Dominion Medical Associates Inc

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation, review of policies, and interviews, the laboratory failed to follow their protocol for labeling patient blood samples for two (2) of 2 patient samples, a total of six (6) blood tubes, received in the laboratory as noted on October 1, 2025. Findings include: 1. During an unannounced follow up survey on 10/1/25 at 1 PM, the inspector observed the phlebotomist tech place 2 plastic cups on the chemistry countertop, each cup containing: two gold top serum separator tubes (SST) and one purple top anti-coagulant ethylenediaminetetraacetic acid (EDTA) tube. The inspector noted that the 6 vacutainer tubes contained blood samples but were not labeled with patient identifiers. The inspector noted that the plastic cups had names and dates handwritten on the outside of each cup. 2. The inspector inquired regarding the protocol for specimen labeling and how the laboratory would properly identify the samples if the cups were to be accidentally knocked over or dropped prior to analysis. The phlebotomist stated on 10/1/25 at 1:30 PM, "Sometimes when busy, I draw blood and put the tubes in cups until I can get time to print the patient labels to place on the tubes. I label the plastic cups." 3. Review of procedures on 10/1/25 at 2 PM revealed: Dominion Medical Blood Collection and Labeling Protocol that stated, "To avoid incorrect identification, apply the patient adhesive label with identifying information onto the sample in the presence of the patient. Each specimen must be labeled with patient's full name, date of birth, medical record number, date and time of collection. Confirm the identification in the presence of the patient. Transport/process the specimen as required and store properly." Reference Laboratory procedures revealed 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 2 -- protocol (titled: LabCorp Introduction to Specimen Collection) that stated, "All primary specimen containers/tubes must be labeled at the time of the collection. All specimens should be labeled in the presence of the patient." 4. An interview with the primary tech on 10/2/25 at 10:30 AM confirmed the above findings. The inspector inquired regarding phlebotomy training for patient collection/sample labeling and specimen rejection protocols for unlabeled blood tubes. The primary lead tech stated, "We review specimen labeling protocols with the phlebotomy staff. They are instructed to label all tubes at the time of draw in presence of the patient." -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dominion Medical Associates, INC August 20-21, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The laboratory was found to be out of compliance with the following standards and conditions of the CLIA program. CONDITION LEVEL DEFICIENCY found to be out of compliance: D 6000 - 42 CFR 493.1403 Condition: Moderate Complexity Testing Laboratory Director *REPEAT DEFICIENCY. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) and maintenance records, onboard instrument data, and interviews, the laboratory failed to follow their routine workload protocols while analyzing/processing chemistry proficiency testing (PT) challenge samples for one (1) of two (2) PT events in calendar year 2025. Findings include: 1. During a review of QC records for the Horiba Pentra 400 chemistry analyzer for the month of May 2025, the inspector noted that QC was not performed on 5/13/25 and 5 /14/25 for the following analytes: Albumin, Alkaline Phosphatase, Alanine Aminotranserase, Aspartate Aminotransferase, Blood Urea Nitrogen, Calcium, Cholesterol, Chloride, Creatinine, Creatine Kinase, Direct Bilirubin, Glucose, Cholesterol, High Density Lipoprotein, Potassium, Magnesium, Sodium, Total Bilirubin, Total Protein, Triglyceride, and Uric Acid. 2. A review of the Pentra's daily maintenance log for 5/13/25 and 5/14/25 revealed documentation that daily maintenance was performed. 3. The inspector inquired regarding the lack of QC records for the two dates noted and requested to review patient test logs for the dates 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 -- in question. The primary testing personnel (TP) pulled patient data log from the analyzer and it was confirmed that no patient samples were assayed on the dates in question but that proficiency samples for 2025 Event 2 were assayed. The inspector inquired regarding the laboratory's protocol for PT testing within their regular patient workload. The primary TP stated on 8/20/25 at 3:00 PM, "I put all of the patient samples in the refrigerator for those days so that I could focus on running proficiency and getting the results submitted. I always make sure QC is ok before I run patients but did not run QC on the PT testing days." 4. An exit interview with the primary TP on 8/21/25 at 2:00 PM confirmed the above findings. D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: A. Based on a review of proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to retain attestation statements signed by the testing personnel (TP) and laboratory director (LD) for five (5) of five (5) events reviewed for the survey timeframe of October 20, 2023 to August 21, 2025. **REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) PT records (2024 Events 1-3, 2025 Events 1-2), a total of 5 events, revealed no TP or LD signed attestations for 2024 AAB-MLE Events 1-3 and 2025 AAB-MLE Events 1-2. A total of 5 of 5 chemistry and hematology module events had no attestation statements signed by TP analysts nor LD to document that proficiency testing samples were tested in the same manner as patient specimens. 2. Interviews with the primary TP on 8/20/25 at 4 PM and on 8/21/25 at 2:00 PM confirmed the above finding. B. Based on a review of proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to retain the AAB-MLE PT program report forms used to record/submit proficiency testing results for four (4) of 5 events reviewed for the survey timeframe of October 20, 2023 to August 21, 2025. Findings include: 1. Review of the laboratory's AAB-MLE PT records (2024 Events 1-3, 2025 Events 1-2), a total of 5 events, revealed no retention of the PT program's packet report forms for 2024 AAB- MLE Events 1-3 and 2025 AAB-MLE Event 1. A total of 4 of 5 chemistry and hematology module records did not include documentation of all steps in the testing /reporting of results for the PT samples (processing the submission of results). 2. Review of the laboratory's 2025 AAB-MLE Event 2 revealed the program's PT instruction sheet with instructions (under heading Reporting Results): "Print the copy that appears on the screen after clicking submit. This copy will include your submission confirmation number. Keep the submission forms in your records." 3. The inspector inquired of the laboratory's policy related to maintaining PT records, including the report forms used to record/submit results. The primary TP stated on 8 /20/25 at 1 PM, "I was not aware that we were to save all of the PT booklet records. I did start with that last event because they had reported one of our results incorrectly before and we did not have a record to show that we actually submitted it correctly. -- 2 of 8 -- When I called them, they told me that I should keep the packet and report forms with the PT records." 4. An exit interview with the primary TP on 8/21/25 at 2:00 PM confirmed the above findings. 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 a tour of the laboratory, review of manufacturer's instructions, and interview, the laboratory failed to follow manufacturer's instructions for the one (1) of 1 personnel safety station's eyewash solution as observed during the dates of inspection, August 20-21, 2025. Findings include: 1. During a tour of the laboratory on 8/20/25 at 10 AM, the inspector noted a Honeywell wall emergency eyewash station in use on the hematology bench. The station consisted of one bottle of saline eye wash reagent (Lot F19050-21). The inspector noted that the reagent had a manufacturer's expiration stamped date of 02/2022. 2. Review of the manufacturer's instructions revealed instructions, "Ensure the eyewash bottle is within its shelf life and not expired. Always check the expiration date printed on the bottle. Expired solution can become stagnant and harbor bacteria, which can lead to serious eye infections." 3. An exit interview with the primary testing personnel on 8/21/25 at 2:00 PM confirmed the above findings. 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. This STANDARD is not met as evidenced by: A. Based on review of chemistry analyzer's maintenance records, lack of documentation, and interviews, the laboratory failed to document Horiba Pentra 400 monthly preventative maintenance procedures according to manufacturer's protocol for two (2) of twelve (12) months in calendar year 2024. **REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's Pentra 400 chemistry monthly maintenance logs revealed instructions to record the following monthly preventative maintenance tasks: Wash/Cleaning Procedure, Syringe Plunger Tip Replacement, Check Glycol level, and Perform Qualitest (CV less than 1%). The inspector noted the above four monthly tasks were not documented as performed in October and June of calendar year 2024. The inspector requested to review records for the performance of the monthly maintenance. No additional records were available for review. 2. Review of the laboratory's monthly Quality Assurance (QA)

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dominion Medical Associates, INC on October 18 and 19, 2023 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, including the Conditions under 42 CFR part 493 CLIA Regulations: D6000 - 42 CFR. 493.1403 Condition: Moderate Complexity Laboratory Director; D6063 - 42 CFR. 493.1421 Condition: Laboratory Testing Personnel. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation, lack of documentation, and interview, the laboratory failed to retain attestation statements signed by the laboratory director (LD) for three (3) of five (5) events during the twenty-one months reviewed (January 2022 to October 18-19, 2023). **REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's PT records revealed: 2022 Medical Laboratory Evaluation (MLE) documentation, a total of 3 events (M1-M3), had no signed LD attestation statements for M2 or M3; 2023 American Association of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Bioanalysts Medical Laboratory Evaluation (AAB-MLE) documentation, total of two events (M1-M2), had no signed LD or designee attestation for M2. A total of 3 of the 5 PT events had no attestation statements signed by the LD. 2. An interview with the practice manager on 10/19/23 at 2 PM confirmed the above finding. 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 tour, review of daily temperature logs, lack of documentation, Centers for Medicare and Medicaid Services Statement of Deficiencies

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Dominion Medical Associates on 12/08/21 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: D6000 - 42 C.F. R. 493-1403 Condition: Laboratory Director (Moderate Complexity). D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of documentation and interviews, the testing personnel (TP) failed to sign three of the five attestation statements reviewed. Findings include: 1. Review of the Medical Laboratory Evaluation (MLE) hematology PT records for third event in 2019 and all three events in 2020 and the first event in 2021 revealed lack of the TP signature of the attestation statements for the following: 2020 MLE M2- no signature by the TP, 2020 MLE M3- no signature by the TP and 2021 MLE M1- no signature by the TP. 2. Interview with the primary TP on 12/08/21 at approximately 2:00 PM confirmed the findings. An exit interview with the lab director on 12/08/21 at approximately 2:20 PM confirmed the findings. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, 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 -- and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of documentation, and interview, the laboratory failed to maintain documentation of the attestation statement for two of seven events reviewed. Findings include: 1. Review of the available Medical Laboratory Evaluation (MLE) PT records revealed lack of documentation of the attestation statement for the 2021 MLE M2 and MLE M3 events. 2. Interview with the primary TP on 12/08/21 at approximately 2:00 PM confirmed the findings. An exit interview with the lab director on 12/08/21 at approximately 2:20 PM confirmed the findings. 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: **REPEAT DEFICIENCY** Based on a review of quality control (QC) records, lack of documentation, and interviews, the laboratory failed to retain the "Boule Quality Control " manufacturer's assay information inserts documenting Complete Blood Cell (CBC) count QC acceptable ranges for seven of eight lot numbers utilized from 06/01 /20 and up to 12/08/21. Findings include: 1. Review of the laboratory's end of the QC lot instrument printouts and daily QC records from 06/01/20 and up to 12/08/21 revealed the laboratory received and utilized eight lot numbers of the "Boule QC" to perform daily QC procedures for the CBC testing. The following seven QC lot numbers lacked documentation of acceptable ranges or manufacturer's package inserts: 22005-31, 22008-21, 22101-31, 22104-01, 22105-31, 22106-31, and 22017- 31. 2. Interview with the primary TP on 12/08/21 at approximately 2:00 PM confirmed the findings. An exit interview with the lab director on 12/08/21 at approximately 2:20 PM confirmed the findings. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for -- 2 of 4 -- the laboratory's patient population. This STANDARD is not met as evidenced by: A. Based on review of the laboratory's performance verification records, and an interview, the laboratory failed to verify the reference (normal) ranges for Complete Blood Cell counts (CBC) performed on the Medonic M-Series hematology analyzer prior to reporting patient results on 05/26/21 and up to the date of survey on 12/13/21. Findings include: 1. Review of the laboratory's Medonic M-Series (serial number 48779, installed 05/26/21) hematology analyzer's performance verification documentation revealed the documentation did not include verification of the reference (normal) ranges for CBCs after the instrument was installed. The surveyor requested to review documentation that the laboratory evaluated and verified the reference (normal) ranges. The laboratory provided no documentation for review. 2. Interview with the primary TP on 12/08/21 at approximately 2:00 PM confirmed the findings. An exit interview with the lab director on 12/08/21 at approximately 2:20 PM confirmed the findings. B. Based on review of the laboratory's performance verification records, and interviews, the laboratory failed to verify the reference (normal) ranges for six immunoassays performed on the Tosoh AIA 2000 analyzer prior to reporting patient results on 12/19/19 and up to the date of survey on 12/13/21. Findings include: 1. Review of the laboratory's Tosoh AIA 2000 (serial number 10638212, installed 12/13/19) immunoassay analyzer's performance verification documentation revealed the documentation did not include verification of the reference (normal) ranges for C-Peptide (C-P), Free Thyroxine (FT4), Vitamin D 25 OH (Vit D), Vitamin B12 (Vit B12), Prostate Specific Antigen (PSA), and Thyroid Stimulating Hormone (TSH) analytes after the instrument was installed. The surveyor requested to review documentation that the laboratory evaluated and verified the reference (normal) ranges. The laboratory provided no documentation for review. 2. Interview with the primary TP on 12/08/21 at approximately 2:00 PM confirmed the findings. An exit interview with the lab director on 12/08/21 at approximately 2:20 PM confirmed the findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records and interviews, the laboratory director failed to ensure that one of one new TP had documented training and competency assessments prior to performing patient testing procedures for hematology (Refer to D6029). REPEAT DEFICIENCY. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently -- 3 of 4 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: **REPEAT DEFICIENCY** Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records and interviews, the laboratory director failed to ensure that one of one new TP had documented training and competency assessments prior to performing patient testing procedures for hematology at the date of survey on 12/08/21. Findings include: 1. Review of CLIA CMS-209 form revealed TP A listed as performing patient testing. (See attached TP Code Sheet). 2. Review of TP records and an interview with TP A on 12 /08/21 at approximately 1:30 PM revealed that TP A was hired sometime after the install of the new hematology analzyer on 05/26/21. They stated "I have been testing CBCs for a few months." The inspector requested to review training and competency assessments performed for TP A. The documentation was not available for review. 3. Interview with the primary TP on 12/08/21 at approximately 2:00 PM confirmed the findings. An exit interview with the lab director on 12/08/21 at approximately 2:20 PM confirmed the findings. -- 4 of 4 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) 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 follow up laboratory tour, review of manufacturer's instructions, and interviews, the laboratory failed to follow Tosoh A1A manufacturer's guidelines for handling of C-Peptide (C-P), Free Thyroxine (FT4), Prostate Specific Antigen (PSA), Thyroid Stimulating Hormone (TSH), and Vitamin D 25 OH (Vit D) immunoassay test reagents on October 24, 2019. Findings include: 1. During the unannounced follow up tour of the laboratory, at approximately 3:30 PM, the inspector noted the following opened Tosoh A1A chemistry reagent boxes with unopened test cup pouches at room temperature (RT) on a lower shelf in the hematology testing area: C- P lot number 514061, with eighty (80) tests; FT4 lot number J317557, with sixty (60) tests; PSA lot number J1128B7, with one hundred (100) tests; TSH lot number J217228, with 60 tests; Vit D lot number J218750, with 60 tests (the box also included three (3) packs of twenty (20) FT4 tests, lot number J317557). The inspector noted that the Tosoh analyzer's menu displayed current onboard supplies of the reagents listed above. 2. Review of the Tosoh manufacturer box revealed the printed instructions "store 2-8 C". Review of the Tosoh package inserts revealed the following instructions: "All unopened test pouches are stable until the expiration date on label when stored at the specified temperature of 2-8 degrees Celsius." The inspector noted that the reagents listed above did not have open dates or modified expiration dates for storage at room temperature. The inspector inquired how long the test kits had been stored on the shelf at room temperature. The primary testing personnel stated, at approximately 4:30 PM, "We do not have room in our refrigerator 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 -- in the lab for the Tosoh reagents. I store them upstairs in the research nurse area in an extra refrigerator. I go up and get what I think we need, and then put the boxes back in the refrigerator at the end of the day with the tests not used". 3. The inspector called the Tosoh technical support number, at approximately 4:55 PM, and inquired of manufacturer's instructions for handling/storage reagent protocols for the A1A. The technical support specialists stated "our package inserts provide strict guidelines for handling test cups once opened and out of the aluminum pouches. The onboard storage is at room temperature and therefore the guidelines for stability are important. We state that unopened boxes or pouches of reagents should be stored at 2-8 C". The technical support specialist provided the following timeframes for stability of opened /onboard analyzer storage of test cups: C-P (7 days), FT4 (24 hours), PSA (24 hours), TSH (24 hours), and Vit D (10 days). The technical support specialist stated "Tosoh does not recommended to repeatedly go from refrigerator to RT and back to refrigerator". 4. In an interview with the primary TP at approximately 5:00 PM, the above findings were confirmed. The primary TP stated, "I have always handled the reagents like this and have had acceptable quality control results". -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dominion Medical Associates, INC on September 11 and 12, 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: D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a laboratory tour and interviews with the primary testing personnel and laboratory director, the laboratory's work environment failed to: 1. provide adequate space to safely conduct pre-analytical, analytical, and post-analytical phases of non- waived hematology and chemistry testing. (See D3001.) 2. ensure minimized contamination of the patient phlebotomy draw station, instrument reagent/supply items, chemistry and hematology analyzer(s) at the time of the survey on September 11 and 12, 2019. (See D3003.) D3001 FACILITIES CFR(s): 493.1101(a)(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 8 -- The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on laboratory tour observations and interviews, the laboratory room environment failed to provide adequate space to safely conduct pre-analytical, analytical, and post-analytical phases of non-waived hematology and chemistry testing. Findings include: 1. During a tour of the laboratory on September 11, 2019 at approximately 10:00 AM, the inspector observed and noted: - two (2) open biohazard waste bins and a large waste can on the floor directly in front of the Horiba Pentra 400 chemistry analyzer bench blocking access to the instrument; - three (3) large cardboard boxes of laboratory supplies and a black canvas luggage type bag (filled with hematology packing slips and instrument print outs) blocking access to the Medonic M Series hematology analyzer bench; - a tube rack holding thirty (30) patient serum samples tipped over behind a box sitting on the hematology workbench; - 3 chairs in the walkway between the laboratory entrance, hematology bench, and the phlebotomy draw chair which was located inside the chemistry testing area; - one (1) rack of twenty-four (24) patient serum tubes and an open biohazard container sitting on top of the Tosoh A1A 900 immunoassay chemistry analyzer (utilized as a bench work area); - a male patient sitting in the phlebotomy chair (adjacent to the Tosoh A1A 900 chemistry immunoassay analyzer) in close proximity (approximately five inches) to a rack of 24 patient serum samples and immunoassay chemical reagents in preparation for an assay; six (6) observations of limitations of space on bench work area and floor plan that prevented safe movement to conduct laboratory testing. The inspector also observed, during the tour at approximately 10:30 AM, the primary testing personnel (TP) tripped on one of the 3 chairs in the testing area while walking to place samples on the hematology rocker (which was on top of the Medonic analyzer). The inspector reached out to assist the TP from falling. The primary TP stated, "I wish we had more space. Please watch your step." 2. In an interview with the laboratory director and primary TP at approximately 12:30 PM on 9/12/19, the above findings were confirmed. The laboratory director stated, "I have noted the limited walking space in the lab room and have had conversations with the staff that it is an area that needs improvement". 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 tour observations and interviews, the laboratory's organization, arrangement, and utilization of bench top and floor space failed to ensure minimized contamination of the patient phlebotomy draw station, instrument reagent/supply items, chemistry and hematology analyzer(s) at the time of the survey on September 11 and 12, 2019. Findings include: 1. During a tour of the laboratory on September 11, 2019 at approximately 10:00 AM, the inspector noted: - dried blood and reagent residue stains on the outer cabinet of the Horiba Pentra 400 chemistry analyzer; - three (3) large cardboard boxes of laboratory supplies and a black canvas luggage type bag (filled with hematology packing slips and instrument print outs) on the floor in front of the -- 2 of 8 -- Medonic M Series hematology analyzer bench; - a patient sitting in the phlebotomy draw chair (which was located inside the chemistry testing area adjacent to the Tosoh A1A 900 analyzer) within close proximity of a biohazard waste container atop of an analyzer, reagent chemical preparations, and a tube rack of twenty-four (24) blood samples. The above observations were noted as indicators that utilization of bench top and floor space failed to ensure minimized contamination for patients, testing personnel, equipment, and supplies (stored on the floor obstructing access to instrumentation). The inspector also noted, at approximately 10:30 AM, primary testing personnel (TP) tripped, almost falling on one of the 3 chairs in the testing area, while walking with blood samples towards the hematology rocker device (which was atop of the Medonic analyzer).The inspector made record of the observation as the potential dropping of a patient specimen could result in the specimen leaking and contaminating the surfaces it comes in contact with and the patient phlebotomy draw station. 2. In an interview with the laboratory director and primary TP at approximately 12:30 PM on 9/12/19, the above findings were confirmed. The laboratory director stated, "I have noted the limited walking space in the lab room and have had conversations with the staff that it is an area that needs improvement". D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on laboratory tours and interviews, the laboratory failed to ensure confidentiality of patient information due to placement of their phlebotomy draw station adjacent to the chemistry immunoassay testing area during the twenty-four (24) of 24 months reviewed. Findings include: 1. During a laboratory tour on 9/11/19, at approximately 10:30 AM, the inspector noted a male patient sitting in the phlebotomy chair (adjacent to the Tosoh A1A 900 chemistry immunoassay analyzer) in close proximity (approximately 5 inches) to where a rack of twenty-four (24) patient serum samples were sitting atop of the Tosoh instrument. The inspector noted that the patient names and tests ordered were visible on the barcoded specimen tubes to the blood draw station chair. The inspector inquired as to a description of the typical specimen loading process for the Tosoh 900. The primary testing personnel (TP) stated, "I am the full time testing person in our lab and I run the samples for the Tosoh. I get all the calibrations and controls that are required loaded and then sort and place the samples for each day's run." The inspector asked what work space was utilized for the work described during the timeframe of August 2017 to the date of the survey. The primary TP stated, "I have used the area on top of the 900 to set up the runs for that all of that time. We do not have extra bench top on this side". 2. On 9/12 /19 at approximately 9:30 AM, the inspector inquired how long the patient phlebotomy blood draw station had been located inside the laboratory testing area. The primary TP stated, "We have had them come into the lab for many years, but it would be better if we could use a patient exam room for blood draws rather than into the lab area so close to all of the instruments and samples." 3. In an interview with the laboratory director and primary TP at approximately 12:30 PM on 9/12/19, the above findings were confirmed. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 -- 3 of 8 -- 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 a tour, review of procedures, manufacturer's guidelines, daily temperature /relative humidity (RH%) logs, calibration records, and an interview, the laboratory failed to: 1. ensure that the Vitamin D, 25 OH chemistry procedure included and followed manufacturer's guidelines for patient specimen collection, storage preservation, and rejection criteria for assays during twenty-four (24) of 24 months reviewed. Timeframe: September 2017 to the date of the survey September 12, 2019. (See D5403); 2. ensure manufacturer's environmental operating requirements were maintained for two chemistry analyzers during 24 of 24 months reviewed. (See D5413 A); 3. monitor the AGEIS Scientific refrigerator to ensure the storage temperature was within Tosoh manufacturer's acceptable range of 2- 8 degrees Celsius for C-Peptide (C-P), Free Thyroxine (FT4), Prostate Specific Antigen (PSA), and Thyroid Stimulating Hormone (TSH) reagents from January 2019 to the date of the survey on September 12, 2019. (See D5413 B); 4. document Tosoh A1A 900 calibration procedures for PSA according to the every ninety (90) day frequency recommended by the manufacturer from 1/2/19 to 5/27/19. (See D5437). 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)