Summary:
Summary Statement of Deficiencies 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 review of i-Stat test procedures, review of i-Stat instrument printouts and test result forms and interview with the testing personnel (TP-1), the laboratory failed to follow established policies and procedures to ensure positive identification of 3 out of 4 patient's specimens from the time of collection through completion of testing and reporting of chemistry and blood gas test results. Findings include: 1. The laboratory performs Chemistry (Chem8+ cartridge) and Arterial Blood Gas (CG4 cartridge) testing on the i-Stat analyzer in the specialty of Chemistry, with a reported annual test volume of 570. 2. The laboratory's established test procedure for the i-Stat analyzer states, "Enter the patient ID number up to 12 digits. Repeat the process for verification." 3. TP-1 interviewed on 8/12/25 at 12:35 PM stated that testing personnel are trained to enter the last four digits of the patient's MQ number into the i-Stat prior to testing the sample, not the patient's MR number. 4. Review of 4 patient's test result forms (with the i-Stat instrument printout affixed to each) indicated the laboratory failed to consistently and correctly enter the patient ID number into the i-Stat analyzer prior to testing patient specimens for 3 out of 4 test results reviewed, as evidenced by: - No patient ID number was entered into the i-Stat for patient MQ# 1344 from testing on 1/12/25 at 13:45 - Patient ID listed on the i-Stat printout was 00701122, for patient MQ# 3340 from testing on 4-13-25 at 07:26 - Printed patient label was affixed to the i- Stat instrument printout over the area where the Patient ID information is located for MQ# 9900 from testing on 10-17-24 at 03:51 5. TP-1 interviewed on 8/12/25 at 12:35 PM confirmed the laboratory failed to follow established policies and procedures 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 2 -- ensure the correct specimen identification was consistently entered into the i-Stat analyzer prior to testing patient specimens. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on review of testing personnel competency documentation from 2024 and interview with testing personnel (TP-1), the technical consultant failed to evaluate the competency of 17 out of 17 testing personnel in 2024. Findings include: 1. Competency documentation reviewed for 17 of 17 testing personnel from 2024 revealed the competency evaluations were performed by TP-1 and not the Technical Consultant. 2. Interview with TP-1 on August 12, 2025 at 10:50 AM confirmed the Technical Consultant failed to evaluate the competency of 17 out of 17 testing personnel during 2024. 3. The laboratory perfoms testing in the specialty of Chemistry with a reported annual test volume of 570. -- 2 of 2 --