Clinical Labs Of Hawaii-Kula Hospital

Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: The surveyor's review of laboratory policies and procedures, and an interview with the technical consultant on February 21, 2025 at 10:30 AM revealed the laboratory director failed to specify in writing the responsibilities and duties of the testing personnel performing the preanalytic, analytic, and post analytic phases of its patient testing to include whether supervision is required for test performance or results reporting and whether consultant or director review is required prior to reporting patient test results. Testing personnel performed an annual volume of 4,000 iSTAT routine chemistry tests, 2,000 urine microscopic examinations, 4,000 manual differential examinations, and 20,000 Sysmex pocH-100i hematology tests. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited 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 2 -- This STANDARD is not met as evidenced by: The surveyor's review of laboratory testing personnel competencies and an interview with the technical consultant on February 21, 2025 at 10:30 AM revealed the technical consultant failed to annually evaluate the competency of one of two testing personnel (TP #1) performing routine chemistry, urinalysis, and hematology patient testing. The technical consultant stated the 2023 and 2024 competencies for TP #1 were performed by a peer testing personnel no longer employed by the laboratory. The laboratory Competency Guidelines 602-127-2.1 delegates the responsibility of annual competency assessments to the technical consultant. The laboratory performed an annual volume of 4,000 iSTAT routine chemistry tests, 2,000 urine microscopic examinations, 4,000 manual differential examinations, and 20,000 Sysmex pocH-100i hematology tests. -- 2 of 2 --

Summary Statement of Deficiencies D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) 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 a review of CAP Critical Care Blood Gas, i-STAT proficiency testing records and an interview with the General Supervisor on 04/26/2023 at 09:00 AM, it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent. The laboratory performed an annual volume of 10,056 tests. The findings include: 1. The laboratory received a 0% score for its unsatisfactory performance in the second AQI-B testing event of 2022. 2. The General Supervisor confirmed the testing personnel failed to test 5 of 5 samples (AQI-06, AQI-07, AQI- 08, AQI-09, AQI-10) for chloride, potassium, sodium, creatinine, glucose and urea nitrogen (BUN) and 3 of 5 samples (AQI-08, AQI-09, AQI-10) for lactate. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or 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) For any unacceptable analyte or testing event score, 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on a review of CAP Critical Care Blood Gas i-STAT proficiency testing records and an interview with the General Supervisor on 04/26/2023 at 09:00 AM, it was determined that the laboratory failed to undertake appropriate training and employ the technical assistance necessary to correct its unsatisfactory performance. The laboratory performed an annual volume of 10,056 tests. The findings include: 1. The laboratory received a 0% score for its performance in the second AQI-B testing event of 2022. 2. The General Supervisor stated the testing personnel testing the proficiency survey samples was not aware of what tests should be performed. The General Supervisor confirmed the individual left after 2 months of employment. See D tag D2088. 3. Documentation of

Summary Statement of Deficiencies D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of laboratory proficiency test records and confirmation by the testing personnel on 09/17/2021 at 09:30 am, it was determined that the laboratory failed to return its 2020 College of American Pathologists (CAP) Critical Care Aqueous Blood Gas (AQI) proficiency testing results within the time frame specified by the program. The findings include: 1. The laboratory obtained a score of 0 for its performance in the 2020 AQI-B testing event. This survey includes chloride, creatinine, glucose, potassium, sodium and blood urea nitrogen (BUN). 2. The testing personnel stated that proficiency test results are forwarded to Maui Memorial Hospital from Clinical Labs of Hawaii Kula Hospital for review and submission before the survey due date. 3. The Proficiency Testing Procedure states "Mail, fax or enter the results on-line well within the allotted time of 10 working days from the date of receipt. If submitting by fax, check the fax verification form to ensure that the transmission was accepted. Retain the fax verification form with PT documentation". If submitting results on-line, "print copy of entered results". "Review all on-line entries, compare to hard copy, and make corrections if necessary". Documentation of fax or on-line activity was not available for review. The testing personnel stated that the laboratory did not track the sendout to and receipt of its proficiency test results at MMH. 4. The laboratory performed 356 Abbott iStat Chem 8+ panels in 2021. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- (1) For any unsatisfactory analyte or test performance or 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) For any unacceptable analyte or testing event score, 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 a review of laboratory proficiency test records and an interview with the testing personnel on 09/17/2021 at 09:45 am, it was determined that the laboratory failed to undertake the appropriate remedial actions to include the appropriate training and employing the technical assistance necessary to correct problems associated with its CAP routine chemistry proficiency testing failures. The findings include: 1. The laboratory obtained an unacceptable grade for its BUN result on sample AQI-07 in the 2021 AQI-B testing event. The laboratory reported 57.0 which had a SDI of -17.6 when compared to its peer group. 2. The laboratory Proficiency Testing Procedure states: "The supervisor, lab manager, and laboratory director/pathologist should all participate in the review of survey results. The reviews should be completed within 30 days of the receipt of the results. Submit all investigation and follow-up reports for unacceptable, ungraded, or failed surveys to the laboratory director/pathologist for review/approval of actions taken. In the case of unacceptable PT results, send a copy of the evaluation to CLH Quality Improvement Manager." Documentation of each of these tasks was not available for review. 3. The Proficiency Testing Procedure states: "Communicate all pertinent