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 a review of the laboratory's initial CLIA application Form CMS-116, 2 patient test reports, and staff interview, the laboratory failed to include on the letterhead of the patient reports the facility name and address of the laboratory location where pathology slide examinations were performed since testing began in August 2018. Findings include: a. The facility name and address listed on CLIA application Form CMS-116 was Colorado Pathology Consultants at Platte Valley Medical Center located at 1600 Prairie Center Parkway, Brighton, CO 80601. b. This facility acts as a reference laboratory for AmeriPath Colorado by performing the professional component (microscopic description) of tissue specimens on glass slides processed by AmeriPath Colorado. d. The letterhead of 2 of 2 final patient test reports showed the facility name and address of AmeriPath Colorado located at 695 S. Broadway, Suite 100, Denver,CO 80209, not the facility name and address of Colorado Pathology Consultants at Platte Valley Medical Center located at 1600 Prairie Center Parkway, Brighton, CO 80601 where the professional component was performed. e. On 2-26-19 at about 2:30 p.m., staff stated that since testing began in August 2018, all of their patient reports have listed the name and address of AmeriPath Colorado on the letterhead because they are the parent company of 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 -- Colorado Pathology Consultants. f. On 2-26-19 at about 2:30 p.m., staff stated that the name and address of Colorado Pathology Consultants at Platte Valley Medical Center was listed on the footer of the final patient reports, and confirmed this laboratory's name and address was not indicated on the letterhead of the patient reports as required by federal CLIA regulation. -- 2 of 2 --