Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on July 24, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the 2023 and 2024 American Proficiency Institute (API) Proficiency Testing (PT) signed attestations, a review of the completed CMS-209 form, and an interview with the laboratory manager, the laboratory failed to ensure that the I-Stat Chem 8 PT specimens were performed by the patient testing personnel, and the laboratory failed to ensure that the 2023 Miscellaneous Chemistry events One and Two for microalbumin and creatinine were rotated among the staff. Findings include: 1. A review of the 2024 API PT signed attestations for the Chemistry Core test events one and two revealed that the personnel who performed the I-Stat Chem 8 PT specimen testing and signed the attestations were not the designated testing personnel listed on the CMS-209 form for the performance of the I-Stat testing. The laboratory manager confirmed that the testing personnel numbers 8 and 9 on the CMS- 209 form were the designated testing personnel for the I-Stat testing. 2. A review of the 2023 API PT signed attestations for the Chemistry, Miscellaneous test events one and two revealed that testing personnel number 4 listed on the CMS-209 form performed the microalbumin and urine creatinine testing for both events. 3. These Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- findings were confirmed during an interview conducted on July 24, 2024 at approximately 12:00 PM. The laboratory performs approximately 111,322 chemistry tests and 34,741 hematology tests annually. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: A review of the 2023 and 2024 American Proficiency Institute (API) Proficiency Testing (PT) chemistry core signed attestations, a review of the written director delegation of duties and an interview and email correspondence with the laboratory manager, the laboratory failed to ensure that the testing personnel performing the I- Stat Chem 8 testing signed the attestation, and the laboratory failed to ensure that the laboratory director or an assigned designee qualified as a technical consultant persuant to 42 CFR 493.1411 signed the attestation. Findings include: 1. A review of the 2023 API PT chemistry core signed attestations for test events two and three revealed that the personnel who performed the I-Stat Chem 8 testing failed to sign the attestations. 2. The 2024 API PT chemistry core test event one signed attestation for the I-Stat Chem 8 testing was not signed by the laboratory director. 3. The 2024 API PT chemistry core test event one signed attestation for the I-Stat Chem 8 testing was not signed by a designee delegated to perform that duty in writing by the director. The personnel who signed as a designee was not qualified as a technical consultant persuant to 42 CFR 493.1411. 4. A review of the policy entitled, "Delegation of Duties to Lab Manager and Lab Supervisor at Wynn Lab" revealed that the laboratory manager is designated the authority to review, sign and date proficiency testing records. 5. These findings were confirmed during an interview with the laboratory manager on July 24, 2024 at approximately 4:00 PM, and via an email received from the laboratory manager on July 29, 2024, which confirmed the personnel signing as the designee for the 2024 test event two was a high school graduate. The laboratory performs approximately 111,322 chemistry tests and 34,741 hematology tests annually. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the 2023 and 2024 American Proficiency Institute (API) hematology Proficiency Testing (PT) records, and an interview with the laboratory manager, the laboratory failed to verify the accuracy of the submitted results for the hematology educational challenges. Findings include: 1. A review of the 2023 API hematology PT results for test event one revealed that the laboratory failed to evaluate -- 2 of 10 -- and document the educational challenges for the Blood Cell Identification specimens ECI-01-ECI-05. The reported result for specimen ECI-02 was "Neutrophil, band (stab)." The reported result for specimen ECI-05 was "Eosinophil, all stages." The expected results column for specimens ECI-02 and ECI-05 stated "See commentary." 2. A review of the 2023 API hematology PT results for test event two revealed that the laboratory failed to evaluate and document the educational challenge for the Platelet estimate for specimen number DIF-02. The reported result for specimen DIF- 02 was "Decreased." The Expected Result for specimen DIF-02 was "Adequate /Normal." 3. A review of the 2023 API hematology PT results for test event three revealed that the laboratory failed to evaluate and document the educational challenge for the Platelet estimate for specimen number DIF-03. The reported result for specimen DIF-03 was "Decreased." The Expected Result for specimen DIF-03 was "Decreased." 4. A review of the 2024 API hematology PT results for test event one revealed that the laboratory failed to evaluate and document the educational challenges for the Blood Cell Identification specimens ECI-01-ECI-05. The reported result for specimen ECI-05 was "Neutrophil, band (stab)." The expected results column for specimens ECI-05 was "Metamyelocyte (juvenile)." 5. The laboratory manager confirmed the findings during an interview conducted on July 24, 2024 at approximately 12:00 pm. The laboratory performs approximately 34,741 hematology tests annually. 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 American Proficiency Institute (API) 2023 Chemistry Core event two Proficiency Testing (PT) records, and an interview with the laboratory manager, the laboratory failed to ensure that documentation of evaluation and