Questions Types of Accreditation Services Offered Does your organization have Medicare DMEPOS deemed status? (Yes/No) Is there an accreditation program for: (Yes/No) Yes Long Term Care (LTC) Pharmacy? Yes Home Health Nursing (including Medicare Deemed Status)? Yes Specialty Pharmacy Services? Yes Home Medical Equipment (HME)/Durable ME (DME)? Yes Clinical Respiratory Services? Yes Community Pharmacy/Retail? Yes Ambulatory Infusion Center (AIC) Yes Any other non-pharmacy related program(s)? Hospice, Home Health Therapeutic Services (PT, OT, ST, MSW), Compounding, Sleep Lab, Behavioral Health Complex Rehab, Fitter Services. Inspections services for Compounding pharmacies Accreditation Standards Used Are there specific standards that apply to infusion pharmacy practice? If yes, what are they? The organization informs the accrediting body and other state/federal regulatory agencies, as appropriate, of negative outcomes from sanctions, regulatory inspection and/or audits. License suspension License probation; conditions/restrictions to license Non-compliance with Medicare/Medicaid Regulations identified during survey by another regulatory body Revocation of Medicare/Medicaid/Third- Party provider number Any open investigation by any regulatory or governmental authority 1
(e.g., 483 s warning letters, state Board of Pharmacy sanctions or consent orders) Standard DRX2-6A: Written policies and procedures are established by the organization in regard to the client/patient's rights to accept or refuse care or treatment, client/patient resuscitation and the right to formulate an Advance Directive. Standard DRX2-6B: Written policies and procedures are established and implemented in regard to resuscitative guidelines and the responsibilities of personnel. Standard DRX4-7C: Written policies and procedures are established and implemented requiring all sterile compounding personnel to receive training and/or education and to competently perform the required client/patient service activities prior to being assigned to work independently. Interpretation: Written policies and procedures define the minimum education and training, licensure, certification, experience, and the minimum competencies required for each service offered, as well as the method for documenting that personnel have received the required training. The organization designs and implements a competency assessment program based on the service provided. Competency assessment is an ongoing process and focuses on the service being provided. Competency assessments are conducted initially during orientation and annually thereafter except when required more frequently, for example, for sterile compounding personnel per USP Chapter <797>. Verification of skills is specific to the employee s role and job responsibilities. Policies and procedures are in place for determining that personnel are competent to provide quality service. Competency may be verified through observation, knowledgebased tests, and self-assessment. All competency assessments and training are documented. A self-assessment tool alone is not acceptable. There is a plan in place for addressing performance and education of personnel when they do not meet competency requirements. 2
Prior to personnel performing sterile compounding, training takes place and competency assessments are performed, which include: Didactic training and written testing Media-fill testing consistent with the risk level of compounding, in accordance with USP Chapter <797> Cleaning and disinfecting procedures Hand hygiene and garbing, in accordance with USP Chapter <797> Gloved fingertip sampling consistent with the risk level of compounding performed For personnel who perform sterile compounding, competency assessments are done annually and/or consistent with the risk level of the compounding, which includes: Didactic training and written testing Media-fill testing consistent with the risk level of compounding, in accordance with USP Chapter <797> Cleaning and disinfecting procedures Hand hygiene and garbing, in accordance with USP Chapter <797> Gloved fingertip sampling consistent with the risk level of compounding performed Standard DRX4-9C: Supervision is available during all hours that care/service is provided. Interpretation: There is administrative and clinical supervision of personnel in all care/service areas provided 24 hours per day, 7 days a week, as applicable. Supervision is consistent with state laws and regulations. Standard DRX4-9D: Written policies and procedures are established and implemented that define that Pharmacy Services are provided according to the client/patient s plan of care with access to a Registered Pharmacist available 24 hours a day, 7 days a week. Interpretation: The organization provides Pharmacy Services 24 hours a day, 7 days a week to meet client/patient needs. An on-call coverage system may be used to provide this 3
coverage during evenings, nights, weekends and holidays. Standard DRX4-14A: All Pharmacy Services are provided by qualified personnel and administered in accordance with each state Board of Pharmacy rules and regulations, the organization s policies and procedures and job descriptions, for states into which medications are dispensed. Interpretation: Pharmacists and Pharmacy Technicians function in accordance with the organization s policies and procedures and job descriptions, accepted ethical and professional practice standards and in accordance with all applicable federal, state and local laws and guidelines set by the Board of Pharmacy. If medications are dispensed in other states, the pharmacy has the appropriate license/permits for those states serviced. Current copies of applicable rules and regulations are available. Standard DRX4-14B: Written policies and procedures are established and implemented in regard to all Pharmacy Services being provided under the direction of a Registered Pharmacist who has documented training and competency in the scope of services provided. Standard DRX4-14C: Written policies and procedures are established and implemented in regard to a Registered Pharmacist supervising Pharmacy Technicians in accordance with the organization s policies and procedures and the state Board of Pharmacy rules and regulations. Standard DRX5-1B: Written policies and procedures are established and implemented relating to the required contents of client/patient records for Clinical Respiratory and Pharmacy Services. Interpretation: Written policies and procedures define the required content of the client/patient record. The content includes, but is not limited to: Physician order's that include medications, dietary, treatment and activity orders (as appropriate to the level of care/service the client/patient is receiving) 4
Advance Directives; if applicable Admission and Discharge dates from a hospital or other institution; if applicable Names of power of attorney and/or healthcare power of attorney; if applicable Evidence of coordination of care/service provided by the organization with others who may be providing care/service; if applicable Signed and dated clinical and progress notes Copies of summary reports sent to physicians; if applicable Client/patient/family response to care/service provided A discharge summary; if applicable Initial plan of care Updated plan of care Standard DRX5-2A: Written policies and procedures are established that describe the process for evaluation/assessment and the plan of care for Pharmacy Services. Interpretation: Written policies and procedures describe the process for a client/patient evaluation/assessment, the development of the plan of care and the frequency and process for the plan of care review. A Registered Nurse, Pharmacist or qualified professional, as per state licensure rules or regulations, conducts an initial evaluation assessment to determine eligibility, care and support needs of the client/patient. The plan of care should be appropriate for the type of care/service that is needed. Care planning is directed toward driving positive client/patient outcomes. Standard DRX5-2C: There is a written plan of care for each client/patient accepted for Pharmacy Services. Interpretation: The plan of care is developed during the initial evaluation/assessment conducted by a Pharmacist, Registered Nurse or other qualified professional, as per state licensure rules or regulations. Care planning is directed toward driving positive client/patient outcomes. The initial plan of care includes, but is not limited to: Start of care date Client/patient demographics Principle diagnosis and other pertinent diagnoses 5
Problems/Needs Medications: dose/frequency/route Allergies Orders for specific clinical services, treatments, procedures (specify amount/frequency/duration) Equipment and supplies Expected client/patient outcomes/goals Interventions Monitoring Functional limitations (if applicable) Diet and nutritional needs (if applicable) Safety measures (if applicable) Care planning is directed toward driving positive client/patient outcomes by identifying the client s/patient's needs interventions and treatments/orders. Physician orders are needed to provide any care/services requiring the administration of medication, treatment(s), ongoing assessments or other activities governed by state law. Standard DRX5-4B: There is evidence of changes in the plan of care based on reassessment data. Interpretation: Changes are noted on the plan of care and/or in the progress notes based on: Client's/patient's requests Client's/patient's condition Client's/patient's response to therapy When physician orders indicate changes There is evidence of communication to the physician regarding the client's/patient's condition. If new or revised client/patient or treatment goals are indicated, they must be reflected in a revised plan of care. Revised plans of care shall be approved by the client's/patient's physician. Standard DRX5-7A: A Registered Pharmacist reviews all client/patient medications and consults with other health care professionals caring for the client/patient, including the physician. All Omnibus Budget Reconciliation Act (OBRA) counseling is completed as specified by law. Interpretation: A licensed Registered Pharmacist reviews all prescription and non-prescription medications that a client/patient is currently taking prior to dispensing medications. 6
A medication profile is established at the start of therapy. This profile is reviewed at least every 30 days, updated whenever there are changes in the client's/patient's medication therapy or as designated by the pharmacy policies and procedures. If the client/patient is transferred to another healthcare entity a copy of the medication profile is offered to the new facility or agency. Standard DRX5-11B: Written policies and procedures are established and implemented which address the timeliness of shipping, shipping errors, turnaround time and lost shipments. Interpretation: Written policies and procedures include, but are not limited to: Timeliness of shipping to ensure the client/patient receives medication prior to administration date Ability to track the products after they leave the organization Notification of client if the shipment will be delayed Processes in place to ensure the client has a continuous supply of medication if shipment is delayed or lost Standard DRX5-15B: Written policies and procedures are established and implemented that describe the process for discharge of a client/patient. Interpretation: Written policies and procedures define the circumstances when a client/patient would be discharged. Reasons for client/patient discharge may include client/patient moves outside of the organization's geographic service area, the client's/patient's condition improves and therefore the client/patient no longer needs the care provided, the physician discontinues the order for care/services or the client/patient declines the care/service and requests discontinuation of services or the client/patient expires. Standard DRX5-17A: Written policies and procedures are established and implemented that identify the drugs or drug classifications and routes that are not approved for administration by the organization's personnel. Interpretation: Written policies and procedures identify the drugs or drug classifications and/or routes not approved by the 7
governing board for administration by nursing personnel. Standard DRX7-8E: Written policies and procedures are established and implemented for preparation and/or component recall. Interpretation: The pharmacy has a mechanism for identifying, in a timely and effective manner, which clients/patients received recalled compounded preparations or their components. Standard DRX7-8F: Written policies and procedures are established and implemented relating to the storage of pharmaceuticals, components (including active pharmaceutical ingredients, excipients, ingredients, and devices) and compounded preparations. Standard DRX7-8G: Written policies and procedures are established and implemented by the Pharmacy relating to the appropriate use, calibration, cleaning and as appropriate, disinfection or sterilization of equipment used for preparing, dispensing, labeling, and shipping of preparations. Interpretation: The written policies and procedures and the implementation must include, but are not limited to: Appropriate use of equipment Calibration of machines and equipment that states frequency and findings Cleaning schedules for equipment Disinfection or sterilization procedures and schedules Testing of equipment Procedure for the use, calibration, maintenance, and accuracy testing of ACDs (applies to sterile compounding only) Standard DRX7-8H: Written policies and procedures are established and implemented in regard to assigning each sterile preparation a Beyond Use Date (BUD) to assure that the preparation retains its strength, purity and quality until the labeled BUD date. Interpretation: Written policies and procedures are established and implemented to ensure that an appropriate BUD is assigned to each sterile preparation, which includes: 8
When the pharmacy lacks stability information that is applicable to a specific drug and preparation, BUDs for sterile preparations are assigned using USP Chapter <797> guidelines for each CSP risk level: Low risk preparations: In the absence of passing a sterility test, storage periods before administration cannot exceed 48 hours at controlled room temperature, 14 days at a cold temperature, or 45 days frozen. Medium risk preparations: In the absence of passing a sterility test, storage periods before administration cannot exceed 30 hours at controlled room temperature, 9 days at a cold temperature, or 45 days frozen. High risk preparations: In the absence of passing a sterility test, storage periods before administration cannot exceed 24 hours at controlled room temperature, 3 days at a cold temperature or 45 days frozen. When BUDs are assigned that exceed USP Chapter <797> guidelines, the rationale for the BUD assignment is based upon the following in order of priority: Stability information derived from validated testing of the specific preparation, conditions, and container USP/NF Monographs Published stability information for similar compounds and formulations with the specific container and conditions Stability studies published in literature (peer reviewed preferred) Manufacturer (if a manufactured product is involved) Professional judgment The rationale/source for the BUD assignment is documented on the MFR Compounded preparations are packaged in a manner that maintains their identity, strength, quality and purity until the labeled BUD 9
Personnel should be aware that potency tests are designed to determine how much of the active drug is in the sample, whereas stability tests are used to determine a BUD for the preparation. Standard DRX7-8I: The organization ensures that pharmaceuticals are stored under appropriate conditions of sanitation, light and temperature in the client's/patient's home. Standard DRX7-8J: Written policies and procedures are established and implemented to assure that compounded preparations are labeled in accordance with applicable laws and regulations, USP standards and standards of good practice. Standard DRX7-8K: Written policies and procedures are established and implemented for compounding preparations that outline the selection of ingredients and are in compliance with applicable law, regulations and standards of good practice. Standard DRX7-8L: Written policies and procedures are established and implemented that outline the contents of the Master Formulation Record for each compounded preparation. Standard DRX7-8N: Written policies and procedures are established and implemented in regard to compounding sterile preparations in accordance with USP Chapter <797> standards, the art and science of pharmacy, applicable laws and regulations. Interpretation: Personnel use appropriate techniques to compound preparations. Written policies and procedures are established and implemented to ensure preparations are made in accordance with applicable USP standards, the art and science of pharmacy, and applicable laws and regulations. Standard DRX7-8P: Written policies and procedures are established and implemented for cleaning, disinfecting and monitoring the controlled air environment(s). Interpretation: Cleaning and disinfection procedures follow 10
requirements set forth by USP General Chapter <797> and the individual state boards of pharmacy Standard DRX7-8Q: Written policies and procedures are established and implemented to assure preparations adhere to requirements for sterility and endotoxin limits. Standard DRX7-9A: Written policies and procedures are established and implemented relating to pharmaceutical storage. Standard DRX7-17A: Written policies and procedures are established and implemented for participating in clinical research/experimental therapies and/or administering investigational drugs. Interpretation: Written policies and procedures include, but are not limited to: Informing clients/patients of their responsibilities Informing clients/patients of their right to refuse investigational drugs or experimental therapies Informing clients/patients of their right to refuse to participate in research and clinical studies Notifying clients/patients that they will not be discriminated against for refusal to participate in research and clinical studies Stating which personnel can administer investigational medications/treatments Describing personnel s role in monitoring a client s/patient s response to investigational medications/treatments Identifying the responsibility for obtaining informed consent Defining the use of experimental and investigational drugs and other atypical treatments and interventions Standard DRX7-17A: Written policies and procedures are established and implemented for participating in clinical research/experimental therapies and/or administering investigational drugs. Interpretation: Written policies and procedures include, but are not limited to: Informing clients/patients of their responsibilities Informing clients/patients of their right to refuse 11
investigational drugs or experimental therapies Informing clients/patients of their right to refuse to participate in research and clinical studies Notifying clients/patients that they will not be discriminated against for refusal to participate in research and clinical studies Stating which personnel can administer investigational medications/treatments Describing personnel s role in monitoring a client s/patient s response to investigational medications/treatments Identifying the responsibility for obtaining informed consent Defining the use of experimental and investigational drugs and other atypical treatments and interventions Are there specific standards that apply to infusion nursing practice? If yes, what are they? Standard DRX2-10D: Infusion Nursing Services are provided according to the client/patient s plan of care with access available 24 hours a day, 7 days per week. Interpretation: The organization provides Infusion Nursing Services 24 hours a day, 7 days a week as necessary to meet client/patient needs. An on-call system is used to provide this coverage during evenings, nights, weekends, and holidays. Standard DRX4-12A: A Registered Nurse or Pharmacist is responsible for supervision of all Infusion Nursing Services. Interpretation: All Infusion Nursing Services must be provided under the direction of a Registered Nurse with infusion nursing services training and education or a licensed and experienced Pharmacist with access to infusion nursing practice consultation Standard DRX4-12B: Written policies and procedures are established and implemented in regard to a Licensed Practical Nurses/Licensed Vocational Nurses (LPN/LVN) being supervised by a Registered Nurse. Interpretation: Written policies and procedures outline the supervision of care/service provided by LPN/LVN personnel. The procedure outlines the process for assessing LPN/LVN practice and a method for assuring that client/patient care 12
needs are met. Supervision includes: Client/patient record reviews Case conferences A visit to the client s/patient s home by the RN, with or without the LPN/LVN present, at least every 60 days, unless state laws requires more frequently Standard DRX4-13B: Written policies and procedures are established and implemented relating to special education, experience or certification requirements for nursing personnel to administer pharmaceuticals and/or perform special treatments. Interpretation: Written policies and procedures define any special education, experience, or licensure/certification requirements necessary for nursing personnel to administer pharmaceuticals and/or perform special treatments. Standard DRX5-7C: A Registered Nurse or Registered Pharmacist reviews all client/patient medications, both prescription and non-prescription, on an ongoing basis as part of the care/services to a client/patient. Standard DRX5-17A: Written policies and procedures are established and implemented that identify the drugs or drug classifications and routes that are not approved for administration by the organization's personnel. Interpretation: Written policies and procedures identify the drugs or drug classifications and/or routes not approved by the governing board for administration by nursing personnel. Are there specific standards that apply to specialty pharmacy practice? If yes, what are they? Do you use other standards and/or measures? If yes, what are Our specialty standards are a combination of our infusion standards along with additional requirements that cover other aspects specifically to the specialty market. These include standards that refer to cost containment, REMs and limited release medications and a more comprehensive requirement for the monitoring of the specialty medication along with patient adherence. ACHC has a section that just measures performance improvement. 13
they? Do you recommend consultants? (Yes/No) How often are your standards reviewed and updated? What is the process for standards review? Are stakeholders involved? When standards are updated, are they provided to currently accredited pharmacies free of charge? ACHC incorporates USP 795,797, OSHA and appropriate FDA requirements into our standards ACHC has educational tools that help with accreditation. These tools include workshops and workbooks that can help any company obtain accreditation. ACHC also has certified ACHC consultants listed on our website. These certified consultants had gone through an onsite training and testing before they can be listed on our website as a consultant. ACHC refers customers to our consultant page. Standards are formally reviewed annually, but updates are only completed if required by industry regulatory changes, customer feedback or patient/employee safety issues. ACHC realizes that every change that is made causes internal cost to our accredited companies. All standards before being approved have to be approved by our Standards and Review committee. This committee has industry experts and presently we have two pharmacists that serve on the review committee. There is no charge to currently accredited pharmacies. Fees and Terms Explain your basic fee structure--what are the criteria for your charges? And, what is the fee for each? Are there additional fees? If yes, for what? How are surveyor/evaluator travel/meal etc. expenses paid? What are the customer s payment options & terms? How long is the accreditation term (in years)? Fees are based on the size (#of physical locations), volume and program(s)/service(s) provided by the organization. No Fees are all inclusive and already include all surveyor expenses. There are several different options for payment. ACHC evens offer monthly payment for accreditation for most of our programs. Options include a 6 month payment plan up to an 18 month payment plan. Accreditation is for 3 years Accreditation Process What is the timeline to accreditation? What accreditation decisions are possible? What are the criteria for resurvey? What is the timeframe for corrective actions after survey? How are corrective actions after survey submitted to the AO for Once ACHC receives all of the application information and signs a contract, the organization goes to our scheduling department. Surveys are scheduled on average 2-3 months from time we receive the contract back from the customer. However, organization do give us a readiness date that could be in the future in which case we would not show up until after that date. Accredited, Accreditation Pending, Dependent, Denied This is usually based on patient safety issues or a Condition Level deficiency for Home Health and Hospice. ACHC has a 30 day timeline ACHC sends a template out with instructions of how to complete 14
review? Are written materials, other than the standards, available for preparation assistance? If so, what are they? How does the accredited pharmacy submit documents for presurvey review? What is the onsite survey timeline? What is the average time from application to first day of on-site survey? Does your staff answer standards questions during preparation phase? During on-site survey? (Yes/No) Does your organization provide customers with a policy and procedure manual? (Yes/No) ACHC has educational tools that help with accreditation. These tools include workshops and workbooks that can help any company obtain accreditation. ACHC also has certified ACHC consultants listed on our website. These certified consultants had gone through an onsite training and testing before they can be listed on our website as a consultant ACHC has developed an online portal that allows customers to upload documents for review prior to survey. Pharmacy is averaging 55 days and nursing averaging 58 days Yes we have full time staff to help answer questions to help a company prepare for survey Presently ACHC does not but a company could use our workbook to design the policies around our standards Payer Recognition Does your accreditation meet eligibility requirements for payer program participation: (Yes/No) Long Term Care (LTC) Pharmacy? yes Home Health Nursing (including Medicare Deemed Status)? Specialty Pharmacy Services? yes Home Medical Equipment (HME)/Durable ME (DME)? yes Clinical Respiratory Services? yes Community Pharmacy/Retail? yes Ambulatory Infusion Center (AIC) yes yes Organizational Information What are your general pass/fail percentages? How many pharmacy surveyors are currently on staff? Are pharmacies always surveyed by a pharmacist surveyor? How many years have your organization surveyed pharmacies for clinical pharmacy standards? How many clinical pharmacy programs are currently accredited by your organization? Over 20 pharmacist on staff to survey Yes Since 2001 Over 1000 locations How many pharmacies (licensed locations) are currently accredited Greater than 5000 15
by for DMEPOS compliance? How many nursing surveyors are currently on staff? Are nursing services always surveyed by a nurse surveyor? Who is your current President/CEO? Who is the key contact person for pharmacy accreditation? Please list contact information (address, phone, email, web) Over 25 nursing on staff to survey For Home Health yes we do but for Infusion Nursing and survey for an Ambulatory Infusion Center, we have trained pharmacist that can complete this type of survey. Jose Domingos CEO Timothy Safley MDA Director of Pharmacy DMEPOS and SLEEP Accreditation Patricia Foster Account Services Representative Toll Free 855-937-2242 Fax 919-785-3011 Email pfoster@achc.org Web www.achc.org 16