Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and staff interview on 06/21/208, the laboratory failed to ensure staining reagents in use had not exceeded the manufacturer's expiration date. Findings include: Observation during a tour of the laboratory revealed the eosin stain in use had expired 05/18/2018. Testing personnel revealed in an interview at 10:25 AM on 06/21 /208, the laboratory failed to have a system in place to ensure staining reagents were discarded on manufacturer's expiration date. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel records and staff interview on 06/21/2018, the technical supervisor failed to evaluate and document the performance for one of three individuals responsible for laboratory testing at least semiannually during the first year the individual performed patient testing. Findings include: Personnel #2 was hired February 2017. There was no record of competency evaluations performed as of February 2018. An interview with testing personnel at 9:30 AM on 06/21/2018, 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 -- revealed the laboratory failed to have a system in place to ensure competencies were performed and documented at least semiannually during the first year the individual performed patient testing. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of personnel records and staff interview on 06/21/2018, the Technical Supervisor failed to perform annual evaluations on two of three individuals responsible for patient testing. Findings include: Record review failed to reveal annual evaluations performed on Personnel #1 and Personnel #3 in 2017. Interview with testing personnel at 9:30 AM on 06/21/2018, revealed the laboratory failed to have a system in place to ensure annual evaluations were performed and documented on individual responsible for patient testing. -- 2 of 2 --