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 the surveyor's observation during the laboratory tour, examination of laboratory reagent materials and solutions, and interviews with the Operation Regional Manager (ORM); the laboratory failed in using reagent materials and solutions when it had exceeded its expiration date. The findings include: 1. During the laboratory tour the surveyor found the following reagents used for Mohs processing /staining of patients' samples used beyond its expiration date: a. Methanol Expired 9 /2025 b. Clearing Reagent Expired: 10/09/2025 c. Hematoxylin Expired: 10/1/2025 d. Eosin Expired 10/9/2025 2. The ORM affirmed by interviews on December 4, 2025, at approximately 4:45 p.m. that the laboratory used the reagent in 1 above beyond its expiration date for patient Mohs patients' samples without noticing their expiration date. 3. According to the testing declaration signed and dated by the laboratory director and submitted at the time of survey (12/4/2025), the laboratory tested and reported approximately 520 patient samples for Mohs annually during the time when reagent stains and solutions used were past its expiration date. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour, review of the laboratory's policies and procedures, and five (5) randomly selected patients' Mohs result; the laboratory director is herein cited for failure to provide quality laboratory services for the analytic phase of testing. See D5417. -- 2 of 2 --