Narcotics and Controlled Drugs Management within Richmond ... · PDF fileNarcotics and Controlled Drugs Management ... Operating Room and Emergency Department narcotic records did

Internal Audit Services

Confidential

Narcotics and Controlled Drugs Management within Richmond Community of Care

Internal Audit Report Risk and Compliance

Mar 24, 2014

Internal Audit Report – Mar 24, 2014 Confidential - Narcotics and Controlled Drugs Management at Richmond COC

2

REPORT DISTRIBUTION Audit & Finance Committee Chair, Audit & Finance Committee Executive Management & Key Stakeholders Dr. Jeff Coleman, VP, Regional Programs and Service Integration Glen Copping, CFO & VP, Systems Development & Performance Dermot Kelly, Director, Medical Administration/Quality & Patient Safety/Perioperative Services, Richmond Natalie McCarthy, Director, Mental Health & Addictions/Residential Care, Richmond Mike Nader, Chief Operating Officer, Richmond Dr. Anup Navsarikar, Department Head of Anaesthesia, Richmond Hospital Dr. Patrick O’Connor, VP, Medicine, Quality & Safety Dr. David Ostrow, President & CEO Claude Stang, Director, Critical Care, Emergency, Medical Services & Patient Flow, Richmond Dr. Brenda Wagner, Senior Medical Director, Richmond

Limitation This report is confidential and has been prepared for internal use only. This report may include policy advice and recommendations protected by the Freedom of Information and Protection of Privacy Act. Copies are not to be distributed without the express written consent of the Director, Internal Audit Services.


3

CONTENT

I. EXECUTIVE SUMMARY ........................................................................................................ 4

Background 4 Findings 4 Overall Conclusion 7

II. DEFINITIONS ......................................................................................................................... 8

III. INTRODUCTION .................................................................................................................... 9

IV. AUDIT OBJECTIVES ............................................................................................................ 10

V. SCOPE ................................................................................................................................. 10

VI. AUDIT APPROACH .............................................................................................................. 10

VII. POSITIVE FINDINGS ........................................................................................................... 11

VIII. FINDINGS ............................................................................................................................. 11

OBJECTIVE 1: Determine whether the processes and controls are adequate to safeguard narcotics and controlled drugs. 11 Finding 1: Documentation of narcotics handled by anaesthesiologists can be improved. 12 Finding 2: Operating Room and Emergency Department narcotic records did not match patient charts. 14 Finding 3: Consider implementing a narcotics policy for anaesthesiologists. 16 Finding 4: Ensure inventory counts are conducted as required. 17 Finding 5: Ensure inventory counts and wastage at Minoru are signed off as required. 18 Finding 6: Consider utilizing additional Omnicell reports to improve monitoring controls. 19 Finding 7: There is an opportunity to improve the security of narcotics. 20 Finding 8: Physical safeguards could be improved in some locations. 21 Conclusion for Objective 1 21 OBJECTIVE 2: Determine whether the processes and controls comply with legislation or regulatory requirements with respect to record-keeping and reporting for narcotics and controlled drugs. 22 Conclusion for Objective 2 22

IX. CONCLUSION ...................................................................................................................... 23

X. ACKNOWLEDGMENT .......................................................................................................... 23


4

I. EXECUTIVE SUMMARY Background The audit of narcotics and controlled drugs (“narcotics”) management is part of the 2013/14 Internal Audit Plan, which was approved by the Audit and Finance Committee of the Board of Directors. VCH staff have a critical role in ensuring narcotics are not misused or diverted. There is a risk that people within the health care system (patients or health care staff) misuse narcotics due to addictions, or divert narcotics for personal profit. The Controlled Drugs and Substances Act, as well as the Narcotic Control Regulations, are federal legislation relating to narcotics. VCH has various policies and procedures that provide detailed requirements relating to narcotics. Given the risks associated with narcotics, as well as the legislative requirements, it is important for VCH to have sufficient controls to prevent misuse or diversion of narcotics. The main objectives of the audit were to determine whether the processes and controls:

1. Are adequate to safeguard narcotics. 2. Comply with legislation or regulatory requirements with respect to record-keeping and

reporting for narcotics. Controls and processes that are in place in the Richmond Community of Care were reviewed. Site visits were conducted at a sample of units at Richmond Hospital (RH) and Minoru Residence. Pharmacy Services controls and processes over narcotics were reviewed in a separate engagement. The results of that audit will be reported as a Fraser Health (FH) audit as FH leads Pharmacy Services for all of Lower Mainland including Richmond COC. Positive Findings The following positive findings were noted:

• There are adequate processes for narcotics issued from pharmacies to the units. • There are adequate processes for narcotics returned from the units to the pharmacies. • Omnicell machines have been installed at most of the acute care units. There are 22

Omnicell machines at RH. Omnicell machines are used to store narcotics at the units and require passwords to be entered for access. These machines result in better physical safeguards and record-keeping processes.

Findings High Risk Findings 1. Documentation of narcotics handled by anaesthesiologists can be improved.

Anaesthesiologists at RH have daily narcotics records which can be used to track narcotics transactions. In a review of a sample of narcotics records it was noted that the documents were not filled out completely and the usage and wastage of narcotics could not be tracked. Without documentation of narcotics usage and wastage, there is a risk that narcotics may be diverted without detection. In addition, accurate tracking and documentation is required


5

under the Government of Canada’s Narcotic Control Regulations. It is recommended that proper documentation of usage and wastage be kept. Management Response: Reformat the Daily Narcotic Record for the Operating Rooms to allow appropriate patient identification and usage per patient and work with anesthesia to ensure that usage and wastage information are accurately and fully completed. Finding Owner: Senior Medical Director, Richmond. Target Completion Date: Feb 15, 2014.

2. Operating Room and Emergency Department narcotic records did not match patient charts. A sample of narcotics noted as administered on narcotic records was compared to the amounts noted on patient charts. Out of a sample of narcotics issued to 11 patients in the OR, discrepancies were found between patient charts and narcotics records for 9 of the patients. Out of a sample of 24 narcotics issued in non-OR units, 2 discrepancies were noted, both of which related to the Emergency Department (ED). The discrepancies could be due to valid wastage; however, as noted in Finding 1, wastage is not always documented. It is recommended that proper documentation of usage and wastage be kept and periodic review of daily narcotic records be conducted. Management Response: For the OR specific concerns mentioned above this will be covered in the response to Finding 1. For the ED, in October we created and implemented a ‘Safe Handling and Storage of Patient Medication SOP.’ This also addresses narcotic wastes. Please see the attachment. During team huddles, ED emphasize for narcotics to be wasted in a timely manner through the Omnicell. This will be emphasized during future education days. Prior to the end of shift it is the duty of the ED PCC to check and resolve discrepancies in all Omnicells. This responsibility will be emphasized in education to ED leadership. Finding Owner: Senior Medical Director, Richmond; Director, Critical Care, Emergency, Medical Services & Patient Flow, Richmond. Target Completion Date: For OR Feb 15, 2014; For ED Feb 15, 2014.

Moderate Risk Findings 3. Consider implementing a narcotics policy for anaesthesiologists.

There are 8 Operating Rooms (ORs) at RH. There is no written policy with respect to anaesthesiologists’ handling of narcotics. It is recommended that a policy on narcotics be instituted for anaesthesiologists, including guidance on documentation, wastage, and the carrying of narcotics. Management Response: Senior Medical Director to bring forward this concern to HAMAC with a request for the Regional Department of Anesthesia to decide if such a policy is necessary and if so to ask that they take the lead on development of this policy. Finding Owner: Senior Medical Director, Richmond. Target Completion Date: June 2014.

4. Ensure inventory counts are conducted as required. Most RH units are equipped with Omnicell machines which store and dispense narcotics. Although policies are silent on how often inventory counts are to be done on units with Omnicell machines, the current practice is for such counts to be conducted at least weekly. IAS reviewed weekly inventory counts that were conducted at the selected RH units during the period May 1, 2013 to June 30, 2013. It was found that inventory counts were not conducted for four weeks on the Emergency Department’s Omnicell machine. To reduce the risk of undetected diversion, staff should be reminded that inventory counts are to be conducted on a weekly basis. The requirement of weekly counts should also be documented in one of the policies. Management Response: In a recent PCC/ Charge nurse meeting in October, staff was reminded to complete the weekly cycle count. PCC/ FLS are reminded to complete the cycle


6

count during team huddles. Educators follow up to ensure the count has been done. To Come - Add the cycle count reminder to the PCC Daily Huddle Sheet. Finding Owner: Director, Critical Care, Emergency, Medical Services & Patient Flow, Richmond Target Completion Date: February 15, 2014.

5. Ensure inventory counts and wastage at Minoru are signed off as required.

During a review of narcotics documentation at Minoru, it was noted that there were instances of inventory counts and wastage not being signed off by two people. 12 of 90 inventory counts did not contain a witness signature in the narcotics register. Also, in the review of 3 narcotics registers, there were 3 instances of wastage where there was no witness signoff. To reduce the risk of diversion, it is best practice for two people to sign off on inventory counts and wastage. Management Response: The Residential Care Educator provided education sessions for nursing staff in November 2013 to ensure sign off by two staff members. The process for sign off was also posted in all medication rooms. The Residential Care Coordinators for each floor are auditing regularly (since November) to ensure nursing staff are adhering to the required sign-off practices and discussing processes in unit huddles to reinforce and/or point out deviation from required practice. The Educator will be providing monthly refreshers on sign-off practices in 2014. Finding Owner: Director, Mental Health & Addictions/Residential Care, Richmond. Target Completion Date: Items above completed November 2013. Ongoing monthly education and regular audits to continue in 2014.

6. Consider utilizing additional Omnicell reports to improve monitoring controls.

Reports relating to weekly cycle counts and discrepancies are reviewed by the Pharmacy Services’ Omnicell System Administrator and a pharmacist; however, narcotic usage and wastage reports are not reviewed by staff at the units. Such reports can provide vital insight into usage patterns to identify unusual transactions and potential diversion. For instance, the narcotic usage report can highlight how a unit staff’s dispensing behaviour compares with that of peers to identify any unusually high amounts of narcotics dispensing. Management should consider working with Pharmacy Services to develop a process for usage and wastage reports. Under this process, Pharmacy Services would generate the reports, which would then be forwarded to unit management for review. Management Response: Richmond CoC operations and Pharmacy recognize the importance of following up on Omnicell narcotic usage and wastage. Collaboratively, we will establish a process to review relevant reports on a periodic basis e.g. quarterly, with clinical/operational managers. Finding Owner: Director, Critical Care, Emergency, Medical Services & Patient Flow, Richmond. Target Completion Date: Process finalized and implemented by April 2014.

7. There is an opportunity to improve the security of narcotics.

From discussion with anaesthesiologists, it was noted that some anaesthesiologists carry narcotics in a cart with a lockbox, whereas others may keep narcotics in their pocket. There is risk of loss where narcotics are not carried in a lockbox. If feasible, carrying narcotics in a lockbox is recommended.

Within the ED, remaining doses of narcotics which are not completely administered may be stored in unsecured locations such as in unlocked drawers or on desks. Narcotics may also be passed from nurse to nurse or disposed of in batches instead of being disposed of immediately.


7

Management Response: With respect to the anesthesiologist use of lock boxes, we will work will work with Anesthesia to ensure that there a sufficient lock boxes in place, that the lock boxes are properly maintained and there a process for immediate attention to a non working lock box. In addition we suggest that the use of lock boxes be included in the policy requested from the Regional Department of Anesthesia. ED has changed its practice and secure all patient medications in a metal box fastened to the desk. Each nursing assignment has their own box to store all patient specific medications including prepared narcotics. (Refer to attached Medication Handling SOP). During team huddles we emphasize for narcotics to be wasted in a timely manner through the Omnicell. Finding Owner: a) Senior Medical Director, Richmond b) Director, Critical Care, Emergency, Medical Services & Patient Flow, Richmond. Target Completion Date: June 2014.

8. Physical safeguards could be improved in some locations. IAS and a representative from Integrated Protection Services visited RH and Minoru Residence units to see if physical safeguards over narcotics are adequate. It was noted that at the RH Emergency Department, a medication room door was left open. Moreover, even though a swipe card reader was installed at the entrances of the medication room, the swipe card reader was inactive. To reduce the risk of diversion, management should consider activating the swipe card reader at the medication room door and making adjustments so the door closes automatically. Management Response: The acute medication room also contains the department’s clean supplies, thus is a high traffic area between nursing, support workers and distribution aides. At times the lock is inactivated but the doors are always closed. We recognize this is an area for improvement and will continue to educate staff of the need to keep the doors secured. The treatment medication room swipe card reader is currently broken and a work order has been requested. Finding Owner: Director, Critical Care, Emergency, Medical Services & Patient Flow, Richmond. Target Completion Date: February 15, 2014.

Overall Conclusion Improvement Needed

There are adequate processes for narcotic movement between the Pharmacy and hospital units. Omnicell machines have been installed at most of the acute care units at RH, which result in better physical safeguards and record-keeping processes Some improvement areas are noted relating to safeguarding of narcotics. Some issues were discovered relating to key record keeping and tracking processes for narcotics. These are required by legislation and therefore more immediate action should be taken to address.


8

II. DEFINITIONS Overall Conclusion:

Good No reportable findings were noted during the audit. Minor issues have been communicated to management separately.

Improvement Needed Some findings should be addressed by management in the near

term to mitigate moderate levels of risk.

Significant Immediate action is required by management to mitigate the organization’s exposure to significant levels of risk.

Findings:

Low Priority The finding does not have a material impact on the organization. Moderate Priority An important issue that should be addressed in the near term.

High Priority An issue that could have a significant impact and should be

corrected immediately. Abbreviations: Noted below is a list of abbreviations used in this report. FH – Fraser Health IAS – Internal Audit Services Narcotics – Narcotics and Controlled Drugs RH – Richmond Hospital VCH – Vancouver Coastal Health


9

III. INTRODUCTION The audit of processes and controls over narcotics and controlled drugs (“narcotics”) is part of the 2013/14 Internal Audit Plan, which was approved by the Audit and Finance Committee of the Board of Directors. This audit is carried out under the Internal Audit Services (IAS) Risk and Compliance service line. Narcotic Abuse and Diversion Vancouver Coastal Health (VCH) staff have a critical role in ensuring narcotics are not misused or diverted. There is a risk that people within the health care system (patients or health care staff) abuse narcotics due to addictions, or divert narcotics for personal profit. The following is some relevant information received from a Health Canada publication entitled ‘Abuse and Diversion of Controlled Substances: A Guide for Health Professionals’:

• A US 2001 National Household Survey on Drug Abuse showed about 15% of 18 and 19 year olds, and 7.9% of 12 to 17 years olds, used prescription medications for non-medicinal purposes.

• There is a lucrative underground market for pharmaceutical products.

• The most sought after pharmaceuticals include morphine, oxycodone, meperidine,

hydromorphone, codeine preparations, sedatives (benzodiazepines) and stimulants (e.g. amphetamines, methylphenidate).

• According to research noted in the Canadian Medical Association Journal, the street

value of narcotics could range from $0.25 for a Tylenol No.3 pill, to $75 per pill of MS Contin (35mg).

According to the March 2011 issue of Canadian Nurse, it is thought that between 10% and 20% of nurses will have a substance abuse problem at some point during their lives. Similarly, according to the US National Council of State Boards of Nursing, approximately 15% of health care staff struggle with drug dependence at some point in their career.

Given the risks associated with narcotics, as well as the legislative requirements, it is important for VCH to have sufficient controls to prevent misuse or diversion of narcotics. Applicable Policies and Legislation Per discussion with management, the Controlled Drugs and Substances Act, as well as the Narcotic Control Regulations, are federal legislation relating to narcotics. There is no VCH-wide policy relating to narcotics; however, there are policies and procedures that apply to each of the Communities of Care within VCH. Controls over Narcotics Within the pharmacies and the units, there are numerous physical controls to prevent theft of narcotics. Examples of such controls include Omnicell automated dispensing machines (Omnicell), vaults, locked cabinets and security cameras. There are also record-keeping requirements, including perpetual inventory records, manual records and periodic counts. As mentioned above, Omnicell units are used for narcotics. The Omnicell machines are used to store narcotics at the units and require passwords to be entered for access. When staff obtain narcotics from these machines, an electronic record is generated within the Omnicell system.


10

Omnicell machines have been installed at most of the acute care units at Richmond Hospital (RH).

IV. AUDIT OBJECTIVES The main objectives of the audit were to determine whether the processes and controls:

1. Are adequate to safeguard narcotics.

2. Comply with legislation or regulatory requirements with respect to record-keeping and reporting for narcotics.

V. SCOPE Controls and processes that are in place in the Richmond Community of Care were reviewed. Site visits were conducted at a sample of units at Richmond Hospital (RH) and Minoru Residence. Pharmacy Services controls and processes over narcotics were reviewed in a separate engagement. Pharmacy Services controls and processes over narcotics were reviewed in a separate engagement. The results of that audit will be reported as a Fraser Health (FH) audit as FH leads Pharmacy Services for all of Lower Mainland including Richmond COC.

VI. AUDIT APPROACH This audit was conducted within the guidance provided by the Institute of Internal Auditors Professional Practices Framework which states that auditors shall perform their work with proficiency and due professional care. The following audit procedures were performed to provide evidence and substantiation of the audit findings and conclusions from this audit engagement:

• Interviewed management and staff at the pharmacies and units. • Reviewed management policies, procedures and manuals. • On a test basis or through other audit procedures considered necessary, examined

relevant documents, processes and controls. • Used the services of pharmacy and security subject matter experts in performing some of

the audit procedures.


11

VII. POSITIVE FINDINGS The following positive findings were noted:

• There are adequate processes for narcotics issued from pharmacies to the units.

• There are adequate processes for narcotics returned from the units to the pharmacies.

• Omnicell machines have been installed at most of the acute care units. There are 22 Omnicell machines at RH. Omnicell machines are used to store narcotics at the units and require passwords to be entered for access. These machines result in better physical safeguards and record-keeping processes.

VIII. FINDINGS OBJECTIVE 1: Determine whether the processes and controls are adequate to safeguard narcotics and controlled drugs. IAS reviewed the Richmond Community of Care processes and controls over safeguarding of narcotics. In addition, a detailed review of processes, controls and relevant documentation was conducted at the following locations:

• RH – Operating Rooms (OR) • RH – Post Anaesthesia Care Unit (PACU) • RH – Emergency Department General (ED) • RH – Surgical Units • Minoru Residence Wards

The table below summarizes the results of some of the key audit procedures that were conducted.

Procedure Result

Reviewed the processes in place for narcotics issued from pharmacies to units.

No exceptions noted.

Reviewed the processes over periodic narcotic inventory counts at selected units.

Exceptions noted.

For the sample of units, determined if a sample of narcotics administered as per narcotics registers agreed to amounts noted on patient charts. IAS obtained the services of pharmacy coordinators for conducting this procedure.

Exceptions noted.

Reviewed a sample of narcotic registers for compliance with the VCH policy requirements.

Exceptions noted.

Reviewed the processes in place for narcotics handled by anaesthesiologists at the RH Operating Rooms.

Exceptions noted.

Performed a high level review of the Omnicell controls over user access and review of reports.

Exceptions noted.

Reviewed the physical security of narcotics at the selected Exceptions noted.


12

locations. IAS and a representative of Integrated Protection Services conducted this review.

The findings below resulted from this review. Finding 1: Documentation of narcotics handled by anaesthesiologists can be improved.

High Priority There are 8 Operating Rooms (ORs) at RH. Per discussion with medical staff, the process surrounding narcotics for anaesthesiologists at the RH ORs is as follows:

• At the beginning of the day, anaesthesiologists sign out narcotics at the OR Omnicell. Narcotics are carried in a lockbox, or in their pocket throughout the day. At the end of the day, anaesthesiologists return leftover narcotics to Omnicell.

• Anaesthesiologists keep a paper copy of a daily narcotic record which they can use to record:

o Amounts of narcotics taken from Omnicell. o Amounts of narcotics administered and patient name. o Amounts of narcotics wasted. o Amounts of narcotics returned to Omnicell.

The daily narcotic record is placed in a binder at the end of the day. IAS reviewed a sample of 23 daily narcotics records (logs) from July 2013 and found that they are not being completed as required. The details are as follows: B.1.4 ^

• 4 logs (17%) ^ ^ did not contain the amounts taken out from Omnicell. • 3 logs (13%) ^ ^ did not contain the amounts issued to patients. • 19 logs (83%) ^ ^ did not contain the amounts wasted. • 3 logs (13%) ^ ^ did not contain the amounts returned to Omnicell. • 21 logs (91%) ^ ^ did not contain a witness signoff for amounts wasted or amounts

returned to Omnicell. Please note that there is a line on the daily narcotics records for a witness to sign off on amounts wasted.

The Government of Canada’s Narcotic Control Regulations state that narcotic records shall be maintained, including “the date a narcotic… was ordered or prescribed and the form and quantity thereof.”1 Implications: Without proper documentation of narcotics usage and wastage, there is a risk that narcotics may be diverted without detection; furthermore, VCH may be in violation of documentation requirements regarding the form and quantity of narcotics ordered found in the Government of Canada’s Narcotic Control Regulations. Without requiring a witness for wastage, there is a risk of narcotics being diverted.

1 Narcotic Control Regulations, C.R.C., c.1041, S.63(a)(vii)


13

Recommendations: Remind anaesthesiologists to record all narcotics transactions (narcotics received, patient names, amounts administered, wastage, returns) on the daily narcotics record. Also, remind anaesthesiologists to have a witness sign off on wastage.

Periodically review daily narcotics records to identify and investigate potential abuse or diversion. Responsibility: Senior Medical Director, Richmond Management Response: Reformat the Daily Narcotic Record for the Operating Rooms to allow appropriate patient identification and usage per patient and work with anesthesia to ensure that usage and wastage information are accurately and fully completed. Target Completion Date: Feb 15, 2014


14

Finding 2: Operating Room and Emergency Department narcotic records did not match patient charts.

High Priority IAS sought to determine whether a sample of narcotics noted as administered on narcotic records (daily narcotic record for OR and Omnicell or manual narcotic register for non-OR units) agreed to the amounts noted on patient charts. IAS obtained the services of a pharmacy coordinator to conduct the review. For the OR, IAS reviewed narcotic amounts administered to 11 patients. The following discrepancies were noted: B.1.3 Pr 13^

• For 5 of the patients (45%)^ , there were instances where the amounts did not agree. For some narcotics, there were higher amounts noted on the patient charts. For other narcotics, there were lower amounts noted on the patient charts. For example, 250mcg fentanyl and 0mg midazolam were written on the daily narcotic record while the patient chart showed 150mcg fentanyl and 1mg midazolam were written as administered on the patient chart.

• For 1 patient (9%)^, more narcotics were noted as administered on the daily narcotic record than on the patient chart.

• For 1 patient (9%)^, less narcotics were noted as administered on the daily narcotic record than on the patient chart.

• For 2 patients (18%)^, there was nothing written as administered on the daily narcotic record while the patient charts showed narcotics were administered.

For non-OR units and Minoru Residence, the review consisted of a sample of 24 narcotic issues (9 issues from RH Emergency Department, and 5 issues from each of RH Surgical Units, RH PACU, and Minoru). It was found that 2 issues (8%) of narcotics from the Emergency Department (ED) had partial doses which were unaccounted for. The details are as follows:

• In one instance, 10mg of morphine was taken out from an ED Omnicell. 3mg was documented as administered in the patient chart. 7mg of morphine was unaccounted for in the documentation. B.1.3 Pr 12 ^

• In the second instance, 10mg of morphine was taken out from an ED Omnicell. 7mg was

documented as administered in the patient chart. 3mg of morphine was unaccounted for in the documentation. B.1.3 Pr 12^

Implications: If the register has an entry for narcotics administered and a similar entry is not made on the patient chart, there is a risk that narcotics may have been diverted. It is acknowledged that the differences may also be due to wastage or other valid reasons. Recommendations: Remind anaesthesiologists and other medical staff to accurately record all narcotics transactions (narcotics received, patient names, amounts administered, wastage, returns, amounts used for priming) on the narcotics record and patient charts. Consider working with Pharmacy Services to implement random checking of narcotics administered per narcotic records with patient charts for the OR and all non-OR units.


15

Responsibility: Senior Medical Director, Richmond; Director, Critical Care, Emergency, Medical Services & Patient Flow, Richmond Management Response: For the OR specific concerns mentioned above this will be covered in the response to Finding 1. For the ED, in October we created and implemented a ‘Safe Handling and Storage of Patient Medication SOP.’ This also addresses narcotic wastes. Please see the attachment. During team huddles, ED emphasize for narcotics to be wasted in a timely manner through the Omnicell. This will be emphasized during future education days. Prior to the end of shift it is the duty of the ED PCC to check and resolve discrepancies in all Omnicells. This responsibility will be emphasized in education to ED leadership. Target Completion Date: For OR Feb 15, 2014; For ED Feb 15, 2014


16

Finding 3: Consider implementing a narcotics policy for anaesthesiologists. Moderate Priority

There is no written policy with respect to anaesthesiologists’ handling of narcotics including guidelines for carrying, documenting usage, and wasting narcotics. . Implications: Without a written policy, medical staff may not be aware of procedures required by VCH. Recommendations: Institute a narcotics policy for anaesthesiologists, including guidance on documentation, wastage, and the carrying of narcotics. Monitoring controls should also be considered to ensure this policy is followed once implemented. Responsibility: Senior Medical Director, Richmond Management Response: Senior Medical Director to bring forward this concern to HAMAC with a request for the Regional Department of Anesthesia to decide if such a policy is necessary and if so to ask that they take the lead on development of this policy. Target Completion Date: June 2014


17

Finding 4: Ensure inventory counts are conducted as required. Moderate Priority

Most RH units are equipped with Omnicell machines which store and dispense narcotics. Issues regarding inventory counts at units with Omnicell machines are noted below.

a) While policies include instructions on the frequency of inventory counts for units without Omnicell machines, there are no similar instructions for units using Omnicell.

b) Although policies are silent on how often counts are to be done on units with Omnicell

machines, the current practice is for inventory counts to be conducted at least weekly. IAS reviewed weekly inventory counts conducted at the selected RH units during the period May 1, 2013 to June 30, 2013. It was found that inventory counts were not conducted for four weeks on the Emergency Department’s Omnicell machine.

Implications:

a) Without instructions for inventory counts in the policies, it may be unclear what proper procedures are resulting in inadequately performed inventory counts.

b) Without a weekly inventory count, narcotics that are diverted may not be detected in a

timely manner. Recommendations:

a) Update policies for inventory counts to include RH units with Omnicell machines.

b) Remind nursing unit staff to perform weekly inventory counts. Responsibility: Director, Critical Care, Emergency, Medical Services & Patient Flow, Richmond Management Response: In a recent PCC/ Charge nurse meeting in October, staff was reminded to complete the weekly cycle count. PCC/ FLS are reminded to complete the cycle count during team huddles. Educators follow up to ensure the count has been done. To Come: Add the cycle count reminder to the PCC Daily Huddle Sheet. Target Completion Date: February 15, 2014


18

Finding 5: Ensure inventory counts and wastage at Minoru are signed off as required. Moderate Priority

IAS reviewed narcotics related documentation at Minoru Residence. The following was noted:

a) The RH Medication Manual (section YAF1400: Documentation) (A.2.12^) states that for units with manual narcotics registers, narcotics inventory counts are to be carried out at the end of every shift and signed off by two staff members. IAS reviewed a sample of 90 end-of-shift inventory counts relating to one month at Minoru Residence. It was found that 12 out of 90 inventory counts (13%) ^ did not contain a witness’ signature in the narcotics register. B1.3 Row 69^

b) The RH Medication Manual (section YAF1900: Wastage) (A.2.12^) states that narcotics that are wasted should be documented with two people signing off on the wastage. In the review of 3 manual narcotics registers at Minoru Residence, there were 3 instances of wastage where there was no witness signoff.

c) The balances that are carried forward to the next page in the narcotics register only have one signature. The balances carried forward from a register to another register are not always signed by 2 people. 2 out of 5 completed narcotics registers sampled had only one staff signature on the carry forward balance from the previous narcotics register It is good practice to require two staff to sign balances carried forward from the previous page and from the previous register (as done at FHA).

Implications: Without a second person signing off on inventory counts, narcotics wastage, and carry forward balances, there is a higher risk of diversion. Recommendations: Ensure processes are in place that require a second person to:

a) sign off on inventory counts. b) sign off on narcotics wastage. c) sign off on carry forward balances. Consider revising the policy to include this

requirement.

Responsibility: Director, Mental Health & Addictions/Residential Care, Richmond Management Response: The Residential Care Educator provided education sessions for nursing staff in November 2013 to ensure sign off by two staff members for items a, b and c above. The process for sign off was also posted in all medication rooms. The Residential Care Coordinators for each floor are auditing regularly (since November) to ensure nursing staff are adhering to the required sign-off practices and discussing processes in unit huddles to reinforce and/or point out deviation from required practice. The Educator will be providing monthly refreshers on sign-off practices in 2014. Target Completion Date: Items above completed November 2013. Ongoing monthly education and regular audits to continue in 2014.


19

Finding 6: Consider utilizing additional Omnicell reports to improve monitoring controls. Moderate Priority

There are 22 Omnicell machines at RH. In addition to being automated storage and dispensing machines for narcotics, Omnicell machines can provide various reports relating to narcotic usage. Review of drug usage data from Omnicell machines is an important control to detect and prevent narcotic abuse or diversion. Presently, certain reports, such as those relating to weekly cycle counts and discrepancies are reviewed by the Pharmacy Services’ Omnicell System Administrator. Other reports, however, such as the narcotic usage and wastage reports are not reviewed. Narcotics usage and wastage reports can provide vital insight into usage patterns to identify unusual transactions and potential diversion. For example, the narcotic usage report can highlight how a unit staff's dispensing behaviour compares with that of peers to identify any unusually high amounts of narcotics dispensing. “Diversion and Abuse of Controlled Substances in Hospitals”1 published by Cegedim stresses the importance of reviewing reports generated by systems like Omnicell. The publication states “In order to effectively monitor, detect and prevent drug diversion and abuse, hospitals need a comprehensive compliance program – something that technology, such as automated dispensing units, cannot replace. In fact, having these units may give hospitals a false sense of security. The units may be able to record the dispensing of drugs, but the data is useless unless it is properly analyzed... Hospitals need to have policies and procedures in place to review, track and trend drug dispensing data, validate drug use through patients’ charts, and investigate any variances in data of drug utilization by nurse, condition, patient, physician, etc.” Implications: The probability of detection of loss of narcotics may be reduced without utilization of valuable Omnicell usage and wastage reports. Recommendations: Management should consider working with Pharmacy Services to develop a process for generating and reviewing usage and wastage reports. Under this process, Pharmacy Services would generate the reports, which would then be forwarded to unit management for review. Also, consider working with Pharmacy Services to generate other useful reports to obtain the full benefit of Omnicell. IAS has made a similar recommendation to Pharmacy Services in a separate audit communication.

Responsibility: Director, Critical Care, Emergency, Medical Services & Patient Flow, Richmond Management Response: Richmond CoC operations and Pharmacy recognize the importance of following up on Omnicell narcotic usage and wastage. Collaboratively, we will establish a process to review relevant reports on a periodic basis e.g. quarterly, with clinical/operational managers. Target Completion Date: Process finalized and implemented by April 2014

1 http://crm.cegedim.com/Docs_Whitepaper/Compliance/Hospital_Drug_Diversion_Whitepaper.pdf


20

Finding 7: There is an opportunity to improve the security of narcotics. Moderate Priority

a) From discussion with anaesthesiologists, it was noted that during the day, narcotics may be

carried around in a cart with a lockbox; however, some anaesthesiologists may also carry the narcotics in their pocket. There is risk of loss where narcotics are not carried in a lockbox.

b) There are risks with narcotics that are administered as partial doses or narcotics that are titrated within the ED. This is because the full amount of narcotic taken from Omnicell is not administered under these situations. Rather, only a portion of the narcotics are administered and the remainder may be stored in unsecured locations such as in unlocked drawers or on desks. These narcotics may also be passed from nurse to nurse or disposed of in batches instead of being disposed of immediately. ED management has stated that they follow up with staff when an unsafe situation arises and that they are aware of the need to improve the current situation.

Implications: a) Narcotics may be lost if not maintained in a lockbox.

b) Narcotics that are stored in unsecured locations, passed along by staff, or not immediately

disposed of have a higher chance of being diverted. Recommendations: a) Consider advising anaesthesiologists to maintain narcotics in a lockbox while transporting

narcotics outside the Operating Rooms.

b) Remind staff that narcotics are to be stored securely or disposed of in a timely manner. Also, consider working with staff to see if there are other feasible methods to ensure narcotics used in partial doses or titration are stored more securely and waste is properly documented.

Responsibility: a) Senior Medical Director, Richmond

b) Director, Critical Care, Emergency, Medical Services & Patient Flow, Richmond Management Response: With respect to the anesthesiologist use of lock boxes, we will work will work with Anesthesia to ensure that there a sufficient lock boxes in place, that the lock boxes are properly maintained and there a process for immediate attention to a non working lock box. In addition we suggest that the use of lock boxes be included in the policy requested from the Regional Department of Anesthesia . ED has changed its practice and secure all patient medications in a metal box fastened to the desk. Each nursing assignment has their own box to store all patient specific medications including prepared narcotics. (Refer to attached Medication Handling SOP). During team huddles we emphasize for narcotics to be wasted in a timely manner through the Omnicell. Target Completion Date: June 2014


21

Finding 8: Physical safeguards could be improved in some locations. Moderate Priority

IAS and a representative from Integrated Protection Services reviewed the physical safeguards over narcotics at the selected RH and Minoru Residence units. During a walkthrough of the units, it was noted that at the RH Emergency Department, a medication room sliding door was left open. Moreover, even though a swipe card reader was installed at the entrances of the medication room, the swipe card reader was inactive. Implications: The unsecured medication room at the RH Emergency Department increases the opportunities for diversion. This is especially crucial as members of the public (i.e. patients and their families) may be present in the Emergency Department. Recommendations: Consider activating the installed swipe card reader at the RH Emergency Department medication room and making adjustments to the door so it closes automatically.

Responsibility: Director, Critical Care, Emergency, Medical Services & Patient Flow, Richmond Management Response: The acute medication room also contains the department’s clean supplies, thus is a high traffic area between nursing, support workers and distribution aides. At times the lock is inactivated but the doors are always closed. We recognize this is an area for improvement and will continue to educate staff of the need to keep the doors secured. The treatment medication room swipe card reader is currently broken and a work order has been requested. Target Completion Date: February 15, 2014 Conclusion for Objective 1 There are adequate processes for narcotics issued from the pharmacies to the units and for returns from the units to the pharmacies. Furthermore, Omnicell machines have been installed at most of the acute care units at RH, which result in better physical safeguards and record-keeping processes. While processes and controls are in place, improvements can be made. Documentation of narcotics transactions in the OR and other units could be improved. Random checking of Omnicell issues to patient charts could be done. A narcotics policy for anaesthesiologists could be instituted. Inventory counts should be conducted regularly by two people, and wastage should be witnessed. Omnicell reports regarding user access, usage and wastage should be reviewed periodically. Lastly, the security of partial doses of narcotics and the security of the medication room in the RH Emergency Department can also be improved.


22

OBJECTIVE 2: Determine whether the processes and controls comply with legislation or regulatory requirements with respect to record-keeping and reporting for narcotics and controlled drugs. IAS reviewed the Richmond Community of Care processes and controls relating to compliance with legislative or regulatory requirements for narcotics record-keeping and reporting. In addition, a detailed review of processes, controls and relevant documentation was conducted at the following locations:

• RH – Operating Rooms (OR) • RH – Post Anaesthesia Care Unit (PACU) • RH – Emergency Department General (ED) • RH – Surgical Units • Minoru Residence Wards

The table below summarizes the results of the key audit procedures that were conducted:

Procedure Result

Determined if narcotic records contain the details required by the Narcotic Control Regulations.

Exceptions noted.

Determined if narcotic records are kept for at least 3 years.


Determined if narcotic losses are reported to Health Canada within 10 days of discovery.


Out of a sample of 23 Operating Room daily narcotic logs tested, 3 (13%) logs did not contain the amounts of narcotics issued to patients. The Government of Canada’s Narcotic Control Regulations state that narcotic records shall be maintained, including “the date a narcotic… was ordered or prescribed and the form and quantity thereof.”1 (See Finding 1 above.) Conclusion for Objective 2 Daily narcotic records are to be used by anaesthesiologists. However, it was found that these are not always being completed as required. This may be in non-compliance with Government of Canada’s Narcotic Control Regulations.

1 Narcotic Control Regulations, C.R.C., c.1041, S.63(a)(vii)


23

IX. CONCLUSION There are adequate processes for narcotic movement between the Pharmacy and hospital units. Omnicell machines have been installed at most of the acute care units at RH, which result in better physical safeguards and record-keeping processes Some improvement areas are noted relating to safeguarding of narcotics. Some issues were discovered relating to key record keeping and tracking processes for narcotics. These are required by legislation and therefore more immediate action should be taken to address.

X. ACKNOWLEDGMENT Internal Audit Services gratefully acknowledges the support and assistance provided by all management and staff during the course of the audit.

Documents

Narcotics and Controlled Drugs Management within Richmond ... · PDF fileNarcotics and Controlled Drugs Management ... Operating Room and Emergency Department narcotic records did