Summary:
Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the freezer temperature logs from 1/1/17 through 12/31/18, review of storage requirements for PSA (prostatic specific antigen) samples, and interview with testing personnel on the day of survey 1/24/19 at 2:00 pm, the laboratory failed to follow the manufacturer's requirements for the storage of PSA samples. Findings include: The Beckman Access 2 procedure for PSA specifies that samples held longer than 24 hours must be frozen at -20 degrees Celsius or colder for up to 5 months. According to the temperature records provided, the freezer used to store PSA samples was not at or below -20 degrees Celsius on 493 days out of 622 days when temperatures were recorded. Testing Personnel confirmed that PSA testing is done twice a week and samples are stored in the freezer when batched awaiting a testing day. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: 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 -- Based on review of personnel records since the last survey on 12-18-2016 and the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the technical consultant failed to evaluate and document the performance of Testing Personnel #3 as listed on the CMS-209, responsible for moderate complexity testing, at least semiannually during the first year this individual tested patient specimens. 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 review of personnel records since the last survey on 12-8-2016, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and lack of documentation of annual evaluations, the technical consultant failed to evaluate and document the performance of the following individuals, responsible for moderate complexity testing, at least annually: Testing Personnel #2, #3, #4, #5, and #6. Findings include: Competency Evaluations for Testing Personnel #2, #4, and #5 were completed on 6/29/17. The next competency evaluations for these Testing Personnel were dated 1/18/19. Testing Personnel #3 (date of hire 6/12/17) did not have a competency evaluation until 1/18/19. Testing Personnel #6 (date of hire 3/20/17) had a semiannual competency evaluation done in 11/2017. The next competency evaluation (due in 3/2018) was done 1/18/19. -- 2 of 2 --