Business process modeling exercise

IT Strategy and Business Value

Business Process Modeling Exercise

During this term our class explored numerous challenges faced by organizations. These challenges may be caused by technology, competitors, government, customers etc. These challenges can only be resolved when the business unites with its technology team to explore the ‘AS-IS’, determine the ‘TO-BE’ and map a course to get from one to the other. Business Process Modeling (BPM) is way of gaining insight into how things are being done. It is a way to get all participants on the same page. The class is a process team tasked with two goals: Firstly you must map the ‘AS-IS’ environment such that collectively you are all on the same page in terms of how things are being done. Secondly you need to identify gaps in terms of support for potential growth. I will participate in this exercise as a business expert available to answer questions or provide detail.

CLINSCI-LAB is a small laboratory specializing in endocrinology testing. The company has a golden reputation in terms of test accuracy, test sensitivity, timeliness and data insight. CLINSCI-LAB is the ‘go to laboratory’ for testing conducted on premature children. The company’s reputation has earned them a place on the clinical trials short list of large bio-tech companies such as Amgen, Eli-Lily and Pfizer. This market will significantly increase the volumes of samples, testing on samples, storage/retrieval requirements, reporting and data access. Management is very sensitive to the importance of the firm’s reputation not only to their growth plans but to their continued survival.

Operational Summary

Current sample volume is between 500 and 1500 samples per day with between 1 and 7 tests conducted on each sample. One sample is associated to one patient and results’ reporting does not cross sample submission times. Essentially this means that if we test your sample today and return results to you, then test another sample submitted at another time there is no way to associate your first sample submission with subsequent sample submissions.

Sample Processing - Arrival

Patient samples arrive throughout the day via an internal courier network, UPS and FEDEX. These samples are delivered to the Accessioning Department for initial processing. Since arrival is intermittent throughout the day, there are two batches processed each day. The

morning batch is closed at 11:00am (PT). Samples assigned to the morning batch will be included in all test assays being setup in the current day. Samples assigned to the afternoon batch will be stored and included in test assays setup the following business day. The accessioning department personnel enter preliminary data into a sample acceptance system (Accessioning System) from the paperwork that comes with the sample. Each sample is assigned an accession number (samples requiring multiple tests are further assigned sub- numbers.

Example:A sample arrives for patient John Doe requesting three tests. Note: accession numbers are created using a combination of the current date and a six digit counter that resets each day. In this case, assuming this sample was the first to be entered in the accessioning system, the master accession number assigned would be 20111020000001. The sub tests are captured by associating the master accession number with test identification numbers (six digits). Identification for this sample would be as follows: Master accession id: 20111020000001Tests:000001 Test1000002 Test2000003 Test3

The samples are sorted (and separated as necessary) into testing facility specific groups and further grouped and racked by assay within each lab. Accession number labels are affixed to each vial. There are three testing facilities (Steroid, Peptide, and Chemistry Panel) within CLINSCI. The paperwork is sent to Data Entry where each sample’s patient data is enriched with more robust patient specific information including free text commentary. Once data enrichment for the current batch is complete a data log is printed. The log is separated equally

between four pairs of personnel. These teams verify the information on the paperwork that arrived with the samples matches what was entered into the system. Once errors are resolved the batch is closed, assay inventory sheets are generated and delivered, with samples, to refrigerator units in each of the three labs.

Sample Processing - Lab Processing

Note: This process is consistent in each of the three labs at CLINSCI.

Lab technicians are assigned assays each day. They take the assay worksheets and fetch the patient samples racked for that assay from the refrigerator. They prepare each sample for the assay and write down the sample accession number with measurement information in a lab assay workbook. Once the samples are prepared, they are transferred to the testing equipment and ordered according to the lab assay workbook. The testing is performed by the machine and a results sheet is printed out. The result sheet is taken by the lab technician and attached to the correct assay in the lab assay workbook. The lab technician manually transfers the results from the lab assay workbook to the assay inventory worksheet and places the completed inventory sheet into the outbound box. The samples are placed in the completed refrigerator in the lab for pickup.

Sample Processing - Post Assay

Accession department personnel sweep through the labs each hour to pickup assay results and completed samples. The completed samples are post-processed. They may be

transferred to long term storage or destroyed. The results are delivered to Data Entry for entry into the accession system. Once all results are entered into the system the result logs are printed out and divided between four pairs of personnel. The teams verify all results were entered properly. Once any errors are resolved the result batch is closed and ready for transmittal to the requestor.

Results Processing

Results are delivered to recipients via mail and fax. Results documents are printed out in batches targeted for either delivery method. Customer service personnel load letters for mailing and send faxes manually until the batches are complete. Fax confirmation sheets are attached to results documents and filed.

Impact of Clinical Trials

If CLINSCI is able to capture clinical trial contracts from the large pharma companies sample volumes will increase to 3000 to 5000 samples per day with between 10 and 30 tests conducted on each sample. The nature of clinical trial testing requires historical grouping of patient data across sample submissions across potentially many years. Reporting is formatted such that each time test results arrive for a patient a cumulative report is generated. In addition an electronic transmission must be sent CPU to CPU to the clinical trial data management firm.