Patient Data Collection and Clinical Annotation

Standard Operating Procedures (SOP 01.003)

Purpose

All patient samples are de-identified at the time of collection and storage. It is necessary to maintain a database that allows for retrieval and re-identification of stored samples by authorized individuals. Laboratory staff are required to protect the confidentiality of all patient information. Tissue donated to the tumor biobank is intended for research studies. The success of translational research, and ultimately personalized medicine, depends on the ability to forge a connection between phenotypic clinical data and molecular measurements on samples. The efficient integration of clinical data with scientific results has become critical in determining populations of patients that may best benefit from a new drug or therapy. Standardized and complete data capture provides the best hope for analyzing large data sets, over many institutions, and will allow comparisons with other similar or collaborative studies.

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Confidentiality of patient information

Personal patient information in possession of the lab (including name, medical record number, etc.) is considered confidential. Any such information should not be disclosed to non-healthcare personnel, or to healthcare staff who have no immediate and definitive responsibility to patient care. Examples include: test request forms, work lists, and patient reports in paper or electronic form. Other data considered to be confidential and protected from unwarranted disclosure includes medical staff information, financial reports, legal documents, and quality assurance information.

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Computer Access

Computer passwords protect both the biorepository database and the hospital electronic medical record system from unauthorized persons accessing confidential information. Each of these systems will time out if left unattended or inactive for several minutes. It is the responsibility of all personnel to log off computers when they are not actively in use.

Collecting patient data

Looking up the electronic medical record for each patient individually, record the following information:

• Patient name
• Medical Record Number
• Date of Birth
• Gender
• Date of Surgery
• Race
• Ethnicity

Records on patients who have consented to tissue collection, who have had samples stored in the repository, must have their records kept in the database for at least two years after all samples collected have been utilized.

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Changes to records

Any changes made to the patient records in the biorepository database must be documented in OpenSpecimen in order to keep track of data integrity.

Storage and Disposal of Paper Records

Confidential information must be stored or disposed of properly. Staff members should check with their supervisor whenever there is a question regarding the confidentiality of information. If documents must be retained outside the hospital, the supervisor should make arrangements to have the documents taken to the hospital's offsite record storage facility where the records can be stored properly and retrieved efficiently, if necessary. The Director of Laboratories will serve as liaison between the laboratory and the Document Management Company. A log will be maintained to track document storage and retention data.

When documents contain confidential information, but do not need to be retained, they should be placed in special receptacles provided by Environmental Services. Environmental Services will pick up disposable confidential materials on a regular basis for shredding and recycling. Arrangements can be made for large pick-ups, by contacting Environmental Services at 215-955-6100.

Contact the Support Service Manager at 215-955-6213 regarding questions about arrangements to have confidential materials removed, shredded and recycled. If there is uncertainty as to the confidentiality of a document, call the Corporate Compliance Office at 215-955-4177.