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 the proficiency testing sample and the laboratory director interview the laboratory fail to test the proficiency for Syphilis Serology, Rapid Reagin Plasma (RPR) method as the same manner as it test patient specimen. Refer to D2006. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on the Proficiency testing records review, worksheet records of Syphilis Serology, Rapid Reagin Plasma (RPR) method, (quantitative and qualitative) and interview of the laboratory director; it was determined that the laboratory failed to test the proficiency specimen as the same manner as it tests patient specimen (years 2021- 2022). The findings include: a. On October 12, 2022 at 11:31 am the Proficiency test scores for syphilis Serology test were reviewed. The documents showed that the initially reactives samples were later tested for the quantitative test twice. b. The proficiency test records showed that, on the first testing event of the year 2021 and the first testing event of the year 2022 the reactive samples were tested twice. For the third testing event of the year 2021 were tested three (3) times. c. On October 12, 2022 at 11:42 am the laboratory written protocol for syphilis serology patient testing was requested to the laboratory director. The laboratory director stated no written protocol was available. d. On October 12, 2022 at 12:05 pm syphilis serology patient testing worksheet was reviewed. The worksheet showed that the patient's samples with an initial reactive test result were diluted only once. The laboratory director stated that the patient samples were diluted only one time. D2072 SYPHILIS SEROLOGY CFR(s): 493.835(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on the proficiency testing record review and laboratory director interview, it was determined that the laboratory failed to take a