Sonoma County Public Health Laboratory

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory's reagent materials used for decontamination of surface areas and other reagents used in the laboratory and interview with the laboratory director (LD); it was determined that the laboratory failed to label various reagents to indicate the reagent's name, opening, preparation, and expiration dates when such reagents are used in the laboratory. The findings included: 1. Based on the surveyor's observation during the laboratory tour on May 3, 2022, at approximately 1: 00 pm.; no opening, preparation, or expiration date labels were used or documented for various reagents used throughout the laboratory (1:10 Sodium hypochlorite and sterile water). 2. The laboratory's LD affirmed in an interview conducted May 3, 2022, at approximately 1:15 p.m. that the reagents mentioned in statement 1 were not labeled with the name, opening, preparation, and expiration dates or documented. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed approximately 105,103 test samples. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on the incomplete laboratory's verification of performance characteristics for high complexity testing for Lyme Disease by ELISA, interview with the laboratory director (LD), and six (6) randomly selected patient test records reviewed from 1/8 /2020 to 1/4/2022; the laboratory failed to demonstrate that it established performance specifications comparable to those established by the manufacturer. The findings included: 1. The laboratory had only partial documentation to show for performance specifications, no date or signature of approval by the LD prior to reporting patient test results. The laboratory must be able to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics and those to be approved by the LD before starting testing patients' samples: (A) Accuracy (B) Precision (C) Reportable range of test results for the test system (D) Sensitivity and (E) Specificity. 2. The laboratory was unable to provide for review additional documents using patient samples to establish the performance specifications stated in 1. 3. The LD affirmed at the time of the survey on 05/03/2022 at approximately 11:30 a.m. that no additional documents could be retrieved to show that all the Lyme Disease test by ELISA method performance specifications were performed prior to reporting patient test results when the laboratory went live testing and reporting Lyme Disease diagnostic tests. 4. Based on the estimated annual tests volumes reported on 5/03/2022; the laboratory performed and reported approximately 227 Lyme Disease test results by the ELISA method. The precision and reliability of the reported results could not be assured. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the laboratory's procedure manual, lack of documentation, observation, and interview with the laboratory director and testing personnel (TP); it was determined that the laboratory failed to perform and document maintenance and calibration as defined by the manufacturer and with at least the frequency specified by the manufacturer for the laboratory's small equipment such as vortexes, centrifuges, and timers. The findings included: 1. The laboratory's standard operating procedure (SOP) indicated that annual maintenance and calibration be performed according to manufacturer's requirements on small equipment: vortexes, centrifuges, and timers. 2. The LD and TP confirmed on May 3, 2022, at approximately 1:00 p.m. that the laboratory failed to follow the SOP for maintenance and calibration of small equipment used in the laboratory. 3. According to the annual test volume declared by the laboratory on 5/3/2022 the laboratory performs approximately 105,103 tests annually. D6082 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's incomplete validation and verification of performance specifications for a new test, lack of labelling of reagents, lack of preventive maintenance of small equipment, and interview with the laboratory director and testing personnel on May 3, 2022; it was determined that the laboratory director failed to ensure that several aspects of the preanalytic, analytic, and posanalytic phases of laboratory testing were monitored. See D5415, D5421, and D5429. -- 3 of 3 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the laboratory test list (Laboratory Testing Declaration, 3/11/19) and patients laboratory reports for Bordetella pertussis (Pertussis) including Culture and Molecular diagnostics methods, the lack of laboratory documents, and interview with Testing person-5 (Technical Supervisor) it was determined that the laboratory failed to have a system that twice each year compared the relationship of the different methodologies for Pertussis. a. Ten of 10 laboratory reports selected at random from 2017 and 2018 included Pertussis results by both Culture and PCR. b. The laboratory was unable to provide for review a policy and documents comparing Pertussis Culture and PCR methods and results at least twice a year. c. Testing person-5 (Technical Supervisor) affirmed (3/12/19 at 5pm) the aforementioned lack of documents; and thus the laboratory's failure to compare and document evaluations of the different methods of testing for Pertussis. d. The reliability and quality of comparisons between Culture and PCR could not be assured in the absence of a policy and procedure to collect and document the evaluation of actual data twice each year. e. Based on the stated test volumes (Laboratory Testing Declaration), the laboratory annually reported 67 Culture results and 98 PCR results. Examples are as follows: Date Lab # ------------------------------------------ 2/03/17 17B0016 3/25/17 17B0048 4/20/17 17B0065 8/11/17 17B0142 9/06/17 17B0152 2/23/18 18B0031 3/15/18 18B0044 5/21 /18 18B0065 5/21/18 18B0066 5/31/18 18B0073 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the serious nature of the deficiency cited (D6078), the Condition of laboratory director, high complexity testing was not met. D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b) (1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and (b)(2)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on review of personnel records, the lack of records documenting training at a public health microbiology laboratory (PHL) and work experience as a PHM, and interview with Testing person-5, the laboratory director did not meet the State's qualifications to manage and direct laboratory personnel and performance of high -- 2 of 3 -- complexity tests at a public health microbiology laboratory. Findings included: a. Testing person-5 affirmed (3/12/19) not having work experience as a PHM nor PHM supervisory experience prior to 2016. b. The Section Chief for State Personnel Licensing evaluated the records and documents submitted by Testing person-5 and determined that the information needed to verify training at a PHL and determine PHM work experience was not provided; and thus was not acceptable. The Section Chief communicated this by email to Testing person-5 on May 2, 2019. c. Records provided by Testing person-5 failed to include at least 4 years of work experience as a PHM, with 2 years of supervisory responsibilities; as required for State qualifications. -- 3 of 3 --