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 review of the standard operating procedures (SOPs) as well as interview with the Laboratory Director (LD), the laboratory failed to draft, approve, and implement Quality Assessment (QA) criteria for ongoing laboratory performance evaluation. FINDINGS: 1. The current, approved SOPs did not include instructions for performing such activity. 2. Confirmed findings by interview with the LD on April 4, 2024, at approximately 11:30 A.M. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the SOPs as well as interview with the LD, the LD failed to draft, 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 -- approve, and implement QA instructions for all phases of the general laboratory system. Refer to D5291. -- 2 of 2 --