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 record review and staff interview, the laboratory (lab) failed to ensure the name and address of all labs' performing hematology testing are included on the test report. Findings include: 1. Review on 1/19/2024 of 1 complete blood count (CBC) test report from 11/30/2023 revealed the test result was reported by personnel not listed on the personnel form. The laboratory and location indicated it was still performed by SVHC Oncology Associates. 2. Interview on 1/19/2024 at 11:00 a.m. with the Technical Supervisor (TS) confirmed the above finding and revealed the lab did not have TP working on 11/30/2023 to evaluate and report CBC test results. The TS revealed when the 1 of 1 testing personnel is not in the lab, the other personnel (lab aid) on the form will load samples on the instrument and personnel from a separate CLIA lab will evaluate and report the CBC results. TS confirmed the personnel from the other laboratory is not listed on the lab's personnel form. D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) The laboratory director must employ a sufficient number of laboratory personnel with 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 -- the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director failed to employ a sufficient number of personnel to perform hematology testing when 1 of 1 Testing Personnel is not able work or has taken time off. Findings include: 1. Review on 1/19 /2024 of the CMS-209 (personnel) form revealed 2 testing personnel, 1 high complexity (TP), 1 moderate complexity (lab aid). 2. Review on 1/19/2024 of personnel records revealed the personnel (lab aid) listed on the personnel form as moderate complexity is only loading CBC control and patient samples on the instrument and is not evaluating results or reporting results. 3. Review on 1/19/2024 of 1 CBC test report from 11/30/2023 revealed the test result was reported by personnel not listed on the personnel form. The laboratory and location indicated it was still performed by SVHC Oncology Associates. 4. Interview on 1/19/2024 at 11: 00 a.m. with the Technical Supervisor (TS) confirmed the above findings and revealed the high complexity TP was not working on 11/30/2023. The TS revealed when the high complexity testing personnel is not in the lab, the other personnel (lab aid) on the form will load samples on the instrument and personnel from a separate CLIA laboratory will evaluate and report the CBC results. TS confirmed the personnel from the other laboratory are not listed on the personnel form. The TS revealed the laboratory does not employee TP to cover when the high complexity TP is off. -- 2 of 2 --