Summary:
Summary Statement of Deficiencies 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 Surveyor review of laboratory's patients tests records, proficiency testing records and interview with the laboratory director on October 31, 2025, at 12:10 p.m., the laboratory failed to enroll in the proficiency testing for chemistry. The findings include: 1. The laboratory used Fastpack system to test for PSA and testosterone. The laboratory participated in the API proficiency testing for the year 2023 and 2024. However, it did not enroll proficiency testing program for the year 2025. Therefore, the accuracy of the patients' test results rendered by the laboratory cannot be assured and may have harmed patient. 2. The laboratory director on October 31, 2025, at 12: 10 p.m., affirmed that the laboratory did not enroll into the proficiency program due to non-payment to the program. 3. The laboratory's testing declaration form, signed by the laboratory director on 10/31/2025, stated that the laboratory performed approximately 1,575 PSA and testosterone tests, annually. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing 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 -- program for the testing performed and that-- This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory patients' tests, proficiency testing records and interview with the laboratory director on October 31, 2025, at 12:10 p.m., the laboratory director failed to ensure that the laboratory enrolled into a proficiency testing program. The findings include: See D2000. -- 2 of 2 --