Healthvisions Md

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Healthvisions MD on 11 /02/22 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 is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. 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 (CLIA) (CMS-209 Form), and an interview, the laboratory failed to rotate PT among the nine testing personnel (TP) for five of five events reviewed. Dates of record review include all 3 events in 2021 and the first 2 events in 2022. Findings include: 1. The review of the American Proficiency Institute (API) PT records revealed that the testing personnel (TP) A performed all 3 events in 2021 and the 1st and 2nd events in 2022. (See attached personnel code list.) 2. Review of the CMS 209 laboratory personnel form revealed nine TP performing patient testing from 01/01/21 and up to the date of survey on 11/02/22. 3. An interview with the primary TP on 11 /02/22 at approximately 1320 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 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 -- activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on the review of the manufacturer's product correction notification, maintenance logs, lack of documentation, and interview, the laboratory failed to retain documentation of the performance of the weekly bleaching procedures for 19 of 43 weeks reviewed. Dates of record review include 01/03/22 up to the date of survey on 11/02/22. Findings include: 1. Review of the Abbott Product Correction notification (dated 02/21/19) revealed instructions to increase the bleach cleaning procedures from monthly to weekly. 2. Review of the Cell-Dyn Emerald instrument event logs indicating performance of maintenance procedures for 2021 and up to the date of survey on 11/02/22 revealed a lack of documentation of the performance of the weekly bleach cleaning procedures for the following weeks: January 3-7, 10-14, 17- 21, 24-28, 2022, January 31, 2022 - February 4, 2022, February 7-11, 14-18, 21-25, 2022, February 28, 2022- March 4, 2022, March 7-11, 14-18, 21-25, March 28- April 1, 2022, April 4-8, 11-15, 18-22, 25-29, 2022, May 2-6, and 9-13, 2022. Total 19 weeks. 3. In an interview with the primary testing personnel on 11/02/22 at approximately 1200, they stated that they thought the event log for their Cell Dyn Emerald could be reprinted to show the performance of the required weekly maintenance. They attempted to retrieve the data from the instrument but was unable to provide the documents for review at the date of the survey on 11/02/22. 4. An exit interview with the primary testing personnel on 11/02/22 at 1320 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Healthvisions MD in Midlothian, Virginia on February 16, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Initial entrance interview conducted on January 4, 2021. Specific deficiencies cited are as follows: D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on review of the laboratory's performance verification records, lack of documentation, and an interview, the laboratory director failed to review and approve the initial performance verification records for Complete Blood Cell counts (CBC) performed on the Abbott Emerald hematology analyzer prior to reporting patient results from August 13, 2020 until January 31, 2021. Findings include: 1. Review of the laboratory's Abbott Emerald (serial number 008105, installed 01/29/20) hematology analyzer's performance verification documentation revealed a lack of documentation of review and approval by the lab director for the accuracy, precision, and reportable range studies. In addition, the documents did not include verification of the reference (normal) ranges for CBCs after the instrument was installed. The instrument was taken out of use with the downgrade of the certificate on 03/12/20 and restarted with use on 08/13/20. 2. An interview with primary testing personnel on February 16, 2021 at approximately 1:30 PM confirmed that the instrument was taken 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 -- out of use and later returned to use in the calendar year 2020. In addition, on February 17, 2021, an email with the primary testing personnel confirmed the lack of documentation by the lab director for review and approval of the initial performance verification documents on January 29, 2020. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Healthvisions, MD on December 10, 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: 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)

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of Healthvisions MD was conducted on January 15, 2019 by a Medical Facilities Inspector with the Virginia Department of Health's Office of Licensure and Certification. The laboratory was inspected under 42 CFR Part 493 CLIA regulations. 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 2018 proficiency testing (PT) records, a total of six (6) events, and an email interview, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for White Blood 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 -- Cell Differential in two (2) of three (3) 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 an email interview, 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) of three (3) Hematology testing events resulting in an unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2017 and 2018 American Proficiency Institute (API) PT records, a total of six (6) events, revealed WBC Differential scores of less than eighty percent (80%) for the following Hematology events: 2018 2nd event - Differential score of 0%, 2018 3rd event - Differential score of 0%, resulting in an unsuccessful PT performance. 2. In an email from the lead medical assistant on January 15, 2019, the findings were confirmed for the PT testing events as outlined above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Healthvisions MD on July 10, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirement. Specific deficiencies cited are as follows: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records and an interview, the laboratory failed to enroll in a Center for Medicare and Medicaid Services (CMS) approved Proficiency Testing (PT) program for one (1) of three (3) PT events reviewed from December 2017 until July 2018. Findings include: 1. Review of the laboratory's PT records revealed the laboratory participated in the following: American Proficiency Institute (API) for 2017 Hematology Third Event, American Proficiency Institute for 2018 Hematology Second Event. The inspector requested documentation for the American Proficiency Institute for 2018 Hematology First Event. No documentation was available for review. 2. An interview with Testing Personnel A at approximately 9:20 AM, confirmed that the laboratory did not participate in a CMS approved PT program for the Hematology First Event of 2018. TP-A stated that she/he realized that the facility did not receive API Hematology 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 -- Event 1. She/he immediately contacted API, enrolled and participated in the 2018 Hematology Second Event. 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 review of the laboratory's performance verification records, and an interview, the laboratory failed to verify the reportable and reference (normal) ranges for Complete Blood Cell counts (CBC) performed on the Abbott Emerald hematology analyzer prior to reporting patient results from December 1, 2017 until July 10, 2018. Findings include: 1. Review of the laboratory's Abbott Emerald (serial number 034509, installed 10/25/17) hematology analyzer's performance verification documentation revealed the documentation did not include verification of the reportable and reference (normal) ranges for CBCs after the instrument was installed. The surveyor requested to review documentation that the laboratory evaluated and verified the reportable and reference (normal) ranges for the Abbott Emerald prior to patient testing. The laboratory provided no documentation for review. 2. An interview with Testing Personnel A at approximately 10:30 AM, confirmed that the laboratory failed to document the verification of the reportable and normal ranges for CBCs performed on the Abbott Emerald analyzer prior to patient testing that began in December 2017. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: A. Based on review of the laboratory's policy and procedure manual, quality assurance (QA) records and interview, the laboratory failed to follow their written QA policy for the review of their analytic system for seven (7) of seven (7) months from December 2017 to July 2018. Findings include: 1. Review of the laboratory's policy and procedure manual revealed a policy, "Quality Assurance Guidelines", which states "Quality Assurance Review - Our laboratory uses this quality assurance program to improve the laboratory services we provide to our physicians and patients. We will perform a quality review at least monthly and review the results with the laboratory director approval. Changes in our policy or procedures resulting from this quality review will be made known to the entire laboratory staff. The laboratory director or supervisor will initial and date our written reviews and actions. Quality -- 2 of 3 -- Assurance Records - The record of our quality assurance reviews are filed with this plan. They are available for review by the director, consultant, staff, and laboratory surveyors. All records are dated and initialed by the staff performing the reviews and the laboratory director." 2. Review of the laboratory's quality assurance records revealed no documentation of the quality assurance review for the seven (7) months from December 2017 until July 2018. The surveyor requested to review documentation that the laboratory performed a quality assurance review December 2017 to July 2018. The laboratory provided no documentation for review. 3. An interview with Testing Personnel A at approximately 2:00 PM confirmed the laboratory did not perform monthly quality assurance reviews as described within the policy from December 2017 to July 2018. B. Based on review of the laboratory's policy and procedure manual, quality control records and interviews, the laboratory failed to follow their written QA policy for the evaluation of their Abbott Emerald quality control program for seven (7) of seven (7) months from December 2017 to July 2018. Findings include: 1. Review of the laboratory's policy and procedure manual revealed a policy, "Quality Assurance Guidelines", which states "Quality Control and Instrumentation-We will evaluate our quality control program for calibration and control data for each test method used in the lab and determine: If calibrators and controls are run according to written policies and procedures. If personnel have taken appropriate