Danbury Hosp Dept Of Lab Med

Summary Statement of Deficiencies 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 record review and staff interview, the laboratory failed to retain patient test records to include instrument printouts for at least 2 years in the specialty of diagnostic immunology. Findings include: 1. Review on 1/22/2020 of a file provided by the laboratory containing records for positive HIV patient #1 collected on 1/18/19 at 15:18 and run on the BioRad BioPlex 2200 instrument revealed, the laboratory did not have the instrument printout for this patient. 2. Record review on 1/27/2020 of the BioPlex 2200 Instrument summary report printed on 1/24/2020 at 17:35 with a date range of 1/18/19 through 1/21/19 revealed: a. The report did not contain the unique patient identifier assigned to each patient. b. The report contained Human Immunodeficiency Virus (HIV) Ag-Ab, Syphilis and Rubella results. 3. Staff interview with the immunology general supervisor (GS) on 1/27/2020 at 10:50 AM confirmed the above findings. The GS stated a representative from BioRad archived all instrument results from 1/1/18 through 1/31/19 and did not retain the unique patient identifier with the results. The GS further stated this is the case for all tests performed by the laboratory on the BioPlex 2200 during this time period, to include Antinuclear Antibody (ANA), Anti-Cyclic Citrullinated Peptide (CCP), Cytomegalovirus, Toxoplasmosis IgG and IgM, Epstein-Barr Virus (EBV), HIV Ag- Ab, Measles, Mumps, Rubella, Varicella, Syphilis Total and Rapid Plasma Reagin (RPR), Vasculitis Myloperoxidase (MPO), Proteinase 3 (PR3), and Glomerular Basement Membrane (GBM). D5014 GENERAL IMMUNOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review and staff interview, the immunology laboratory failed to meet the requirements in 493.1230 through 493.1256, and 493.1281 through 493.1299. The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results. Refer to D5205, D5207, D5291, D5311, D5403, D5407, D5409, D5411, and D5807. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to have a system in place to investigate and document complaints and problems reported to the laboratory. Findings include: 1. During staff interview with the immunology general supervisor (GS) on 1/21/2020 at 9:30 AM, surveyor requested results of a complaint investigation (C1) received by the Connecticut Department of Public Health concerning incorrect and delayed reporting of HIV results, specimen collection requirements and storage conditions. The GS stated he/she was aware of the problem but did not have documentation concerning this investigation. 2. Record review on 1 /22/2020 of the laboratory's 'Quality Plan' revealed, the plan did not contain a system to investigate and document complaints and problems reported to the laboratory. 3. Record review on 1/27/2020 of the GS's handwritten document entitled, 'CT State Inspection 1/21/2020 - 1/22/2020 HIV Increase Reactivity Summary' revealed: a. A notation regarding a 3/5/19 field action report received from Bio-Rad, "Bulletin increase HIV reactivity." b. A meeting with a provider to discuss positive HIV numbers, complaint investigation (C2). 4. Record review on 1/27/2020 of the 'US Field Action Increased Reactivity for BioPlex 2200 HIV Ag-AB Kit Lot No. 300-868' report revealed: a. An increase level of reactivity with the BioPlex 2200 for lot number 300-868. b. Request to immediately discontinue use and dispose of any unused product. c. Documentation of 3 kits destroyed. 5. Staff interview with the GS regarding C2 on 1/27/2020 at 1:30 PM: a. Confirmed the laboratory does not have a procedure to ensure documentation of all complaints. b. The GS stated most of the investigation into the increase in positive HIV results was done verbally with Biorad field technical personnel and the laboratory did not receive written documentation as to suggestions on troubleshooting the above problem. c. The GS's notes were the only documentation/investigation other than the product recall that he/she had regarding the above increase in positive HIV testing. The above summary was compiled from various notes by the GS for surveyor review on 1/22/2020. D5207 COMMUNICATIONS CFR(s): 493.1234 -- 2 of 11 -- The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to identify and document problems with communicating reactive Human Immunodeficiency Virus (HIV) Antigen (Ag) Antibody (Ab) screen results and ensure the required confirmatory supplemental testing was completed or properly communicated to the provider in the subspecialty of general immunology. Findings include: 1. Record review on 1/22/2020 of the 'Danbury Hospital Department of Pathology & Laboratory Medicine Technically Speaking July 2016: Vol. 10, No 5' provider bulletin revealed: a. A test reporting table describing various scenarios of test results for HIV-1 p24 Ag, Anti HIV-1 or Anti HIV-2 with corresponding interpretations and required supplemental testing. b. The CDC flowchart for the recommended laboratory HIV testing algorithm. c. The table and flowchart do not correlate. 2. Record review on 1 /28/2020 of BioPlex HIV Ag-Ab assay reactive patient results revealed the following were not tested as required by the CDC guidelines: a. 7 of 25 reactive HIV-1 or HIV-2 antibody BioPlex specimens in 2018 did not have confirmatory nucleic acid test (NAT) testing performed when the HIV-1/HIV-2 antibody differentiation immunoassay results were negative. b. 5 of 25 reactive HIV p24 Ag BioPlex specimens in 2018 did not have the HIV-1/HIV-2 antibody differentiation immunoassay performed. c. 1 of 36 reactive HIV-1 or HIV-2 antibody BioPlex specimens in 2019 did not have confirmatory NAT testing performed when the HIV-1 /HIV-2 antibody differentiation immunoassay results were negative. d. 4 of 36 reactive HIV p24 antigen BioPlex specimens in 2019 did not have the HIV-1/HIV-2 antibody differentiation immunoassay performed. 3. Record review on 1/21/2020 of the laboratory 'Critical Tests in the Clinical Laboratory - Network AD.5.8.2' revealed: a. "Critical test results must be communicated to a physician or other clinical personnel responsible for the patient's care as quickly as possible, following uniform procedures that ensure prompt, accurate and effective communication." b. "Laboratory personnel will communicate critical test results by telephone call as soon as feasible (generally within 30 minutes) to a physician or other clinical personnel responsible for the patient's care." c. "The caller must document the notification and read-back in the laboratory information system (LIS) or other permanent document." d. "HIV inc. occupational exposure and Labor and Delivery" is listed as a critical test. 4. Record review of Patient #2 HIV Ag -Ab reactive test results on 1/27/2020 revealed: a. Reactive HIV Ag Ab screen was confirmed and called to provider on 8/2/18. b. HIV differentiation test auto verified from reference laboratory on 8/6/18. c. HIV Ag-Ab screen was resulted in the LIS on 8/6/18. d. Provider notification of the differentiation test result was called on 8/15/18. 5. Record review on 1/28/2020 of the 2018 and 2019 BioPlex HIV Ag-Ab assay reactive patient results revealed the laboratory policy for provider notification of critical test results was not followed: a. 8 of 25 reactive HIV Ag-Ab assay results in 2018. b. 13 of 36 reactive HIV Ag-Ab assay results in 2019. 6. Record review on 1/28/2020 of an email dated 2/28/19 from the immunology general supervisor (GS) to laboratory staff revealed: a. "Providers may be called by immunology staff to collect additional blood for HIV confirmation." b. Each test requires one full lavender top tube. c. Order as a miscellaneous send out (Mayo HVDIP, Mayo HIVQN) d. The confirmation tests are not built in the LIS. 7. Record review on 1/28/2020 of 2019 BioPlex HIV Ag-Ab reactive patient results follow-up confirmatory testing revealed: a. The laboratory did not have documentation of -- 3 of 11 -- confirmatory testing for 6 of 36 Reactive HIV Ag Ab screen results. b. 3 of 36 reactive HIV Ag Ab screen results had the wrong confirmatory tests ordered and reported. 8. Record review on 1/28/2020 of the Mayo Clinic collection instructions for the HIV Ab Confirm/Differentiation (HVDIP) and HIV-1 RNA Detection and Quantification, Plasma (HIVQN) tests revealed, "Centrifuge blood collection tube and aliquot plasma into plastic vial per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes)." 9. Staff interview with the immunology general supervisor (GS) on 1/27/2020 at 11:00 AM revealed: a. Provider notification of change in specimen type for the confirmatory testing did not occur. b. Additional sample(s) are requested along with the appropriate Mayo order code when a reactive screen result is called to the provider. c. GS was not aware of the stability requirement of 2 hours for the HVDIP or HIVQN tests. d. The required confirmatory HIV testing is entered into the LIS as a miscellaneous test code by laboratory personnel. This leads to errors in the correct supplemental tests being performed if ordered by the provider incorrectly. e. Confirmatory testing results auto- verify from Mayo Clinic in the LIS, therefore GS manually monitors send out results and enters the HIV Ag-Ab screen reactive result when time allows. This may occur days later. 10. Staff interview with the operations manager (OM) on 1/27/2020 at 10: 22 AM confirmed the findings in 4, 5 and 6 above. OM did not know why the 9 day delay of provider notification occurred. 11. Staff interview with the technical supervisor (TS) on 1/28/2020 at 9:00 AM confirmed the findings in 1, 2 and 3 above. He/she stated the laboratory test is 5th generation and can do step two of the CDC guidelines. Upon further review of the above documents, TS concluded the laboratory had been following the Technically Speaking table which is incorrect. 12. The laboratory performed 7,418 HIV Ag-Ab tests in 2018 and 7,792 tests in 2019. 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. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems associated with Human Immunodeficiency Virus (HIV) testing in the subspecialty of diagnostic immunology. Findings include: 1. Record review on 1/22 /2020 of the laboratory's 'Quality Plan' revealed: a. Section 2B: Personnel Training and Development, "Training is also provided when new procedures are being implemented and when procedures are changed." b. Section 5A: Development and Use of Standard Operation Procedures, "New procedures or those with major revisions require Medical Director or designee signature before they are implemented." c. Section 5I: Communication of Critical Results, "Criteria are in place for the release of laboratory results and procedures for immediate notification of the ordering physician (including read back) when results of certain tests fall into established 'alert' or 'critical' ranges." d. Section 5K: Record Retention, "Records including test orders, patient result reports, retired procedures or older versions of procedures are kept in accordance with licensing agency standards." e. Section 7: Performance Improvement, "Based on the examination of pre-analytical, analytical and post-analytical processes, data is evaluated to determine whether opportunities for -- 4 of 11 -- the improvement of laboratory processes exist." f. Section 7A: Deviations/Adverse Events and