QRA Update - State Board Inspection Guidance for Veterinarians

What is the state of the opioid epidemic in America?

According to the Centers for Disease Control’s figures from December 2018 there are 130 people who die every day in America from an opioid overdose¹.  While we occasionally will have some good news related to a downward trend in the misuse and abuse of opioids, there remain concerns and far too many individuals are being adversely affected.  As such, national, state and local regulatory agencies are looking at any and all angles to stem the tide.  Around the country, State Boards of Pharmacy (SBOP) have increased the scrutiny of veterinary practices by conducting inspections, as one way to curb the trend.  Most of these inspections are meant as informational and not punitive, allowing for correction and documentation of the actions to remedy any deficiencies found.  However, prior notice of an inspection in the majority of states is not required.

The goal of this article is to provide insight into the more common areas evaluated during a SBOP audit, related to both controlled substances as well as non-controlled substances, and how you can be better prepared when an inspector, regardless of their agency, knocks on your door.

Ralph Waldo Emerson said, “Knowledge is an antidote to fear”. 

The first rule for any inspection is to prepare your team. If an inspector enters your practice and is greeted by a calm and kind individual, that first impression should make a difference. Your team member should ask for official credentials from the inspector if they haven’t already provided them. They can then offer the inspector to wait in the lobby until you or an individual you have designated (and prepared) to act in your absence is available. An inspector should never be granted access beyond the lobby without an escort.

Inspectors will typically have a list of items currently being emphasized by their particular agency for review during an inspection. It is highly recommended that you answer the question being asked, succinctly.  The inspection playbook is typically broken down into multiple sections for completeness. Start to evaluate your hospital’s compliance by working through the following list.  Remember each state has some specifics but by performing this review you’ll have an idea of what areas you may still need to focus on.

Based on our experience with quantitative risk assessment (QRA), below are some of the most common areas evaluated during compliance inspections.

Section 1 Licensing:

• Are all required professional licenses current and available for inspection?
  • All states require the individual who purchases the practices drugs to have a state DVM and Federal DEA (some states also require a state controlled substance registration).
• Are all required facility licenses current and available for inspection?
  • Several state Veterinary licensing boards or SBOP require separate location-based licenses.
• Are other licensed employees current with their credentials?
  • Do all of your employed DVMs and Credentialed Technicians have proof of current licenses?
• Do you have other required publicly posted documents (for example, OSHA, FMLA, and Minimum Wage).
• Of course you’ll also need to have your state required radiation license as well.

Section 2 Medical Records:

• What type of record keeping system does your practice use?
  • In describing the process for your hospital – are you using all paper charts, - electronic medical records (EMR), or some combination of both?
  • Can prescribers “sign-off” electronically when verifying drugs ordered, administered, or dispensed?
    • Are routes of administration documented?
    • Are cage or treatment sheets initialed by Technicians and DVMs?
    • Do Prescription pill vials get checked and initialed by a Technician and DVM before being released?
    • Are Prescribing DVMs reviewing and adding a wet ink initial to prescriptions in a reasonable time?
  • What are your back-up protocols if utilizing EMRs?
• Do patient records contain all required information in a legible format?
  • Each state can have very specific guidelines and requirements about the information contained in a patient’s medical record.
  • A good rule of thumb would be to ask yourself – could another practitioner easily continue care of this patient if I were no longer available?
• Are you properly retaining all patient records for the appropriate period of time?
  • Then ask – if requested, are records readily retrievable within the required timeframe?
    • Each state has a specific retention time listed in statue and can range from two years up to seven years.
    • Your state may also require records not be kept at an on-off site storage facility without prior approval.

Section 3 Minimum Facility Standards:

• Is your practice clean?
• Does it have adequate lighting?
• Is it without serious odor and free of hazards?
• Does your practice maintain the proper equipment to operate a veterinary facility?
  • Your state may have a specific list of required equipment for different types of facilities listed in statute
• Is the area where drugs are being stored in your practice temperature controlled?
• Are drug/vaccine storage refrigerators in good working order and appropriately labeled “non-human food refrigerator”?
• Do refrigerators have some type of temperature monitoring available for notification a diversion outside the desired temperature range?

Section 4 Security:

• Do all exterior doors have suitable locks and does your hospital have an after-hours security system?
  • Your state rules could have allowances when monitored security systems are in place.
• Are all controlled substances stored in a secure environment per federal and state guidelines?
  • All lock boxes must be secured when not being accessed.
• Are protocols and procedures in place to monitor for and determine if a controlled substance diversion has taken place?
  • What is the interval for controlled substance inventory counts?
    • The DEA requires every two years as a minimum and an increasing number of states have moved to an annual requirement as a means to better monitor for diversion. We feel an annual inventory should be a minimum and encourage a perpetual count as best practice.
    • Is a copy of your latest inventory available for review?
  • Any and all inventory discrepancies or unusual activities are investigated for possible diversion.
  • Is access limited to controlled substances?
    • Access should be limited to authorized persons only and you should have a list of those individuals assigned available for review.
  • What is the process to report when a drug theft or loss is determined to be significant?
    • Any significant loss of a controlled substance is required to be promptly reported to the SBOP and the DEA via a form 106 (online). Identified diversion is also reported to local law enforcement per their recommendation.
    • The DEA definition of a significant loss can cause even more confusion. The DEA states²  the following items related to significant loss.
      • When determining whether a loss is significant, a registrant should consider, among others, the following factors:
        • The actual quantity of controlled substances lost in relation to the type of business;
        • A pattern of such losses, and the results of efforts taken to resolve them; and, if known,
        • Local trends and other indicators of the diversion potential of the missing material.

Section 5 Drug Purchase Records and Accountability:

• Do you have all drug purchase and use records (for both controlled and non-controlled) available for the required retention timeframe on hand for inspection?
  • Again this varies by state.
• Does the clinic use DEA-222 forms to order C-II controlled substances?
  • Describe hospital’s process for ordering and receiving schedule II drugs. Some hospitals use 222 forms, others use the DEA’s electronic ordering system (CSOS).
  • If the clinic uses the DEA-222 forms, are blank forms properly secured and are completed forms properly filed and available for review?
• Do you have all C3 – C5 controlled substance receiving invoices available and available for review?
• Do you have proof you are purchasing your drug products from state licensed distributors?

Section 6 Drug Dispensing Records and Accountability:

• Does the clinic utilize prescription drug samples?
  • States can require samples be logged and dispensed at no charge and may have very specific sample labeling requirements.
• Are your practice’s prescription labels in compliance with state specific information requirements?
• Are all drugs prescribed and dispensed within a valid veterinarian-client-patient relationship (VCPR)?

Section 7 Outdated Drugs and Drug Destruction:

• Are there expired medications on your shelves for dispensing?
  • Develop a process or visual system to identify and remove these from your dispensing shelves.
• Are all known expired medications segregated from the dispensable clinic drug stock?
• Can you legally destroy controlled or non-controlled drugs at your practice?
  • If so – do you have a written policy and procedure for each type of drug?
    • What is your process?
      • Will drugs be rendered “non-retrievable”?
      • Non-retrievable means: for the purpose of destruction, the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance's physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes.³
    • Who can perform the process?
    • What documentation do you need?
      • A DEA form 41 for controlled substances.
    • If not – how do you legally dispose of outdated drugs?
  • On a related topic - a new U.S. EPA rule ‘Management Standards for Hazardous Waste Pharmaceuticals’ (also known as the “Hazardous Waste Pharmaceuticals Sewer Ban”) will become effective on August 21, 2019

Section 8 OSHA:

• Only fill sharps containers to the designated “full” line.
  • This has been mentioned as a common deficiency  in veterinary hospitals and fines for over filling can be levied for each container found out of compliance. OSHA fines can be as high as $13,260 per violation.⁴
• Don’t have food of drinks within the “clinical areas”.
  • This is another common problem found. All beverages and food for human consumption is required to be located out of a possible contamination area.
• Make sure your hazards communication program is in place and up to date.
  • There are many hazards associated with working in a veterinary practice. As an employer you are required to access those hazards and inform your team how they can protect themselves.

Section 9 Ambulatory Vehicles:

• • Does your practice use a vehicle to treat animals in the field?
    • Different rules exist for exclusive mobile clinic vehicles in each state.
    • If you have an ambulatory portion of your practice, the vehicle used is typically classified as an extension of your building may have  rules in place related to:
      • Drug storage temperature controls.
      • Drug storage security controls.
      • Records and documentation of controlled substance inventories available.

  Where do I go from here?

  You’ll note that each states’ Veterinary or Pharmacy Licensing Board plays a large part in regulating our profession within its borders.  Please keep in mind, as a practitioner and license holder it is your responsibility to be well informed about your particular state’s board of Pharmacy or Veterinary Licensing Boards’ laws and rules.

References

1. https://www.cdc.gov/drugoverdose/epidemic/index.html ; Accessed July 1, 2019
2. https://www.deadiversion.usdoj.gov/fed_regs/rules/2003/fr0708.htm; Accessed July 30, 2019
3. https://www.deadiversion.usdoj.gov/21cfr/cfr/1300/1300_05.htm; Accessed July 30, 2019
4. https://www.osha.gov/penalties; Accessed July 30, 2019