Summary:
Summary Statement of Deficiencies D0000 . A recertification survey was performed on May 19, 2025 at Dearborn Surgery Center by the State of Michigan Licensing and Regulatory Affairs Department. During the survey, it was determined Immediate Jeopardy (IJ) existed for the following condition- level deficiencies: 493.1219 Condition: Histopathology. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observation and interviews with the administrator and the laboratory director, the laboratory failed to establish written policies to ensure positive identification of its patient histopathology slides (refer to D5203), failed to establish test procedures for its frozen section histopathology testing to include the preparation of slides, performance of gross tissue examinations, and microscopic tissue examinations (refer to D5403), and failed to ensure quality control programs were established to include predictable staining characteristics for its hematoxylin and eosin staining materials at least each day of patient testing (refer to D5473). 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: . Based on observation and interviews with the administrator and the laboratory director, the laboratory failed to establish written policies to ensure positive identification of its patient histopathology slides for 9 (patients) of 11 patient cases performed between 6/9/23 to 5/19/25. Findings include: 1. A review of the laboratory's test volume revealed the laboratory performed histopathology frozen sections for 11 patients between 6/9/23 to 5/19/25. Nine of the 11 patient cases had slides available for review. The slides included patient identification stickers with the name of another laboratory, laboratory B under a different CLIA certificate. These stickers overlapped the coverslip on some of the slides, showing they were added after the specimen slides were prepared. The surveyor peeled back and held the slides to the light to see what the labeling was underneath the stickers to reveal the following information: a. Patient #1, with testing performed on 6/28/23, had 10 slides prepared and read at this laboratory: i. Two slides did not include any labeling. ii. Eight slides included the case number and letters denoting the sections, "B1-1", "B1-2", "C1-1", C1-2", "D1-1", "D1-2", "E1-1", and "E1-2". iii. No name was included on the slides. b. Patient #3, with testing performed on 1/10/24, had seven slides prepared and read at this laboratory: i. Two slides did not include any labeling. ii. Five slides included letters and numbers denoting the sections, "A2-1", "A2-2", "A3-1", "A3-2", and "A3- 3". iii. No name or case number was included. c. Patient #4, with testing performed on 6/13/24, had six slides prepared and read at this laboratory: i. All six slides included letters and numbers denoting the sections, "A1/1", "A1/2", "B1/1", "B1/2", "C1/1" and "C1/2". ii. No name or case number was included. d. Patient #6, with testing performed on 7/6/23, had six slides prepared and read at this laboratory: i. Two slides did not include any labeling. ii. Four slides included the case number and letters denoting the sections "B1-1", "B1-2", "C1-1", and "C1-2". iii. No name was included. e. Patient #7, with testing performed on 6/9/23, had six slides prepared and read at this laboratory: i. Two slides did not include any labeling. ii. Four slides included the letters denoting the sections "A2-1", "A2-2", "A3-1", and "A3-2". iii. No name or case number was included. f. Patient #9, with testing performed on 2/23/24, had four slides prepared and read at this laboratory: i. Two slides did not include any labeling. ii. Two slides included the numbers denoting the sections "1-3" and 1-4". iii. No name or case number was included. g. Patient #10, with testing performed on 11/22/23, had 12 slides prepared and read at this laboratory: i. Six slides did not include any labeling. ii. Six slides included the letters denoting the sections "A3 11", "A3 12", "A4 11", "A4 12", "C 11", and "C 12". iii. No name or case number was included. h. Patient #11, with testing performed on 8/25/23, had six slides prepared and read at this laboratory: i. All six slides include the letters denoting the sections "A1-1", A1-2", "B1", "B12", "C1.1", and "C1.2". No name or case number was included. i. Patient #12, with testing performed on 10/12/23, had four slides prepared and read at this laboratory: i. Three slides included a last name and first initial with "B12", "BLL", and "F212A". No full name or case number included. ii. One slide included "F211 A" without a name or case number. 2. A review of the laboratory's "Specimen collection- Care, Handling, and Disposal" procedure revealed a lack of specimen labeling policy. 3. An interview on 5/19/25 at 2:04 pm with the administrator and the laboratory director confirmed the slides listed above were not labeled to ensure positive patient identification while the specimens were at the laboratory. The stickers on the slides were generated after the frozen section histopathology testing at the laboratory was completed and sent to reference laboratory for additional testing. D5403 PROCEDURE MANUAL -- 2 of 5 -- 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)