Summary:
Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the regional manager, staff A, the laboratory did not record the time of specimen receipt in the laboratory for three of three Mohs tissue specimens from one of four randomly reviewed patients. Findings include: 1. Review of laboratory records including patient logs, Mohs maps and patient test reports for four randomly chosen patients showed staff did not record the time of specimen receipt in the laboratory for three of three Mohs tissue samples from one of four patients. Patient 1: Tissues from three of three stages received. 2. Interview with staff A on October 12, 2022, at 12:47 PM confirmed the laboratory did not record the time of specimen receipt in the laboratory for three of three Mohs tissue specimens from one of four randomly reviewed patients. 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 --