Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was performed on October 18, 2022 at EM Dimitri DO PMC (DBA Dimitri Dermatology), CLIA ID # 19D2173568. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and interview with personnel, the laboratory failed to ensure policies and procedures were approved annually per laboratory policy. Findings: 1. Review of the laboratory's "Review Policy" revealed "This procedure manual is reviewed by the Laboratory Director annually and at other time as required by major changes in procedure or other circumstances affecting laboratory performance of the test." 2. Further review of the "Review Policy" revealed the Laboratory Director did not review the policies in 2021. The Laboratory Director's documented review was December 2019. 3. In interview on October 18, 2022 at 2:00 pm, the Operations personnel confirmed the laboratory did not have documentation of the Laboratory Director's annual review of policies for 2021. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: **Repeat deficiency from survey performed February 9, 2021 ** Based on observation by surveyor, review of policies, and interview with personnel, the laboratory failed to ensure reagents did not exceed their expiration dates. Findings: 1. Observation by surveyor during the laboratory tour on October 18, 2022 at 1:01 pm revealed the following expired items: a) Gill's Hematoxylin III stain solution, Lot 125623, Expiration Date: 2022-07-31, Quantity: four (4) bottles 2. Review of the laboratory's "Storage, Use and Handling" policy revealed " Do not use reagent after expiration date." 3. In interview on October 18, 2022 at 2:00 pm, the Laboratory Director and Operations personnel confirmed the identified items were expired. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the laboratory's records and interview with personnel, the laboratory failed to have documentation of the cryostat's annual performance of preventative maintenance (PM) for 2021. Findings: 1. Review of the laboratory's service report records revealed the laboratory did not have documentation of performance of preventative maintenance for their cryostat for 2021. 2. In interview on October 18, 2022 at 2:25 pm, the Operations personnel stated the service order for the PM was initiated December 2021; however, service did not perform the task until January 2022. The Operations personnel confirmed the laboratory did not have documentation of the annual PM for the cryostat for 2021. D5781