CoP Medical Record Services
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A-0431 482.24 The hospital must have a medical record service that has administrative responsibility for medical records. A medical record must be maintained for every individual evaluated or treated in the hospital.
Interpretive Guidelines §482.24
The term “hospital” includes all locations of the hospital.
The hospital must have one unified medical record service that has administrative responsibility for all medical records, both inpatient and out patient records. The hospital must create and maintain a medical record for every individual, both inpatient and out patient evaluated or treated in the hospital.
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.
A-0432 482.24(a) The organization of the medical record service must be appropriate to the scope and complexity of the services performed. The hospital must employ adequate personnel to ensure prompt completion, filing, and retrieval of records.
Interpretive Guidelines §482.24(a)
The medical records service must be organized, equipped, and staffed in accordance with the scope and complexity of the hospital’s services and in such a manner as to comply with the requirements of this regulation and other Federal and State laws and regulations.
There must be an established medical record system that is organized and employs adequate personnel to ensure prompt:
• Completion of medical records;
• Filing of medical records; and
• Retrieval of medical records.
The term “employs adequate personnel” includes:
• That medical record personnel are employees of the hospital;
• That the hospital employs an adequate number of medical record personnel, employs adequate types of medical record personnel, and employs personnel who possess adequate education, skills, qualifications and experience to ensure the hospital complies with requirements of this regulation and other Federal and State laws and regulations.
A-0438 The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries.
Interpretive Guidelines §482.24(b)
The hospital must maintain a medical record for each inpatient and outpatient evaluated or treated in any part or location of the hospital.
All medical records must be accurately written. The hospital must ensure that all medical records accurately and completely document all orders, test results, evaluations, care plans, treatments, interventions, care provided and the patient’s response to those treatments, interventions and care.
All medical records must be promptly completed. Every medical record must be complete with all documentation of orders, diagnosis, evaluations, treatments, test results, care plans, discharge plans, consents, interventions, discharge summary, and care provided along with the patient’s response to those treatments, interventions, and care. The record must be completed promptly after discharge in accordance with State law and hospital policy but no later than 30 days after discharge.
The medical record must be properly filed and retained. The hospital must have a medical record system that ensures the prompt retrieval of any medical record, of any patient evaluated or treated at any location of the hospital within the past 5 years. [ §482.24(b)(1) addresses the 5 year medical record retention requirement]
The medical record must be accessible. The hospital 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 hospital within the past 5 years to be accessible by appropriate staff, 24 hours a day, 7 days a week, whenever that medical record may be needed.
Medical records must be properly stored in secure locations where they are protected from fire, water damage and other threats.
Medical information such as consultations, orders, practitioner notes, x-ray interpretations, lab test results, diagnostic test results, patient assessments and other patient information must be accurately written, promptly completed and properly filed in the patients’ medical record, and accessible to the physicians or other care providers when needed for use in making assessments of the patient’s condition, decisions on the provision of care to the patient, and in planning the patient’s care. This requirement applies to the medical records of current inpatients and outpatients of the hospital.
The hospital must have a system of 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 and must protect the security of all medical record entries. The medial record system must ensure that medical record entries are not lost, stolen, destroyed, altered, or reproduced in an unauthorized manner. Locations where medical records are stored or maintained must ensure the integrity, security and protection of the records. These requirements apply to both manual and electronic medical record systems.
A-0439 482.24(b)(1) Medical records must be retained in their original or legally reproduced form for a period of at least 5 years.
Interpretive Guidelines §482.24(b)(1)
Medical records are retained in their original or legally reproduced form in hard copy, microfilm, computer memory, or other electronic storage media. The hospital must be able to promptly retrieve the complete medical record of every individual evaluated or treated in any part or location of the hospital within the last 5 years.
In accordance with Federal and State law and regulations, certain medical records may have retention requirements that exceed 5 years (for example: FDA, OSHA, EPA).
A-0440 482.24(b)(2) The hospital must have a system of coding and indexing medical records. The system must allow for timely retrieval by diagnosis and procedure, in order to support medical care evaluation studies.
No information available.
A-0441 482.24(b)(3) The hospital must have a procedure for ensuring the confidentiality of patient records. Information from or copies of records may be released only to authorized individuals, and the hospital must ensure that unauthorized individuals cannot gain access to or alter patient records. Original medical records must be released by the hospital only in accordance with Federal or State laws, court orders, or subpoenas.
Interpretive Guidelines §482.24(b)(3)
Release of Information from or Copies of Records:
The hospital must have a procedure to ensure the confidentiality of each patient’s medical record, whether it is in paper or electronic format, or a combination of the two, from unauthorized disclosure. Confidentiality applies wherever the record or portions thereof are stored, including but not limited to central records, patient care locations, radiology, laboratories, record storage areas, etc.
A hospital is permitted to disclose medical record information, without a patient’s authorization, in order to provide patient care and perform related administrative functions, such as payment and other hospital operations.
• Payment operations include hospital activities to obtain payment or be reimbursed for the provision of health care to an individual.
• Health care operations are administrative, financial, legal, and quality improvement activities of a hospital that are necessary to conduct business and to support the core functions of treatment and payment. These activities include, but are not limited to: quality assessment and improvement activities, case management and care coordination; competency assurance activities, conducting or arranging for medical reviews, audits, or legal services, including fraud and abuse detection and compliance programs; business planning, development, management, and administration and certain hospital-specific fundraising activities.
The hospital must develop policies and procedures that reasonably limit disclosures of information contained in the patient’s medical record to the minimum disclosure necessary, except when the disclosure is for treatment or payment purposes, or as otherwise required by State or Federal law.
When the minimum necessary standard is applied, a hospital may not disclose the entire medical record for a particular purpose, unless it can specifically justify that the whole record is the disclosure amount reasonably required for the purpose.
A hospital may disclose information from the medical record electronically, and may also share an electronic medical record system with other health care facilities, physicians and practitioners, so long as the system is designed and operated with safeguards that ensure that only authorized disclosures are made.
The hospital must obtain written authorization from the patient or the patient’s representative for any other disclosure of medical record information.
Preventing Unauthorized Access
The hospital must ensure that unauthorized individuals cannot gain access to patient records. This applies to records in electronic as well as hard copy formats. Patient records must be secure at all times and in all locations. This includes open patient records for patients who are currently inpatients in the hospital and outpatients in outpatient clinics. For hard copy records, techniques such as locked cabinets or file rooms and limiting access to keys or pass codes may be employed. For electronic records technical safeguards, such as business rules that limit access based on need to know, passwords, or other control mechanisms must be in place. When disposing of copies of medical records, physical safeguards might include first shredding documents containing confidential information, taking appropriate steps to erase information from media used to store electronic records, etc.
Release of Original Records
The hospital must not release the original of a medical record that exists in a hard copy, paper version only, unless it is required to do so in response to a court order, a subpoena, or Federal or State laws. For electronic records, the hospital must ensure that the media or other mechanism by which the records are stored electronically is not removed in such a way that all or part of the record is deleted from the hospital’s medical record system. The hospital must have policies and procedures that address how it assures that retains its “original” medical records, unless their release is mandated by law/court order/subpoena.
A-0449 482.24(c) The medical record must contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient’s progress and response to medications and services.
Interpretive Guidelines §482.24(c)
The medical record must contain information such as notes, documentation, records, reports, recordings, test results, assessments etc. to:
• Justify admission;
• Justify continued hospitalization;
• 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 evaluations, interventions, care provided, services, care plans, discharge plans, and the patient’s response to those activities.
Patient medical record information, such as, laboratory reports, test results, consults, assessments, radiology reports, dictated notes, etc. must be promptly filed in the patient’s medical record in order to be available to the physician and other care providers to use in making assessments of the patient’s condition, to justify continued hospitalization, to support the diagnosis, to describe the patient’s progress, and to describe the patient’s response to medications, interventions, and services, in planning the patient’s care, and in making decisions on the provision of care to the patient.
A-0450 482.24(c)(1) All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures.
Interpretive Guidelines §482.24(c)(1)
All entries in the medical record must be legible. Orders, progress notes, nursing notes, or other entries in the medical record that are not legible may be misread or misinterpreted and may lead to medical errors or other adverse patient events.
All entries in the medical record must be complete. A medical record is considered complete if it contains sufficient information to identify the patient; support the diagnosis/condition; justify the care, treatment, and services; document the course and results of care, treatment, and services; and promote continuity of care among providers. With these criteria in mind, an individual entry into the medical record must contain sufficient information on the matter that is the subject of the entry to permit the medical record to satisfy the completeness standard.
All entries in the medical record must be dated, timed, and authenticated, in written or electronic form, by the person responsible for providing or evaluating the service provided.
• The time and date of each entry (orders, reports, notes, etc.) must be accurately documented. Timing establishes when an order was given, when an activity happened or when an activity is to take place. Timing and dating entries is
necessary for patient safety and quality of care. Timing and dating of entries establishes a baseline for future actions or assessments and establishes a timeline of events. Many patient interventions or assessments are based on time intervals or timelines of various signs, symptoms, or events. (71 FR 68687)
• The hospital must have a method to establish the identity of the author of each entry. This would include verification of the author of faxed orders/entries or computer entries.
• The hospital must have a method to require that each author takes a specific action to verify that the entry being authenticated is his/her entry or that he/she is responsible for the entry, and that the entry is accurate.
The requirements for dating and timing do not apply to orders or prescriptions that are generated outside of the hospital until they are presented to the hospital at the time of service. Once the hospital begins processing such an order or prescription, it is responsible for ensuring that the implementation of the order or prescription by the hospital is promptly dated, and timed in the patient’s medical record.
When a practitioner is using a preprinted order set, the ordering practitioner may be in compliance with the requirement at §482.24(c)(1) to date, time, and authenticate an order if the practitioner accomplishes the following:
• Last page: Sign, date, and time the last page of the orders, with the last page also identifying the total number of pages in the order set.
• Pages with Internal Selections: Sign or initial any other (internal) pages of the order set where selections or changes have been made.
o The practitioner should initial/sign the top or bottom of the pertinent page(s);and
o The practitioner should also initial each place in the preprinted order set where changes, such as additions, deletions, or strike-outs of components that do not apply, have been made.
• It is not necessary to initial every preprinted box that is checked to indicate selection of an order option, so long as there are no changes made to the option(s) selected.
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.
Authentication of medical record entries may include written signatures, initials, computer key, or other code. For authentication, in written or electronic form, a method must be established to identify the author. When rubber stamps or electronic authorizations are used for authentication, the hospital must 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 to another individual. It should be noted that some insurers and other payers may have a policy prohibiting the use of rubber stamps as a means of authenticating the medical records that support a claim for payment. Medicare payment policy, for example, no longer permits such use of rubber stamps. Thus, while the use of a rubber stamp for signature authentication is not prohibited under the CoPs and analysis of the rubber stamp method per se is not an element of the survey process, hospitals may wish to eliminate their usage in order to avoid denial of claims for payment.
Where an electronic medical record is in use, the hospital must demonstrate how it prevents alterations of record entries after they have been authenticated. Information needed to review an electronic medical record, including pertinent codes and security features, must be readily available to surveyors to permit their review of sampled medical records while on-site in the hospital.
When State law and/or hospital policy requires that entries in the medical record made by residents or non-physicians be countersigned by supervisory or attending medical staff members, then the medical staff rules and regulations must address counter-signature requirements and processes.
A system of auto-authentication in which a physician or other practitioner authenticates an entry that he or she cannot review, e.g., because it has not yet been transcribed, or the electronic entry cannot be displayed, is not consistent with these requirements. There must be a method of determining that the practitioner did, in fact, authenticate the entry after it was created. In addition, failure to disapprove an entry within a specific time period is not acceptable as authentication.
The practitioner must separately date and time his/her signature authenticating an entry, even though there may already be a date and time on the document, since the latter may not reflect when the entry was authenticated. For certain electronically-generated documents, where the date and time that the physician reviewed the electronic transcription is automatically printed on the document, the requirements of this section would be satisfied. However, if the electronically-generated document only prints the date and time that an event occurred (e.g., EKG printouts, lab results, etc.) and does not print the date and time that the practitioner actually reviewed the document, then the practitioner must either authenticate, date, and time this document itself or incorporate an acknowledgment that the document was reviewed into another document (such as the H&P, a progress note, etc.), which would then be authenticated, dated, and timed by the practitioner.
A-0454 482.24(c)(2) All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or by another practitioner who is responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.
Interpretive Guidelines §482.24(c)(2)
The hospital must ensure that all orders, including verbal orders, are dated, timed, and authenticated promptly. The Merriam-Webster online dictionary defines “prompt” as performed readily or immediately.
Verbal orders are orders for medications, treatments, interventions or other patient care that are transmitted as oral, spoken communications between senders and receivers, delivered either face-to-face or via telephone.
The receiver of a verbal order must date, time, and sign the verbal order in accordance with hospital policy. CMS expects hospital policies and procedures for verbal orders to include a read-back and verification process.
The prescribing practitioner must verify, sign, date and time the order as soon as possible after issuing the order, in accordance with hospital policy, and State and Federal requirements.
Authentication of a verbal order may be written, electronic, or faxed. The hospital must have a method for establishing the identity of the practitioner who has given a verbal order, including verification of the author of faxed verbal orders or computer entries.
In some instances, the ordering practitioner may not be able to authenticate his or her order, including a verbal order (e.g., the ordering practitioner gives a verbal order which is written and transcribed, and then is “off duty” for the weekend or an extended period of time). In such cases it is acceptable for another practitioner who is responsible for the patient’s care to authenticate the order, including a verbal order, of the ordering practitioner as long as it is permitted under State law, hospital policies and medical staff bylaws, rules, and regulations. Hospitals may choose in their policies to restrict which practitioners it would authorize to authenticate another practitioner’s orders. For example, a hospital could choose to restrict authentication of orders for pediatric patients to practitioners who are privileged to provide pediatric care. (77 FR 29053, May 16, 2012)
• All practitioners responsible for the patient’s care are expected to have knowledge of the patient’s hospital course, medical plan of care, condition, and current status.
• When a practitioner other than the ordering practitioner authenticates an order, that practitioner assumes responsibility for the order as being complete, accurate and final.
• A qualified non-physician practitioner, such as a physician assistant (PA) or nurse practitioner (NP), who is responsible for the care of the patient may authenticate a physician’s or other qualified non-physician practitioner’s order only if the order is within his/her scope of practice.
If State law requires that the ordering practitioner authenticate his/her own orders, or his/her own verbal orders, then a practitioner other than the prescribing practitioner would not be permitted to authenticate the verbal order in that State.
(71 FR 68682 and 77 FR 29053, May 16, 2012)
NOTE CONCERNING VERBAL ORDERS FOR LABORATORY TESTS:
The requirement to authenticate promptly a verbal order applies to verbal orders associated with both inpatients and outpatients. It is possible that a hospital verbal order for a laboratory test could be authenticated in compliance with the Clinical Laboratory Improvement Amendment (CLIA) regulatory standard of authentication, i.e., within 30 days, but nonetheless be out of compliance with the hospital Medical Records Services requirement for prompt authentication of all orders, including verbal orders. Because CLIA laboratories – even if physically situated in a hospital – are surveyed for compliance only with CLIA regulations, the laboratory would not be cited for a deficiency by a CLIA survey team. However, hospital surveyors conducting a survey would cite the hospital’s inpatient or outpatient recordkeeping for deficiencies under the Medical Record Services CoP if the lab order originated for a patient during a hospital inpatient stay or hospital outpatient clinic visit and the order was not authenticated promptly.
A-0457 482.24(c)(3) Hospitals may use pre-printed and electronic standing orders, order sets, and protocols for patient orders only if the hospital:
(i) Establishes that such orders and protocols have been reviewed and approved by the medical staff and the hospital’s nursing and pharmacy leadership;
(ii) Demonstrates that such orders and protocols are consistent with nationally recognized and evidence-based guidelines;
(iii) Ensures that the periodic and regular review of such orders and protocols is conducted by the medical staff and the hospital’s nursing and pharmacy leadership to determine the continuing usefulness and safety of the orders and protocols; and
(iv) Ensures that such orders and protocols are dated, timed, and authenticated promptly in the patient’s medical record by the ordering practitioner or another practitioner responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.
Interpretive Guidelines §482.24(c)(3)
What is covered by this regulation?
There is no standard definition of a “standing order” in the hospital community at large (77 FR 29055, May 16, 2012), but the terms “pre-printed standing orders,” “electronic standing orders,” “order sets,” and “protocols for patient orders” are various ways in which the term “standing orders” has been applied. For purposes of brevity, in our guidance we generally use the term “standing order(s)” to refer interchangeably to pre-printed and electronic standing orders, order sets, and protocols. However, we note that the lack of a standard definition for these terms and their interchangeable and indistinct use by hospitals and health care professionals may result in confusion regarding what is or is not subject to the requirements of §482.24(c)(3), particularly with respect to “order sets.”
• Not all pre-printed and electronic order sets are considered a type of “standing order” covered by this regulation. Where the order sets consist solely of menus of treatment or care options designed to facilitate the creation of a patient-specific set of orders by a physician or other qualified practitioner authorized to write orders, and none of the treatment choices and actions can be initiated by non-practitioner clinical staff before the physician or other qualified practitioner actually creates the patient-specific order(s), such menus would not be considered “standing orders” covered by this regulation. We note in such cases the menus provide a convenient and efficient method for the physician/practitioner to create an order, but the availability of such menu options does not create an “order set” that is a “standing order” subject to the requirements of this regulation. The physician/practitioner may, based on his/her professional judgment, choose to: use the available menu options to create an order; not use the menu options and instead create an order from scratch; or modify the available menu options to create the order. In each case the physician/practitioner exercises his privileges to prescribe specific diagnosis and/or treatment activities that are to be implemented for a patient.
• On the other hand, in cases where hospital policy permits treatment to be initiated, by a nurse, for example, without a prior specific order from the treating physician/practitioner, this policy and practice must meet the requirements of this regulation for review of standing orders, regardless of whether it is called a standing order, a protocol, an order set, or something else. Such treatment is typically initiated when a patient’s condition meets certain pre-defined clinical criteria. For example, standing orders may be initiated as part of an emergency response or as part of an evidence-based treatment regimen where it is not practical for a nurse to obtain either a written, authenticated order or a verbal order from a physician or other qualified practitioner prior to the provision of care.
• Hybrids, where a component for non-practitioner-initiated treatment is embedded within a menu of options for the physician or other qualified practitioner, still require compliance with the requirements for a standing order for that component. For example, if an order set includes a protocol for nurse-initiated potassium replacement, that protocol must be reviewed under the requirements of this regulation before it may become part of a menu of treatment options from which a physician or other qualified practitioner would select treatments for a particular patient.
Requirements for “Standing Orders”
Hospitals have the flexibility to use standing orders to expedite the delivery of patient care in well-defined clinical scenarios for which there is evidence supporting the application of standardized treatments or interventions.
Appropriate use of standing orders can contribute to patient safety and quality of care by promoting consistency of care, based on objective evidence, when orders
may be initiated as part of an emergency response or as part of an evidence-based treatment regimen where it is not practicable for a nurse or other non-practitioner to obtain a verbal or authenticated written order from a physician or other practitioner responsible for the care of the patient prior to the provision of care.
In all cases, implementation of a standing order must be medically appropriate for the patient to whom the order is applied.
Much of the evidence on the effectiveness of standing orders in hospitals has been narrowly focused on aspects of their use by Rapid Response Teams addressing inpatient emergencies. However, standing orders may also be appropriate in other clinical circumstances, including, but not limited to:
• Protocols for triaging and initiating required screening examinations and stabilizing treatment for emergency department patients presenting with symptoms suggestive of acute asthma, myocardial infarction, stroke, etc. (This does not relieve a hospital of its obligations under the Emergency Medical Treatment and Labor Act (EMTALA) to have qualified medical personnel complete required screening and, when applicable, stabilizing treatment in a timely manner.)
• Post-operative recovery areas.
• Timely provision of immunizations, such as certain immunizations for newborns, for which there are clearly established and nationally recognized guidelines.
Standing orders may not be used in clinical situations where they are specifically prohibited under Federal or State law. For example, the hospital patient’s rights regulation at §482.13(e)(6) specifically prohibits the use of standing orders for restraint or seclusion of hospital patients.
When deciding whether to use standing orders, hospitals should also be aware that, although use of standing orders is permitted under the hospital Conditions of Participation, some insurers, including Medicare, may not pay for the services provided because of the use of standing orders. (77 FR 29056)
Minimum requirements for standing orders. Hospitals may employ standing orders only if the following requirements are met for each standing order for a particular well-defined clinical scenario:
• Each standing order must be reviewed and approved by the hospital’s medical staff and nursing and pharmacy leadership before it may be used in the clinical setting. The regulation requires a multi-disciplinary collaborative effort in establishing the protocols associated with each standing order.
• The hospital’s policies and procedures for standing orders must address the process by which a standing order is developed; approved; monitored; initiated by authorized staff; and subsequently authenticated by physicians or other practitioners responsible for the care of the patient.
• For each approved standing order, there must be specific criteria clearly identified in the protocol for the order for a nurse or other authorized personnel to initiate the execution of a particular standing order, for example, the specific clinical situations, patient conditions, or diagnoses by which initiation of the order would be justified. Under no circumstances may a hospital use standing orders in a manner that requires any staff not authorized to write patient orders to make clinical decisions outside of their scope of practice in order to initiate such orders.
Since residents are physicians, this regulation does not require specific criteria for a resident to initiate the execution of a particular standing order. However, there may be State laws governing the practice of residents in hospitals that are more restrictive; if so, the hospital is expected to comply with the State law. Likewise, the hospital may choose through its policies and medical staff bylaws, rules and regulations to restrict the role of residents with respect to standing orders.
• Policies and procedures should also address the instructions that the medical, nursing, and other applicable professional staff receive on the conditions and criteria for using standing orders as well as any individual staff responsibilities associated with the initiation and execution of standing orders. An order that has been initiated for a specific patient must be added to the patient’s medical record at the time of initiation, or as soon as possible thereafter.
• Likewise, standing order policies and procedures must specify the process whereby the physician or other practitioner responsible for the care of the patient acknowledges and authenticates the initiation of all standing orders after the fact, with the exception of influenza and pneumococcal vaccines, which do not require such authentication in accordance with § 482.23(c)(2).
(76 FR 65896, October 24, 2011 & 77 FR 29056, May 16, 2012)
• The hospital must be able to document that the standing order is consistent with nationally recognized and evidence-based guidelines. This does not mean that there must be a template standing order available in national guidelines which the hospital copies, but rather that the content of each standing order in the hospital must be consistent with nationally recognized, evidence-based guidelines for providing care. The burden of proof is on the hospital to show that there is a sound basis for the standing order.
• Each standing order must be subject to periodic and regular review by the medical staff and the hospital’s nursing and pharmacy leadership, to determine the continuing usefulness and safety of the orders and protocols. At a minimum, an annual review of each standing order would satisfy this requirement. However, the hospital’s policies and procedures must also address a process for the identification and timely completion of any requisite updates, corrections, modifications, or revisions based on changes in nationally recognized, evidence-based guidelines. The review may be prepared by the hospital’s QAPI program, so long as the medical staff and nursing and pharmacy leadership read, review, and, as applicable, act upon the final report. Among other things, reviews are expected to consider:
• Whether the standing order’s protocol continues to be consistent with the latest standards of practice reflected in nationally recognized, evidence-based guidelines;
• Whether there have been any preventable adverse patient events resulting from the use of the standing order, and if so, whether changes in the order would reduce the likelihood of future similar adverse events. Note that the review would not be expected to address adverse events that are a likely outcome of the course of patient’s disease or injury, even if the order was applied to that patient, unless there is concern that use of the standing order exacerbated the patient’s condition; and
• Whether a standing order has been initiated and executed in a manner consistent with the order’s protocol, and if not, whether the protocol needs revision and/or staff need more training in the correct procedures.
• An order that has been initiated for a specific patient must be added to the patient’s medical record at the time of initiation, or as soon as possible thereafter. The hospital must ensure each standing order that has been executed is dated, timed, and authenticated promptly in the patient’s medical record by the ordering practitioner or another practitioner responsible for the care of the patient. Another practitioner who is responsible for the care of the patient may date, time and authenticate the standing order instead of the ordering practitioner, but only if the other practitioner is acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules and regulations.
The hospital’s standing orders policies and procedures must specify the process whereby the responsible practitioner, or another authorized practitioner, acknowledges and authenticates the initiation of each standing order after the fact, with the exception of standing orders for influenza and pneumococcal vaccines, which do not require such authentication. Further, the responsible practitioner must be able to modify, cancel, void or decline to authenticate orders that were not medically necessary in a particular situation. The medical record must reflect the physician’s actions to modify, cancel, void or refusal to authenticate a standing order that the physician determined was not medically necessary. (76 FR 65896, October 24, 2011)
A-0458 482.24(c)(4)(I)(A) A medical history and physical examination completed and documented no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services. The medical history and physical examination must be placed in the patient’s medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.
Interpretive Guidelines §482.24(c)(4)(i)(A)
The medical record must include documentation that a medical history and physical examination (H&P) was completed and documented for each patient no more than 30 days prior to hospital admission or registration, or 24 hours after hospital admission or registration, but in all cases prior to surgery or a procedure requiring anesthesia services.
The purpose of an H&P is to determine whether there is anything in the patient's overall condition that would affect the planned course of the patient's treatment, such as an allergy to a medication that must be avoided, or a co-morbidity that requires certain additional interventions to reduce risk to the patient.
The H&P documentation must be placed in the medical record within 24 hours of admission or registration, but in all cases prior to surgery or a procedure requiring anesthesia services, including all inpatient, outpatient, or same-day surgeries or procedures. (71 FR 68676) The H&P may be handwritten or transcribed. An H&P that is completed within 24 hours of the patient’s admission or registration, but after surgery or a procedure requiring anesthesia would not be in compliance.
A-0461482.24(c)(4)(I)(B) An updated examination of the patient, including any changes in the patient’s condition, when the medical history and physical examination are completed within 30 days before admission or registration. Documentation of the updated examination must be placed in the patient's medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.
Interpretive Guidelines §482.24(c)(4)(i)(B)
When an H&P is completed within the 30 days before admission or registration, the hospital must ensure that an updated medical record entry documenting an examination for any changes in the patient's condition is placed in the patient's medical record within 24 hours after admission or registration, but, in all cases involving surgery or a procedure requiring anesthesia services, prior to the surgery or procedure.
The update note must document an examination for any changes in the patient's condition since the time that the patient's H&P was performed that might be significant for the planned course of treatment. The physician, oromaxillofacial surgeon, or qualified licensed individual uses his/her clinical judgment, based upon his/her assessment of the patient’s condition and co-morbidities, if any, in relation to the patient’s planned course of treatment to decide the extent of the update assessment needed as well as the information to be included in the update note in the patient’s medical record.
If, upon examination, the licensed practitioner finds no change in the patient's condition since the H&P was completed, he/she may indicate in the patient's medical record that the H&P was reviewed, the patient was examined, and that "no change" has occurred in the patient's condition since the H&P was completed. (71 FR 68676) Such statements in the medical record would meet the requirement for documenting the H&P update.
Any changes in the patient’s condition must be documented by the practitioner in the update note and placed in the patient’s medical record within 24 hours of admission or registration, but prior to surgery or a procedure requirement anesthesia services. Additionally, if the practitioner finds that the H&P done before admission is incomplete, inaccurate, or otherwise unacceptable, the practitioner reviewing the H&P, examining the patient, and completing the update may disregard the existing H&P, and conduct and document in the medical record a new H&P within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia.
A-0463 482.24(c)(4)(ii) Admitting diagnosis.
Interpretive Guidelines §482.24(c)(4)(ii)
All inpatient medical records must contain the admitting diagnosis.
A-0464 482.24(c)(4)(iii) Results of all consultative evaluations of the patient and appropriate findings by clinical and other staff involved in the care of the patient.
Interpretive Guidelines §482.24(c)(4)(iii)
All patient records, both inpatient and outpatient, must 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 must 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 or continued hospitalization, 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.
A-0465 482.24(c)(4)(iv) Documentation of complications, hospital acquired infections, and unfavorable reactions to drugs and anesthesia.
Interpretive Guidelines §482.24(c)(4)(iv)
All patient medical records, both inpatient and outpatient, must document:
• Hospital-acquired infections;
• Unfavorable reactions to drugs; and
• Unfavorable reactions to anesthesia.
A-0466 482.24(c)(4)(v) Properly executed informed consent forms for procedures and treatments specified by the medical staff, or by Federal or State law if applicable, to require written patient consent.
Interpretive Guidelines §482.24(c)(4)(v)
Informed consent is discussed in three locations in the CMS Hospital CoPs. See also the guidelines for 42 CFR 482.13(b)(2) pertaining to patients' rights, and the guidelines for 42 CFR 482.51(b)(2), pertaining to surgical services.
The medical record must contain a document recording the patient’s informed consent for
those procedures and treatments that have been specified as requiring informed consent. Medical staff policies should address which procedures and treatments require written informed consent. There may also be applicable Federal or State law requiring informed consent. The informed consent form contained in the medical record should provide evidence that it was properly executed.
Informed Consent Forms
A properly executed informed consent form should reflect the patient consent process. Except as specified for emergency situations in the hospital’s informed consent policies, all inpatient and outpatient medical records must contain a properly executed informed consent form prior to conducting any procedure or other type of treatment that requires informed consent. An informed consent form, in order to be properly executed, must be consistent with hospital policies as well as applicable State and Federal law or regulation. A properly executed informed consent form contains the following minimum elements:
• Name of the hospital where the procedure or other type of medical treatment is to take place;
• Name of the specific procedure, or other type of medical treatment for which consent is being given;
• Name of the responsible practitioner who is performing the procedure or administering the medical treatment;
• Statement that the procedure or treatment, including the anticipated benefits, material risks, and alternative therapies, was explained to the patient or the patient’s legal representative; (Material risks could include risks with a high degree of likelihood but a low degree of severity, as well as those with a very low degree of likelihood but high degree of severity. Hospitals are free to delegate to the responsible practitioner, who uses the available clinical evidence as informed by the practitioner’s professional judgment, the determination of which material risks, benefits and alternatives will be discussed with the patient.)
• Signature of the patient or the patient’s legal representative; and
• Date and time the informed consent form is signed by the patient or the patient’s legal representative.
If there is applicable State law governing the content of the informed consent form, then the hospital’s form must comply with those requirements.
A well-designed informed consent form might also include the following additional information:
• Name of the practitioner who conducted the informed consent discussion with the patient or the patient’s representative.
• Date, time, and signature of the person witnessing the patient or the patient’s legal representative signing the consent form.
• Indication or listing of the material risks of the procedure or treatment that were discussed with the patient or the patient’s representative;
• Statement, if applicable, that physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery, in accordance with the hospital’s policies and, in the case of residents, based on their skill set and under the supervision of the responsible practitioner.
• Statement, if applicable, that qualified medical practitioners who are not physicians who will perform important parts of the surgery or administration of anesthesia will be performing only tasks that are within their scope of practice, as determined under State law and regulation, and for which they have been granted privileges by the hospital.
A-0467 482.24(c)(4)(vi) 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.
Interpretive Guidelines §482.24(c)(4)(vi)
The requirement means that the stated information is necessary to monitor the patient’s condition and that this and other necessary information must be in the patient’s medical record. In order for necessary information to be used it must be promptly filed in the medical record so that health care staff involved in the patient’s care can access/retrieve this information in order to monitor the patient’s condition and provide appropriate care.
The medical record must contain:
• All practitioner’s orders (properly authenticated);
• All nursing notes (including nursing care plans);
• All reports of treatment (including complications and hospital-acquired infections);
• All medication records (including unfavorable reactions to drugs);
• All radiology reports;
• All laboratory reports;
• All vital signs; and
• All other information necessary to monitor the patient’s condition.
A-0468 482.24(c)(4)(vii) Discharge summary with outcome of hospitalization, disposition of case, and provisions for follow-up care.
Interpretive Guidelines §482.24(c)(4)(vii)
All patient medical records must contain a discharge summary. A discharge summary discusses the outcome of the hospitalization, the disposition of the patient, and provisions for follow-up care. Follow-up care provisions include any post hospital appointments, how post hospital patient care needs are to be met, and any plans for post-hospital care by providers such as home health, hospice, nursing homes, or assisted living.
The MD/DO or other qualified practitioner with admitting privileges in accordance with State law and hospital policy, who admitted the patient is responsible for the patient during the patient’s stay in the hospital. This responsibility would include developing and entering the discharge summary.
Other MD/DOs who work with the patient’s MD/DO and who are covering for the patient’s MD/DO and who are knowledgeable about the patient’s condition, the patient’s care during the hospitalization, and the patient’s discharge plans may write the discharge summary at the responsible MD/DO’s request.
In accordance with hospital policy, and 42 CFR Part 482.12(c)(1)(i) the MD/DO may delegate writing the discharge summary to other qualified health care personnel such as nurse practitioners and MD/DO assistants to the extent recognized under State law or a State’s regulatory mechanism.
Whether delegated or non-delegated, we would expect the person who writes the discharge summary to authenticate, date, and time their entry and additionally for delegated discharge summaries we would expect the MD/DO responsible for the patient during his/her hospital stay to co-authenticate and date the discharge summary to verify its content.
The discharge summary requirement would include outpatient records. For example:
• The outcome of the treatment, procedures, or surgery;
• The disposition of the case;
• Provisions for follow-up care for an outpatient surgery patient or an emergency
department patient who was not admitted or transferred to another hospital.
A-0469 482.24(c)(4)(viii) Final diagnosis with completion of medical records within 30 days following discharge.
Interpretive Guidelines §482.24(c)(4)(viii)
All medical records must contain a final diagnosis. All medical records must be complete within 30 days of discharge or outpatient care.
B100 482.60(b) Meet the Conditions of Participation specified in 482.1 through 482.23 and 482.25 through 482.57;
The hospital is either accredited by JCAHO or AOA; or meets the Condition of Participation for Hospitals, §§482.1 through 482.23 and §§482.25 through 482.57.
B101 482.60(c) Maintain clinical records on all patients, including records sufficient to permit CMS to determine the degree and intensity of treatment furnished to Medicare beneficiaries as specified in 482.61; and
No information available.
B102 482.60(d) Meet the staffing requirements specified in 482.62.
No information available.
B103 The medical records maintained by a psychiatric hospital must permit determination of the degree and intensity of the treatment provided to individuals who are furnished services in the institution.
The clinical record should provides information that indicates need for admission and treatment, treatment goals, changes in status of treatment and discharge planning, and follow-up and the outcomes experienced by patients.
The structure and content of the individual patient’s record must be an accurate functional representation of the actual experience of the individual in the facility. It must contain enough information to indicate that the facility knows the status of the patient, has adequate plans to intervene, and provides sufficient evidence of the effects of the intervention, and how their interventions served as a function of the outcomes experienced. You must be able to identify this through interviews with staff, and when possible with individuals being served, as well as through observations.
B104 482.61(a) Medical records must stress the psychiatric components of the record, including history of findings and treatment provided for the psychiatric condition for which the patient is hospitalized.
No information available.
B105 482.61(a)(1) The identification data must include the patient’s legal status.
Definition: Legal Status is defined in the State statutes and dictates the circumstances under which the patient was admitted and/or is being treated - i.e., voluntary, involuntary, committed by court, evaluation and recertification are in accordance with state requirements.
Determine through interview with hospital staff the terminology they use in defining “legal status.” If evaluation and recertification is required by the State, determine that legal documentation supporting this status is present. Changes in legal status should also be recorded with the date of change.
B106 482.61(a)(2) A provisional or admitting diagnosis must be made on every patient at the time of admission, and must include the diagnosis of intercurrent diseases as well as the psychiatric diagnosis.
There is an admission or working psychiatric diagnosis (including rule-out diagnoses) written in the most current edition of the American Psychiatric Association’s Diagnostic and Statistical Manual (DSM) or the approved International Classification of Diseases (ICD) nomenclature. This diagnosis is made and entered into the chart of each patient at the time of the admission examination. The final diagnosis may differ from the initial diagnosis if subsequent evaluation and observation support a change.
If a diagnosis is absent, there must be justification for its absence. For example, if a patient was psychotic on admission and was not accompanied by family or significant others.
Intercurrent (other than psychiatric) diagnoses must be documented when they are made. Attention should be paid to physical examination notes, including known medical conditions, even allergies and recent exposure to infections, illness, or substance abuse, and to available laboratory or test reports which identify abnormal findings to see that these are reflected by appropriate diagnosis.
These diagnoses may be found in a variety of locations in the medical record, e.g., the identification/face sheet, the finding of admission physical examination, the psychiatric evaluation the “admission work up “ or the physician’s progress notes. Diagnostic categories should include physical illness when present.
B107 482.61(a)(3) The reasons for admission must be clearly documented as stated by the patient and/or others significantly involved.
The purpose of this regulation is to provide an understanding of what caused the patient to come to the hospital, and the patient’s response to admission.
The hospital records the statements and reason for admission given by family and by others, as well as the patient (preferably verbatim), with informant identified, in a variety of locations, e.g., in transfer and admission notes from the physician, nurses and social workers.
Records should not contain vague, ill-defined reports from unknown sources. Records should record “who,” “what,” “where,” “when,” and “why.”
B108 482.61(a)(4) The social service records, including reports of interviews with patients, family members, and others, must provide an assessment of home plans and family attitudes, and community resource contacts as well as a social history.
The purpose of the social work assessment is to determine the current baseline social functioning (strengths and deficits) of the patient, from which treatment interventions and discharge plans are to be formulated.
Patient length of stay is a key factor influencing hospital documentation policy, i.e., establishing timeframes for completion, documentation, and filing of the psychosocial assessment, and treatment planning in the medical record.
A psychosocial history/assessment must be completed on all patients. Three key components to be addressed:
A. Factual and Historical Information
1. Specific reasons for the patient’s admission or readmission;
2. A description of the patient’s past and present biopsychosocial functioning;
3. Family and marital history, dynamics, and patient’s relationships with family and significant others;
4. Pertinent religious and cultural factors;
5. History of physical, sexual and emotional abuse;
6. Significant aspects of psychiatric, medical, and substance abuse history and treatment as presented by family members and significant others;
7. Educational, vocational, employment, and military service history;
8. Identification of community resources including previously used treatment sources;
9. Identification of present environmental and financial needs.
B. Social Evaluation
1. Patient strength and deficits;
2. High risk psychosocial issues requiring early treatment planning and intervention - i.e., unattended child(ren) in home; prior noncompliance to specific treatment and/ or discharge interventions; and potential obstacles to present treatment and discharge planning.
C. Conclusions and Recommendations
Assessment of Sections A and B shall result in the development of (C) recommendations related to the following areas:
1. Anticipated necessary steps for discharge to occur;
2. High risk patient and/or family psychosocial issues requiring early treatment planning and immediate intervention regardless of the patient’s length of stay;
3. Specific community resources/ support systems for utilization in discharge planning - i.e., housing, living arrangements, financial aid, and aftercare treatment sources;
4. Anticipated social work role(s) in treatment and discharge planning.
B109 482.61(a)(5) When indicated, a complete neurological examination must be recorded at the time of the admission physical examination.
Upon admission the patient should receive a thorough history and physical examination with all indicated laboratory examinations. These investigations must be sufficient to discover all structural, functional, systemic and metabolic disorders. A thorough history of the patient’s past physical disorders, head trauma, accidents, substance dependence/abuse, exposure to toxic agents, tumors, infections, seizures or temporary loss of consciousness, and headaches, will alert the physician to look for the presence of continuing pathology or possible sequelae any of which may turn out to be significant and pertinent to the present mental illness. Equally important is a thorough physical examination to look for signs of any current illness since psychotic symptoms may be due to a general medical condition or substance related disorder.
The screening neurological examination
As part of the physical examination, the physician will perform a “screening” neurological examination. While there is no precise definition of a screening neurological examination in medical practice such examination is expected to assess gross function of the various divisions of the central nervous system as opposite to detailed, fine testing of each division. Gross testing of Cranial Nerves II through XII should be included. Statements such as “Cranial Nerves II to XII intact” are not acceptable. These areas may be found in various parts of the physical examination and not just grouped specifically under the neurological.
In any case where a system review indicate positive neurological symptomatology, a more detailed examination would be necessary, with neurological work-up or consultation ordered as appropriate after the screening neurological examination was completed.
Complete neurological examination.
A complete, comprehensive neurological examination includes a review of the patient’s history, physical examination and for psychiatric patients, a review of the psychiatric evaluation. The neurologist/psychiatrist himself/herself also takes a history to obtain the necessary information not already available in the medical record or referral form. The neurological examination is a detailed, orderly survey of the various sections of the nervous system. As an example, whereas a simple reading of a printed page will be sufficient to assess grossly the patient’s sight (cranial nerve II) in a complete neurological examination, the neurologist may test visual acuity with a snellen chart, perform a fundoscopic examination of both eyes (sometimes after dilating the pupils) and he/she will examine the patient’s visual fields. In the examination of the motor system, the power of muscle groups of the extremities, the neck and trunk are tested. Where an indication of diminished strength is noted, testing of smaller muscle groups and even individual muscles are tested. In a complete neurological examinations all the systems are examined, but the physician will emphasize even more the areas pertinent to the problem for which the examination was requested.
B110 Each patient must receive a psychiatric evaluation that must--
The psychiatric evaluation is done for the purpose of determining the patient’s diagnosis and treatment and, therefore, it must contain the necessary information to justify the diagnosis and planned treatment.
The psychiatric evaluation is a total appraisal or assessment of the patient’s illness. It is the physician’s assessment of the contributing factors and forces in the evolution of the patient’s illness including the patient’s perception of his or her illness. Through the psychiatric evaluation the physician seeks to secure a biographical-historical perspective of the patient’s personality, with a clear psychological picture of the patient as a specific human being with his or her individual problems. While performing the psychiatric evaluation, the physician reaches an understanding of the patient’s basic personality structure, of the patient’s developmental period, of his or her value systems, of his or her past medical history including surgical procedures and other treatments, his or her past psychological traumatic experiences, his or her defense mechanisms, his or her supporting systems, any precipitating factors and how all these may have impacted and interplayed with each other to result in the present illness. In the psychiatric evaluation the patient should emerge as a dynamic human being with a past, a present and a potential future with a thread of logical continuity.
The psychiatric evaluation includes all the requirements described in this standard and the information necessary to justify the diagnosis and treatment. A physician’s signature is necessary. In those cases where the mental status portion of the psychiatric evaluation is performed by a non-physician, there should be evidence that the person is credentialed by the hospital, legally authorized by the State to perform that function, and a physician review and countersignature is present, where required by hospital policy or State law.
In order to satisfy the requirements §482.61(b) (1-7) of this standard, and to meet the standards of medical practice, the psychiatric evaluation should include the following component parts:
B111 482.61(b)(1) Be completed within 60 hours of admission;
No information available.
B112 482.61(b)(2) Include a medical history;
The psychiatric evaluation must include the non-psychiatric medical history including physical disabilities, intellectual disabilities and treatment.
B113 482.61(b)(3) Contain a record of mental status;
The mental status must describe the appearance and behavior, emotional response, verbalization, thought content, and cognition of the patient as reported by the patient and observed by the examiner at the time of the examination. This description is appropriate to the patient’s condition.
Explore the mental status for descriptions of the patient’s presentation during the examination that are relevant to the diagnosis and treatment of the patient. An example of a portion of the patient interview: The patient periodically states the examiner’s name correctly during this examination after hearing it once, accurately describes his past history in great detail, precisely characterizes his present situation, can list events in logical sequence that have led to his present illness, but believes that his pre-admission insomnia, anorexia, and 35 pound weight loss over the past four months are totally the result of his sexual promiscuity of ten years ago and have nothing to do with his concurrent use of 50 to 60 mg. of Amphetamine daily.” From this information one can conclude that the patient is oriented, his memory is intact, but that he has poor judgment and no insight. It is not acceptable just to write “oriented, memory intact, judgment poor, and insight nil,” without any supportive information.
B114 482.61(b)(4) Note the onset of illness and the circumstances leading to admission;
In a hospitalized patient, the identified problem should be related to the patient’s need for hospital admission. The psychiatric evaluation includes a history of present illness, including onset, precipitating factors and reason for the current admission, signs and symptoms, course, and the results of any treatment received.
B115 482.61(b)(5) Describe attitudes and behavior;
The problem statement should describe behavior(s) which require change in order for the patient to function in a less restrictive setting. The identified problems may also include behavioral or relationship difficulties with significant others which require active treatment in order to facilitate a successful discharge.
B116 482.61(b)(6) Estimate intellectual functioning, memory functioning and orientation; and
Refer to §482.61(b)(3)
B117 482.61(b) (7) Include an inventory of the patient’s assets in descriptive, not interpretive fashion.
Although the term strength is often used interchangeably with assets, only the assets that describe personal factors on which to base the treatment plan or which are useful in therapy represent personal strengths. Strengths are personal attributes i.e., knowledge, interests, skills, aptitudes, personal experiences, education, talents and employment status, which may be useful in developing a meaningful treatment plan. For purposes of the regulation, words such as “youth,” “pretty,” “Social Security income,” and “has a car” do not represent assets. (See also §482.61(c)(1).)
B118 482.61 (c)(1) Each patient must have an individual comprehensive treatment plan
Guidance §482.61 (c)(1)
The patient and treatment team collaboratively develop the patient’s treatment plan. The treatment plan is the outline of what the hospital has committed itself to do for the patient, based on an assessment of the patient’s needs. The facility selects its format for treatment plans and treatment plan updates.
B119 482.61(c)(1) The plan must be based on an inventory of the patient’s strengths and disabilities.
A disability is any psychiatric, biopsychosocial problem requiring treatment/intervention. The term disability and problem are used interchangeably. The treatment plan is derived from the information contained in the psychiatric evaluation and in the assessments/diagnostic data collected by the total treatment team. Based on the assessment summaries formulated by team members of various disciplines, the treatment team identifies which patient disabilities will be treated during hospitalization. Patient strengths that can be utilized in treatment must be identified. (See also §482.61(b)(7).)
Treatment planning depends on several variables; whether the admission is limited to crisis intervention, short-term treatment or long-term treatment. The briefer the hospital stay, the fewer disciplines may be involved in the patient’s treatment.
There must be evidence of periodic review of the patient’s response and progress toward meeting planned goals. If the patient has made progress toward meeting goals, or if there is a lack of progress, the review must justify: (1) continuing with the current goals and approaches; or (2) revising the treatment plan to increase the possibility of a successful treatment outcome.
Consideration must be given to the type of psychiatric program(s) under review to determine the timeframe for treatment plan review. The interval within which treatment plan reviews are conducted is determined by the hospital, however, the hospital’s review system must be sufficiently responsive to ensure the treatment plan is reviewed: whenever a goal(s) has been accomplished; when a patient is regressing; when a patient is failing to progress; or when a patient requires a new treatment goal. The facility is expected to pursue aggressively the attendance of all relevant participants at the team meetings. Question any routine and regular absences of individuals who would be expected to attend.
B120 482.61(c)(1)(i) The written plan must include substantiated diagnosis;
The substantiated diagnosis serves as the basis for treatment interventions. A substantiated diagnosis is the diagnosis identified by the treatment team to be the primary focus upon which treatment planning will be based. It evolves from the synthesis of data from various disciplines.
At the time of admission, the patient may have been given an initial diagnosis or a rule-out diagnosis. At the time of treatment planning, a substantiated diagnosis must be recorded. It may be the same as the initial diagnosis, or, based on new information and assessment, it may differ.
Rule-out diagnoses, by themselves are not acceptable as a substantiated diagnosis.
Data to substantiate the diagnosis may be found in, but is not limited to, the psychiatric evaluation, the medical history and physical examination, laboratory tests, medical and other psychological consults, assessments done by disciplines involved in patient evaluations and information supplied from other sources such as community agencies and significant others.
B121 482.61(c)(1)(ii) The written plan must include short-term and long range goals;
Based on the problems identified for treatment, short-term and long-range goals are developed. Whether the use of short-term or a combination of short-term and long-range goals is appropriate is dependent on the length of hospital stay.
Short-term and long-range goals include specific dates for expected achievement. As goals are achieved, the treatment plan should be revised. When a goal is modified, changed or discontinued without achievement, the plan should be reviewed for relevancy, and updated as needed.
In crisis intervention and short-term treatment there may be only one timeframe for treatment goals. As the length of hospital stay increases (often because of the long-term chronic nature of the patient’s illness), both long-range and short-term goals are needed.
The long-range goal is achieved through the development of a series of short-term goals, i.e., smaller, logical sequential steps which will result in reaching the long-range goal. Both the short-term and long-range goals must be stated as expected behavioral outcomes for the patient. Goals must be related to the problems identified for treatment. Goals must be written as observable, measurable patient behaviors to be achieved. Discharge criteria may be included as long-range goals.
B122 482.61(c)(1)(iii) The written plan must include the specific treatment modalities utilized;
This requirement refers to all of the planned treatment modalities used to treat the patient during hospitalization. Having identified the problems requiring treatment, and defining outcome goals to be achieved, appropriate treatment approaches must be identified.
Modalities include all of the active treatment measures provided to the patient. It describes the treatment that will be provided to the patient. It describes the treatment that will be provided by various staff.
A daily schedule of unit activities does not, in itself, constitute planned modalities of treatment. It is expected that when a patient attends various treatment modalities/activities, it is a part of individualized planning with a specific purpose and focus for that patient.
Simply “naming” modalities (i.e., individual therapy, group therapy, occupational therapy, medication education) is not acceptable. The focus of the treatment must be included.
Simply “stating” modality approaches (i.e., “set limits,” “encourage socialization,” “discharge planning as needed”) is not acceptable. Modality approaches must be specifically described in order to assure consistency of approach.
Observation of staff implementing treatment, both in structured and non-structured settings, is a major criterion to determine whether active treatment is being provided in accordance with planned treatment.
It must be clear to you that the active treatment received by the patient is internally consistent and not simply a series of disconnected specific modalities delivered within certain scheduled intervals.
B123 482.61(c)(1)(iv) The written plan must include the responsibilities of each member of the treatment team; and
There are no “correct” number of staff who comprise the treatment team. The disciplines involved in the patient’s treatment depend upon the problems to be treated, the short-term and long-range goals and the treatment approaches and modalities used to achieve the goals.
The intent of the regulation is to insure that each individual on the treatment team who is primarily responsible for ensuring compliance with particular aspects of the patient’s individualized treatment program is identified. Identification of the staff should be recorded in a manner that includes the name and discipline of the individual. If other professionals or paraprofessionals provide care, the facility has the latitude to decide the manner with which it will identify them on the treatment plan.
The patient, as well as family/significant others, should be aware of the staff responsible for various aspects of treatment.
B124 482.61(c)(1)(v)The written plan must include adequate documentation to justify the diagnosis and the treatment and rehabilitation activities carried out.
When the progress and treatment notes are reviewed, the content of the notes must relate to the treatment plan. The notes must indicate what the hospital staff is doing to carry out the treatment plan and the patient’s response to the interventions.
B125 482.61(c)(2) The treatment received by the patient must be documented in such a way to assure that all active therapeutic efforts are included.
Active treatment is an essential requirement for inpatient psychiatric care. Active treatment is a clinical process involving ongoing assessment, diagnosis, intervention, evaluation of care and treatment, and planning for discharge and aftercare, under the direction of a psychiatrist. The patient is in the hospital because it has been determined that the patient requires intensive, 24 hour, specialized psychiatric intervention that cannot be provided outside the psychiatric hospital. The medical record must indicate that the hospital adheres to the patient’s right to be counseled about medication, its intended effects, and the potential side effects. If the patient requires, because of danger to self or others, a more restrictive environment, the hospital must indicate that the staff attempted to care for the patient in the least restrictive setting before progressing to a more restrictive setting.
Through observation, look for evidence that each patient is receiving all the aspects of treatment to which the hospital has committed itself based upon his/her assessment, evaluation and plan of care. It is the hospital’s responsibility to provide those treatment modalities with sufficient frequency and intensity to assure that the patient achieves his/her optimal level of functioning.
Through observation and interviews, look for evidence that each patient’s rights are being addressed and protected. There should be policies and procedures in place to address the following areas: informed consent, confidentiality, privacy, and security. Expect to see detailed policies and procedures regarding the therapeutic use of restrictions, such as visitors, mail, and phone calls. Seclusion and restraint policies and procedures must address patient protection and safety while in a restricted setting.
Clarification of the types of notes found in the medical record.
Treatment notes are recordings in the medical record that indicate provision of, and a patient’s response to, a specific modality. This modality may be drug therapy, individual, family, marital, or group therapy, art therapy, recreational therapy, and any specialized therapy ordered by the physician or anyone credentialed by the facility, in accordance with the State law, to write orders in the medical record.
A combined treatment and progress note may be written.
Progress notes are recordings in the medical record that are written by persons directly responsible for the care and active treatment of the patient. Progress notes give a chronological picture of how the patient is progressing toward the accomplishment of the individual goals in the treatment plan. These are frequently shift notes, weekly notes, or monthly notes.
B126 482.61(d) Progress notes must be recorded by the doctor of medicine or osteopathy responsible for the care of the patient as specified in 482.12(c),
Refer to §482.61(c)(2) Guidance for clarification between treatment notes and progress notes. The recording of progress is evidence of individual patient performance. Specifically, the progress notes recorded by the professional staff, or others responsible for the patient’s treatment, must give a chronological picture of the patient’s progress or lack of progress towards attaining short and long-range goals outlined in the individual treatment plan. Progress notes should relate to the goals of the treatment plan. Notes that state, “patient slept well” or “no complaints” constitute observations and do not indicate how the patient is responding to treatment and progressing towards set goals. Frequency alone does not determine the adequacy of progress notes. Expect to see greater frequency when patients are more acutely ill and/or in a crisis of some kind. Notes should be dated and signed (signature and title or discipline).
B127 482.61(d) nurse
No information available.
B128 482.61(d) social worker
No information available.
B129 482.61(d) when appropriate, others significantly involved in active treatment modalities.
No information available.
B130 482.61(d) The frequency of progress notes is determined by the condition of the patient but must be recorded at least weekly for the first 2 months and at least once a month thereafter, 482.61(d) and must contain
No information available.
B131 482.61(d) recommendations for revisions in the treatment plan as indicated as well as
No information available.
B132 482.61(d) a precise assessment of the patient’s progress in accordance with the original or revised treatment plan.
No information available.
B133 482.61(e) The record of each patient who has been discharged must have a discharge summary that includes a recapitulation of the patient’s hospitalization and
The record of each patient who has been discharged should indicate the extent to which goals established in the patient’s treatment plan have been met.
As part of discharge planning, staff consider the discharge alternatives addressed in the psychosocial assessment and the extent to which the goals in the treatment plan have been met.
The surveyor should refer to hospital policy for discharge timeframes.
The discharge summary should contain a recapitulation of the patient’s hospitalization, which is a summary of the circumstances and rationale for admission, and a synopsis of accomplishments achieved as reflected through the treatment plan. This summary includes the reasons for admission, treatment achieved during hospitalization, a baseline of the psychiatric, physical and social functioning of the patient at the time of discharge, and evidence of the patient/family response to the treatment interventions.
B134 482.61(e) recommendations from appropriate services concerning follow-up or aftercare
The patient’s discharge summary should describe the services and supports that are appropriate to the patient’s needs and that will be effective on the day of discharge.
• A complete description of arrangements with treatment and other community resources for the provision of follow-up services. Reference should be made to prior verbal and written communication and exchange of information;
• A plan outlining psychiatric, medical/physical treatment and the medication regimen as applicable;
• Specific appointment date(s) and names and addresses of the service provider(s);
• Description of community housing/living arrangement;
• Economic/financial status or plan, i.e., supplemental security income benefits;
• Recreational and leisure resources; and
• A complete description of the involvement of family and significant others with the patient after discharge.
B135 482.61(e) a brief summary of the patient’s condition on discharge.
The patient’s discharge planning process should address anticipated problems after discharge and suggested means for intervention, i.e., accessibility and availability of community resources and support systems including transportation, special problems related to the patient’s functional ability to participate in aftercare planning.
The discharge summary and/or plan should contain information about the status of the patient on the day of discharge, including psychiatric, physical and functional condition.