Compliance Inspections
OVERVIEW
It is the policy of the Texas Board Veterinary Medical Examiners to conduct risk-based inspections. The Board will conduct a risk-based inspections of a veterinarian’s practice based on information obtained from the veterinarian or another source concerning the veterinarian’s use, handling, prescribing, dispensing, or delivery of controlled substances. In addition, the Board will inspect equipment and business premises; examine and/or copy client and patient records, drug records, including, but not limited to, invoices, receipts, transfer documents, inventory logs, surgery logs; and all other associated records relating to the practice of veterinary medicine or equine dentistry.
While inspecting a licensee with identified risks, other licensees operating within the same clinic may be inspected.
As part of its Sunset Review, the Texas Legislature indicated its desire that the Board have an effective, consistent, and timely inspection process. The Sunset Commission recommended all licensees be inspected at least once every eight (8) years.
INSPECTION RULES
801.164. RISK-BASED INSPECTIONS RELATED TO CONTROLLED SUBSTANCES PRACTICES.
The board may conduct a risk-based inspection of a veterinarian’s practice based on information obtained from the veterinarian or another source concerning the veterinarian’s use, handling, prescribing, dispensing, or delivery of controlled substances.
RULE §573.63 Inspection of Facilities and Records
Licensees shall admit a representative of the Board, during regular business hours, to inspect equipment and business premises; examine and/or copy client and patient records, drug records, including, but not limited to, invoices, receipts, transfer documents, inventory logs, surgery logs; and all other associated records relating to the practice of veterinary medicine or equine dentistry.
RULE §573.75 Duty to Cooperate with Board
A licensee shall:
(1) cooperate fully with any Board inspection or investigation;
Key Compliance Issues:
TBVME conducts unannounced on-site compliance inspections to ensure licensees adhere to professional standards. These inspections focus on but are not limited to:
CONTROLLED DRUGS
Monitoring Harmful Prescribing and Dispensing Patterns (Occupations Code 801.5011)
A review of prescribing and dispensing information will occur to determine whether a veterinarian is engaging in potentially harmful prescribing or dispensing patterns or practices.
In determining the conduct that constitutes a potentially harmful prescribing or dispensing pattern or practice, the board, at a minimum, shall consider: the number of times a veterinarian prescribes or dispenses: opioids; benzodiazepines; barbiturates; or carisoprodol; for patterns of prescribing or dispensing combinations of those drugs and other dangerous combinations of drugs.
Controlled Substances Record keeping for Drugs on Hand Logs (Rule 573.50)
Texas veterinarians shall maintain at their place of business records of all scheduled drugs listed in the Texas Controlled Substances Act in their possession. These records shall be maintained for a minimum of five years. A record shall be kept for each scheduled drug. The records shall be complete, contemporaneous, and legible.
Administering / Dispensing records must reflect the date of acquisition; quantity purchased; date administered or dispensed; quantity administered or dispensed; name of client and patient receiving the drug(s); and a total balance on hand of the scheduled drug.
Minimum Security for Controlled Substances (Rule 573.61)
Veterinarians shall adhere to the following to ensure security of controlled substances: Establish adequate security to prevent unauthorized access to controlled substances; Establish adequate security to prevent the diversion of controlled substances; During the course of business activities, do not allow any individual access to controlled substances storage areas except those authorized agents required for efficient operations.
Controlled substances listed in Schedules I, II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet or security cabinet.
The cabinet must be constructed as to resist any entry by simple tools of attack such as screw drivers, crow bars, tire tools, pry bars, etc. Hinges should not be mounted with bolts or screws on outside of door and the locking devices should be installed internally as in a dead bolt type or the device should be of a type that has protected mounting screws or bolts to inhibit removal. The cabinet should be permanently constructed or attached to the building structure or fixtures so as to prevent the cabinet from being physically removed from the premises. If the cabinet is a metal file cabinet type, it should be permanently attached to prevent easy removal and have an external locking bar that secures the drawer or drawers.
Controlled Substance Registration (Rule 573.43)
A licensed veterinarian shall comply with all requirements of the federal Drug Enforcement Administration (DEA) regarding controlled substance registration and A licensed veterinarian registered with the DEA must comply with all relevant state and federal statutes and rules, including but not limited to Chapter 481 of the Texas Health and Safety Code, Chapter 13 of Part 1 of Title 37 of the Texas Administrative Code, and Chapter 13 of Title 21 of United States Code.
Inventory Requirements (Title 21 CFR 1304.11)
An inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location.
Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances. In the event a person commences business with no controlled substances on hand, he/she shall record this fact as the initial inventory.
After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.
Drug Labeling (Rule 573.40)
A veterinarian shall affix labels to all unlabeled containers containing any medication dispensed and to all factory labeled containers that contain prescription (legend) drugs and/or controlled substances dispensed.
The label must be affixed to the immediate container and include: the veterinarian’s name, address, and telephone number (including area code); date of delivery or dispensing; patient/client name (and address if drug is a controlled substance); species of the animal; name, strength, and quantity of the drug dispensed; directions for use; and cautionary statements as required by law, i.e. not for human consumption, poisonous, withdrawal periods, etc.
In addition, all compounded drugs must bear the labeling information required under shall include: date on which the drug was compounded; name and strength of medically active ingredients; identity of treated animals; withdrawal/withholding times if needed; and condition or disease to be treated; a date dispensed and an expiration date.
PATIENT RECORD KEEPING
Patient Records (573.52 / 573.53)
Individual records shall be maintained at the veterinarian’s place of business, shall be complete, contemporaneous and legible.
Alternative Therapy Forms (573.14 / 573.16 / 573.17 / 573.18)
A veterinarian practicing Chiropractic and Other Forms of Musculoskeletal Manipulation shall obtain as a part of the patient’s permanent record a signed acknowledgment by the owner or other caretaker of the patient that animal chiropractic or MSM is considered by Texas law to be an alternate therapy.
A veterinarian practicing Acupuncture: Before acupuncture may be used in the treatment of an animal, the veterinarian must obtain a signed statement from the animal’s owner or caretaker acknowledging that acupuncture is an alternate therapy in veterinary medicine and approving its use in the treatment of the animal. Before signing the statement, the veterinarian shall inform the client of the conventional treatments available and their probable ability to cure the problem. The statement shall become a permanent part of the patient’s record.
A veterinarian practicing Holistic Medicine: Client Consent Required. Before holistic medicine may be used in the treatment of an animal, the veterinarian must obtain a signed statement from the animal’s owner or caretaker acknowledging that holistic medicine is an alternate therapy in veterinary medicine and approving its use in the treatment of the animal. Before signing the statement, the veterinarian shall inform the client of the conventional treatments available and their probable ability to cure the problem. The signed statement shall become a permanent part of the patient’s record.
A veterinarian practicing Homeopathy: Client Consent Required. Before homeopathy may be used in the treatment of an animal, the veterinarian must obtain a signed statement from the animal’s owner or caretaker acknowledging that homeopathy is an alternate therapy in veterinary medicine and approving its use in the treatment of the animal. Before signing the statement, the veterinarian shall inform the client of the conventional treatments available and their probable ability to cure the problem. The signed statement shall become a permanent part of the patient’s file.
FACILITY
Sanitation (573.79)
Licensees must maintain their offices/clinics/hospitals and the offices/clinics/hospitals in which they work, including mobile facilities, in a clean and sanitary condition without any accumulation of trash, debris, or filth. Such premises shall be maintained in full compliance with all health requirements of the city or county in which located and in conformity with the health laws of the State of Texas; further, they shall use properly sterilized instruments and clean supplies.
Notice to Client Displayed (573.29)
A licensed veterinarian or licensed equine dental provider shall provide an effective way to inform clients and other visitors to the premises, clinic or hospital of how to file complaints with the Board.
Acceptable forms of providing the information in subsection (a) of this section may include a: written notice form, with print size of at least 14 point, prominently displayed in the area of each clinic or hospital that is most frequented by the public; brochure available in the area of each clinic or hospital that is most frequented by the public; or statement on each written bill, invoice or receipt.
License Displayed (573.35)
Each licensee, including a relief veterinarian, shall post or display at the licensee’s practice location, whether mobile or fixed, his or her Board license. This document must be displayed where it is visible to the public. A legible photocopy of the original document is acceptable.
Contact Information (573.76)
Each licensee shall report to the Board the licensee’s: name and license number; clinic or practice name; physical business address; mailing address; residence address; business telephone number; and residence and/or cellular telephone number.
A mailing address may be a post office box number. A physical business address shall be a physical location and shall not be a post office box number. If a remote practice location does not have a physical business address, the licensee must provide as the physical business address sufficient directions as to how the practice location may be found.
A relief veterinarian’s physical business address shall be the physical business address where the relief veterinarian regularly conducts the largest percentage of his or her relief work at one clinic. If the relief veterinarian does not have one clinic where he or she conducts the largest percentage of his or her work, then the relief veterinarian shall use the physical address of one of the locations where he or she works. If the relief veterinarian is not actively working, then the relief veterinarian may use his or her physical residence address, which shall not be a post office box number.
A licensee shall notify the Board of any change of items required under subsection (a) of this section not later than the 60th day after the change takes place.
