Summary:
Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/13/19. The findings were reviewed with the point of care coordinator/technical consultant at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policy and interview with the point of care coordinator/technical consultant, the laboratory failed to have a written technical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) At the beginning of the survey, the surveyor reviewed personnel records for competency assessments performed during 2017, 2018 and 2019. There was no evidence competencies had been performed for the technical consultant, based on their job responsibilities between 09/07/17 and 04/09/19; (2) The surveyor asked the point of care coordinator/technical consultant if a written policy to evaluate the technical consultant based on job responsibilities was available and if additional competencies had been peformed. (3) The point of care coordinator/technical consultant stated a written policy to evaluate the technical consultant based on job responsibilities had not be written and additional competencies had not been performed. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the point of care coordinator /technical consultant, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2017, 2018 and 2019 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) Critical Care Aqueous Blood Gas (i) AQI-B 2017 Event (aa) 1 of 5 TCO2, AQI-10 (2) The surveyor further reviewed the records and could not locate documentation verifying the laboratory had performed a self- evaluation of the non-graded result; (3) The surveyor asked the point of care coordinator/technical consultant if the result had been documented as evaluated. The point of care coordinator reviewed the records and stated the non-graded result had not been documented as reviewed. 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 records and interview with the point of care coordinator /technical consultant, the laboratory failed to ensure patient test reports included the address of the laboratory location. Findings include: (1) At the beginning of the survey, the point of care coordinator/technical consultant stated to the surveyor the following testing was performed: (a) Adult ICU (Intensive Care Unit) performed Glucose, Potassium, Ionized Calcium, CO2, Hematocrit, Hemoglobin, pH, pO2, pCO2 using the CG8+ cartridge on the Abbott iSTAT 1 analyzer; (b) NeuroTrauma ICU performed Glucose, Potassium, Ionized Calcium, CO2, Hematocrit, Hemoglobin, pH, pO2, pCO2 using the CG8+ cartridge and PT/INR (Prothrombin Time /International Normalized Ratio) using the PT/INR cartridge on the Abbott iSTAT 1 analyzer; (c) Cardiovascular ICU performed Glucose, Potassium, Ionized Calcium, CO2, Hematocrit, Hemoglobin, pH, pO2, pCO2 using the CG8+ cartridge and the ACT (Activated Clotting Time using the ACT cartridge on the Abbott iSTAT 1 analyzer; (c) Rapid Response Team performed Glucose, Potassium, Ionized Calcium, CO2, Hematocrit, Hemoglobin, pH, pO2, pCO2 using the CG8+ cartridge and the ACT (Activated Clotting Time using the ACT cartridge on the Abbott iSTAT 1 analyzer; (2) The surveyor then reviewed 1 patient report: (a) Report #1 - CG8+ -- 2 of 3 -- cartridge testing performed on 06/11/19 (3) The surveyor identified that the address of the laboratory was not on the report; (4) The surveyor reviewed the report with point of care coordinator/technical consultant who stated the address was not on the report. -- 3 of 3 --