Chapman Laboratory

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 record review and staff interview, it was determined that the laboratory did not have a quality systems policy for monitoring, assessing, and

Summary Statement of Deficiencies D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to evaluate the competency of all testing personnel (TP). Findings include: 1. Record review on 3/15 /2022 of the laboratory's 2020 and 2021 TP competency records revealed 9 of 9 TP had incomplete 2020 and 2021 competency records. 2. Staff interview with the laboratory manager on 3/15/2022 at 11:00 AM confirmed the above findings. 3. The laboratory performs 169,886 tests annually. 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 --