CMS SOM App. W, Tag C-1102

(1) The CAH maintains a clinical records system in accordance with written policies

and procedures.

Interpretive Guidelines §485.638(a)(1)

The CAH must have a system of patient records, pertinent medical information, author

identification, and record maintenance that ensures the integrity of the authentication and

protects the security of all record entries. The medical record system must correctly

identify the author of every medical record entry. The medical record system must

protect the security of all medical record entries. The medical record system must ensure

that medical record entries are not lost, stolen, destroyed, altered, or reproduced in an

unauthorized manner. All locations where medical records are stored or maintained must

ensure the integrity, security and protection of the records.

The CAH must have a system in place that ensures that the identity of the author of each

entry is correct. The author of every entry must take a specified action to identify

himself/herself as the author (or responsible person) of the entry, the time and dating of

the entry, that the entry is accurate, and that he/she takes responsibility for accuracy of

the entry.

If the CAH uses computer entries there must be security system in place to ensure the

integrity of the record system, to ensure that the author of each entry is correctly

identified, to ensure that record entries are not altered or lost, that limits access to medical

records to only authorized persons, and ensures that records are not released to

unauthorized individuals. For the purposes of this regulation, electronic signatures

comply with those medical record entries that include a requirements for a signature.

There should be a current list of authenticated signatures, as well as a list of computer

codes and signature stamps (when used for authorship purposes) that have been

authorized by the governing body and are protected by adequate safeguards. CAH

policies and procedures should provide for appropriate sanctions for unauthorized or

improper use of computer codes or signature stamps.

The CAH must maintain a medical record for each inpatient and outpatient evaluated or

treated in any part or location of the CAH. A unit record for both inpatients and

outpatients may be used; however, when two different systems are used they must be

appropriately cross referenced. When a patient reimbursement status changes from acute

care services to swing bed services, a single medical record may be used for both stays as

long as the record is sectioned separately. Both sections must include admission and

discharge orders, progress notes, nursing notes, graphics, laboratory support documents,

any other pertinent documents, and discharge summaries.

The medical record must be properly filed and retained. The CAH must have a medical

recording system that ensures the prompt retrieval of any medical record, of any patient

evaluated or treated at any location of the CAH within the past 6 years.

The medical record must be accessible. The CAH must have a medical record system

that allows the medical record of any patient, inpatient or outpatient, evaluated and/or

treated at any location of the CAH within the past 6 years to be accessible by appropriate

staff, 24 hours a day, 7 days a week, whenever that medical record may be needed.

Survey Procedures §485.638(a)(1)

• Verify that a medical record is maintained for each person receiving care.

• Verify that written procedures ensure the integrity of authentication and protect

the security of patient records.

• Verify that medical records are stored and maintained in locations where the

records are secure, with protection from damage, flood, fire, theft, etc., and limits

access to only authorized individuals.

• Verify that records are accurate, completed promptly, easily retrieved and readily

accessible, as needed.

• Verify that there is an established system that addresses at least the following

activities of the medical records services:

o Timely processing and retrieval of records;

o Protecting the confidentiality of medical information;

o Compiling and retrieval of data of quality assurance activities.

• Verify that the system policies and procedures are reviewed and revised as

needed.

• Verify that the CAH employs adequate medical record personnel who possess

adequate education, skills, qualifications and experience to ensure the CAH

complies with requirements of the medical records regulations and other

appropriate Federal and State laws and regulations.

• Are medical records promptly completed in accordance with State law and CAH

policy?

• Select a sample of past patients of the CAH (inpatient and/or outpatient). Request

those patient’s medical records. Can the CAH promptly retrieve those records?