Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency assessment procedure and interview with the general supervisor (GS), the laboratory failed to follow their established procedure to assess the competency of 2 of 2 technical supervisor (TS) and 1 of 1 GS for their supervisory responsibilities performed from 11/17/2021 to the date of the survey. Findings include: 1. The laboratory's GEN 9 GEN: Competency procedure states, " Competency must be assessed for Technical Supervisor, General Supervisor, Technical Consultant, and Clinical Consultant as well as for all delegated duties at least annually. The section director or Laboratory Director is responsible for performing and recording competency assessment for high complexity testing." 2. On the day of survey, 10/31/2023 at 11:30 am, the laboratory failed to provide site specific competency assessment records for 2 of 2 TS (CMS 209 personnel # 2, and # 8) and 1 of 1 GS (CMS 209 personnel # 3) for their supervisory responsibilities performed from 11/17/2021 to 10/31/2023. 3. The GS confirmed the findings above on 10/31/23 at 03:00 pm. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, College of American Pathologists (CAP) proficiency testing (PT) records and interview with the general supervisor (GS), the laboratory failed to verify the accuracy of the PT results obtained for 4 of 4 CAP chemistry testing events reviewed for 2023. Findings include: 1. The laboratory's GEN 11 GEN: Proficiency Testing procedure states, " Ungraded PT challenges such as: Results submitted after the cut-off date, Failure to submit results, Incorrect completion of the result, PT challenges that were not graded because of lack of consensus, and All other ungraded PT results will be reviewed and evaluated against the participant summary and/or materials provided by the PT vendor." 2. On the day of survey, 10/19/2023 at 09:54 am, review of the laboratory's CAP PT records revealed that the laboratory did not verify the accuracy for the following 4 of 4 CAP chemistry testing events for 2023 that were not graded by the PT agency: - Drug Monitoring for Pain Management (DMPM-A-2023, DMPM-B-2023) -Urine Drug Adulterant/Integrity (DAI-A-2023, DAI-A-2023) 3. The CAP's actions laboratories should take when a PT result is not graded document states, "the laboratory is required to review participant summary for comparative results and document performance accordingly. Evaluation criteria is not established for educational challenges. Laboratories should determine their own evaluation criteria approved by their laboratory director for self-evaluation." 4. The GS confirmed the findings above on 10 /31/2023 at 03:00 pm D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP), and Pennsylvania Department of Health Drugs of Abuse (PA DOH DOA) proficiency testing (PT) records and interview with the general supervisor (GS), the laboratory failed to document the evaluation and verification activities for PT testing performed in chemistry (toxicology) from 11/17/2021 to the date of the survey. Findings Include: 1. On the day of the survey, 10/31/2023 at 09:54 am, review of PT records revealed that the laboratory did not document the review and