Skin Cancer Surgery Center Llc

Summary Statement of Deficiencies 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)

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 procedure manual, laboratory patient log, and patient electronic medical record (EMR) review and interview with the laboratory staff, the laboratory did not follow the established policies and procedures to ensure positive identification of histology specimens from the time of collection through completion and reporting of patient results. Findings: 1. The procedure manual shows an example of how to label the histology slides. The histotech is required to include the last two digits of the current year followed by the next sequence number for that year. 2. A random review of patient records showed that Patient A was listed as "Case # 19-349" in the patient log. Examination of the patient's histology slides showed that 2 of 6 slides were labeled "19-249" and 4 of 6 slides were labeled "19-349"; and 3. A review of the patient final record in the EMR showed that the Mohs map and the final report were both labeled "19-249." 4. During an interview on 7/26/19 at 11:30 AM, the laboratory staff confirmed that histology specimens were not correctly identified from the time of collection through completion and reporting of patient 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 1 --