CMS SOM App. L, Tag Q-0181

Drugs must be prepared and administered according to established policies and

acceptable standards of practice

Interpretive Guidelines: §416.48(a)

Drugs and biologicals used within the ASC must be administered to patients in

accordance with formal policies the ASC has adopted, and those policies and the ASC’s

actual practices must conform to acceptable standards of practice for medication

administration.

“Accepted professional practice” and “acceptable standards of practice” mean that

drugs and biologicals are handled and provided in the ASC in accordance with applicable

State and Federal laws as well as with standards established by organizations with

nationally recognized expertise in the clinical use of drugs and biologicals. This would

include organizations such as the National Association of Boards of Pharmacy, the

Institute for Safe Medication Practices, the American Society of Health-System

Pharmacists, etc.

The ASC must have policies and procedures designed to promote medication

administration consistent with acceptable standards of practice. The policies and

procedures should address issues including, but not limited to:

• A physician or other qualified member of the medical staff acting within their

scope of practice must issue an order for all drugs or biologicals administered

in the ASC. The administration of the drugs or biologicals must be by, or

under the supervision of, nursing or other personnel in accordance with

applicable laws, standards of practice and the ASC’s policies.

• Following the manufacturer’s label, including storing drugs and biologicals as

directed; disposing of expired medications in a timely manner; using single-dose vials of medication for one ASC patient only; etc.

• Avoiding preparation of medications too far in advance of their use. For

example, while it may appear efficient to pre-draw the evening before all

medications that will be used for surgeries scheduled the following day, this

practice may, depending on the particular drug or biological, promote loss of

integrity, stability or security of the medication.

• Any pre-filled syringes must be initialed by the person who draws it, dated

and timed to indicate when they were drawn, and labeled as to both content

and expiration date.

• Employing standard infection control practices when using injectable

medications.

There must be records of receipt and disposition of all drugs listed in Schedules II, III,

IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970, if the

ASC uses any such scheduled drugs. The ASC’s policies and procedures should also

address the following:

• Accountability procedures to ensure control of the distribution, use, and

disposition of all scheduled drugs.

• Records of the receipt and disposition of all scheduled drugs must be current and

must be accurate.

• Records to trace the movement of scheduled drugs throughout the ASC.

• The licensed health care professional who has been designated responsible for the

ASC’s pharmaceutical services is responsible for determining that all drug records

are in order and that an account of all scheduled drugs is maintained and

reconciled.

• The record system, delineated in policies and procedures, tracks movement of all

scheduled drugs from the point of entry into the ASC to the point of departure,

either through administration to the patient, destruction, or return to the

manufacturer. This system provides documentation on scheduled drugs in a

readily retrievable manner to facilitate reconciliation of the receipt and disposition

of all scheduled drugs.

• All drug records are in order and an account of all scheduled drugs is maintained

and any discrepancies in count are reconciled promptly.

• The ASC’s system is capable of readily identifying loss or diversion of all

controlled substances in such a manner as to minimize the time frame between the

actual loss or diversion to the time of detection and determination of the extent of

loss or diversion?

Survey Procedures: §416.48(a)

• Is there evidence in the medical records reviewed that there is an order, signed by

a physician or other qualified practitioner, for every drug or biological

administered to the patient?

• Are drugs or biologicals administered only by nurses or other qualified

individuals, or under the supervision of nurses or other qualified individuals, as

permitted under Federal or State law and the ASC’s policy?

• Determine whether medications are properly labeled, stored, and have not

expired.

• Using the infection control survey tool, determine whether the ASC employs safe

injection practices.

• If the ASC uses scheduled drugs:

• Determine if there is a record system in place that provides information on

controlled substances in a readily retrievable manner.

• Review the records to determine that they trace the movement of scheduled

drugs throughout the ASC.

• Determine if there is a system, delineated in policies and procedures, that

tracks movement of all scheduled drugs from the point of entry into the ASC

to the point of departure, either through administration to the patient,

destruction or return to the manufacturer. Determine if this system provides

documentation on scheduled drugs in a readily retrievable manner to facilitate

reconciliation of the receipt and disposition of all scheduled drugs.

• Determine if the licensed health care professional who is in charge of the

ASC’s pharmaceutical services is responsible for determining that all drug

records are in order and that an account of all scheduled drugs is maintained

and periodically reconciled.

• Is the ASC’s system capable of readily identifying loss or diversion of all

controlled substances in such a manner as to minimize the time between the

actual losses or diversion to the time of detection and determination of the

extent of loss or diversion?

• Determine if facility policy and procedures minimize scheduled drug

diversion.