Summary:
Summary Statement of Deficiencies D0000 A validation survey was conducted by the Pennsylvania State Agency at the Gettysburg Family Practice on 06/06/2024. The laboratory was found out of compliance with the following conditions: 493.801 Condition: Enrollment and testing of samples 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) reports, patient test results, and interview with the technical supervisor (TS), the laboratory failed to enroll in an HHS approved proficiency testing (PT) program for Cell Identification (hematology) from 06/06/2022 to 06/06/2024. Findings include: 1. On the date of the survey, 06/06/2024 at 01:30 pm, review of 3 of 3 patient test results revealed the laboratory reported the following analytes: - 05/28/2024: Patient ID #: 004000945 Manual Differential with Red Blood Cell (RBC) and Platelet (PLT) Morphology - 04 /18/2023: Patient ID #:004002187 Manual Differential with RBC and PLT Morphology - 01/30/2024: Patient ID # 000282204 Manual Differential with RBC Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- and PLT Morphology 2. During an interview on 06/06/2024 at 03:30 pm, the TS confirmed the laboratory was not enrolled in an HHS approved PT program for Cell Identification from 06/06/2022 to 06/06/2024. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with the technical supervisor (TS), the laboratory failed to examine hematology API PT testing events in the same manner as patient specimens from 2023 to the date of the survey. Findings include: 1.The laboratory's 2023 Hematology/Coag 3rd event API PT