Upc Medpointe Family Medicine

Summary Statement of Deficiencies D0000 An unannounced, onsite, focused complaint survey was conducted at UPC Medpointe Family Medicine on October 24, 2024, by the West Virginia Office of Laboratory Services. The laboratory was assessed and the complaint was found to be Substantiated. The laboratory was determined to be out of compliance with the following Conditions of the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493: 42 CFR 493.801 Proficiency Testing, Enrollment and Testing of Samples 42 CFR 493.1403 Laboratory Director, Moderate Complexity 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 record review and staff interview, the laboratory failed to enroll in an approved proficiency testing (PT) program for Hematology in 2024. Findings: 1. Review of the CMS 155D report for the laboratory's PT revealed no enrollment for the specialty of Hematology in the 1st and 2nd testing events of 2024. 2. An interview with testing personnel (TP1), 10/24/24 at 12:15 PM, TP1 stated the laboratory had not enrolled in PT due to a "miscommunication" and contacted the PT provider by phone on 10/23/24. 3. An exit interview with TP1 and the office manager, 10/24/24 at 1:20 PM, confirmed the laboratory had not enrolled in PT for hematology testing in 2024. 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 -- D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the CMS ASPEN system information for current laboratory personnel of record, lack of documentation, and interviews, the facility failed to ensure a current, qualified laboratory director (LD) was in place for the operation and oversight of the laboratory's moderate complexity hematology testing from June 2024 to the date of survey (10/24/24). Findings: 1. The State survey team arrived at UPC Medpointe Family Medicine on 10/24/2024 at 11:00 AM to conduct an onsite complaint survey. Surveyors provided identification, stated the purpose of the visit, and requested to speak with the laboratory director on record in the CMS ASPEN system. The receptionist stated the laboratory director had "left months ago". Surveyors then requested to speak to management. During an interview on 10/24/24 at 11:13 AM, the office manager stated that the LD had left months ago but was "still the lab director". 2. A phone interview was initiated with the hospital CEO, 10/24/24 at 11:22 AM. During interview, the CEO stated the LD had left but remained on the lab's CLIA certificate and that the LD "had not been here or employed by us for a while". The CEO stated no documentation could be provided to show the LD of record was fulfilling the required responsibilities from June 2024 through date of survey (10/24 /24). 3. A phone interview 10/24/24 at 1:00 PM, was conducted with the LD of record (CMS ASPEN system) for UPC Medpointe Family Medicine. The LD of record confirmed departure from the facility in May of 2024 and had not overseen or reviewed "anything since June 2024" for the laboratory. 4. An exit interview with the office manager and testing personnel (TP1), 10/24/24 at 1:20 PM, confirmed the position of laboratory director had not been filled since the LD of record left the facility in May of 2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at UPC Medpointe Family Medicine on April 5, 2021, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the laboratory proficiency testing (PT) records and an interview with the laboratory manager, the laboratory failed to successfully participate in 1 of 3 PT events for Hematology in 2019. Findings: 1. Review of the laboratory American Proficiency Institute (API) PT records identified an unsatisfactory performance of 0% for the 1st API testing event of 2019 in Hematology. 2. During an interview with the laboratory manager, on 4-5-2021 at approximately 1:30 pm, the laboratory manager confirmed the findings. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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 -- 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of laboratory quality assessment (QA) records, written policies and procedures (P&P), and an interview with the laboratory director, the laboratory failed to perform and document the monthly quality assessment checklists for 12 of 12 months in 2020 and 4 of 4 months in 2021. Findings: 1. Review of the laboratory manual revealed a Quality Assessment P&P that states "once a month, complete the Monthly QA Checklist, including the chart review portion." 2. Review of QA records identified no Monthly QA Checklist forms documented for 2020 and 2021. 3. An exit interview with the laboratory director, on 4-5-2021 at approximately 1:30 PM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced, on site, complaint survey was conducted at MedPointe of Harrison County on September 8, 2020, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) and the West Virginia state rule WV 64 CFR 57 Clinical Laboratory Technician and Scientist Licensure and Certification Rule. Specific deficiencies are explained below. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based upon a review of the laboratory testing personnel (TP) files, the West Virginia licensure verification source, and an interview with the laboratory manager and laboratory director, 3 out of 9 laboratory TP did not have current West Virginia laboratory licenses as required by the West Virginia state rule WV 64 CFR 57 Clinical Laboratory Technician and Scientist Licensure and Certification Rule. Findings: 1. A comparative review of the laboratory TP files with the West Virginia licensure verification source, identified 3 of 9 TP that had expired West Virginia laboratory licenses. a. TP1 had a license that expired 9/1/2020. b. TP2 had a license that expired 9 /1/2020. c. TP3 had a license that expired 8/01/2019. 2. An interview with the laboratory manager and the laboratory director (LD), on 9/08/2020 at approximately 11:30 AM, identified 1 of 3 TP with expired West Virginia laboratory licenses had performed laboratory patient testing without a current license. 3. The laboratory manager immediately began the process of reinstating the 3 TP expired West Virginia laboratory licenses. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 records and interview with the technical consultant, the laboratory failed to rotate proficiency testing samples among all testing personnel. Findings: 1. Review of the 2018 proficiency testing records in the binder labeled "American Proficiency Institute" demonstrated that the three testing events for 2018 were completed by only two of the eight employed testing personnel. Events 1 and 3 were completed by Testing Personnel 1 (TP1), while event 2 was completed by Testing Personnel 2 (TP2). 2. Interview with technical consultant on 3/25/2019 at approximately 1:10PM confirmed the findings. 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)