Community Physicians North Hills Pulmonary Lab

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 surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the technical consultant, the laboratory director or designee did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for three of three Chemistry Core events in 2020. Findings include: 1. Review of the 2020 Chemistry Core API PT records showed the laboratory director or designee did not sign the attestation statements for three of three events. 2. Interview with the technical consultant on August 30, 2021 at 2:00 PM confirmed the laboratory director or designee did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for three of three Chemistry Core events in 2020. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on surveyor review of competency evaluation records and interview with testing personnel, the technical consultant did not evaluate the competency for two out of two testing personnel in 2017 for the i-STAT analyzer. Findings include: 1. Review of competency evaluation records for personnel using the i-STAT analyzer showed no evidence of evaluation for two of two testing personnel in 2017. 2. Interview with testing personnel (staff A) on March 7, 2019 at 9:30 AM confirmed the technical consultant did not evaluate the competency for two of two testing personnel annually in 2017 for the i-STAT analyzer. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --