CMS SOM App. C, Tag D2016

(a) Each laboratory performing nonwaived testing must successfully participate in a

proficiency testing program approved by CMS, if applicable, as described in

subpart I of this part for each specialty, subspecialty, and analyte or test in which

the laboratory is certified under CLIA.

(b) Except as specified in paragraph (c) of this section, if a laboratory fails to

participate successfully in proficiency testing for a given specialty, subspecialty,

analyte or test, as defined in this section, or fails to take remedial action when an

individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart

R of this part.

(c) If a laboratory fails to perform successfully in a CMS-approved proficiency

testing program, for the initial unsuccessful performance, CMS may direct the

laboratory to undertake training of its personnel or to obtain technical assistance, or

both, rather than imposing alternative or principle sanctions except when one or

more of the following conditions exists:

(1) There is immediate jeopardy to patient health and safety.

(2) The laboratory fails to provide CMS or a CMS agent with satisfactory

evidence that it has taken steps to correct the problem identified by the

unsuccessful proficiency testing performance.

(3) The laboratory has a poor compliance history.

Interpretive Guidelines §493.803

Only the PT program has the capability to correct scores in the CMS PT monitoring

system. See SOM section 6056.

No single PT enforcement protocol is universally applicable for all situations. Unique

circumstances may require special considerations or actions that may not conform to the

general approach outlined below. The laboratory’s compliance history, its willingness to

take remedial actions, and the professional judgment of surveyors and enforcement

personnel may be factors in determining an appropriate PT enforcement plan.

Careful review of PT performance reports and other available information should always

be performed to determine whether the PT results truly represent failed PT. The potential

of a PT program data input error or other factors beyond the laboratory’s control should

be considered. If the laboratory has made a transcription error(s), it is considered

erroneous PT result(s).

If review and verification of PT performance reports confirm unsuccessful PT, cite as a

Condition-level deficiency (use D2016 on the Form CMS-2567).

NOTE: The CMS PT monitoring system may NOT be used alone to determine

unsuccessful participation. Surveyors must verify any unsuccessful participation

indicated in the PT monitoring system. This may be done by reviewing PT results

supplied by the approved PT program (they will send copies to the surveyor if requested)

or from results sent to the laboratory by the PT program.

If the unsuccessful PT participation is the first occurrence for the laboratory, and none of

the exceptions listed at §493.803(c)(1)-(3) exist, cite the laboratory at the condition-level

(D2016). Notify the laboratory to seek training of its personnel, obtain the necessary

technical assistance to correct the problem causing the unsuccessful participation, or

both. SAs may initiate training and/or technical assistance after first obtaining CMS’

concurrence. No on-site review is required to initiate this action.

The laboratory must submit an allegation of compliance, listing completion dates and

other pertinent information for its training and/or technical assistance efforts. Follow-up

is necessary to verify that the laboratory has carried out its allegation of compliance. If a

laboratory refuses to take acceptable training and/or technical assistance actions

(including failure to submit an allegation of compliance, or failure to complete its

allegation of compliance), a sanction action may be initiated by CMS.

When the unsuccessful PT participation is not the first such occurrence for the laboratory,

cite as a condition-level deficiency and take appropriate enforcement action. In some

cases, it may also be necessary to cite the laboratory director in order for the laboratory to

achieve compliance. Citing of the laboratory director in addition to PT citations, is at the

discretion of the surveyor. For immediate jeopardy cases, the procedures in Subpart R

apply. For non-immediate jeopardy situations, enforcement procedures should be

completed within 90 days from the date that the unsuccessful PT was first identified. In

immediate jeopardy situations, enforcement procedures should be completed within 23

days from the date unsuccessful participation of PT is first identified.

Example 1: Initial Unsuccessful

A laboratory scores 60% on a testing event in Sodium. On the next testing event, the

laboratory fails to participate in Sodium (Na). The citations are D2096 (§493.841(f)) and

D2016 (§493.803). D6000 (§493.1403) or D6076 (§493.1441) are laboratory director

citations. (Note: It is not necessary to cite the standard for unsatisfactory analyte

performance. However, it is necessary to cite the standard when the laboratory fails to

participate in a testing event so that the laboratory is made aware that such deficient

practice results in a score of 0 for the testing event.)

Analyte 2019 2020 2021 2022

Event

1

Score

Event

2

Score

Event

3

Score

Event

1

Score

Event

2

Score

Event

3

Score

Event

1

Score

Event

2

Score

Event

3

Score

Event

1

Score

Event

2

Score

Event

3

Score

Sodium

(Na)

100%

80%

100%

100%

80%

80%

100%

80%

80%

60%

0%

100%

Example 2: Initial Unsuccessful

A laboratory scores 60% on uric acid PT samples. On the next testing event, the

laboratory scores 40% on the same analyte. The citations are D2096 (§493.841(f)) and

D2016 (§493.803). D6000 (§493.1403) or D6076 (§493.1441) are laboratory director

citations. (Note: Cite the standard for unsuccessful performance and the condition for

unsuccessful participation. It is not necessary to cite the standard for unsatisfactory

analyte performance.)

Analyte 2019 2020 2021 2022

Event

1

Score

Event

2

Score

Event

3

Score

Event

1

Score

Event

2

Score

Event

3

Score

Event

1

Score

Event

2

Score

Event

3

Score

Event

1

Score

Event

2

Score

Event

3

Score

Uric

Acid

(UA)

100%

100%

80%

100%

100%

100%

80%

80%

100%

60%

40%

100%

Example 3: Non-initial (Subsequent) Unsuccessful - Rolling Timeframe

A laboratory scores 60% in Sodium for two consecutive PT events resulting in initial

unsuccessful PT performance. The citations are D2096 (§493.841(f)) and D2016

(§493.803). The laboratory scores 80% for the next three PT events. After the three

successful PT events, the laboratory scores 60% in two consecutive PT events resulting in

non-initial unsuccessful PT performance. The citations are D2096 (§493.841(f)) and

D2016 (§493.803). D6000 (§493.1403) or D6076 (§493.1441) are laboratory director

citations. Non-initial unsuccessful PT performance is referred to CMS for enforcement

actions. See SOM sections 6050 and 6054.

Analyte 2019 2020 2021 2022

Event

1

Score

Event

2

Score

Event

3

Score

Event

1

Score

Event

2

Score

Event

3

Score

Event

1

Score

Event

2

Score

Event

3

Score

Event

1

Score

Event

2

Score

Event

3

Score

Sodium

(Na)

100%

80%

100%

80%

100%

60%

60%

80%

80%

80%

60%

60%

When recommending to CMS that a laboratory be subject to sanctions, submit copies of

the laboratory’s testing event or analyte score(s) that were unsatisfactory and the correct

responses provided by the PT program. Also, enclose copies of any correspondence sent

to or received by the laboratory concerning its PT performance.

Probes:

Do the laboratory’s PT results show satisfactory performance in the next PT event?

Did the laboratory verify its corrective action or training and technical assistance was

successful?