Summary:
Summary Statement of Deficiencies D0000 The validation survey was performed on 01/21/2026. Standard-level deficiencies were cited. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the respiratory manager, the laboratory failed to follow the manufacturer's instructions for Blood Gas testing for three of five test reports reviewed from January through September 2025. Findings include: (1) On 01/21/2026 at 10:00 am, the respiratory manager stated Blood Gas (pH, pCO2, pO2) testing was performed using the CG4+ cartridge and iSTAT 1 analyzer; (2) A review of the manufacturer's instructions contained in the iSTAT 1 Wireless User Guide in the table titled, "Blood Collection Options and Test Timing" required the samples be tested within 10 minutes of collection; (3) A review of patient testing records from January through September 2025 identified three of five patient records had not been documented as being tested within ten minutes of collection: (a) Patient Report #3004088; tested on 04/26/2025 - The collection time had been documented as 02:33 pm and the testing time had been documented as 03:37 pm; (b) Patient Report #3004099; tested on 05/19/2025 - The collection time had been documented as 05:00 pm and the testing time had been documented as 07:04 pm; (c) Patient Report #3004163; tested on 09/30/2025 - The collection time had been documented as 08:51 pm and the testing time had been documented as 09:58 pm. (4) The records were reviewed with the respiratory manager who stated on 01/21/2026 at 01:10 pm, there was no additional documentation to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- prove the specimens had been tested within the timeframe required by the manufacturer. 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 a review of records and interview with the respiratory manager, the laboratory failed to review and evaluate proficiency testing results for one of six Chemistry Proficiency testing events reviewed in 2024 and 2025. Findings include: (1) A review of Chemistry Proficiency testing records for six events (First 2024, Second 2024, Third 2024, First 2025, Second 2025, and Third 2025) identified the following failure with no evidence that