Northwest Medical Plaza- Westside

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Through a review of proficiency test documentation for 2021 and 2022 it was determined the laboratory director failed to sign attestation statements for one of six testing events in 2021 and 2022 and testing personnel failed to sign attestation sheets for two of six testing events in 2021 and 2022. Survey findings follow: A. A review of the Attestation Statement for 3rd Hematology / Coagulation Proficiency Testing Event of 2021 revealed that the testing personnel failed to sign the Attestation Statement. B. A review of the Attestation Statement for 2nd Hematology / Coagulation Proficiency Testing Event of 2022 revealed that the laboratory director and testing personnel failed to sign the Attestation Statement. C. In an interview at 14:45 on 2/8/2023, laboratory employee #1 (as listed on the Entrance And/Or Exit Conference Attendance Record) confirmed that the laboratory director failed to sign the Attestation Statement for one proficiency testing event in 2022 and that testing personnel failed to sign Attestation Statements for one event in 2021 and one event in 2022. 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 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: Through a review of personnel records for four personnel listed on the form CMS- 209, lack of documentation, and interviews with laboratory staff, it was determined the technical consultant failed to evaluate performance of one new employee semiannually the first year of testing. Survey findings include: A. Through a review of personnel records for the four employees listed on the form, it was determined that employee #2 (as listed on the form CMS-209) had started testing since the last survey conducted on 8/22/2018. Employee #3 stated, in an interview at 1:44 p.m. on 3/23 /2021, that employee #2 started performing testing in 2019. The personnel records for employee #2 include only annual competencies documented on 10/4/2019 and 9/25 /2020. B. In the interview at 1:44 on 3/23/2021, laboratory employee #3 confirmed that competencies were only performed and documented annually on employee #2 instead of semiannually, as required by the regulation. 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 D5785