Clinical Labs Of Hawaii-Kohala Psc

Summary Statement of Deficiencies 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 review of College of American Pathologists (CAP) proficiency test records and interview with testing personnel on 11/30/2022 at 10:45 a.m., the laboratory failed to review and evaluate its 2021 FH1-A survey ungraded blood cell identification result. The findings included: a. There was non-consensus among participant responses for blood cell identification sample BCP-10. The targeted response was "blast". The laboratory reported "malignant lymphoid cell". Evidence of laboratory review and evaluation of this result was not documented. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory technical consultant on 11 /30/2022 at 11:45 a.m., the laboratory failed to have procedures for evaluation of the competency of 4 of 4 testing personnel to include direct observations of routine test performance, including patient preparation, specimen handling, processing and testing. The laboratory performed 534 chemistry and 2993 hematology tests annually. The findings included: a. The laboratory failed to include direct observation of iStat 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 -- 8+ chemistry, microscopic urinalysis and hematology test performance in 2020. b. The laboratory failed to include direct observation of iStat 8+ chemistry, microscopic urinalysis and hematology test performance in 2021. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation and an interview with the testing personnel and outreach laboratory manager on 12/03/2018 at 11:00 a.m., it was determined that the laboratory failed to ensure its Modified Wrights stain was not used beyond its expiration date. The findings include: 1. A bottle of Sigma Aldrich Modified Wrights stain, lot SLBT6367, opened on 04/29/2018 and expired on 10/01/2018 was available for use in the laboratory. 2. 22 patient hematology blood smears were stained with the expired reagent in October. 3. 23 patient hematology blood smears were stained with the expired reagent in November. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on direct observation and an interview with the testing personnel and outreach laboratory manager on 12/03/2018 at 11:00 a.m., it was determined that the laboratory failed to assure the quality of the Modified Wrights stain it used to stain 45 patient blood smears. Refer to D5417. 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 --