STANDARD 23: Medical Records

23.1 General

1. The healthcare organization shall have a medical record service that has administrative responsibility for medical records. A medical record shall be maintained for every individual evaluated or treated in the healthcare organization.

NOTE 1 The term "medical records" includes at least written documents, computerized electronic information, radiology film and scans, laboratory reports and pathology slides, videos, audio recordings, and other forms of information regarding the condition of a patient.

23.2 Organization and Staffing

1. The medical record service shall be appropriate to the scope and complexity of the services performed.

2. The healthcare organization shall employ adequate personnel to ensure prompt completion, filing, and retrieval of records.

23.3 Medical Record Requirements

1. The healthcare organization shall maintain a medical record for each inpatient and outpatient. 2. Medical records shall be accurately written, promptly completed, properly filed, retained, and accessible.

3. Medical records shall be retained in their original or legally reproduced form for a period of at least 5 years or in accordance with the national law.

4. The healthcare organization shall have a medical record system that allows the retrieval of any patient record treated within the scope of the healthcare organization. These records shall be for immediately available and retained as documented information as described in 23.3.4. above.

5. Medical records shall be properly stored in secure locations where they are protected from fire, water damage and other threats.

6. The medial record system shall ensure that medical record entries are not lost, stolen, destroyed, altered, or reproduced in an unauthorized manner or accessed by unauthorized personnel.

7. Additionally, medical records service shall comply with the requirement of STANDARD 4.4.

NOTE 1 Medical record are retained in their original or legally reproduced form in hard copy, microfilm, computer memory, or other electronic storage media.

23.4 Identification of Authors

1. The medical record system shall correctly identify and preserve the identity of the author of every medical record entry.

23.5 Confidentiality

1. The healthcare organization shall have a procedure for ensuring the confidentiality of patient records.

2. Information from, or copies of, any records shall be released only to authorized individuals. The healthcare organization shall ensure that unauthorized individuals cannot gain access to or alter patient records.

3. Copies of original medical records shall be released by the healthcare organization only in accordance with applicable laws and regulations, court orders, or subpoenas.

4. Patient records shall be secure at all times and in all locations. This specifically includes open patient records within the healthcare organization scope of services.

5. The healthcare organization’s staff and consultants shall have access to only that portion of information that is necessary to provide effective responsive services to that individual.

NOTE 1 The right to confidentiality means safeguarding the content of information, including patient identification, paper records, video, audio, and/or computer stored information from unauthorized disclosure without the specific informed consent of the individual, parent of a minor child, or legal guardian (see STANDARD 11.10.) Confidentiality applies to both central records and clinical record information that may be kept at dispersed locations.

23.6 Content of Record

1. The medical record shall contain information to justify admission, support the diagnosis, and describe the patient’s progress and response to medications and services. (See also the requirements 4.1.3–4.1.5).

2. All entries shall be legible, complete, dated, and timed. They shall be authenticated by the person responsible for providing care consistent with healthcare organization policy.

3. The medical record shall contain information such as notes, documentation, records, reports, recordings, informed consents, test results and assessments to support the diagnosis and describe the patients progress and response to medications and services including any safety incidents including near misses and adverse events.

4. The medical record shall contain complete information/documentation regarding completed evaluations, co-morbidities identified, interventions, care plans, and resulting care provided. Additionally, the record shall contain documentation of the patient’s response, services provided, discharge summaries, and associated plans of follow-up.

NOTE 1 The requirements for dating and timing do not apply to orders or prescriptions that are generated outside of the healthcare organization until they are presented to the healthcare organization at the time of service. Once the healthcare organization begins processing such an order or prescription, it is responsible for ensuring that the implementation of the order or prescription by the healthcare organization is promptly dated and timed in the patient’s medical record.

NOTE 2 In the case of a pre-established electronic order set, the same principles would apply, so that the practitioner would date, time, and authenticate the final order that resulted from the electronic selection/ annotation process, with the exception that pages with internal changes would not need to be initialed or signed if they are part of an integrated single electronic document.

5. When an electronic medical record (EMR) is in use, the healthcare organization shall prevent alterations of record entries after they have been authenticated. The EMR shall be immediately available for authorized review.

6. A practitioner shall review and authenticate all electronic and dictated records to assure accuracy and appropriate content. This documentation shall not become part of the patient medical record until this responsibility is completed.

7. If an EMR is generated, the practitioner shall date, time, and sign this record when the review and authentication actually occur.

NOTE 3 An appropriate authentication occurs when a related entry confirming same is made in the medical record.

8. All verbal orders shall be authenticated based upon applicable laws and regulations. If there are no applicable laws and regulations that designate a specific time frame for the authentication of verbal orders, verbal orders shall be authenticated within 48 hours.

9. In some instances, the ordering practitioner may not be able available. In this case the attending practitioner shall authenticate his or her verbal order.

10. There shall be an appropriate history and physical place in the medical record according to STANDARD 8.9.

11. All patient records, both inpatient and outpatient, shall contain the results of all consultative evaluations of the patient and appropriate findings by clinical and other staff involved in the care of the patient. This information shall be promptly filed in the patient’s medical record in order to be available to the physician or other care providers to use in making assessments of the patient’s condition, to justify treatment and continued care within the healthcare organization, to support or revise the patient’s diagnosis, to support or revise the plan of care, to describe the patient’s progress, and to describe the patient’s response to medications, treatments, and services.

12. All records shall document complications, hospital acquired infections, and unfavorable reactions to medications and anesthesia.

13. All records shall document all practitioners’ orders, nursing notes, reports of treatment, medication records, radiology, and laboratory reports, and vital signs and other information necessary to monitor the patient’s condition.

14. The medical record shall include a discharge summary in keeping with the parameters of patient care as described in 23.6.4. above, outcome of healthcare organization treatment, disposition of case, and provisions for follow-up care.

15. All records shall document the final diagnosis and shall be complete within 30 days following discharge.

16. When rubber stamps or electronic authorizations are used for authentication, the healthcare organization shall have policies and procedures to ensure that such stamps or authorizations are used only by the individuals whose signature they represent. There shall be no delegation of stamps or authentication codes and tokens to another individual.

NOTE 4 Authentication of medical record entries may include written signatures, initials, computer key, token, or other code. For authentication, in written or electronic form, a method shall be established to identify the author.

NOTE 5 All practitioners responsible for the patient’s care are expected to have knowledge of the patient’s medical course, plan of care, condition, and current status.