Northern Virginia Carenow Urgent Care Llc

Summary Statement of Deficiencies D0000 An announced off-site CLIA recertification survey was conducted at Bettermed Urgent Care-Spotsylvania on February 23, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on January 29, 2021 and virtual record review conducted on February 18, 2021. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Bettermed Urgent Care-Spotsylvania is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. The specific deficiency is 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 the Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), proficiency testing (PT) records, policies, and an interview, the laboratory failed to rotate PT among personnel performing patient complete blood counts (CBC), d-Dimer, Troponin, Severe Acute Respiratory Syndrome-Corona Virus 2 (SARS CoV-2) testing from January 2019 until December 2020. Findings include: 1. Review of the CMS 209 revealed a total of sixteen (16) laboratory testing personnel (TP) identified as performing non-waived Hematology, Chemistry and SARS CoV-2 testing. 2. Review of the laboratory's American Proficiency Institute (API) 2019 Hematology, Chemistry and SARS PT documentation revealed the following: TP A signed attestations and performed the following: 2019 Chemistry Core Event 2; 2020 Chemistry Core Events 3; 2019 Hematology/Coagulation Events 1, 2, and 3; 2020 Hematology Event 1, 2 and 3; 2020 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 -- SARS Events 2. TP A signed and performed one (1) of three (3) Chemistry events in 2019; 1 of 3 Chemistry events in 2020; 3 of 3 Hematology/Coagulation events in 2019; 3 of 3 Hematology/Coagulation events in 2020; and 1 of 1 SARS events in 2020. TP B signed attestations and performed the following: 2019 Chemistry Core Event 1 and 3; 2020 Chemistry Core Events 1 and 2. TP B signed and performed two (2) of 3 Chemistry events in 2019; 2 of 3 Chemistry events in 2020. (See Personnel Code Sheet.) 3. Review of the laboratory's policies revealed a proficiency testing policy, "Policy for Training and Signing off on API proficiency Testing", which stated "PT samples are to be treated the same as patient samples." 4. In an interview with the Site Manager on February 23, 2021 at approximately 11:40 AM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at BetterMed Urgent Care on October 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 test proficiency testing specimens in the same manner as it tested patient specimens for five (5) of eleven (11) events participated in from May 2017 until October 2018. Findings include: 1. Review of the CMS 209 and American Proficiency Institute (API) Chemistry and Hematology PT records (a total of 11 events) revealed that two testing personnel tested the same PT specimens in the following PT events: 2017 Hematology/Coagulation Event 3 attestation signed by TP J and TP K, 2018 Hematology/Coagulation Event 1 attestation signed by TP B and TP L, 2018 Hematology/Coagulation Event 2 attestation signed by TP B and TP G, 2018 Chemistry Event 2 attestation signed by TP B and TP C, 2018 Chemistry Event 3 attestation signed by TP B and TP G, a total of 5 PT events ran in duplicate. (See attached Personnel Code Sheet.) 2. In an interview with the Testing Personnel A (TP A)/Site Manager at approximately 12:00 PM, TP A stated that the individual who draws the blood performs the testing on the specimen. They do not have another individual repeat the testing on the specimen prior to reporting. 3. In an exit interview with TP A and TP L at approximately 1:00 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 -- PM, it was confirmed that the laboratory failed to test PT specimens in the same manner as patient specimens by running the events above in duplicate. 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: Based on a review of quality control (QC) records, and interviews, the laboratory failed to retain the Cell Dyn manufacturer's assay information inserts documenting Complete Blood Cell (CBC) count QC acceptable ranges for seven (7) of eight (8) QC lot numbers utilized from May 2017 until October 2018. Findings include: 1. Review of the laboratory's QC for the Cell Dyn Emerald May 2017 until October 2018 revealed 8 lot numbers of "Cell Dyn 18+" QC material were utilized to document and evaluate patient testing on the Cell Dyn Emerald analyzer. The following 7 QC lot numbers had no acceptable range documentation or manufacturer's package inserts retained: 7128 exp 8/25/18, 7156 exp 9/22/17, 7212 exp 11/17/17, 7296 exp 2/9/18, 8015 exp 5/4/18, 8099 exp 7/27/18, and 8127 exp 8/24/18. 2. The inspector requested to review the package inserts for the 7 lot numbers of QC listed above. Testing Personnel A (TP A) stated the laboratory failed to retain the "Cell Dyn 18 +" inserts. No documentation was provided. 3. In an exit interview with TP A and TP L at approximately 1:00 PM, it was confirmed that the laboratory failed to retain the manufacturer's assay information package inserts for the "Cell Dyn 18+" QC for the lot numbers outlined above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency testing (PT) desk review was conducted for BetterMed Urgent Care Fredericksburg on May 22, 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: D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an off-site desk review of the laboratory's 2017 and to date 2018 proficiency testing (PT) records, a total of four (4) events, and interviews with the practice nurse 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 -- manager on May 22, 2018, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for White Blood Cell Differential in two consecutive Hematology testing events resulting in unsuccessful PT performance. See 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's proficiency testing (PT) records and interviews, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for White Blood Cell (WBC) Differential in two (2) consecutive Hematology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2017 and to date 2018 American Proficiency Institute (API) PT records, a total of four (4) events, revealed WBC Differential scores of less than eighty percent (80%) for the following Hematology events: 2017 3rd event - Differential score of 73%, Granulocytes 60%, Lymphocytes 60%; 2018 1st event - Differential score of 67%, Granulocytes 40%, Lymphocytes 60%; resulting in an unsuccessful PT performance. 2. In email and subsequent telephone interviews with the nurse manager on May 22, 2018 it was confirmed that the laboratory was unsuccessful for the API Hematology PT testing events as outlined above. -- 2 of 2 --