Quest Md Clinics Minden

Summary Statement of Deficiencies D0000 A Recertification survey was performed on February 22, 2022 at Quest MD Minden, CLIA ID # 19D2170631. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with personnel, the laboratory failed to ensure the Laboratory Director signed the performance evaluation form for one (1) of six (6) proficiency testing events reviewed. Findings: 1. Review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records for 2020 and 2021 revealed the Laboratory Director did not sign the performance evaluation form for the following one (1) event: a) FH9-B 2020 Hematology Auto Differentials 2. In interview on February 22, 2022 at 10:20 am, Personnel 3 confirmed the Laboratory Director did not sign the above identified PT event in 2020. D6018 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 An Initial Certification survey was performed at Quest MD Clinics Minden, CLIA ID # 19D2170631 on March 11, 2020. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure the Laboratory Director and Testing Personnel signed the attestation statement for one (1) of one (1) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's College of American Pathologists (CAP) proficiency testing records revealed the Laboratory Director and Testing Personnel did not sign the attestation statement for the following event: a) FH9-A 2020 Hematology Automated Differential Survey Event 1 2. In interview on March 11, 2020 at 01:20 pm, the facility representative stated that the missing signatures was an oversight. The facility representative confirmed the attestation statement was not signed for the above event. D5781