SOW Clinton Watonga 8-27-2021.pdf

Clinton Indian Health Center

Watonga Indian Health Clinic

Indian Health Service

10321 N. 2274 Rd.

Clinton, Oklahoma 73601

Phone: (580) 331-5000 Fax: (580) 323-2579

SCOPE OF WORK

Clinton and Watonga Indian Health Center

Indian Health Service Chapter 7 Security Requirements

I. Objective:

The intent and objective is to provide the Clinton Indian Health Center and The Watonga Indian Health Clinic the security requirements outlined in Chapter 7 of the Indian Health Manual.

II. Background:

Pharmacy services within the Indian Health Service are required to provide the security measures listed in the Scope of Work below.

Scope of Work:

Electronic Access Control:

o Any door leading into the pharmacy shall have security-enhanced or Cipher-type locks in order to prevent unauthorized access into the pharmacy.

o Cipher-type locks must have individual access codes; group codes shall not be used.

o Clinton currently uses an AMAG/Symmetry Professional version 9 system which the contractor will use..

o Watonga does not have system in place. Two Pharmacy doors will require the card readers with keypads.

o Both security-enhanced and Cipher-type door locks shall provide a centralized, readily retrievable history of entrance into the pharmacy.

o Only pharmacists shall have physical keys that can override security-enhanced or Cipher-type locks. Physical key use shall be restricted to times when security-enhanced or Cipher-type locks are not functioning (e.g. power outage).

o Electronic access control will be added to three interior doors, the two doors leading into the clinic area and the supply room door.

o Electronic access controls with keypads will be installed on three exterior doors, two employee entrances in the back of the building and the conference room exterior door.

o The combination of the Cipher lock shall be capable of being changed every 90 days and as soon as possible after an employee leaves the IHS facility employment.

Alarm System required at both sites:

o An alarm system with motion detectors and an auto-dialer shall be installed to alert law enforcement and health center management to unauthorized after-hour access to the pharmacy.

o Alarm system(s) shall be routinely tested.

o Alarm system(s) shall have at least a 24-hour battery or other standby power source(s) in the event of commercial power failure.

Pharmacy Windows:

Pharmacy windows located on the exterior of the facility (Clinton only) shall have bars or bullet-resistant glass, which is sufficient to deter/prevent forcible entry into the pharmacy. Windows on the exterior of the pharmacy but interior of the facility shall have barriers sufficient to prevent unauthorized access to the pharmacy. Barriers shall include bars, bullet-proof glass, or security shutters. If security shutters are used, pharmacy personnel shall be physically present at all times while shutters are open.

Chapter seven of the Indian Health Manual referenced above

3-7.7 PHARMACY SECURITY

A. All Controlled Substances must be secured and under the control of pharmacy services.

B. Controlled substance stock shall not be dispersed with general pharmacy inventory.

C. Schedule II - V Drugs should be secured in strongly constructed metal cabinet(s) or safe(s) as per DEA regulations.

D. Schedule II - V Drugs may be securely stored in automated systems (ex. BD - Pyxis C2 Safe, Omnicell

Controlled Substance Manager or similar products/systems). The automated system shall be locked at all times when not in use for dispensing or restocking. It shall be located in a manner that a pharmacist can easily observe when the controlled substances cells are being accessed.

E. Access to controlled substances within the pharmacy is controlled and limited.

1. The Chief Pharmacist will maintain a list of pharmacy staff with access to controlled substances and this list will be readily retrievable.

2. Local policy and procedures must ensure that there is a controlled, limited number of pharmacy employees that have access to stocks of scheduled drugs including the safe, working stock, and automated dispensing systems.

3. Only pharmacists should have access to controlled substances if there is not an electronic monitoring system in place.

4. All controlled substance prescriptions waiting for pick-up must be kept in a securely locked storage area to decrease the risk of diversion by staff. Access will be limited to pharmacists.

5. Closed Circuit Television Cameras.

1. Closed-circuit TV Cameras will be installed inside the pharmacy and at remote medication storage areas to document and prevent diversion of scheduled controlled substances.

2. The recorded footage must be securely stored with restricted access.

3. Cameras should provide adequate coverage of the following areas:

1. medication filling/handling location(s),

2. counseling room(s),

3. controlled substance safe(s),

4. pharmacy patient reception,

5. automated dispensing unit(s)/robot(s),

6. prescription shelving/storage, and

7. pharmacy entrance(s)/exit(s)

4. Cameras must:

1. be protected against tampering/disabling;

2. have a video quality of high resolution, with motion activation to trigger recording;

and

3. have storage hardware for recorded footage, capable of saving up to 30 days of security footage for each camera, and should be easily upgradeable to accommodate future expansion/increased storage capacity as needed.

6. After Hours Pharmacy Access to Medications.

a. A secured emergency medication storage cabinet or ADC must be used to store medications that are approved by the local P&T Committee for afterhours use.

b. Only appropriate providers, within scope of practice, may access the ADCs. Access to the pharmacy after hours is limited to pharmacists.

c. A local policy must be in place to accept medication deliveries outside of pharmacy hours to include identification of individuals authorized to sign for the delivery, and designation of a secure storage location.

Electronic Access Control.

a. Any door leading into the pharmacy will have security-enhanced or Cipher-type locks in order to prevent unauthorized access into the pharmacy.

Examples of security-enhanced locks include electronic access control using a Personal Identity Verification Card or Biometrics (i.e. fingerprint or retina scan).

Cipher-type locks may only be used if they have individual access codes; group codes shall not be used.

Both security-enhanced and Cipher-type door locks must provide a centralized, readily retrievable history of entrance into the pharmacy.

Only pharmacists may have physical keys that can override security-enhanced or Cipher-type locks. Physical key use will be restricted to times when security-enhanced or Cipher-type locks are not functioning (e.g. power outage).

b. The combination of the Cipher lock should be changed every 90 days and as soon as possible after an employee leaves the IHS facility employment.

All visitors and non-pharmacy personnel entering the pharmacy must be escorted by the pharmacy personnel at all times and sign a log book recording, at a minimum, the following information: name, reason for entry, time of entry, time of exit.

An alarm system with motion detectors and an auto-dialer must be installed to alert law enforcement and health center management to unauthorized after-hour access to the pharmacy.

1. Alarm system(s) will be routinely tested.

2. Alarm system(s) must have at least a 24-hour battery or other standby power source(s) in the event of commercial power failure.

Automated Dispensing Robots and Cabinets.

1. All automated dispensing robots and cabinets in the facility should possess biometric authentication to identify the end user.

2. When biometric authentication is not available, user passwords may be used and must be changed every 90 days in compliance with government standards for password security.

Pharmacy windows located on the exterior of the facility will have bars or bullet-resistant glass, which is sufficient to deter/prevent forcible entry into the pharmacy. Windows on the exterior of the pharmacy but interior of the facility will have barriers sufficient to prevent unauthorized access to the pharmacy. Barriers may include bars, bullet-proof glass, or security shutters. If security shutters are used, pharmacy personnel must be physically present at all times while shutters are open.