HospitalInspections.org

Based on a review of clinical records, hospital documentation, policies, and interviews, it was determined that the hospital failed to meet the Condition of Participation for Governing Body as evidenced by:


1. The Governing Body did not ensure that services offered and provided met the Medicare Conditions of Participation. Areas of noncompliance identified include: Quality Assessment and Performance Improvement (QAPI) and Laboratory Services.


2. The Governing body failed to maintain an effective, hospital-wide, data-driven quality assessment and performance improvement program, specifically Laboratory Services. Refer to A-263 and A-308.


3. The Governing body failed to function effectively to ensure the Immunology Laboratory followed manufacturer instructions for Human Immunodeficiency Virus (HIV) testing and reporting, failed to have a complete procedure manual, failed to follow record retention regulations, failed to establish and follow quality assurance procedures to monitor and assess complaint issues, failed to maintain specimen integrity for reference lab testing and failed to properly communicate HIV test results to providers. Refer to A-576, and A-582


Please refer to Danbury Hospital Department of Lab for CLIA findings. Event ID# HW1L11, EID date 2/6/2020.

Based on a review of clinical records, review of facility meeting minutes, review of policies, and interviews, the hospital failed to meet the Condition of Participation for Quality Assessment and Performance Improvement (QAPI) as evidenced by:

The hospital failed to ensure reactive Human Immunodeficiency Virus (HIV) testing and reporting was properly performed as required to ensure accuracy and reliability of patient test results. The hospital failed to demonstrate that these concerns were incorporated into the hospital's Quality Assurance program.

Please refer to A-308

Please refer to Danbury Hospital Department of Lab for CLIA findings. Event ID# HW1L11, EID date 2/6/2020.

Based on a review of clinical records, review of facility meeting minutes, review of policies, and interviews, the hospital failed to ensure that recalled Human Immunodeficiency Virus (HIV) testing kits and an increase in positive HIV screens was discussed or reported in the Laboratory quality meetings in accordance with facility policy. As a result, the pertinent information was not incorporated into the hospital's Quality Assurance program. The finding includes:


Review of the hospital line list of HIV screens performed by the facility from 1/10/19 to 11/22/19 noted that 34 reactive HIV screens were identified.

A bulletin to the facility from Laboratory #2, dated 3/5/19, directed to discontinue the use of the HIV Ag-Ab kit with lot #'s 300-868 due to an identified increased reactivity. Subsequent to receipt of the recall, the hospital identified that three (3) unused HIV Ag-Ab kits remained in the hospital and were subsequently removed from stock.

Review of Laboratory staff meeting minutes dated April 2019 and May 2019, and quality meeting minutes dated 4/25/19 failed to reflect documentation that the HIV kit recall was discussed as directed in the hospital quality plan.

Review of the clinical records of Patient (P) #1, P #6, and P #8 indicated the patients underwent a reactive human immunodeficiency virus (HIV) screening test collected by the facility on 5/16/19, 5/6/19 and 5/13/19 respectively.

During review of the Core laboratory meeting minutes (monthly staff meetings) dated 6/6/19 indicated the facility laboratory had 10 reactive screen samples in May 2019. Pertinent information from the Core meetings is then reported at the monthly Performance Improvement meetings, however, Laboratory quality meeting minutes dated 8/15/19 failed to reflect documentation that the increased sample reactivity was discussed and the actions taken by the facility as a result of the reactive screens.

Interview with the Operations Manager on 1/22/20 at 10:12 AM indicated that the recall and increase in positive HIV screens was not discussed or reported in the Laboratory quality meetings in accordance with facility policy.

Interview with the Director of Quality and review of the 2019 Hospital-wide Quality Improvement Committee meeting minutes on 1/22/20 at 11:40 AM noted that the meeting minutes lacked documentation from the Laboratory Department reporting of quality data during 2019, including blood and tissue reports.

The Laboratory quality plan identified performance improvement monitors would include manufacturer recalls. The quality plan further identified that data would be shared with departments outside the laboratory as appropriate, and at the Hospital PI (performance improvement) meetings.

The Quality and Patient Safety Plan identified that the Quality Committee of the Board was responsible to provide direction, review, assessment, monitoring, and reporting on all programs.


Please refer to A582: Adequate Laboratory Services

Please refer to Danbury Hospital Department of Lab for CLIA findings. Event ID# HW1L11, EID date 2/6/2020.

The Condition of Participation for Laboratory Services has not been met. Based on record review and staff interview, the immunology laboratory failed to follow manufacturer instructions for HIV testing and reporting, failed to have a complete procedure manual, failed to follow record retention regulations, failed to establish and follow quality assurance procedures to monitor and assess complaint issues, failed to maintain specimen integrity for reference lab testing and failed to properly communicate HIV test results to providers. The cumulative effect of these systemic problems and the laboratory director's failure to provide overall management and direction, resulted in the laboratory's inability to ensure the accuracy and reliability of HIV patient test results in the sub-specialty of general immunology.

Please refer to A582: Adequacy of Laboratory Services.

Please refer to Danbury Hospital Department of Lab for CLIA findings. Event ID# HW1L11, EID date 2/6/2020.

LABORATORY SERVICES CFR(s): 482.27 The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients. The hospital must ensure that all laboratory services provided to its patients are performed in a facility certified in accordance with Part 493 of this chapter. This CONDITION is not met as evidenced by:
The Condition of Participation for Laboratory Services has not been met. Based on record review and staff interview, the immunology laboratory failed to follow manufacturer instructions for HIV testing and reporting, failed to have a complete procedure manual, failed to follow record retention regulations, failed to establish and follow quality assurance procedures to monitor and assess complaint issues, failed to maintain specimen integrity for reference lab testing and failed to properly communicate HIV test results to providers. The cumulative effect of these systemic problems and the laboratory director's failure to provide overall management and direction, resulted in the laboratory's inability to ensure the accuracy and reliability of HIV patient test results in the sub-specialty of general immunology.
Please refer to A582

ADEQUACY OF LABORATORY SERVICES CFR(s): 482.27(a)
The hospital must have laboratory services available, either directly or through a contractual agreement with a certified laboratory that meets the requirements of part 493 of this chapter. This STANDARD is not met as evidenced by:
Based on clinical record reviews, review of facility documentation, and interviews, the facility failed to ensure reactive Human Immunodeficiency Virus (HIV) testing and reporting was properly performed as required to ensure accuracy and reliability of patient test results.
The findings include:
Information received by the State Agency identified a concern regarding incorrect and delayed reporting of HIV results. (CT 26825 )
Review of facility documentation identified the following:
a. Review of the 'Bio-Rad BioPlex 2200 system HIV Ag-Ab Instructions for Use' on 1/22/2020 revealed: "Initially reactive specimens must be retested in duplicate. If they are repeatedly reactive, they must be investigated by additional, more specific, or supplemental tests. Refer to CDC guidelines for the current recommended HIV testing algorithm."
b. 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:
i. 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.
ii. The CDC flowchart for the recommended laboratory HIV testing algorithm.
iii. The table and flowchart do not correlate.
c. Review on 1/28/2020 of the CDC guideline 'Recommended Laboratory HIV testing Algorithm for Serum or Plasma Specimens, Updated January 2018' revealed:
i. Specimens with a reactive/repeatedly reactive antigen/antibody immunoassay should be tested with an FDA-approved supplemental antibody immunoassay that differentiates HIV-1 antibodies from HIV-2 antibodies.
ii. Specimens with a reactive on the initial HIV antigen (Ag) /antibody (Ab) immunoassay and non-reactive or indeterminate on the HIV-1/HIV-2 antibody differentiation immunoassay should be tested with an FDA-approved HIV-1 Nucleic acid test (NAT).

d. 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)."
e. Review of laboratory's Bio-Rad BioPlex 2200 analyzer procedure manual on 1/22/2020 revealed the HIV procedure lacked the following required elements:
i. Specimen stability requirements for referral confirmatory HIV samples.
ii. Proper interpretation of results according to CDC guidelines.
iii. System of when and how to enter patient HIV test results in the Cerner laboratory information system.
iv. Protocol for provider notification and documentation of critical/reactive HIV test results.
v. Proper ordering of confirmatory diagnostic testing according to CDC guidelines.
f. Review on 1/28/2020 of the laboratory's 'BioRad Bioplex 2200 Analyzer' policy signed and approved by the laboratory director on 6/16/19, revealed the following current practices are not included:
i. Section 2: Specimen Collection and Handling, does not mention double spinning SST tubes.
ii. Section 8: Reference Range and interpretation:
iii. Human Immunodeficiency Virus (HIV) screen results do not autoverify. They are manually entered.
iv. Email provider notification is not addressed.
g. Review on 1/22/2020 of the laboratory's 'Quality Plan' revealed:
i. Section 2B: Personnel Training and Development, "Training is also provided when new procedures are being implemented and when procedures are changed."
ii. 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."
iii. 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."
iv. 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 the improvement of laboratory processes exist."
v. Section 7A: Deviations/Adverse Events and Corrective Action, "Events and resolution of events are reported at the monthly PI meeting."
vi. Section 7C: Quality Monitoring/Performance Improvement, "Policies, processes and procedures are in place to continuously improve the operational processes and quality management system in pre-analytic, analytic and post-analytic phases. Data is shared with departments outside the laboratory as appropriate and at the Hospital PI meetings. Example of monitored areas include: investigation of product recalls, market withdrawals, episodes, complaints, deviations, etc."
vii. Section 11: Non-Conformance, "The procedure to be implemented when it detects that a non-conformance shall ensure that:
viii. The results of nonconforming examinations already released are recalled or appropriately identified if necessary.
ix. Laboratory management shall document and implement any changes required to its operational procedures resulting from non-conformance investigations."
h. 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.
i. Review on 1/27/2020 of the Immunology General Supervisor (GS)'s handwritten document entitled, 'CT State Inspection 1/21/2020 - 1/22/2020 HIV Increase Reactivity Summary' revealed:
i. A notation regarding a 3/5/19 field action report received from Bio-Rad, "Bulletin increase HIV reactivity."
ii. A meeting with a provider to discuss positive HIV numbers, complaint investigation (C2).
j. 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:
i. An increase level of reactivity with the BioPlex 2200 for lot number 300-868.
ii Request to immediately discontinue use and dispose of any unused product.
iii. Documentation of 3 kits destroyed.
k. Review of the Danbury Hospital Document Control Log on 1/28/2020 revealed:
i. Procedure Number CC-BP.1.
ii. Title: BioRad Bioplex 2200 Analyzer
iii. Original/Master copy effective date: 6/27/13.
iv. Record of procedural changes as follows: 11/19/13, 3/27/15, 4/2016, 2/5/19, 5/15/19 and 1/27/2020.
l. Review on 1/28/2020 of the procedure records for the BioRad BioPlex 2200 Analyzer CC-BP.1 revealed the laboratory does not have the original/master procedure (6/27/13) and the first two revisions of the procedure (11/19/13 and 3/27/15).
m. 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:
i. The report did not contain the unique patient identifier assigned to each patient.
ii. The report contained Human Immunodeficiency Virus (HIV) Ag-Ab, Syphilis and Rubella results.
n. Record review on 1/21/2020 of the laboratory "Critical Tests in the Clinical Laboratory - Network AD.5.8.2' revealed:
i. "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."
ii. "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."
iii. "The caller must document the notification and read-back in the laboratory information system (LIS) or other permanent document."
iv. "HIV inc. occupational exposure and Labor and Delivery" is listed as a critical test.
o. Review on 1/28/2020 of an email dated 2/28/19 from the GS to laboratory staff revealed:
i. "Providers may be called by immunology staff to collect additional blood for HIV confirmation."
ii. Each test requires one full lavender top tube.
iii. Order as a miscellaneous send out (Mayo HVDIP, Mayo HIVQN).
iv. The confirmation tests are not built in the LIS.

Review of final patient test reports and records identified the following:

a. 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(3:18PM) and run on the BioRad BioPlex 2200 instrument revealed, the laboratory did not have the instrument printout for this patient.
b. 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:
i. 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.
ii. 5 of 25 reactive HIV p24 Ag BioPlex specimens in 2018 did not have the HIV-1/HIV-2 antibody differentiation immunoassay performed.
iii. 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.
iv. 4 of 36 reactive HIV p24 antigen BioPlex specimens in 2019 did not have the HIV-1/HIV-2 antibody differentiation immunoassay performed.
c. Review of Patient #2 HIV Ag -Ab reactive test results on 1/27/2020 revealed:
i. Reactive HIV Ag Ab screen was confirmed and called to provider on 8/2/18.
ii. HIV differentiation test auto verified from reference laboratory on 8/6/18.
iii. HIV Ag-Ab screen was resulted in the LIS on 8/6/18.
iv. Provider notification of the differentiation test result was called on 8/15/18.
d. 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:
i. 8 of 25 reactive HIV Ag-Ab assay results in 2018.
ii. 13 of 36 reactive HIV Ag-Ab assay results in 2019.
e. Review on 1/28/2020 of 2019 BioPlex HIV Ag-Ab reactive patient results follow-up confirmatory testing revealed:
i. The laboratory did not have documentation of confirmatory testing for 6 of 36 Reactive HIV Ag Ab screen results.
ii. 3 of 36 reactive HIV Ag Ab screen results had the wrong confirmatory tests ordered and reported.
f. Review on 1/28/2020 of the collection and receipt records for 11 BioPlex 2200 reactive patients revealed:
i. Confirmatory testing requires an additional blood collection of EDTA plasma.
ii. 6 of the 11 above specimens exceeded the 2 hour time limit required by the reference laboratory for testing.
g. Review on 1/28/2020 of final test reports for patients with reactive Human Immunodeficiency Virus (HIV) -1 p24 Antigen tests and nonreactive HIV-1 and HIV-2 antibodies revealed:
i. The reports had the following result interpretation, "A test is preliminary positive for HIV-1 p24 antigen in the absence of reactivity for HIV-1 or HIV-2 antibodies may indicate an acute HIV-1 infection. Result is not diagnostic, and the diagnosis of HIV infection should be made based on the results of an HIV-1 RNA quantification test."
ii. In 2018, 4 of 4 patients had the above incorrect interpretation on their test report and did not have the required supplemental testing performed.
iii. In 2019, 6 of 6 patients had the above incorrect interpretation on their test report and did not have the required supplemental testing performed.
iv. The report interpretation does not request the appropriate follow-up testing.

Interview with the GS on 1/27/2020 at 10:50 AM indicated 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 indicated 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).

Interview with the 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.
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 identified 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.

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.

Interview with the operations manager (OM) on 1/27/2020 at 10:22 AM confirmed a delay in patient reporting. OM did not know why the 9 day delay of provider notification occurred.
Interview on 1/28/2020 at 1:00 PM with the immunology general supervisor (GS):
a. Confirmed the laboratory does not always document employee training or education when changes in procedures occur.
b. Stated the HIV procedure changes frequently depending on who is complaining. The procedure is not always updated to reflect the most recent and updated policy, therefore the laboratory director's signature is not always on the most current procedure.
c. The GS was confused concerning the BioPlex HIV procedure signature page. GS wasn't sure if the correct information is included beside the revision date and the signature date. Information on what was revised was not always clear.
d. Confirmed critical HIV screening results are not always called according to the laboratory policy. The GS stated that results can also be emailed to providers and sometimes the results are called days later or not at all. When confirmatory results are received they autoverify in the LIS. The screening results do not autoverify after the confirmatory results autoverify. Testing personnel do not enter results because the results are often entered incorrectly. The GS manually monitors for confirmatory test results completion and then results the preliminary screen in the LIS when he/she has time. In addition, callers do not always get the name of the person spoken to.
e. The laboratory does not have Bioplex instrument printouts with patient identifiers from 1/1/18 to 1/31/19 as they were de-identified during archive by the manufacturer.
f. The GS received the technical bulletin for the HIV kit recall on 3/5/19, but it was not discussed at the laboratory core lab meeting until 6/6/19. GS notes, read, "HIV increased reactivity - spin samples." The GS indicated the laboratory does not have official minutes from the core lab meetings, therefore notes are relied upon. The GS indicated he/she double spins, but is not sure if any other testing personnel do it. Double spinning SST tubes is not addressed in the procedure.
g. GS did not have an investigative file for the complaint concerning HIV results with C2. GS had notes in several places and did not have written documentation from the manufacturer for visits made to address the complaint.
h. The procedure contains incorrect information concerning confirmatory testing. The procedure does not contain the required confirmatory testing as published by the CDC. The specimens are not sent out for Western Blot testing as indicated. The GS was told by the technical supervisor that their test was a 5th generation and therefore could suffice as a step 2 screening test by the CDC guidelines.
i. The procedure does not contain the requirement to spin, separate and freeze the sample within 2 hours of collection. The GS stated he/she was unaware of this requirement.
j. The samples are not automatically sent out for confirmatory testing as indicated in the procedure because confirmatory testing requires EDTA plasma and patients must be redrawn.

Interview with the Hospital Director of Quality on 1/22/2020 at 11:40 AM indicated the 2019 meeting minutes of the hospital wide Quality Improvement Committee did not contain any laboratory quality data during the year.
Interview with the send out supervisor (SOS), GS and OM on 1/28/2020 at 12:30 PM confirmed some samples exceeded the stability limit for confirmatory HIV testing. The SOS and GS indicated they did not realize there was a time limit on when the specimens must be spun down and frozen.
Interview with the GS on 1/27/2020 at 1:55 PM confirmed:
a. Results of the reactive HIV screens are either called or emailed and the email protocol is not in the procedure.
b. Staff do not inform the provider to order the required CDC Step 2 supplemental HIV 1 & 2 Antibody testing when the p24 Antigen is reactive.
c. The reactive HIV screen results are only entered after the supplemental HIV results have been reported and this manual process is not defined in the procedure.

Interview on 1/28/2020 at 1:00 PM with the GS indicated the HIV procedure changes frequently depending on who is complaining. The procedure is not always updated to reflect the most recent and updated policy, therefore the laboratory director's signature is not always on the most current procedure.
Interview with the immunology general supervisor on 1/28/2020 at 9:45 AM confirmed the laboratory does not have the original/master procedure (6/27/13) and the first two revisions of the procedure (11/19/13 and 3/27/15).
Interview with the technical supervisor (TS) on 1/28/2020 at 9:00 AM indicated the laboratory test is 5th generation and can do step two of the CDC guidelines. Upon further review of the CDC guidelines, TS concluded the laboratory did not follow the manufacturer instructions for confirmatory testing and the laboratory had been following the incorrect protocol.
The laboratory performed 7,418 HIV Ag-Ab tests in 2018 and 7,792 tests in 2019.