San Mateo County Public Health Lab

Summary Statement of Deficiencies D3003 FACILITIES CFR(s): 493.1101(a)(2) (a)(2) Contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on surveyor's observation during the laboratory tour, review of records, and interview with the laboratory director (LD), technical supervisor (TS), and general supervisor (GS) on December 3, 2025; the laboratory failed to minimize possible cross contamination of patient specimens, equipment, instruments, reagents, materials, and supplies during the polymerase chain reaction (PCR) procedure. Findings include: 1. During the laboratory tour at approximately 3:00 p.m. the surveyor observed that the preparation of the master mix used in the PCR procedure was prepared in the same area/room as the template addition. 2. During an interview on December 3, 2025, at approximately 3:30 p.m., the TS and GS confirmed that the laboratory failed to minimize possible cross contamination of patient specimens, equipment, instruments, reagents, materials, and supplies during the PCR procedure. 3. The laboratory's testing declaration form, signed by the laboratory director on December 2, 2025, stated that the laboratory performs approximately 32,000 Virology testing samples annually that include Real Time PCR molecular diagnostic tests annually. D3005 FACILITIES CFR(s): 493.1101(a)(3) (a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on direct observation of the facilities layout, observation of the laboratory's Polymerase Chain Reaction (PCR) testing for the presumptive detection of various viral agents, interviews with the laboratory's director (LD), technical supervisor (TS), and general supervisor (GS) on December 3, 2025 on its molecular amplification procedure; it was determined that the laboratory failed to ensure that the PCR procedures which are not contained in closed systems have an unidirectional flow with separate areas for specimen preparation, master mix, reagents preparation, amplification, and product detection. The findings included: 1. The laboratory performed PCR testing for the detection of various viral agents such Monkey Pox and Respiratory Syncytial Virus (RSV) using manual methods for preparation of the Master-Mix (MM), controls and reagents, and addition of template. 2. During the laboratory tour on December 03, 2025, at approximately 3:00 p.m. the surveyor observed that preparation of reagents for the MM and sample template addition was all performed in the same room/area with no unidirectional flow. 3. The LD, TS, and GS confirmed by interview that the laboratory's molecular PCR testing was not set up following unidirectional flow. 4. Based on laboratory records, the laboratory performed and reported approximately 32,000 Virology testing samples that include Real Time PCR molecular diagnostic tests annually. 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 the surveyors' observation during the laboratory's tour and interview with the laboratory's general supervisor (GS) and technical supervisor (TS) on the day of the survey, December 3, 2025, the laboratory failed to label disinfectant solution used in the laboratory to indicate, as appropriate, opening, preparation, and expiration dates when such solutions are used in the laboratory. The findings include: 1. Based on the surveyors' observation during the laboratory tour on December 3, 2025, at approximately 2:30 p.m., it was noted that the laboratory lacked labeling for the 70% Backdown Disinfectant for received, opening, preparation, and/or expiration dates, as appropriate, used throughout the laboratory. 2. The laboratory's LD and TS affirmed in an interview on December 3, 2025, at approximately 2:45 p.m., that the solution material mentioned in statement #1 above were not labeled with the reagent's date received, opening, preparation, and/or expiration dates, as applicable. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed and reported approximately 46,303 for which the disinfectant used all throughout the laboratory was not properly labelled. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour, review of the laboratory's policies and procedure, six (6) randomly selected patient records, and interviews with laboratory director (LD) and technical supervisor (TS); the laboratory failed to perform and document preventive maintenance (PM) and calibration as defined by the manufacturer and with at least the frequency specified by the manufacturer for the digital thermometers and conventional thermometers used in the laboratory. The findings included: 1. At the time of survey on December 3, 2025, based on the surveyors' observation during the laboratory tour and review of records and documentation at approximately 11:00 a.m.; it was determined that the laboratory failed to present documentation of calibration on the thermometers, both mercury and digital, for the years 2022, 2023, 2024, and 2025 for the hot plate located in bacteriology. 2. The laboratory failed to calibrate digital timers in the Panther instrument room; expired February 2, 2022, and November 2, 2023. 3. The LD and TP affirmed on December 3, 2025, at approximately 2:15 p.m. that the calibration was missed for the thermometers and digital timers for the years 2022, 2023, 2024, and 2025. 3. According to the laboratory's testing declaration submitted by the LD, the laboratory performed and reported approximately 46,302 patient samples annually for which no calibration for the thermometers or digital timers used in the laboratory in different testing areas. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) 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 the surveyor's direct observation, review of policies and procedures, randomly selected patient test records, and interviews with the laboratory's director, technical supervisor, and general supervisor on December 3, 2025; the laboratory director is herein cited due to failure to ensure that aspects of the preanalytic and analytic phases of the laboratory testing were monitored. The findings include See D5415 and D5429. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and This STANDARD is not met as evidenced by: Based on surveyor's observation and review of laboratory's workflow during the laboratory tour and interview with the laboratory's laboratory director, technical supervisor, and general supervisor on December 3, 2025, at approximately at 3:30 p. m., the laboratory director failed to ensure that the risk of cross-contamination was minimized during the processes for the polymerase chain reaction (PCR) testing and -- 3 of 4 -- that unidirectional flow existed when PCR testing was performed. The findings include: See D3003 and D3005. -- 4 of 4 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance two out of three consecutive testing events in the specialty of Mycology, constituting unsuccessful PT performance. (See D2046) 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 -- D2046 MYCOLOGY CFR(s): 493.827(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for Mycology, resulting in an "initial" (first) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for Mycology , as follows: 2018 Q3 2019 Q1 Mycology 60% 70% Q1 = First Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for Mycology. 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 severity of the deficiencies cited herein, the Condition: Laboratories Performing High Complexity Testing: Laboratory director was not met. The laboratory director, high complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6089) D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a desk review of CMS PT records, it was determined the laboratory director, high complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For Mycology, the laboratory repeatedly failed to achieve satisfactory performance in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2046) -- 2 of 2 --