Freeman Health System East Campus

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 2021 chemistry proficiency testing results reported to the CLIA database by the proficiency testing provider and phone interview with the technical consultant, the laboratory failed to successfully participate in proficiency testing. See D-tag 2096, unsatisfactory performance in two consecutive blood gas PH proficiency testing challenges. 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 2021 and phone interview with the general supervisor, the laboratory failed to achieve satisfactory performance for the PH analyte testing in two consecutive PT events. Findings: 1. Review of the chemistry PT results for the first event of 2021 revealed the laboratory obtained an unsatisfactory score of 60 percent for the analyte, PH. 2. Review of the chemistry PT results for the second event of 2021 revealed the laboratory obtained an unsatisfactory score of 20 percent for PH. 3. Phone interview with the technical consultant on August 19, 2021 at 11:25 AM confirmed the laboratory failed to achieve satisfactory performance for PH testing in two consecutive events for 2021. -- 2 of 2 --

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: Based on review of procedures, i-Stat calibration verification and interview with the technical consultant the laboratory failed to follow "i-Stat QC policy". Findings: 1. Review of "i-Stat QC policy" states "calibrant solutio and calibration", "At least every 6 months". 2. Review of i-Stat calibration verification showed no documentation for 2018. 3. Interview with the technical consultant on September 25, 2019 at 11:30AM showed the laboratory failed to follow i-Stat procedure and perform calibration verification every six months in 2018. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. 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 3 -- Based on review of 2018, 2019 instrument comparison documentation and interview with the technical consultat on September 25, 2019 at 11:30 AM, the laboratory failed to perform instrument comparisons for four i-Stat blood gases two times a year. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of testing personnel competencies and interview with the technical consultant, the technical consultant failed to evaluate the competency for two of fourteen testing personnel in 2018. Findings: 1. Review of competencies showed no technical consultant documentation of competency for testing personnel #10 and #11. 2. Interview with the technical consultant on September 25, 2019 at 11:00 AM confirmed the technical consultant failed to evaluate two testing personnel competencies in 2018. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of personnel records revealed and interview with the technical consultant confirmed, the laboratory failed to have academic credentials required to qualify one of thirteen testing personnel for the speciality of chemistry for moderate complexity testing (refer to tag #6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the technical consultant, the -- 2 of 3 -- laboratory failed to have documentation of academic credentials to qualify one of thirteen testing personnel for moderate complexity testing. Findings: 1. Review of the personnel records for testing personnel # 3 for the speciality of chemistry revealed the laboratory failed to have academic credentials to qualify this individual. 2. Interview with the technical consultant on September 25, 2019 at 1:00 PM confirmed, the laboratory failed to have the required documentation to qualify the individual serving as testing personnel #3 of moderate complexity chemistry testing. -- 3 of 3 --