Ael - Conway

Summary Statement of Deficiencies 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 review of proficiency test documentation and interviews with laboratory staff, the laboratory director failed to sign proficiency testing attestation statements for three of four proficiency events reviewed from 2022 and 2023. Survey findings include: A. A review of proficiency testing documentation from 2022 and 2023 it was determined the testing personnel failed to sign the attestation statement on the First, Second, and Third Hematology Testing Event of 2022. B. In an interview, at 12:10 p. m. on 07/19/2023, Testing Personnel #1 (as listed on the form CMS-209) confirmed the attestation statements listed above had not been signed by the testing personnel. 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 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: Through observation, lack of documentation and interview it was determined that the laboratory failed to monitor room temperature in one of three rooms in which storage temperature dependent supplies were stored. Findings follow: A) In a tour of the laboratory at 2:20 p.m. on 7/6/21, fifty ea. of BD EDTA blood collection tubes lot # 0100223 expiration date of 2021-08-31 and fifty ea. Vacuette Red Top blood collection tubes lot # 455010P expiration date 2022-01-12 were observed in a separate sample collection room identified as the "Covid Sample Collection Room". B) Upon request, the laboratory was unable to provide documentation of the room temperature of the room identified above. C) In an interview on 7/6/21 at 2:45 p.m. the laboratory staff members, identified as numbers one and seven on the CMS 209 form, confirmed that temperature dependent supplies were stored in the "Covid Sample Collection Room" and room temperature was not monitored in the room. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Through observations made during a tour of the laboratory and interviews with staff, it was determined the laboratory had supplies available for use when they had exceeded their expiration date. Survey findings follow: A) During a tour of the laboratory on 7/6/2021 at 2/20 p.m., the surveyor observed one plastic bag containing 12 BD Blue Top Trace Element blood collection tubes lot# 0133402 expiration date 2021-5-21. B) In an interview on 7/6//21 at 2:20 p.m.. laboratory employees, identified as numbers one and seven on the CMS 209) confirmed the supplies were available for use when they had exceeded their expiration date. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: . Through a review of the Laboratory ' s quality assessment plan, lack of documentation, as well as interview with staff, it was determined the laboratory failed to follow their own quality control assessment procedure to correct problems identified in the general laboratory system. As evidenced by: A. The American Esoteric Laboratory "Quality Control Assessment" policy states: "This laboratory has established the following goals for our Quality Assessment Program. The laboratory intends to: 1) evaluate the effectiveness of our written policies and procedures: 2) correctly perform and review all quality control and calibrations performed and document properly. Each of the following systems in our laboratory will be evaluated at least twice annually to be sure that it meets the quality goals set. " B. The following problems were not identified through the laboratory's quality assessment program: 1. Failure to ensure effective quality control system: refer to D5481 2. The laboratory failed to take