1st Home Infusion & Specialty Pharmacy Consulting

Advance Your Home Infusion,
Specialty Pharmacy and Infusion Services
&
Achieve Accreditations

We are a Boutique Consulting Firm for Healthcare Organizations

Establishing Advanced Home Infusion, Specialty Pharmacy and Infusion Services

From Setup and Regulatory Compliance to Seamless Operations, through Accreditations, and Ongoing Excellence –

Our Consulting Service

Navigating Your Opportunities and Challenges:

The demand for home infusion, specialty pharmacy, and ambulatory infusion services is growing, driven by payer-led strategies and a shift toward alternate-site settings. This trend presents significant opportunities for healthcare organizations to expand their services and enhance patient care.

However, capitalizing on these opportunities requires specialized knowledge and expertise to navigate complex regulatory requirements effectively. Without the right guidance, organizations may face challenges such as compliance issues, inefficiencies, and financial setbacks, which can hinder their ability to fully realize these opportunities.

Our Solutions: 

We provide expert consulting to navigate the complexities of establishing advanced home infusion and specialty pharmacy services—strategically mitigating risks and ensuring success.

Our End-to-end support covers every critical phase:

  • Master Planning to Implementation 
  • Compliance to Operations Optimization
  • Accreditation to Growth

Deep expertise ensures you build high-performing, accredited infusion and specialty pharmacy that:

  • Delivers Clinical Excellence
  • Ensures Optimized Operations
  • Simplifies Ongoing Compliance Process
  • Promotes Financial Performance

Our Clients and Our Expertise

Need to Build an Advanced Home Infusion Pharmacy?

We provide solutions to:

  • Design and build advanced, state-of-the-art cleanroom suites.
  • Develop sterile compounding policies, procedures, and QA programs compliant with USP 797, USP 800, and accreditation standards.
  • Create Infusion therapy clinical programs tailored to each infusion drug.
  • Home infusion pharmacy software selection, implementation
  • Streamline processes with lean pharmacy methods for operational excellence.
  • Ensure seamless accreditation.

Need to Build a High-Performing Specialty Pharmacy?

We specialize in:

  • ACHC and URAC-aligned Policies and Procedures with practical, simplified guidance to establish your specialty pharmacy.
  • Securing ACHC, URAC, and dual accreditations as strategic tools for growth.
  • Accelerating growth through strategic accreditation leverage.
  • Implementing key programs, including Clinical PM and QM Programs, that drive measurable outcomes.
  • Developing Compliance Programs with precise standard interpretation, eliminating unnecessary complexities.

Our Consultants

Understanding Your Challenges:

Establishing advanced specialty and home infusion services requires a high level of specialized knowledge and practical insight. We understand the complexities involved and are committed to providing the support needed to navigate these challenges effectively.

Our Expert Solutions:

All our services are delivered directly by top-level,  specialty and home infusion pharmacist consultants who have devoted their careers to advancing the field of home infusion, specialty pharmacy, and patient care. Their extensive qualifications, combined with their deep-rooted dedication and passion for excellence, are reflected in every solution they provide, ensuring practical, real-world applications that drive meaningful results.

Their qualifications include:

  • Board Certified (BCSCP)

Pharmacists:Expertise in sterile compounding,ensuring compliance with USP 797 and USP 800.

  • ACHC Certified Consultants: Expert guidance on the accreditation process for streamlined success.
  • Accreditation Surveyors: Clear insights from active surveyors, ensuring accurate interpretation of standards and industry best practices.
  • Senior-Level Practitioners: Advanced strategies and innovative solutions driven by extensive experience in home infusion and specialty pharmacy practices. 

We prevent and resolve a variety of challenges organizations may face, including:

  • Compliance Challenges: Misinterpreted or overlooked regulations can lead to unnecessary risks. Our precise guidance ensures full compliance with all requirements and best practices.
  • Project Delays: Errors or overcomplicated processes can slow progress and increase costs. We proactively prevent common pitfalls and eliminate overcomplication, keeping your projects on schedule and within budget.
  • Operational Inefficiencies: Ineffective workflows can waste resources and hinder productivity. We optimize your operations for maximum efficiency and impact.

Your team will work closely with our BCSCP Board Certified and ACHC Certified Pharmacist Consultants throughout the project.

Our Dual Approach

Understanding Potential Challenges:

Establishing advanced home infusion and specialty pharmacy services requires not only specialized guidance but also operational expertise. Finding these resources, especially during a new launch or innovation, can be challenging. Without comprehensive support, organizations may face:

  • Regulatory Compliance Gaps: Our expert guidance ensures your operations meet all regulatory requirements, preventing issues before they arise.
  • Operational Inefficiencies: We identify and address process gaps, streamlining operations for optimal performance and reduced risk.
  • Project Delays: Our strategic planning prevents delays and cost overruns, keeping your projects on schedule and within budget.

Our Dual Role Solutions:

1. Specialized Consulting Services

We guide you through every stage of service establishment with end-to-end consulting, including:

  • Initial regulatory compliance
  • Facility design and build-out
  • Key program development
  • Operational setup
  • Accreditation achievement

This comprehensive approach prevents compliance failures, operational errors, and ensures continuous optimization.

2. Hands-On Contracting Services

Beyond consulting, we step in as key personnel to:

  • Manage complex tasks
  • Oversee strategic programs
  • Streamline operations
  • Provide essential staff training

Our hands-on involvement mitigates delays, reduces financial risks, and drives sustained growth and operational excellence.

Our Specialized Solutions at a Glance

1. Home Infusion Pharmacy Solutions -Specialized Support-

From initial regulatory compliance through operational readiness to accreditation, ensuring continuous optimization and growth

Key Services:

  • Master Planning for Infusion Service Establishment
  • Modular Sterile Compounding Facility Design & Build
  • USP 797 & 800 Compliance & Policy Development
  • Sterile Compounding Pharmacy Licensure
  • Board Inspection Preparation & Mock Inspections
  • Software Selection & Implementation
  • Key Program Development & Operational Readiness
  • Accreditation Preparation & Mock Surveys
  • Ongoing Compliance & Quality Assurance

Outcomes:

  • Full compliance with USP 797 & 800 standards
  • State-of-the-art cleanrooms and infusion suites
  • Tailored key infusion programs to meet your specific needs
  • Integrated clinical programs within pharmacy software
  • Enhanced patient safety through rigorous quality control
  • Operational excellence and accreditation success

2. Specialty Pharmacy Solutions -Comprehensive Support-

From initial establishment through accreditation, ongoing compliance, and optimization, helping you excel in a competitive market

Key Services:

  • Master Planning for Key Program Implementation
  • Accreditation Mastery, Including Mock Surveys
  • Streamlined Compliance Tool Integration into Pharmacy Software
  • Clinical PM Program Integration into Pharmacy Software
  • Quality Management Program Development to Meet Your Specific Needs
  • Strategic Business Development
  • Data Tool Development and Validation Support

Outcomes:

  • Leverage accreditation to build a high-performing specialty pharmacy maximizing its benefits.
  • Internally developed clinical programs for clinical and financial success
  • Simplified compliance integrated into pharmacy operations
  • Robust Quality Management Driving Success
  • Optimizes market positioning

3. Accreditation Solutions
-Strategic Support-

Understanding Your Challenges

Navigating the aaccreditation process can be complex:

For First-Time Applicants: Uncertainty about which accreditation aligns with your business goals and how to effectively manage the process.

For Reaccreditation: Identifying compliance gaps can create urgency and uncertainty about the best mitigation strategies.

Without expert guidance, organizations may face:

  • A weak compliance framework
  • Missing the full benefits of accreditation by focusing solely on passing the test
  • Inefficient use of resources, leading to delays and increased costs
  • Accreditation denial due to lack of timely, effective corrective actions

Our Proven Solutions for 100% Sustainable Success

We provide a clear, actionable roadmap to address immediate compliance needs while building robust key programs and optimizing processes for long-term success. Beyond simply securing accreditation, our goal is to build a streamlined infrastructure that propels your organization to the next level.

Our Proven Approach

  • Strategic Tool: Leverage accreditation as a powerful foundation for building advanced services, not just as an end goal.
  • End-to-End Support: From thorough gap analysis and strategic corrective actions to the implementation of robust procedures.
  • Lean Methods: Simplify and integrate key processes into workflows for sustainable, efficient compliance.

ACHC Preferred Partner Discount Program

EK Specialty Pharmacy Consulting’s clients will receive the highest discount benefits when applying for ACHC accreditation, thanks to our status as an ACHC Preferred Partner.

Don’t miss out on this opportunity!

Use the discount code: EK21

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Looking for expert solutions for home infusion, specialty pharmacy, and accreditation?

Share your inquiries or details with us, and we’ll respond promptly.

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