Fairfax County Health Dept Laboratory

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at the Fairfax County Health Department Laboratory on March 19-20, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency cited is as follows: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: A. Based on a review of the laboratory's policies and procedures, chemistry Analytical 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 -- Measuring Range (AMR)/linearity validation studies, lack of documentation, and interviews, the laboratory failed to follow their established policy to perform AMR /linearity validation studies, every six months, for one (1) of six (6) AMR/linearity studies for the twenty-two (22) analytes analyzed on the Siemens Atellica chemistry analyzer from 12/28/2022 until the date of the survey on 3/20/2024 (15 months). The findings include: 1. Review of the laboratory's procedures revealed a policy, "Quality Control Policy", with the statements, "The AMR (Analytical Measuring Range) is verified as part of the initial instrument evaluation to ensure the measuring range is as stated by the manufacturer. The AMR must be reverified every six months...." 2. Review of the laboratory's AMR/linearity studies for the Atellica chemistry analyzer from June 2022 until the date of the survey on March 20, 2024 revealed AMR verification studies were performed for 22 analytes on 12/28/2022, 5/15/2023, and 8 /23/2023. The surveyor requested to review the every 6 month AMR/linearity studies for the 22 analytes performed on the Atellica for February 2024. The laboratory provided no documentation to review. The director stated on March 20, 2024 at 10:30 AM, "We have ordered the linearity kit and will perform the studies when the kit arrives. 3. Review of the Atellica test menu revealed the following 22 analytes were analyzed and reported for patients from 8/23/23 until the date of the survey on March 20, 2024: Albumin Alkaline Phosphatase Alanine Aminotranserase Aspartate Aminotransferase Blood Urea Nitrogen Calcium Cholesterol Cholesterol, High Density Lipoprotein Cholesterol, Low Density Lipoprotein Chloride Carbon Dioxide Creatinine Gamma Glutamyl Transferase Glucose Iron Lactate Dehydrogenase Phosphorus Potassium Sodium Total Bilirubin Total Protein Triglyceride Uric Acid 4. In an exit interview with the laboratory director, medical director and quality manager on March 20, 2024 at approximately 2:00 PM, the findings were confirmed. B. Based on a review of the laboratory's policies and procedures, chemistry Analytical Measuring Range (AMR)/linearity validation studies, lack of documentation, and interviews, the laboratory failed to follow their established policy to perform AMR /linearity validation studies, every six months, for six (6) of 6 drugs of abuse analyzed on the Siemens Atellica chemistry analyzer from 12/28/2022 until the date of the survey on 3/20/2024 (15 months). The findings include: 1. Review of the laboratory's procedures revealed a policy, "Quality Control Policy", with the statements, "The AMR (Analytical Measuring Range) is verified as part of the initial instrument evaluation to ensure the measuring range is as stated by the manufacturer. The AMR must be reverified every six months...." 2. Review of the laboratory's AMR/linearity studies for the Atellica chemistry analyzer from June 2022 until the date of the survey on March 20, 2024 revealed the following AMR verification documentation: 6-AM (Herione Marker) performed on 11/23/2022, 4/25/2023, and 8/18/2023 (due 2/2024). Buprenorphine performed 11/29/2022, 4/19/2023, and 9/19/2023 (due 3/2024).. Ethanol performed on 10/27/2022 and 4/6/2023 (due 10/2023). Methadone performed on 12/1/2022, 4/14/2023, and 9/1/2023 (due 3/2024). Phencyclidine performed on 12 /22/2022, 4/14/2023, and 8/15/2023 (due 2/2024). MDMA (Ecstasy) performed on 12 /16/2022, 5/2/2023, and 7/3/2023 (due 1/2024). The surveyor requested to review additional documentation of the every 6 month AMR studies for the analytes listed above. The laboratory provided no documentation for review. 3. In an exit interview with the laboratory director, medical director and quality manager on March 20, 2024 at approximately 2:00 PM, the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Fairfax County Health Department Lab on May 24-25, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: The laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on the review of quality control (QC) records, lack of documentation and interviews, the lab failed to retain API E Reagent QC records from 03/06/20 up to 04 /30/21 (total 13 months). Findings include: 1. Review of the API E Reagent QC records revealed lack of documentation of the performance of QC procedures from 03 /06/20 up to 04/30/21 (total 13 months). An interview with the technical supervisor on 05/24/22 at approximately 10 AM revealed that the records could not be located at the date of survey on 05/24/22. 2. An exit interview with the technical supervisors, lab director, and quality assurance manager on 05/24/22 at approximately 1500 confirmed the findings. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies 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 -- and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of daily logs, quality control (QC) records, manufacturer instructions, lack of documentation, and interviews, the lab failed to follow the manufacturer instructions for utilizing fresh 18-24 hour cultures when performing QC procedures with the API 20 E Reagent QC on 05/06/21. Findings include: 1. Review of the daily logs for bacteriology and interview with the technical supervisor on 05/24 /22 at approximately 10 AM revealed the testing personnel re-sub the Enterobacter cloacae, Proteus hauseri and Myroides odoartus QC organisms each week for fresh growth. 2. Review of the API 20 E Reagent QC Test Kit QC logs from April 2020 up to April 2022 revealed QC organisms cultured on 04/26/21. The lab performed QC procedures on 05/06/21. The records lacked documentation of testing personnel re- culturing or fresh culture growth of QC organisms 18-24 hours prior to performing the QC procedures on 05/06/21. The surveyor requested to review documentation of the testing personnel re-subbing the aforementioned QC organisms 18-24 hours prior to performing API 20 E Reagent QC procedures on 05/06/21. The documentation was not available for review. 3. Review of the API 20 E Reagent QC manufacturer instructions revealed the following statement, "Preparation of Cultures- Fresh 18-24 hour cultures of the recommended organism should be used for quality control procedures." 4. An exit interview with the technical supervisors, lab director, and quality assurance manager on 05/24/22 at approximately 1500 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Fairfax County Health Department Laboratory on January 22 and 23, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: D2089 ROUTINE CHEMISTRY CFR(s): 493.841(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 laboratory's College of American Pathologists (CAP) proficiency testing (PT) records, lack of documentation and interview, the laboratory failed to submit PT results for Alanine Transaminase (ALT), Albumin, Alkaline Phosphotase, Aspartate Aminotranferase (AST), Total Bilirubin, Calcium, Chloride, Cholesterol, Cholesterol-High Density Lipoprotein (HDL), Creatinine, Glucose, Iron, Lactate Dehydrogenase (LDH), Potassium, Sodium, Total Protein, Triglycerides, Blood Urea Nitrogen (BUN), Uric Acid within the specified time frame for one (1) of six (6) Chemistry testing events reviewed in 2018 and 2019. Findings include: 1. Review of the laboratory's CAP 2018 and 2019 C-General Chemistry/Therapeutic Drugs PT records, a total of 6 events, revealed a lack of documentation of the submitted records for 2018 CAP Event B analytes: Alanine Transaminase (ALT), 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 -- Albumin, Alkaline Phosphotase, Aspartate Aminotranferase (AST), Total Bilirubin, Calcium, Chloride, Cholesterol, Cholesterol-High Density Lipoprotein (HDL), Creatinine, Glucose, Iron, Lactate Dehydrogenase (LDH), Potassium, Sodium, Total Protein, Triglycerides, Blood Urea Nitrogen (BUN), Uric Acid. 2. At approximately 10:30 AM on January 22, 2020, the surveyor requested documentation of the submission of CAP 2018 General Chemistry/Therapeutic Drugs Event B. The laboratory provided no documentation to review. Technical Supervisor #1 stated "We analyzed the PT specimens but failed to submit the results in time. We did complete a self-grading of the event." 3. In an exit interview with the technical supervisors on January 23, 2020 at approximately 12:45 PM, the above findings were confirmed. 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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory policies, testing personnel records, lack of documentation, and interviews, the technical supervisors (TS) or general supervisors (GS) failed to perform annual competency assessment evaluations in calendar year 2019 for one (1) of the fifteen (15) testing personnel (TP) reviewed. Findings include: 1. Review of the CMS 209 form revealed three (3) personnel performed the duties of TS, 3 personnel perform the duties of GS and 15 TP who perform high-complexity testing. 2. Review of the laboratory's Standard Operating Procedure Manual revealed a "FCHDL Quality Manual" that stated: "Testing Personnel competency is reviewed. assessed, and signed off initially at 6 months and annually thereafter by the PHLS II(CLIA GS) or PHLS III (CLIA TS) following all regulatory guidelines." 3. Review of 15 TP records revealed TP I lacked a 2019 annual competency assessment. (See Personnel Code Sheet.) The surveyor requested to review TP I's 2019 competency assessment. The laboratory provided no records to review. 4. In an exit interview with the technical supervisors on January 23, 2020 at approximately 12:45 PM, the findings were confirmed. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), testing personnel records, and interviews, the laboratory failed to retain documentation of education qualifications for two (2) of -- 2 of 4 -- fifteen (15) testing personnel responsible for reporting high complexity Chemistry, Microbiology, and Diagnostic Immunology patient test results during the twenty-one (21) months reviewed. See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) -- 3 of 4 -- (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), testing personnel records, and interviews, the laboratory director failed to obtain/retain documentation of education qualifications for two (2) of fifteen (15) testing personnel (TP) responsible for high complexity Chemistry, Microbiology and Diagnostic Immunology test results during the twenty- one (21) months reviewed . Findings include: 1. Review of the CMS 209 form revealed 15 TP identified as responsible for reporting high complexity patient test results during the twenty-one (21) months reviewed. 2. Review of the laboratory's personnel records revealed job descriptions for the 15 TP to include performance of high complexity Chemistry, Microbiology and Diagnostic Immunology testing. Review of the education records in the personnel files revealed a lack of documentation of the educational qualifications for TP I and TP L. The surveyor requested the education qualification records for TP I and TP L. The laboratory provided no documentation of the education qualification records for TP I and TP L to review. (See Personnel Code Sheet) 3. In an exit interview with the technical supervisors on January 23, 2020 at approximately 12:45 PM, the findings were confirmed. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Fairfax County Health Department Laboratory on March 22 - 23, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of the Laboratory Personnel Report Form (CMS 209), procedure and policy manual, laboratory personnel files, and interviews, the laboratory did not establish and follow a policy for the technical consultant's competency assessment in calendar years 2016 and 2017. Findings include: 1. Review of the CMS 209, revealed that Testing Personnel A serves as Technical Consultant (TC). (See Personnel Code Sheet) 2. Review of the laboratory procedure and policy manual revealed no protocol outlining documentation of the competency assessment of the laboratory's TC. 3. Review of the personnel files revealed that the laboratory director (LD) failed to document competency assessments in 2016 and 2017 for Testing Personnel A in the role of TC. 4. In an interview with the LD at approximately 11:30 AM on 3/22/18, and with the TC and nurse manager at approximately 2:30 PM on 3/23/18, it was confirmed that laboratory director did not document competency assessment for the TC in calendar years 2016 and 2017. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) 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 -- Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of manufacturer's package inserts, instrument quality assurance (QA) protocols and logs, and interviews, the laboratory failed to follow the manufacturer's instructions for Aptima Gen-Probe specimen test contamination monitoring protocols for ten (10) of fourteen (14) months reviewed. Findings include: 1. Review of the Panther Aptima package inserts revealed a Lab Contamination Monitoring Protocol that stated "Many laboratory specific factors may contribute to contamination and should be taken into consideration when contamination monitoring frequency is established. Intervals for contamination monitoring should be established in the laboratory's practice and procedures". 2. Review of the laboratory's Panther instrument QA protocol revealed a contamination and monitoring log sheet that stated "a total of 14 environmental samples will be run each month as required with normal patient testing". The inspector noted that the following environmental samples were outlined for monitoring: Immunology accessioning bench, Aptima room light switch, computer keyboard, reagent prep bench, sample prep bench, Panther computer screen, Panther reagent door, Panther sample door, Panther Target Capture Reagent door, Panther Left Tip drawer, Panther Right Tip drawer, Panther MTU drawer, Panther Fluid drawer, and Panther Waste drawer. The inspector reviewed the laboratory's Gen- Probe Aptima Panther Monthly Environmental Control Logs from January 2017 to the date of the survey on March 23, 2018. The inspector noted that there was no documentation of the QA protocols for the following months: 2017- January, February, March, April, May, June, July, October, and November; 2018- February The inspector requested to review the QA logs. The laboratory technical consultant (TC) and general supervisor (GS) stated, on 3/23/18 at approximately 1:00 PM, that the lab had experienced a staffing turnover and that the contamination protocols had been overlooked during the transition. No records were available to review. 3. In an interview with the nurse manager, TC, and GS on 3/23/2018 at approximately 2:30 PM, it was confirmed that the laboratory failed to follow the manufacturer's Aptima Gen-Probe instructions for test contamination monitoring protocols in ten (10) of fourteen (14) months reviewed, while reporting patient test panels on the Panther analyzer as outlined above. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of manufacturer's user guide, the laboratory procedure and policy manual, equipment maintenance records, patient test logs, and -- 2 of 3 -- an interview, the laboratory failed to follow the Biorad Evolis immunology analyzer's monthly maintenance protocols four (4) of twenty-four (24) months reviewed in calendar years 2016 and 2017. Findings include: 1. During a laboratory tour, the inspector noted a Biorad Evolis System analyzer (Serial Number 9163700330R) in use for patient immunology panel testing that include: Hepatitis (Hepatitis B Surface Antibody, Hepatitis B Surface Antigen, Hepatitis B Core Antibody), Human Immunodeficiency Virus Panel (HIV 1/2 Combo), and Syphilis. 2. Review of the Evolis analzyer user guide revealed five (5) required monthly maintenance protocols. The user's guide states: "monthly maintenance procedures should be performed monthly to ensure ongoing trouble-free operation". The manufacturer's guide outlined the following required monthly protocols: Disinfect the System Liquid Container, Pipette, and Wash Module (make fresh wash solution and replenish the water after clean), Disinfect the Sample and Reagent Racks, Clean the Plate Transport Area and Room Temperature Incubators, Inspect the Reagent Racks, Clean the Washer Plate Sensor. 3. Review of the laboratory's procedure and policy manual revealed a written quality assurance (QA) policy that stated "all instrument maintenance will be performed as required". 4. Review of the laboratory's 2016 and 2017 Evolis analyzer maintenance records revealed no documentation of the required monthly maintenance protocols in January 2016, December 2016, February 2017, and October 2017. The inspector requested to review the maintenance documentation for the four (4) months listed above. No documentation was available for review. 5. In an interview with the nurse manager, technical consultant, and general supervisor on 3/23/18, at approximately 2:30 PM, it was confirmed that the laboratory failed to follow the Biorad Evolis System analyzer's monthly maintenance protocols for the months outlined above in 2016 and 2017. -- 3 of 3 --