Gonzaga Pediatrics & Family Medicine

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on remote record review and phone interview with the technical consultant (TC), the laboratory failed to log hematology proficiency testing (PT) samples with the laboratory's regular patient workload. Findings: 1. The laboratory performed Complete Blood Count (CBC) testing. All patients tested for CBC were documented on a hematology testing log that contained columns for date of testing, patient name, patient date of birth and testing personnel identification. 2. Instrument printouts from the 2020 2nd hematology PT event showed that PT samples were tested on 07/29 /2020. The hematology testing patient log that documented patient CBC testing from 01/16/2020 - 07/31/2020 did not show the PT samples listed with the regular patient workload. 3. Instrument printouts from the 2020 3rd hematology PT event showed that PT samples were tested on 11/13/2020. The hematology testing patient log that documented patient CBC testing from 09/02/2020 - 12/22/2020 did not show the PT samples listed with the regular patient workload. 4. Instrument printouts from the 2021 1st hematology PT event showed that PT samples were tested on 03/12/2021. The hematology testing patient log that documented patient CBC testing from 01/20 /2021 - 04/13/2021 did not show the PT samples listed with the regular patient workload. 5. During the phone interview on 06/02/2021 at 1:00 PM, the TC confirmed that the hematology PT samples were not recorded on the hematology testing patient log with the laboratory's regular patient workload. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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 remote review of personnel records and procedures and phone interview with the technical consultant (TC), the laboratory failed to establish and follow written policies and procedures to assess TC competency. Findings: 1. The credentials and competency assessments of personnel listed on the Laboratory Personnel Report, form CMS-209, were reviewed. There were no records for the competency assessment of the TC that was listed on the CMS-209. 2. Review of the procedure titled "Administrative Delegation of Duties" found that there were no instructions for how to assess the competency of the TC based on the position's responsibilities, how frequently TC competency should be assessed, nor who is responsible for TC competency assessment. 3. During the phone interview on 06/02/2021 at 1:00 PM, the TC confirmed that that no competency assessment had been performed for the TC and that the laboratory had no procedures for competency assessment of the TC. -- 2 of 2 --

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: Based on review of the hematology proficiency testing (PT) records, procedure manual and interview with the testing person, the laboratory failed to ensure that all PT records were being saved; PT summaries were being reviewed by the laboratory director or designee; the testing person who performed the test initialed the instrument printouts in the same manner as the patients; the final results were being reviewed by the laboratory director or designee; and the records were maintained for two years as required. Findings: 1. The PT records from the third event of 2016 through the second event of 2018 (6 events) were reviewed. 2. The PT records showed that 4 of the 6 events did not include a copy of the completed PT worksheet showing the results submitted to the PT agency. 3. The PT records showed that the attestation worksheets for 6 of the 6 events were not signed by the laboratory director or the designee. The attestation worksheets were signed by a testing person and the laboratory director's son. The Personnel Laboratory Report (CLIA) (CMS-209) listed the laboratory director as the technical consultant. The laboratory director's son is not listed on the CMS-209 and the testing person is not qualified to be the designee. 4. The PT records Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- showed that the instrument printouts from 4 of the 6 events did not include the initials of the person who performed the tests and signed the PT attestation sheet. The procedure manual requires the testing person to initial the instrument printout with the patient's results. 5. The PT records showed that the final results for 5 of the 6 events were not signed by the laboratory director or the designee and 3 of the 6 had no signature showing that the document had been reviewed. 6. The policy and procedure manual did not identify who was the qualified designee for signing the attestation worksheets and the final review of the PT results. The persons who signed the attestation worksheets and final reports were not listed on the CMS-209 or were not qualified with a Bachelor of Science (4 year degree) and 2 years' experience in the specialty of hematology. 7. During the survey on 10/12/2018 at 2:00 PM the testing person confirmed that the PT records were not maintained for two years and signed by the appropriate laboratory staff. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's record system and interview with the testing personnel, the laboratory failed to maintain a record system that included retention of quality assessment records for at least 2 years. Findings: 1. Review of the "Medonic Weekly QC Sign Off" worksheets showed that there were no records available prior to the second week of July 2017. 2. Review of the "Monthly Laboratory Staff Responsibilities Checklist" worksheet showed that there were no records available prior to September 2017. 3. Review of the "Maintenance Medonic M-Series Hematology Analyzer" worksheets showed that there were no maintenance records available prior to June 2018. 4. Review of the proficiency testing records showed that 4 of the 6 events did not include a copy of the completed PT worksheet showing the results submitted to the PT agency. Cross refer to D2015 for details. 5. Review of the "