Baptist Leake Primary Care Center

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of hematology proficiency testing (PT) records since the last survey on 3-30-17, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and personnel records, hematology proficiency testing was not rotated among the testing personnel who performed patient complete blood count (CBC) testing during this time frame. Findings include: Review of the CMS 209 personnel form and PT records since the last survey on 3-30-17 revealed Testing Personnel #2, listed on the CMS 209 personnel form, performed four of the five PT events since 3-30-17. There was no documentation that Testing Personnel #1 participated in performance of hematology PT since 3-30-17 or that Testing Personnel #3 participated in performance of hematology PT since this individual's initial laboratory training on 11- 7-17. THIS IS A REPEAT DEFICIENCY. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 review of hematology proficiency testing (PT) records since the last survey on 3-30-17, the Policy and Procedure Manual, and lack of documentation of investigative and

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 2/4/19, the laboratory has not successfully participated in proficiency testing for HEMATOCRIT. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOCRIT: PROFICIENCY TESTING PROVIDER: American Proficiency Institute Year 2018 2nd Event 60% Year 2018 3rd Event 60% Scores less than 80% 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 -- 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. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 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 2/4/19, the laboratory has not successfully participated in proficiency testing for HEMATOCRIT. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOCRIT: PROFICIENCY TESTING PROVIDER: American Proficiency Institute Year 2018 2nd Event 60% Year 2018 3rd Event 60% 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. -- 2 of 2 --