staff at
[TELEPHONE NUMBER].
Sincerely,

[NAME/TITLE]
[BRANCH NAME]
[DIVISION NAME]

Enclosure: Sanctions Final Letter

cc: [STATE AGENCY NAME]


23 RO (5/16/07) – sanction – attestation statement – sanctions final, attestation for director or owner

ATTESTATION

By my signature below, I, ___________, [CHOOSE ONE: director, owner] of [NAME OF


LABORATORY] located at [ADDRESS], [CLIA NUMBER], am attesting that [NAME OF
LABORATORY] has ceased operations as of the revocation date of [REVOCATION DATE]. I
understand that effective [REVOCATION DATE] the laboratory may not perform patient laboratory
testing, including waived testing and provider performed microscopy procedures, regardless of whether it
charges for such testing. I am also attesting to the following (please check one and complete as
appropriate):

_____ As of [REVOCATION DATE] when [NAME OF LABORATORY]'s CLIA certificate was


revoked, I was owner, operator, and/or director of the following laboratories:

Name Address CLIA Number Position

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

_____ I have removed myself from the position of owner, operator and/or director of the above
laboratories effective ______________ and am submitting evidence of having so removed myself
along with this signed attestation by [NOTICE DATE + 15 CALENDAR DAYS].

_____ As of [REVOCATION DATE], the date that [NAME OF LABORATORY]’s CLIA certificate
was revoked, I was not the owner, operator, and/or director of any laboratory other than [NAME
OF LABORATORY]. I am returning this signed attestation by [NOTICE DATE + 15
CALENDAR DAYS].

[USE FOLLOWING PARAGRAPH FOR DIRECTOR:

Due to the revocation of [NAME OF LABORATORY], I understand that I am prohibited from


owning or operating (including directing), in fact or by proxy, any laboratory, including laboratories
performing only waived testing or provider performed microscopy procedures, until at least
[REVOCATION DATE + 2 YEARS]. I further understand that before I can be reinstated into the
CLIA program as an owner, operator, or director of any laboratory, I must first apply for reinstatement
[USE IF APPLICABLE: directly to the CMS Regional Office], and the laboratory I seek to own,
operate or direct must submit to a survey and be found in compliance with all applicable CLIA
requirements. In addition, I understand that any person who intentionally violates the requirements of
CLIA shall be subject to imprisonment, fine, or both. See 42 U.S.C. § 263a(l). ]

[USE FOLLOWING PARAGRAPH FOR OWNER:

Due to the revocation of [NAME OF LABORATORY]’s CLIA certificate, I understand that 1) I am


prohibited from owning or operating (including directing), in fact or by proxy, any laboratory, including
laboratories performing only waived testing or provider performed microscopy procedures, until at least
[REVOCATION DATE + 2 YEARS]; 2) before I can be reinstated into the CLIA program as an owner,
operator, or director of any laboratory, I must first apply for reinstatement [USE IF APPLICABLE:
directly to the CMS Regional Office], and the laboratory I seek to own, operate or direct must submit to a
survey and be found in compliance with all applicable CLIA requirements; 3) I must pay all outstanding
Civil Money Penalty amounts including any applicable interest before I can be reinstated into the CLIA program
in the capacity of owner, operator or director of any laboratory. In addition, I understand that any person who
intentionally violates the requirements of CLIA shall be subject to imprisonment, fine, or both. See 42
U.S.C. § 263a(l). ]

Signature

______________________________________ ______________________________
Name Date

________________________________________________________________________________
Contact address other than laboratory address

_____________________________________
Contact telephone number
24 RO (5/16/07) – sanction – public notice request – sanctions final, request newspaper publication of public
notice

[DATE]

[NAME OF CONTACT]
Advertising Placement Coordinator
Newspaper Service Bureau
[ADDRESS]
[CITY, STATE, ZIP CODE]

Dear [NAME OF CONTACT]:

With reference to Purchase Order (PO) ___________________________, we are requesting that the
enclosed newspaper advertisement be published as follows:

NAME OF PAPER: [NEWSPAPER NAME]

DATE TO BE PUBLISHED: Next available date

SUBJECT: [SANCTIONS TO BE PUBLISHED, FOR EXAMPLE: Revocation of CLIA


Certificate/Cancellation of Medicare Payment] for [NAME OF LABORATORY],
CLIA number [CLIA NUMBER]

STAFF PERSON/PHONE NUMBER: [STAFF NAME] / [TELEPHONE NUMBER]

ADVERTISING ORDER (AO) NUMBER: [AO NUMBER]

In all billing and/or correspondence, please refer to the Purchase Order listed above and the
appropriate Advertising Order number for this particular ad. Please mail all invoices as well as proof
of publication to the Centers for Medicare & Medicaid Services, ATTN: [NAME OF
ADMINISTRATIVE OFFICER], [RO ADDRESS, CITY, STATE, ZIP].

If you have any questions, please contact [STAFF NAME] at [TELEPHONE NUMBER]. Thank
you.

Sincerely yours,

[NAME]
Administrative Officer
Enclosure

______________________________________
[NAME], Manager
[BRANCH]
[DIVISION]
[NEWSPAPER NAME]

ATTENTION: LEGAL ADVERTISING DEPARTMENT

NEWSPAPER NOTICE

Print in Public Notice Section of Newspaper

CLIA Notice to the Public


Sanctions against [NAME OF LABORATORY]
CLIA certificate number [CLIA NUMBER]

Notice is hereby given that the Secretary of the United States Department of Health and Human Services
imposed under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) the following
principal sanctions against the above laboratory located at [ADDRESS, CITY STATE, ZIP]: [LIST
SANCTION SUCH AS revocation of its CLIA certificate] effective [DATE]; [LIST SANCTION
SUCH AS suspension of its CLIA certificate] effective [DATE]; [LIST SANCTION SUCH AS
limitation of its CLIA certificate for the [CHOOSE AS APPROPRIATE: analyte, specialty,
subspecialty] of [NAME OF ANALYTE, SPECIALTY, SUBSPECIALTY] effective [DATE];
[LIST SANCTION SUCH AS cancellation of its approval to receive Medicare payments] effective
[DATE]. [LIST SANCTION SUCH AS suspension of its approval to receive Medicare payments for
the [CHOOSE AS APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE,
SPECIALTY, SUBSPECIALTY] effective [DATE]. [ADD IF APPLICABLE: A Civil Money
Penalty was also assessed.] [STATE REASON FOR SANCTION SUCH AS: This action was based
on deficiencies cited at a [SURVEY DATE] survey of the laboratory, which resulted in the
determination of immediate jeopardy to public health and safety.]

CLIA regulations prohibit the laboratory's owner, [OWNER NAME], and its director, [DIRECTOR
NAME], from owning, operating or directing any laboratory for two years from the date of the
revocation, or until [REVOCATION DATE + 2 YEARS].

[NAME OF RO MANAGER]
[NAME OF BRANCH]
[NAME OF DIVISION]
25 RO (5/16/07) – sanction – client notification – notice to clients of lab regarding sanctions imposed

IMPORTANT NOTICE – PLEASE READ CAREFULLY

CERTIFIED MAIL - Return Receipt Requested

[DATE]

[NAME OF CLIENT]
[ATTN: NAME]
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: Notice of CLIA Sanction Action against [NAME OF LABORATORY], CLIA Number [CLIA
NUMBER]

Dear [NAME]:

This notice is being sent to you because you have been identified as a client who ordered patient testing at
[NAME OF LABORATORY]. This laboratory was sanctioned recently by the Centers for Medicare &
Medicaid Services (CMS) as a result of serious quality problems discovered at a survey conducted on
[DATE], which led CMS to determine that the laboratory was out of compliance with [NUMBER]
Condition-level CLIA requirements. [ADD IF APPLICABLE: The serious nature of the deficient
practices resulted in the determination that the laboratory posed immediate jeopardy to patient health
and safety.]

[ADD IF APPLICABLE: Due to the laboratory’s continued failure to correct the cited deficiencies,
the laboratory’s CLIA certificate was suspended effective [DATE] and its approval to receive
Medicare and Medicaid payments canceled effective the same date. The laboratory may not legally
perform any CLIA laboratory testing for patients while its CLIA certificate is suspended.]

We are writing both to inform you of the current sanction action and to alert you that CLIA laboratory
test results you received in the past from [NAME OF LABORATORY] may not be accurate or
reliable. We are calling this matter to your attention so that you can take whatever measures, including
patient retesting, that you deem appropriate.

[ADD IF APPLICABLE: Currently, a revocation action is pending against the laboratory’s CLIA
certificate. If revoked, the owner [NAME] and director [NAME] of the laboratory will be prohibited
from owning or operating a laboratory for a period of two years from the date of the revocation.]

If you have any questions regarding this notice, please contact [STAFF NAME] of my staff at
[PHONE NUMBER/ADDRESS/EMAIL].

Sincerely,

[NAME/TITLE]
[OFFICE]
26 RO (5/16/07) – sanction – PT – suspension of Medicare agreement - lab agreement to not charge
Medicare beneficiaries or other insurance carriers for lab services for analyte/subspecialty/specialty for
which Medicare payment is suspended

AGREEMENT

By my signature below, [NAME OF LABORATORY] located at [ADDRESS], agrees (in return


for not having its Medicare approval cancelled immediately) not to charge Medicare beneficiaries or
their private insurance carriers for laboratory services in the [CHOOSE ONE AS
APPROPRIATE: analyte, specialty, subspecialty] of [NAME OF ANALYTE, SPECIALTY,
SUBSPECIALTY] for which Medicare is suspended effective [MEDICARE SUSPENSION
DATE].

I understand that failure to provide this written agreement by [NOTICE DATE + 10 CALENDAR
DAYS] will result in the automatic cancellation of the laboratory’s approval to receive Medicare
payment for all laboratory services effective [MEDICARE SUSPENSION DATE]. I also
understand that signing this agreement does not affect the laboratory’s appeal rights in connection
with this sanction action.

In addition, I understand that pursuant to 42 C.F.R.§ 493.1840(a)(7) violation of this agreement


will result in the immediate revocation of [NAME OF LABORATORY]’s CLIA certificate under
42 C.F.R. § 493.1840(a)(1) and pursuant to 42 C.F.R. § 493.1826(a)(1)(ii) in the immediate
cancellation of the laboratory’s approval to receive Medicare payments for all laboratory services.

_________________________________ _________________________
Signature Date

_________________________________
Print Name and Title

__________________________________________________________________________
Contact address other than laboratory address

_________________________________ __________________________
Contact telephone number Contact FAX number
27 RO (5/16/07) – sanction – referral to OIG form
OIG REFERRAL
TO: [NAME]
Special Agent in Charge
Office of Inspector General
[ADDRESS]
[CITY], [STATE] [ZIP]

FROM: Centers for Medicare & Medicaid Services


Division of Survey and Certification/CLIA Program
[ADDRESS]
[CITY], [STATE] [ZIP]

RE: CLIA # Laboratory:

Owner(s): Director:

We are referring the case for your investigation per regulations cited below:

493.1840(a)(1) Guilty of misrepresentation in obtaining a CLIA certificate.

493.1840(a)(2) Performed, or represented the laboratory as entitled to perform, a laboratory


examination or other procedure that is not within a category of laboratory examinations or other
procedures authorized by its CLIA certificate.

493.1840(a)(6) Violated or aided and abetted in the violation of any provisions of CLIA and its
implementing regulations.

493.1840(b) Adverse action based on improper referrals in proficiency testing. Laboratory


intentionally referred its proficiency testing samples to another laboratory for analysis.

Per 42 C.F.R. 493.1840(f), CMS notifies the OIG of any of the above violations within 30 days of the
determination of the violation.

Failure to grant immediate access to determine compliance with CLIA, which is basis for OIG
permissive exclusion per 42 C.F.R. 1001.1301(a)(1)(i)(E).

Sanction letters and/or background material attached (include ownership info & CMS-855 if available).

Comments:

Please respond in writing within 60 days whether the case has been accepted for investigation.
If so, please provide name and telephone number of agent assigned to the case.
Referral Contact: Phone Number: Date: