Needs Assessment for Quality Improvement

Introduction

            Needs assessment is defined as the methodical and systematic process through which the expectations, desires, needs, and wants of a particular set group are determined with the primary objective of instituting appropriate interventions that will lead to an improvement of the current situation (Rouda & Kusy, 1995).

Five critical questions – What, why, where, when, why, and how – inform the needs assessment process. This paper describes a needs assessment for the Human Investigation Committee (HIC) Office Process at Wayne State University which seeks to reduce the time taken from submission of protocol to approval of research.

1. a) A description of the chosen process

This section describes the Human Investigation Committee (HIC) Process of Wayne State University. The HIC is the principal Institutional Review Board for the university together with all its eleven affiliates (Wayne State University, 2008). The board is tasked with the mandate of ensuring that all biomedical and or behavioral research conducted in the University and its affiliates and involving human participation strictly conforms to the stringent regional federal and national regulations.

The review process begins once the primary investigator presents his/her proposal to the HIC office. The first step involves verification by the receptionist. Here, the proposal is checked to make certain that the primary investigator’s signature is appended as required. Additionally, verification is carried out to ascertain that the signatures of the investigator’s supervisor as well as the department’s head are correctly affixed. The correct number of copies is also verified. If all the requirements have been met, the receptionist is required to stamp “received” on the protocol and indicate the day’s date. Thereafter, different tracking sheets are filed by the receptionist and fastened onto the stamped protocol. Yellow tracking sheets are fastened on studies funded by industry and blue for studies not funded by industry (Wayne State University, 2008).

Once this is done, the protocols are put into the Coeus in box. The next step is undertaken by the File Room Professional Technician who picks the protocol and enters the data contained therein into the Coeus repository. Additionally, the technician gives the protocol a HIC number and in cases for studies funded by industry, he/she originates the Drug Letter. Finally, the technician authenticates that the “Responsible Conduct in Research On-Line Training Program” has been appropriately filled. Once this is completed, the protocols are forwarded to the HIC or IRB head to be reviewed depending on the research activity described.  Specifically, review is carried out for Full Board, Expedited and Exempt research (Wayne State University, 2008)..

Exempt review is started once the head of the HIC receives the protocols, which can either be medical or behavior exempted.  The review may also be carried out by a person other than the head but who is selected by the latter. The decision made is communicated to the investigator upon completion of the review. For protocols which fall below the exemption requirements of the board, the investigator is requested to present his/her protocol again using the medical or behavioral protocol summary form as may apply. The re-submitted protocol is reassessed by the same reviewer and a decision reached. The protocol is filed, data pertaining to the process entered into the repository, and a memo drafted once a Concurrence of Exemption is arrived at.

The same procedure is followed for expedited reviews. However, the Notice of Expedited Approval is raised once authorization has been granted. The Full Board Review follows a different procedure.  The process begins once the protocol is received from the technician as described before. However, it is initially reviewed by a pre-reviewer before it can go to the board. The purpose of this step is to make certain that all the required data is appropriately filled and contained in the protocol. Where there are omissions or errors, the primary investigator is contacted and asked to make corrections (Wayne State University, 2008).

The technician is thereafter required to make ready the re-submitted protocols   seven days before the board meeting. It is required that the protocol be submitted alongside accompanying documents such as Consent/Assent/Information Sheets,  Educational materials to be distributed to participants, Questionnaires/Surveys, Advertisements/

Flyers/Notices, Full Research Proposal and Investigator’s Brochures.

            Thereafter, the board will deliberate on the protocol and make a ruling on the matter. Once this has been done, it is upon the reviewers to complete the HIC reviewer form which is then appraised by the board’s head and conveyed to the primary investigator. Where the board finds that amendments need to be made, the investigator is informed and his/her feedback returned to the initial board head for review (Wayne State University, 2008).

            Finally, the HIC Reviewer Form is attached to the HIC transcript together with comments by the reviewer. These are then entered into the repository, minutes created, and the protocol archived as soon as authorization is granted (Wayne State University, 2008).

1. b) An “As-Is” flow chart of the process to be analyzed.

Figure 1: Schematic representation of the HIC process
c) Describe the relationship of the process to the organization’s strategic plan.

The Wayne University Research Division’s mission is to build “an institutional culture that values integrity in the conduct of research as well as the pursuit of knowledge and innovation that provide human benefit” (Wayne State University, 2008).This is aligned with the University’s strategic plan which seeks to place it among the premier research institutions for biomedical research in the country.

The HIC protocol described is a critical component of this plan because it is the one which determines whether or not research will be undertaken. An effective process will lead to high quality research that is carried out without delays while protecting the subjects and the public from harm. On the other hand, an ineffective process will result in sub-standard research being carried out which would expose subjects and the public to harm, possibly placing the university in difficulties with the government regulatory authorities.

1. d) Identify the internal and external customers that are currently impacted by the process that would benefit from the process improvement.

The internal customers affected by the process who would benefit include the students, faculty staff, members of the HIC and IRB, and the Research Division.  Others include the receptionists and technicians involved in the documentation process.

The external customers affected by the process and who will benefit include the University’s affiliates namely the Children’s Hospital of Michigan, Detroit Receiving Hospital/University Health Center, Harper University Hospital, Hutzel Women’s Hospital, Rehabilitation Institute of Michigan, John D. Dingell Veterans Administration Medical Center, Huron Valley/Sinai Hospital, the Michigan Orthopedic Surgery Hospital, Barbara Ann Karmanos Cancer Institute and the Sinai-Grace Hospital.

Additionally, industry stakeholders funding the various studies will immensely benefit
e) Identify the most appropriate Quality Management tool that can be used to collect and present data on the process improvement changes

Quality management tools are many and varied. Among the quality management tools available are relations, affinity, and force field diagrams, brainstorms, building consensus, flowcharts, cause and effect diagrams, and tree diagrams. Others include Pareto, pie, radar, bar, and control charts; scatter and normal test plots and histograms (Skymark, 2008).

In the process improvement changes, we find the Pie Chart to be the most ideal quality management tool for the process. This is because it is simple to use and will adequately represent the variances sought.
f) Utilize your selected quality tool to analyze your process and identify process improvement opportunities.

Figure 2: Pie chart representing the total time taken by the HIC Process

KEY

1=Verification by Receptionist

2= entry into Coeus & submission for review

3= review process

4= corrections by principal investigators

As can be seen in the pie chart above, more than 75% of the time (>720 hours) is spent on carrying out corrections on the protocols as identified by the board/HIC. On average, close to 200 hours is spent on the actual review itself while less than 20 hours are consumed by both the verification by the receptionist and preparation by the Technician.

The solution to this problem would lie in reducing the time consumed by amendments of the protocols. Towards this end, it is suggested that a needs training be conducted for the students and other persons seeking to do research in order to acquaint them with the whole authorization process, with an emphasis on the requirements so that the revisions can be cut down. Additionally, an average of 122 hours is spent between submission of protocols to the board and convening of meetings and another 70 hours on submission of board decision to investigators.  A suitable solution would include the integration of modern communication aids such as pod casts and e-mails to communicate the decisions to the investigators.

g) Estimate the level of improvement that could be realized and the value of implementing this process improvement.
Implementation of the improvement process, as detailed before, would entail conducting exhaustive training programs on the HIC Process for the concerned parties. This is expected to cut down the protocols returned for corrections. A s a result, cost savings will be attained by the board members who would spend minimal time on each protocol. Thus, they will have more time to concentrate on their teaching and administrative duties.

Secondly, most studies run on tight budgets and an even tighter time line. reduction of time spent on corrections would enable the researchers to have adequate time for their research hence producing higher quality research, which after all, is the objective of the university.

Conclusion

            The HIC process of the Wayne University is a critically important process which ensures that the university’s mission of high quality and ethical research is attained. However, significant delays occasioned primarily by the frequent need of revisions may compromise the research efforts. This paper finds that an effective training program conducted for the investigators is a suitable solution for the identified problem.

References

Padhi, N. (2008). The Eight Elements of TQM. Six Sigma. Retrieved on 15^th September,

 2008 from http://www.isixsigma.com/library/content/c021230a.asp

Rouda, H.R. and Kusy. M.E. (1995). Needs Assessment: The First Step. Retrieved on 15^th

September, 2008 from http://alumnus.caltech.edu/~rouda/T2_NA.html

Skymark. (2008). Classic Tools. Retrieved on 15^th, September, 2008 from

            http://www.skymark.com/resources/tools/management_tools.asp

Wayne State University. (2008). Human Investigation Committee. Retrieved on 15^th

August, 2008 from http://www.hic.wayne.edu/

Wayne State University. 2006. Office Process. Retrieved on 15^th September, 2008 from

http://www.hic.wayne.edu/HRPP_Manual/18-2_New_Protocol_Submissions-OfficeProcess.pdf