Electronic Records: An Open Discussion AATB s 31st AnnualMeeting Boston Marriott Copley Place September17, Scott Brubaker, CTBS

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Philip Dalton
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1 Electronic Records: An Open Discussion AATB s 31st AnnualMeeting Boston Marriott Copley Place September17, 2007 Scott Brubaker, CTBS

2 Overview The AATB has received requests to develop minimum, uniform standards for electronic records Software sales - varying protocols Expectations - confusing Some AATB inquiries were made to FDA for current thinking on this topic - answers reviewed Possible areas for discussion described

3 Inquiries to FDA In the part below, what is the intent of 'concurrently'? " Records. (a) General. You must maintain records concurrently with the performance of each step required in this subpart and subpart C of this part. Any requirement in this part that an action be documented involves the creation of a record, which is subject to the requirements of this section. All records must be accurate, indelible, and legible. The records must identify the person performing the work and the dates of the various entries, and must be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular HCT/P involved."

4 Concurrently We acknowledge that frms have been cited over the years for not keeping records "concurrently" as required by the regulation at 21 CFR "Concurrently" means at the same time or immediately after the step in manufacturing is performed. Adrienne Hornatko-Munoz Branch Chief, Manufacturers Assistance & Technical Training Branch (MATTB) OCTMA/CBER/FDA In consultation with Offce of Compliance and Biologics Quality (OCBQ) and Division of Human Tissues (DHT)

5 Inquiries to FDA What is your current thinking in regard to this scenario? A written record is produced at screening (e.g., the medical hx & behavioral risk assessment questionnaire or other relevant medical record) or at recovery (physical assessment record). An hour later, or within a specifed time period, the hand written record can be entered into the software program and the handwritten record is then shredded. There currently is no check required by a second person that verifes the electronic entries indeed match the handwritten document.

6 Shredding In this example you provide (below), the frms are keeping concurrent paper records but then entering the information into a computer database and destroying the original paper record. This is unacceptable. If the information was directly entered into the system as the steps in donor screening were performed, that would constitute concurrent record keeping. Or, if the information was entered into the database for backup purposes, with all the needed Quality Assurance (QA) etc., that would also be acceptable.

7 Shredding Destroying the original concurrent record which would contain all the required information does not seem to be supported by (c) Methods of Retention, which requires that maintenance of records concurrent with the performance of each step (from (a)) might be done electronically (i.e. concurrent electronic records), as original paper records OR as TRUE COPIES such as photocopies, microfche or microflm.

8 Verifcation You also indicate in your inquiry that "there currently is no check required by a second person that verifes the electronic entries indeed match the handwritten document." Although not required by our regulations, we would agree that this practice is worrisome, and remind that, at the very least, computer verifcation or validation would be necessary as the information entered into the system is being used for determining donor eligibility (which is a core GTP).

9 Software We also point out that while we require recordkeeping, we do not regulate software marketed for this purpose. Thus, we caution establishments when purchasing software that claims to be "FDA-approved." End ofinquiries, to date, to FDA.

10 Electronic Signatures A request was m ade to allow these but require com pliance to Part 11...

11 More Discussion Topics The audit trail of an electronic system does not replace the handwritten signature of the person performing the actual step in the process. An example would be in a case when the person actually performing the physical assessment may be listed in the audit trail, internal to the system, but still needs to be documented on the recovery paperwork as doing the exam. I am afraid that we are loosing the traceability, accountability and verifcation steps we currently have as we move from paper to electronic systems. Unless the system has security steps that clearly document who is performing each task this may be an area of concern. An electronic signature would work.

12 More Topics Person performing the task vs. the person enter the information into the electronic system is a concern which raises the source document issue. If the information is entered in the system concurrently by the person performing the task, this is not an issue. If the information is documented on paper and then entered later we would require the source document as part of the chart for review. In cases when a person entering the data is just transcribing the information and entering the name of the actual person performing the task, I do not believe that to be acceptable.

13 More Topics Can one person take responsibility of the entire record with their signature? This responsible person would verify that all the names listed on the forms are those who performed the steps and the information was entered according to protocol. Is this acceptable? If the record is printed and signed by one responsible person (not performing the tasks) at the recovery agency, is that acceptable? Is it acceptable for that same person to electronically sign for the entire case?

14 More Topics A responsible person is expected to perform and document each step of the recovery, including plasma dilution (evaluation), medical records review, etc. The system performing this calculation automatically would constitute determination of donor eligibility and would open up the electronic system to review under Part 11.

15 More Topics Change control of forms and documents apply to electronic forms as they apply to paper, as do all other applicable standards. Correction of electronic charts one line cross out with date and initial is now out the window. What would we require and since the (electronic) correction may override the original response how do we capture that?

16 More Topics Is the recovery agency ultimately responsible for their practice in monitoring who is entering the data or it is still the processor s responsibility to verify that each step of the process complies? Do we (the establishment determining fnal donor suitability) require documented proof of validation by the recovery agency? Is the recovery agency ultimately responsible for the system? Can E-charts be ed without using an encrypted secure system which complies with privacy standards?

References to Computer and Software in FDA s CGTPs (Final Rule and Draft Guidance) for HCT/Ps Preamble to the CGTP Final Rule

References to Computer and Software in FDA s CGTPs (Final Rule and Draft Guidance) for HCT/Ps Preamble to the CGTP Final Rule Preamble to the CGTP Final Rule Pages 68626-68627 Computers Proposed 1271.160(e) would require establishments to validate computer software used as part of manufacturing or tracking or for maintaining