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/policies/administrative/uwhc/department-specific/pharmacy/administration/119.policy

201608224

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UWHC,

Policies,Administrative,UWHC,Department Specific,Pharmacy,Administration

Regulatory Compliance Inspections (1.19)

Regulatory Compliance Inspections (1.19) - Policies, Administrative, UWHC, Department Specific, Pharmacy, Administration

1.19

POLICY & PROCEDURE





Effective Date:

May 2003

Chapter: Administrative

Chapter:

Policy #: 1.19


Revision 8/16

Page 1
of 2

Title: Regulatory Compliance
Inspections



I. PURPOSE: To outline procedures for conducting and documenting inspections of all areas
where medications are dispensed, administered, or stored.

II. POLICY: A designated auditor will conduct and document inspections to maintain
medication integrity, promote medication availability, minimize the risk of diversion and
reduce potential for dispensing errors.
A. Monthly audits will be conducted to ensure that:
1. Medications, prescription blanks and tamper resistant paper are secured in a
manner which will prevent unauthorized access to these items.
2. Medications that are expired, damaged, and/or contaminated are removed
from storage and are separated from medications available for
administration.
3. Medication storage conditions are maintained according to manufacturer
recommendations or pharmacist instructions.
4. Medications are supplied and maintained according to approved medication
standards.
5. Controlled substances are stored according to policy, law and regulation.
6. Any samples present are authorized, in date, and consistent with current
UWHC sample policies.
7. Adequate references (drug information and safety) are available.
8. Patient confidentiality is not compromised.
B. Twice Monthly audits will be conducted to ensure that:
1. All opened multi-dose vials are discarded the first week of the month and
the third week of the month

III. PROCEDURE:
A. An electronic database will be utilized to perform and document monthly
inspections for all medication storage locations.
B. Criteria for inspection will be established and maintained by the department’s
regulatory compliance manager.
C. Using the appropriate electronic inspection form, medication storage areas will be
inspected by an auditor designated by the manager for that area.

POLICY & PROCEDURE





Effective Date:

May 2003

Chapter: Administrative

Chapter:

Policy #: 1.19


Revision 8/16

Page 1
of 2

Title: Regulatory Compliance
Inspections

D. Upon completion of the audit, the auditor will document the results of the audit
within the electronic database, including any follow up and corrective actions
taken.
E. Inspections should be completed as follows:
1. Monthly audits will be completed by the 20th of the month by the
designated auditor.
2. Twice monthly audits will be completed by the end of the day on
Thursday of the designated week.
F. Pharmacy managers will review the non-compliance report on or shortly after
the assigned completion date any additional follow up and corrective actions
needed so all audits can be completed as designated.
G. Non-compliance reports will be reviewed, at least quarterly, at the department
regulatory committee meetings to identify potential system improvement
initiatives.
H. Electronic audit results will be saved for a minimum of three years.

IV. RELATED POLICIES
A. Pharmacy Policy 13.13 Medication Floor Area Stock
B. Hospital Policy 8.36 Control of Trial Supplies of Prescription Medications:
Samples, Drug Vouchers and Starter Supplies
C. Pharmacy Policy 1.32 Medication Refrigerator Audit Policy
D. Pharmacy Policy 1.43 Storage, Handling, Security and Disposition of
Medications


Approved By: _________________________
Director, Pharmacy Services

Date:______________