Chg Hospital Mcallen Llc

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: D6063 - 42 C.F.R. 493.1421 Condition: testing personnel D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's iSTAT CG4+ quality control records from July 2022 to December 2023 and staff interview, the laboratory failed to have documentation of monitoring quality control values over time for 18 of 18 months. The findings include: 1. A review of the laboratory's iSTAT CG4+ quality control records from July 2022 to December 2023 determined the laboratory performed quality control testing monthly and with each new lot or shipment of cassettes. 2. Further review of the quality control records determined the laboratory graphed a single point for each of the three levels of quality control material tested. The laboratory graphed the monthly quality control, but did not graph the quality control tested with each new lot or shipment. Graphing a single point does not allow the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- assessment of quality control results to identify any shifts or trends. 3. The technical consultant confirmed the findings in an interview conducted on 01/09/2024 at 1020 hours in the conference room. D5785

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 laboratory policies, review of the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in interview of laboratory personnel, the laboratory failed to retain all proficiency testing records for one of five events reviewed. The findings included: 1. Review of the laboratory's policy titled 'Proficiency Testing' stated, "...All records, reports, and

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY resulting in a finding of IMMEDIATE JEOPARDY: D5300 - 42 C.F.R. 493.1240 Condition: Pre-analytic Systems Note: To abate the immediate jeopardy, the facility provided a letter stating they would follow manufacturer's instructions. Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the