Central Ozarks Medical Center

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(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: Based on review of 2020 and 2021 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the technical consultant, the laboratory failed to successfully participate in PT. See D-tag 2096, unsatisfactory performance in two out of three consecutive PT challenges for the analyte chloride. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 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 review of chemistry proficiency testing (PT) results for 2020, 2021 and phone interview with the technical consultant, the laboratory failed to achieve satisfactory performance for the chloride analyte testing in two out of three PT events. Findings: 1. Review of the chemistry PT results for the third event of 2020 revealed the laboratory obtained an unsatisfactory score of 60 percent for the analyte, chloride. 2. Review of the chemistry PT results for the second event of 2021 revealed the laboratory obtained an unsatisfactory score of 60 percent for the analyte, chloride. 3. Phone interview with the technical consultant on August 19, 2021 at 10:30 AM confirmed the laboratory failed to achieve satisfactory performance for chloride testing in two out of three testing events for 2017, 2018. -- 2 of 2 --

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 American Proficiency Institute's hematology and chemistry proficiency testing (PT) records for 2019/2020 and interview with the testing personnel #1, the laboratory failed to ensure two of three full-time testing personnel participated in the PT process who routinely perform patient testing. Findings: 1. No documentation was available to show testing personnel # 2 or #3 participated in hematology and chemistry PT for 2019 and 2020. 2. Interview on June 1, 2021 at 1:30 P.M., testing personnel #1 confirmed the laboratory failed to include all personnel who routinely perform patient testing, in the PT process. 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 identify any problems that require

Summary Statement of Deficiencies 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: Based on review of procedures and interview with testing personnel on September 26, 2018 at 10:30 AM the laboratory failed to establish policies and procedures for monitoring, assessing and when indicated correcting problems identified in the general laboratory systems. 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: Based on review of chemistry quality control (QC) procedure and interview with testing personnel #1 the laboratory failed to follow procedure when controls are not with in acceptable limits. Findings: 1. Review of ABX Pentra 400 procedure shows "if any control results are outside acceptable ranges, perform the following: Re-run the control, clean the system and re-run the control, open a new vial of control, recalibrate the system. 2. On August 21, 2018 Glucose QC was ran 4 times and normal control 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 -- was out with no documentation of

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 review of 2018 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the laboratory manager, the laboratory failed to successfully participate in PT. See D-tag 2096, unsatisfactory performance in two consecutive Chloride (CL) PT challenges. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of 2018 chemistry proficiency test (PT) results revealed that the laboratory failed to achieve satisfactory performance for the chemistry analyte Chloride (CL) in two consecutive testing events. Findings: 1. The laboratory obtained an unsatisfactory score of 20 per cent for the chemistry analyte CL in the first testing event of 2018. 2. The laboratory obtained an unsatisfactory score of 60 per cent for the chemistry analyte CL in the second event of 2018. 3. Phone interview laboratory manager on July 26, 2018 at 3:15 PM confirmed the laboratory failed to achieve a satisfactory PT result for the chemistry analyte CL in two consecutive testing events. -- 2 of 2 --