Covenant Medical Group

Summary Statement of Deficiencies 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 review of 20 testing personnel competency records, lack of documentation for 6 month competencies and annual competencies and upon interview with the Laboratory Manager, determined the laboratory failed to document 6 month competencies after hire and annual competencies for 2017 for testing personnel who perform Complete Blood Count's (CBC's). The findings include: 1. Review of 20 testing personnel competency records hired after 2016. 2. Lack of 6 month competencies for 4 of 20 testing personnel after hire dates. 3. Lack of 2017 annual competencies for 8 of 20 testing personnel. 4. Interview with the Laboratory Manager at approximately 1:00 p.m. April 8, 2019 confirmed the laboratory failed to document 6 month competencies after hire date for 4 testing personnel and annual competencies for 2017 for 8 testing personnel who perform CBC testing. ==================================== D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining 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 3 -- This STANDARD is not met as evidenced by: =================================== Based on review of Proficiency Testing for presence or absence of sperm since 2018, lack of procedure for post- vasectomy analysis and upon interview with the Medical Laboratory Technician (MLT), determined the providers were performing post-vasectomy analysis and review of procedure manual revealed there was no procedure in place for this test. The findings include: 1. Review of Proficiency Testing revealed analysis performed for presence or absence of sperm since 2018. 2. Lack of procedure for post-vasectomy analysis. 3. Interview with the MLT at approximately 1:00 p.m. April 8, 2019 confirmed the providers were performing post-vasectomy analysis and there was no procedure in place for collection, testing and reporting of post vasectomy specimens. ==================================== D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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: ____________________________________ Hematology: The laboratory failed to maintain satisfactory participation in two out of two events for the automated White Blood Cell (WBC) Differential, resulting in the first unsuccessful Proficiency Testing (PT) occurrence for the automated WBC differential analyte (Refer to D2130). ____________________________________ D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: ____________________________________ Based on a desk review of the CMS CASPER Report 0155D and the Laboratory's 2017 and 2018 Proficiency Testing (PT) Program results, determined the Laboratory failed to maintain satisfactory performance in two consecutive events for the WBC Auto Differential, event three of 2017 and event one of 2018 resulting in the first unsuccessful occurrence. The findings include: 1. A review of the CMS CASPER Report 0155D for Proficiency Testing revealed the WBC Auto Diff scores as 40% for event three of 2017 and 73% for event one of 2018. 2. A review of the PT Program results for the WBC Auto Differential revealed an unsatisfactory score calculated as 40% for event three of 2017 and 73% score for event one of 2018, resulting in the first unsuccessful occurrence for the WBC Auto Differential. _____________________________________ -- 2 of 2 --