Ca Dept Of Public Health, Drinking Water &

Summary Statement of Deficiencies 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 laboratory procedure review, maintenance and performance record review, and laboratory personnel interview, the laboratory failed to maintain documentation to indicate that all ICP-MS required daily instrument maintenance activities were performed. Findings include: a. According to the laboratory's protocol titled "Standard Operating Procedures for Measuring Toxic Elements in Human Blood by Inductively Coupled Plasma Mass Spectrometry (SOP 010)," analysts are expected to perform all required daily maintenance and performance checks listed on the Perkin Elmer NexION 350D, Inductively-Coupled Plasma Mass Spectrometer (ICP-MS) instrument daily maintenance and performance checklist, and indicate by checkmark on the checklist that the activity was performed. b. Review of ICP-MS Instrument-B and Instrument-C daily maintenance and performance checklists, showed that the laboratory maintained no checkmark documentation to indicate that nebulizer and spray chamber cleaning was performed for both instruments on October 12, 2021, October 19, 2021, October 20, 2021, October 22, 2021 and October 28, 2021. d. The checkmark spaces on the checklists for the listed dates were blank. e. The technical supervisor confirmed on March 29, 2023 at 3.40 p.m. that the laboratory maintained no documentation to indicate that all required daily maintenance was performed. f. The laboratory reports an annual test volume of 100. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on laboratory procedure review, maintenance and performance record review, and laboratory personnel interview, the laboratory failed to maintain documentation to indicate that all ICP-MS required daily instrument function checks were performed. Findings include: a. According to the laboratory's protocol titled "Standard Operating Procedures for Measuring Toxic Elements in Human Blood by Inductively Coupled Plasma Mass Spectrometry (SOP 010)," analysts are expected to perform all required daily maintenance and performance checks listed on the Perkin Elmer NexION 350D, Inductively-Coupled Plasma Mass Spectrometer (ICP-MS) instrument daily maintenance and performance checklist, and indicate by checkmark on the checklist that the activity was performed. b. Review of ICP-MS Instrument-B daily maintenance and performance checklists, showed that the laboratory maintained no checkmark documentation to indicate daily function checks for: i. Tuning (Smart Tune Manual (dual detector calibration)) on April 6, 2022, April 7, 2022, April 19, 2022, April 20, 2022, and May 17, 2022. ii. Chiller turn off after plasma turn off on October 19, 2021. iii. Vacuum in Torr reading on October 20, 2021. c. Review of ICP- MS Instrument-C daily maintenance and performance checklists, showed that the laboratory maintained no checkmark documentation to indicate daily function checks for: i. Tuning (Smart Tune Manual (dual detector calibration)) on October 20, 2021, October 28, 2021, April 19, 2022, August 10, 2022, August 22, 2022, August 23, 2022 and December 23, 2022. ii. Vacuum in Torr reading on October 22, 2021. iii. Exhaust duct connection and function check on December 19, 2022. iv. Chiller turned on check on December 19, 2022, December 20, 2022, and December 23, 2022. d. The checkmark spaces on the checklists for the listed dates were blank. e. The technical supervisor confirmed on March 29, 2023 at 3.40 p.m. that the laboratory maintained no documentation to indicate that all required daily function checks were performed. f. The laboratory reports an annual test volume of 100. -- 2 of 2 --

Summary Statement of Deficiencies 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 laboratory personnel interviews and PerkinElmer NexION 350D operations manual record review on March 22, 2021 at 10:15 am, the laboratory failed to maintain documentation to indicate that the laboratory performed manufacturer required daily maintenance on the PerkinElmer NexION 350D. Findings included: a. The laboratory's chemical terrorism testing protocols included the use of the PerkinElmer NexION 350D to perform patient CDAA, HG-U, TES, and VM tests. b. According to the operations manual for the NexION 350D, PerkinElmer required that daily maintenance included "daily cleaning." c. The laboratory maintained no documentation to indicate that the laboratory had performed the manufacturer required daily maintenance of "daily cleaning" each day the PerkinElmer NexION 350Ds were used. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 of the laboratory's CDC proficiency testing (PT) submission records on October 11, 2018, the laboratory director failed to attest in writing to the routine integration of the PT samples into the laboratory patient workload using the laboratory's routine methods. Findings include: 1. The laboratory receives CDC proficiency testing kits for 12 analytes three times a year. For the years 2017 and 2018 the laboratory testing personnel and the general supervisor are the only signatures on five out of five PT testing records. a. Event 01-2017 d. Event 01-2018 b. Event 02- 2017 e. Event 02-2018 c. Event 03-2017 2. Although the testing personnel and the general supervisor signed the attestation for the integration of PT samples into the routine workload, the general supervisor does not have documented delegated authority to perform this responsibility for the laboratory director. 3. The laboratory director, technical supervisor and general supervisor confirmed by interview the lack of designation/delegation of authority to the laboratory general supervisor on October 11, 2018 at approximately 10:00 am. 4. The laboratory reports performing 100 tests per year. 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 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 -- 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 personnel record review and training and competency records on October 11, 2018, the laboratory director failed to 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. Findings include: 1. The laboratory lists four testing personnel on the CMS-209. The laboratory utilizes the general supervisor and two additional staff (A), (B) as subject matter experts (SME) to perform portions of the testing personnel's direct observation and monitoring of testing performance during annual competency and training processes. 2. The annual competency and training records for 4 out of four testing personnel do not identify the level of performance each individual is authorized to perform or if the individuals requires supervisory or director review prior to reporting patient test results. 3. The laboratory director failed to specify in writing the responsibilities and duties of the technical supervisor or general supervisor. See D tag 2009. 4. The testing personnel identified as SME's (A), (B), do not have documentation indicating they have the authority to perfom as SME's by the laboratory director. 5. The laboratory director, by interview on October 11, 2018 at approximately 10:00 am, confirmed the lack of written authorization for the technical supervisor, general supervisor, subject matter experts or testing personnel, specifying the level of performance each individual are authorized to perform. 6. The laboratory reports performing approximately 100 specimens annually. D6128 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 annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review of testing personnel training and annual competency records on October 11,2018, the laboratory director/ technical supervisor failed to delegate to the general supervisor the responsibility for providing orientation to all testing personnel; and annually evaluating and documenting the performance of all testing personnel. Findings include: 1. According to the CMS-209 submitted by the laboratory on the day of survey, the laboratory listed four testing personnel. Two testing personnel had been hired during the survey review years 2017(C) and 2018 (D). a. The general supervisor had conducted and signed off the training and midyear reviews of the new staff (C), (D). b. The general supervisor had conducted and signed off the annual competency for staff (C) and the midyear and annual competency for testing personnel (D). 2. The laboratory general supervisor did not have a letter of -- 2 of 3 -- delegation of authority for approving training and annual competency for testing personnel. 3. The laboratory director and/or technical supervisor failed to document approval of testing personnel initial training, semi-annual and annual competency records of the new testing personnel (C), (D) and the annual competency of the testing personnel (A), (B) indicating what level of competecny each were approved for testing, reporting laboratory specimens specimens. see D tag 6107. 4. The laboratory director, the technical supervisor and the general supervisor confirmed by interview on October 11, 2018 at approximately 10:00 am, that the general supervisor did not have a delegation of authority for the general supervisor to perform the responsibilities of the laboratory director or Technical Supervisor in accordance to 42 CFR 493.1445(a)((e)(4)(15). 5. The laboratory reports performing approximately 100 specimens annually. -- 3 of 3 --