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 CLIA application Form CMS-116, two test reports, and staff interview, the laboratory failed to include the facility name and address of the laboratory location where moderate complexity urine dipstick testing was performed in April 2019. Approximately 18 patient specimens were reported. Findings include: a. The facility name and address listed on CLIA application Form CMS-116 was KFHP Castle Rock Laboratory located at 4318 Trail Boss Drive, Castle Rock, Colorado, 80104. b. The letterhead of 1 of 1 final patient test report listed the facility name and address of Kaiser Regional Reference Laboratory located at 11000 E. 45th Ave., Denver, CO 80239, not the facility name and address of KFHP Castle Rock Laboratory located at 4318 Trail Boss Drive, Castle Rock, Colorado, 80104 where the urine dipstick testing was performed. c. One of one Health Connect patient reports reviewed indicated that the urine specimen had been collected at the Castle Rock laboratory but did not indicate the address of the Castle Rock laboratory where the urine dipstick testing had been performed. d. On 3-25-19 at about 10:30 a.m., staff stated that all of their patient reports have on their letterhead the name and address of Kaiser Regional Reference Laboratory. e. On 3-25-19 at about 10:30 a.m., staff stated that only the name of the Castle Rock laboratory was listed in the body of the Health 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 -- Connect patient report. Staff confirmed the laboratory's address was not indicated on the letterhead of the patient report nor on the Health Connect patient report as required by federal CLIA regulation. -- 2 of 2 --