Controlled Substance Monitoring

DEPARTMENT : Clinical Services Group -

Pharmacy

POLICY DESCRIPTION : Controlled Substance

Monitoring

PAGE: 1 of 13 REPLACES POLICY DATED: 3/1/08, 5/31/10,

5/1/11

EFFECTIVE DATE: November 1, 2011 REFERENCE NUMBER: CSG.MM.001 (formerly

QM.003)

APPROVED BY: Ethics and Compliance Policy Committee



SCOPE: All Company-affiliated facilities including, but not limited to, hospitals, ambulatory surgery centers, home health centers, home health agencies, physician practices, outpatient imaging centers, service centers and all Corporate departments, Groups, Divisions and Markets where controlled substances are utilized.

PURPOSE: To establish controls related to ordering, receiving, prescribing, dispensing and administering controlled substances and documenting such activities. The term “controlled substance” means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V

(including IIN and IIIN) of the Controlled Substance Act. The facility should continue to follow federal and state controlled substance laws and regulations.

POLICY: In order to detect intentional or unintentional breach of procedure in controlled substance handling, the facility must establish a process for monitoring compliance with its policies and procedures that relate to ordering, receiving, prescribing, dispensing and administering controlled substances and documenting such activities.

Facility Administration must designate a person in writing to be responsible for insuring that the monitoring described herein is performed, monitoring results are collected, and trending data is analyzed to detect variances in practice.

______________________ (name) at __________________________(facility) will be responsible for overseeing policy compliance.

The facility must ensure that any discrepancies identified in ordering, receiving, administering, or reconciling the inventory of controlled substances is investigated immediately upon discovery.

Similarly, the manager of the department or designee with such a discrepancy must investigate any situation that indicates a breach in product integrity ( e.g.

, broken or cracked containers, broken seals) or a failure to follow appropriate policies related to controlled substances.

DEFINITION:

Outpatient practices , for purposes of this policy, are not hospital-based or included within a hospital or Ambulatory Surgery Center license, certification or accreditation.

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PROCEDURE:

A.

Ordering and Receiving Controlled Substances, Schedule II

Ordering and receiving of C-II controlled substance may be completed by either of the two processes outlined in Section 1 (preferred) or Section 2 (immediately below) or a combination of both processes.

Section 1: Use of the Controlled Substance Ordering System to Purchase Controlled

Substances, Schedule II .

Effective May 2005, the Drug Enforcement Agency (DEA) implemented the Controlled Substance

Ordering System (CSOS) which allows for a secured electronic transmission of controlled substance orders (e222) without the supporting paper DEA Form 222. Company-affiliated facilities are encouraged to adopt the CSOS process for ordering controlled substances. The efficiencies of the electronic ordering system make the system easy to use for most Schedule II (C-

II) transactions while maintaining security requirements. Use of the paper DEA Form 222 will continue to be allowed for the foreseeable future and will even be required for certain processes, including the return of C-II controlled substances to the wholesaler. a.

The CSOS regulations require the following persons to be identified:

1) DEA Registrant – the person who last signed/renewed a DEA 224 application. HCA affiliates are required to specify the Chief Executive Officer (CEO), Administrator, or

Practice Manager of the facility as the DEA registrant. For outpatient practices, an individual practitioner who is an agent or employee of another practitioner (other than a mid-level practitioner) registered to dispense controlled substances may, when acting in the normal course of business or employment, administer or dispense (other than by issuance of prescription) controlled substances if and to the extent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices, under the registration of the employer or principal practitioner in lieu of being registered him/herself. Further duties associated with controlled substance ordering/management may be delegated by the CEO, Administrator, or Practice Manager using a Power of

Attorney (POA). Facilities may specify the Director of Pharmacy or designee be delegated this duty with a POA in an inpatient setting and the Administrator in an outpatient setting.

Outpatient physician practices should have a practice DEA Registrant for ordering controlled substances for use in the practice setting.

2) CSOS Coordinator – each DEA Registrant identifies a person to hold the DEA number, monitor license renewal, designate those employees eligible to order controlled substances electronically, retain all digital certificates, and to manage these activities. The Company recommends that the Director of Pharmacy be the CSOS Coordinator for the facility. The

DEA Registrant shall convey this responsibility through a POA.

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3) Power of Attorney (POA) Designees –The Company recommends that a named individual be identified as the primary person to order C-II controlled substances for the facility

(primary designee). The DEA Registrant or CSOS Coordinator may assume this duty of ordering C-II controlled substances. Alternatively, the CSOS Coordinator may identify another employee as the primary designee. The primary designee must have a POA submitted to the DEA for final authorization to order C-II controlled substances.

Additional staff may also be identified to order C-II controlled substances in the absence of the primary designee, but the number of POAs should be limited based on the need of the facility. Such ‘secondary designees’ must also have a POA submitted to the DEA to be fully authorized to submit orders. b. The CSOS Coordinator must submit all required documents to the DEA for issuance of digital signatures to the individuals granted POAs and maintain a copy of each document submitted in a secure area in the Pharmacy or a secured location in areas without a Pharmacy. c. Each individual granted a POA will be e-mailed his or her access code and delivered by U.S. mail the password. POA access codes and passwords must not be shared with any other persons. d. With the digital signatures, the CSOS Coordinator must download the Digital Certificates from the DEA website to the facility-based computer. One computer should be used for placing and receiving all CSOS orders. This is important as records will be downloaded from the wholesale vendor website to the facility-based computer that will include the order placed for the C-II controlled substances and the receipt acknowledgment of the order. The digital certificate files, order acknowledgment files and receipt acknowledgment files must be copied to an external CD, floppy disk, or flash drive after each order receipt occurs. This file copy must be maintained in a secure area with limited access as defined by the CSOS Coordinator. e. The CSOS Coordinator is responsible for notifying the facility’s wholesale vendor that the facility will place orders electronically for C-II controlled substances. This includes account setup for CSOS ordering at the wholesale vendor website. It includes the creation of access to the wholesale vendor website for all staff with POA privileges. f. Separation of Ordering/Receiving Functions – Ordering and receiving of C-II controlled substances must be performed by different individuals unless mitigating circumstances prevent this from occurring. In such instances, compensating controls should be implemented

( e.g.

, additional independent reviews, outside audits). The facility should consider limiting the ordering and receiving authority of any Controlled Substance product to designated staff members, not all Pharmacy Department Staff members. As part of CSOS use, both ordering and receiving must be done in the wholesale vendor website program.

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APPROVED BY: Ethics and Compliance Policy Committee g. The receiving process must include a reconciliation of controlled substances received against the packing slip or invoice. The printed invoice must be signed and dated by the receiver indicating completion of this phase of receipt of product. With the invoice signed and dated, the receiver or another staff member with POA access must receive the C-II controlled substances in the wholesale vendor website system. Completion of this activity will allow downloading of the receipt record into the facility personal computer for permanent storage. A backup must be performed after each C-II controlled substance receipt into the facility pharmacy. Note: The receiver’s signature and dating of the invoice must be a separate action from the signing of the invoice by the Director or authorized person approving payment for

Accounts Payable.

Section 2: Use of DEA Form 222 to Purchase Controlled Substances, Schedule II a.

Authority to Purchase Controlled Substances. Company-affiliated facilities are required to specify the Chief Executive Officer (CEO), Administrator, or Practice Manager of the facility as the DEA registrant. For outpatient practices, an individual practitioner who is an agent or employee of another practitioner (other than a mid-level practitioner) registered to dispense controlled substances may, when acting in the normal course of business or employment, administer or dispense (other than by issuance of prescription) controlled substances if and to the extent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices, under the registration of the employer or principal practitioner in lieu of being registered him/herself. Further duties associated with controlled substance ordering/management may be delegated by the CEO, Administrator, or Practice

Manager using a Power of Attorney (POA). Facilities may specify the Director of Pharmacy or designee be delegated this duty with a POA in an inpatient setting and the Administrator in an outpatient setting. Outpatient physician practices should have a practice DEA Registrant for ordering controlled substances for use in the practice setting.

b.

Each pharmacy director should have a duly executed POA, signed by the CEO of the facility, to order all controlled substances in schedules II, II-N, III, III-N, IV, and V for the institution.

DEA 222 forms are used for ordering Schedule II and II-N. It is not required for lower schedule controlled substances. The POA should be permanently kept with other controlled substance records. Additional powers of attorney may be required if another individual, e.g.

, a

Pharmacy Supervisor, is to be able to order (sign) DEA Form 222 order forms in the Pharmacy

Director’s absence. c.

Control of and Access to DEA Form 222 (Schedule I & II Order Forms). DEA Form 222 is the official form used to order controlled substances in Schedules I & II from manufacturers, wholesalers, or other sources. Upon receipt of DEA Form 222 ordering forms from the Drug

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Enforcement Agency, the Pharmacy Director or designee must record each DEA Form 222 number onto a control log to document all forms received into the facility. Unused DEA 222 forms should be stored in a secured area, e.g.

, in the controlled substances vault or a locked drawer, accessible only by those individuals authorized to order controlled substances in

Schedules I & II. By Federal regulation, Controlled Substances in the Schedules III, III-N, IV, and V do not require a DEA Form 222 for ordering. d.

Pre-Signing DEA Form 222. DEA Form 222 should be signed by the authorized agent/attorney only as orders are placed . Blank forms should never be pre-signed in anticipation of future use. e.

Execution of DEA Form 222. In completing DEA Form 222, care should be taken so that no erasures or alterations are made anywhere on the form. If a mistake is made, void all copies of the form and maintain the voided copy in your records. Only one item should be ordered on a single line and the number of different items ordered should always correspond to the “number of items ordered” entry on the form. The Supplier’s Copy 1 and DEA Copy 2 are sent to the drug wholesaler/supplier and Purchaser’s Copy 3 retained in the pharmacy. f.

Separation of Ordering/Receiving Functions. Check and balance systems should be in place so that the ordering and receiving of controlled substances are performed by different individuals unless mitigating circumstances prevent this from occurring. In such instances, compensating controls should be implemented ( e.g.

, additional independent reviews, outside audits). The facility should consider limiting the ordering and receiving authority of any Controlled

Substance product to designated staff members, not all staff members. g.

Reconciliation of Invoices/Packing Slips for Controlled Substances. The receiving process must include a reconciliation of controlled substances received against the packing slip or invoice accompanying the order as well as the DEA 222 ordering form. On the “blue” copy

(Purchaser’s Copy 3) of the DEA Form 222, the number of packages received and date received must be filled in. Both the DEA Form 222 and the invoice must be signed and dated by the receiver. The Director must not be precluded from stapling the DEA 222 form to the invoice or packing slip. If stapled together, the attached documents must be stored together in a different location from all other DEA 222 ordering forms. If the DEA 222 form is not affixed to the invoice or packing slip, the Director should store the DEA Form 222 in a separate and independent location from the invoice copy signed and dated by the receiver, and the packing slip signed by the receiver for Schedule II controlled substances. Note: The receiver’s signature and dating of the invoice must be a separate action from the signing of the invoice by the Director or authorized person approving payment for Accounts Payable.

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Section 3: Receiving of Controlled Substances a.

Direct Delivery of Controlled Substances. All controlled substances should be delivered directly to the Pharmacy Department (or designated location in facilities without a pharmacy) and never through an intermediary, such as the Purchasing Department. Only authorized personnel should be allowed to “receive” such orders. Exception: non DEA designated controlled substances can be delivered with other non-controlled substance medications. Once the delivery reaches the pharmacy it must be received and entered into the non-DEA designated controlled substance inventory. b.

Immediate Resolution of Order Discrepancies/Shortages/Breakage. In case of any order discrepancy, shortage or breakage, the wholesaler must be notified immediately and the incident documented on the packing slip/invoice. c.

Inventory System for Controlled Substances. An inventory system that assures accuracy of all controlled substances is required. For all controlled substances, an inventory system must be maintained. The inventory system may be either manual or computerized as long as the disposition of all controlled substances ( e.g.

, all controlled substances received, dispensed to nursing units, or returned to reverse wholesalers) is accurately tracked. d.

Biennial Inventory: The DEA requires that a controlled substance inventory must be taken at least once every two years. However, HCA Accounting Policy Guide (APG #07) requires a minimum annual inventory. The inventory should be signed and dated by the person conducting the inventory. A separate inventory is required for non-DEA designated controlled substances. e.

Monthly Record of Controlled Substance Purchases. The Pharmacy Director or Administrator must maintain the purchasing summary available from drug wholesalers, or a written history of all controlled substance purchases made by the facility for the month, sorted by date. f.

Monitoring Procedure for Ordering and Receiving Controlled Substances. The Pharmacy

Director or Administrator must employ the following methods for monitoring the ordering and receipt of controlled substances.

1) Check off all DEA 222 (e222) numbers on Wholesaler Customer Narcotic Purchase

Record against inventory; and

2) Randomly select 3 deliveries per month and confirm the presence of proper documentation on the DEA 222 (e222) form, match units received as documented by invoice and receiving personnel notation on the DEA 222 form, and match units received against the inventory.

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B.

Transferring Controlled Substances

1.

A DEA form 222 is required for each transfer of a schedule II controlled substance.

2.

Schedule III-V controlled substances must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred. The document must include the names, addresses, and DEA registration numbers of the parties involved in the transfer of the controlled substances.

3.

Non-DEA designated Controlled Substances must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred. The document must include the names, and addresses of the parties involved in the transfer of the controlled substances.

4.

Transfer can occur only for the purpose of general dispensing to patients.

5.

The receiving facility/practitioner must be registered with the DEA.

6.

The distribution is recorded by the distributing party and by the receiving party.

7.

The total number of dosage units of all controlled substances distributed by the facility/practitioner during each calendar year does not exceed five percent of the total number of dosage units of all controlled substances distributed/dispensed by the facility/practitioner during the same year.

C.

Prescribing Controlled Substances

Prescribing of controlled substances is limited to a Licensed Independent Practitioner (LIP) or

APP (Advanced Practice Professional) with controlled substance prescribing privileges that have been granted only if the practitioner has a verified and current DEA registration with an in-state address, as defined in Compliance Alert #28. Additionally, an LIP or APP with controlled substance prescribing privileges must have verified and current state controlled substance registration when practicing in a State that requires registration.

D.

Medical Staff a.

Hospitals and ASCs shall have medical staff bylaws or a policy that shall specify the requirements for an LIP or APP with controlled substance prescribing privileges to have a verified and current DEA registration with an in-state address, as defined in Compliance Alert

#28. Additionally, an LIP or APP with controlled substance prescribing privileges must have verified and current state controlled substance registration when practicing in a state that

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APPROVED BY: Ethics and Compliance Policy Committee requires it. b.

DEA registration and State controlled substance registration shall be verified with the primary source agency that issued the registration. Verification shall be done by designated facility staff (e.g., the medical staff services department, the human resources department, an authorized centralized credentials verification service, or other designation). i.

DEA registration shall be verified through the National Technical Information Service

(NTIS) website: http://www.deanumber.com/ . ii.

State controlled substance registration shall be verified with the appropriate State agency. c.

Primary source verifications of DEA registration and state controlled substance registration, if applicable, shall be done at the following times: i.

At the time of an initial request for privileges , including temporary privileges. ii.

Prior to the expiration date(s) so that verification can be completed by the expiration date(s).

1.

A practitioner whose registration cannot be verified through primary source verification ( i.e.

, through NTIS for DEA) by the expiration date(s) must have controlled substance prescribing privileges suspended until the primary source verification can be completed.

2.

A secondary source of information ( i.e.

, the paper copy of registration from the practitioner) shall not be accepted.

3.

There are no grace periods. Registration is recognized only when primary source is verified. Registration will be considered expired on the date of expiration. iii.

It is also required that registration must be re-verified from the primary source at the time of reappointment . iv.

It is additionally required that registration must be re-verified from the primary source when new controlled substance prescribing privileges, or an increase in controlled substance prescribing privileges, are requested.

d.

Primary source verifications of DEA registration and state controlled substance registration shall: i.

Confirm the registration number. ii.

Confirm the date verified and the expiration date. iii.

Confirm in-state registration for DEA registration (reference Compliance Alert #28). iv.

Confirm that the authorized schedules of controlled substances match the prescribing privileges of the practitioner.

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APPROVED BY: Ethics and Compliance Policy Committee e.

If the practitioner is an APP, the following will also be confirmed before controlled substance prescribing privileges are granted: i.

That the scope of State licensure for the APP allows prescribing controlled substances in the schedules requested (note: check state laws and regulations). ii.

That if the APP is allowed to prescribe only under LIP supervision, and/or with a delegated service agreement, and/or with approved protocols, then confirmation has been made to ensure this is in place ( i.e.

, the agreement or protocol is on file in the

APP’s credentials file at the facility). iii.

That if the APP is allowed to prescribe only under LIP supervision, then the supervising LIP has a verified and current in-state DEA registration and State controlled substance registration for the schedules of controlled substances to be prescribed by the APP. f.

If DEA registration or state controlled substance registration cannot be verified as outlined above, then prescribing privileges for controlled substances shall not be granted or continued.

The medical staff bylaws or medical staff policy shall be followed regarding privileging actions to be taken. g.

DEA registration and state controlled substance registration shall be obtained by each individual practitioner. An individual practitioner shall not be allowed to prescribe controlled substances under a hospital’s DEA registration. h.

When DEA registration and state controlled substance registration (when required) is confirmed through primary source verification, and controlled substance prescribing privileges are granted, the information regarding registration shall be entered into the MIS Provider

Dictionary, and flags shall be set in the Meditech pharmacy module to alert pharmacists prior to dispensing the controlled substance if the order is not authorized. i.

The MIS Provider Dictionary shall be immediately updated with DEA registration and state controlled substance registration information when that information changes. “Immediately” is defined as the same business day as notification of a change.

E.

Controlled Substance Dispensing

Ordering and dispensing controlled substances must conform to all facility Policies and

Procedures as well as all State and Federal regulatory requirements.

1.

Manual System Monitoring a.

Controlled substances must be dispensed to match the items requested. Changes to

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APPROVED BY: Ethics and Compliance Policy Committee items/units dispensed versus items requested must be noted on the requisition sheet.

Monitoring must be performed on all requisition sheets submitted for two random days selected each month to determine that items/units dispensed match items requested or exceptions are documented on the requisition form. Monitoring must also confirm that items/units dispensed match the inventory documentation for the withdrawals. b.

There must be signed documentation of the receipt of controlled substances by the receiving personnel. Monitoring must be performed on all receipts signed on two random days selected each month to confirm that items/units received match the items dispensed as documented on the Master Control Dispensing Log.

2.

Automated Dispensing Cabinet (ADC) System Monitoring

A process must exist for matching controlled substances distributed to the automated dispensing cabinets with the inventory. For example, the quantity of controlled substance distributed to each automated dispensing cabinet as documented in the cabinet system reports shall be reconciled with the amount signed out on the Controlled Substance Perpetual Log in the Pharmacy vault. Monitoring of this process must be performed on two randomly selected days each month. Reconciliation of the controlled substance cabinet removal report with the

ADC loaded/stocked report will suffice.

3.

Security of Automated Dispensing Cabinets . Automated dispensing cabinets can be accessed electronically through logon, bioID, and passwords and also physically through traditional locks and keys. a.

Electronic Access –Only patient care staff members who have completed an authorization/access form and have had the form approved by the individual designated to approve such forms may remove controlled medications from the ADC. The following healthcare providers may request access to controlled substances based on their job description and competencies: LIPs, APPs, RNs, LPNs/LVNs, Anesthesia Assistants,

Registered Pharmacists, Pharmacy Technicians, and other qualified staff as authorized by the facility. Contracted staff will only receive access to the ADC on the unit in which they are scheduled to work. Access should be limited to areas that are needed to perform assigned duties and for the designated time period of the contract. Access for staff working on a shift-to-shift basis is limited to the shift assigned. A staff member’s, LIP’s or APP’s access to medications may be terminated at any time if policy infractions occur.

A physician may request access to controlled substances for a qualified staff member who will work under his/her direction ( e.g.

, RN, LPN/LVN, radiology technologist, medical assistant) when working in an outpatient imaging center or physician office practice. All staff, LIPs, and APPs will protect their access to ADCs. ADC pin numbers should be changed every 90/180 days, as appropriate, or when the user suspects the integrity of their

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APPROVED BY: Ethics and Compliance Policy Committee access has been compromised. Other locking mechanisms will be changed routinely based on the facility policy. This does not apply to facilities using bioID. b.

Physical Key Access – Pharmacy shall review automated dispensing cabinet lock status with the manufacturer to document the status of the current physical locks with respect to lock duplication in the same cabinets or other cabinets within the facility. The existence and current location of all physical keys including master keys shall be determined. If an inventory of all keys cannot be determined, the facility shall institute steps to replace the automated dispensing cabinet locks as soon as possible.

1) Pharmacy Management team shall retain all physical keys to the automated dispensing cabinets in a locked/secured location within the Pharmacy.

2) The physical keys shall only be issued to a staff member of the Pharmacy Department at the time of need for the purpose of opening the automated dispensing cabinet for

Department use or maintenance by authorized personnel.

3) Pharmacy Staff shall remain with the automated dispensing cabinet during the entire time the cabinet is unlocked, unless all medications have been removed. At no time is the Pharmacy Staff to relinquish possession of the key(s) to any other person outside of those staff within the Pharmacy authorized to use the key. Keys shall not be given to maintenance/service personnel.

4) Pharmacy shall take appropriate action to take possession of any automated dispensing cabinet keys found to be in the possession of anyone other than authorized Pharmacy personnel immediately.

F.

Controlled Substance Administration

1.

Count Verification

Count verification will be performed any time a controlled substance medication is accessed.

2.

Wastage Documentation a.

Any controlled substance packaged in an amount larger than the dose being administered must be wasted immediately. b.

Wastage documentation will be performed by two (2) licensed individuals, one of whom must be an employee of HCA. c.

Signatures of each individual involved with the wastage of a controlled substance medication must be performed electronically or ascribed on the manual documentation form.

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3.

Order Verification on Chart

All controlled substance medication administration must be supported by a physician order contained in the patient’s medical record. STAT or NOW verbal orders issued by the physician during emergency situations, operative or other procedures ( e.g.

, Endoscopy, cardiac cath) must be documented in the patient’s medical record as soon as possible after the procedure. In such cases, it is recommended that the medication orders be documented as separate events with individual dose orders rather than one event with a totaled dose.

4.

Administration Documentation

Documentation of administration of a controlled substance must occur immediately after administration by the administering individual.

G.

Loss or Theft of Controlled Substances (see also EC.025

)

1.

Notice of a theft or significant loss must be reported to DEA, local law enforcement, and state regulatory agencies immediately upon discovery.

2.

Where circumstances of the theft or significant loss are immediately known, a DEA Form 106,

Report of Theft or Loss of Controlled Substances, should be used to detail the circumstances of that theft or significant loss. When details concerning the specific circumstances surrounding the theft or loss are unknown at the time of discovery, initial notice should be provided by faxing a short statement to local DEA advising of the theft or significant loss.

3.

Any theft regardless of amount is to be reported.

4.

Any unexplained loss or discrepancy should be reviewed within the context of a registrant's business activity and environment.

5.

Individual registrants should examine both their business activities and the external environment in which those business activities are conducted to determine whether unexplained losses of controlled substances are significant. When in doubt, registrants should err on the side of caution in alerting the appropriate law enforcement authorities, including

DEA, of thefts and losses of controlled substances.

6.

Breakage, damage or spillage does not constitute a “loss of controlled substances.” In such situations, any recoverable controlled substance should be wasted.

7.

See also the HCA Medication Diversion Prevention Policy, CSG.MM.003

.

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H.

Required Records

1.

Official order forms (DEA Form 222).

2.

Power of Attorney authorization to sign order forms.

3.

Receipts and invoices for controlled substances.

4.

All inventory records of controlled substances, including the initial and biennial inventories.

5.

Records of controlled substances transferred.

6.

Report of Theft or Loss (DEA Form 106).

7.

DEA registration certificate.

ACRONYMS AND DEFINITIONS

LIP – Licensed Independent Practitioners (physician, dentist, podiatrist, with a valid DEA registration specific to the State of which the facility is located and a State controlled substance registration is applicable).

APP – Advance Practice Professional (physician assistant [PA] or advanced practice registered nurse

[APRN, CRNA,CNM])

REFERENCES:

Reporting Compliance Issues and Occurrences to the Corporate Office Policy, EC.025

HCA Medication Diversion Prevention Policy, CSG.MM.003

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