Summary:
Summary Statement of Deficiencies 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: Based on review of American Proficiency Testing (API) Proficiency testing (PT) records and an interview with the Laboratory Director (LD), The LD failed to sign PT attestations or delegate the responsibility for signing the attestation forms to a technical consultant designee. Findings include: 1. Review of PT records for year (s) 2021 and 2022 showed that the laboratory director failed to sign five (5) of six (6) testing event attestation forms. 2. The laboratory did not have a delegation of responsibilities assigned to the technical consultant (TC) who had signed five (5) of six (6) API PT attestation forms for year (s) 2021 and 2022. 3. Interview with LD on 04/11/2023 at 04:00 PM confirmed that there was no delegation of responsibility assigned to a technical consultant to sign PT attestations. 4. The laboratory reports performing 33,889 patient tests annually. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director (LD), the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- laboratory failed to retain analyzer quality control (QC) printouts and patient test records for the month of October 2022. Findings include: 1. During record review of QC printouts and patient records revealed for the month of October 2022 laboratory documents could not be located. 2. Interview with LD on 4/11/2023 at 04:00 PM confirmed that October 2022 QC and patient records were not available during the day of the survey. 3. The laboratory reports performing 33,889 patient tests annually. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on request, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to establish and verify the accuracy of qualitative serum human Chorionic gonadotrophin (hCG) with the Medline HCG Combo. Findings include: 1. Review of the laboratory's test menu showed that qualitative Serum HCG was not enrolled in Proficiency Testing to verify accuracy. 2. Review of records showed no documentation of accuracy performed for Medline HCG Combo for the year (s) 2021 and 2022. 3. Interview with LD on 4/11/2023 at 04:00 PM confirmed that enrolment in PT or verification of accuracy for qualitative serum HCG Combo for the year (s) 2021 and 2022. 4. The laboratory records indicate the laboratory performed Serum qualitative hCG testing twice in 2021, once in 2022, and once in 2023. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the quality assessment procedure and interview with the Laboratory Director (LD), the LD failed to include quality assessment (QA) assessments for the ongoing effectiveness of