CMS-378 Ambulatory Surgical Center Survey Report Form

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

Form Approved
OMB No. 0938-0266

AMBULATORY SURGICAL CENTER SURVEY REPORT

MEDICARE SUPPLIER NUMBER

FACILITY NAME AND ADDRESS (City, State, Zip Code)

NAME OF SURVEYOR AND PROFESSIONAL TITLE

SURVEYOR’S PROFESSIONAL TITLE
1.

■ Initial Survey

2.

■ Resurvey

LIST ADDITIONAL SURVEYOR’S NAMES

TITLES

SURVEY TEAM COMPOSITION
Indicate the Number of Surveyors According to Discipline:
A.

Administrator

H.

Life Safety Code Specialist

B.

Nurse

I.

Laboratorian

C.

Dietitian

J.

Sanitarian

D.

Pharmacist

K.

Therapist

E.

Records Administrator

L.

Physician

F.

Social Worker

M.

National Institute of Mental Health

G.

Qualified Mental Retardation Professional

N.

Other

NOTE: More than one discipline may be marked for surveyors qualified in multiple disciplines.
Indicate the Total Number of Surveyors Onsite: ______

Q1
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Q2

N/A

EXPLANATORY STATEMENTS

§416.40 Condition For Coverage: Compliance With State
Licensure Law.
The ASC must comply with state licensure requirements.

Q3

§416.41 ConditIon For Coverage: Governing Body and
Management
The ASC must have a governing body that assumes full
legal responsibility for determining, implementing, and
monitoring policies governing the ASC’s total operation and
for ensuring that these policies are administered so as to
provide quality health care in a safe environment. When
services are provided through a contract with an outside
resource, the ASC must assure that these services are
provided in a safe and effective manner.

Q4

(a) Standard: Hospitalization.
The ASC must have an effective procedure for the
immediate transfer to a hospital, of patients requiring
emergency medical care beyond the capabilities of the
ASC. This hospital must be a local, Medicare participating
hospital or a local, non-participating hospital that meets the
requirements for payment for emergency services under
§482.2 of this chapter. The ASC must have a written
transfer agreement with such a hospital, or all physicians
performing surgery in the ASC must have admitting
privileges at such a hospital.

Q5

§416.42 ConditIon for Coverage: Surgical Services.
Surgical procedures must be performed in a safe manner
by qualified physicians who have been granted clinical
privileges by the governing body of the ASC in accordance
with approved policies and procedures of the ASC.

Q6

(a) Standard: Anesthetic rIsk and evaluation.
A physcian must examine the patient immediately before
surgery to evaluate the risk of anesthesia and of the
procedure to be performed. Before discharge from the
ASC, each patient must be evaluated by a physician for
proper anesthesia recovery.

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Q7

N/A

EXPLANATORY STATEMENTS

(b) Standard: Administration of anesthesia.
Anesthetics must be administered by only —
(1) A qualified anesthesiologist; or
(2) A physician qualified to administer anesthesia, a
certified registered nurse anesthetist, a supervised
trainee in an approved educational program or an
anesthesia assistant as defined in §410.68(b). In
those cases where a nonphysician administers the
anesthesia, the anesthetist must be under the
supervision of the operating physician, and in the
case of anesthesiologist’s assistant, under the
supervision of an anesthesiologist.

Q8

(c) Standard: Discharge.
All patients are discharged in the company of a responsible
adult, except those exempted by the attending physician.

Q9

§416.43 ConditIon for Coverage: Evaluation of Quality.
The ASC, with the active participation of the medical staff,
must conduct an ongoing, comprehensive self-assessment of
the quality of care provided, including medical necessity of
procedures performed and appropriateness of care, and use
findings, when appropriate, in the revision of center policies
and consideration of clinical privileges.

Q10

§416.44 ConditIon of Coverage: Environment.
The ASC must have a safe and sanitary environment,
properly constructed, equipped, and maintained to protect
the health and safety of patients.

Q11

(a) Standard: Physical environment.
The ASC must provide a functional and sanitary
environment for the provision of surgical services.

Q12

(1) Each operating room must be designed and equipped
so that the types of surgery conducted can be
performed in a manner that protects the lives and
assures the physical safety of all individuals in the
area.

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Q13

(2) The ASC must have a separate recovery room and
waiting area.

Q14

(3) The ASC must establish a program for identifying
and preventing infections, maintaining a sanitary
environment, and reporting the results to appropriate
authorities.

Q15

N/A

EXPLANATORY STATEMENTS

(b) Standard: Safety from fire.
The ASC must meet the provisions of the Life Safety Code
of the National Fire Protection Association (NFPA-1981
edition) that are applicable to ambulatory surgical centers,
with the following exception. In consideration of a
recommendation by the State survey agency, CMS may
waive, for periods deemed appropriate, specific provisions of
that code which, if rigidly applied, would result in
unreasonable hardship upon an ASC, but only if the waiver
will not adversely affect the health and safety of the patients.

Q16

(c) Standard: Emergency equipment.
Emergency equipment available to the operating rooms must
include at least the following:

Q17

(1)
Yes

(2)
No

(1) Emergency call system.
(2) Oxygen.
(3) Mechanical ventilatory assistance equipment
including airways, manual breathing bag, and
ventilator.
(4) Cardiac defibrillator.
(5) Cardiac monitoring equipment.
(6) Tracheostomy set.
(7) Laryngoscopes and endotracheal tubes.
(8) Suction equipment.
(9) Emergency medical equipment and supplies
specified by the medical staff.
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Q18

N/A

EXPLANATORY STATEMENTS

(d) Standard: Emergency personnel.
Personnel trained in the use of emergency equipment and
in cardiopulmonary resuscitation must be available
whenever there is a patient in the ASC.

Q19

§416.45 ConditIon for Coverage: Medical Staff.
The medical staff of the ASC must be accountable to the
governing body.

Q20

(a) Standard: Membership and clinical privileges.
Members of the medical staff must be legally and
professionally qualified for the positions to which they are
appointed and for the performance of privileges granted.
The ASC grants privileges in accordance with
recommendations from qualified medical personnel.

Q21

(b) Standard: Reappraisals.

Q22

Medical staff privileges must be periodically reappraised by
the ASC. The scope of procedures performed in the ASC
must be periodically reviewed and amended as appropri­
ate.
(c) Standard: Other practitioners.
If the ASC assigns patient care responsibilities to
practitioners other than physicians, it must have estab­
lished policies and procedures, approved by governing
body, for overseeing and evaluating their clinical activities.

Q23

§416.46 ConditIon for Coverage: Nursing ServIces.
The nursing services of ASC must be directed and staffed to
assure that the nursing needs of all patients are met.

Q24

(a) Standard: Organization and staffing.
Patient care responsibilities must be delineated for all
nursing and service personnel. Nursing services must be
provided in accordance with recognized standards of
practice. There must be a registered nurse available for
emergency treatment whenever there is a patient in the ASC.

Q25

§416.47 CondItion for Coverage: Medical Records.
The ASC must maintain complete, comprehensive, and
accurate medical records to ensure adequate patient care.

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Q26

N/A

EXPLANATORY STATEMENTS

(a) Standard: Organization.
The ASC must develop and maintain a system for the
proper collection, storage, and use of patient records.

Q27

(b) Standard: Form and content of record.
The ASC must maintain a medical record for each patient.
Every record must be accurate, legible, and promptly
completed. Medical records must include at least the
following:

Q28

(1)
Yes

(2)
No

(1) Patient identification.
(2) Significant medical history and results of physical
examination.
(3) Pre-operative diagnostic studies (entered before
surgery), if performed.
(4) Findings and techniques of the operation, including a
pathologist’s report on all tissues removed during
surgery, except those exempted by the governing body.
(5) Any allergies and abnormal drug reactions.
(6) Entries related to anesthesia administration.
(7) Documentation of properly executed informed
patient consent.
(8) Discharge diagnosis.
Q29

§416.48 Condition for Coverage: Pharmaceutical Services.
The ASC must provide drugs and biologicals in a safe and
effective manner, in accordance with accepted professional
practice, and under the direction of an individual designated
responsible for pharmaceutical services.

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Q30

N/A

EXPLANATORY STATEMENTS

(a) Standard: Administration of drugs.
Drugs must be prepared and administered according to
established policies and acceptable standards of practice.

Q31

(1) Adverse reactions must be reported to the physician
responsible for the patient and must be documented
in the record.

Q32

(2) Blood and blood products must be administered by
only physicians or registered nurses.

Q33

(3) Orders given orally for drugs and biologicals must be
followed by a written order, signed by the prescribing
physician.

Q34

§416.49 CondItion for Coverage: Laboratory and
Radiologic Services.
The ASC must have procedures for obtaining routine and
emergency laboratory and radiologic services, from
Medicare approved facilities, to meet the needs of patients.

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Form CMS-378 (01/97)

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