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 surveyor's observation of the reagents used for Moh's slide testing and an interview with the office manager and a telephone conversation with the Moh's technician, the laboratory failed to discontinue the use of expired histology reagents. Findings: It was confirmed by the Moh's processor via a telephone conversation on November 13, 2018 at approximately 11:30 am, that the laboratory failed to discard an expired reagent: Eosin Lot # F018-12, expired 1/25/18. Approximately 44 patient specimens were tested and results released during that time. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of procedures and an interview with the Moh's processor via a telephone conversation, the laboratory director failed to ensure that the laboratory's QA program was maintained as part of the laboratory's overall quality systems program. Refer to D5417 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --