Summary:
Summary Statement of Deficiencies D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on lack of a pathology test report for review and interview with the facility personnel, the laboratory failed to provide the pathology report for one out of three patient records reviewed during the survey. Findings include: 1. The laboratory performs Frozen Biopsy testing in the subspecialty of Histopathology. The laboratory utilizes an electronic medical record (EMR) system to maintain patients' pathology test reports. 2. The laboratory failed to provide evidence of the frozen biopsy test report (P22-545A from 6/28/22) for one of out three patient records reviewed during the survey. 3. The facility personnel interviewed on August 24, 2023 at 11:50 AM confirmed the laboratory failed to provide evidence of the frozen biopsy report as indicated above. 4. The laboratory's reported annual test volume in the subspecialty of Histopathology is 3,671. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on lack of documentation of a semi-annual competency evaluation for one out of one testing personnel and interview with the facility personnel, the technical 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 -- supervisor failed to evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individuals tested patient specimens. Findings include: 1. No semi-annual competency evaluation documentation was presented for review for one out of one testing personnel who began grossing patient specimens in January 2023. 2. The facility personnel interviewed on August 24, 2023 at 12:11 PM confirmed the technical supervisor failed to document a semi-annual competency evaluation for the testing personnel indicated above. 3. The laboratory's reported annual test volume in the subspecialty of Histopathology is 3,671. -- 2 of 2 --