Summary:
Summary Statement of Deficiencies D0000 A routine recertification survey was conducted May 13-15, 2024. It was determined that Immediate Jeopardy existed for the following condition level deficiencies: 42 C.F. R. 493.1290 Condition: Postanalytic Systems 42 C.F.R. 493.1341 Condition: Laboratories Performing High Complexity Testing: Laboratory Director D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7) that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the lack of postanalytic procedures, lack of documented postanalytic processes, and patient test results within the EMR that did not match the test logs, the laboratory failed to monitor and evaluate overall quality of the post analytic system and correct problems identified in testing performed for each specialty and subspecialty. (Refer to D5801, D5891, D5893) D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of three of three patient test records, electronic medical record reports (EMR), and interview with the office manager, the laboratory failed to have an adequate manual or electronic system(s) in place to ensure scabies preparation and potassium hydroxide (KOH) preparation test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination. Findings: 1. Review of 1 scabies preparation, and 2 KOH preparation patient test records and electronic final test reports found 3 of 3 patient test results in the EMR did not match the laboratory patient test record. a. Scabies test log- 9/12/(no year entry). The test result showed a minus sign (negative), single entry. The EMR record from 9/12/22 showed the KOH prep was listed with "Examination of slide showed +/- results" for examinations of both left radial dorsal hand and right ulnar dorsal hand. Review of "Impression/Plan" reveals: "Scabies (B86)" b. KOH test log-6/28/22. The test result showed "negative." The EMR record for the KOH prep showed "Examination of slide showed: branching hyphae." c. KOH test log 10/2//22. The test result showed "negative." The EMR record showed no documentation of a KOH exam or test result. 2. Interview with the office manager on 5 /13/24 at 11:30 a.m. confirmed, the laboratory failed to have an adequate manual or electronic system(s) in place to ensure scabies preparation and potassium hydroxide (KOH) preparation test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based upon the lack of procedures, test log with results that did not correlate with the patient EMR, and interview with the office manager, the laboratory failed to have written policies and procedures for an ongoing process to monitor, assess, and correct problems in the postanalytic system. Findings: 1. The surveyor requested the post analytic quality assessment procedure after evidence was found of test logs and EMR records that did not match. 2. No postanalytic system procedure was available for review. 3. Interview with the office manager on 5/13/24 at 11:45 a.m. confirmed, the laboratory failed to have written policies and procedures for an ongoing process to monitor, assess, and correct problems in the postanalytic system. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of