University of Colorado Hospital Policy and Procedure

Anesthesia Operating Room Pharmacy Controlled Substances Policy and Procedure

Related Policies and Procedures:Drug and Alcohol Free Workplace

Fitness for Duty

Employee/Volunteer Health Screen

Employee Discipline

Description:University of Colorado Hospital Operating Room and the Department of Anesthesiology are committed to a safe, healthy, and productive work environment for all employees, free from the effects of substances that impair employee judgment, and could resultin increased safety risks, injuries, and faulty decision-making.

Accountability:All anesthesia care providers that handle controlled substances.

Responsibility:A provider who assumes ownership of documented controlled substances.

Definitions:

  • Responsible Party: The last provider who the controlled substances were either dispensed to and/or handed-off to.
  • Impaired Employee:Alterations in behavior, cognitive abilities, physical agility, and dexterity due to the ingestion of ethyl alcohol or drugs, including substances with known mind or function altering effects on the person.
  • Controlled Substance/Drug:Any substance that has known mind or function-altering effect on a person, including psychoactive substances and including but not limited to, substances prohibited or controlled by state and federal laws. Drugs may include prescription or nonprescription, and legal or illegal substances.
  • Discrepancy: A variation from a quantity expected. An OR pharmacy employee will compare the distribution/administration records(s) [narcotic return bag] with the anesthesia record. The amount dispensed should equal the amount given, plus the amount to credit, if any, plus the amount to waste. Any differences found versus what was expected in quantities returned or charted, will be considered discrepant.
  • Deviation: Not following established procedures in the handling, charting or safe keeping of controlled medications, resulting in lost or uncharted medications.

Policies/Procedures:

1)Failure to keep controlled drugs securely stored on your person, in a locked cart/cabinet as provided by the facility, or through physical and direct line of sight visual control is considered a violation of this policy.

a)The first occurrence of a controlled substance left unsecured will result in a warning.

b)The second occurrence of a controlled substance found unsecured in one year’s (12 month) time will result in an unresolved discrepancy and is subject to the actions in 5a subsection 3.

2)The OR Pharmacy shall have locked storage for all controlled substances. All records for controlled substances shall be maintained in a readily retrievable manner for five years. Controlled substances records will be maintained in a manner to establish receipt and distribution of all controlled substances. Records of all controlled substances will be maintained separately from non-controlled medication records. The OR pharmacist will maintain a perpetual inventory of all controlled substances used in the operating room setting. Administration and wasting records will be maintained separately from the patient charts. An OR pharmacy employee will compare the distribution/administration records(s) [narcotic return bag]with the anesthesia record.

a)If any discrepancy is found in checking the narcotic bag against the anesthesia record, the anesthesia provider that signed for the controlled substances and any providers who received documented handoff of the controlled substances will be questioned about the discrepancy. This deviation is considered anon-reconciled controlled substance doseand handled via the protocol of section 5a.

b) Poorly documented transactions, illegible handwriting or failure to document doses/ incomplete records will be subjectively deemed a deviation and follow the protocols of section 5a.

3)Controlled substances procedure during OR Pharmacy open hours (06:30-2230M-F, 0700-1530 Weekends/Holidays)

a)The anesthesia provider will obtain standard “narcotic bags” or individual controlled medications from Pyxis or the OR pharmacy. The provider is responsible for ensuring that a patient name label and their name is written or placed on the bag.

b)The OR Pharmacy will maintain a continuous and perpetual inventory using the controlled drug daily record (CDDR) and/or Pyxis. If using the CDDR, enter only one drug (and quantity) or “narcotic bag” per line and the provider will sign for the drugs. Pharmacy will also sign/initial each line and enter OR suite number and time.

c)All medications administered to the patient will be recorded in the anesthesia record. The amounts of controlled drugs administered, returned for credit and amounts to be wasted will be written on the narcotic bag. All non-administered medications to waste or credit (unopened containers) are placed inside the bag and returned to the pharmacy or drop box at the end of the case. Partial vials or syringes with cap, but no needles, may be used for returns.

i)For broken or spilled controlled medications a witness statement with signatures can be given to pharmacy and/or included in the narcotic bag.

d)Pharmacy will verify all narcotic bags and controlled drugs are returned by noting on the CDDR or with Pyxis reports. The anesthesia record will be used to compare the narcotic bag entries for given and returned medications. The amount dispensed should equal the amount given, plus the amount to credit, if any, plus the amount to waste.

e)If the provider fails to return the bag or individual medications after the case, the anesthesia provider will write an explanation explaining the discrepancy or deviation. An explanation of the discrepancy will be kept with the bag until it is resolved. Hospital security will file a report and all other reports (for lost/stolen medications) will be completed as required by law.

f)Qualitative and quantitative analysis will be used by pharmacy to monitor returns. Two pharmacy personnel, pharmacist and/or technician, will waste the previous day’s narcotic bags. They will both verify amounts to waste and initial the bag as witnesses. The empty narcotic bags will be filed by date and area and kept for required lengths of time as per state and federal law.

g)Any discrepancies are considered deviations from the policy (see 2a above), and will be considered anon-reconciled controlled substance dose. This is handled via the protocol in section 5a.

h)Controlled substances may only be checked out by credentialed faculty and instructors of the University of Colorado Health.

4)Controlled substances procedures when the OR Pharmacy is not open.

a)When the OR pharmacies are not open, providers will obtain controlled medications from the Pyxis. Central pharmacy is available for medications not stocked in Pyxis. Providers are responsible for labeling the narcotic bags with patient and provider names and medication given and returned. Returns will be placed in the narcotic drop boxes.

b)The Pharmacist collects all narcotic return bags from drop box the next "open" morning and checks them against the inventory record and Pyxis reports and reconciles any discrepancies according to the procedures when the OR Pharmacy is open.

c)For UCH surgery sites without onsite pharmacy support, controlled drug returns and waste may be performed with a video linked witness at Central UCH for wasting functions. Pyxis reports will be utilized also to assist in comparing removals, charting and wasting of controlled medications.

d)Poorly documented transactions, illegible handwriting or failure to document doses/ incomplete records will be subjectively deemed a deviation and follow the protocols of section 5a.

5)Deviations from the Anesthesia Operating Room Pharmacy Controlled Substances Policy and Procedure.

a)Non-reconciled controlled substance doses will be immediately investigated. If the discrepancy / deviation cannot be resolved within 24 hours of discovery, the following protocol will be put into action:

i)At the time of notification, the first incident of deviation from the controlled substances policy and procedure will result in an initial reporting email of the incident to all providers and students (if any) and the attending physician, or designee (s).

(1)If after two business days the deviation/discrepancy has not been resolved, a second email will be sent toall providers and students (if any) the attending physician, the Chief of Anesthesiology, the Medical Director of Perioperative Services, andthe provider’s supervisors, or designee. The anesthesia care provider(s) must submit the unresolved discrepancy resolution within forty-eight hours of being requested with an accompanying written explanation and a documented action plan to assure total compliance with controlled substances in the future.

(2)Aninitialunresolved discrepancy by an anesthesia care provider(s) requires urine/blood testing authorized by the Department of Anesthesiology.

(3)If the discrepancy remains unresolved within four business work days, a formal email is sent to the Chief of Anesthesiology defining the discrepancy and the following actions occur:

(a)The responsible party (ies) are sent for a urine/blood test; and

(b)An emergency meeting with the Chief of Anesthesiology, the pharmacySupervisor, and the Medical Director of Perioperative Services must occur regarding the unresolved discrepancy.

(4)Any lost or stolen drugs will be reported to the appropriate government agencies per Pharmacy policy.

(5)The responsible party (ies) on the case in question will be required to attend the emergency meeting as described above and may be put on administrative leave until a negative urinary and/or blood test is received pending discussion. Providers who appropriately documented usage or the hand-off of the narcotics prior to the discrepancy will not be subject to this section.

b)The second incident of deviation from the controlled substances policy and procedure will result in an initial reporting email of the incident to all providers, students (if any), attending physician and provider’s supervisor or designee.

(1)If after two business days, the deviation/discrepancy has not been resolved, a second email goes to all providers, students (if any), attending physician and provider’s supervisor, the Chief of Anesthesiology, and the Medical Director of Perioperative Services. The anesthesia care provider(s) must submit the unresolved discrepancy resolution within two business days of being requested with an accompanying written explanation and a documented action plan to assure total compliance with controlled substances in the future.

(2)If the discrepancy remains unresolved within four business work days, a formal email is sent to the Chief of Anesthesiology defining the discrepancy and the following action occur:

(a)Referral to Colorado Physician Health Program (CPHP) and for urine or blood drug test;

(b)An emergency meeting to create a written action plan for reinstatement to the operating room must be agreed upon by the Chief of Anesthesiology, the pharmacy supervisor, and the Medical Director of Perioperative Services regarding the unresolved discrepancy.

(3)Any lost or stolen drugs will be reported to the appropriate government agencies per Pharmacy policy.

(4)All providers on the case in question will be required to attend the emergency meeting as described above and may be put on administrative leave until a negative urinary and/or blood test is received pending discussion. Any providers who appropriately documented usage or the hand-off of the narcotics prior to the discrepancy will not be subject to this policy.

(a)Administrative leave exists until a negative urine sample result is received by the Department of Anesthesiology.

(b)Administrative leave would be deducted from a faculty academic time or Advanced Practice Provider’s education days or from a resident’s education day allotment for that fiscal year.

c)After a third unresolved discrepancy by the same provider within one year (12 months), any and all penalty(ies) will be at the discretion of the Chief of Anesthesiology.

d)All anesthesia care providers are subject to for cause drug testing at the discretionary date and time of the Department (Chief of Anesthesiology and/or the designee).

6)Resolved Discrepancies: If a fifth occurrence of a resolved discrepancy is documented in a 12 month period, it will be dictated as an initial unresolved discrepancy and is subject to the actions in 5a subsection 3.

7)Student learners cannot obtain or check-out any controlled substances.

a)Student learners may only handle controlled substances under the direct supervision of their preceptor (faculty or instructor).

b)The preceptor is responsible for any actions and behaviors of the student learner and is liable for any deviations of the drugs used by their student learners.

c)If a student-originated deviation should occur, the preceptor, attending physician, Medical Director of Perioperative Services, program director, or designee (s) will be notified via email.

d)Further investigations may occur if a student learner is flagged for multiple discrepancies under one or more preceptors.

8)If an unsecured controlled substance is found by Operating Room (OR) or Perioperative Staff, they should be taken to the Charge anesthesia care provider or OR Pharmacist to take the appropriate action(s).

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