Linn County Public Health

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) proficiency testing records and confirmed by interview with General Supervisors (GS) #1 and #2 at 9:51 am on 11/06/2024, the laboratory failed to perform a self evaluation when the laboratory received three ungraded PT scores from two out of five testing events from 01/01/2023- 11/06/2024. The findings include: 1. For 2024 1st event, the laboratory received ungraded PT test scores for the following: *CAP D5-A 2024 Gram stain: morphology (specimens D5-02 and D5-05) 2. For 2024 2nd event, the laboratory received ungraded PT test scores for the following: *CAP D5-B 2024 Gram stain: morphology (specimen D5-06) 3. At the time of the survey, GS #1 and #2 confirmed the laboratory did not perform a self evaluation for the ungraded PT test scores listed above. THIS IS A REPEAT DEFICIENCY. 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 D2026 BACTERIOLOGY CFR(s): 493.823(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel #1 (refer to Laboratory Personnel Report) at approximately 9:30 am on 1/25 /2023, the laboratory failed to document