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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Client Reviews
Our Future Growth is Not Possible Without EK Specialty Pharmacy Consulting on Our Side.
With EK Specialty Pharmacy Consulting, we achieved initial, reaccreditation and dual accreditations. EK provided us with regulatory and ongoing compliance, BOP inspections, mock surveys, management and development of clinical programs, quality improvement programs and operations management support. EK also provided Pharmacist in Charge and Pharmacist staff training and provided marketing support. All their services were conducted in an efficient professional manner with cost saving and within budget. EK’s expertise and knowledge has created opportunity for us to grow our specialty and home infusion business. The investment in their services paid off quicker than we planned. Our future growth is not possible without EK specialty pharmacy consulting on our side.
Our Future Growth is Not Possible Without EK Specialty Pharmacy Consulting on Our Side.
With EK Specialty Pharmacy Consulting, we achieved initial, reaccreditation and dual accreditations. EK provided us with regulatory and ongoing compliance, BOP inspections, mock surveys, management and development of clinical programs, quality improvement programs and operations management support. EK also provided Pharmacist in Charge and Pharmacist staff training and provided marketing support. All their services were conducted in an efficient professional manner with cost saving and within budget. EK’s expertise and knowledge has created opportunity for us to grow our specialty and home infusion business. The investment in their services paid off quicker than we planned. Our future growth is not possible without EK specialty pharmacy consulting on our side.
Our Future Growth is Not Possible Without EK Specialty Pharmacy Consulting on Our Side.
With EK Specialty Pharmacy Consulting, we achieved initial, reaccreditation and dual accreditations. EK provided us with regulatory and ongoing compliance, BOP inspections, mock surveys, management and development of clinical programs, quality improvement programs and operations management support. EK also provided Pharmacist in Charge and Pharmacist staff training and provided marketing support. All their services were conducted in an efficient professional manner with cost saving and within budget. EK’s expertise and knowledge has created opportunity for us to grow our specialty and home infusion business. The investment in their services paid off quicker than we planned. Our future growth is not possible without EK specialty pharmacy consulting on our side.
Our Future Growth is Not Possible Without EK Specialty Pharmacy Consulting on Our Side.
With EK Specialty Pharmacy Consulting, we achieved initial, reaccreditation and dual accreditations. EK provided us with regulatory and ongoing compliance, BOP inspections, mock surveys, management and development of clinical programs, quality improvement programs and operations management support. EK also provided Pharmacist in Charge and Pharmacist staff training and provided marketing support. All their services were conducted in an efficient professional manner with cost saving and within budget. EK’s expertise and knowledge has created opportunity for us to grow our specialty and home infusion business. The investment in their services paid off quicker than we planned. Our future growth is not possible without EK specialty pharmacy consulting on our side.
We were in a rush due to the expiration of the previous accreditation. EK helped us achieve accreditation within 4 months. EK was strategic and the process was extremely efficient. The consultant helped us simplify all processes by removing unnecessary steps that were previously in place and then implementing missing key components. The accreditation preparation process with EK tremendously helped us to establish a solid structure to grow our home infusion and specialty pharmacy business (both administrative and clinical pharmacy areas) - thanks to her hands on experience in regulatory compliance, pharmacy operations, clinical programs, marketing in specialty, home infusion pharmacy. We appreciate EK’s education. Our employees learned something valuable and were inspired by the consultant at each meeting. After the accreditation project ended (full accreditation with no deficiencies), we happily engaged EK Specialty Pharmacy Consulting for further business development in addition to ongoing maintenance. EK’s principal consultant provides a very unique service definitely beyond consulting.
Before starting the reaccreditation project with EK Specialty, we were uncertain if we were prepared for the accrediting agency survey process. The education provided by EK was exceptional. We are grateful for EK's education and guidance with the requirements and best practices of each standard. EK also compared the requirements of other accrediting bodies to incorporate them as best practices into our processes. EK consultant orchestrated everything and led the entire project from the initial diagnostic survey to the development of important programs and implementations, audits, participating PI meetings through the final walk-through mock survey. She efficiently and smoothly led the project, providing solutions to any challenge we encountered. EK consultant’s strategy and dedicated support saved us tremendous time and resources. Thanks for everything you have done for us. Your guidance has been extremely helpful and appreciated.
EK Specialty Pharmacy Consulting has been more than a consulting service. The detailed and personalized service has been vital for our accreditation project. Our reaccreditation project began with many doubts and concerns for the implementation. It grew into a project with clear concepts and logistics and today we have robust and well-defined processes. We owe this to the guidance that EK Specialty Pharmacy Consulting provided us. EK has helped us optimize everything for the benefit of our patients and our company, from our Clinical Patient Management Program to our administration guidelines and compliance standards. Today, our organization is an advanced specialty pharmacy with absolutely 100% compliance thanks to the kind guidance and additional recommendations (industry best practices, other accreditors’ requirement, etc ) EK Specialty Pharmacy Consulting provided. We'll always be grateful".
We are so glad we found EK Specialty Pharmacy Consulting for our re-accreditation preparation. We had many concerns before we started the project. EKs service was definitely not just about consulting to pass the accreditation. EK consultant truly has hands-on experience and knows every element of specialty pharmacy operations and clinical knowledge as an active pharmacist, not just accreditation and regulatory elements. We truly see the significant benefits of the preparation process through EKs genuine approach. We see great value of the accreditation preparation process with EK. With EKs help, we have outstanding specialty pharmacy programs including clinical programs that we are proud of, and we will definitely promote these services to our patients, doctors, payers and manufacturers with greater outcome data.
Mock survey with EK’s principal consultant was a great experience. EK consultant was performing a survey that resembles the real survey process. During the mock survey process, the consultant provided strategies to finetune each preparation process and educated us on the intent of each requirement and how we can correct deficient areas. We were able to complete our re-accreditation preparation thanks to EK’s education and detailed guidance. Your guidance and support were the key to this achievement. We are very happy. Thank you again for all your guidance and your dedicated support.
We knew we were non-compliant in some areas but were not clear on what was truly missing or how to make remediation plans in order to pass our upcoming re-accreditation survey. EK’s mock survey and comprehensive gap analysis executive report helped us to understand the level of our compliance and gauge our readiness for our upcoming reaccreditation survey. Based on EK’s gap analysis, the consultant helped to develop a customized project master plan that helped us prioritize each key section and thus we were able to complete all tasks within the timeframe. The accurate diagnostic survey and the strategic remediation plans provided us clear guidance and solutions on what and how to correct all the deficiencies in a correct way such a short time. We are so glad that we engaged EK SRx.
EK Consultant trained us in all aspects of accreditation standards, CA Pharmacy law, USP797 and USP800. I am very fortunate to have received this training. She helped our pharmacy correct all non-complaint areas. It was a breeze when the board of pharmacy inspector visited us for the sterile compounding license inspection. We also received our accreditation report with no deficiencies. With EK specialty pharmacy consulting, we now have clarity and confidence for ongoing compliance.
EK Specialty Pharmacy Consulting helped us pass our sterile compounding Board of Pharmacy inspection and accreditation with a flawless report, and also helped us to streamline the compliance process. The consultant trained our key staff with up-to-date laws and regulations and corrected all the issues identified in limited time. Thank you EK Specialty.
EK consultant helped us develop our distinguished Patient Management (PM) program, specifically tailored to our business model, our current operations including our software programs. We were able to build a platform in our software program without purchasing an additional clinical program platform which would have cost tons and double our personnel time in order to manage two different programs. Our disease specific PM program is highly effective and covers every single accreditation requirement. This program saves our pharmacist a tremendous amount of time as well as our patient time to complete all clinical activities. With our program, we were able to perform clinical assessments for over 400 patients for the past 3 months for our 2020,2021 active patients.
EK consultant helped us develop an exceptional clinical patient management program and build the patient record system in our pharmacy software. It is a highly effective program that allows us to take excellent care of our specialty patients by using specific disease protocols. It is perfectly streamlined to our operations. As an important part of our marketing strategies, we introduce our PM program to our patients and to the providers, including physicians and hospital case managers.
Excited to Share Proven High Quality Outcome Data With Any Stakeholders
EK consultant helped us to develop an outstanding QM/PI Program. She started the project with extensive education about all aspects of the QM program, then helped us to implement each program. With EKs guidance, we were able to collect, track, trend and analyze meaningful data on each key area. Since we developed this program with EK, we utilize our QM program to monitor every aspect of our services, our compliance and operational efficiency and to promote outcomes. She educated us to clearly understand that all accreditation requirements are organically connected to each other, which ultimately improves the quality of all aspects of our specialty pharmacy services. All makes sense! We are excited to share proven high quality outcome data with any stakeholders including patients, providers, payers and manufacturers.
After the accreditation project ended, we happily engaged EK Specialty Pharmacy Consulting for further business development in addition to ongoing maintenance. EK’s principal consultant is closely involved in decision making as part of our leadership team. EK helps us further develop our Clinical Programs so we can expand our service line. EK helped us build key programs in our pharmacy dispensing software so all employees can enter data in a standardized format. These new programs are highly effective in taking great care of our patients and saves tremendous resources and PI program has been bringing significant improvement in organizational performance. EK also provides extremely valuable marketing strategies and helps to present our distinguished clinical program to physicians and hospital case managers. Simultaneously, EK helps us constantly update our service programs and train our Pharmacist in Charge to deliver the same service we promised to all our stakeholders.
"Our re-accreditation preparation project started with EKs diagnostic survey. EK consultant provided extensive education on each accreditation standard domain so we could have a clear understanding of requirements vs recommendations accurately. EKs comprehensive gap analysis report helped us to accurately diagnose the level of compliance and prioritize tasks to remediate gaps identified. Our consultant was very thorough and listened to our business needs prior to making recommendations. EK created a master plan and helped us develop key programs that fit our business model and our operations. With EKs guidance, we successfully implemented these essential programs in such a limited time and our compliance level is close to 100%. EK consultant was absolutely a vital member of our team along with our three excellent pharmacists, compliance officer and HR director, EK's process has been truly exceptional and key to our success in achieving and maintaining our now near perfect compliance level."
EK’s mock survey was outstanding and the mock survey itself helped us greatly. It was like we were going through a real survey. EK principal consultant simulated the actual survey from the opening conference, thorough review of entire policies and each required document in detail, staff interview during facility tour, process observations, citing deficiencies all the way to the closing conference. Throughout the mock survey, the consultant provided strategies to correct all deficient areas and refine each area. We learned so much through EKs mock survey and we were able to put all the remaining puzzles together to complete our re-accreditation preparation with greater confidence and clarity. I truly believe the mock survey was a key part of us being able to understand where we were in terms of compliance and with EK's help establish/implement a plan to improve it.
With EK’s principal consultant, we were able to build our clinical patient management program tailored to our pharmacy software. We are sure our PM program will bring exceptional value to our patients and to our specialty pharmacy business and we expect the clinical and financial outcomes, patient, provider and our pharmacist’s satisfaction will be significantly improved. We are very proud of our unique clinical Patient Management program and thankful for the clinical, regulatory, technical guidance EK principal consultant provided. Thank you for all your support! We wouldn't be where we are without it.