Albemarle Pediatrics

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, surveyor observation and technical consultant (TC) interview 06/02/25, the laboratory failed to ensure 3 vials of Boule Con-Diff Tri-Level quality control (QC) reagent were labeled with an open date and new expiration date once opened. Findings: Review of manufacturer's instruction for the Boule Con-Diff Tri-Level QC reagent revealed "STORAGE AND STABILITY.... Open vial stability 14 days after opening when returned to the refrigerator after each use.". At approximately 1:00 p.m. surveyor observed 3 vials of Boule Con-Diff Tri- Level QC reagent; Lot # 22503-01, 22503-02, and 22503-03, in a paper cup on a shelf in the laboratory refrigerator. The vials were in use and not labeled with an open date and the new expiration date. Interview with TC at approximately 1:00 p.m. confirmed the 3 vials of QC reagent were in use and not labeled with an open date and the new expiration date. 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 D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on the absence of records and interview with the TC (technical consultant) 1/17 /23, the laboratory failed to retain records used to verify performance of the TriMed EMR (electronic medical records system) prior to use for reporting patient test results. Review of laboratory records revealed there were no records available to document activities performed by the laboratory to verify the performance of the TriMed EMR prior to using it for reporting patient test results. During the survey, the staff was able to provide copies of emails from TriMed which included a timeline of events for conversion from Athena EMR to TriMed EMR during November and December 2020, examples of test patients, and a notification dated 12/16/20 that "all internal and external setup and testing has been completed. ..." During interview at approximately 1:50 p.m., the TC stated she was not aware the laboratory had changed their EMR. 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 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 -- 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)