M D Express Urgent Care - Yorktown

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at MD Express Urgent Care-Yorktown on August 30, 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 Regulations. Specific deficiencies cited are as follows: 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 the laboratory's proficiency testing (PT) record binders, lack of documentation, and an interview, the laboratory failed to retain copies of the attestation statement signed by the laboratory director/testing personnel and hematology/chemistry instrument printouts for two of six PT testing events during the twenty-one (21) month inspection review timeframe (November 2020 to August 30, 2022). Findings include: 1. Review of the laboratory's American Academy of Family Physicians (AAFP) chemistry and hematology PT records(2020 Event C, 2021 Events 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 -- A-C, 2022 Events A-B) revealed no signed attestation statements, Medonic hematology instrument print outs, or Alere Triage chemistry print outs retained in the binders for the following events: 2020 AAFP Event C, 2021 AAFP Event A. The inspector requested to review the PT records' documentation outlined above. The lab clinical coordinator located the laboratory's AAFP transmission print outs that were generated on the date of submission. No additional records were available for review for the PT events outlined above. 2. An exit interview with the lab clinical coordinator on 8/30/22 at approximately 3:30 PM, confirmed the above findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to document a review/evaluation of two of six chemistry and hematology PT modules during the twenty-one (21) month inspection review timeframe (November 2020 to August 30, 2022). Findings include: 1. Review of the laboratory's American Academy of Family Physicians (AAFP) chemistry and hematology PT records (2020 Event C, 2021 Events A-C, 2022 Events A-B) revealed no AAFP retained results or documentation of review/evaluation for: 2020 AAFP Event C: Hematology Module Complete Blood Count (CBC) and Auto Differential for five of five challenge samples HD11 - HD15, Chemistry Module Complete Cardiac Markers for five of five challenge samples CD11-CD15; 2021 AAFP Event A: Hematology Module CBC and Auto Differential for five of five challenge samples HD1 - HD5, Chemistry Module Complete Cardiac Markers for five of five challenge samples CD1-CD5; The inspector requested to review the AAFP results and evaluation documentation for the two hematology and chemistry module events outlined above. No additional documentation was available for review. 2. An interview with the lab clinical coordinator on 8/30/22 at approximately 3:30 PM, confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at MD Express- Yorktown on November 18, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 11/2/2020 and virtual record review conducted on 11/5/2020. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: 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 tour, review of manufacturer's package insert instructions, and interviews, the laboratory failed to follow cardiac and lipid chemistry quality control (QC) storage requirements for eight (8) of 8 reagent kits on the date of the inspection on November 18, 2020. Findings include: 1. During a tour of the laboratory on 11/18/20 at approximately 1:30 PM, the inspector noted a bench top freezer with a Fisher Scientific Traceable digital temperature whose reading was -11 C. The freezer was labeled with printed directions: "Temp for this freezer must be -18 Degrees or below". The inspector inquired of the staff regarding the temperature monitoring of the freezer. The testing personnel stated: "We store Quidel Triage and Piccolo chemistry quality control vials in there. We are now putting our send out COVID-19 test samples in there for courier pick up. We do open it many times a day to put the COVID samples in and that makes the temperature vary." The inspector noted approximately twelve (12) send out samples bagged for LabCorp reference laboratory and the following eight (8) boxed chemistry reagents stored in the freezer: Two (2) 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 -- boxes of NOD Liquid Assayed Chemistry Lipid Controls (Lot Numbers 465020002 and 465020003); Three (3) boxes of Quidel Triage Total 5 Controls Level 1 (Lot Number C3553AN); Three (3) boxes of Quidel Triage Total 5 Controls Level 2 (Lot Number C3577AN). 2. Review of the NOD Lipid Control package revealed storage temperature instructions "store at -15 C to -25 C". Review of the Quidel outer package revealed storage temperature instructions as - 20 C. The package insert stated: "The Quidel Triage Total 5 Controls are assayed materials to be used with Quidel Triage Cardiac Panel for Triage Meters to assist the laboratory in monitoring patient test performance. Store frozen at -20 C or colder in non-defrosting freezer. Do not store near the freezer door. Controls should not be used if thawed upon receipt. Controls should not be refrozen." 3. The inspector inquired of the office manager and coordinator to describe the temperature monitoring protocols for the bench top freezer. The office manager stated, at approximately 2:00 PM: "The staff normally record the temperatures in the morning before the freezer is opened and it is in range. We had not thought about the temperature fluctuations due to opening it so many times during the day for adding the COVID-19 send outs". The laboratory coordinator stated "As far as I know by looking back at the temp logs, the freezer has been in range every day when checking it. My guess is that with constant opening and shutting to put specimens in its been going up and down. This is the first time I've heard about this so I'll be checking on it for a solution." 4. In an exit interview with the office manager and coordinator at approximately 2:30 PM, the above findings were confirmed. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of procedures, quality assurance (QA) records, lack of documentation, and an interview, the laboratory failed to document a validation or check of their hematology and chemistry analyzer's automated interfaces in order to verify transmission of Complete Blood Count (CBC), Creatine Kinase Myocardial Band (CK-MB), Myoglobin, and Troponin (cTn1) results from May 2020 to the date of the laboratory tour on November 18, 2020. Findings include: 1. During an entrance interview with the laboratory's coordinator on 11/5/20 at approximately 1:00 PM, the inspector was informed that the laboratory no longer manually entered CBC, CK-MB, Myoglobin, or cTn1 results into the patient electronic medical record (EMR). The facility had purchased an information system (LabDaq) in May 2020 that interfaced the Medonic hematology and Triage chemistry analyzers to the EMR. 2. Review of the laboratory's QA procedures revealed no record of a validation of the LabDaq electronic interface for the transmission of the Medonic CBC or Triage Cardiac Panel results from the date of the interface installation in May 2020 to the date of the virtual record review on 11/5/20. The inspector requested to review validation documentation of the LabDaq transmission of patient results. The coordinator stated on 11/5/20 at -- 2 of 3 -- approximately 2:30 PM: "I will check with LabDaq and ask for the validation data". 3. During the onsite tour on 11/18/20, the inspector requested to review validation documentation of the LabDaq transmission of patient results. No records were available for review. 4. In an exit interview with the office manager and coordinator at approximately 2:30 PM, the above findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at MD Express on June 7, 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: 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 the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of hematology analyzer performance verification documentation, manufacturer's user guide instructions, patient test logs, and an interview, the laboratory director failed to evaluate and verify the normal values (reference ranges) for Complete Blood Count (CBC) testing prior to reporting one hundred ten (110) patient CBC panels from March 22, 2018 to the date of the survey, June 7, 2018. Findings include: 1. Review of the laboratory's instrument validation records revealed a new hematology analyzer installation, by a Medonic field service technical specialist, occurred on 3/22/18. The inspector noted that no validation, by the lab director, of the CBC patient normal values for the new Medonic M Series (Serial Number 29611) was documented. The inspector requested to review documentation that the laboratory director validated the Medonic's patient normal value ranges prior to patient testing. No documentation was available for review. 2. Review of 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 4 -- Medonic M Series Users Guide for new instrument installation revealed instructions: "The patient Reference Range must be validated by the Lab Director". 3. Review of the patient test log from the laboratory's Electronic Medical Record revealed that the lab had reported one hundred ten (110) CBC reports from 3/22/18 to the date of the survey on 6/7/18. 4. In a telephone interview with the clinical coordinator at approximately 12:30 PM, it was confirmed that the laboratory director failed to evaluate and validate the patient reference range for CBC testing prior to reporting patient results from the new M Series hematology instrument as outlined above. 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 maintenance records, manufacturer's operations manual, quality assurance (QA) logs, and an interview, the laboratory failed to document hematology instrument daily and monthly maintenance from March 22, 2018 to the date of the survey, on June 7, 2018. Findings include: 1. Review of the laboratory's Medonic M Series hematology maintenance logs revealed preventative maintenance procedures for Check Reagent Levels, Verify Background Count, and Aspiration Probe Exterior Cleaning listed as "perform on a daily basis" and Monthly Cleaning (Hypochlorite) and Clot Prevention (Enzymatic) listed as "perform on a monthly basis". The inspector noted that the available hematology maintenance logs from 3/22/18 to 6/7/18 revealed no daily maintenance was documented for seventy- seven (77) of seventy-seven (77) days reviewed and no monthly maintenance was documented in April and May. 2. Review of the Medonic M Series Operations Manual revealed manufacturer's instructions to "perform the following procedures at the scheduled time intervals of ": Check Reagent Levels, Verify Background Count, and Aspiration Probe Exterior Cleaning are scheduled as daily; Cleaning (Hypochlorite) and Clot Prevention (Enzymatic) procedures are scheduled as monthly. 3. Review of the laboratory's QA monthly log revealed no documentation of