Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of established Quality Assessment (QA) policies and procedures for review and interview with the facility personnel on 9/23/25 at 11:32 AM, (A) the laboratory failed to establish QA policies and procedures for the general laboratory systems including patient confidentiality; specimen identification and integrity; complaint investigations; communications; personnel competency; and proficiency testing performance, and (B) the laboratory failed to establish policies and procedures for the accuracy verification process of Mohs specimens tested by the laboratory. Findings include: 1. The laboratory performs the microscopic interpretation of Mohs specimens in the subspecialty of Histopathology with a reported annual test volume of 144. A2. No documentation was presented for review to indicate the laboratory established QA policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements including: Patient confidentiality; Specimen identification and integrity; Complaint investigations; Communications; Personnel competency; and Proficiency testing performance. B3. No documentation was presented for review to indicate the laboratory established policies and procedures related to the accuracy verification process for Mohs testing, including but not limited to, the frequency of the review, number of cases reviewed, individual or laboratory performing the review and a remedial action plan in the event of a noted discrepancy. 4. The facilty personnel interviewed on 9/23/25 at 11:32 AM confirmed the laboratory failed to establish a written policy and procedure specific to the verification of accuracy process for the 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 -- microscopic interpretation of Mohs specimens, and failed to establish QA policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements indicated above. 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: Based on review of the Mohs test procedure on September 23, 2025 at 11:02 AM and interview with the facility personnel, the laboratory director failed to approve, sign and date the Mohs test procedure before use. Findings include: 1. The laboratory began testing on 2/25/25 and performs the microscopic interpretation of Mohs specimens in the subspecialty of Histopathology, with a reported annual test volume of 144. 2. The Mohs test procedure presented for review on 9/23/25 failed to include the approval, signature and date of the current laboratory director. 3. The facility personnel interviewed on 9/23/25 at 11:02 AM acknowledged that the Mohs Section Procedure was not approved, signed and dated by the current laboratory director before use. -- 2 of 2 --