Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Regional Laboratory Director, the laboratory failed to operate as a separate laboratory to comply with 493. 43 for 2 (March 2022 to March 2024) of 2 years reviewed. Findings include: 1. The surveyor observed the laboratory testing area was located at the same address as two other laboratories, 23D0038123 Aspirus Keweenaw Hospital Laboratory and 23D03821310 Aspirus Laurium Clinic. 2. A review of the laboratory's Form CMS- 116 revealed the laboratory operates Monday-Friday 7:00 am to 3:00 pm. 3. An interview on 3/12/24 at 11:35 am with the Regional Laboratory Director revealed the laboratory follows the same policies as the 23D0038123 Aspirus Keweenaw Hospital Laboratory, that this laboratory operates 24 hours a day, 7 days a week, confirming the laboratories are testing concurrently, and they use the same staff. . D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. 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 -- This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with Testing Personnel #2, the laboratory failed to follow its specimen labeling policy for three patient histopathology slides observed. Findings include: 1. The surveyor observed three patient histopathology slides labeled with "32", "81A", and "136C" on 3/12/24 at 9:24 am. 2. A review of the laboratory's "Tissue Sectioning Procedure" revealed a section titled "Labeling Slides" stating, "Label the slides with the same identifier as the block (i.e. S10-001 A, S10-001 B, etc.). If more than one slide per block label each slide: 1, 2, 3, etc. in the upper right hand corner indicating the number of the secession per block." 3. An interview on 3/12/24 at 9:24 am with Testing Personnel #2 confirmed the slides did not include the same identifiers as the blocks. 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)