Baptist Memorial Medical Group Inc

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: The laboratory failed to maintain satisfactory performance in two out of three proficiency testing events, resulting in the first unsuccessful proficiency testing occurrence for the hematocrit analyte. (Refer to D2130) 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. 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 a desk review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2020 and 2021 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the hematocrit analyte in two out of three PT events, resulting in the first unsuccessful PT occurrence for the hematocrit analyte. The findings include: 1) Review of the CMS 155 revealed the following unsatisfactory PT scores for the hematocrit analyte: 2020 event two: 0% 2021 event one: 60% 2) Review of the laboratory's proficiency testing records revealed the following: 2020 event two: Hematocrit analyte scored as 0% for "Failure to Participate." 2021 event one: Sample numbers HEM-02 and HEM-04 scored as unacceptable for the hematocrit analyte, resulting in an overall score of 60%, and the first unsuccessful PT occurrence for the hematocrit analyte. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the 2018 proficiency testing (PT) records, the bi-monthly quality assessment (QA) documentation and interview with the laboratory liaison, the laboratory failed to verify accuracy twice annually for the wet prep, in 2018. The findings include: 1) Review of the 2018 PT records revealed the wet prep received failing scores in 2018: event two is 0% and and three is 0%. 2) Review of the bi- monthly QA documentation revealed the

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Citation number one Based on review of the procedure titled "KOH Preparation", four patient test reports for Potassium Hydroxide (KOH), and interview with technical consultant number one, the laboratory failed to follow policy for reporting KOH for 3 of 4 patients reviewed in 2017. The findings include: 1. Review of the procedure titled "KOH Preparation" revealed the following: Expected results: Positive or negative for fungal elements; Reporting criteria = : No fungal elements seen, rare; Occasional, 1+, 2+, 3+, 4+. 2. Review of patient test report numbers 10, 11, and 12 dated June 15, 2017 revealed the following results for KOH: Patient #10=Positive for clue cells. Positive whiff. Patient #11=Clue Cells Patient #12=Clue cells 3. Interview with technical consultant number one on April 11, 2018 at 2:45 pm confirmed the laboratory failed to follow procedure for reporting KOH for 3 of 4 patients in 2017. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- identify any problems that require