Pedsplus Urgent Care, Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at PedsPlus Urgent Care, LLC (King George) on April 3, 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 includes the Conditions under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems, D6076 -42 CFR. 493.1411 Laboratory Director. 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 tour, review of manufacturer's package insert, and interview, the laboratory failed to follow manufacturer's instructions for one (1) of 1 box of Abbott Piccolo Complete Metabolic Panel (CMP) test cartridges stored in the nurse laboratory station beyond expiration date as observed on the date of the inspection, April 3, 2024. Findings include: 1. During an entrance tour on 4/3/24 at 10:00 AM, the inspector noted one Abbott Piccolo XPress point of care analyzer in the nurse station laboratory. The inspector noted one box of Piccolo CMP reagent test cartridges open for use and stored in the reagent refrigerator was expired (lot number 3102DA1, expiration date 2/28/24). 2. Review of the Piccolo CMP reagent package revealed instructions, "Store reagent discs in their sealed pouches at 2-8 degrees Celsius. Reagent discs may be used until the expiration date on the package". Review of the package insert also revealed manufacturers instructions "Discard after expiration date has passed." 3. The inspector inquired regarding the expired CMP reagents. The general supervisor (GS) stated on 4/3/24 at 11 AM, "The nurse lead is over this section of the laboratory. I have been told that they are no longer using the Piccolo." Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- The inspector requested the date that the instrument was discontinued. The date of discontinuation was not available. 4. An exit interview with the GS on 4/3/24 at 2:00 PM confirmed the above findings. D2026 BACTERIOLOGY CFR(s): 493.823(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of 2024 proficiency testing (PT) records, PT

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at PedsPlus Urgent Care, LLC (King George) on June 28, 2022 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 pre-survey review of the Centers for Medicare and Medicaid Services CLIA Application and Survey Summary (CMS Casper 0096D Report), tour, review of hematology analyzer performance verification records, lack of documentation, and interviews, the laboratory failed to document an evaluation/verification of precision and reportable range for Beckman Coulter AcT Diff 2 Complete Blood Count (CBC) testing after a hematology analyzer re-installation to a new physical laboratory address on February 8, 2021. Findings include: 1. A pre-survey review of the laboratory's CMS Casper 0096D Report on 6/24/22 revealed a physical address listed as: 7967 Kings Highway - King George, Virginia 22485. During an email interview with the laboratory director on 6/24/22 at approximately 10:30 AM, the inspector was notified that the office and laboratory had moved to 8163 Kings Highway - King George, Virginia 22485. 2. During the tour of the laboratory on 6/28/22 at approximately 9:00 AM, the inspector noted one (1) Beckman Coulter AcT Diff 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 4 -- (Serial Number AM34983) in use for CBC patient testing. The inspector inquired of the instrument move and date of re-installation. The lead nurse stated: "We moved on February 8, 2021." 3. Review of the AcT Diff 2 hematology analyzer's performance verification documentation revealed no lab director approved evaluation/verification of CBC precision or reportable for the timeframe of the installation at the new laboratory location on 2/8/21 up to the date of the inspection, 6/28/22. The inspector requested the performance verification records. No documentation was available for review. 4. An exit interview with the lead nurse on 6/28/22 at approximately 11:30 AM 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 procedures, manufacturer's user guide, maintenance records, lack of documentation, and an interview, the laboratory failed to document the following required Beckman Coulter AcT Diff 2 hematology analyzer maintenance: monthly protocol for nine (9) of eighteen (18) months reviewed and two (2) semi- annual maintenance protocols in calendar year 2021 (review timeframe: December 2020 to the date of the inspection on June 28, 2022). Findings include: 1. Review of the laboratory's procedures and maintenance guidelines revealed the following instructions: Quality Assurance Monthly Checklist - under Analytic Systems, "All required instrument maintenance is performed and documented"; Coulter AcT Diff 2 Maintenance Log - "Perform Monthly: Clean baths"; Coulter AcT Diff User Guide - "Every six months replace RBC Diluent Filters, clean Dust Filter, replace Diluent Filters". 2. Review of the laboratory's available Coulter AcT Diff 2 Maintenance log records from 12/1/20 to 6/28/22 revealed no documentation of the "Perform clean baths monthly" during the following eight months in calendar year 2021: January, February, April, June, September, October, November, and December; and one month in 2022- February. The inspector noted that the three semi annual maintenance protocols outlined above were all documented once (on 2/10/22) during the review timeframe. A total of 9 of 18 months lacked documentation of the required monthly protocol and 2021 records lacked twice annual maintenance recorded as outlined above. The inspector requested to review additional documentation of the monthly aperture bath cleaning protocol and the every 6 month filters replacement/dust filter cleaning. No record or