Pediatric Center-West End

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Center-West End on November 29, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The survey included a follow up interview with the Operations Manager and Lead Laboratory Tech/Floor Nurse on 12/01/22 and 12/05 /22 respectively. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific mandatory Condition deficiency cited as the following 42 CFR part 493 CLIA Regulation: D1002- 42 CFR. 493.41 Reporting of SARS-CoV-2 Test Results. D1002 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 tour, review of procedures, test log records, electronic medical record (EMR) log, lack of documentation, and interviews, the laboratory failed to report seven hundred three (703) positive patient SARS-CoV-2 (COVID-19) results assayed on one hundred thirty-three (133) days during five of eleven months reviewed in calendar year 2022. Findings include: 1. During a tour of the laboratory on 11/29/22 at approximately 10:00 AM the inspector noted a BD Veritor Plus analyzer in use for COVID-19 testing and requested to review the procedure, test logs, and evidence of results reporting to state agency. 2. Review of the laboratory procedures revealed a BD Veritor SARS-CoV-2 procedure which included the manufacturer's package insert / instructions for use (IFU). The IFU outlined General Instructions as: "Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities." 3. Review of available test log 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 -- records revealed there was no evidence of reporting COVID-19 results to the state agency during the timeframe of June 1, 2022 to the date of the inspection, 11/29/22. The inspector requested evidence of reporting for the five month timeframe outlined above. The Lead Laboratory/Floor Nurse stated on 11/29/22 at approximately 11:30 AM, "We were registered online to report to the department of health but for some reason the staff have not been reporting since June." 4. Review of the electronic medical record (EMR) Allscripts test logs revealed 703 positive COVID-19 tests were resulted on the following number of days while not being reported to the state agency: June 2022: twenty-three (23) days, July 2022: twenty-one (21) days, August 2022: twenty-four (24) days, September 2022: twenty-two (22) days, October 2022: 22 days, November 2022: 21 days. A total of 133 days from June 1, 2022 to 11/29/22 during which 703 positive COVID-19 tests were resulted by the laboratory while not reported to the state agency per procedure protocol. 5. An exit interview with the Lead Laboratory/Floor Nurse on 11/29/22 at approximately 12:00 PM, follow up interviews with the Operations Manager on 12/02/22 at 3:00 PM, and Lead Laboratory/Floor Nurse on 12/05/22 at 5:00 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Center-West End on November 29, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and includes a Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems. 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 a tour, review of manufacturer's instructions for use (IFU), procedures, user guide/package inserts, test logs, daily temperature/environment logs, manufacturer's operations manual, hematology analyzer maintenance records, instrument calibrations, lack of documentation, and interviews, the laboratory failed to: 1. have a written policy on protocols to report patient SARS-CoV-2 (COVID-19) positive results to the state agency during the timeframe of June 1, 2022 to the date of the inspection on November 29, 2022. See D5401; 2. monitor refrigerator temperatures to ensure manufacturer's storage requirements were followed for hematology quality control materials utilized for Complete Blood Count (CBC) patient testing for three of twelve months reviewed in calendar year 2021. See D5413; 3. document performance of required twice annual hematology instrument preventative maintenance in calendar year 2021. See D5429; 4. perform CBC calibration procedures for patient testing on 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 -- the Abbott Emerald analyzer every six months according to their procedure in calendar year 2021. See D5437. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a tour, review of manufacturer's instructions for use (IFU), procedures, test logs, lack of documentation, and interviews, the laboratory failed to have a written policy on protocols to report patient SARS-CoV-2 (COVID-19) positive results to the state agency during the timeframe of June 1, 2022 to the date of the inspection on November 29, 2022. Findings include: 1. During a tour of the laboratory on 11/29/22 at approximately 10:00 AM, the inspector noted a BD Veritor Plus analyzer in use for COVID-19 testing and requested to review the procedure. 2. Review of the laboratory procedures revealed a BD Veritor SARS-CoV-2 procedure which included the manufacturer's package insert / instructions for use (IFU). The IFU outlined General Instructions as: "Laboratories within the United States and its territories are required to report SARS-CoV-2 results to the appropriate public health authorities." 3. Review of the policies and procedures revealed no documentation of a policy for reporting patient COVID-19 results to the state agency. The inspector inquired of the reporting protocols to ensure positive patient results were reported to the Virginia Department of Health (VDH). No policy was available for review. The Lead Laboratory/Floor Nurse stated at approximately 11:30 AM on 11/29/22: "Our staff were enrolled and reporting online to VDH but at first of June this year, they discontinued logging in to report and we do not have a written policy yet." 4. Review of test logs revealed 1,165 positive COVID-19 tests were resulted during the five month timeframe outlined above (6/1/22-11/29/22). 5. An exit interview with the Lead Laboratory/Floor Nurse on 11/29/22 at approximately 12:00 PM confirmed the above findings. 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, manufacturer's user guide/package inserts, daily temperature/environment logs, lack of documentation, and an interview, the laboratory failed to monitor refrigerator temperatures to ensure manufacturer's storage requirements were followed for hematology quality control (QC) materials utilized for Complete Blood Count (CBC) patient testing for three of twelve months reviewed in -- 2 of 4 -- calendar year 2021. Findings include: 1. During a tour of the laboratory on 11/29/22 at approximately 10:00 AM, the inspector noted Abbott Cell-Dyn QC vials stored in refrigerator labeled #1. The refrigerator was monitored with a digital Fridge-Tag 2L thermometer. The inspector inquired regarding the laboratory's protocol for recording refrigerator temperatures. The Lead Laboratory/Floor Nurse responded at approximately 10:15 AM, "The staff write the temperature reading from the thermometer onto a log each day and we also print out the digital report monthly." 2. Review of the laboratory's procedures revealed Quality Assurance protocols that outlined daily monitoring of environmental conditions that included laboratory refrigerator temperatures. The policy stated, "Monitor temperatures closely, staff is to write initials and record temperatures daily and after each month has ended the logs will be retained for three years" 3. Review of the Abbott manufacturer's guidelines revealed the following requirements: Cell-Dyn QC package insert - "Stable through expiration date when stored 2-8 C, opened stability is eight consecutive days after open stored at 2-8 C". 4. Review of the available refrigerator temperature monitoring records for calendar year 2021 revealed no records for the following three months: January, February, March. The inspector requested to review documentation of the refrigerator monitoring to manufacturer's specifications. No written temperature logs or digital Fridge-Tag 2L data log records for the three months outlined above were available for review. 5. An exit interview with the Lead Laboratory/Floor Nurse on 11 /29/22 at approximately 12:00 PM confirmed the above findings. 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 manufacturer's operations manual, hematology analyzer maintenance records, lack of documentation, and an interview, the laboratory failed to document performance of required twice annual Abbott Emerald hematology instrument preventative maintenance in calendar year 2021. Findings include: 1. Review of the laboratory's hematology procedures revealed an Abbott Emerald Operations Manual with manufacturer's instructions to "perform Lubricating Syringe Pistons maintenance procedure twice annually" (under heading: Preventative Maintenance: Semi-Annual). 2. Review of the laboratory's available Emerald analyzer's maintenance logs revealed syringe pistons maintenance was documented once in the twelve months of calendar year 2021 (dated 6/8/21). 3. The inspector requested to review documentation of additional semi annual maintenance for the Abbott Emerald analyzer in calendar year 2021. No additional record was available for review. 4. An exit interview with the Lead Laboratory/Floor Nurse on 11/29/22 at approximately 12:00 PM confirmed the above findings. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) -- 3 of 4 -- Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of procedures, instrument calibration records, lack of documentation, and an interview, the laboratory failed to perform Complete Blood Count (CBC) calibration procedures for patient testing on the Abbott Emerald analyzer every six months, according to their procedure, during calendar year 2021. Findings include: 1. Review of the laboratory's procedure manual revealed a Hematology Calibration policy that outlined to calibrate CBC testing at a frequency of every six months. The policy stated: "Calibration is a procedure that confirms the accuracy and precision of the Emerald equipment and is performed every six months or more frequently as needed." 2. Review of the laboratory's 2021 Abbott Emerald instrument calibration documentation revealed one calibration record dated 06/08/21. 3. The inspector requested to review additional calibration records for the Abbott Emerald analyzer in calendar year 2021. No additional calibration documentation was available for review. 4. An exit interview with the Lead Laboratory/Floor Nurse on 11/29/22 at approximately 12:00 PM confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. 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 an interview, the laboratory failed to provide documentation that the technical consultant (TC) performed annual Hematology competency evaluations for three of six testing personnel (TP) in calendar year 2021. Findings include: 1. Review of the CMS 209 form revealed that the laboratory director (LD) also performed the duties of TC and that six testing personnel were identified as responsible for moderate complexity hematology Complete Blood Count patient testing in the twenty-three months reviewed (January 2021 through 11/29/22). 2. Review of personnel files revealed no annual hematology competency evaluations for TP A, B, and C during calendar year 2021. The inspector requested the records. No documentation was available. (SEE PERSONNEL CODE SHEET.) 3. An exit interview with the Lead Laboratory/Floor Nurse on 11/29/22 at approximately 12:00 PM confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted for Pediatric Center West End on January 12, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 1/6/2021 and virtual record review conducted on 1/8/2021. The inspector noted that the laboratory performs 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 2019 and 2020 proficiency testing (PT) documentation, and an interview, the laboratory failed to retain attestation statements signed by the laboratory director (LD) for two (2) of six (6) events and attestations signed by testing personnel (TP) for one (1) of 6 events reviewed. Findings include: 1. Review of the laboratory's 2019 and 2020 College of American Pathologists (CAP) hematology PT documentation, a total of 6 events, revealed: 2020 Event B- no LD signed attestation; 2020 Event C- no LD or TP signed attestations. The inspector requested to review 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 2 -- attestation documentation outlined above. No documentation was available for review. 2. In an interview with the lead laboratory TP on 1/12/21, at approximately 3: 00 PM, the above findings were confirmed. 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 analyzer performance verification documentation, manufacturer's user guide instructions, and an interview, the laboratory director (LD) failed to evaluate and verify the normal values (reference ranges) for Complete Blood Count (CBC) testing of a newly installed hematology analyzer from the installation date of April 3, 2019 to the date of the survey, January 12, 2021. Findings include: 1. Review of the laboratory's instrument validation records revealed a new Abbott Emerald analyzer (Serial Number 007317) installation by Peak Technical Application Specialist occurred on 4/3/19. During the tour of the laboratory on 1/12/21 at approximately 2:30 PM, the inspector requested to review documentation that the laboratory director validated the new instrument's patient normal value ranges prior to patient testing. No documentation was available for review. The primary testing personnel stated at approximately 2:30 PM: "When we replaced our CD 1800 with the Emerald, Peak Services completed the instrument set up for us. I will email our rep and have to follow up with you." 2. Review of the Abbott Emerald user guide for new instrument installation revealed instructions "The patient Reference Range must be validated by the Lab Director". 3. In an interview with the lead laboratory TP on 1/12 /21, at approximately 3:00 PM, the above findings were confirmed. -- 2 of 2 --