Summary:
Summary Statement of Deficiencies 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 review of patient test reports and the CMS (Centers for Medicare and Medicaid) personnel report form, and staff interview, the laboratory failed to ensure the correct name and address of the testing location was correct on 6 of 21 patient test reports reviewed (IS22-01433, IS22-00811, IS22-00799, IS22-00736, IS22-01143, IS22-01687) from 6/13/22 through 12/30/22. The findings were: 1. Review of patient test reports showed the following concerns: a. Review of case IS22-01433 reported on 11/18/22 showed the specimen was collected at Ivinson Memorial Hospital, processed at Summit Pathology in Loveland, CO, and interpreted at Ivinson Memorial Hospital by pathologist #1. Review of the CMS-209 personnel report showed pathologist #1 did not intrepret slides at the Laramie location. b. Review of case IS22-00811 reported on 7/20/22 showed the specimen was collected at Ivinson Memorial Hospital, processed at Summit Pathology in Loveland, CO, and interpreted at Ivinson Memorial Hospital by pathologist #2. Review of the CMS-209 personnel report showed pathologist #2 did not interpret slides at the Laramie location. c. Review of case IS22- 00799 reported on 6/27/22 showed the specimen was collected at Ivinson Memorial Hospital, processed at Summit Pathology in Loveland, CO, and interpreted at Ivinson Memorial Hospital by pathologist #3. Review of the CMS-209 personnel report 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 -- showed pathologist #3 did not interpret slides at the Laramie location. d. Review of case IS22-00736 reported on 6/13/22 showed the specimen was collected at Ivinson Memorial Hospital, processed at Summit Pathology in Loveland, CO, and interpreted at Ivinson Memorial Hospital by pathologist #4. Review of the CMS-209 personnel report showed pathologist #4 did not interpret slides at the Laramie location. e. Review of case IS22-01143 reported on 9/9/22 showed the specimen was collected at Ivinson Memorial Hospital, processed at Summit Pathology in Loveland, CO, and interpreted at Ivinson Memorial Hospital by pathologist #5. Review of the CMS-209 personnel report showed pathologist #5 did not interpret slides at the Laramie location. f. Review of case IS22-01687 reported on 12/30/22 showed the specimen was collected at Ivinson Memorial Hospital, processed at Summit Pathology in Loveland, CO, and interpreted at Ivinson Memorial Hospital by pathologist #6. Review of the CMS-209 personnel report showed pathologist #6 did not interpret slides at the Laramie location. 2. Interview with the laboratory director on 1/20/23 at 1: 17 PM confirmed the name and address of the testing laboratory was inaccurate. -- 2 of 2 --