Waianae Coast Comp Health Ctr

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of laboratory personnel competency records and confirmation by the Administrative Laboratory Director and General Supervisor #2 on 02/15/2022 at 11:30 a.m., it was determined that the laboratory failed to establish written policies and procedures to assess the competency of its11 testing personnel. The findings include: 1. The Administrative Laboratory Director confirmed that the laboratory did not have a policy or procedure to describe testing personnel training, competency assessments and remediation activities. Testing personnel performed 5486 microbiology tests, 3101 general immunology tests, 192,157 chemistry tests and 51,317 hematology tests in 2021. 2. The Administrative Laboratory Director and General Supervisor #2 stated that they were available to perform testing on an on-call basis. The Administrative Laboratory Director stated that he came in over the previous weekend to perform a wet prep, an iRis urinalysis and a Liat COVID PCR test. Competency assessments for 2019, 2020 and 2021 were not performed for the Administrative Laboratory Director and General Supervisor #2. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. 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 -- This STANDARD is not met as evidenced by: Based on a review of laboratory procedure manuals and confirmation by the Administrative Laboratory Director on 02/15/2022 at 12:20 p.m., it was determined that the laboratory failed to establish written policies and procedures for an on going mechanism to monitor, assess, and when indicated, correct problems identified in its general laboratory systems. The findings include: 1. The Administrative Laboratory Director confirmed that the laboratory did not make available to its testing personnel written polices and procedures to assess the following: a. Patient confidentiality b. Complaint investigations c. Communications d. Personnel competency e. Proficiency testing performance D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on a review of laboratory procedure manuals and confirmation by the Administrative Laboratory Director on 02/15/2021 at 11:45 a.m., it was determined that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems. The findings include: 1. The Administrative Laboratory Director confirmed that the laboratory did not have a written quality assessment plan that describes the ongoing review process of its practices related to test requests, specimen submission, handling and rejection, the identification and resolution of problems, and continuous improvement activities. 2. The Administrative Laboratory Director confirmed that testing personnel were not made aware of and were not involved in laboratory quality assessment activities. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of laboratory procedure manuals, quality control and instrument maintenance records and confirmation by the Administrative Laboratory Director on 02/15/2021 at 11:20 a..m. and the General Supervisor #2 on 02/15/2021 at 12:15 p.m., it was determined that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. The findings include: 1. The Administrative Laboratory Director confimed that the laboratory did not have a written policy or procedures that describes how the following analytic systems are assessed: a. Test procedures b. Accuracy and reliability of test systems, equipment, -- 2 of 5 -- instruments, reagents, materials, and supplies c. Specimen and reagent storage conditions d. Equipment/instrument/test system maintenance and function checks e. Method performance specifications f. Calibration and calibration verification activities g. Quality control results h.

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and laboratory personnel interviews conducted on 7/9/19 , the laboratory failed to maintain copies of all 2018 PT records, including a copy of the PT report forms used by the laboratory to record PT results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens. Findings included: a. For 2018, the laboratory was enrolled in the following PT modules: Alcohol, Blood Gases, Cardiac Marker/Isoenzymes, Chemistry (Basic & Comprehensive), Glycohemoglobin, Lipids, Therapeutic Drug Monitoring, Urine Drug Screening, Coagulation, Blood Cell Identification, Hematology with WBC Differential, D-dimer, Throat/Urine Culture, Clinical Microscopy, and Urinalysis. b. The laboratory maintained no copies of the laboratory's 2018 PT reports forms used by the laboratory to record PT results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director. c. Laboratory personnel confirmed that copies of the 2018 PT attestation statements not maintained by the laboratory. 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 -- D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on bacteriology media quality control record review and laboratory personnel interviews conducted on 7/9/19, the laboratory failed to maintain documentation to indicate that, before or concurrent with initial use, the laboratory checked each batch of media for its ability to support growth for batches of Remel blood agar media received during 2018. Findings include: a. In 2018, it was the practice of the laboratory to test patient Strep Screen samples using Remel blood agar media. b. The laboratory maintained no documentation to indicate that, before or concurrent with initial use, the laboratory checked each batch of Remel blood agar media for its ability to support growth received and used for patient Strep Screen testing in 2018. c. According to laboratory records, the laboratory performed and reported approximately 3,000 patient Strep Screen culture results in 2018. d. Laboratory personnel confirmed that in 2018 each batch of Remel blood agar media received and used was not checked for its ability to support growth before or concurrent with initial use. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on laboratory procedure manual record review and laboratory personnel interviews conducted on 7/9/19, the laboratory director, high complexity testing, failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the testing process, including a written protocol that detailed the laboratory's system that, twice a year, evaluated and defined the relationship between tests results when the same test is performed using different methodologies or instruments as required by 42 C.F.R. 493.1281(a). Findings included: a. It was the practice of the laboratory to perform patient troponin testing on either of two Siemens Stratus CS instruments. b. Although the laboratory maintained documentation to indicate that the laboratory had evaluated and defined the relationship between troponin test results for two instruments twice a year, the laboratory maintained no written protocol detailing the procedure used. c. Laboratory personnel confirmed that no such written protocol was available. d. According to laboratory records, the laboratory performed 3,147 troponin tests from 7/1/18-6/30/19. -- 2 of 2 --