Summary:
Summary Statement of Deficiencies D0000 493.45 Requirements for a registration certificate. Laboratories performing only waived tests, provider performed microscopic procedures (PPMP), or any combination of these tests , are not required to obtain a registration certificate. (a ) A registration certificate is required-- (1) Initially for all laboratories performing test procedures of moderate complexity (other than the subcategory of PPMP) or high complexity, or both; and (2) For all laboratories that have been issued a certificate of waiver or certificate for PPMP that intend to perform tests of moderate or high complexity, or both, in addition to those tests listed in 493.15(c ) or specified as PPMP. This requirement for registration is not met as evidenced by: The laboratory failed to register for a certificate of registration for moderate complexity testing, in 2017 and 2018, (Refer to D5024). D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of patient numbers one and two electronic medical records (EMR) and interview with testing personnel number one, the laboratory failed to register for a certificate of registration for moderate complexity testing, in 2017 and 2018. The findings include: 1) Observation of the laboratory on March 23, 2018 at 11:50 am revealed the laboratory performing waived testing for strep A, influenza A/B, infectious mono, urine dipstick, hemoglobin, with no complete blood count (CBC) instrument. 2) Review of patient electronic medical records (EMR) revealed patient complete blood count (CBC) reporting on 10-16-17 for patient number one and on 02-02-18 for patient number two with no laboratory name and address listed. The CBC includes white blood count, red blood count, 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 -- hemoglobin, hematocrit, platelet count and a three part automated differential. 3) Interview on March 23, 2018 at 12: 30 p.m. with testing personnel number one confirmed the Care Rite, PLLC laboratory located down the hall performed complete blood count (CBC) testing using their Sysmex XP-300 (serial number B2036) for the Mid-South Convenient Care PLLC (MSCC) from October 12, 2017 to February 2, 2018. The CBC is performed on the Sysmex XP-300 with results transferring to the laboratory information system (LIS). The LIS sends the results to the Care Rite EMR system. Testing personnel number one opens Care Rite EMR system, physically prints the CBC results, then scans the CBC results into the Mid-South Convenient Care (MSCC) EMR patient file. 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 observation of the laboratory, review of patient numbers one and two electronic medical records (EMR) and interview with testing personnel number one, the laboratory failed to have the name and address of the laboratory location where the complete blood count (CBC) was performed, in 2017 and 2018. The findings include: 1) Observation of the laboratory on March 23, 2018 at 11:50 am revealed the laboratory performing waived testing for strep A, influenza A/B, infectious mono, urine dipstick, and hemoglobin, with no complete blood count (CBC) instrument. 2) Review of patient electronic medical records (EMR) revealed patient complete blood count (CBC) reporting on 10-16-17 for patient number one and on 02-02-18 for patient number two with no laboratory name and address listed. The CBC includes white blood count, red blood count, hemoglobin, hematocrit, platelet count and a three part automated differential. 3) Interview on March 23, 2018 at 12: 30 p.m. with testing personnel number one confirmed the Care Rite, PLLC laboratory located down the hall performed complete blood count (CBC) testing using their Sysmex XP-300 (serial number B2036) for the Mid-South Convenient Care PLLC (MSCC) from October 12, 2017 to February 2, 2018. The CBC is performed on the Sysmex XP-300 with results transferring to the laboratory information system (LIS). The LIS sends the results to the Care Rite EMR system. Testing personnel number one opens Care Rite EMR system, physically prints the CBC results, then scans the CBC results into the MSCC EMR patient file. There is no laboratory name and address on the EMR CBC patient report. -- 2 of 2 --