Ca Dph Environmental Health Laboratory

Summary Statement of Deficiencies D0000 A recertification survey was conducted 05/12/2025 through 05/13/2025. Standard level deficiencies were cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the Laboratory Personnel Report (CLIA) form Centers for Medicare & Medicaid Services-209(CMS-209), College of American Pathologists Proficiency Testing (CAP PT), and interview with testing person-1 (TP-1), the laboratory failed to ensure blood lead proficiency testing samples were analyzed by personnel who routinely perform blood lead testing for four of four PT events. Findings included: 1. Review of the laboratory's Form CMS-209 (signed by the laboratory director 05/13/2025) listed two testing persons who routinely perform blood lead testing. 2. Review of CAP PT Blood Lead Survey attestation statement forms in 2024 (3 events) and 2025 (1 event) included TP-1's signature for analyzing four PT events. 3. During an interview on 05/12/2025 at 12:12 PM, TP-1 confirmed the PT events reviewed above were performed by by one of two TPs for submission and grading. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's written procedure, direct observation, and interview with TP-1, the laboratory failed to follow their blood lead testing procedures for storing 44 of 44 quality control (QC) vials (random sampling observed). Findings included: 1. Review of the laboratory written procedure for blood lead testing (SOP /Rev. No: 132/R4, revised date 03/27/2024) stated, "12.5. Internal quality control materials ...12.5.3. Each pool of the reference material is aliquoted into 50 mL conical tubes with ~40 mL each, and stored at -20 C. They are stable for at least three years and are analyzed in the same manner as urine specimens ...." 2. During a tour of the laboratory on 05/13/2025 at 10:38 AM, the medium and low levels of quality control material were observed stored in a -80 C freezer ("Freezer #2"), as follows: a. One box of small cryogenic specimen containers with "Blood QCC Low" (low QC level) and "Blood QCM" (medium QC level), a total of 43. b. A rack of 50 mL conical tubes, a sample included a tube labeled "Blood Reference Material LIMS: E_BMI_QCL Blood Batch: 11142011 Vial #13." The QC in cryogenic specimen containers were aliquoted from the 50 mL conical tubes for one-time use (low and medium quality control levels were prepared 11/14/2011). The laboratory did not follow their procedure for storing QC material at -20C. 3. During an interview on 05 /13/2025 at 10:38 AM, TP-1 stated QC was moved from -20 C to a -80 C freezer. The laboratory was unable to provide establishment studies to support this new storage temperature and stability for QC used in a laboratory developed test (blood lead). Refer to D5423. Word Key: SOP - standard operating procedure Rev. - revision No. - number mL - milliliters LIMS - laboratory information management system D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the laboratory's written procedure, direct observation, and interview with TP-1, the laboratory failed to monitor and document the temperature for one of one refrigerator where solutions for blood lead testing were stored. Findings included: 1. Review of the laboratory written procedure for blood lead testing (SOP /Rev. No: 132/R4, revised date 03/27/2024) stated, "7. Preparation of Reagents and Calibration Standards 7.1 Basic sample diluent ...7.1.6. Make the final volume to 2 L with 18.2 megaohm-centimeter water. The solution is stable for 3 months when stored at 4 C ..." Components for the sample diluent included, "n-Butanol (BuOH) 3.5%, NH4OH 1%, Triton X-100 0.005%, H4EDTA 0.080%, Ga, Ge, Rh, Re, Ir, Bi, DI Water." 2. Further review stated, "7.2 Basic standard diluent with synthetic matrix ... used for preparation of intermediate calibration standards ...7.2.2. Transfer the purified sodium chloride solution to 500 mL Teflon container and add the remaining -- 2 of 6 -- synthetic matrix components listed in Table 3. The solution is stable for 3 months when stored at 4 C. Table 3. Preparation of the basic standard diluent with synthetic matrix ...NH4OH 2.0%, H4EDTA 0.20%, NaCl 0.80%, DI Water." A temperature range was not defined for the storage of the two prepared diluents. 3. During a tour of the laboratory on 05/13/2025 at 10:34 AM, an "Upstreman" refrigerator was observed and used to store blood lead solutions, as follows: a. One bottle labeled as, "BuOH 3.5%, NH4OH 1%, Triton 0.005%, EDTA 0.08% AU 1ppm, Ga 10ppb, Rh, Re. IR 1 ppb, Bi 4 ppb, Ge 12 ppb, 2/14/25 (TP-1 initials)" (basic sample diluent) b. One bottle labeled as, "Basic SM, NH4OH 2%, EDTA, Au 1 ppm, 2/13/2025" (basic standard diluent with synthetic matrix) 4. During an interview on 05/13/2025 at 10:34 AM, records of the refrigerator temperature were requested, TP-1 confirmed the temperature was not monitored and documented. He stated the refrigerator was put in- use "about a year ago." Word Key: NH4OH - ammonium hydroxide H4EDTA/EDTA - ethylenediaminetetraacetic acid Ga - gallium Ge - germanium Rh - rhodium Re - rhenium Ir - iridium Bi - bismuth DI Water - deionized water NaCl - sodium chloride ppm - parts per million ppb - parts per billion SM - sythetic matrix D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure and direct observation, the laboratory failed to label 44 of 44 vials of prepared blood lead quality control material (low and medium) with expiration dates as defined in their written procedure. Findings included: 1. Review of the laboratory written procedure for blood lead testing (SOP /Rev. No: 132/R4, revised date 03/27/2024) stated, "12.5. Internal quality control materials ...12.5.3. Each pool of the reference material is aliquoted into 50 mL conical tubes with ~40 mL each, and stored at -20 C. They are stable for at least three years and are analyzed in the same manner as urine specimens ...." and "12.5.10 ...The original expiration date may be extended as long as a revised mean value is within +/- 30% of the previous mean value. Otherwise, the internal QC material should be discarded and freshly prepared." 2. During a tour of the laboratory on 05/13/2025 at 10:38 AM, the medium and low levels of quality control material were observed stored in a -80C freezer ("Freezer #2"), as follows: a. One box of small cryogenic specimen containers with "Blood QCC Low" and "Blood QCM", a total of 43. b. A rack of 50 mL conical tubes, a sample included a tube labeled "Blood Reference Material LIMS: E_BMI_QCL Blood Batch: 11142011 Vial #13." The QC in cryogenic specimen containers were aliquoted from the 50 mL conical tubes for one- time use (quality control was prepared 11/14/2011). 3. The laboratory did not label the QC with expiration dates (11/14/2014) and did not have documentation of extending the expiration date 11 more years based on +/- 30% of the original mean in 2011. The laboratory had not established stability when QC material was moved from -20 C to -80 C freezer. Refer to D5423. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) -- 3 of 6 -- (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure, direct observation, and interview with TP-1, the laboratory failed to ensure 44 of 44 vials of prepared blood lead quality control material (low and medium) were not available for use. Findings included: 1. Review of the laboratory written procedure for blood lead testing (SOP/Rev. No: 132 /R4, revised date 03/27/2024) stated, "12.5. Internal quality control materials ...12.5.3. Each pool of the reference material is aliquoted into 50 mL conical tubes with ~40 mL each, and stored at -20 C. They are stable for at least three years and are analyzed in the same manner as urine specimens ...." and "12.5.10 ...The original expiration date may be extended as long as a revised mean value is within +/-30% of the previous mean value. Otherwise, the internal QC material should be discarded and freshly prepared." 2. During a tour of the laboratory on 05/13/2025 at 10:38 AM, expired medium and low levels of quality control material were observed stored in a -80C freezer ("Freezer #2"), as follows: a. One box of small cryogenic specimen containers with "Blood QCC Low" and "Blood QCM", a total of 43. b. A rack of 50 mL conical tubes, a sample included a tube labeled "Blood Reference Material LIMS: E_BMI_QCL Blood Batch: 11142011 Vial #13." The QC in cryogenic specimen containers were aliquoted from the 50 mL conical tubes for one-time use (quality control was prepared 11/14/2011). 3. According to the laboratory's procedure, prepared QC material expiration date is "at least three years" or "may be extended as long as a revised mean value is within +/-30% of the previous mean value." The QC material expired 11/14/2014 and there was no documentation to support the QC material was stable for 11 additional years with a +/-30% acceptability of the original mean value from 2011. In addition, the laboratory had not established stability when QC material was moved from -20C to -80C freezer. Refer to D5423. 4. During an interview on 05/13/2025 at 10:38 AM, TP-1 had not prepared new QC material and used the vials from the above freezer. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) (b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (b)(2)(i) Accuracy. (b)(2)(ii) Precision. (b)(2)(iii) Analytical sensitivity. (b) (2)(iv) Analytical specificity to include interfering substances. (b)(2)(v) Reportable range of test results for the test system. (b)(2)(vi) Reference intervals (normal values). (b)(2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on interview with testing person-1 (TP-1) and review of the laboratory's written procedures, the laboratory failed to establish the performance specifications for one of one Agilent 8900 inductively coupled plasma mass spectrometry (ICP-MS) analyzer -- 4 of 6 -- when installed 07/31/2023 for blood lead testing and for stability of their QC material. Findings included: 1. During an interview on 05/12/2025 at 9:45 AM, testing person-1 and the technical supervisor confirmed that there was a change of instrumentation in 2023. An Agilent 8900 analyzer had replaced their previous instrumentation and was installed 07/31/2023. 2. Review of the laboratory's written procedures did not include conducting studies on new instrumentation. 3. During an interview on 05/12/2025 at 9: 45 AM, testing person-1 stated quality control and calibration was analyzed. The laboratory did not provide documentation of verifying their existing test method on a new analyzer for blood lead testing that was reviewed and approved by the laboratory director. Refer to D6086. 4. Review of the laboratory written procedure for blood lead testing (SOP/Rev. No: 132/R4, revised date 03/27/2024) stated, "12.5. Internal quality control materials ...12.5.3. Each pool of the reference material is aliquoted into 50 mL conical tubes with ~40 mL each, and stored at -20 C. They are stable for at least three years and are analyzed in the same manner as urine specimens ...." 5. During a tour of the laboratory on 05/13/2025 at 10:38 AM, the medium and low levels of quality control material were observed stored in a -80 C freezer ("Freezer #2"), as follows: a. One box of small cryogenic specimen containers with "Blood QCC Low" and "Blood QCM", a total of 43. b. A rack of 50 mL conical tubes, a sample included a tube labeled "Blood Reference Material LIMS: E_BMI_QCL Blood Batch: 11142011 Vial #13." The QC in cryogenic specimen containers were aliquoted from the 50 mL conical tubes for one-time use (quality control was prepared 11/14/2011). 6. During an interview on 05/13/2025 at 10:38 AM, TP-1 stated QC was moved from -20 C to a -80 C freezer. The laboratory was unable to provide establishment studies to support this new storage temperature and stability for QC used in a laboratory developed test (blood lead). D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on review of the laboratory's written procedures and in interview with TP-1, the laboratory director failed to ensure studies were conducted, reviewed and approved for one of one Agilent 8900 analyzer (installed 07/31/2023). Findings included: 1. The laboratory's written procedures did not include conducting studies on new instrumentation. 2. During an interview on 05/12/2025 at 9:45 AM, testing person-1 stated quality control and calibration was analyzed. 3. The laboratory was not able to provide documentation of verifying their existing test method on a new analyzer for blood lead testing. Refer to D5423. The laboratory director did not ensure that the Agilent 8900 analyzer studies were conducted, reviewed and approved. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on review of CAP PT, CMS-209 form, and interview with the technical supervisor, the laboratory director failed to ensure blood lead CAP PT review was delegated to an individual listed on the CMS-209 form (four of four PT events reviewed). Findings included: 1. Review of CAP PT Blood Lead Survey attestation statement forms in 2024 (3 events) and 2025 (1 event) included the Biochemistry Section Chief's signature under "Director (or Designee) (signature required)" and "Reviewed By" for PT results. 2. Review of the CMS-209 form (signed by the laboratory director 05/13/2025) did not list the Section Chief in a designated CLIA high complexity role. 3. During an interview on 05/13/2025 at 9:30 AM, the technical supervisor confirmed the laboratory director delegated PT review duties to the Biochemistry Section Chief in writing. The Biochemistry Section Chief did not have a California licensure; therefore, could not be listed as a technical supervisor. The laboratory director failed to delegate CLIA responsibilities to a qualified individual, as outlined in CFR 493.1449. -- 6 of 6 --

Summary Statement of Deficiencies 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 laboratory testing personnel competency assessment records, review of laboratory procedures, and interview with laboratory personnel on April 18, 2023, the laboratory failed to follow its written procedures to assess employee competency. a. According to laboratory procedure, "Analyst Training and Competency," continuing competency will be documented on the 'Continuing Competency Form.' b. At the time of the survey on April 18, 2023, the laboratory maintained no documentation to indicate that competency of testing personnel (TP#2) at least semiannually during the first year of patient testing had been assessed in 2022. c. The technical supervisor confirmed on April 18, 2023 at 11.21 a.m. the failure to follow written procedures to document testing personnel competency assessment at least semiannually during the first year of patient testing. See D6127 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: 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 -- Based on observation, review of laboratory procedures, and interview with laboratory personnel on April 18, 2023, the laboratory failed to follow its procedure to perform annual analytical balance calibration. Findings included: a. During a tour of the laboratory on April 18, 2023, Mettler Toledo analytical balance, S/N: B109116570, past due calibration service, January 2023, was observed. b. According to laboratory procedure, 'Equipment Calibration and Maintenance,' analytical balances are to be calibrated annually. At the time of the survey on April 18, 2023, the laboratory maintained no documentation to indicate that the annual calibration of the Mettler Toledo analytical balance had been performed. c. Based on interviews with laboratory personnel, it is the practice of the laboratory to perform calibration checks of pipettes used in patient testing using the Mettler Toledo analytical balance. d. The laboratory director and testing personnel confirmed on April 18, 2023 at 9.39 a.m. that the annual calibration of the analytical balance had not been performed. D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory testing personnel training and competency records, and interview with laboratory personnel on April 18, 2023, the technical supervisor failed to evaluate and document the performance of individuals responsible for high complexity patient testing at least semiannually during the first year of patient testing. Findings include: a. Evaluations of testing personnel (TP#2) competency for performing patient testing were documented initially in 2022 during the first year of patient testing, and annually in 2023. b. At the time of the survey on April 18, 2023, the laboratory maintained no documentation to indicate that competency of testing personnel (TP#2) at least semiannually during the first year of patient testing had been assessed by the technical supervisor in 2022. c. The technical supervisor confirmed on April 18, 2023 at 11.21 a.m. the failure to evaluate and document the performance of TP#2 competency at least semiannually during the first year of patient testing. See D5209 -- 2 of 2 --

Summary Statement of Deficiencies 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 policy manual and the laboratory testing personnel competency reviews on November 16, 2018 the laboratory failed to follow written policies and procedures to assess employee and, if applicable, consultant competency. Findings include: a. The laboratory policy on performing training and competency assessments states that the laboratory would perform and document initial training and competency assessment of all new testing staff s followed by a semi-annual competency and annually competency thereafter. b. The laboratory hired one new testing personnel during the recertification survey review years of 2017-2018. c. The laboratory failed to follow its policy and procedure's regarding performing a semi- annual competency on the new testing personnel in the first year of hire. d. The laboratory technical supervisor confirmed by interview on November 16, 2018 at approximately 11:45 am, the failure to perform and document the semi-annual competency of the new testing personnel. e. The laboratory reports performing approximately 1000 high complexity lead specimens annually. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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 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 -- 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 personnel records, review of the laboratories policy and procedures, and the laboratory training and competency records on November 16, 2018, the laboratory director failed to 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. Findings Include: a. Review of personnel competency records and review of the laboratory policy and procedure manual revealed that the laboratory did not have a policy or procedure for evaluating the competency of the individuals identified on the CMS-209 as the technical supervisor, clinical consultant or the general supervisor. b. The laboratory did not have documentation of competency for technical supervisor, the clinical consultant or the general supervisor for the survey review years of 2016, 2017, or 2018. c. The laboratory technical supervisor confirmed this lack of policy by interview on November 16, 2018 at approximately 1:00 pm. d. The laboratory reports performing 1000 high complexity lead testing annually. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory personnel policy manual, staff competency records on November 16, 2018, the laboratory director failed to specify, in writing, the responsibilities and duties of each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. Finding Includes: a. The laboratory has a multi-layered process for review for patient testing results prior to releasing of reports to the requestor. Review of patient testing flows through unlicensed testing personnel, unlicensed personnel, to the general supervisor, and then to technical supervisor. b. Upon review of the laboratory staff training and competency records, the laboratory has no documentation regarding the extent of the responsibilities and duties of the laboratory technical supervisor, the general supervisor, the licensed testing personnel, and unlicensed personnel who are engaged in preanalytic, analytic and postanalytic phases of patient testing, regarding delegated duties, responsibilites and testing approval authorized by the laboratory director. c. The laboratory technical supervisor, -- 2 of 3 -- general supervisor confirmed by interview on November 16, 2018 at approximately 12:30 pm the lack of documentation regarding the roles, responsibilities and authorization for staff engaged in patient testing. d. The laboratory reports performing 1000 high complexity lead tests annually. D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the personnel training and competency records on November 16, 2018, the technical supervisor failed to evaluate and document the performance of new individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Findings Include: a. The laboratory hired one new testing personnel (#6 on CMS-209) on November 2016, the initial training of the testing personnel was signed off on January 9, 2017. b. The next competency for testing personnel (TP) #6, was performed on April 23, 2018. c. The laboratory did not perform a semiannual competency during the first year of testing on TP #6. See D tag 5209 d. The omission of the semiiannual competency was confirmed by interview by the laboratory Technical Supervisor on November 16, 2018 at approximately 11:00 am. e. The laboratory reports performing 1000 high complexity lead tests annually. D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on review of the laboratory personnel licensing and education transcripts, the laboratory failed to ensure that each individual performing high complexity testing possess a current license issued by the State in which the laboratory is located, if such licensing is required. Findings Include: a. The laboratory is a public Health Laboratory for California. California has testing personnel licensing requirements. b. Two of two CMS-209 identified testing personnel lack state licensure for Toxicology testing in accordance to CA BPC 1206.5 (c )(3). and CMS 42 CFR 493.1461(a). c. The laboratory technical supervisor confirmed by interview on November 16, 2018 at approximately 11:00 am, that the two testing personnel did not have the required state licensure. d. The laboratory reports performing approximately 1000 high complexity Lead specimens annually. -- 3 of 3 --