Pathologists Diagnostic Laboratory, Pa

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and review of 2019, 2020, and 2021 CAP (College of American Pathologists) proficiency testing records 11/9 /21, the laboratory failed to ensure ungraded proficiency testing results were evaluated. Findings: The laboratory's "INTERLABORATORY COMPARISON PROGRAM FOR HISTOLOGY AND IMMUNOHISTOCHEMISTRY" policy states "... II. PROCEDURE ... G. All CAP results will be reviewed by the histology supervisor. Any incorrect responses will be investigated and

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 interviews of the general supervisor (GS) and staff interview on 7/12/18, the laboratory failed to discard material that had exceeded the expiration date and was available for use. Finding: During tour of the laboratory at 3: 00 p.m. the surveyor observed one bottle of 0.1% Gold Chloride, Lot No.: 160830101; and, Exp. Date: 08/30/20017 located on the door of refrigerator $1. During interview with GS and staff at 3:00 p.m., it was confirmed that the solution was expired and immediately took possession of the solution for immediate disposal. D6149 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(b)(1) The director or technical supervisor may delegate to the general supervisor the responsibility for assuring that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications. This STANDARD is not met as evidenced by: Based on testing personnel Competency Assessment records review on 7/12/18 the laboratory director failed to delegate the responsibility and duty to the general 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 -- superiors. The general supervisor had documented testing personnel competency assessments, but the director had not delegated in writing the responsibility and duty to the general supervisors. -- 2 of 2 --