Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of Standard Operating Procedures (SOPs), lack of Proficiency Testing (PT) records, as well as interviews with the Testing Personnel (TP) and Practice Manager (PM), the laboratory failed to successfully participate in a histopathology specialty PT program. FINDINGS: 1. There was no documentation of Mohs histopathology twice year verification performance for 2020, 2021,2022, 2023, and 2024. 2. The current, approved SOPs did not include instructions for performing such activity. 3. The TP and PM confirmed the findings on April 29, 2025, at approximately 2:30 P.M. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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: 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 -- Based on review of the SOPs as well as interview with the TP, the laboratory failed to document approval and date of approval by the current Laboratory Director (LD) before use. FINDINGS: 1. There was no documentation of LD approval and date of approval for the 2020, 2021,2022, 2023, 2024, and 2025 SOPs. 2. The TP confirmed the findings on April 29, 2025, at approximately 2:30 P.M. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of SOPs, lack of PT documentation, as well as interview with the TP, the LD failed to provide overall management and direction of laboratory services. Refer to D2000 and D5407. -- 2 of 2 --