Banner Health Physicians West Llc

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel files, review of the CMS-209 Laboratory Personnel Report, lack of documentation, policy and procedure review, and staff interview, the laboratory failed to ensure the competency assessments included the direct observation of routine patient testing, specimen handling processing and testing; monitoring the recording and reporting of test results; a review of test results or worksheets, proficiency testing results, and an assessment of problem solving skills for 5 of 5 testing personnel (MD #1, MD #2, MD #3, MD #4, RN #1). In addition, the laboratory failed to ensure an initial and a semi-annual competency assessment was completed for MD #2. The findings were: 1. Review of the CMS-209 Laboratory Personnel Report showed the laboratory listed 4 physicians and 1 registered nurse as testing personnel. The following concerns were identified: a. Review of the personnel files for MD #2 failed to include an initial and a semiannual competency assessment which included all of the required elements. b. Review of the personnel files for MD #1, MD #2, MD #3, MD #4, and RN #1 failed to include an annual competency assessment which included all the required elements. 2. Review of the "Duties and Responsibilities of Laboratory Director, Technical Consultant, Clinical Consultant, and General Supervisor", dated 10/7/22, showed it was the responsibility of the technical consultant to evaluate the competency of testing personnel as administered by the laboratory manager. The procedure outlined the required elements of the competency assessment; however, the policy and procedure failed to include the requirement for an initial and semiannual assessment. 3. Interview with the laboratory manager on 8/23/23 at 11:11 AM confirmed the competency assessments did not 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 -- include all of the required elements and an initial and a semiannual competency assessment had not been completed for MD #2. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of documentation, proficiency testing records review, and interview with staff, the laboratory failed to retain proficiency testing intermediate work sheets used by the laboratory to record the microscopic test results prior to entering the test results into the agency report form for 6 of 6 proficiency testing events reviewed. Findings include: 1. American Academy of Family Physicians (AAFP) proficiency testing records review lacked the intermediate work sheets testing personnel used to record results for proficiency testing events C of 2017; A, B, and C of 2018; and for events A and B of 2019 prior to entering the results into the agency report form for final submission to the AAFP proficiency testing agency. 2. In an interview conducted on 07/31/2019 at approximately 11:45 A.M. staff stated the laboratory recorded the intermediate test results on sticky notes or scrap paper prior to entering the results into the agency report form. Staff stated the intermediate paper was not retained after results were submitted to the proficiency testing agency. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on proficiency testing records review and interview with staff, the laboratory lacked documentation 5 of 6 proficiency testing events reviewed were reviewed by the 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 -- director/technical consultant to evaluate the laboratory's performance for testing microscopic analysis of potassium hydroxide (KOH) preparations for vaginal and skin scraping specimens, vaginal saline wet mounts, and urinalysis specimens. Findings include: 1. Proficiency testing records review for American Association of Family Practice proficiency testing events C of 2017, A, B, and C of 2018 and A of 2019 lacked documentation proficiency test results were reviewed to evaluate the laboratory's performance for each testing event. 2. In an interview conducted on 07/31 /2019 at approximately 11:40 A.M. the laboratory testing staff person confirmed the laboratory failed to document they reviewed proficiency test results for microscopic testing for KOH preparations, wet mounts and microscopic urinalysis. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on centrifuge maintenance records review, urinalysis procedure review, and interview with staff, the laboratory failed to perform and document they performed urinalysis centrifuge revolutions per minute (rpm) and timer check maintenance activities. Findings include: 1. Centrifuge maintenance record review dated 02/25 /2019 failed to include an rpm and timer check. 2. Urinalysis procedure review included the instructions that urine specimens were to be centrifuged for 3 to 5 minutes at 3381 rpm. 3. In an interview with staff on 07/31/2019 at approximately 11: 00 A.M. staff confirmed the maintenance reports failed to include the rpm and timer checks to ensure microscopic urinalysis were performed by the procedure specifications. -- 2 of 2 --

Summary Statement of Deficiencies D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on procedure manual review, lack of documentation, and interview with staff, the laboratory failed to include the dates of discontinuance for biannual correlation assessment of microscopic urinalysis, vaginal wet prep, and potassium hydroxide (KOH) tests with the hospital laboratory. Findings include: 1. The laboratory quality assessment procedure manual included a policy to perform twice a year correlation between the laboratory and hospital. 2. The laboratory failed to document twice annual correlation of test results between the laboratory and the hospital. 3. In an interview with staff on 04/03/2018 at approximately 12:00 Noon, staff stated the laboratory no longer had the opportunity for correlation of microscopic testing with the hospital laboratory for at least two years of testing performed. The laboratory staff confirmed the procedure did not include the date the policy was discontinued. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on procedure manual review, patient test records review, and interview 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 -- staff, testing personnel failed to follow the laboratory's procedure to perform microscopic urinalysis for specimens testing positive for the presence of nitrite and leukocyte esterase for 3 of 3 urine specimens reviewed from 10/06/2017 to 10/10 /2017 testing positive for the presence of nitrite and leukocyte esterase. Findings include: 1. Laboratory procedure manual review included the procedure for urinalysis performance stating, "When a urine specimen meets the criteria to be looked at under the microscope, it should be spun at 3381 rpm for 3-5 minutes." Criteria list included: "positive nitrite - do microscopic exam. Leukocyte esterase - If positive do microscopic at the discretion of the physician." 2. Patient test record review included documentation patients tested for urinalysis chemistry dip stick analysis was positive for both Nitrite and Leukocyte esterase for patient #191879 tested on 10/06/2017, patient #195131 tested on 10/09/2017, and patient #193190 tested on 10/10/2017. Microscopic examinations were not performed for specimens #191879, #195131, and #193190. 3. In an interview conducted on 04/03/2018 at approximately 11:45 A.M., staff confirmed microscopic testing was not performed as stated in the laboratory urinalysis procedure. -- 2 of 2 --