Corinth Medical Specialists

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the personnel testing records on 11/12/19 (day of survey) and the lack of education documentation, the laboratory director did not ensure that testing personnel #3 listed on the CMS (Centers for Medicare and Medicaid Services) 209 personnel form had the appropriate education and training to perform moderate complexity testing prior to testing patients. Findings include: 1. According to review of the personnel records the day of survey, there was no documentation of education, training or competency for testing personnel (TP) #3. 2. Interview with laboratory manager/TP #1 revealed TP #3 was trained to perform patient and quality control testing on the Vitros 350 and ECI chemistry analyzers but training was not documented. 3. No documentation of TP #3's education was available for review. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and the Centers of Medicare and Medicaid Services (CMS) 209 personnel form, the technical consultant failed to evaluate and document the competency of testing personnel #3 who was hired to perform moderate complexity testing, at least semiannually during the first year of employment. Testing personnel #3 began performing testing on patient specimens in April 2019. D6067 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Each individual performing moderate complexity testing must have training to ensure that the individual has-- (A) the skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (B) the skills required for implementing all standard laboratory procedures; (C) the skills required for performing each test method and for proper instrument use; (D) the skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed; (E) a working knowledge of reagent stability and storage; (F) the skills required to implement the quality control policies and procedures of the laboratory; (G) an awareness of the factors that influence test results; and (H) the skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on lack of personnel training documentation available on the day of survey and interview with the laboratory manager/testing personnel (TP) #1, TP #3 listed on the Centers of Medicare and Medicaid Services 209 form had no documentation of training for performing moderate complexity testing in the laboratory. TP #3 began moderate complexity testing in April of 2019. Findings include: 1. There were no training documents for the Vitros 350 or ECI Chemistry Analyzers for TP #3 available for review on the day of survey 11/12/19. 2. Interview with the laboratory manager revealed that there was no written documentation of training for TP #3 before beginning to test patient samples on the Vitros 350 or ECI chemistry analyzers. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 7/31/19, the laboratory has not successfully participated in proficiency testing for MAGNESIUM, TOTAL PROTEIN, TRIGLYCERIDE and BLOOD UREA NITROGEN (BUN). Findings include: Our records indicate the following proficiency testing scores for your laboratory for: MAGNESIUM, TOTAL PROTEIN, TRIGLYCERIDE and BLOOD UREA NITROGEN (BUN). PROFICIENCY TESTING PROVIDER: American Proficiency Institute MAGNESIUM: Year 2018 Event 3 - 40% Year 2019 Event 2 - 0% TOTAL 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 -- PROTEIN: Year 2018 Event 3 - 20% Year 2019 Event 2 - 0% TRIGLYCERIDE: Year 2018 Event 3 - 40% Year 2019 Event 2 - 0% BLOOD UREA NITROGEN (BUN): Year 2018 Event 3 - 20% Year 2019 Event 2 - 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 7/31/19, the laboratory has not successfully participated in proficiency testing for MAGNESIUM, TOTAL PROTEIN, TRIGLYCERIDE and BLOOD UREA NITROGEN (BUN). Findings include: Our records indicate the following proficiency testing scores for your laboratory for: MAGNESIUM, TOTAL PROTEIN, TRIGLYCERIDE and BLOOD UREA NITROGEN (BUN). PROFICIENCY TESTING PROVIDER: American Proficiency Institute MAGNESIUM: Year 2018 Event 3 - 40% Year 2019 Event 2 - 0% TOTAL PROTEIN: Year 2018 Event 3 - 20% Year 2019 Event 2 - 0% TRIGLYCERIDE: Year 2018 Event 3 - 40% Year 2019 Event 2 - 0% BLOOD UREA NITROGEN (BUN): Year 2018 Event 3 - 20% Year 2019 Event 2 - 0% -- 2 of 2 --