Alaska Regional Hospital Poc Testing

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on an on-site review of the laboratory's 2023 American Proficiency Institute (API) proficiency testing (PT) results and an interview with Technical Consultant (1), the laboratory failed to enroll in PT for the first event of 2023, and did not submit results for BUN and Creatinine for the second event of 2023. Findings include: 1. The laboratory was successfully enrolled in proficiency testing from WSLH Proficiency Testing in 2022. 2. A request was made to review the PT results for the first event of 2023 and PT enrollment could not be provided or verified. There was no documentation or

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on interview with the Technical Consultant #1 (TC1) and electronic medical record review of patient test reports, the laboratory failed to provide normal values for male, female, and pediatric patients for hemoglobin and hematocrit for 2 of 2 records reviewed (EMR #37151675 and #35859060). Findings include: 1. The laboratory uses Abbott's i-STAT CG8+ cartridges and the Siemens EPOC Blood Analysis System point of care analyzers that include hemoglobin and hematocrit testing. 2. The results from the i-STAT and EPOC are uploaded into the hospital's electronic medical record (EMR). 3. Review of hemoglobin and hematocrit test reports from the EMR for male and female patients revealed the reference ranges were not age- or gender-specific. 4. The TC1 stated in an interview on 3/11/2021 at 12:00 pm that the EMR was not programmed with separate male, female, or pediatric reference ranges for hemoglobin and hematocrit. 5. The laboratory performs 13,874 Hematology tests annually. 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 D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of test records and interview with the technical consultant, the laboratory did not perform, document, and evaluate the comparison of test results for tests that are performed on multiple instruments at least twice a year. Findings: 1. The laboratory performs pH, pO2, pCO2, sodium, potassium, ionized calcium, glucose, lactate, and hematocrit on both the IL Gem Premier 3500 and Abbott i-STAT CG4+ and CCG8+ cartridges. 2. The laboratory performs Activated Clotting Times (ACT) on both the Medtronic ACT and Abbott i-STAT ACT cartridges. 3. The laboratory has 18 Abbott i-STATs, 1 IL Gem Premier, 1 Metronic ACT, and performs approximately 25,000 chemistry tests and 1,000 ACTs annually. 4. Missing were comparisons of test results for these analytes. 5. The technical consultant confirmed these findings on 12/6/2018 at 13:30. 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 --