Sollis Health La, Pc

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records and interviews with the technical consultant (TC) and laboratory supervisor (LS), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for the Creatine Kinase analyte in the second event of 2025 (Q2-2025). The findings include: 1. The surveyor reviewed the PT records wherein API reported an unsatisfactory score of 20% for the Creatine Kinase analyte in Routine Chemistry for the Q2-2025 event. The report is as followed: Sample Reported Expected CH-06 18 17 - 27 CH-07 *193 211 - 318 CH-08 95 92 - 139 CH-09 *150 159 - 239 CH-10 259 278 - 418 Legend: * = unsatisfactory score 2. The TC and TP affirmed by interviews on February 5, 2026, at approximately 12:35 p.m. that the laboratory obtained the unsatisfactory PT scores for Creatine Kinase analyte as mentioned in statement #1. 3. The accuracy and reliability of patient test reported cannot be determined. 4. According to the laboratory's testing declaration form (Lab-144) submitted on the day of the survey, the laboratory performed approximately 50 patient test samples annually for Creatine Kinase analyte during the time the laboratory received unsatisfactory proficiency testing scores. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's proficiency testing documentation and interviews with the technical consultant and laboratory supervisor on February 5, 2026, this deficiency is herein cited for the laboratory director due to failure to ensure that proficiency testing samples were tested as required under Subpart H of this part. See D2087. -- 2 of 2 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records for evaluation of proficiency testing performance and an interview with laboratory personnel (LP) on 8 /9/22 between 2:00 p.m. and 3:30 p.m, it was determined that there were proficiency testing (PT) scores below 80 % for one testing cycle. The issue relates to Bordetella Parapertussis testing. Findings include: 1. On 8/9/22, an inspection was conducted between 2:00 p.m. and 3:30 p.m. 2. During a review of the laboratory documentation from AP (American Proficiency Institute- the agency providing the proficiency specimens), it was noted at approximately 2:30 p.m. that the laboratory had unacceptable Microbiology results as indicated below. The testing was performed on the BioFire FilmArray. 3. The findings and acceptable ranges were as follows: Cycle 1 2022 Test: Respiratory Bordetella Parapertusis Sample Actual Result Expected Result (range) Rsp-01 Detected Not Detected Rsp-02 Detected Not Detected Rsp-03 Detected Not Detected Rsp-04 Detected Not Detected Rsp-05 Detected Not Detected 4. The laboratory reporting testing for approximately 200 Respiratory Panels for a one year period, and Bordetella Pertusis is a component of the Biofire Respiratory panel. 5. The LP recognized the above results. D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records for evaluation of proficiency testing performance and an interview with laboratory personnel (LP) on 8 /9/22 between 2:00 p.m. and 3:30 p.m, it was determined that there were proficiency testing (PT) scores below 80 % for one testing cycle. The issue relates to C-Reactive Protein (CRP). Findings include: 1. On 8/9/22, an inspection was conducted between 2:00 p.m. and 3:30 p.m. 2. During a review of the laboratory documentation from AP (American Proficiency Institute- the agency providing the proficiency specimens), it was noted at approximately 3:00 p.m. that the laboratory had unacceptable Immunology results as indicated below. The testing was performed on the Abaxis Picollo instrument. 3. The findings and acceptable ranges were as follows: Cycle 1 2022 Test: C-Reactive Protein (CRP) Sample Actual Result Expected Result (range) Crp-01 22.4 2.15-2.97 Crp-02 5.00 0.00-0.30 4. The laboratory reporting testing for approximately 100 general Immunology tests to include CRP. 5. The LP recognized the above results. -- 2 of 2 --