Tips for Surviving a CMS Survey
Standards and Regulations taken from FORM CMS-2567(02-99)
*Bolded states regulation *{Italicized provides examples of area competency} **Documentation
A 492 482.25 (1)
PHARMACIST RESPONSIBILITIES
A full-time, part-time, or consulting pharmacist must be responsible for developing,
supervising, and coordinating all the activities of the pharmacy services.
{record review and interviews will take place to ensure pharmacist supervises and evaluates
performance and competency of pharmacy personnel who provide pharmacy services pharmacy
services when the Consultant Pharmacist (PIC) is not on the premises}
**Necessary documents: include evidence of COMPETENCY EVALUATIONS and ORIENTATION
for pharmacy/drug room personnel specifically for the pharmacy/drug room by the Consultant
Pharmacist (PIC).
A 494 482.25(a) (3) PHARMACY DRUG RECORDS
Current and accurate records must be kept of the receipt and distribution of all scheduled
drugs.
{record review and interviews will take place with hospital staff to ensure that a system is in
place to track all scheduled drugs from the point of entry into the hospital to the point of
disposition either through the administration to patients or wastage. Records must be current
and accurate, reconciled by pharmacy personnel and the system provides documentation in a
readily retrievable manner. Surveyors may ask staff if periodic review of documentation of doses
given and wastage documented are done by pharmaceutical services. Surveyors may also ask if
drug discrepancies are analyzed and trended to determine possible diversion.}
**Necessary documents: Partial Dose Administration and Wastage Documentation and DRUG
DIVERSION PREVENTION POLICY and current and accurate records of controlled inventory.
A 505 482.25(b)(3) UNUSABLE DRUGS NOT USED
Outdated, mislabeled, or otherwise unusable drugs and biological must not be available for
patient use.
{record review, observation, and interviews with hospital staff will take place to ensure facility as
a system in place to identify outdated, mislabeled or unusable drugs in the hospital. Routine
inspections of all medication storage areas must be done and documented by pharmacy/drug
room personnel to identify outdated, mislabeled or unusable drugs. Examples of findings could
include missing documentation of monthly inspections of all medication storage areas in
hospital, outdated drugs in radiology department or crash carts, IV fluids or solutions in warmer
or hood not properly labeled with date made and expiration date and a temperature log kept, or
unlabeled syringes.}
**Necessary documents: MONTHLY INSPECTION OF MEDICATION STORAGE AREAS throughout
hospital by drug room personnel and PIC, POLICY FOR MONITORING EXPIRED OR UNUSABLE
MEDICATIONS.
A 508 482.25(B)(6) PHARMACY: REPORTING ADVERSE EVENTS
Drug administration errors, adverse drug reactions, and incompatibilities must be
immediately reported to the attending physician and, if appropriate, to the hospital’s quality
assessment and performance improvement program.
{record review and interviews with hospital staff must ensure that medication errors identified
by the hospital are measured, analyzed and tracked. Review of Medical Staff Meetings minutes
should have evidence of review, analysis or tracking of medication errors identified in incident
reports. Quality Assurance Performance Improvement (QAPI) program or medical staff meeting
minutes should have evidence and documentation that medication errors are reviewed, analyzed
or tracked.
**Necessary documents: POLICY FOR REPORTING AND TRACKING MEDICATION ERRORS AND
ADVERSE DRUG EVENTS and MEDICATION INADVERTENT INCIDENT REPORTING FORM.
A 535 482.26(b) SAFETY POLICY AND PROCEDURES
The radiologic services, particularly ionizing radiology procedures, must be free from hazards
for patients and personnel.
{interview and observation will include IV bags used for procedures, that should include patient
name, date, and single use procedure. High level disinfectants (HLD) will be inspected to ensure
proper storage and use including within date inspection and temperature log and test strip
results. Product information and MSDS sheets should be kept and readily accessible for staff.
Policy and Procedure should be written including method for use as well as staff education and
competency exams. Crash carts will be inspected for in-date medications as well as proper
materials included and clean packaging. A crash cart contents sheet is recommended to be
placed on top of cart as a reference tool for personnel during evaluations of the carts content
and operations. Monthly monitoring recommended to ensure compliance and safety.
**Necessary documents: MONTHLY INSPECTION OF MEDICATION STORAGE AREAS throughout
hospital by drug room personnel and PIC (including labs and crash carts) , POLICY FOR
MONITORING EXPIRED OR UNUSABLE MEDICATIONS (including those medications contained
within lab and crash carts).