Summary:
Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 8/29/23. Monument Health Dermatology laboratory was found not in compliance with the following requirement: D5805. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to clearly identify the location of the laboratory that had performed testing for one of one sampled patient specimen (Mohs procedure) report that would allow a provider viewing those results to contact the testing laboratory in the event additional information or interpretation was needed. Findings include: 1. Review on 8/29/23 at 10:35 a.m. of the test results for a random sampled patient's Mohs procedure report revealed the laboratory report header identified the reporting facility as Monument Health Dermatology. The address of the testing facility was not documented on the patient test report. Review of the facility's annual test count form revealed the laboratory had processed and reported 320 patient Mohs procedure tissue specimens in 2022. Review of the Centers for Medicare and Medicaid Services 116 form revealed the name of the laboratory was Monument Health Dermatology, located at 550 East Colorado Boulevard, Spearfish, SD 57783. Review of the Clinical Laboratory Improvement Amendments Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- database revealed two laboratories with the name Monument Health Dermatology. The Monument Health Dermatology laboratories had been located in Spearfish and Rapid City, South Dakota. Interview with testing personnel A on 8/29/23 at 10:35 a. m. revealed: *She confirmed the patient test report had not contained the laboratory's address. *The computer system (EPIC) was maintained and operated by Monument Health Hospital Rapid City. Interview on 8/29/23 at 10:45 a.m. with the laboratory director confirmed the laboratory address was not included on the patient test result report. -- 2 of 2 --