Virginia Physicians, Inc Laboratory Services

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Virginia Physicians, Inc- Laboratory Services on September 3-4, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 a review of policies, system maintenance logs, lack of documentation, and interviews, the laboratory failed to document performance of daily checks of their Evoqua Water System's resistivity per their policy for thirteen (13) of one hundred seventy-three days reviewed in eight (8) months randomly selected for review (timeframe of January 2023 to September 4, 2024). Findings include: 1. Review of the policy manual revealed a policy (title: Water Quality) that outlined the following protocol to be performed daily: observe and document resistivity (range =>10). 2. Review of 8 randomly selected monthly logs (2023: May, June, July, August, September, October and 2024: April, May) revealed the following dates with no water resistivity checks documented: 5/17/23, 6/15/23, 6/16/23, 8/16/23, 8/17/23, 9/15/23, 9 /22/23, 10/24-10/27/23, 4/25/24, and 4/26/24. 3. Interviews on 9/4/24 with the Technical Supervisor at 12 PM and Technical Consultant at 3:30 PM confirmed the above findings. 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 -- 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 a review of instrument validation records, manufacturer's operations manual, immunoassay analyzer maintenance records, lack of documentation, and interviews, the laboratory failed to document performance of required monthly maintenance for eight (8) of 8 months reviewed (timeframe: January 2024 to the last date of the recertification inspection on September 4, 2024). Findings include: 1. Review of laboratory instrument validation records revealed that a new immunoassay analyzer was installed on 11/1/2023 (OC-Auto Sensor io, Serial Number 021UL1490). The inspector noted that the laboratory started testing patients on the new analyzer on January 4, 2024. 2. Review of the OC-Auto Sensor io instruction manual revealed manufacturer's instruction (under Section 11 "Maintenance") to perform the following monthly cleaning protocols: Clean Deionized Water and Wash Solution Bottles, Clean the Drain Tank, and Clean Sample Racks. 3. Review of monthly maintenance logs (January 2024 to 9/4/24) for the analyzer outlined above revealed that the laboratory failed to document performance of two of the three-monthly protocols (clean water and wash bottles, clean drain tank) for 8 of the 8 months reviewed. The inspector noted that the laboratory failed to document the third monthly protocol to clean sample racks in January, March, April, and June of 2024; four of 8 months reviewed lacked documentation that the sample racks were cleaned. The inspector requested to review documentation that the monthly maintenance tasks outlined above were performed per manufacturer's guide. No additional records were available. 4. Interviews on 9/4/24 with the Technical Supervisor at 1:30 PM and Technical Consultant at 3:30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Virginia Physicians, Inc- Laboratory Services on December 13-14, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs COVID-19 testing and was in compliance with the applicable SARS-CoV-2 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: 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: A. Based on a review of policies and procedures, proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to follow their established policy for laboratory director (LD) review on one of six Immunology PT events (timeframe: January 2021 to 12/14/22). Findings include: 1. Review of the laboratory's policies and procedures revealed a PT protocol (title: "Proficiency Testing Surveys") that stated, "The director receives copies of all surveys. The director reviews the results, signs and dates the PT result form. After the director review, the appropriate senior tech is given the survey for review." 2. Review of the laboratory's American Proficiency Institute (API) Immunology PT events (2021 Events 1-3, 2022 Events 1-3) revealed no LD signature of review for API 2022 Immunology Event 2. The inspector requested to review documentation of the LD's signature of review. No record was available. 3. An exit interview with the laboratory manager on 12/14/22 at approximately 11 AM confirmed the above findings. B. Based on a review of policies and procedures, proficiency testing (PT) records, and interviews, the laboratory failed 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 -- to follow their established policy of required review of non graded PT results on two of six Microscopy Vaginal Wet Preparation (KOH) events during the twenty-three months reviewed (January 2021 to 12/14/22). Findings include: 1. Review of the laboratory's policies and procedures revealed a PT protocol (title: "Proficiency Testing Surveys") that stated, "The senior tech will document any non graded PT results. This will be done by hi-lighting analyte not graded. A brief note will be written on the evaluation report as to where Virginia Physicians, Inc Laboratory falls in the expected result along with any other information." 2. Review of six American Proficiency Institute (API) Microscopy PT events (2021 Events 1-3, 2022 Events 1-3) revealed no documentation of review for the following non graded KOH PT challenge samples: API 2021 Event 3 KOH sample VKP-03, API 2022 Event 2 KOH sample VKP-02. The inspector requested to review documentation of an evaluation for the non graded challenges outlined above. No records were available for review. 3. An exit interview with the laboratory manager on 12/14/22 at approximately 11 AM confirmed the above findings 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 a review of procedures, equipment user's guide, maintenance records, lack of documentation, and interviews, the laboratory failed to document hematology Hematek Stainer's quarterly preventative maintenance according to manufacturer and laboratory log protocols during the twenty-three months reviewed (timeframe: January 2021 to the date of the inspection on December 12, 2022). Findings include: 1. Review of the laboratory's procedures revealed a hematology protocol (title: Hema- Tek 1000 Slide Stainer) that stated "Replace Pump Tubing quarterly as tubing may lose its elasticity and later the volume of stain solution pumped. Replace the Under Platen Tubing quarterly". 2. Review of the hematology slide stainer user's guide revealed instruction, "Tubing should be replaced after three stain packs and at minimum quarterly". 3. Review of the laboratory's 2021 and 2022 Hematek monthly maintenance logs revealed indicator "Quarterly- Replace Tubing and Platen Tubing". The inspector noted documentation of the quarterly maintenance as performed: 2021 - 04/01/21 and 08/31/21; 2022 - 01/07/22 and 10/07/22. The inspector requested additional documentation of the quarterly tubing replacement maintenance. The laboratory supervisor stated on 12/13/22 at approximately 1:30 PM, "The tubing could have been changed more often than is documented on the logs". 4. An exit interview with the laboratory manager on 12/14/22 at approximately 11 AM confirmed the above findings. 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 -- 2 of 3 -- 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: Based on a review of procedures, chemistry calibration verification records, lack of documentation, and interviews, the laboratory failed to perform linearity validation studies, every six months, for twenty-eight (28) of 28 analytes utilized for patient testing on two (2) of 2 chemistry instruments according to the policy in calendar 2022. Findings include: 1. Review of the laboratory's procedures revealed a policy to perform calibration verification at least once every six months (title: Calibration and Calibration Verification). The policy stated "every six months the laboratory must use calibration materials appropriate for the methodology to verify the established reportable range of patient test results which must include at least a minimal value, a mid point value, and maximum value at the upper limit of the range". 2. Review of the laboratory's two Beckman Coulter DxC 700 AU chemistry analyzers' calibration verification records for the review timeframe of January 2021 to 12/13/22 revealed the following documentation: Beckman Coulter DxC 700 AU "03" (Serial Number 2020031415) Calibration Verification performed and accepted by supervisor on 04/01 /21, 09/28/21, and 8/10/22; Beckman Coulter DxC 700 AU "04" (Serial Number 2020021358) Calibration Verification performed and accepted by supervisor on 04/01 /21, 09/28/21, and 8/10/22. 3. Review of the Beckman Coulter DxC 700 AU test menu revealed the following 28 analytes utilized for patient testing were included in the laboratory's linearity calibration verification guidelines on both analyzer's outlined above: Albumin Alkaline Phosphatase Alanine Aminotranserase Amylase Aspartate Aminotransferase Blood Urea Nitrogen Calcium Cholesterol Cholesterol, High Density Lipoprotein Cholesterol, Low Density Lipoprotein Cloride Creatine Phosphokinase Carbon Dioxide Creatinine Direct Bilirubin Glucose Iron Magnesium Phosphorus Potassium Sodium Total Bilirubin Total Protein Triglyceride Uric Acid Urine Creatinine Urine Microalbumin Urine Total Protein 4. The inspector requested to review additional documentation of calibration verification for the 28 analytes outlined above utilized for patient testing on the two analyzers in calendar year 2022. No additional documentation was available for review. The supervisor stated on 12/13 /22 at approximately 2 PM, "We were behind this year and did not get the studies finished until August. I plan to do additional linearity studies by the end of this month". 5. An exit interview with the laboratory manager on 12/14/22 at approximately 11 AM confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted for Virginia Physicians, Inc-Laboratory Services on January 28-29, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey also included an entrance telephone interview with initial virtual record review conducted on 1/27/2021. The inspector noted that the laboratory performs COVID-19 testing and was in compliance with the applicable SARS-CoV-2 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 a review of policies, system maintenance logs, and interviews, the laboratory failed to document performance of their Evoqua Water System's water culture monitoring for six (6) of eight (8) quarters reviewed (review timeframe 1/1/19 to 1/29/21). Findings include: 1. Review of the policy manual revealed two (2) water quality policies: Quality Assurance protocol ("Water Quality") that stated: "Once per quarter, a water sample is to be collected and cultured. A colony count must be determined. The maximum CFU/ml is 10. If results exceed the limit, a retest will be performed. If retest exceeds limits, Evoqua must be called to troubleshoot the water system."; Quality Assurance protocol ("Bacterial Testing of Laboratory Water") that 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 -- stated: "Ideally, Clinical Lab Reagent Water (CLRW) should be bacteria free. Virginia Physicians Core Lab will verify CLRW on a quarterly basis". 2. Review of the Evoqua Water System maintenance logs and attached culture results from January 2019 to the date of the survey, on 1/28/21, revealed that water culture reports were completed and reviewed by the general supervisor on the following dates: 06/01/19; 02 /17/20; 03/09/20 -noted water system line dropped for DXC 700 and AU, system decontaminated. The inspector requested to review additional quarterly water maintenance reports performed in 2019 and 2020. No records were available for review. The chemistry general supervisor stated on 1/29/21 at approximately 11 AM: "Yes, we got the water check done only once in 2019. The reference lab that we sent our water samples to for the culture counts notified us that they had discontinued doing the tests. It has taken me a while to get another protocol of quarterly water bacteria colony count checks in place". 3. The technical supervisor confirmed the above findings on 1/29/21 at approximately 1:00 PM. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Virginia Physicians, Inc Laboratory Services on September 11 and 12, 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: D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on the review of chemistry instrument correlation documents and interview, the laboratory failed to perform instrument comparison of test results for the two (2) Beckman Coulter DxC 660i chemistry analyzers twice a year in 2017. Findings include: 1. Review of the laboratory's "chemistry instrument correlation" documents revealed that the laboratory performed an instrument comparison of test results for the 2 Beckman Coulter DxC 660i chemistry analyzers (serial numbers 006581 and 006616) on July 27, 2017. The inspector requested to review additional documentation, a second comparison, performed in the calendar year 2017. The documentation was not available for review. 2. Interviews with the laboratory director, technical and general supervisors on September 12, 2018 at approximately 2: 45 PM confirmed that the laboratory failed to perform the instrument comparison of test results for the 2 chemistry analyzers twice in 2017. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) 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 -- 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 the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, and interviews, the technical supervisor (TS) failed to perform the semi-annual competency assessment for one (1) TP in 2018. Findings include: 1. Review of the CMS-209 Form revealed that TP A performs patient testing (See attached personnel code list). 2. Review of TP A records revealed training and initial assessment performed between June and September 2017. There was no documentation of the TS performing a semi-annual competency assessment for TP A in 2018. 3. Interviews with the laboratory director, technical supervisor and general supervisor on September 12, 2018 at approximately 2:45 PM confirmed that the TS failed to perform the semi-annual competency assessments for TP A in 2018. -- 2 of 2 --