CMS SOM App. W, Tag C-1110

record that includes, as applicable--

(i) Identification and social data, evidence of properly executed informed consent

forms, pertinent medical history, assessment of the health status and health care

needs of the patient, and a brief summary of the episode, disposition, and

instructions to the patient;

Interpretive Guidelines §485.638(a)(4)(i)

The medical record must include evidence of properly executed informed consent forms

for any procedures or surgical procedures specified by the medical staff, or by Federal or

State law, if applicable, that require written patient consent.

Informed consent means the patient or patient representative is given the information,

explanations, consequences, and options needed in order to consent to a procedure or

treatment.

A properly executed consent form contains at least the following:

• Name of patient, and when appropriate, patient’s legal guardian;

• Name of CAH;

• Name of procedure(s);

• Name of practitioner(s) performing the procedures(s);

• Signature of patient or legal guardian;

• Date and time consent is obtained;

• Statement that procedure was explained to patient or guardian;

• Signature of professional person witnessing the consent;

• Name/signature of person who explained the procedure to the patient or guardian.

The medical record must contain information such as progress and nursing notes,

documentation, records, reports, recordings, test results, assessments etc. to:

• Justify admission;

• Support the diagnosis;

• Describe the patient’s progress;

• Describe the patient’s response to medications; and

• Describe the patient’s response to services such as interventions, care, treatments,

etc.

The medical record must contain complete information/documentation regarding medical

history, assessment of the health status and health care needs of the patient, and a

summary of the episode, disposition, and instructions to the patient. This information and

documentation is contained in a discharge summary.

A discharge summary discusses the outcome of the CAH stay, the disposition of the

patient, and provisions for follow-up care. Follow-up care provisions include any post

CAH appointment, how post CAH patient care needs are to be met, and any plans for

post-CAH care by providers such as swing-bed services, home health, hospice, nursing

homes, or assisted living. A discharge summary is required following any CAH acute

care stay prior to and following a swing-bed admission and discharge.

The MD/DO or other qualified practitioner with admitting privileges in accordance with

State law and CAH policy, who admitted the patient is responsible for the patient during

the patient’s stay in the CAH. This responsibility would include developing and entering

the discharge summary.

The MD/DO may delegate writing the discharge summary to other qualified health care

personnel such as nurse practitioners and physician assistants to the extent recognized

under State law or a State’s regulatory mechanism. The MD/DO may also delegate

writing the discharge summary to another MD/DO who is familiar with the patient.

Survey Procedures §485.638(a)(4)(i)

• Verify that the medical staff have specified which procedures or treatments

require a written informed consent.

• Verify that medical records contain consent forms for all procedures or treatment

that are required by CAH policy.

• Verify that consent forms are properly executed.

• Examine a sample of patient records and/or facility records of requests for

information contained in patient records to determine if there are signed and dated

consent forms, when required, medical history, health status and care needs

assessment, and discharge summary in each record, as needed.

• Review of sample of active and closed medical records for completeness and

accuracy in accordance with Federal and State laws and regulations and CAH

policy. The sample should be at least 10 percent of the average daily census, as

appropriate.