Medical Center At Caverna, The

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 10/08/2025 and concluded on 10/09/2025. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on laboratory policy review, laboratory document review, and interview, the laboratory failed to provide evidence of a self-evaluation for 1 of 28 proficiency testing (PT) events that were returned as not graded by the PT provider. Findings included: A laboratory policy titled, "Proficiency Testing," dated 11/07/2024, revealed, "B. Upon receipt of the data summary from the Proficiency Testing Program, the Laboratory Director/Manager will evaluate the report. The proficiency report will be reviewed for the following: 1. Ungraded results." A laboratory document titled, "American Proficiency Institute (API) Proficiency Testing Performance Evaluation, 2025 - Chemistry Core - 2nd Event," dated 07/01/2025, revealed the following analytes (a substance undergoing chemical analysis) and samples marked as not graded: Total Bilirubin, samples CH-07, CH-09, & CH-10 and Folate, samples IA-07 and IA-09. The document failed to reveal notation of the ungraded analytes/samples on the performance evaluation page or a participant summary sheet. During an interview on 10/08/2025 at 2:45 PM, the Technical 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 -- Supervisor (TS) stated that he had noted the ungraded results at the time the proficiency testing report was received but could not explain why the self-evaluation had not been performed. This confirmed the findings. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, laboratory document review, and interview, the laboratory failed to perform a periodic function check of a repetitive diluent dispenser used in an immunohematology procedure for 24 of 24 months reviewed. Findings included: On 10/09/2025 at 9:45 AM, an observation revealed a (Company Name) Repetitive 1.0 ml (milliliter) dispenser in a laboratory refrigerator. A laboratory document titled, "CMS [Centers for Medicare & Medicaid Services]-116," dated 10/08/2025, revealed the laboratory employed the (Company Name) blood typing system for performing antibody screening under the specialty Immunohematology and sub-specialty of Antibody Detection. An undated laboratory document titled, "[Company Name] Dispenser - Repetitive Dispenser of 0.5 or 1.0 mL, Instructions for Use," revealed the section titled, "Calibration Check," specified, "A calibration check should be done as part of a routine laboratory quality control schedule and after each repair." During the survey, a review of laboratory procedures and maintenance documents failed to reveal a requirement to perform the indicated calibration checks and failed to reveal documentation that the calibration checks had been performed. During an interview on 10/09/2025 at 12:35 PM, the Technical Supervisor (TS) stated that he was not aware of the calibration check requirement and confirmed that the calibration checks had not been performed. This confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and staff interview on 05/29/2019 and 05/30/2019, the laboratory failed to verify the performance specifications established by the manufacturer for accuracy and precision when the Sed Rate Mini-Cube was installed 02/01/2019. Findings include: 1. Review of records of installation performed 02/01 /2019, failed to reveal verification of accuracy to ensure the testing method produced correct results. 2. Review of records of installation performed 02/01/2019, failed to reveal assessments of day-to-day, run-to-run, and with-in run precision to ensure reproducibility was verified prior to reporting patient results. The Technical Supervisor acknowledged in an interview at 10:00 AM on 05/30/2019, the laboratory failed to have a system in place to demonstrate the laboratory can obtain performance specifications comparable to those established by the manufacturer for accuracy and precision prior to patient testing. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and staff interview on 05/29/2019 and 05/30/2019, the laboratory failed to perform and document weekly maintenance on the MTS Dispenser since 07/21/2017, as required by the manufacturer of the MTS Gel Test System. Findings include: Review of the policy for the MTS Gel Test System revealed under Weekly Maintenance "Clean the MTS Dispenser with 70% isopropyl alcohol and rinse with deionized or distilled water. Record the cleaning in the Equipment Quality Control Log." Review of the Equipment Quality Control Log failed to reveal documentation of weekly maintenance of the MTS Dispenser since 07 /21/2017. The Technical Supervisor acknowledged in an interview at 2:00 PM on 05 /29/2019, the laboratory failed to establish a system to ensure maintenance procedures were performed and documented as required by the manufacturer. -- 2 of 2 --