Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the Laboratory Supervisor (LS), the laboratory director (LD) failed to ensure that the laboratory was in compliance with Pennsylvania Department of Health (PA DOH) directives and regulatory requirements prior to the start of patient testing for 1 of 1 chemistry test performed from 08/28/2024 to the date of the survey. Findings Include: 1. On the day of survey, 08/12/2025 at 10:15 a.m., observation of the laboratory and interview with the LS revealed the laboratory performed macroscopic urinalysis examinations (Dipstick) from 08/28/2024 to the date of the survey. 2. Review of the laboratory's PA Clinical Laboratory permit (issued 08/15/2024) revealed Dipstick urinalysis testing was not currently listed as an approved test. 3. The laboratory failed to provide documentation of approval by the PA DOH to perform 1 of 1 chemistry test (Dipstick urinalysis) prior to the start of patient testing from 08/28/2024 to 08/12/2025. 4. The LS confirmed the findings above on 08/12/2025 at 10:35 a.m. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) 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. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with the Laboratory Supervisor (LS), the laboratory failed to verify the accuracy of the PT results that were not graded for 7 of 7 API PT Performance Evaluation reports reviewed for microbiology testing events performed from 2023 to 2025. Findings: 1. The API Proficiency Testing performance Evaluation form stated "Laboratories are responsible for documenting and performing