Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 10/13/25 at 3:50pm, four (of 8) containers of "ExacTip 200uL Pipette Tips" (Azeri Scientific, lot 20210513-306-D, Cat No:ES80755, expiration date 5/13 /24) and six (out of six) "Next Generation Tip Refill 100-1250uL" (VWR, lot 940C6- 940H, Cat No:89079-486 expiration date 9/23) were observed in the laboratory, available for use beyond the expiraton date. C) In an interview on 10/13/25 at 3:50pm the technical consultant confirmed that the items, identified above, had exceeded their expiration date and were available for use in the laboratory. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals 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 the CMS-209 form, laboratory personnel files, lack of documentation, and interviews with laboratory staff, the technical supervisor failed to 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 -- assess the competency of one out of one clinical laboratory testing personnel annually after the first year. A) The CMS-209 form for the clinical laboratory, dated 10/10/25, included one testing personnel. B) Through a review of personnel files it was determined that one employee had documentation that they had been employed for more than one year. C) One of one laboratory testing personnel, who were employed over one year, failed to have competency documented in the last year (12 months) D) In an interview, at 1:55 pm on 10/13/25, the Technical Supervisor confirmed that competency assessments have not been documented in the last year. -- 2 of 2 --