DEPARTMENT: Quality Management - POLICY DESCRIPTION: Controlled Substance Pharmacy Monitoring PAGE: 1 of 9 REPLACES POLICY DATED: EFFECTIVE DATE: March 1, 2008 REFERENCE NUMBER: QM.003 SCOPE: This policy applies to personnel in all Company-affiliated facility departments where controlled substances are utilized, particularly Pharmacy and Nursing departments. PURPOSE: To establish monitoring controls related to ordering, receiving, storing, 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 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, storing, 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. The facility must have a procedure to ensure that any discrepancies identified in ordering, receiving, administering, or reconciling the inventory of controlled substances is investigated immediately. 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. 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 Sections 1 and 2 immediately below or a combination of both processes. 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. 1/2008 DEPARTMENT: Quality Management - POLICY DESCRIPTION: Controlled Substance Pharmacy Monitoring PAGE: 2 of 9 REPLACES POLICY DATED: EFFECTIVE DATE: March 1, 2008 REFERENCE NUMBER: QM.003 a. The CSOS regulations require the following persons to be identified: 1) DEA Registrant – the person who last signed/renewed a DEA 224 application. The Company specifies that the DEA Registrant must be the Chief Executive Officer (CEO) of the facility. Further duties associated with controlled substance ordering/management may be delegated by the CEO using a Power of Attorney (POA). The Company recommends that the Director of Pharmacy be delegated this duty with a POA. 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. 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. 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. 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 hospital-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 hospital-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 wishes to place orders electronically for C-II controlled substances. This includes 1/2008 DEPARTMENT: Quality Management - POLICY DESCRIPTION: Controlled Substance Pharmacy Monitoring PAGE: 3 of 9 REPLACES POLICY DATED: EFFECTIVE DATE: March 1, 2008 REFERENCE NUMBER: QM.003 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. g. The receiving process must include a reconciliation of drugs 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 hospital personal computer for permanent storage. A backup must be performed after each C-II controlled substance receipt into the hospital pharmacy. Note: The receiver‟s signature and dating of the invoice and receipt into the wholesale vendor software system must be a separate action from the signing of the invoice by the Director or authorized person approving payment for Accounts Payable. 2. Use of DEA Form 222 to Purchase Controlled Substances, Schedule II a. Authority to Purchase Controlled Substances. The CEO must be designated as the DEA Registrant. Each pharmacy director should have in his or her possession a duly executed POA, signed by the CEO of the facility, authorizing a named individual, usually the Director of Pharmacy, 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 drugs. The POA should be permanently kept with other controlled substance records in the pharmacy‟s controlled substance safe/vault. 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. b. 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 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 1/2008 DEPARTMENT: Quality Management - POLICY DESCRIPTION: Controlled Substance Pharmacy Monitoring PAGE: 4 of 9 REPLACES POLICY DATED: EFFECTIVE DATE: March 1, 2008 REFERENCE NUMBER: QM.003 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. However, for the purposes of this Control Substance Monitoring Policy, drugs in the Schedule III, III-N, IV, and V must be included in the audit process. c. 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. d. 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. e. 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. f. Direct Delivery of Controlled Substances to Pharmacy Department. All controlled substances should be delivered directly to the Pharmacy Department and never through an intermediary, such as the Purchasing Department. Only authorized pharmacy personnel should be allowed to “receive” such orders. g. Reconciliation of Invoices/Packing Slips for Controlled Substances. The receiving process must include a reconciliation of drugs 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 1/2008 DEPARTMENT: Quality Management - POLICY DESCRIPTION: Controlled Substance Pharmacy Monitoring PAGE: 5 of 9 REPLACES POLICY DATED: EFFECTIVE DATE: March 1, 2008 REFERENCE NUMBER: QM.003 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. h. 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. i. Inventory System for Controlled Substances. An inventory system that assures accuracy of all controlled substances is required. For all Schedule II, II-N, III, III-N controlled substances, a perpetual 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. j. Monthly Record of Controlled Drug Purchases. The Pharmacy Director must maintain the “Monthly Customer Record of Controlled Substances” purchasing summary available from drug wholesalers, or a written history of all controlled drug purchases made by the facility for the month, sorted by date. k. Monitoring Procedure for Ordering and Receiving Controlled Drugs. The Pharmacy Director must employ the following methods for monitoring the ordering and receipt of controlled drugs. 1) Check off all DEA 222 numbers on Wholesaler Customer Narcotic Purchase Record against master log book or computer log; and 2) Randomly select 3 deliveries per month and confirm the presence of proper documentation on the DEA 222 form, match units received as documented by invoice and receiving personnel notation on the DEA 222 form, and match units received against the master log book or computer log. B. 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. Pharmacy personnel must dispense controlled substances to match the items requested. Changes to items/units dispensed to items requested must be noted on the requisition sheet by Pharmacy personnel. 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 1/2008 DEPARTMENT: Quality Management - POLICY DESCRIPTION: Controlled Substance Pharmacy Monitoring PAGE: 6 of 9 REPLACES POLICY DATED: EFFECTIVE DATE: March 1, 2008 REFERENCE NUMBER: QM.003 also confirm that items/units dispensed match the Pharmacy Master Log book documentation for the withdrawals. b. Pharmacy personnel must have 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 Pharmacy Master Log book 2. Automated Dispensing Cabinet System-Monitoring. A process for matching controlled substances distributed to the automated dispensing cabinet with the Pharmacy Controlled Substance Master Log book must exist. As an example, the quantity of drug distributed to each automated dispensing cabinet as documented in the cabinet system reports shall be reconciled to the amount signed out on the Controlled Substance Perpetual Log in the Pharmacy vault. Monitoring of this process on two randomly selected days each month must be performed by Pharmacy personnel. 3. Security of Automated Dispensing Cabinets. Automated dispensing cabinets (i.e., AcuDose, Omnicell, Pyxis) can be accessed electronically through logon and passwords and also physically through traditional locks and keys. Pharmacy shall be responsible for Policies and Procedures that define both forms of access. Pharmacy shall be responsible for granting both forms of access. a. Electronic Access – Pharmacy shall work with Human Resources to identify the employment status of all users seeking electronic access to the work cabinets. Policies and procedures shall be in place to identify how users can apply for access and the scope of the user access. Policies shall include processes for removing users when their access is no longer necessary in the facility. The physical granting of user access shall be limited within the Department of Pharmacy and documentation of access granted to users shall be in place. This process shall also define granting access to non-employees (e.g., Physicians, CRNAs, contract employees). 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. 1/2008 DEPARTMENT: Quality Management - POLICY DESCRIPTION: Controlled Substance Pharmacy Monitoring PAGE: 7 of 9 REPLACES POLICY DATED: EFFECTIVE DATE: March 1, 2008 REFERENCE NUMBER: QM.003 3) Pharmacy Staff shall remain with the automated dispensing cabinet during the entire time the cabinet is unlocked, unless all drugs 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. 4. Patients’ Medications Brought from Home: Each facility should have a policy that addresses how the facility will handle a patient‟s own medication brought from home that is a controlled substance. The company recommends that the facility not allow patients to maintain and/or self-administer their own controlled substances in most cases. C. Controlled Substance Administration 1. Count Verification. Count verification will be performed any time a controlled substance medication is accessed AND per facility policy. 2. Wastage Documentation. a. Any controlled substance packaged in a dose larger than the dose being administered must be wasted immediately before or after administration. b. Wastage documentation will be performed involving two (2) staff members, one of whom must be licensed (e.g., Nurse or Pharmacist). c. Signature of each individual involved with the wastage of a controlled substance medication must be performed electronically or ascribed on the manual documentation form. 3. Order Verification on Chart. All controlled substance medication administration must be validated 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. 1/2008 DEPARTMENT: Quality Management - POLICY DESCRIPTION: Controlled Substance Pharmacy Monitoring PAGE: 8 of 9 REPLACES POLICY DATED: EFFECTIVE DATE: March 1, 2008 REFERENCE NUMBER: QM.003 5. Controlled Substance Medication Audit. a. Each facility must perform a minimum of two controlled substance audits per quarter. The drugs may be selected randomly but must include one high volume drug. The second audit may be for a high or low volume drug. Each audit should cover at least a 48 hour period of retrospective review. Facilities may choose to conduct their audit simultaneously for all locations or may conduct the audits at different times for each. Nursing Reviews should include the technique of “Velocity Audits” where the volumes of use of the drug under review are examined per individual staff administering the drug to determine high volume drug administering staff. When variations in the number of doses of the drug administered is found, further investigation should be initiated to determine why the variation occurred. These findings should be documented in the Controlled Substance Medication Audit document. b. Drugs identified in each area must be reviewed for policy compliance in each of the following items: administration documentation, discrepancy resolution, charted order for medication, wastage documentation, and verification of current inventory levels of selected medications. c. Many ancillary patient treatment areas, e.g., Cath Lab, Gastro Lab, and Pulmonary Lab, stock controlled substances as well. Staff in these ancillary departments must perform a random audit of controlled substance use and documentation on all patients being treated in the ancillary department on the day of the audit. These audits must be conducted at least once quarterly. All requirements for the audit as described in 5.b. immediately above should be completed during the audit. The audit results must be forwarded to the facility person retaining all audit records. d. The facility shall identify all areas with high use of controlled substances (e.g., Surgery, Cath Lab, Endoscopy). In such areas, a concurrent audit and reconciliation process should be established to monitor controlled drug usage on a daily basis. As an example, standardized „kits‟ of controlled substances may be created and issued to each authorized clinician for use during the day. Each clinician is responsible for documenting drugs removed from the „kit‟ on a „kit‟ log, including doses administered and wasted on each patient. The „kit‟ can be checked back in at the end of shift where a reconciliation of count and the „kit‟ log is performed by another licensed individual. Both parties sign the „kit‟ log acknowledging a proper count. e. The Pharmacy Department or other designated responsible party must verify that reports and audits carried out by area management are returned to designated storage areas (e.g., Director of Pharmacy Office or Risk Management Office). 1/2008 DEPARTMENT: Quality Management - POLICY DESCRIPTION: Controlled Substance Pharmacy Monitoring PAGE: 9 of 9 REPLACES POLICY DATED: EFFECTIVE DATE: March 1, 2008 REFERENCE NUMBER: QM.003 f. All monthly medication audits must be documented on the “Institution Audit Log” along with documentation of any discrepancies and their associated resolutions. The „Institution Audit Log‟ must be either the sample form attached, or a similar form with all fields defined in „b‟ above at a minimum. g. All “Institution Audit Log” forms and facility documentation must be stored in a central location as designated in facility policy and be readily retrievable for internal and external audits. See Corporate E&C Record Retention Policies for length of storage requirements. 1/2008 Attachment to QM.003 HCA CONTROLLED SUBSTANCE MONITORING AUDIT SHEET Facility: _________________________________________ Date of Audit: _____________________________________ Facility Area: ___________________________________________ Drug under Review: ______________________________________ Instructions for Use: Three sections must be completed on the form. Reviewer shall enter Header information for each monitor session in Section 1. Reviewer shall “ ” beside the Monitoring Process being performed in Section 2. Reviewer shall use entire Section 3 (Patient, Discrepancies, & Resolution) for data from the process being monitored. Enter Patient name (as applicable). Details of Identified Discrepancies and the Discrepancy Resolution shall be entered as identified. Enter „None” when appropriate. IDENTIFIED DISCREPANCY MONITORING PROCESS PATIENT DISCREPANCIES RESOLUTION Ordering & Receiving: All DEA 222 forms are recorded into Control Log Ordering and Receipt of C-II drugs are performed by different Staff All completed „blue copy‟ DEA 222 forms have packages received, date received, and signature of receiver. All received C-II drugs on the „blue copy‟ match to the Master Control Log or Computer Log entries in Pharmacy. Dispensing: Requisition drugs match drugs dispensed from Pharmacy and dispensing documents match Master Control Log Items dispensed have a signed receipt or the ADM record matches the Master Control Dispensing Log Administration: Random check of Medical Record confirms a physician order for the medication under review. Random check of eMAR matches drug administration documentation with the Narcotic Administration Record or ADM drug removal record. Drug wastage is documented by 2 licensed Staff Narcotic Counts and Findings are documented at least once per shift.