Presidio Health Associates Llc Dba Cat

Summary Statement of Deficiencies D0000 The Presidio Health Associates LLC DBA Catalina Post Acute Care and Rehabilitation laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey on February 12, 2026. 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records from 2022, 2023 and 2024 and interview with the testing personnel (TP-1), the laboratory failed to test PT samples by testing personnel who routinely perform patient testing in the laboratory, using the laboratory's routine methods. Findings include: 1. The laboratory participates in 3 PT events annually for testing performed in the specialties of Chemistry and Hematology. 2. The CMS-209, Laboratory Personnel Form presented during the survey conducted on 11/13/24 listed 17 testing personnel who routinely perform patient testing. 3. Interview with testing personnel during the survey confirmed that the PT samples were not rotated among the 17 testing personnel in the laboratory and that the same testing personnel: initals "SP" performed PT testing for every PT event from 2022- 2024. 4. The TP-1 interviewed on 11/13/24 at 11:30 AM confirmed that the same individual participated in each testing event as indicated above. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on information the Proficiency Testing (PT) provider furnished to the State 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 -- Agency, the laboratory failed to to attain an overall testing event score of at least 80 percent for the regulated analytes, pH and PCO2 Blood Gas, during the 3rd testing event of 2022 resulting in an unsatisfactory PT performance. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records and interview with the testing personnel, the laboratory failed to undergo appropriate training and employ the technical assistance necessary to correct the PT failures for the regulated analytes, pH and PCO2 Blood Gas during the 3rd event of 2022. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records from 2022 through 2024 and interview with the testing personnel (TP-1), the laboratory failed to provide a documented review of PT results from the 1st and 2nd testing events of 2024, 1st and 3rd testing events of 2023, and the 3rd testing event of 2022. Findings include: 1. The laboratory performs patient testing on the i-STAT under the specialties of Chemistry and Hematology. The laboratory performs 3,500 tests annually. 2. No evidence, either by written comment or signature, was presented during the survey conducted on 11/13 /2024 to indicate the laboratory director or other laboratory personnel reviewed the PT results for the 1st and 2nd testing events of 2024. 3. No evidence, either by written comment or signature, was presented during the survey conducted on 11/13/2024 to indicate the laboratory director or other laboratory personnel reviewed the PT results for the 1st and 3rd testing events of 2023. 4. No evidence, either by written comment or signature, was presented during the survey conducted on 11/13/2024 to indicate the laboratory director or other laboratory personnel reviewed the PT results for the 3rd testing event of 2022. 5. The TP-1 interviewed on 11/13/24 at 11:30 AM confirmed the PT results indicated above were not reviewed by laboratory personnel. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review of the laboratory's refrigerator temperature logs and interview with the lead Registered Respiratory Therapist (RRT-1) on August 11, 2022, the laboratory failed to follow their "

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) attestation statements for 2018 and interview with the laboratory personnel, the laboratory failed to have the director or a qualified designee sign the attestation statements for the 2nd and 3rd events of PT performed under the specialty of Chemistry. Findings include: 1. The PT attestation statements noted above did not have the signature either of the director or an individual that would qualify as a designee; a technical consultant meeting the qualifications under CLIA regulation 493.1409. 2. The laboratory personnel acknowledged that the attestation statements indicated above lacked the signature of the director or designee. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of current manufacturer's quality control (QC) and calibration verification (CalVer) assay information sheets for the i-Stat blood gas analyzer for review and interview with the laboratory personnel, the laboratory failed to retain 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 2 -- records indicated above for a minimum of two years. Findings include: 1. Based on the laboratory's IQCP policies, the laboratory performs monthly liquid QC for blood gas testing and performs 2. The laboratory failed to provide the Control Value Assignments Sheets (CLEW Sheets) that indicated the correct control target values and ranges for the CG8+ control cartridges utilized for the following months: November 2018 (lot # W18268), January 2019 (lot #W18339), and July 2019 (lot #W19200243). 3. The laboratory failed to provide the Calibration Verification Assignment Sheets (CLEW Sheets) that indicates the manufacturer's acceptable ranges for the CalVer performed on February 1, 2018 (lot #219W172600240) 4. The laboratory personnel acknowledged that the documents indicated above could not be located on the day of the survey. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) scores for 2018 and 2019 and interview with the laboratory personnel, the laboratory failed to provide a documented review of the PT results for 2018 and 2019 for the sub-specialty of routine chemistry and the specialty of hematology. Findings include: 1. No documented reviews, including a written comment and signature, were presented during the survey to indicate that the laboratory director or designee reviewed the results for the testing events indicated above for blood gas testing. 2. There must be evidence of a review of the PT scores for each event even if the laboratory received a score of 100%. 4. The laboratory personnel acknowledged that there were no documented reviews of the PT scores for the events listed above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on lack of a documented annual quality assessment (QA) review for 2018 and as indicated in the laboratory's policy and procedure manual and interview with the facility personnel, the laboratory failed to provide a documented annual QA review for 2018. 1. The laboratory's policy indicated that the following areas are to be reviewed on an annual basis: Test procedures Package Inserts Instrument Manuals Policy or processes not covered by the QA review Normal Ranges Reportable Ranges Limitations of test methods. 2. The facility personnel acknowledged that the documented annual review could not be located. -- 2 of 2 --