Section 250.1510  Medical Records

a)         Facilities

1)         Suitable medical record facilities, with adequate supplies and equipment, shall be maintained by the hospital.

2)         Medical records shall be stored safely.  Medical records are to be handled so as to assure safety from water seepage or fire damage and are to be safeguarded from unauthorized use.

b)         Organization

1)         Responsible Personnel

A)        It is recommended that a qualified medical record practitioner (registered medical record administrator or accredited medical record technician) be employed as the director of the medical records department.

B)        The director of the medical records department shall participate in educational programs relative to medical record activities, in on-the-job training and orientation of other medical record personnel and in-service medical record educational programs.  Professional consultation services should be provided for the medical record practitioner.

2)         An adequate, accurate, timely, and complete medical record shall be maintained for each patient.  Minimum requirements for medical record content are as follows:

A)        patient identification and admission information;

B)        history of patient as to chief complaints, present illness and pertinent past history, family history, and social history;

C)        physical examination report;

D)        provisional diagnosis;

E)         diagnostic and therapeutic reports on laboratory test results, x-ray findings, any surgical procedure performed, any pathological examination, any consultation, and any other diagnostic or therapeutic procedure performed;

F)         orders and progress notes made by the attending physician and when applicable by other members of the medical staff and allied health personnel;

G)        observation notes and vital sign charting made by nursing personnel; and

H)        conclusions as to the primary and any associated diagnoses, brief clinical resume, disposition at discharge to include instructions and/or medications and any autopsy findings on a hospital death.

3)         For record requirements pertaining to maternity patients and newborn infants, see Section 250.1830(i).

4)         A committee of the organized medical staff shall be responsible for reviewing medical records to ensure adequate documentation, completeness, promptness, and clinical pertinence.

5)         Requirements for the completion of medical records and for the retention period for medical records shall be established.  It is recommended that definite policies and procedures pertaining to the use of medical records and the release of medical record information be issued and that discharge diagnoses be expressed in acceptable terminology of a recognized disease nomenclature.

c)         Authentication of Medical Record Entries

1)         All entries into the medical record shall be authenticated by the individual who made or authorized the entry.  "Authentication," for purposes of this Section, means identification of the author of a medical record entry by that author, and confirmation that the contents are what the author intended.

2)         Medical record entries shall include all notes, orders or observations made by direct patient care providers and any other individuals required to make such entries in the medical record, and written interpretive reports of diagnostic tests or specific treatments including, but not limited to, radiologic or electrocardiographic reports, operative reports, reports of pathologic examination of tissue and other similar reports. The medical record may include entries that are transmitted by facsimile machine, provided that the faxed copies will be maintained on non-thermal paper and that the faxed copies will be dated and authenticated in accordance with hospital policy approved by the medical staff.

3)         Written signatures or initials and electronic signatures or computer-generated signature codes are acceptable as authentication.  All signatures or initials, whether written, electronic, or computer-generated, shall include the initials of the signer's credentials.

4)         In order for a hospital to employ electronic signatures or computer-generated signature codes for authentication purposes, the hospital's medical staff and Board must adopt a policy that permits authentication by electronic or computer-generated signature.  The policy shall identify those categories of the medical staff, allied health staff or other personnel within the hospital who are authorized to authenticate patient records using electronic or computer-generated signatures.

5)         At a minimum, the policy shall include adequate safeguards to ensure confidentiality, including, but not limited to, the following:

A)        Each user must be assigned a unique identifier that is generated through a confidential access code.

B)        The hospital must certify in writing that each identifier is kept strictly confidential.  This certification must include a commitment to terminate a user's use of a particular identifier if it is found that the identifier has been misused.  "Misused" shall mean that the user has allowed another person or persons to use his or her personally assigned identifier, or that the identifier has otherwise been inappropriately used.

C)        The user must certify in writing that he or she is the only person with user access to the identifier and the only person authorized to use the signature code.

D)        The hospital must monitor the use of identifiers periodically and take corrective action as needed.  The process by which the hospital will conduct the monitoring shall be described in the policy.

6)         A system employing the use of electronic signatures or computer-generated signature codes for authentication shall include a verification process to ensure that the content of authenticated entries is accurate.  The verification process shall include, at a minimum, the following provisions:

A)        The system shall require completion of certain designated fields for each type of document before the document may be authenticated, with no blanks, gaps or obvious contradictory statements appearing within those designated fields.  The system shall also require that correction or supplementation of previously authenticated entries shall be made by additional entries, separately authenticated and made subsequent in time to the original entry.

B)        The system must make an opportunity available to the user to verify that the document is accurate and that the signature has been properly recorded.

C)        The hospital must, as part of its quality assurance activities, periodically sample records generated by the system to verify the accuracy and integrity of the system.

7)         A user may terminate authorization for use of electronic or computer-generated signature upon written notice to the Director of Medical Records or other person designated by the hospital's policy.

8)         Each report generated by a user must be separately authenticated.

d)         Indexing

1)         A patient index that serves as a key to the location of the medical record of each person who is or has been an inpatient shall be maintained as a perpetual master index, using either a card index or a computer facility system.  A daily register of patients admitted to the hospital and babies born in the hospital shall be maintained.

2)         Medical records shall be classified and indexed according to diagnoses, surgical procedures, and physician, and other indices shall be developed as deemed necessary for the advancement of medical care.

3)         It is recommended that the latest edition of the "International Classification of Diseases," or an adaptation thereof, be used as the statistical classification for purposes of uniformity and compatability of data between and among hospitals.

e)         Preservation

1)         All original medical records or photographs of such records shall be preserved in accordance with a hospital policy based on American Hospital Association recommendations and legal opinion.

2)         The hospital shall have a policy for the preservation of patient medical records in the event of the closure of the hospital.

(Source:  Amended at 23 Ill. Reg. 9513, effective August 1, 1999)