Americare Health Plaza Medical Center

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation and interview with TP (testing personnel) #1 on 4/3/25, the laboratory failed to discard supplies that were past their expiration dates for use. During a tour of the laboratory at approximately 2:00 pm, the surveyor observed the following expired materials in a drawer, available for use: 1. 5 stool collection kits with 3 Para-Pak vials in each kit, including one C&S (culture & sensitivity) vial, one SAF (sodium acetate-acetic acid-formalin) vial, and one Clean vial. Each kit contained one or more expired vials which included two C&S vials lot 437730-P expiration 12/23/23, three SAF vials lot 417540-P expiration 8/17/23, and three SAF vials lot 413340-P expiration 1/17/25. 2. 2 Total-Fix MCC (Medical Chemical Corporation) collection vials for Ova and Parasite detection, lot 3645-00 expiration 07- 24. 3. 3 orange Aptima Multi-test Swabs with Transport Media (STM), lot 331072 expiration 2/29/24. During an interview at approximately 2:15 pm, TP #1 stated the the supplies are not used by the laboratory. 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 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)

Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of personnel records, the absence of records, and interview with staff 5/16/19, the laboratory failed to have personnel in place who met the qualification requirements to serve as technical consultant in a moderate complexity laboratory. Review of personnel records revealed the laboratory did not have anyone on staff or under contract at the time of the survey who met the qualification requirements to serve as technical consultant in a moderate complexity laboratory. There were no records available to indicate that anyone employed by the laboratory had the education, training, or experience to serve as technical consultant. During interview at approximately 12:00 p.m., the Clinical Supervisor confirmed that they did not have a qualified technical consultant on staff or under contract. D6044 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(6) (b) The technical consultant is responsible for-- (b)(6) Ensuring that patient test results are not reported until all