Martin County Rural Health Clinic

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on staff interview and record review during a survey conducted January 21, 2020, the laboratory director failed to establish a quality assessment program to monitor, assess, and, when indicated, correct problems for the specialty of Hematology from February 1, 2018 through January 20, 2020. Findings include: 1. Record review failed to reveal quality assessment review of Hematology quality control, maintenance records, temperature logs and proficiency testing. 2. In an interview on 01/21/2020 at 11:02 AM, testing personnel acknowledged that the laboratory failed to have a system in place to document quality assessment measures in the specialty of Hematology. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: 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 -- Based on staff interview and record review during a survey conducted January 21, 2020, the laboratory failed to perform and document review of temperature logs and maintenance records from February 2018 through January 2020. Findings include: 1. Record review revealed no documented review of maintenance records or temperature logs. There is an area on each page where it is indicated a supervisor should document the date of review. 2. An interview with testing personnel on January 21, 2020 at 10: 30 AM revealed the facility failed to have a system in place to ensure that maintenance records and temperature logs are being reviewed. -- 2 of 2 --

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and staff interview on 01/31/2018, the laboratory failed to ensure normal values were available to the authorized person for six (6) of six (6) patient Complete Blood Cell (CBC) test reports. The findings include: A CBC was reported on Patient #1 on 07/14/2016. The report failed to include reference ranges for each analyte. A CBC was reported on Patient #2 on 11/03/2016. The report failed to include reference ranges for each analyte. A CBC was reported on Patient #3 on 03/20 /2017. The report failed to include reference ranges for each analyte. A CBC was reported on Patient #4 on 06/22/2017. The report failed to include reference ranges for each analyte. A CBC was reported on Patient #5 on 09/06/2017. The report failed to include reference ranges for each analyte. A CBC was reported on Patient #6 on 12/06 /2017. The report failed to include reference ranges for each analyte. An interview with the personnel at 10:50 AM on 01/31/2018, determined the laboratory failed to establish a system to ensure reference ranges were available for all tests reported. 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 --