Duly Health And Care - Lockport Ir

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, record review, and interview with the technical consultant (TC); the laboratory failed to perform electronic quality control procedures as specified by the laboratory for activated clotting time (ACT) testing for two of five days of patient testing reviewed. Findings include: 1.Review of the laboratory's policy and procedure manual identified the procedure titled "POC.01 Activated Clotting Time" that stated: "C. electronic Quality control (EQC) for signature elite system: EQC can be used to provide a two level electronic verification of instrument performance. This testing does not use any external device. The time interval to perform EQC is recommended by the manufacturer to occur every eight (8) hours of each patient-testing day .... Manual Performance of EQC: 1.Display the QC status menu by pressing the "QC" key before a cuvette is inserted. 2.Press "1-EQC". The test chamber warms to temperature and the EQC test begins. The results are displayed while the test is progressing. 3.When the test is completed, the results are displayed on the screen and written to the QC database." 2. Review of records titled "Activated clotting time EQC" revealed the laboratory had failed to document the use of EQC on two of five dates reviewed. Dates ECQ not recorded: 02/07/25 11/06/25 3. 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 -- An interview with laboratory TC at 09:45 am on 04/15/2026 confirmed the laboratory failed to follow the laboratory's established quality control procedure for Activated Clotting time testing. 4. Review of records titled "Interventional Radiology ACT Patient log" revealed a total of two patients were tested on dates without electronic quality control performed. MRN Date of testing GE11983533 02/07/25 GE12434583 11/06/25 -- 2 of 2 --

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review the laboratory's procedure manual; patients' test reports; and interview with the laboratory director, the laboratory failed to have a written or electronic request for patient testing from an authorized person for its Activated Clotting Time test. Findings: 1. Review of the laboratory's procedure manual revealed that there were no written procedures that described how tests are ordered. 2. Review of 5 patients test reports revealed that there was no documentation to show that the tests were ordered from an authorized person for 5 of 5 reviewed. 3. On December 7, 2020 at 10:30 AM, the laboratory director confirmed the surveyor's 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)