Santa Clara County Public Health Department

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 (TSs), and testing personnel (TP) June 24, 2026; the laboratory failed to minimize possible cross contamination of patient specimens, equipment, instruments, reagents, materials, and supplies during the polymerase chain reaction (PCR) procedure and overall sample processing. Findings include: 1. During the laboratory tour at approximately 2:30 p.m. the surveyor observed that over all the laboratory floor was very dirty. 2. All the biosafety cabinets (BSC) in the lab were crowded with pipettes, boxes, and some even had the BSC grill covered. 3. The surveyor observed the decontamination of the BSC where the preparation of reagents for the PCR had just taken place. The TP just passed rapidly the decontamination towelette over the working surface and did not decontaminate the equipment, pipettes used, reagents, and pipette tips boxes inside the cabinet. 4. During an interview on June 24, 2026 , at approximately 3:30 p.m., the LD, TS and TP confirmed that the laboratory failed to minimize possible cross contamination of patient specimens, equipment, instruments, reagents, materials, and supplies during the PCR procedure and non-PCR sample processing. 3. The laboratory's testing declaration form, signed by the laboratory director on June 16, 2026, stated that the laboratory performed approximately 20, 984 testing samples annually when the risk of cross contamination was not minimized. D3005 FACILITIES CFR(s): 493.1101(a)(3) 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 -- (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. 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) preparation of the Master Mix (MM) for testing for the presumptive detection of various viral and microbiologic agents, interviews with the laboratory's director (LD), technical supervisors (TSs), and testing personnel (TP) on June 24, 2026 on its molecular amplification procedure; 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 bacterial agents using manual methods for preparation of the MM, controls, reagents, and addition of template. 2. During the laboratory tour on June 24, 2026, at approximately 3:00 p.m. the surveyor observed that preparation of reagents for the MM was performed at the entrance of the lab after receiving specimen, where staff were going back and forth passing the MM preparation PCR cabinet area. In addition, there was non-functional equipment, boxes, other TP performing tests, and paperwork surrounding the non-enclosed PCR working cabinet area. 3. The LD, TS, and TP confirmed by interview that the laboratory's molecular PCR testing was not set up in a separate area and did not follow unidirectional flow. 4. Based on laboratory test volumes reported on the Form Lab 144A , the laboratory performed and reported approximately 11,00 molecular test samples that included Real Time PCR molecular diagnostic tests annually. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the lack of a written and approved laboratory Safety Plan, the surveyor's direct observation during the laboratory tour, and interviews with the laboratory director (LD) and technical supervisors (TSs) the laboratory failed to have and follow a written safety procedures to ensure protection from physical, chemical, and biohazardous materials. The findings include: 1. The laboratory conducted and included in each test protocol a safety risk assessment when performing the tests. However, the laboratory failed to have and follow a current and approved written general laboratory Safety Plan (policies and procedures) based on a risk assessment to provide protection from physical and biohazardous materials as needed. There were no written policies and procedures for biological or chemical spills, cuts, injuries, earthquake, or fire at the time of the survey. 2. No policies and procedures were available for decontamination of surfaces and of biosafety cabinets. 3. The LD and TSs affirmed by interview on June 24, 2026, at approximately 3:00 p.m., that the laboratory lacked a current written general laboratory Safety Plan based on a risk assessment that is approved, signed, and dated by the laboratory director. 4. The -- 2 of 4 -- safety of laboratory personnel cannot be assured at this time. 4. The annual testing declaration form submitted at the time of the survey stated 20,984 patient samples were processed and reported during the time when the laboratory failed to have and follow written safety procedures. D5525 PARASITOLOGY CFR(s): 493.1264(b)(d) (b) The laboratory must calibrate and use the calibrated ocular micrometer for determining the size of ova and parasites, if size is a critical parameter. This STANDARD is not met as evidenced by: Based on the surveyor's direct observation during the laboratory tour, lack of documentation, and interviews with the laboratory director (LD) and technical supervisor (TS); the laboratory failed to calibrate the ocular micrometer for determining the size of ova and parasites for the years 2023, 2024, 2025, and 2026. The findings include: 1. The parasitology TS could not find any documentation for the calibration of the oculars for the microscope used to read ova and parasites test samples and proficiency testing for the years 2023, 2024, 2025, and 2026. 2. The microscope had a sticker of last calibration conducted on 02/18/2021. However, no documentation of the calibration data was found. 3. The parasitology department failed to have a policy and procedure of how to conduct microscope ocular calibrations. 4. The LD and TS affirmed by interview on the day of the survey that there were no policy and procedure available for calibration of the parasitology microscope oculars and that the oculars were not calibrated for the years 2023, 2024, 2025, and 2026. 5. The laboratory's test volume declaration Form LAB 144A signed by the LD on 06/18/2026, indicated that the laboratory tested and reported 31 samples including proficiency testing samples during the time no calibration of the oculars was performed. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(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 College of American Pathologist (CAP) laboratory proficiency testing (PT) results, Casper Report 155, six (6) randomly selected patient records ranging from 01/03/2022 to 03/01/2024, and interviews with the laboratory director (LD) and technical supervisors (TSs); it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent in Bacteriology which is an unsatisfactory performance. The findings included: 1. The laboratory attained a score of 72% for Bacteriology on the analyte "Bacterial Identification" obtaining Unacceptable Grades for samples D-08 and D-10 for the second PT event of 2022 (Q2-2022) 2. The LD and TSs affirmed on 3/14/2024 at approximately 3:25 p.m. that the laboratory received the above unsatisfactory proficiency testing scores. 3. Based on the laboratory's annual testing declaration submitted 3/14/2024 at the time of the survey, the laboratory performed and reported approximately 1,104 bacteriology organisms identifications on patients' samples. D2056 VIROLOGY CFR(s): 493.831(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 WSLH Proficiency Testing (PT) records and interviews with Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- the laboratory director (LD) and the technical supervisors (TSs); it was determined that the laboratory failed to attain a score of least 80 percent of acceptable responses for Measles and Mumps (MM) PCR testing. The findings included: 1. Based on review of PT records for the second event of 2023 (Q2-2023), WSLH reported an unsatisfactory score of 66% for MM tests performed as follow: Sample Result Acceptable Score MM-10 Positive Positive Pass MM-11 Negative Positive Fail MM- 12 Negative Negative Pass 2. The LD and TSs affirmed that the laboratory received the above unsatisfactory PT score for Q2-2023. 3. Based on the laboratory's testing declaration at the time of the survey on March 14, 2024, the laboratory reported 97 patient samples for Virology including Measles and Mumps tests. D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records for the first event of 2023 (Q1- 2023), and interviews with the laboratory director (LD) and technical supervisors (TS); it was determined that the laboratory failed to participate a testing event for General Immunology which is unsatisfactory performance and resulted in a score of 0 for the testing event. The findings included: 1. Laboratory proficiency testing records showed the laboratory attained an overall score of 0% for General Immunology testing during Q1-2023 as follow: Oral HIV test = 0.0 % 2. The LD and TS affirmed on March 14, 2024, at approximately 3:25 p.m. the unsatisfactory score of 0% obtained by the laboratory on General Immunology testing for Q1-2023. 3. Based on the annual test volume reported at the time of survey, the laboratory performed and reported approximately 5,236 tests for General Immunology. D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on surveyor observation during the laboratory tour, review of records, and interview with the laboratory director (LD) on March 14, 2024; it was determined that the laboratory failed to perform the decontamination procedure for the cabinet where the master mix used for polymerase chain reaction (PCR) is prepared. Findings include: 1. During the laboratory tour at approximately 4:00 p.m. the surveyors' observed that the cabinet where the master mix is prepared had no log for -- 2 of 5 -- decontamination procedure nor was a procedure present at the time of the survey. 2. During an interview on March 14, 2024, at approximately 4:00 p.m., the LD confirmed that the laboratory failed to provide documentation for decontamination of patient specimens, equipment, and desk materials, when processing samples on the bench. 3. The laboratory's testing declaration form, signed by the laboratory director on March 14, 2024, stated that the laboratory performs approximately 20,350 samples annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --