Rosemark Women Care Specialists

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on Proficiency testing (PT) record review and an interview with the nurse manager on 12/02/2020, the laboratory failed to ensure that the individual testing the PT samples and the laboratory director attested to the routine integration of the samples into the patient workload. The findings include: 1. A PT record review revealed that the American Proficiency Institute (API) 2018 microbiology 3rd event attestation statement was not signed by the person performing the BD Affirm testing or by the laboratory director. 2. An interview with the nurse manager on 12/02/2020 at 09:40 am confirmed that the API 2018 microbiology 3rd event attestation was not signed by the person performing the BD Affirm testing or by the laboratory director. 3. The laboratory reports performing 2184 BD Affirm test annually. 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 a review of procedures and an interview with the nurse manager on 12/02 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 -- /2020, the laboratory failed to have a written procedure for Proficiency Testing (PT) available for the laboratory personnel to follow. 1. A review of procedures for the laboratory revealed that there was no policy or procedure for PT testing, documentation, signing of attestation and reporting results to the PT provider. 2. The attestation statement for 2018 event 3 PT from the American Proficiency Institute was not signed by the person performing testing or the laboratory director. 3. An interview with the nurse manager on 12/02/2020 at 9:40am, confirmed that the laboratory did not have a procedure for Proficiency Testing. 4. The laboratory reports performing 2184 BD Affirm tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a record review of personnel documents an interview with the laboratory lead, the technical consultant failed to evaluate and document the competency of employees at least semiannually during the first year of patient testing on the BD Affirm VP Microbial Identification system since the last survey on July 12, 2016. Findings: 1. A record review of personnel competency assessment documents revealed 3 out of 8 testing personnel listed on the CMS-209 Personnel Report form failed to have evalutations performed at least semiannually during the first year of patient testing. 2. An interview on June 28, 2018 at 12:15 PM, with the laboratory lead, confirmed the technical consultant failed to perform competency assessments at least semiannually on 3 testing personnel. 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 --