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									   DEPARTMENT: Clinical Services Group -              POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                           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.




9/2011
   DEPARTMENT: Clinical Services Group -                POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                             Monitoring
   PAGE: 2 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


   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.


9/2011
   DEPARTMENT: Clinical Services Group -                 POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                              Monitoring
   PAGE: 3 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

              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.


9/2011
   DEPARTMENT: Clinical Services Group -                 POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                              Monitoring
   PAGE: 4 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


         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


9/2011
   DEPARTMENT: Clinical Services Group -               POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                            Monitoring
   PAGE: 5 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

            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.



9/2011
   DEPARTMENT: Clinical Services Group -               POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                            Monitoring
   PAGE: 6 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

         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.


9/2011
   DEPARTMENT: Clinical Services Group -                POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                             Monitoring
   PAGE: 7 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



   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


9/2011
   DEPARTMENT: Clinical Services Group -               POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                            Monitoring
   PAGE: 8 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

             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.


9/2011
   DEPARTMENT: Clinical Services Group -               POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                            Monitoring
   PAGE: 9 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


         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


9/2011
   DEPARTMENT: Clinical Services Group -               POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                            Monitoring
   PAGE: 10 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

                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


9/2011
   DEPARTMENT: Clinical Services Group -              POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                           Monitoring
   PAGE: 11 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

                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.



9/2011
   DEPARTMENT: Clinical Services Group -              POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                           Monitoring
   PAGE: 12 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



         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.


9/2011
   DEPARTMENT: Clinical Services Group -                POLICY DESCRIPTION: Controlled Substance
   Pharmacy                                             Monitoring
   PAGE: 13 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



   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




9/2011

								
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