Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was performed on October 19, 2021 at Hope Medical Group for Women, CLIA ID # 19D0694775. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy manual, personnel records and interview with personnel, the laboratory failed to ensure written, detailed instructions for initial training and six month competency assessment for testing personnel. Findings: 1. In interview on October 19, 2021 at 10:30 am, the facility adminstrator stated that Personnel 5 was hired as a testing personnel in May 2021. 2. Review of the laboratory's policy for "Responsibilities of Laboratory Director, Technical Consultant, and Clinical Consultant" revealed "Annually evaluates and documents the performance of all testing personnel". 3. Further review of the laboratory's policy manual revealed the laboratory did not have a policy to define an intial training evaluation and six (6) month evaluation to assess competency for testing personnel and who is to perform assessments. 4. Review of the laboratory's personnel records revealed the laboratory did not have documentation for an initial and six (6) month evaluation for Personnel 5. 5. In interview on October 19, 2021 at 11:17 am, the facility administrator stated the Laboratory Director performs the annual competency assessments for testing personnel. The facility administrator further stated the laboratory has not hired any new testing personnel in a few years so there was no need to have an inital and/or six (6) month evaluation policy. 6. In further interview on 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 -- October 19, 2021 at 11:17 am, the facility administrator confirmed the laboratory did not have a policy for initial and (6) month evaluation and did not perform an evaluation for the identified personnel for testing. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of laboratory policy, personnel records and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Refer to D5209. -- 2 of 2 --