# Presentation: 037636

## MSKCC Specimen Banking Process

**Patient**

**OR**

**Pathology**

**Standard **
**Clinical**
**Tests**

- PI

- PI

- PI

**Tissue Procurement**

-           NT
-                T
-                A
-                B
-                C
-                D
-                E

**Request**

- C1

- C2

- C3

**1.**

**2.**

**3.**

**4.**

**MSKCC Specimen Banking Process**
**(Specimen Flow from Surgery to Distribution from Tumor Bank)**

**Request**

**Tumor Bank**

**Patient Consent **
**Required**

**Notes:**
The 1st step in this process was understanding the flow of specimen from the time of surgery until the specimen is distributed from the Tumor Bank.

As you see above, each of the numbered areas (I-IV) indicates the time points when tissue is depleted from the initial procedure.

Is when tissue is sent to pathology to perform standard clinical testing. If any tissue remains it is then sent to TPS.
Shows specimens distributed immediately for Requests for Fresh Specimens.  In order to be distributed the patient must sign a consent.  The consent may be for the particular IRB protocol or in the cases of a pilot study, the patient must have previously signed MSKCC’s generic tissue consent form.
Any remaining tissue will be stored in the bank for future use
Future requests for specimens that have been stored in the bank.  In this case the same rules for consent apply

## MSK Specimen Tracking System Goals

**1.****	****Coherent management of tissue requests**
**2.****	****Information management of resource depletion **
**3.****	****Linkage of distributed specimens with clinical outcome data**
**4.****	****Ability to distribute specimens and related data anonymously**
**5.****	****Improved accession of tissue**
**6.****	****Ability to reserve tissue either before or after banking **

**Notes:**
After the design team reviewed the Specimen Flow, several goals were set for the system.

A Relational database will be developed to ensure that the database can accomplish in an efficient and non-redundant manner the proposed technical specification.  This is necessary due to the multi-dimensional nature of the system (eg, multiple parts per specimen, multiple distributions)
Coherent Mgmt since some specimens are distributed on the onset and some are distributed later.
In addition to recording the storage of the tissue it is necessary to track an accurate record of the depletion
The availability of baseline and f/u info is important for many scientific projects for which the TB resource is utilized
Anonymized distribution will be a requirement for many studies.  This is challenging since it will involve the actual distribution of the specimens and the associated clinical data simultaneously
The current system succeeds in obtaining only a subset of available specimens, a practical goal is more complete ascertainment of available specimens.

## Specimen Tracking & Research Results Database Relationships 

**CRDB = Clinical Research Database**

**Decision Support Tables**

**CRDB**
**(Clinical Outcome Data)**

**Specimen Tracking System**

**Patient MRN**
**Specimen ID#**

**Pathological Research Results**

**Specimen ID# **_***Only***_

**Notes:**
It was decided to create the Specimen Tracking System within MSKCC’s Clinical Research Database in order to take advantage of the collected clinical outcome data.  The data from Specimen Tracking can be linked to the CRDB through the the patient MRN and the specimen ID#.  This specimen ID# can also be linked to the pathological research results.  Decision support tables were then created to link the three areas of information together.

## Data Entry Forms / Tables

**Specimen Accession Form**
**Specimen Accession**
**Specimen Part**
**Specimen Bank**
**Specimen Bank Detail**
**Specimen Request Form**
**Specimen Request**
**Specimen Request Detail**
**Specimen Distribution Form**
**Specimen Distribution**

**Notes:**
For this system 3 data entry forms were created (Accession, Request and Distribution).  Here is a list of each of the data entry forms and each of the data tables.  I will talk about each in more detail.

## Specimen Accession Tables

**Specimen Accession**
**Accession of individual specimens; clinical details about the patient from whom the specimen was obtained**
**Specimen Part(s)**
**Details about the individual part(s) that are created from a single surgical procedure**
**Specimen Bank**
**All specimens received by the bank**
**Specimen Bank Detail**
**Details about all specimens and their distribution**

**Notes:**
There are 4 tables to describe the specimens that are sent to the bank and the patients from whom the specimens are obtained.

Describe each

## Specimen Accession: Data Elements

**Patient Identifiers & Diagnosis Information**
**Pathology Date & Accession #**
**Procurement Date**
**Service Code**
**Specimen Part # **
**Specimen Identifiers (Site and Cell Type)**
**Bank # **
**Specimen Type (e.g., Tissue, Blood)**
**Amount of Specimen Available**
**Distribution ID**
**Allocation Time**
**Distribution Time**
** **

**Notes:**
Here are some of the data elements from the previous tables

Highlight a few...

Distribution ID, Allocation Time and Distribution Time refer to specimen distribution and I will address each of them in a moment

## Specimen Accession Form (Page 1)

**Notes:**
Review some fields...

One Accession and multiple parts per accession

## Specimen Accession Form (Page 2)

**Notes:**
Review some fields...

Each group of specimens are given an TB #

The bottom block shows each specimen  part broken down into pieces ready for distribution.  Also, the Distribution ID and the Request ID fields indicate specimens that have been distributed form the bank

## Specimen Request Tables

**Specimen Request**
**Contains information about the individual request for specimens**
**Specimen Request Detail**
**Information about the types of specimen that are requested (including the specific site(s) and cell type(s) needed to fill the request)**

**Notes:**
The Specimen Request

## Specimen Request: Data Elements

**Request ID**
**Requester Information**
**Request Date**
**Distribution Type (e.g., Anonymous)**
**Type of Request**
**IRB Protocol**
**Pilot Study**
**Clinical Review**
**Single Patient Request**
**Specimen Information (Site and Cell Type)**
**Billing Criteria**

## Specimen Request Form (Page 1)

**Notes:**
Review some fields...

## Specimen Request Form (Page 2)

**Notes:**
Review some fields...

Billing

Multiple specimen options

## Specimen Distribution Table
Information about specimens distributed from the bank. This process includes:

Selection of Current Requests
Ability to Query Available Specimens in Bank
Distribution of Specimens Based on Patient’s Consent Status
Anonymization of Information

Specimen Distribution Data Elements
Distribution ID
Request ID
Additional Data From Previous Tables by Way of Hidden Patient Identifiers

**Information about specimens distributed from the bank. This process includes:**
**Selection of Current Requests**
**Ability to Query Available Specimens in Bank**
**Distribution of Specimens Based on Patient’s Consent Status**
**Anonymization of Information**
**Specimen Distribution Data Elements**
**Distribution ID**
**Request ID**
**Additional Data From Previous Tables by Way of Hidden Patient Identifiers**

## Specimen Distribution Form (Page 1)

**Notes:**
Review some fields...

Selection of Request ID

Search Button

Individual Patients

Clear Parameters

## Specimen Distribution Form (Page 2)

**Notes:**
Review some fields...

Items from Search

Allocation

Consent Status Verification

## Specimen Distribution Form (Page 3)

**Notes:**
Review some fields...

Expected vs. Allocated vs. Distributed

Distribution Block

## Non-Anonymized Distribution

**(*****patient identity known*****)**** **
**Patients give full consent for the specific molecular or genetic tests that will be conducted**
**No restrictions are placed on the coding variables  (each specimen may be identified by  patient identifiers, facilitating a direct link with clinical outcome data)**

## Investigator Anonymized Distribution

**(*****samples coded but linked to patient identity***** )**
**Investigators will be unable to identify the patient**
**Specimens will be distributed with a coded identification number that will identify the specimen**
**Clinical information may also be supplied via the Specimen Bank #**

## Fully Anonymized Distribution

***(irrevocably unlinked to patient identity*****)**
**Once a specimen is distributed it can *****never***** be re-linked to the patient**
**All clinical data *****must***** be available at the time of distribution**

## Specimen Accession

**SPC_ACCESSION**
**Specimen code #**
**MSKCC accession number #**
**Procurement_date #**
**Patient ID**
**Patient diagnosis**
***Other stuff...***

**SPC_PART**
**Part number #**
**Subpart number #**
**Specimen site**
**OR procedure (CPT code)**
**Specimen histology**
***Other stuff...***

**SPC_BANK_DTL**
**Bank Sequence ID #**
**Specimen Amount/Unit**
**Specimen category**
**IRB protocol ID**
**Specimen location *****(freezer)***
**Billing Amount**
***Distribution ID**
**Distribution date/time**

**SPC_REQUEST**
**Bank ID #**
**Request ID #**
**Requestor Info**
**Request Date**
**Request_type (*****what’s it for?*****)**
**Distribution type (*****Anonymized,***
***Investigator Anonymized or Not Anonymized*****)**
***Other stuff...***

**Specimen Accession**

**Specimen Distribution**

**Specimen Request**

**SPC_DISTRIBUTION**
***Bank ID#**
***Request ID #**
***Distribution Sub-ID #**
***Patient identifying information******(blank unless non-anonymized***
***distribution is selected)***
***Any diagnosis/treatment/***
***outcome data that may be***
***required after the link has been broken***

**Specimen Banking**

**SPC_BANK**
**Bank ID #**
**Specimen Type # *****(tissue,***
***	******blood, etc)***
**Specimen Sequence ID #**
***Other stuff...***

****These three fields (Bank ID,***
***Request ID and Distribution Sub-ID***
***in the Specimen Distribution table***
***are combined to form the Distribution***
***ID in the Specimen Banking Detail***
***table, which is only filled out***
***when the specimen has been***
***allocated***

***If a truly anonymized***
***distribution is performed,***
***the Distribution ID is replaced with***
***all zeroes at distribution,***
***breaking the link to the***
***Specimen Distribution table***

***Note that the Specimen Request table***
***is entirely independent of Accession***
***and Banking, to enable requests to be***
***entered (i.e., reservations to be made)***
***for specimens not yet available in the***
***bank***