Medical Records

Standards for Medical Records generally require policies for organization, content, security, and privacy. The standards apply to both paper and electronic formats. Policies must comply with State and Federal laws. The HIPPA and HITECH laws are important to follow when developing Medical Record policies. ASGE references to be considered in developing Endoscopy Unit Medical Record policies address specific issues in regard to the content of medical records. There are specific detailed references recommending documentation for informed consent.

Medicare requirements for medical records are found in three different sections: Medical Records (416.47), Patient Rights (416.50), and Surgery (416.52). The specific conditions and standards are listed as follows:

For more in-depth information regarding interpretative guidance and surveyor procedures, access the Centers for Medicare and Medicaid Services (CMS) State Operations Manual, Guidance for Surveyors: Ambulatory Surgical Centers (Appendix L).¹

1. §416.47 Condition for Coverage: Medical Records
   

   
   The ASC must maintain complete, comprehensive, and accurate medical records to ensure adequate patient care.
   
   

2. §416.47(a) Standard: Organization
   

   
   The ASC must develop and maintain a system for the proper collection, storage, and use of patient records.

3. §416.47(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:

1. Patient identification;
2. Significant medical history and results of physical examination (as applicable);
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; and
8. Discharge diagnosis.

CMS Conditions and Standards Related to Patient Rights:

1.  §416.50(e) Standard: Exercise of Rights and Respect for Property and Person

   (1) The patient has the right to the following:
   

     iii. Be fully informed about a treatment or procedure and the expected outcome before it is performed.

CMS Conditions and Standards Related to Surgery:

1. §416.52(a) Standard: Patient Assessment and Admission

   (1) The ASC must develop and maintain a policy that identifies those patients who require a medical history and physical examination prior to surgery. The policy must-- (i) Include the timeframe for medical history and physical examination to be completed prior to surgery. (ii) Address, but is not limited to, the following factors: patient age, diagnosis, the type and number of procedures scheduled to be performed on the same surgery date, known comorbidities, and the planned anesthesia level. (iii) Be based on any applicable nationally recognized standards of practice and guidelines, and any applicable State and local health and safety laws.

1. §416.52(a) Standard: Admission and Pre-Surgical Assessment
   
   (2) Upon admission, each patient must have a pre-surgical assessment completed by a physician who will be performing the surgery or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy.
   
   (3) The pre-surgical assessment must include documentation of allergies to drugs and biologicals.
   
   (4) The patient's medical history and physical assessment (if any) must be placed in the patient's medical record prior to the surgical procedure.

1. A statement should be made citing the ASGE references as recommendations from a nationally recognized specialty society that were used in the development of this reference.

2. If other nationally recognized society guidelines are also being used to develop policies and procedures, it is important to review those policies and reconcile differences so that contradictory policies are not developed.

3. The Association of Operating Room Nurses (AORN) has specific policies requiring surgical attire, staffing, and restricted areas that endoscopy facilities may not wish to adopt. In the interpretive guidelines, AORN’s standards are mentioned as an example of nationally recognized standards. CMS surveyors, therefore, may hold facilities to those standards unless they have specifically adopted others.

4.  Documentation of the adoption of ASGE guidelines should be referenced in the meeting minutes of the organization’s governing body. The reference should include the guideline, the portion of the guideline to be adopted, and an education plan for staff and providers as needed.

1. CMS State Operations Manual, Guidance for Surveyors: Ambulatory Surgical Centers (Appendix L). Centers for Medicare and Medicaid Services. Https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory.pdf.

2. Informed Consent for GI Endoscopy. GASTROINTEST ENDOSC 2007; 66(2): 213-17.

3. Quality Indicators Common to All GI Endoscopic Procedures. GASTROINTEST ENDOSC 2015; 81(1): 3-14.

4. Guidelines for Sedation and Anesthesia in Gastrointestinal Endoscopy. GASTROINTEST ENDOSC 2017 87(2): 327-35.

5. Open Access Endoscopy. GASTROINTEST ENDOSC 2015; 81(6): 1326-28.