Advent Health Lenexa

Summary Statement of Deficiencies D0000 A validation survey was completed 4/15/25 on Advent Health Lenexa laboratory was found not in compliance with the following CONDITIONAL LEVEL DEFICIENCIES: D5800 - 42 C.F.R. 493.1290 Condition: Postanalytic Systems D6076 -42 C.F.R 493.1441 Condition: Laboratories Performing High Complexity Testing; Laboratory Director 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 a review of proficiency testing (PT) records from College of American Pathologists (CAP) for 2023 and to date of survey 2025, and interview with general supervisor (GS), the laboratory failed to evaluate its unacceptable proficiency testing results for one analyte in 2024. Findings: The following sample was scored unacceptable by CAP. No documentation of the laboratory's evaluation was provided at the time of survey. Listed by event, sample ID, and analyte. 1. C-A 2024 General Chemistry/Therapeutic Drugs, sample CHM-02 for acetaminophen. 2. Interview with the GS on 04/15/25 at 11:30 a.m. confirmed the laboratory failed to evaluate its unacceptable proficiency testing results for one analyte in 2024. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records from College of American Pathologists (CAP) and interview with technical consultant #1(TC#1), the laboratory failed to evaluate its proficiency testing results that were not scored by the PT program for twelve events in 2024. Findings: Review of PT results from CAP for 2024 revealed the following ungraded results with no evaluation provided at the time of survey. 1. BCP-B 2024 Blood Cell Identification Ungraded five samples missing self-assessments for BCP-16, BCP-17, BCP-18, BCP-19, and BCP-20. 2. BCP-C 2024 Blood Cell Identification Ungraded five samples missing self-assessments for BCP-26, BCP-27, BCP-28, BCP-29, and BCP-30. 3. C-A 2024 General Chemistry /Therapeutic Drugs missing self-assessments for one sample CHM-02 Bilirubin, Direct 4. FH9-A 2024 Hematology Auto-Differentials are missing self-assessments for ten samples: a. IG % Sysmex XN-L Series: FH9-01, FH9-02, FH9-03, FH9-04, and FH9-05. b. IG Absolute Sysmex XN-L Series: FH9-01, FH9-02, FH9-03, FH9- 04, and FH9-05. 5. FH9-B 2024 Hematology Auto-Differentials are missing self- assessments for ten samples: a. IG % Sysmex XN-L Series: FH9-06, FH9-07, FH9-08, FH9-09, and FH9-10. b. IG Absolute Sysmex XN-L Series: FH9-06, FH9-07, FH9- 08, FH9-09, and FH9-10. 6. FH9-C 2024 Hematology Auto-Differentials are missing self-assessments for ten samples: a. IG % Sysmex XN-L Series: FH9-11, FH9-12, FH9-13, FH9-14, and FH9-15. b. IG Absolute Sysmex XN-L Series: FH9-11, FH9- 12, FH9-13, FH9-14, and FH9-15. 7. J-B 2024 Transfusion Medicine (Comp) missing self-assessments for 18 samples: a. ABO Conf for J in EXM: J-08R, J-09R, and J- 11R. b. ABO Subgroup Conf in EXM: J-08R, J-09R, and J-11R. c. Rh Conf for J in EXM: J-08R, J-09R, and J-11R. d. Unit ABO Conf: EXM-04R, EXM-05R, and EXM- 06R. e. Unit Rh Conf: EXM-04R, EXM-05R, and EXM-06R. f. Electronic Crossmatch: EXM-04, EXM-05, and EXM-06. 8. J-C 2024 Transfusion Medicine (Comp) missing self-assessments for 18 samples: a. ABO Conf for J in EXM: J-15R, J-16R, and J-17R. b. ABO Subgroup Conf for EXM - J-15R, J-16R, and J-17R. c. Rh Conf for J in EXM: J-15R, J-16R, and J-17R. d. Unit ABO Conf: EXM-07R, EXM- 08R, and EXM-09R. e. Unit Rh Conf: EXM-07R, EXM-08R, EXM-09R. f. Electronic Crossmatch: EXM-07, EXM-08, and EXM-09. 9. K-A 2024 Ligand General hCG, serum quant had five samples missing self-assessments: K-01, K-02, K-04, and K-05. 10. K-B 2024 Ligand General hCG, serum quant had five samples missing self- assessments: K-06, K-07, K-08, K-09, and K-10. 11. K-C 2024 Ligand General hCG, serum quant had five samples missing self-assessments: K-11, K-12, K-13, K-14, and K-15. 12. CAR-C 2024 Cardiac Markers, Troponin T, quant had one sample missing self-assessments: HCR-14. 13. Interview with TC#3 on 4/15/25 at 11:30 a.m. confirmed the laboratory failed to evaluate its proficiency testing results that were not scored by the CAP PT program for twelve events in 2024. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on the review of the Individualized Quality Control Plan (IQCP) for eleven drugs of abuse utilizing the MedTox Diagnostics, Profile - V MedTox Scan Drugs of -- 2 of 6 -- Abuse Test System (MedTox), MedTox quality control (QC) records, MedTox patient logs, and interview with technical consultant #1 (TC#1), the laboratory failed to perform QC as required for 11 of 11 drugs of abuse as required by the IQCP from 11/5 /24 thru 11/9/24. Findings: 1. Review of the IQCP for drugs of abuse panel using the MedTox required positive control and negative control QC to be performed weekly. This IQCP was approved by the Laboratory Director and the last annual review was on 3/24/25. 2. The drugs of abuse panel included the following analytes: amphetamines, barbiturates, benzodiazepines, cannabinoids (THC), cocaine, methadone, methamphetamine, opiates, oxycodone, phencyclidine (PCP), and tricyclic antidepressants (TCA). 3. Review of QC records for 11/5/24, revealed: a. QC for amphetamines, negative control performed, no positive control performed. b. QC for barbiturates, negative control performed, no positive control performed. c. QC for benzodiazepines, negative control performed, no positive control performed. d. QC for THC, negative control performed, no positive control performed. e. QC for cocaine, negative control performed, no positive control performed. f. QC for methadone, negative control performed, no positive control performed. g. QC for methamphetamine, negative control performed, no positive control performed. h. QC for opiates, negative control performed, no positive control performed. i. QC for oxycodone, negative control performed, no positive control performed. j. QC for PCP, negative control performed, no positive control performed. k. QC for TCA, negative control performed, no positive control performed. l. No

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of personnel records and interview, the laboratory failed to have educational credentials required to qualify six of twenty-six testing personnel to perform moderate complexity testing (refer to D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on the review of the CMS 209 form, lack of educational records and interview, 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 -- the laboratory failed to have the educational credentials required for six of twenty-six testing personnel (TP) to perform moderate complexity laboratory testing at time of survey. Findings: 1. The CMS 209 form provided at survey listed twenty-six moderate complexity TP. 2. No documentation of educational qualifications for TP #15, TP #18, TP#19, TP#22, TP#25 and TP#26 were available for review at the time of survey. 3. The six TP having no educational qualification documents at the time of survey performed 515 creatinine tests on the EPOC analyzer from 3/23/2021 thru 3/22 /2023 in the radiology department. 4. Interview with the general supervisor #4 on 3/22 /2022 at 1:40 p.m. confirmed the laboratory failed to have the educational credentials required for six of twenty-six TP to perform moderate complexity laboratory testing. -- 2 of 2 --