2. Review the Standards
The ACHC Specialty Pharmacy (SRX) Standards are divided into seven sections, each with its own focus. Here is a high-level overview of the intent of these sections, as well as some specific challenges and helpful tips.
Section 1 – Who are you?
This section examines your organizational structure—the governing body, ownership, bylaws, decision making authority, and, in general, who is a part of your business. Most practices have overarching policies and procedures and an organizational chart that meet these requirements. Ensuring that all applicable licenses needed are current and active is also an important part of this section of standards.
Section 2 – How do you operate?
The entire business, not just the pharmacy, is required to meet the standards in this section. Section 2 is concerned with how your practice handles ethical issues and any patient complaints or grievances. These standards address diversity, communications, and ensuring there is a toll-free number in place that can report on wait times and any dropped calls.
Section 3 – What is your financial outlook?
Physician practices are constantly reviewing expenses, revenue and margin to help ensure continued growth. Section 3 looks at how the dispensing program fits into the overall financial picture of the practice. Having a budget for the dispensing program and clear recordkeeping is an important part of this section. Monitoring of cash pricing, financial assistance, and general charges and billing processes will be required to meet these standards.
Section 4 – Is your staff trained?
Your practice’s human resources department and director must be on board with the accreditation process. ACHC surveyors will be required to meet with HR personnel, and have access to employee files to ensure the standards in this section are being met. Most standards in this section can be met by a thorough review of the “New Employee Orientation” process. Annual training, testing, competency, and other requirements can be reviewed during the annual “Performance Review” process for employees—ensuring that elements of these standards don’t get missed. Tuberculosis testing, Hepatitis B vaccination, and drug testing policies are key to passing the accreditation survey in this area.
Section 5 – Are you offering quality care?
This section is where your program—whether physician dispensing or closed-door retail pharmacy—is able to show the quality and consistency of care that is being provided. Surveyors will review patient records for content and retention. It is important to review the materials you are using to educate and inform patients about their medications and the information you are sharing with other healthcare providers. Communication to patients regarding the timeliness of delivery of their medications, both new and refills will also be reviewed. In this section, the concept of a patient “Plan of Care” is introduced. These plans of care are required to be initiated with the initial prescription, reviewed at least monthly, and involve patient interaction. Care plans may be manual or integrated into your software, but they must be in place for all patients on specialty medications.
TIP: For PioneerRx users, VitalSource™ GPO offers pharmacy care plans integrated within the software to help simplify these requirements.
Section 6 – How are you performing?
This section tends to be the most difficult and time-consuming for practices. In Section 6, the practice is asked to prepare a written “Performance Improvement Plan” outlining the elements that they commit to monitoring - in writing. Some of these elements include:
- Adverse events
- Patient complaints
- Patient record content
- Patient satisfaction surveys
- Billing and coding accuracy
Additional metrics may be added at the practice’s discretion. An annual report is required and must include a complete review of the dispensing program, including:
- Number of patients served
- Number of prescriptions dispensed
- Prescriptions per payor
- Delivery times
- Patient complaints
- Toll-free phone call metrics
- Satisfaction surveys
It is important to be specific regarding what is being monitored, where the data is coming from, who is responsible for pulling the data, how often the data is being pulled, the benchmark or goal you are striving for, and any action to be taken if that benchmark is not reached or that goal is not obtained. This section requires a lot of time and effort during initial accreditation, but also is an important part to keep running smoothly for the re-accreditation process.
Section 7 – Is your facility safe?
Section 7 looks back at the practice as a whole and ensures that the dispensing program and pharmacy staff are aware of policies and procedures that keep them safe while working. This section includes standards for an emergency preparedness plan, disaster training, fire safety and the handling of hazardous drugs. Storage of medications, medication recalls, and any REMS (Risk Evaluation and Mitigation Strategy) program policies and procedures will also be reviewed during the survey process.
TIP: Your VitalSource™ GPO Practice Consultant is here to help you review the standards, set up a project plan, provide site visits, and walk you through the entire accreditation process.
The Oncology Distinction (ONC): Section 11
Practices dispensing oral chemotherapy agents are also eligible for an Oncology Distinction (ONC). ONC standards focus on the specific needs of the cancer patient and how those needs are met. Obtaining this distinction enables you to obtain additional accreditation, which may be required by some pharmacy networks. The ONC is also an excellent way to demonstrate, and be recognized for, the quality of care you are providing for your patients
The requirements focus on the processes, policies, and operating procedures that make cancer care unique. You will be asked to form a “Professional Advisory Committee” that regularly meets to problem-solve issues related to patients receiving oral chemotherapy medications. Ongoing staff education in areas specific to cancer patients, is required. Ensuring that orders are initiated and reviewed by the physician and the dispensing program to ensure proper dosing and monitoring is key to meeting this distinction. Ensuring that financial assistance and patient advocacy support is provided to each patient is also a requirement, as is compliance with USP <800> standards pertaining to the dispensing of oral hazardous drugs.
TIP: Organize and add oral chemotherapy regimens to your EMR to help meet these standards.