Universtity Of Miami Hospital And Clinics- Lennar

Summary Statement of Deficiencies D0000 A recertification survey conducted on 08/12-13/2020 found that the University of Miami Hospital and Clinics - Lennar clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and staff interview, the laboratory competency assessment did not follwo the employee competency policy for yease 2019 and 2020; for 14 (TP 10 to TP 22) out of 22 (TP 1 to TP 22) testing personnel (TP).for 2 out of 2 years reviewed (2019-2020). Findings include: 1) Review of CMS form 209, Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 08/12/2020 revealed that there were 22 TP. 2) Review of Employee Competency Policy # Gen-07 revealed the criteria to follow when conducting an Employee Competency Evaluation. 3) Review of employee folders revealed that for TP 10 to 22, the procedure to perform the competency assessment was the Ongoing Professional Practice Evaluation. 4) Review of the Ongoing Professional Practice Evaluation policy revealed that this does not meet the CLIA requirements listed in the Employee Competency Policy. During an interview on 08/12/202 at 11:30 AM, with LD, she confirmed that the laboratory followed the Ongoing Professional Practice Evaluation for TP 10 to 22 to document competency assessment for the TP of reference. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on College of American Pathologist (CAP) proficiency testing (PT) record review and Technical Supervisor (TS) interview, the facility failed to obtain an 80 % proficiency test score for the 3rd event of 2017 for the specialty of Endocrinology. Findings include: Record review of CAP Endocrinology proficiency test results revealed that the laboratory received a score of 60 % for the test for serum detection of human chorionic gonadotropin (hCG) and Endocrinology for 2017 3rd event CAP PT. During an interview on 10/29/2018 at 11:30 AM, the TS confirmed that the laboratory failed the Endocrinology event of reference. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview with the Histopathology Technical Supervisor 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 -- (HTP), the laboratory failed to document the histopathology room humidity during 2016, 2017 and 2018. Findings include: Review of the cryostat manual Leica CM1950 indicated a requirement for room humidity not above 60 %. Quality control records of histopathology room revealed that no documentation of humidity done during 2016, 2017 and 2018. During an interview on 10/29/18 at 3:00 p.m., the HTP confirmed that there was no record of room humidity for the period of reference. -- 2 of 2 --