Summary:
Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to maintain a record system that included the identity of the testing personnel performing the hematology complete blood cell count testing for seven (#2 and #4-#9) of nine patient charts audited. Findings include: 1. On September 18, 2018 at 12:00 PM, record review for seven (#2 and #4-#9) of nine patient charts audited revealed the laboratory did not have a record system in place that included the identity of the testing personnel who ran the specimens on the hematology Beckman Coulter AcT diff2 analyzer. 2. During the interview on September 18, 2018 at 12:00 PM, technical consultant #1 as listed on the CMS-209 confirmed the identity of the testing personnel was not available on the patient's final test reports. 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 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 -- 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 document review and interview, the laboratory failed to identify the name and address of the laboratory where the hematology complete blood cell count testing was performed for five (#5-#9) of nine patient charts audited. Findings include: 1. On September 18, 2018 at 12:00 PM, document review for five (#5-#9) of nine patient charts audited revealed the name and address of the testing facility was not included in the patient's final test report. 2. During the interview on September 28, 2018 at 12:00 PM, technical consultant #1 as listed on the CMS -209 confirmed the name and address of the testing facility was not included on the patient's final test reports. -- 2 of 2 --