Summary:
Summary Statement of Deficiencies D0000 A federal surveyor from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted a recertification survey, the following standard level deficiency was cited: D5805 TEST REPORT CFR(s): 493.1291(c) (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 the laboratory's patient final test reports, and interview with the laboratory manager, the laboratory failed to ensure patient test reports included the name and address (of the Tinian clinic) where the test was actually performed for three of three patient test reports reviewed as evidenced by: 1. In review of the following three patient test reports, all of them had the main laboratory's name and address (1178 Hinemulu St. Garapan, MP 96950) on them not the clinics name and address (San Jose Village, Tinian , MP 96952 ) where the actual tests were being performed. It looked like the main laboratory was performing the testing not the clinic. a. patient 600265 - a complete blood count was performed on Tinian not the main laboratory, it had the main laboratory's address on it. b. patient 611288- Biofire panel was performed on Tinian not at the main laboratory, it had the main laboratory's address on it. c. patient 600275 a microscopic urine was performed on Tinian not at the main laboratory, it had the main laboratory's address on it. 2. In interview with the 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 -- laboratory manager at 1035 he confirmed that the three patient were performed at the Tinian clinic not the main laboratory and believe it may be an IT issue. -- 2 of 2 --