Arkansas State Board of Pharmacy
101 East Capitol, Suite 218
Little Rock, AR 72201
501-682-0190  Fax 501-682-0195
www.arkansas.gov/asbp
Hospital Pharmacy Inspection Survey
DATE:
FACILITY:
ADDRESS:
COUNTY:
DIRECTOR:
LICENSE:
PHARMACY PERMIT #:
DEA #:
EXP.:
DEA POWER OF ATTORNEY:
ADMINISTRATOR:
DON:
LICENSED BEDS:
AVG. CENSUS:
LENGTH OF STAY:
DRUG SYSTEM:
DRUG STORAGE AREAS:
Pharmacy Hours:
M-F:
S & S:
Hours/week:
Pharmacist’s schedule of visits:
YES
NO
N/A
Pharmacy administered in accordance with accepted professional principles
Pharmacist trained in hospital pharmacy operations
Training/experience
Pharmacist responsible for control of all medications and pharmacy services
Oral/telephone orders signed within 24 hours
Physical facilities provided for all pharmacy operations and storage of drugs
Proper lighting, ventilation and temperature controls
Special locked storage provided for controlled substances, bulk alcohol and drugs
Provision for emergency pharmacy services/after hours
NOTES:
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YES
NO
N/A
Pharmacist oversees all compounding and dispensing
Supportive personnel perform technical functions to assist pharmacist. The
pharmacist supervises these functions and assumes responsibility. Final check
and verification certified by Pharmacist’s signature, initials, or other ID mark.
Drugs issued to all floor units in accordance with approved policies & procedures
Floor stocks properly controlled
Approved stock lists stating quantities (exact or range) posted in drug area and
included in Policy and Procedure Manual
All drug storage areas checked monthly by Pharmacy Services
Documentation:
Temperature of drug & biological storage refrigerator(s) documented daily
36 to 46 degrees F (2 to 8 degrees C)
Controlled substances verified for accuracy periodically:
Pharmacy:
Floor Stock:
ER:
Other locations:
Abuses and losses of controlled substances reported in accordance with Federal
and State law to appropriate individuals
Proper equipment available for compounding and dispensing:
Graduates 0.1 ml to 500 ml
Mortars & pestles
Hot and cold running water
Spatulas (steel and non-metal)
Funnels
Stirring rods
Class A balance and appropriate weights
Typewriter or other label printer
Apparatus for small volume sterile solutions
Suitable containers and labels
Laminar Flow Hood
Last Inspection Date:
Cleaning/log:
IV Admixtures:
Pharmacists:
Technicians:
Nurses:
NOTES:
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YES
NO
N/A
Inpatient labels—name & strength of medication—expiration date—lot or control
number - label or container into which medication is placed bear name & room
number of patient
Outpatient labels - patient name - date – prescriber – directions - name & strength
of medication (unless directed otherwise by prescriber)
Adequate reference library includes:
American Hospital Formulary Service
Pharmacology text
USP DI (3VOL) & Advice for Patient or Facts & Comparisons and Drug Facts
For Patients
Compatibility of parenteral products text
Current professional journals
Repackaged medications - records maintained
Packages and labels:
Verification:
Expiration dating:
Unused medications (except U/D) destroyed rather than returned to stock
Deteriorated, damaged, or outdated medications destroyed or returned for credit
Unusable controlled substances returned to ADH for destruction
Date of last shipment:
Medication errors & adverse drug reactions reported to Pharmacy for review
Discharge medications consistent with immediate medical needs of patient
Adequate number of personnel to ensure quality services
Director:
Interns/Residents:
Assistant Director:
Technicians:
Staff Pharmacists:
Clerical Personnel:
Technicians are licensed, properly trained & under the direct supervision of
pharmacist performing only allowed duties
Staffing each week complies with allowed ratio
In-services documented:
CE documented:
NOTES:
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YES
NO
N/A
Records maintained for requisitioning & dispensing of medications
Records maintained to effectively & accurately charge patients
Records kept of transactions of Pharmacy (New Rx, refills, floor stock, IV, etc.)
Records maintained by Pharmacy separate from other hospital records for each
(in and out) patient to include - full name of patient – prescriber - name and
strength of medication - manufacturer or tradename – quantity - Pharmacist’s
initials. Should also reflect medications returned
MAR accurately reflects drug administered when generics substituted for trade
names that are ordered
Records of procurement, stock on hand, & dispensing of controlled substances
maintained & readily retrievable in a manner to afford readily traced disposition of
any item
Sell to another registrant:
Profiles clearly marked:
Wastage recorded & witnessed:
Controlled substances stored properly, inventoried and accounted for
Date of Last DEA Inventory:
Controlled substances in specialty areas not staffed by licensed personnel each
shift are counted on each shift covered by licensed personnel.
All records and inventories of Schedule II items stored separately
All drug records maintained in a readily retrievable manner for at least two years
NOTES:
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PHARMACY & THERAPEUTICS COMMITTEE
YES
NO
N/A
A committee or equivalent to include at least one physician, the Administrator or a
designated representative, DON or designated representative, & the Pharmacist
is established in the hospital.
Committee meets at least quarterly and minutes are kept
Dates of meetings:
Committee assists in formulation of broad policies & procedures regarding
evaluation, appraisal, selection, procurement, storage, distribution, use, safety
procedures, and all matters relating to medications in hospital & advises the
medical staff and Pharmacist
Composition, function, frequency should be in Medical Staff Bylaws and the
Pharmacy Policy and Procedure Manual
Pharmacy Policy & Procedure Manual is approved on an annual basis.
This can be done by the Director of Pharmacy
Date:
Pharmacist with aid of P & T Committee is responsible for specifications as to
quality, quantity, and source of all medications
Committee develops, reviews & amends periodically a formulary or drug list
The formulary or drug list is approved annually
Date:
Committee makes recommendations on medications to be stocked at nursing
units and as emergency stocks.
Floor stock lists & emergency drug lists are approved annually
Date:
Committee evaluates clinical data concerning new medications or preparations
requested for use in the hospital.
Committee monitors & controls use of antibiotics for prevention and use of
antibiotics in the presence of infection
Committee discusses reports of medication errors as to types & trends;
conclusions & recommendations are made
Committee discusses reports of adverse drug reactions and makes
recommendations for preventive action
(If neither of the above have occurred, this is so stated in the minutes)
Committee implements & follows a policy for use & control of investigational drugs
& research in the use of recognized medications
NOTES:
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YES
NO
N/A
Committee implements a policy on all toxic or dangerous drugs as to automatic
stop orders. Policy is monitored & enforced.
C-II injectables:
C-II oral:
C-3,4-5:
Toradol (Ketorolac):
Antibiotics:
Cortisones:
Anticoagulants:
Oxytocics:
Antineoplastics:
PATIENT
ID #
MEDICATION
DATE
ORDERED
LAST
DOSE
# DAYS
LATE
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POLICIES & PROCEDURES
YES
NO
N/A
Policies & procedures are maintained, updated, and revised
Date
Job descriptions, duties, responsibilities, & minimum requirements
Procurement, storage, distribution, & drug control
Charging patients (what record used, who performs)
Records
Labeling
Back-up stock—list—log or record—labeling
Obtaining medications after hours
Floor stock, requisitioning, with limits stocked
Emergency room patient medications
Emergency kits/carts—lists of medications & replacements
Medications brought in by patients
Bedside medications
Drug recall
Destruction of medication
Destruction of controlled substances in facility
Storage of controlled substances in facility
Controlled substance audits—reporting discrepancies
Discharge—outpatient—employee prescriptions
Investigational drugs—if not allowed, so stated
Medication errors----adverse drug reactions
Child resistant packaging for discharge—outpatient—employee—ER prescriptions
IV Hood
Time on:
Cleaning:
Inspection:
PPIs—Estrogens, progestational medications, etc.
Multi-dose vials
Repackaging---labeling---dating
MAR reflects actual medication administered
Samples
Herbal and Nutraceutical Agents
Sound Alike/Look Alike Medications
High Alert/ High Risk Medications
NOTES:
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YES
NO
N/A
Physician in ER is on call or in hours
All dispensing by physician or nurses with pre-dispensed doses
Medications dispensed from ER limited to 48 hour supply
Patients assessed—written orders for all medications administered/dispensed
Prescription pads are secured
Pharmacy gets record of medications administered or dispensed or reviews log
Back-up stock
Location:
Labels complete with lot # and expiration date
Pharmacy checks medications against prescriber’s orders
Methods of signing out medications:
Who handles take home X-ray preparations:
Properly labeled and packaged
Routine orders for preparations
Hospital based ambulance service
Does hospital supply medications?
Who receives them?
Record of issuance:
Signed order received & maintained by hospital as record of disposition
Medications properly secured & stored at proper temperatures
Private physician clinics in hospital
Medication provided
Written procedure for medications
Who supplies medication
On what record are medications ordered:
Signed orders
Specialty units (EEG, Cardiac, Cath, etc.) with medications
Who administers medications?
Where are orders recorded and signed by prescriber?
Where are medications charted & initialed?
NOTES:
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TECHNICIANS
YES
NO
N/A
Pharmacist is physically present to observe, direct, and supervise technicians at
all times the technician performs approved duties. Pharmacist is totally and
absolutely responsible for technician’s actions.
Documentation by each technician of all duties and tasks performed in the
preparation and processing of medications. Pharmacist is responsible for final
check and verification. Performance, check and verification are recorded on a
record maintained by the department which includes signature, initials, or other
identifying mark of each person.
ELECTRONIC DATA PROCESSING
YES
NO
N/A
System is approved by Arkansas State Board of Pharmacy
Input may be performed by Pharmacist or technician. Final verification made by
Supervising Pharmacist. Judgmental decisions made only by Pharmacist.
Patient medication profile may be on line or hard copy. Final copy maintained
Name, ID #, prescriber, drug name, strength, and dosage form, # of doses issued,
initials, name, or ID of PD approving order, & order date
Hard copy of daily medication printout is required.
Date, patient name, ID #, drug name, strength & dosage form, # issued, & the
initials of PD who checked
Print out of daily log signed by all Pharmacists filling orders. May be replaced by a
monthly log containing same information. May use a bound log book with
attestation statement. Include times started and finished. Keep for 2 years.
Confidentiality is assured
Hard copy printout of all reports are available within 48 hours
Auxiliary record keeping system in place in lieu of breakdown
EMPLOYEE PRESCRIPTIONS
YES
NO
N/A
Schedule IIs kept separate
Proper information recorded
Date & signature of dispensing Pharmacist
Name, address of patient, address & DEA # of prescriber
NOTES:
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NURSING UNITS
1. LOCKED STORAGE
a. Area locked when unattended
2. CONTROLLED SUBSTANCES
a. Locked separately
b. Double locked
c. On disposition sheets
d. Two nurses count & sign
e. Wastage recorded
f. Wastage witnessed
g. Errors marked correctly
h. Patient’s full name
i. Nurse’s full name & title
3. REFRIGERATOR
a. Temperature checked and documented
b. Proper drugs refrigerated
c. Drugs separated from food
4. DATED DRUGS CURRENT
5. APPROVED STOCK LIST POSTED
6. CRASH CART OR KIT
a. List on outside
b. Sealed
NOTES:
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HOSPITAL PHARMACY SERVICES SURVEY
DIRECTOR OF PHARMACY
LICENSE #
ASSISTANT DIRECTOR
LICENSE #
STAFF PHARMACIST
LICENSE #
LICENSE #
LICENSE #
LICENSE #
LICENSE #
LICENSE #
PHARMACY TECHNICIAN
LICENSE #
LICENSE #
LICENSE #
LICENSE #
LICENSE #
LICENSE #
LICENSE #
LICENSE #
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PHARMACEUTICAL COMPOUNDING OF STERILE PREPARATIONS
YES
NO
N/A
Policies, procedures, and operational guidance are maintained, communicated,
and adhered to by all personnel responsible for compounding sterile preparations
(CSP’s) including hazardous drugs, and in packaging and labeling sterile
medications.
Pharmacy personnel are oriented, trained, and demonstrate competency in
CSP’s, including hazardous drugs, and in packaging and labeling compounded
sterile preparations.
Pharmacists assign the appropriate risk level (low, medium, or high) for each
compounding activity based on adequate knowledge and experience in good
sterile compounding practices.
Pharmacists assign the appropriate risk level (low, medium, or high) for each
compounding activity based on adequate knowledge and experience in good
sterile compounding practices.
Pharmacist select beyond-use date based on the results of direct stability testing
or extrapolation from reliable literature source.
CSP’s are properly labeled with the following: names and amounts or
concentrations of all ingredients, total volume, beyond-use date, appropriate route
of administration, storage conditions and other information for safe use.
CSP’s are visually inspected for physical integrity and expected appearance,
including final fill amount, after compounding and again during dispensing.
CSP’s are properly stored if not immediately dispensed for administration.
Compounding sterile preparations in ISO Class 5 (Class 100 hood) controlled
environments.
Surfaces of ceilings, walls, floors, fixtures, carts, shelving, counters, and cabinets
in the buffer zone or room are smooth, impervious free from cracks and crevices,
nonshedding and resistant to sanitizing agents.
Does the buffer zone or room contain sinks or floor drains?
Within the ante area or anteroom, supplies for compounding are uncartoned and
disinfected. No shipping or other external cartons are taken into the buffer zone
or room.
Objects that shed particles are not brought into the buffer zone or room, including
pencils, cardboard cartons, paper towels and cotton items. Only nonshedding
paper related products can be brought into the buffer zone or room.
Floors in the buffer zone or room are cleansed by mopping once daily during a
time when no aseptic compounding is in progress. Floor cleaning begins in the
buffer zone or room and proceeds to the ante area or anteroom.
NOTES:
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YES
NO
N/A
Before compounding, all work surfaces are cleaned of loose materials and residue
from spills followed by an application of a residue-free sanitizing agent that is left
on for a time sufficient to exert its antimicrobial effect.
Critical area work surfaces are cleaned between batches.
Certification for proper function and air quality requirement (Class 100) of each
LAFW and barrier isolator is preformed.
Date last certified:
Air quality of the buffer zone or room and anteroom is evaluated.
Date last certified:
Compounding personnel perform didactic review and pass written and medial-fill
validation testing of aseptic manipulative skills initially and annually thereafter for
low-risk and medium-risk level compounding.
Refrigerator, freezer and incubator temperatures are checked daily and recorded
and equipment problems are addressed promptly.
Multiple-dose parenteral medications vials (MDV’s) when used, are refrigerated
after opening unless otherwise specified by the manufacturer. Beyond-use dating
unless otherwise referenced in the package insert does not exceed 28 days once
the vial has been opened.
Outdated and unused CSP’s are returned to the pharmacy for disposal or possible
reuse.
Hazardous drugs are compounded and packaged in one of the following: a
properly vented and certified vertical LAFW, or Class II or Class III biological
safety cabinet or barrier isolator.
Hazardous drugs are labeled with a warning label stating the need for special
handling and disposal.
Reuse of MDI inhaler mouthpiece by sterilization or cleaning and redispensing to
another allowed.
Permit the reuse of cartridge components of insulin pens for administration to
patients.
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