"Strategy, Education, Direction with Oncology Expertise- for Physicians, Pharma and Managed Care"
DGH Consulting Compliance Division(a resource for oncology practices regarding USP Chapter <797> and Chapter <800> regulations for compounding, administration and handling of hazardous drugs)
The managment, handling, compounding and administration of hazardous drugs is an integral part of cancer care delivery in physician practics and hospital cancer centers.
Prudent clinical practice requires that oncology cancer centers and practices review their own processes and facilities for compliance , and address the impact of compliance with United States Pharmacopeia (USP) Chapter <797> and the imminent Chapter <800> as well as develop an ongoing continuous quality improvement process for future applications and requirements.
Organizations ranging from the Federal Drug Administration, state and federal Occupational OSHA, state boards of pharmacy and legislatures, and clinical research and healthcare networks are selectively regulating and enforcing compliance with USP Chapters in the oncology pharmacy space, including in oncology cancer centers and practices.
USP Compliance is about facilities, training, operating procedures, monitoring, and continuous quality improvement. Most "clean room" advisors are not familiar with the oncology center sites of service, and are not equipped to make cost effective analyses or recommendations for these settings.
The DGH Consulting Compliance Division provides specialized services to help oncology practices and cancer centers understand the issues and details related to USP <797> and <800> compliance, as well as to facilitate cost effective contracts with contractors knowledgeable in both USP compliance and oncology center environments, and to provide resources for training, operations and training support, and certification.
Dawn G. Holcombe, MBA, ACHE, FACMPE
Dawn Holcombe, President of DGH Consulting, has experience in strategic direction, environmental assessment, payer trends and relations, practice strategy and operations, quality/value programs, physician networks and state association issues, and business development, especially in the field of oncology. Dawn Holcombe’s thirty plus years in healthcare have included executive, strategic, financial, and marketing positions in academic and private health systems as well as physician practices. She is a a Fellow in the American College of Medical Practice Executives (ACMPE), and earned her MBA at the University of Michigan. Her healthcare career includes decades of oncology practice, strategy, advocacy, and payer relations experience. She is a past President of the national Administrators in Oncology Hematology Assembly (AOHA), a member of the American College of Healthcare Executives, and current Editor of the national journal Oncology Practice Management.
Willis C. Triplett, PharmD
Willis Triplett is a pharmacist who has spent his entire career working in and around the compounding of sterile products. He got his Bachelors in Pharmacy from Ohio State in 1976, and after working two years at The Ohio State University Hospitals, he went on to obtain his Doctor of Pharmacy from the Philadelphia College of Pharmacy and Science in 1980. He is the corporate pharmacy strategist for HQAA, a Medicare-deeming accreditation body and is a member of the Standards Committee of the National Home Infusion Association. Since the Fungal Meningitis outbreak of 2012, he has been involved with trying to help pharmacies improve their compliance with USP Chapter <797> and was appointed by the Indiana Board of Pharmacy to an expert committee that is revising sterile compounding regulations for the state.
The DGH Consulting Compliance Team of Dawn Holcombe and Willis Triplett provide clients with an external, unbiased perspective of the development and implementation of systems and facilities for use in sterile compounding activities. Further, the DGH Consulting Team will develop a strategic framework to encompass all aspects of sterile compounding that are needed to ensure a design and implementation that are compatible with the client objectives.
We Help oncology practices and cancer centers understand the issues and details related to USP <797> and <800> compliance
We Facilitate cost effective contracts with contractors knowledgeable in both USP compliance and oncology center environments
We Provide resources for training, operations and training support, and certification.
We Specialize in:
Compliance with USP <797> and USP <800> in Oncology
Standard Operating Procedures (SOPs),
Certification and Trusted Contractor Guidance
Sample Consulting Projects Can Include:
Phase 1 - Assessment: A Situation and GAP analysis of Existing Sterile Compounding Practices, and state and national implications of <797> and <800>, including: (Estimate – 1-2 weeks)
Review current situation relative to overarching regulatory environment
Identify State and National Activities/Implications for CCBD compliance
Walk through the physical facilities
Observe the physical facilities in dynamic condition
Observe the customary practices of staff
Ask detailed procedural questions of admixture personnel
Conduct GAP Analysis including:
Understanding of USP Chapters <797> and <800>
Compounding Staff Responsibilities
CSP Microbial Contamination Risk Levels
Risk Level Quality Assurance
Media Fill Risk Levels and Personnel Training and Evaluation
Verification of Compounding Accuracy and Sterility
Environmental Quality and Control
Patients and Caregiver Training, Monitoring and Adverse Events Reporting
Continuous Quality Improvement Program (CQI)
Review monitored data – compare and contrast with SOP requirements. Topics include:
Cleaning and disinfection
Certifications of SEC(s) and PEC(s)
Assess Quality Management process
Examine root-cause analyses
Review evidence of training and competency demonstrations of staff
Review labeling and storage practices
Compile report of findings, focusing on challenges, opportunities and gaps
Review report with Leadership
The Deliverable for this project shall be an executive level overview, Completed GAP Analysis Report, slide deck and presentation notes following site visit and reviews by DGH Consulting team of Dawn Holcombe and Willis Triplett.
Improvement Process - Close Gaps to Improve Sterile Compounding Practices
Contract Options: (6 – 8 weeks calendar time) May be negotiated as a bundle or as individual elements, and will be dependent upon findings of the GAP Analysis
Compliance Quality Improvement Plan-
Create a plan and time lines with client based upon findings of GAP Analysis
Identify contractors and equipment/facility solutions to meet compliance needs and compare and contrast alternatives by relative costs, advantages, and disadvantages.
Compliance Quality Improvement Plan Oversight and Management
Monitor and manage the improvement plan, including construction, training, operations, documentation, and validation
Monitor, measure and validate the effectiveness of SOP deployment and of the corresponding staff training
Document closure of gaps
Develop a continuous quality improvement process for ongoing quality, validation and compliance and identify the leaders and stakeholders who will maintain this process beyond the life of the Phase 2 contract. Ad hoc consultations with the DGH Consulting Team may be negotiated upon request
Standard Operating Procedures - Provide or obtain appropriate Standard Operating Procedures (SOPs) and training resources, tied to the GAP Analysis and work with the client to prioritize implementation
We recomend that oncology centers consider certification by the Quality Compounding Certification Program (QCCP), a division of Healthcare Quality Association on Accreditation (HQAA). More information is available at the link provided above:
The Quality Compounding Certification Program exists to help organizations that compound medications become compliant with the standards for compounding as published by the United States Pharmacopeia.
QCCP is a division of Healthcare Quality Association on Accreditation (HQAA). HQAA has provided accreditation services for DMEPOS, Pharmacies, Infusion / Home IV Compounding, Ventilator Units and Third Party Billing companies for over 10 years. HQAA was created out of a need and mandate by the Centers for Medicare and Medicaid, as a result of the Medicare Modernization Act of 2003 and is one of only ten organizations with “Medicare-Deeming Status.” This means that once an organization has been accredited by HQAA, it is “deemed” to be eligible for payment by Medicare Part B.
The unique methodology that HQAA conceptualized was to create and implement an entirely on-line method to prepare for an on-site survey by industry experts. This methodology has proven to be very successful for all sizes of operations, from small, single-site companies to very large scale organizations with hundreds of locations. It has been copied by the legacy accreditation bodies and has changed the face of accreditation for the better.
QCCP was created in the wake of the Fungal Meningitis debacle caused by a Massachusetts-based compounding pharmacy masquerading as a drug manufacturer. In working with compounding experts on the heels of the FDA Inquiry, it became perfectly clear that adherence to USP compounding standards would no longer be left to chance. State boards of pharmacy, FDA, third-party payers, and provider networks suddenly began to demand more rigorous compliance and much better documentation and providers have been left to urgently adapt to the new regulatory environment. Obviously, there are no new revenues to offset the increased overhead.
Almost all healthcare providers are attempting to act in the most professional way and thousands have provided safe patient care for decades, but their policies and procedures, labeling, physical environments, product-dating, staff training, and overall documentation fall far short of compliance with USP standards. They are completely unprepared to face unannounced inspections from outsiders who show up at their door armed with a checklist on a clipboard, but who have never practiced in a clinical compounding environment. Few providers are ready to face a two-week unannounced visit from such a team backed by the authority of government.
Affordable preparedness for such outside audits is an urgent need for every health care provider who performs compounding. It became clear that the same highly-efficient methodology HQAA had pioneered for Medicare accreditation was the best solution to this problem, so we created QCCP.
QCCP will provide the tools, the framework and the guidance for its client organizations to understand, implement, and comply with the USP standards that apply to their practice. Compliance is a process, not an event, so our clients can work through all of the necessary steps at their own chosen pace. Our web-based approach allows them to make progress at 5 A.M. or 11 P.M. and ensures that they can never lose track of where they are on their pathway to compliance.
QCCP certification ties to USP standards in a logic, understandable working order. QCCP standards are positioned in an electronic, web-based workroom that is individually designed for each customer and securely accessible via their web browser of choice. The standards that each customer sees are only those that pertain to their scope of practice and the types of compounded medications that they create.
Along with the methodical, step-by-step path that ultimately leads you to certification, QCCP assigns a Resource Technician to serve as a coach, resource and guide through the process. The Resource Technician is never far away when there are questions or needs identified by the customer. Teaming up together to develop the proper tools, techniques, documentation and methods to ensure compliance is our mission. Positive headlines always outweigh the negative when it can be said that you’ve taken extra measures and precautions to ensure the safety and health of the patients you serve.
The steps toward Certification are logical, sequential and clear.
Application for certification occurs on-line. The customer provides information regarding scope of business, demographics and contact persons.
Upon submission of the application, an individualized Workroom is created; only those standards that fit within your scope will appear in your Workroom. QCCP takes the guesswork out of trying to determine, using the entire United States Pharmacopeia, what standards your organization should adhere to.
The person managing the Workroom and Certification process then has username and password access to your organization’s information. The assigned Resource Technician makes an introductory contact and schedules an orientation to the process.
The Workroom portion of the process is such that each standard is laid out in succinct language with additional supporting text describing and defining what the organization can do to implement the requirements, what our surveyor will want to observe, what the intent of each standard is describing, and additional resources if necessary. Each standard does ask for the corresponding Standard Operating Procedure (SOP) that describes how your organization meets the intent of that standard. A simple upload, as easy as attaching a document to an email, places your policy at the foot of each standard, making a solid correlation between what is expected and how you deliver. If your SOP does not exist or misses the mark, we help you see how to hit the target.
Once all standards have been worked through and all SOP’s have been uploaded, the organization goes to the next step which we call, Pre-Survey. This is the time period where companies learn of a time period in which the expert surveyor will arrive and this time is used to ensure that everything in place for that on-site observation.
When the on-site surveyor arrives, they will have already reviewed the SOP’s in your personal workroom so that they have a very good idea of who you are and what you do before they walk through the door. They will spend more time with people than with your policy documents and you will learn at light speed. Prior to their leaving, they will provide a summary of findings so that you know exactly where you stand with your survey.
The survey report is processed within 72 hours and returned with a narrative summary as well as a description of any deficient areas found. A corrective action plan (CAP) may be required to be submitted in order to validate improvement efforts.
If a CAP is required, information is given as to timeframes for review and acceptance.
The final step prior to certification is one last final overview by a Board of Directors appointed committee tasked with ensuring fair, equitable and objective treatment has been given by the surveyor. Upon unanimous decision by the group, the company is deemed Certified. Certification is granted for two (2) years