Samples will be obtained from the anonymous <Indicate which Crimson Bank> maintained by the BWH Specimen Bank. The investigator and study staff will select appropriate samples from the available inventory. Samples are released with age and gender only to the IRB protocol of the receiving investigator. Materials will be used for <Indicate use of the samples>
If you are receiving microbial isolates:
Microbial isolates will be obtained from the Isolate Bank maintained by the Crimson Core. The investigator and study staff will select appropriate isolates from available inventory. Samples are released with the microbial species (if available), antibiogram and source, if available, to the IRB protocol of the receiving investigator. Materials will be used for <Indicate use of the samples>.
Samples will be collected through the Crimson application used by the Crimson Core in the BWH Clinical Laboratories. Study requests for samples are first registered with the core. A study can be activated after verification that its IRB protocol is active, and subsequent discussion with study staff regarding materials to be collected. Upon activation of the study, rule sets can be created to locate pertinent discarded samples meeting defined criteria. Queries are run against a 30 day rolling window of data on all accessions coming into the clinical laboratories. Searchable fields include the patient age, sex, ordering location, patient status (inpatient, outpatient, e.g.), tests ordered, test results and lab or visit ICD.9 codes.
The investigator and study staff will be given privileges in Crimson to view a daily list of all accessions found by their queries. This "picklist" includes data found on a laboratory accession, namely the accession#, patient MRN, name and DOB. Investigators may then perform necessary medical record checks (medications, radiology reports, e.g.) to determine which samples should be collected. Within the application, study staff will check off samples not meeting additional criteria, leaving a list of samples for collection by the Specimen Bank. When samples are collected, the Specimen Bank staff physically remove the lab accession label and enter the sample in the application. A new SampleID and PatientID are created and associated with the sample. This action physically de-identifies all samples collected by the core.
While links to patient data are retained, samples may not be released to study staff until (1) the patient has been consented to allow links to remain, or (2) all links to identifying information within Crimson have been broken (anonymized). Thus, investigators either receive a consented or anonymized patient sample from the core.
In addition, you must include what data will be reviewed (pharmacy, radiology reports, etc), from what source (charts, EMR, etc) and that all links to identifiers will be removed after completion of the analysis.
If you need to include specific annotations from the data review
samples to be collected, you must provide the Specimen Bank a
list of canned comments that will be used. Specimen Bank staff will
associate canned comments with samples to be collected. Free-text
entries are not allowed, as they could potentially be used to
Time-limited links allow identified information to remain associated
with a discarded sample for a limited window of time, generally
<<30days. Limited links may be in place to allow final resulting
of test results desired in the anonymized dataset associated with
samples, chart review to create canned comments to annotate collected
samples, or for clinical purposes if materials need to be held in
escrow should the Clinical Laboratories or Pathology department need to
retrieve materials set aside for eventual research use, to complete
additional diagnostic testing.
During the window period of the
limited link, samples will not be released to study staff. The
Crimson Core acts as the honest broker and will hold all samples until
such time as links to identified information are broken.
requests use of time-limited links to proected health information for
the purposes of <state reason(s)>. A period of <# days>
days is requested. During the period of the link, Crimson will retain a
link between the patient MRN and LIMS-generated sample and subjectIDs. Study
staff do not have access to samples while links are in place; materials
remain in posession of the Crimson Core. After links to protected
health information have been removed in the LIMS, samples may be
released to study staff.
An "Already Collected List" will be maintained in the Crimson Core. This list is used to prevent duplicate collection of samples from the same patient. Prior to accessioning a new sample, the MRN is checked against this list to make certain materials have not been previously collected. After accession of a discarded sample, core staff will list MRNs from samples collected for each query. The Already Collected List is routinely sorted to be in numeric order such that no one MRN can be associated with a sample. The list thus represents an aggregate of MRNs with no link to any collected sample. Study staff will not have access to MRNs on the list.
The List may persist as long as the investigator's IRB protocol is valid. Upon expiration of the IRB protocol, the list will be permanently deleted.
After obtaining consent, study staff wil register patients in the Crimson Application for sample collection under the investigator's study. Each night, samples recently accessioned in the BWH Clinical Labs will be searched for materials matching the list of patients consented by the study. In particular, we will be collecting <enter sample type(s) to be collected - serum, purple tops, etc. >. <Enter number of samples to be collected per patient - one tube only, all samples, etc. >