Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA initial certification survey conducted at your facility on 1/12/2023. 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. 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 the laboratory's proficiency testing (PT) records and an interview with the laboratory supervisor, the laboratory director failed to attest to the routine integration of the samples into the patient workload using the laboratory's routine methods for the third microbiology event in 2022. Findings include: 1. Review of the American Proficiency Institute (API) PT attestation forms from 2022 revealed that the laboratory director failed to sign the attestation form for the third microbiology PT event in 2022. 2. The laboratory supervisor confirmed these findings in an interview at approximately 11:00 AM on 1/12/2023. The laboratory performs approximately 360 microbiology tests annually. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on lack of competency assessment documentation, lack of a competency assessment policy, and electronic communication with the laboratory supervisor, the laboratory failed to establish and follow written policies and procedures to assess competency for employees performing provider performed microscopy (PPM) tests for sperm presence/absence and urine sediment. Findings include: 1. The laboratory failed to provide documentation of competency assessments for nine of nine mid-level practitioners performing provider performed microscopy (PPM) tests for sperm presence/absence and urine sediment. 2. The laboratory failed to provide documentation of a policy for assessing the competency of testing personnel performing PPM tests for sperm presence/absence and urine sediment. 3. The laboratory supervisor confirmed these findings by electronic mail on 1/23/2023 at 11: 29 AM. The laboratory performs approximately 300 PPM procedures annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) evaluation, the laboratory's PT documentation and an interview with the laboratory supervisor, the laboratory failed to ensure that the unacceptable results for Molecular Bacti-Urine and Molecular Mycology -Vaginal in the second event of 2022 and for Mycoplasma genitalium in the third event of 2022 were evaluated. Findings include: Review of API PT documentation from the second bacteriology PT event for 2022 revealed that sample UTI-04 had unacceptable results for two of fifty-six analyte targets, Staphyloccocus sp. and Staphylococcus epidermis, resulting in a score of 95% for Molecular Bacti - Urine. Review of API PT documentation from the second mycology PT event for 2022 revealed that sample VGP-04 had unacceptable results for two of six analyte targets, Candida albicans and Candida tropicalis, resulting in a score of 67% for Molecular Mycology -Vaginal. Review of API PT documentation from the third PT event for 2022 revealed that sample MPG-06 had unacceptable results for the analyte Mycoplasma genitalium. Review of the laboratory's PT documentation revealed that no investigations were documented for the unacceptable results for samples UTI-04, VGP-04, and MPG-06. The laboratory supervisor confirmed these findings in an interview at approximately 11:00 AM on 1/12/2023. The laboratory performs approximately 360 microbiology 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) -- 2 of 6 -- evaluations, lack of laboratory documentation, and an interview with the laboratory supervisor and clinic manager, the laboratory failed to verify the accuracy of Molecular Mycology-Vaginal and provider performed microscopy (PPM) tests for sperm presence/absence and urine sediment at least twice a year. Findings include: 1. Review of the API PT evaluations for Molecular Mycology-Vaginal revealed a score of 67% and 0% for the second and third events of 2022, respectively. 2. The laboratory supervisor confirmed these findings in an interview at approximately 11:00 AM on 1/12/2023. 3. Review of the API PT evaluations for PPM revealed a score of 0% for the first and third PPM events in 2022 for sperm presence/absence and urine sediment. 4. The laboratory was unable to provide evidence that additional verification of accuracy had been performed during 2022. 5. The clinic manager confirmed these findings in an interview at approximately 11:00 AM on 1/12/2023. The laboratory performs approximately 360 microbiology tests and approximately 300 PPM tests annually. 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 review of the laboratory's standard operating procedures (SOPs) and an interview with the clinic manager, the laboratory failed to ensure that a written policy and procedure was established to monitor, assess, and, when indicated, correct problems identified in proficiency testing (PT) performance for provider performed microscopy (PPM) PT tests. Findings include: 1. The laboratory was unable to provide the SOP regarding review, verification, and