Condition-Level Deficiencies and Plan of Correction
During a CLIA survey of a moderate-complexity laboratory, the surveyor finds three condition-level deficiencies: (1) expired reagents were used for chemistry testing for three months; (2) the laboratory did not enroll in proficiency testing for one specialty it reports; and (3) competency assessment was missing for two technologists hired eight months ago. The laboratory director says the problems are "paperwork issues" and wants to correct them after the survey without notifying anyone. The surveyor issues a statement of deficiencies, and the laboratory receives it on a Friday. The laboratory continues to report patient results. The owner asks whether the laboratory can simply submit a memo saying the problems are fixed, and what will happen if the laboratory does not respond within the required time.
1. What must the laboratory do in response to the statement of deficiencies, and within what time frames? What must a plan of correction contain?
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The laboratory must respond formally, not with an informal memo. After receiving the statement of deficiencies, it must submit a plan of correction within the required short time frame, generally 10 calendar days, and correct the deficiencies within the required correction period.
A sufficient plan of correction should state, for each deficiency:
- The corrective action taken or planned.
- Who is responsible.
- The completion date.
- How the laboratory will monitor to prevent recurrence.
- How already-affected patient results will be reviewed.
Examples here include removing expired reagents, obtaining PT enrollment for the specialty, completing competency assessments, and auditing records. The plan must be specific and verifiable; "we will be more careful" is not acceptable.
The laboratory should also preserve records and cooperate with the state agency. Continuing to report results while deficiencies remain may increase risk, especially the PT and expired-reagent findings.
2. Are these deficiencies condition-level, and what enforcement actions could CMS impose if the laboratory fails to correct them? Can the laboratory continue testing?
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Yes, they are condition-level deficiencies as described. Expired reagents affect test accuracy, absence of PT removes an external accuracy check, and missing competency assessment means personnel performance is unverified. These go to the core of CLIA compliance, not just paperwork.
If the laboratory fails to correct them, CMS or the state agency may impose sanctions, including:
- A directed plan of correction.
- Civil money penalties.
- Suspension of the laboratory's certificate or of specific testing.
- Revocation in serious cases.
- Restrictions on the laboratory director or owner.
The laboratory may continue testing only if the agency does not impose a suspension or immediate-jeopardy action. That is not permission to ignore the deficiencies. The laboratory should consider voluntarily limiting testing where accuracy cannot be assured, especially for the specialty without PT and for chemistry performed with expired reagents.
3. What should the laboratory do about patient results reported during the deficient period (expired reagents, no PT, no competency)?
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The laboratory should perform a focused patient-result review. The deficiencies raise three separate questions:
- Expired reagents: identify the tests and dates affected, determine whether reagent stability data support any extension, and retest retained specimens or compare with an alternative method where possible. If results may be inaccurate, notify clinicians and issue corrected reports.
- No PT for a specialty: determine whether the lack of PT means accuracy was never externally verified. Review QC and calibration records for that period and arrange PT enrollment immediately. Consider retesting or confirmatory testing for affected results.
- Missing competency: assess whether the two technologists were performing tests correctly. Perform direct observation, review QC and PT performance, and complete competency assessments now. If errors are found, review their patient results.
The laboratory should document the review, clinician notifications, and corrective actions in the plan of correction. The director's view that these are "paperwork issues" is incorrect because each deficiency can affect result validity and patient safety.