To enhance its comprehensive reproductive services, Fertility Cryobank approached Koves Technologies to develop an FDA, HIPAA and CDHS compliant Enterprise Application (EA) and Management Information System (MIS); one that makes the sperm donor selection process an innovative, interactive experience for recipients.

Through Web technology, Fertility Cryobank wanted to make choosing a sperm donor accessible for any individual or couple—from the privacy of their own home—with complete information available at their fingertips. As a licensed andrology laboratory in the state of California, Fertility Cryobank and its MIS are required to be in 100% compliance with the following regulations:

• Health Insurance Portability and Accountability Act (HIPAA) – HIPAA, enacted by the United States Department of Health and Human Services in 1996, specifies how personal health data is gathered, maintained and communicated in a confidential and secure manner.
• U.S. Food and Drug Administration (FDA) Title 21, CFR 1271 – These regulations promulgated by the FDA include strict requirements for: donor screening; specimen processing and testing; specimen labeling, storage and tracking; recipient testing and procedure follow-up; and reporting of adverse events.
• California Department of Health Services Regulations – The State of California has promulgated stringent regulations to ensure quality standards in clinical and public health laboratories and laboratory scientists through licensing, examination, routine inspection, education, and proficiency testing.

The Solution

Koves Technologies developed a custom web-based data system for Fertility Cryobank; one that maintains highly-sensitive donor and recipient information in a secure, centralized database. From the time a potential sperm donor submits an online application to Fertility Cryobank, their appointments, test results and samples are tracked through a documented process of screening, donation, quarantine, selection and shipment. Each step is securely safeguarded, monitored, evaluated and validated by a secure, state-of-the art, Web-based system.

The solution offers the following features:

• Registration and screening of sperm donors per HIPAA, FDA, California-state regulations and Fertility Cryobank procedures
• Donor information and history management with auto-flagging for discrepancies, errors, omissions and out-of-range values.
• Data elements comply with HL-7 standards
• User-specific laboratory/cryobank workflow with automatic task generation
• User-specific online calendar
• Controlled inventory management for blood vials, semen vials and cryogenic tanks (with barcode scanning and label printing)
• Inventory-synchronized E-Commerce for purchasing accounts and vials
• Daily and periodic reporting
• Electronic Medical Record (EMR) archiving
• Electronic signatures (compliant with FDA 21 CFR Part 11)
• Biometric-thumbprint scanning
• Security controls
• Results management module for blood and infectious disease testing
• Results management module for genetic, psychological and IQ testing
• Document management center
• Medical professional (physician, psychologist, geneticist, laboratory technician) interface, management and account tracking
• Recipient interface, management and account tracking
• Automated TM/Vial semen analysis form calculation

In addition to clinical aspects of the application, the new system provides the following business advantages:

• Automates the screening, matching and management processes for sperm donors reducing staff time and manual processes.
• Allows referring physicians and their staff to securely access vital information over any web connection.
• Provides critical insight into administrative and clinical data and offers ability to analyze treatment methods and outcomes.
• Integrates QuickBooks Enterprise to allow for seamless, complete financial recording.
• Incorporates E-commerce/Authorize.net to manage donor commissions, vial purchases, recipient account fees, donor database subscription fees all through one system.
• Provides more than just electronic medical records, since the fertility clinic management information system is developed to improve the entire clinic. It’s built in knowledgebase, online protocols, compliance parameters, educational information and access to real-time information supports quality care measures.
• Transforms the clinic to a paperless office
• Enables enterprise-wide scheduling and communications
• Includes lab data, supply and asset management

To facilitate clinic-specific outcome analysis and reporting and Aggregate data research, the Koves MIS is equipped with the most sophisticated On Line Analytical Processing (OLAP) engine, offering customized, multidimensional analysis to administrative, clinical and practice data:

• Demographics, scheduling and registration information
• History, prior evaluations and outcomes
• Endocrine, andrology tests

In summary, the system features secure, reliable, point-of-care information over the Web. It helps to streamline workflow processes and allows practitioners to disseminate critical information better and faster, while maintaining a keen eye on true patient care via:

• Patient profile, history and intake
• Appointment reminders and confirmations
• Consents, letters and instructions

In conjunction with implementation of the Fertility Cryobank enterprise solution, staff received training and were able to access a built-in on-line help reference module.

The Results

The system has been in use by Fertility Cryobank since 2008. Since that time, the company has passed their California Department of Health inspections and U.S. Food and Drug Administration (FDA) inspections. Other results include, but are not limited to:

• Paperwork reduction
• Process time reduction/labor savings
• Decreased phone/support/faxes which saves time, money and makes the company greener