Unc Reach Enhanced Primary Care

Summary Statement of Deficiencies 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 laboratory records, lack of documentation and interviews with laboratory director (LD) and technical consultant (TC) 06/11/25, the laboratory failed to enroll in a proficiency testing (PT) program for the Complete Blood Cell Count with Differential (CBCD) performed on the PixCell HemoScreen analyzer since testing began in January of 2025. Findings: Review of laboratory records revealed no documentation of enrollment in a PT program for the CBCD performed on the PixCell HemoScreen analyzer. Interview with LD at approximately 10:00 a.m. confirmed CBCD testing began on the PixCell HemoScreen analyzer in January of 2025. Phone interview with TC at 2:30 p.m. confirmed the laboratory had not enrolled in a PT program for the CBCD testing. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on review of TC personnel records, lack of documentation and interview with TC 06/11/25, the laboratory failed to establish a procedure for the competency assessment of the responsibilities delegated to the TC and failed to perform annual competency assessments of the TC. 1. The laboratory failed to establish a procedure for the competency assessment of the responsibilities delegated to the TC. Findings: Review of TC personnel records revealed a form entitled "Technical Consultant Documentation". The form lists the "Technical Consultant Responsibilities" and states "By signing, trainee indicates understanding of the Technical Consultant role, responsibilities and requirements.". The forms also states "By signing, the CLIA Laboratory Director is delegating the employee as a Technical Consultant with the roles and responsibilities indicated above.". The form delegates and lists the responsibilities of the TC but fails to include a procedure for the assessment of the TC's delegated responsibilities. Phone interview with TC at approximately 2:30 p.m. confirmed the facility does not have a separate policy or procedure for the assessment of the TC. They stated they thought the form was what could be used to demonstrate an annual TC competency. 2. The laboratory failed to ensure annual competency assessments of the TC were performed. Findings: Review of TC personnel records revealed form entitled "Technical Consultant Documentation". The form states "Technical Consultants must have documented evidence indicating education and experience qualifications, successful completion of annual competency assessment for point-of-care testing, as well as documented Technical Consultant (TC) training and annual TC competency thereafter.". There was no documentation of an annual TC competency assessment. Phone interview with TC at approximately 2:30 p.m. confirmed the facility does not have a separate policy or procedure for the assessment of the TC. They stated they thought the form was what would be needed to demonstrate an annual TC competency. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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 review of manufacturer package insert, absence of records, interview with the technical consultant (TC #2) 7/12/2023 and email received 7/13/2023 from TC #1, the laboratory failed to monitor and document the room temperature of its Primary Care laboratory since testing began in August 2021, a period of approximately 24 months. Findings: Review of the package insert for the MedTox Profile-V MedTox Scan instrument revealed "Section 6....Reagents and Materials Provided/Storage Conditions...The kit, in its original packaging, should be stored at 2-25 degrees Celsius until the expiration date on the label.". Review of records for documentation of room temperature monitoring of the Primary Care laboratory revealed no documentation. Interview with TC #2 at approximately 1:10 p.m. 7/12/2023 confirmed there was no documentation of room temperatures in the Primary Care laboratory. Email received by TC #1 at approximately 2:16 p.m. 7/13/2023 confirmed the room temperature of the Primary Care laboratory was not monitored or documented since testing began in August of 2021. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) 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 -- (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of quality control (QC) records for the MedTox Profile-V MedTox Scan instruments and interview with TC #2 7/12/2023, the laboratory failed to ensure QC was acceptable one of four weeks in June 2023 for the instrument located in the Crisis Assessment laboratory. And failed to ensure QC was acceptable one of four weeks in June 2023 for the instument located in the Primary Care laboratory. Findings: Review of laboratory's policy "Point of Care Ambulatory Quality Control Program...D. Quality Control Review for Acceptability" revealed "Quality control results will be reviewed for acceptability before reporting patient results....". Review of QC records revealed the following dates in which QC was unacceptable: 1. 6/19/23, the Crisis Assessment laboratory failed to attain an acceptable negative buprenorphine QC result prior to patient testing. 2. 6/26/23, the Primary Care laboratory failed to attain an acceptable positive buprenorphine QC result prior to patient testing. Interview with TC #2 at approximately 11:30 a.m. confirmed the laboratory failed to obtain acceptable QC results prior to patient testing on 6/19/23 and 6/26/23. -- 2 of 2 --