Summary:
Summary Statement of Deficiencies D0000 As a result of the CLIA recertification inspection, the laboratory is not in compliance with the following Conditions of Participation required for certification in the CLIA program at 4 D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel;2 CFR part 493: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of laboratory policy, proficiency testing records, the CMS-209 laboratory personnel report, and interview with facility personnel, the laboratory failed to include 3 of 6 testing personnel who routinely perform patient testing in proficiency testing for 2018. The findings included: 1. Based on review of the laboratory policy "Proficiency Testing", under Testing Proficiency Samples, the procedures state the following: "Samples are to be tested by personnel who normally perform laboratory testing. Follow the included instructions in the testing packet for specimen preparation needs. These are also available online." 2. Based on a review of proficiency testing records and the CMS-209 laboratory personnel report, all proficiency testing events from the end of 2017 through 3 events in 2018 were performed by Testing Person 1, Testing Person 6, or the Laboratory Director /Technical Consultant: 2017 3rd event Hematology/Coagulation performed by Testing Person 1 2018 1st Event Basic Chemistry performed by Testing Person 1 2018 1st Event Comprehensive Chemistry performed by Testing Person 1 2018 1st event Cardiac markers performed by Testing Person 1 2018 1st event Hematology with Diff A performed by Testing Person 6 2018 1st event Urinalysis performed by Testing Person 6 2018 2nd event Basic Chemistry performed by Testing Person 6 2018 2nd Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- event Cardiac Markers performed by Lab Director/Technical Consultant 2018 2nd event Lipids performed by Testing Person 6 2018 2nd event Blood Cell Identification performed by Testing Person 1 2018 2nd event Hematology with Diff A performed by Testing Person 6 2018 2nd event Pregnancy performed by Testing Person 6 2018 2nd event Urinalysis performed by Testing Person 1 2018 2nd event Comprehensive Chemistry performed by Lab Director/Technical Consultant 2018 2nd event Basic Chemistry performed by Lab Director/Technical Consultant 2018 2nd event Cardiac Markers performed by Testing Person 1 2018 3rd event Urinalysis performed by Testing Person 1 2018 3rd event Hematology with Diff A performed by Lab Director /Technical Consultant 2018 3rd event Blood Cell Identification performed by Lab Director/Technical Consultant Testing Persons 2, 3, 4, and 5 did not participate in proficiency testing in 2018. 3. In an interview at 11:00 on 2/19/2019 in the laboratory, the Lab Director stated the lab had not rotated all testing personnel in performing proficiency testing and stated it was challenging for the laboratory because testing persons 2,3,4 and 5 did not work as frequently and predictably as Testing Person 1 and Testing Person 6. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of maintenance records and interview with facility personnel, the laboratory failed to retain documentation of maintenance procedures for 4 of 4 months between January 2018 and April 2018 for the Emerald hematology analyzer and the Dimension EXL chemistry analyzer. 1. In a review of maintenance records at 15:15 hours on 2/19/2019, the surveyor observed the following 4 of 4 months were missing for the Emerald hematology analyzer and the Dimension EXL chemistry analyzer.: January 2018 February 2018 March 2018 April 2018 2. In an interview at 15:29 hours on 2/19/2019 in the laboratory, the Laboratory Manager stated the laboratory could not find the maintenance records for January 2018 through April 2018 and that they were likely in a binder somewhere but couldn't be located at the time of the survey. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 review of the Cell-Dyn Emerald operator's manual, surveyor observations, and interview with facility personnel, the laboratory failed to store 9 of 9 hematology control vials in a central location away from the door in the laboratory refrigerator. The findings included: 1. Based on review of the Abbott Cell-Dyn Emerald operator's manual (09H40-01), on page 11-9, under Quality Control Guidelines, the operator's manual states the following: "Pay particular attention to the following: " Check the -- 2 of 7 -- condition of incoming control material. Be sure that vials are at the proper temperature and are not leaking. Check for hemolysis. " If controls are stored inside a refrigerator, place them in a central location away from the door." 2. At 14:07 hours on 2/19/2019 in the laboratory, the surveyor observed the following 9 of 9 hematology vials stored in the door of the refrigerator: Lot: 8351 Expiration date: 2019 - 04 - 05 3 vials - open and in use, levels 1,2 and 3. 6 vials, unopened and not in use, two vials of level 1, two vials of level 2, two vials of level 3. 3. In an interview at 14:07 hours on 2 /19/2019, the laboratory director stated he was unaware of the requirement in the operator's manual to store the controls in a central location and not in the door. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: I. Based on review of the Cell-Dyn Emerald operator's manual, review of maintenance records, and interview with facility personnel, the laboratory failed to perform and document required monthly maintenance 8 of 12 months and semi-annual maintenance 1 of 2 6-month periods in calendar year 2018. The findings included: 1. Based on review of the Abbott Cell-Dyn Emerald operator's manual (09H40-01), on page 9-13, under Semi-annual Maintenance, the operator's manual states the following: "Lubricating the Pistons For optimal operation, the Syringe Pistons should be lubricated every six months as described below." and; On page 9-11, the operator's manual states: "Monthly Maintenance: Bleach Cleaning: Clean the system with a bleach solution is performed monthly or as needed when a measurand is repeatedly rejected." 2. Based on review of maintenance records, the laboratory was not able to find documentation of maintenance procedures for 4 months, January 2018, February 2018, March 2018, and April 2018. Refer to D3031. Based on review of maintenance records from May 2018 through December 2018: Monthly maintenance is documented on May 3, 2018. The document the laboratory was using was "Cell-Dyn 3200 Maintenance Log", but the analyzer in use is a different model, the Emerald. The Emerald does not have an auto-clean, but does require a monthly bleaching procedure. Monthly Maintenance is documented as performed on June 28th, 2018. There is no documentation of monthly maintenance for July 2018. Monthly maintenance is documented as performed two times for August 2018 on 8/1/2018 and 8/6/2018. There is no documentation of monthly maintenance for September 2018. The semi- annual "Lube the Pistons" procedure is documented on 9/27/ 2018. Monthly Maintenance is documented as performed on October 19, 2018. There is no documentation of monthly maintenance for November 2018. There is no documentation of monthly maintenance for December 2018. 3. In an interview at 14: 41 hours on 2/19/2019 in the laboratory, the Laboratory manager stated he was not able to find the maintenance records for January through April 2018 and stated some of the maintenance may have been performed on preventative maintenance procedures, but were acknowledged they were not documented on these records. II. Based on review of the chemistry analyzer operator's manual, laboratory maintenance records, and interview with facility personnel, the laboratory failed to perform all of the seven (7) monthly maintenance procedures for 6 of 6 months between August 2018 and January 2019. The findings included: 1. Based on review of the Dimension EXL System Operator's guide, on page 7-8, the manual states the following: "Monthly -- 3 of 7 -- Maintenance Only trained operators should perform these procedures. The seven monthly maintenance procedures are: *Cleaning the Clot Check Drain on the IMT Port * Replacing IMT Pump Tubing * Cleaning the IMT system * Replacing Instrument Air Filters *Styletting HM Wash Probes * Replacing HM Pump heads on wash station * Cleaning the R2 and R3 drains The replacement procedures use tools and commonly replaced parts that are provided in your Accessory Spare Parts kit. After using a spare part from this kit, be sure to order a new one from Siemens Healthcare Diagnostics." There was no documentation of training for 6 of 6 testing personnel for the Dimension EXL maintenance. Refer to D6045. 2. Based on a review of Dimension EXL maintenance records: Seven (7) of seven (7) monthly procedures were not performed in August 2018 * Replacing IMT Pump Tubing * Cleaning the IMT system * Replacing Instrument Air Filters *Styletting HM Wash Probes * Replacing HM Pump heads on wash station * Cleaning the R2 and R3 drains Five of Seven procedures were not performed in September 2018: * Replacing IMT Pump Tubing * Replacing Instrument Air Filters *Styletting HM Wash Probes * Replacing HM Pump heads on wash station * Cleaning the R2 and R3 drains Five of Seven procedures were not performed in October 2018: * Replacing IMT Pump Tubing * Replacing Instrument Air Filters *Styletting HM Wash Probes * Replacing HM Pump heads on wash station * Cleaning the R2 and R3 drains Five of Seven procedures were not performed in November 2018: * Replacing IMT Pump Tubing * Replacing Instrument Air Filters *Styletting HM Wash Probes * Replacing HM Pump heads on wash station * Cleaning the R2 and R3 drains Six of Seven procedures were not performed in December 2018: * Replacing IMT Pump Tubing * Cleaning the IMT system * Replacing Instrument Air Filters *Styletting HM Wash Probes * Replacing HM Pump heads on wash station * Cleaning the R2 and R3 drains Seven (7) of seven (7) monthly procedures were not performed in January 2019 * Replacing IMT Pump Tubing * Cleaning the IMT system * Replacing Instrument Air Filters *Styletting HM Wash Probes * Replacing HM Pump heads on wash station * Cleaning the R2 and R3 drains 3. In an interview at 15:29 hours on 2/19/2019 in the laboratory, the Laboratory Manager stated the laboratory could not find the maintenance records for January 2018 through April 2018 and that the seven monthly maintenance procedures had not been performed each month. D5783