Pima Heart Asc, Llc

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of i-Stat instrument printouts, i-Stat test procedures and interview with the technical consultant (TC-1), the laboratory failed to follow established policies and procedures to ensure positive identification of the patient's specimen from the time of collection through completion of testing and reporting of results. Findings include: 1. The laboratory utilizes the i-Stat analyzer to perform patient testing under the specialty of Hematology and the subspecialty of Routine Chemistry with an annual reported test volume of 1,972. The laboratory performs Activated Clotting Time (ACT) testing using the ACT cartridge and basic chemistry testing using Chem8+ test cartridge. 2. The laboratory's established test procedure for testing performed on the i-Stat analyzer states, "Follow handheld prompts. Enter Operator ID number as assigned to each user. Enter Patient ID number...Attach printout to Lab Report Form, verifying that patient ID numbers match." 3. Instrument printouts reviewed and printed from the i-Stat analyzer during the survey for one out of four patients, Patient# 436822429101815 from 2/14/25 revealed this patient's ACT was measured. 4. The patient ID number entered into the i-Stat as indicated above (# 436822429101815) was not a valid patient ID number or the patient ID was incorrect, as this patient ID number could not be traced back to a specific patient during the survey. 5. The laboratory failed to follow established policies and procedures to maintain positive patient identification on patient specimens throughout the entire testing process on the i-Stat analyzer. 6. The TC-1 interviewed on 6/24/25 at 1:30 PM confirmed that the laboratory failed to follow established policies and procedures 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 -- related to the i-Stat analyzer to ensure positive patient identification throughout the entire testing process. -- 2 of 2 --

Summary Statement of Deficiencies 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 deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation of Chem8+ test cartridges used for the i-Stat analyzer, review of the manufacturer's storage requirements and interview with the facility personnel, the laboratory used test cartridges that exceeded the expiration date. Findings include: 1. The laboratory began patient testing in the subspecialties of Chemistry and Hematology, with an approximate annual test volume of 5,810. The laboratory performs the Chem8+ test on the i-Stat analyzer. 2. During the survey conducted on 5/23/2023, direct observation of two separate Chem8+ test cartridges stored on a laboratory counter at room temperature and used for patient testing revealed a hand written expiration date of 5/06/23. 3. Review of the manufacturer's storage requirements for i-Stat test cartridges indicated Chem8+ test cartridges may be stored at room temperature for up to 14 days. 4. The two Chem8+ test cartridges referenced above were expired on the date of the survey. The test cartridges expired on 5/20/23. 5. The number of patients tested using expired Chem8+ test cartridges could not be determined at the time of the survey. 6. The facility personnel interviewed on 5/23/2023 at 4:35pm confirmed that the Chem8+ test cartridges indicated above were expired. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on lack of education credentials for review and interview with the technical consultant, the laboratory director failed to ensure that prior to testing patients' specimens, all personnel have the appropriate education for the type and complexity of services offered. Findings include: 1. No evidence of education credentials was presented for review for one testing personnel. 2. The technical consultant interviewed on 05/23/2023 at 3:30pm confirmed the laboratory failed to provide a copy of the education credentials for the testing personnel indicated above. 3. The laboratory began patient testing in the specialties of Chemistry and Hematology in October 2021, with an approximate annual test volume of 5,810. -- 2 of 2 --