Kaiser Permanente Southwood

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on April 1, 2026. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A tour of the laboratory confirmed that the laboratory failed to perform maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. THE FINDINGS INCLUDE: 1. A tour of the testing laboratory environment revealed the refrigeration and freezer used for storing patients' specimens and testing reagents was affixed with a maintenance sticker that stated, "NO PREVENTIVE MAINTENANCE REQUIRED," 2. The equipment included Follett Undercounter Refrigerators (x2), Follett Undercounter Freezers (x2), Helmer Upright Refrigerators (x2), a Helmer Upright Freezer, and a Quincy Lab MicroIncubator Model 10E. 3. A review of p. 7-11 of FOLLETT FZR SERIES UNDERCOUNTER FREEZER INSTALLATION, OPERATIONS, & SERVICE MANUAL and p. 10 - 14 of FOLLETT FZR SERIES UNDERCOUNTER REFRIGERATOR INSTALLATION, OPERATIONS, & SERVICE MANUAL listed the following required maintenance: 1. Annual Cleaning Removal of dust and other particulates from air intake areas and the condenser; 2. Essential Preventative Maintenance Tasks have quarterly, annually, biannually, and as needed maintenance " Condenser Cleaning (Annual); " Air Intake/Vent Cleaning (Monthly); " Door Gasket Inspection (Monthly; " Drain Pan/Line Maintenance (Quarterly; " General Cleaning (Monthly); and " Temperature Monitoring (Daily). 4. A review of pp. 27 of the Helmer Scientific 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 -- Upright Refrigerator User Manual and pp. 19 of Helmer Scientific Upright Freezer User Manual revealed the following required maintenance statement and maintenance requirements: Helmer Scientific's high-performance medical-grade equipment requires regular maintenance for optimum performance. It is important to regularly maintain all scientific equipment to reduce failures and protect your precious medication, vaccine, blood and patient samples. We offer a range of Service Agreements offering Preventative Maintenance, Calibrations, Repairs, Installations, Loaners, and Removal of old equipment. QUARTERLY: - Test the high and low temperature alarms. - Test the power failure alarm. - Check the temperature calibration on the monitor and change it if necessary. - Clean the condenser grill. - Inspect ground strap (Units prior to serial number 2022299) - Electrical compartment o Inspect electrical components and wiring terminals in the electrical box for discoloration. Contact Helmer Technical Service if any discoloration is found. o Inspect all wiring for terminals for secure connection. Tighten wiring terminal connections as necessary. ANNUALLY: Examine the probe bottles and clean or replace if necessary. BIANNUALLY: Replace the monitoring system back-up battery. AS NEEDED: - Test the door alarm (as required by your organization's protocols). - Check the level of the solution in the probe bottles. Refill or replace solution if necessary. - Clean the door gaskets, interior, and exterior of the freezer. - Models with Chart Recorders Check the backup battery for the chart recorder after an extended power failure and change it if necessary, or change the battery if it has been in service for one year. Refer to the Temperature Chart Recorder Operation and Service Manual. 5. A review of the p. 4 of the QUINCY LAB MICROINCUBATOR MODEL 10E under MAINTENANCE/ CONTROL CALIBRATION header contained the following required maintenance: - Clean interior and exterior surfaces - Periodically, check the accuracy of the control's temperature display against a known accurate or calibrated device. - Calibrate the control in the control's functions menu, level 3. 6. An interview with the Quality Assurance Team Leader confirmed that preventative maintenance stickers indicated that required maintenance was not performed on the above identified equipment in use for patient testing. 7. An exit interview, with Technical Supervisor and Quality Assurance Personnel, on Aril 1, 2026, at 1:30pm confirmed that the laboratory failed to perform maintenance at least the frequency specified by the manufacturer. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 25, 2021. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Event 3 of 2019 & Event 1of 2020), resulting Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- in the first unsuccessful occurrence for Theophylline analyte #0735 in the specialty of Toxicology. Findings include: Refer to D2118 D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Event 3 of 2019 & Event 1 of 2020), resulting in the first unsuccessful occurrence for Theophylline analyte #0735 in the specialty of Toxicology. 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Theophylline #0735, on Event 3 of 2019 and Event 1 of 2020 with a score of 0% for both events. 2. The criteria for acceptable performance for the specialty of Toxicology is 80%. 3. Desk review of the laboratory's proficiency testing reports from the College of American Pathology (CAP) confirmed the laboratory failed analyte #0735 Theophylline for Event 3 of 2019 and Event 1 of 2020 resulting in the first unsuccessful performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on an in-office desk review of proficiency testing (PT) records, the Laboratory Director failed to ensure the laboratory successfully participated in two out of three proficiency testing events (Event 3 of 2019 and Event 1 of 2020) for analyte #0735 Theophylline in the specialty of Toxicology. Findings include: Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's -- 2 of 3 -- proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Event 3 of 2019 and Event 1 of 2020), resulting in the first unsuccessful occurrence for Theophylline #0735. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed #0735 Theophylline on Event 3 of 2019 and Event 1 of 2020 with 0%. 2. The criteria for acceptable performance for the specialty of Toxicology is 80%. 3. Desk review of the laboratory's proficiency testing reports from College of American Pathology (CAP) confirmed the laboratory failed Theophylline #0735 Event 3 of 2019 and Event 1 of 2020 resulting in the first unsuccessful performance. -- 3 of 3 --