Nowcare - First Colonial

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at NowCare-First Colonial on April 10, 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 and include the following Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 review of the Centers for Medicare and Medicaid Services Laboratory Personnel form (CMS 209), available proficiency testing (PT) records, and interviews, the laboratory failed to rotate PT among testing personnel (TP) performing Complete Blood Count (CBC) patient testing for four (4) of the 4 PT events reviewed. Findings include: 1. Review of the CMS Form 209 revealed the laboratory director identified three (3) testing personnel qualified/responsible for performing patient CBC testing during the review timeframe of 7/19/22 to 4/10/24. 2. Review of the laboratory's American Proficiency Institute (API) PT documentation, a total of 4 events (2023 Events 1-3, 2024 Event 1), revealed that TP #1 signed into the analyzer as operator and performed the following CBC PT: 2023 API Hematology Event 1; 2023 API Hematology Event 2; 2023 API Hematology Event 3; 2024 API Hematology Event 1. TP #1 performed 4 of 4 PT events outlined above. (See Personnel Code Sheet.) 3. An exit interview with the quality manager and assistant on 4/10/24 at 12 noon 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 4 -- 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: 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 laboratory director (LD) and testing personnel (TP) for five (5) of 5 PT events as reviewed on the date of the inspection, April 10, 2024. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) hematology PT documentation, a total of 5 events (2022 Event 3, 2023 Events 1-3, 2024 Event 1), revealed that the laboratory failed to retain attestations signed by LD and TP for the following: 2022 API Event 3; 2023 API Event 1; 2023 API Event 2; 2023 API Event 3; 2024 API Event 1. The inspector requested to review the attestation documentation for the 5 events outlined above. The records were not available for review. 2. An exit interview with the quality manager and assistant on 4/10/24 at 12 noon confirmed the above findings. B. Based on a review of proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to retain the hematology analyzer printed results for one (1) of five (5) PT events reviewed on the date of the inspection, April 10, 2024. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) hematology PT documentation, a total of 5 events (2022 Event 3, 2023 Events 1-3, 2024 Event 1), revealed that the laboratory failed to retain the Abbott Emerald analyzer printed results for the PT challenges assayed for 2022 API Event 3. 2. The inspector requested to review the analyzer printed records for the API 2022 event outlined above. The records were not available for review. 3. An exit interview with the quality manager and assistant on 4/10/24 at 12 noon confirmed the above 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 Centers for Medicare and Medicaid Services Statement of Deficiencies

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at NowCare-First Colonial on July 19, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS-CoV-2 (COVID- 19) testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and include two Conditions under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems, D6063 -42 CFR. 493.1421 Condition Testing Personnel. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services CLIA Certification form (CMS 116), review of procedures, maintenance logs, lack of documentation, and an interview, the laboratory failed to document performance of required monthly calibration checks for the Sofia 2 analyzer utilized for COVID-19 testing for nineteen (19) of 19 months reviewed (January 2021 to the date of the inspection on July 19, 2022). Findings include: 1. During a pre-survey review on 07/18 /21, the inspector noted that the laboratory director (LD) indicated on the submitted CMS 116 form that patient COVID-19 testing was performed by utilizing Quidel Sofia SARS Antigen test cassettes. 2. During a laboratory tour on 07/19/22 at approximately 2:00 PM, the inspector noted that one (1) Sofia analyzer (Serial Number 29043224) was in use for COVID-19 testing in the urgent care facility laboratory. 3. During a review of the laboratory procedures, the inspector noted 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 6 -- Sofia 2 Flu + SARS Antigen, Food and Drug Administration's (FDA) Emergency Use Authorizations (EUA) package insert in use as the procedure dated January 2021. The review revealed manufacturer's instructions: "The Calibration Check is a required function that checks the Sofia 2 optics and calculations systems using a specific calibration cassette. The Calibration Check is to be performed every 30 days." 4. Review of the available maintenance logs revealed no documentation of the calibration function checks as outlined above. The inspector requested to review calibration checks performed from January 2021 to July 2022. No records were available for review. 5. An exit interview with the primary testing personnel and clinical coordinator on 7/19/22 at approximately 4:30 PM confirmed the above 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 the laboratory's procedures, Centers for Medicare and Medicaid Services Statement of Deficiencies

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at NowCare-First Colonial on March 4, 2020 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: 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 procedures, daily temperature/environment logs, manufacturer's user guides, lack of documentation, and interviews, the laboratory failed to monitor the daily relative humidity percent (%) to ensure manufacturer's operating and storage requirements were followed for one (1) chemistry and one (1) hematology analyzer utilized for patient Basic Metabolic Panel (BMP) and Complete Blood Count (CBC) testing for twenty-two (22) of 22 months reviewed. Findings include: 1. During a tour of the laboratory at approximately 10:00 AM, the inspector noted: Abbott iSTAT analyzer system, Serial Number (SN) 353327, in use for BMP chemistry testing; Abbott Emerald, SN 030609-000686, in use for CBC hematology testing; Thermco Products Hygro-Thermometer, SN 2949, in use for monitoring laboratory room humidity. 2. Review of the laboratory's procedures revealed Quality Assurance protocols that outlined daily monitoring of environmental conditions. The 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 -- clinical coordinator and lead testing personnel stated at approximately 11:30 AM on 03/04/20: "All of our NowCare laboratory personnel monitor temperatures of the lab room, refrigerators, freezers, and humidity levels daily". 3. Review of the daily temperature/environmental logs from 05/01/18 to 03/04/20, revealed no record of humidity monitoring. The inspector requested to review documentation of the monitoring. No records were available for review. The primary testing personnel stated at approximately 12:00 PM on 03/04/20: "I have discussed the lack of recording with the technical consultant. The staff do observe the humidity reading on the Thermco each day but have not been recording on the charts". 4. Review of the two (2) analyzers' user guides revealed the following operating requirement: iSTAT manufacturer's technical specifications stated "environmental conditions for running instrument is humidity levels less than 80% non-condensing"; Emerald manufacturer's guide stated "Environmental Specifications: relative humidity range is 80% maximum". 5. In an exit interview with the clinical coordinator and primary testing personnel on 3/4/20 at approximately 12:45 PM the above findings were confirmed. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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 and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on a review of the laboratory's Center for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), personnel files, lack of documentation, and interviews, the laboratory director (LD) failed to document competency assessment for the technical consultant (TC) in calendar year 2018. Findings: 1. Review of the laboratory's CMS 209 form revealed that the LD identified technical consultant ("TC A") as also responsible for non-waived hematology testing during the twenty-two (22) months reviewed. (See Personnel Code Sheet.) 2. Review of the laboratory's personnel files revealed no competency assessment documentation for TC A in 2018. The inspector requested to review the competency assessment documentation. The lead testing personnel and clinical coordinator stated at approximately 10:30 AM on 3/4/20: "We most likely have competency documents at one of our other facilities or in files boxed up here". The clinical coordinator was unable to locate the competency documents. 3. In an exit interview with the clinical coordinator and primary testing personnel on 3/4/20 at approximately 12:45 PM the above findings were confirmed. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform -- 2 of 3 -- test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, lack of documentation, and interviews, the technical consultant (TC) failed to document hematology competency assessment for one (1) testing personnel (TP) in calendar year 2018. Findings include: 1. Review of the CMS 209 personnel form revealed that the laboratory director (LD) identified a TC and three (3) TP as responsible for performing non-waived hematology patient testing during the twenty-two (22) months reviewed. 2. Review of personnel records revealed no Abbott Emerald hematology competency assessment for TP A in calendar year 2018. The inspector requested to review the documentation. The clinical coordinator stated at approximately 11:30 AM on 3/4/20: "The tech is no longer working in the lab but we should have that record for 2018. I should be able to find it". No records were made available for review. (See Personnel Code Sheet.) 3. In an exit interview with the clinical coordinator and primary testing personnel on 3/4/20 at approximately 12:45 PM the above findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Nowcare- First Colonial on May 17, 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 review of proficiency testing (PT) records, Laboratory Personnel Report form (CMS 209), and interviews, the laboratory failed to rotate proficiency testing among the three (3) testing personnel for four (4) of the six (6) events reviewed. Findings include: 1. The review of the American Proficiency Institute (API) hematology PT records revealed that the same testing personnel, TP A, performed all three (3) events in 2017 and the first event in 2018. (See attached personnel code list.) 2. An interview with the primary testing personnel at approximately 11:00 AM and review of the CMS 209 laboratory personnel form revealed three (3) testing personnel performing testing in 2017 and up to the date of survey on May 17, 2018. 3. An interview with the primary testing personnel and quality support specialist at approximately 12:00 PM confirmed that the laboratory failed to rotate the API PT events among all 3 testing personnel in 2017 and for the first event in 2018. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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 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 and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on the review of the policy and procedures, quality control records, personnel competency assessments, and interviews, the laboratory director did not delegate, in writing, the job duties and responsibilities of technical consultant (TC) to the individual performing the duties of TC from January 1, 2017 at the date of survey on May 17, 2018. Findings include: 1. Review of the quality control records in the specialties hematology and competency assessments performed in 2017 revealed that TP A was performing duties of TC in the calendar year of 2017 and up to the date of survey in 2018. 2. Review of the policy and procedure manuals revealed no documentation of the delegation of duties of TC, in writing, by the laboratory director to the TP A. The inspector requested to review the above-mentioned documentation. The documentation was not available for review. 3. An interview with the primary testing personnel and quality support specialist at approximately 12:00 PM confirmed that the laboratory director did not delegate the job duties and responsibilities of TC to the individual that was performing the duties of TC in 2017 and up to the date of survey on May 17, 2018. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on the review of the testing personnel (TP) records, and interviews, the technical consultant failed to include the review of laboratory worksheets, proficiency testing records, quality control records or instrument maintenance records as part of the competency assessments performed on two (2) of the two (2) TP in 2016 and 2017. Findings include: 1. Review of the available testing personnel competency assessments for 2016 and 2017 revealed that the competency assessments records for TP B and C failed to include the review of laboratory worksheets, proficiency testing records, quality control records or instrument maintenance records for TP B and C. (See attached list.) 2. An interview with the primary testing personnel and quality support specialist at approximately 12:00 PM confirmed that the technical consultant failed to include the above-specified monitors of competency assessment for the TP B and C in 2016 and 2017. -- 2 of 2 --