Commonwealth Primary Care Laboratory

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Commonwealth Primary Care Laboratory on November 13-14, 2025 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 and include the Conditions under 42 CFR part 493 CLIA Regulation: D5200 -42 CFR. 493.1230 General Laboratory Systems D5400 -42 CFR. 493.1250 Analytic Systems *Repeat Deficiency D2025 BACTERIOLOGY CFR(s): 493.823(c) (c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of the Centers of Medicaid and Medicare Services CLIA Survey Summary Report (CMS 0096D), proficiency testing (PT) records, and interviews, the laboratory failed to submit Microbiology PT results receiving unsatisfactory scores for one (1) of six (6) events reviewed (timeframe: January 2024 through November 13- 14, 2025). Findings include: 1. A pre-survey review of the CMS 0096D revealed zero percent (0%) scores were reported on 2024 Event 2 for speciality code 0005 Bacteriology. 2. Review of the laboratory's American Proficiency Institute (API) Microbiology PT module event results (2024 Events 1-3, 2025 Events 1-3), a total of 6 events, revealed the following unsatisfactory scores for the API 2024 Event 2: Bacteriology 0%, Susceptibility Testing 0%, Urine Colony Count 0%, Urine Identification 0%. The inspector noted that API reported "Failure to Participate". 3. The inspector inquired regarding the failure to submit for the event outlined above. The Technical Supervisor (TS) stated on 11/13/25 at 4 PM, "We ran the samples but failed to get them submitted by the deadline". The inspector requested to review self Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- grading for the event. The documentation presented for review had no

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Commonwealth Primary Care Laboratory on January 10 & 11, 2024 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 was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5400 - 42 C.F.R. 493-1250 Condition: Analytic Systems. **Repeat Deficiency** D6168 - 42 C.F.R. 493-1487 Condition: Testing Personnel. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the review of policy and procedures (P&P), pipette records, chemistry records, microbiology media plate records, inventory shipment documents, lack of documentation and interview, the lab failed to 1. Perform the pipette calibrations every six months as defined in the policy for eight of eight pipettes reviewed. Refer to D5403. 2. Perform calibration verification procedures every six months as defined in the P&P for four of four analytes in 2022 and 30 of 30 analytes in 2023. Refer to D5439. and 3. Perform and document the sterility, ability to support or inhibit growth, physical characteristics for a total of eight shipments of microbiology media plates received by the lab from 05/01/23 up to 10/30/23. Refer to D5477. D5403 PROCEDURE MANUAL 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 -- 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 D0000 An announced CLIA Recertification survey was conducted at the Commonwealth Primary Care Laboratory on 03/01/22 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 was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5200- 42 C.F.R. 493.1230 Condition: General Laboratory Systems. D5400 - 42 C.F.R. 493- 1250 Condition: Analytic Systems. The laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of documentation and interview with the technical supervisor, the lab failed to verify the accuracy of the urine microalbumin, urine creatinine and C-reactive protein (quantitative) twice a year in 2020. Refer to D5217. **REPEAT DEFICIENCY** D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. 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 -- This STANDARD is not met as evidenced by: **REPEAT DEFICIENCY** Based on the review of proficiency testing (PT) records, lack of documentation and interview with the technical supervisor, the lab failed to verify the accuracy of the urine microalbumin, urine creatinine and C- reactive protein (quantitative) twice a year in 2020. Findings include: 1. Review of the American Proficiency Institute (API) PT records revealed the lab utilizes API PT samples for verification of accuracy twice a year for the urine microalbumin, urine creatinine and C-reactive protein (quantitative), categorized as non-regulated analytes. 2. API provides two events per calendar year for the urine microalbumin and urine creatinine analytes and provides three events for C-reactive protein (quantitative) analyte. Review of API PT results revealed the laboratory received the following scores: 2020 Routine Chemistry Event 1- 33% for urine microalbumin and urine creatinine, 2020 Routine Chemistry Event 2- 100% for both analytes. 2020 Immunology Event 1- 100% for C-reactive protein (quantitative), 2020 Immunology Event 2- 50% for C-reactive protein (quantitative) and 2020 Immunology Event 3- 50% for C-reactive protein (quantitative). On 03/01/22 at approximately 11:15 AM, the surveyor requested the technical supervisor provide documentation of an alternative method(s) for verification of accuracy twice a year for the above-specified analytes in 2020. The documentation was not available for review. 3. An exit interview with the technical supervisor on 03/01/22 at approximately 1715 confirmed the findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of policy and procedures (P&P), calibration records, lack of documentation, daily patient test log and interview, the lab failed to follow the established P&P for calibration of the Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) every 90 days in 2020 and 2021 (Refer to D5437) **REPEAT DEFICIENCY**. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as -- 2 of 3 -- acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: **REPEAT DEFICIENCY** Based on review of policy and procedures (P&P), calibration records, lack of documentation, daily patient test log,

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Commonwealth Primary Care Laboratory on October 8 - October 9, 2019 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: D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records and an interview, the laboratory failed to evaluate non-graded endocrinology Parathyroid Hormone (PTH) PT results for one (1) of four (4) events in the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT results for PTH (2018 Events 1 and 2, 2019 Events 1 and 2), a total of four (4) events, revealed that the PT program reported non-graded responses for the 2018 Event 1 samples IAT 01, IAT 02, and IAT 03 due to result variance. The laboratory's 2018 Event 1 documentation revealed no evaluation/verification of accuracy for the non- graded responses listed above. The inspector requested to review additional accuracy records. No additional documentation was available for review. 2. In an interview with the general supervisor, at approximately 2:30 PM on 10/9/19, the above findings were confirmed. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) 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 -- At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: A. Based on a review of proficiency testing (PT) records and interviews, the laboratory failed to perform twice annual accuracy verification for C-Reactive Protein (CRP) immunology testing in calendar year 2018 and up the date of the inspection on October 9, 2019. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT results (2018 Events 1-3, 2019 Events 1-2), a total of five (5) events, revealed that the laboratory received unsatisfactory CRP scores of fifty percent (50%) on the following four (4) Diagnostic Immunology modules: 2018 2nd Event, 2018 3rd Event, 2019 1st Event, and 2019 2nd Event. The laboratory's CRP scores resulted in an Unsuccessful Long-Term Performance rating from API in calendar year 2018 and year to date 2019. The inspector requested to review documentation of accuracy verification during the timeframe of the events outlined above. No records were available for review. The general supervisor stated, on 10/8 /19 at approximately 5:00 PM, "We did attempt to repeat the missed challenges but do not have the instrument print outs for three of the four events that we received unsatisfactory scores". 2. In an interview with the general supervisor, at approximately 2:30 PM on 10/9/19, the above findings were confirmed. B. Based on a review of proficiency testing (PT) records and interviews, the laboratory failed to perform twice annual accuracy verification for Parathyroid Hormone (PTH) endocrinology testing in calendar year 2018. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) endocrinology PTH results (2018 Events 1-2, 2019 Events 1-2), a total of four (4) events, revealed that the laboratory received an unsatisfactory PTH score of sixty-seven percent (67%) on 2018 Event 1. The laboratory's PTH scores on 2018 Event 2 were not graded by API due to sample variance. The inspector requested to review documentation of PTH accuracy verification during the timeframe of the events outlined above. No records were available for review. The general supervisor stated, on 10/8/19 at approximately 5:00 PM, "I looked back at my records and noted that I printed the peer group for Event 2 but do not have a record of assessing our performance". 2. In an interview with the general supervisor, at approximately 2:30 PM on 10/9/19, the above findings were confirmed. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: -- 2 of 5 -- Based on review of procedures, calibration records, and an interview, the laboratory failed to document calibration procedures for Human Chorionic Gonadotropin (hCG) and Follicle Stimulating Hormone (FSH) according to the every ninety (90) day frequency required by the manufacturer in calendar years 2018 and 2019. Findings include: 1. Review of the laboratory's procedure manual revealed a Tosoh A1A 360 manufacturer's calibration guideline for hCG and FSH that stated: "The calibration curve is stable for up to 90 days. Calibrate at a frequency of every 90 days. Calibration may be necessary more frequently if controls are out of the established ranges". 2. Review of the laboratory's 2018 and 2019 Tosoh A1A 360 instrument's calibration worksheet records revealed the following calibration dates: hCG: 03/30/18, 07/20/18, 05/24/19, 09/18/19; FSH: 02/12/19, 04/12/19, 08/13/19. The lab inspector requested to review hCG calibration records for the time periods of: 06/30/18 to 07/19 /18; 10/20/18 to 05/23/19; 08/24/19 to 09/17/19; The lab inspector requested to review FSH calibration records for the time periods of: 07/12/19 to 08/12/19; 3. In an interview with the general supervisor, at approximately 2:30 PM on 10/9/19, the above findings were confirmed. 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: Based on a review of procedures, chemistry analyzer calibration verification records, and an interview, the laboratory failed to follow their procedure to document Total and Free Triodothyronine (TT3 and FT3) calibration verification twice annually in calendar year 2018. Findings include: 1. Review of the procedure manual revealed a quality assurance policy (titled: Calibration Verification) that stated "perform calibration verification at least once every six months for the Architect i2000 analytes: TSH, PSA, TT3, FT3 and Ferritin". 2. Review of the laboratory's Architect calibration verification worksheets from November 2017 to the date of the inspection, on 10//9 /19, revealed the following verification dates for TT3 and FT3: 12/28/17, 06/26/18, 02 /13/19, 06/07/19. The inspector requested to review additional documentation of TT3 and FT3 calibration verification performed in calendar year 2018. The documentation -- 3 of 5 -- was not available for review. 3. In an interview with the general supervisor, at approximately 2:30 PM on 10/9/19, the above 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 one (1) of four (4) testing personnel responsible for reporting high complexity hematology and microbiology patient test results during the twenty-four (24) 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 -- 4 of 5 -- 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) (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 one (1) of four (4) testing personnel (TP) responsible for high complexity hematology and microbiology test results during the twenty-four (24) months reviewed. Findings include: 1. Review of the CMS 209 form revealed 4 TP identified as responsible for reporting high complexity patient test results during the twenty-four (24) months reviewed. 2. Review of the laboratory's personnel records revealed job descriptions for the 4 TP to include performance of high complexity hematology and microbiology identification testing. Review of the education records in the personnel files revealed a foreign institution education document for TP A. The inspector requested an evaluation of United States credentials equivalency for TP A. No documentation was available for review. The general supervisor stated, at approximately 11:00 AM on 10/8/19, "he recently enrolled to complete a Medical Laboratory Technician Associate's degree. We have not requested an equivalency for his Bangladesh studies yet." (See Personnel Code Sheet) 3. In an interview with the general supervisor, at approximately 2:30 PM on 10/9/19, the above findings were confirmed. -- 5 of 5 --

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 --