SAMPLE MANAGEMENT AND ADMINISTRATION KEVIN MEAGHER INFORMATION MANAGEMENT SERVICES, INC. OCTOBER 13, 2016

Transcription

1 SAMPLE MANAGEMENT AND ADMINISTRATION KEVIN MEAGHER INFORMATION MANAGEMENT SERVICES, INC. OCTOBER 13, 2016

2 WHO AM I? Vice President at Information Management Services Worked in IT for bioinformatics for 32 years Involved in software for biobanking for 19 years Chair of the ISBER Informatics Working Group Consulted on NCI Best Practices (biospecimens.cancer.gov/practices) Designer of the BSI system

3 AGENDA IT for biobanking and why it matters Centralized vs. disparate systems Considerations for specimen tracking software Security and privacy considerations

4 CURRENT LANDSCAPE LIMS Freezer Location Software Excel Paper Other

5 IT FOR BIOBANKING AND WHY IT MATTERS Without a system you have boxes of stuff IT gives you inventory tracking Map to processes Link to resources Link sample data to patient data IT makes teamwork efficient Persistence of knowledge and history Turnover kills historical knowlege

6 IT FOR BIOBANKING AND WHY IT MATTERS COMPONENTS A system is: Software & Platform & Support Growth and change: Scalability & Flexibility Regulations and compliance Security, privacy, and continuity Longevity

7 IT FOR BIOBANKING AND WHY IT MATTERS SOFTWARE, PLATFORM, AND SUPPORT Software: know your requirements Platform: Cloud vs Local Different hardware, backup, IT stack Different operations support options Support: Tech support Development

8 IT FOR BIOBANKING AND WHY IT MATTERS GROWTH AND CHANGE Biobanking collections are always growing from IT perspective Repository perspective: A successful biobank is an empty biobank IT perspective: Never discard anything Scalability in size, users, collections, workflows, repositories, EVERYTHING Flexibility in handling situations and adding new procedures

9 IT FOR BIOBANKING AND WHY IT MATTERS REGULATIONS AND COMPLIANCE Alphabet soup 21CFR, HIPAA, HITECH, FISMA, ANNEX, CDISC, Common Rule, Safe Harbor,.. Processing SOPs If it is not documented, it did not happen Cheryl Michels: Software is not compliant, Systems are compliant

10 IT FOR BIOBANKING AND WHY IT MATTERS SECURITY, PRIVACY, AND CONTINUITY Security Guidelines FISMA, HITECH, FEDRAMP, OWASP, HIPAA, Gramm-Leach-Bliley, Homeland Security Layered defenses in place Backup, restore, repeat Continuity and incidence response plans What is acceptable downtime Failover vs DR

11 SECURITY AND PRIVACY CONSIDERATIONS LIMS SOFTWARE Role based Permission/Function Access control what you can do Data Access Control what you can see Authentication vs Authorization SSO systems Careful with LDAP

12 IT FOR BIOBANKING AND WHY IT MATTERS LONGEVITY The system will be around a lot longer than you think Change is hard Code Rot? End of life problems Upgrades Key point: make sure your system can grow

13 CENTRALIZED VS. DISPARATE SYSTEMS Advantages and disadvantages to both Centralized promotes standardization, cross pollination, resource sharing, integration, etc Centralization is restrictive and cumbersome Disparate is faster, more customized, easier Disparate is brittle, unsustainable People at the top like Centralized People at the bottom like disparate (sometimes) Assimilation is inevitable

14 CENTRALIZED VS. DECENTRALIZED SYSTEMS Lab 1 Repository Lab 2 Central LIMS/LIS Outside Vendor

15 Path to Data Sharing and Collaboration CENTRALIZED VS. DECENTRALIZED SYSTEMS Local Systems LIMS Common Data Format Data API Centralized Information System Reporting and Collaboration Tools Centralized LIMS Specimen Index Spread sheet Text File C Data Import Utility Harmonized Data Store Specimen Request Reporting Dashboard Note Book Web Forms Data Mining and Analytics

16 CENTRALIZED VS. DISPARATE SYSTEMS Integration can take multiple forms Data standardization during storage Data standardization during transmission Data translation Hubs Timing Continuous Periodic

17 CENTRALIZED VS. DISPARATE SYSTEMS Carrots and sticks Funding, recognition, belief Mandates, defunding Even centralized systems are disparate Standardization/Adaptation is the key

18 INTRAOPERABILITY API Permanence Enhancements Who makes the call? When standards matter

19 CHOOSING A SYSTEM Know your requirements: ISBER Checklist Local vs Cloud hosted Vendor reputation/history One vs many players

20 LIMS SOFTWARE KEY REQUIREMENTS Capabilities does the system meet your workflows? Storage, Processing, Reporting, Linking,. Flexibility can the system be configured for change? Scalability can the system handle data and user growth? Integrity does the system have edit checking capability Standardization does the system provide enforced data code lists?

21 LIMS SOFTWARE KEY REQUIREMENTS - 2 Audit trail who, what, when, how, and why? Integration it is all about a network Configuration vs Customization Availability Support Cost

22 LIMS SOFTWARE KEY REQUIREMENTS - 3 Controlled lists avoid free text Normalization of data Unique IDs IDs are just IDs Tables vs Forms

23 BUILD VS BUY THE QUESTION One of the oldest questions in IT keeps getting more complicated as new options emerge Should you build your own application from scratch that will meet all your requirements Purchase a commercial application that will meet >80% of your needs Contract for a custom system that will meet almost all of your needs

24 BUILD VS BUY WISDOM Buy when you need to automate commodity business processes Build/Customize when you re dealing with the core processes that differentiate your company or give you a competitive advantage Don t be fooled that what you do is unique

25 BUILD VS BUY BUILD IT! Pros Ultimate Flexibility Only the features you need Competitive advantage You will be very involved in the process Cons Development time/costs Maintenance & Scalability Sustainability You will be very involved in the process

26 BUILD VS BUY BUY IT! Pros Possible cost savings Professionally developed Already solved a lot of implementation problems Experience/best practices built in Cons Adapt to their tools You can t always get what you want Reliance on 3 rd party Possible cost issues

27 BUILD VS BUY CUSTOMIZE IT! Pros Possible cost savings Faster than building it Turn 80/20 into 90/10 Cons Support issues Abandonment issues More customization = more costs

28 BUILD VS BUY REQUIREMENTS How is the product going to be supported? What is the amount of funding? What office politics and practices might affect decision? Need to project these requirements into the future Everyone involved in the project must understand the requirements!

29 BUILD VS BUY REQUIREMENTS

30 BUILD VS BUY THE WINNER IS There is no clear winner. The decision is a strategic, functional, financial, and often a political decision that must be arrived at by each organization. The key to the answer is in your functional and workflow requirements you must realize and document them before approaching the question to Build or Buy.

31 ISBER Creates opportunities for sharing ideas and innovations in biobanking Harmonizes approaches to evolving challenges for biological and environmental repositories Great place for information and to ask questions

32 BSI SYSTEMS Centralized LIMS Samples, freezers, subjects, consent, workflows LIMS, web portal, translation hub, API, data warehouse No per user/per repository pricing

33 TAKE AWAY IT is critical to biobanking Excel is not a viable option Plan for flexibility, longevity, and continuity Need buy in from management - Education is key

34 QUESTIONS? Kevin Meagher Information Management Services