Ssm Health Dean Medical Group - Wisconsin Dells

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116) and interview with the laboratory director, the laboratory director did not ensure compliance with regulations requiring notification to Health and Human Services (HHS) or its designee no later than six months after discontinuing a specialty or subspecialty included on the certificate for one of one specialty including three of three subspecialties. Findings include: 1. Review of the Form CMS-116 submitted by the laboratory prior to the November 30, 2023, survey showed the laboratory had discontinued the mycology and parasitology subspecialties in the laboratory. 2. Interview with the laboratory director on November 30, 2023, at 2:00 PM confirmed testing in the specialty of microbiology, with subspecialties of bacteriology, mycology and parasitology had been discontinued on February 3, 2023. Further interview confirmed the laboratory director did not inform HHS or its designee of the discontinuation for the specialty and subspecialties within six months of discontinuation. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the laboratory director, the laboratory did not retain records of the calibration performed on the Sysmex KX-21 hematology analyzer on May 24, 2021. Findings include: 1. Review of laboratory records showed a calibration of the Sysmex KX-21 analyzer was performed on May 24, 2021; the calibration report was not included in the laboratory records. 2. Interview with the laboratory director on December 13, 2021 at 11:25 AM confirmed the laboratory did not retain the calibration report from May 24, 2021. Further interview at 11:45 AM revealed the calibration was performed by a Sysmex employee and confirmed the records were not available through Sysmex. D6069 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(a) Each individual performs only those moderate complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the laboratory director, testing personnel (staff A) performed testing and entered and verified test results for three complete blood counts (CBC) without differential, two CBCs with 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 -- automated differentials and one CBC with a manual differential on December 2, 2021 that were not authorized by the director. Findings include: 1. Review of test records from the laboratory information system (LIS) showed staff A performed a CBC with manual differential on patient one on December 2, 2022 and verified the results at 12: 55 PM. Review of additional records showed staff A also performed CBCs with automated differentials on patients two and five and CBCs without differentials on patients three, four, and six. 2. Review of the CMS209 'Laboratory Personnel Report' provided for this survey showed staff A was not included on the form. The form was signed by the director on December 13, 2020. 2. Interview with the laboratory director on December 13, 2021 at 12:20 PM revealed staff A was in the laboratory on December 2, 2021 supporting an instrument 'go live' and the director had not authorized staff A to perform hematology testing in this laboratory. -- 2 of 2 --