Summary:
Summary Statement of Deficiencies D0000 Federal Surveyors from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted a recertification survey on 7/14/2025 and 7/15/2025. The following standard level deficiencies were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: I. Based in review of the manufacturer's instructions, the laboratory's procedures, review of patient testing records, and interview with the technical supervisor #1, the laboratory failed to follow and document the conditions of transportation (temperature) of ferritin serum specimens when received into the laboratory according to their procedures in 2025 for 5 of 5 Saipan patients reviewed as evidenced by: 1.In review of manufacturer's instructions for ferritin states under specimen collection and preparation, "Serum, heparin, K3-ETDA plasma samples are 24 hours at 20-25 degrees, 7 days at 2-8 degree C, 12 months at -20 degrees +/- 5 degrees C". 2. In review of the laboratory's procedures Ferritin Cobas technical procedures states, "ambient stability 24 hours at 20-25 degrees C, refrigerated stability 7 days at 2-8 degrees C." 3. In review of the laboratory's patient testing records from Saipan, the laboratory did not document the conditions of transport (temperature) upon arrival of ferritin serum specimens for 2025. The laboratory did not have documentation that the specimens (2025) were transported at 2-8 degrees C. 4.The following ferritin patients were past the room temperature 24 hours specimen integrity: a. Patient YF49760525 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- on 6/30/2025 was received 347.9 hours after collection with no documentation of transportation temperature conditions. b. Patient YF49764181 on 6/30/2025 was received 33 hours after collection with no documentation of transportation temperature conditions. c. Patient YF49979837 on 7/2/2025 was received 35.1 hours after collection with no documentation of transportation temperature conditions. d. Patient YF50402441 on 7/7/2025 was received 33.3 hours after collection with no documentation of transportation temperature conditions. e. Patient YF50750376 on 7 /10/025 was received 32.7 hours after collection with no documentation of transportation temperature conditions. 5.In an interview with technical supervisor #1 at 0845 at 7-15-2025 he stated that he believed that everything coming in from outside facilities from Saipan were refrigerated when they switch to DHL a few years ago. 47107 II. Based on review of the laboratory's procedures, test volumes, direct observation, review of patient testing records, and interview with Technical Supervisor (TS)-1, according to the Centers for Medicare and Medicaid (CMS) Form 209, the laboratory failed to follow and document the conditions of transportation (temperature) of Rapid Plasma Reagin (RPR) serum specimens when received in the laboratory according to their procedures in 2025 for 1 of 1 Saipan patients reviewed. Findings Included: 1. Review of the laboratory's procedures for RPR titled 'Diagnostic Laboratory Services, Inc. RPR G400.70.90' stated the following on page 1 of 6: "2.2 Stability: Serum is stable up to 5 days at 2-8 degrees Celsius. If more than 5 days, specimen should be frozen at -20 degrees Celsius or below." 2. Review of the laboratory's patient testing records showed an annual RPR test volume of 4,624. 3. In direct observation on July 15, 2025 at 2:44 PM, the following RPR patient sample(s) were observed shipped from Saipan and received by the laboratory all in one box labeled 'Room Temperature, Refrigerate & Frozen', with no mechanism in place to track shipping transport (temperature) conditions: a. Patient YF51108686, Gold-Top Serum Separator Tube (SST), with no documentation of transportation temperature conditions. 4. In review of the laboratory's patient testing records from Saipan, the laboratory did not document the condition of transport (temperature) upon arrival of RPR specimens for 2025. The laboratory did not have documentation that the specimens were transported at 2-8 degrees Celsius or at -20 degrees Celsius and colder. 5. In an interview at 2:45 PM in the laboratory, TS-1 stated and confirmed the observation that specimens received from Saipan and other facilities come together in one package, even if room temperature, refrigerated or frozen requirements for transport and/or storage, and the laboratory did not have a mechanism in place to track transport temperatures. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on direct observation, review of the laboratory's policy, temperature records, test volumes, and interview with the Technical Supervisor (TS)-2 according to the Centers for Medicare and Medicaid (CMS) Form 209, the laboratory failed to document calculation of the average yearly room temperature where the Microscan Walkaway System 40Si was in use for 2 of 2 years (2024 and 2025). Findings Included: 1. In direct observation on 7/15/2025 at 10:39 AM in the microbiology -- 2 of 7 -- section, 1 Microscan Walkaway System 40Si was observed in use for ID and Antibiotic Susceptibility Testing (AST). 2. Review of the laboratory's policy titled, 'Diagnostic Laboratory Services, Inc. Microscan Walkaway System 40Si G401.90. EQP.01' stated the following annual temperature calculation requirement: "Store at 2- 25 degrees Celsius, excursions permitted to 30 degrees Celsius. Average yearly temperature not to exceed 25 degrees Celsius. Transient temperature spikes are acceptable, as long as average storage temperature does not exceed 25 degrees Celsius." 3. Review of the microbiology section's room temperature records showed an acceptable range of 15 to 30 degrees Celsius, but no annual temperature average calculation completed by the laboratory in 2023 and 2024. 4. Review of the laboratory's test volumes in 2024 for the Microscan Walkaway System 40Si showed the following: a. Staph Sensi - 1,802 b. Gram Negative Sensi - 7,076 c. Enterococcus Sensi - 572 d. Pseudomonas Sensi - 383 5. In an interview on 7/15/2025 at 10:45 AM in the conference room, TS-2 confirmed that the laboratory did not follow their own policy to do an annual calculation of average recorded room temperature in the microbiology section (not to exceed 25 degrees Celsius) where the Microscan Walkaway System 40Si was in use. II. Based on direct observation, review of the manufacturer's instructions, laboratory policy, test volume records, and interview with the Technical Supervisor (TS)-2, according to the Centers for Medicare and Medicaid (CMS) Form 209, the laboratory failed to follow its own policy for using a high intensity incandescent lamp for 1 of 1 test methodology (Becton Dickinson Macro- Vue Rapid Plasma Reagin Card Test). Findings Included: 1. In direct observation on 7 /14/2025 at 3:19 PM in the laboratory, the Rapid Plasma Reagin (RPR) workbench had dim room lighting and did not have a high intensity incandescent lamp for RPR card test readouts. 2. Review of the manufacturer's instruction from Becton Dickinson (BD) for the Macro-Vue RPR Card Test 18 mm Circle Qualitative and Quantitative stated the following requirement: "Reading of Card Test Results: Read immediately following rotation in the "wet" state under a high intensity incandescent lamp or strong daylight." 2. Review of the laboratory's policy titled 'Diagnostic Laboratory Services, Inc. RPR G400.70.90' stated the following on page 3 of 6: "Immediately read macroscopically in the 'wet' state under a high intensity incandescent lamp". 3. Review of the laboratory's patient testing records showed an annual RPR test volume of 4,624. 4. In an interview on 7/14/2025 at 3:21 PM in the laboratory, TS-2 confirmed that an incandescent lamp was not utilized for RPR testing, in accordance with the laboratory's policy. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)