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 review of laboratory proficiency testing (PT) documentation, confirmed by staff interview, the laboratory failed to enroll in an approved PT program for thyroid stimulating hormone (TSH) testing performed on the Qualigen Fastpack analyzer. Findings: 1. In the course of the survey, laboratory PT documentation for 2018 and 2019 was reviewed. With the exception of a remedial evaluation survey dated 11-18- 2019 by the American Proficiency Institute (API), no PT documentation for TSH could be offered. 2. In an interview at the site on 11-22-2019, the laboratory technical consultant (CMS form 209) confirmed that the laboratory had not been enrolled in PT for TSH testing for the previous two years. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: . Based on review of laboratory proficiency testing documentation for 2018 and 2019, confirmed by staff interview, the laboratory failed to verify the accuracy of testing for testosterone, prostate specific antigen (PSA) and vitamin D 25-hydroxy using the Qualigen Fastpack analyzer. Findings: 1. Review of laboratory PT documentation revealed no accuracy verification testing for testosterone, PSA or vitamin D 25- hydroxy testing. 2. In an interview at the site on 11-22-2019, the laboratory technical consultant stated she was not aware that accuracy verification testing for analytes not listed in Subpart I was required. . D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on review of laboratory quality control (QC) documentation for 2017, 2018 and 2019, the laboratory failed to perform quality controls for testosterone, TSH, PSA and vitamin D 25-hydroxy testing performed using the Qualigen Fastpack analyzer. Findings: 1. Review of laboratory QC documentation revealed the following: No QC results for testosterone, TSH or PSA were available for the period from 12-04-2017 to 11-14-2019. No QC results for vitamin D 25-hydroxy were available for the period from 12-18-2017 to 11-14-2019. 2. In an interview at the site on 11-22-2019, the laboratory technical consultant confirmed that no QC had been performed on the dates in question. . D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: . Based on review of laboratory PT documentation, confirmed by staff interview, the laboratory director failed to ensure that the laboratory was enrolled in an approved PT program for TSH testing using the Qualigen Fastpack analyzer. Refer to D2000. . D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) -- 2 of 3 -- (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: . Based on review of laboratory PT documentation, confirmed by staff interview, the laboratory technical consultant failed to ensure that the laboratory was enrolled in an approved PT program for TSH testing using the Qualigen Fastpack analyzer. Refer to D2000. -- 3 of 3 --