Kern County Public Health Laboratory

Summary Statement of Deficiencies D2029 MYCOBACTERIOLOGY CFR(s): 493.825(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the first event 2022 (Q1-2022), of the College of American Pathologist (CAP) proficiency testing records, random review of six (6) patient testing records, and interview with the laboratory general supervisors (GS); it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent in Mycobacteriology. The findings included: 1. For (Q2-2022), CAP reported an unsatisfactory proficiency testing result for Mycobacteriology with score of 71%. 2. Based on the laboratory's testing declaration submitted on 7/11/2023 signed by the LD, the laboratory analyzed and reported approximately 628 Mycobacteriology test including acid fast smears and organism identification. 3. The GS affirmed on 7/11 /2023 at approximately 11:20 a.m. that the laboratory received the above unsatisfactory score. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on interviews with the general supervisors, review of proficiency test reports documents for Mycobacteriology, and policies and procedures record on July 11, 2023; the laboratory director failed to ensure that laboratory personnel are properly 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 -- trained and competent when performing the test methods as required for accurate and reliable results. See D2029. -- 2 of 2 --

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of patient test records, laboratory's policy and procedure manual, and interview with the general supervisor (GS); it was determined that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the post analytic systems. The findings included: 1. The laboratory did not have a written policy or procedure for turnaround time (TAT) established for all the tests performed in the laboratory. 2. Based on the laboratory's annual test declaration submitted and signed by the laboratory director at the time of the survey on May 17, 2022; the laboratory analyzed and reported 29,207 test results for which there was no TAT established policy to monitor timely test results reporting during the postanalytic phase of testing. 3. The GS on May 17, 2022, at approximately 12:45 p.m. affirmed that the laboratory did not have a written policy or procedure for monitoring TAT for each test performed in the laboratory. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical 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 -- consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of laboratory's policies and procedures, five (5) randomly chosen patients, and interview with the general supervisor; it was determined that the laboratory director failed to be responsible for the overall operation and administration of the laboratory including assuring compliance with applicable regulations by delegating responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. See D5891. -- 2 of 2 --