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Complying with the CMS Restraint and Seclusion Standards: the Most Problematic CMS Standard

CMS has about 50 pages that address the restraint and seclusion standards, the most problematic standard in the hospital CoP manual. Here’s the evidence: the Jan. 15 CMS quarterly deficiency reports shows 1,289 deficiencies from tag 154 to 214.

All patients have to right to be free from unnecessary restraint and seclusion. A restraint is defined to include any manual method, physical, or mechanical device, material, or equipment that immobilizes or reduces the ability of the patient to move his or her arms, legs, body, or head freely. Mechanical restraints include wrist restraints, vest restraints, elbow immobilizers, ties, or cuffs. However, most hospitals report no longer using vest restraints. Tucking patients’ sheets so tightly they cannot move or wrapping patients up in a sheet would constitute a restraint. The use of an enclosure bed that prevents the bed from freely exiting would also constitute a restraint. A patient who is unable to freely exit a geri chair or a wheelchair with a seat belt on could also be construed by the CMS surveyor to be a restraint. Hospitals should include the definition of what constitutes a policy in the hospital’s policy and procedure.

The policy should also include what constitutes a drug used as a restraint. This could include a drug used as a restriction to manage the patient’s behavior and is not part of a standard treatment or standard dosage for the patient’s condition. This could include using an off label drug or a dose that is two or three times the normal dosage. A drug is not a restraint if the medication is within the pharmacy parameter set by the FDA and the manufacturer for use. If it follows a national practice standard, is used to treat a specific condition based on the patient’s symptoms, or is standard treatment to enable the patient to be more effective, then it is not a drug used as a restraint. An example would be the use of Ativan for a patient with alcohol withdrawal symptoms.

CMS’s terminology is different than that of The Joint Commission (TJC). TJC is one of the four accreditation organizations (AOs) that have deemed status. This means that hospitals that are accredited by one of the four AOs can get paid for taking care of Medicare patients without have CMS do a survey every three years or so. CMS uses the terminology that the patient is either violent and or self destructive or non-violent and non-self destructive. TJC refers to the patients as either behavioral health or non-behavioral health patients. CMS says it is not the department that the patient is located but the behavior.

Part two will include recommendations to ensure compliance with the restraint and seclusion standards. CMS requires on-going education so hospitals should consider annual training for all staffs who work with patients in restraint or seclusion. CMS has ten pages of educational requirements and the hospital should ensure staff on trained on everything on the list. The policy should include any state specific laws or accreditation organization requirements. Many states have specific laws for hospitals that have a separate behavioral health department. Staff should be trained in the policy. CMS requires that any physician or other licensed independent practitioner who writes an order for restraint and/or seclusion should be trained on the hospital policy. This is why some hospitals will provide a copy of the current policy and have these practitioners sign an attestation that is put in their file during the every two year re-credentialing and re-privileging process that they have received a copy of the current policy and have read and understand it. This process should also be done whenever there is a significant change in the hospital policy and procedure.

  • The deficiency reports are here.
  • The current CMS CoP manual is here.



Restraint and Seclusion: The Most Problematic of all CMS Standards


Outpatient Services and the New CMS RegulationsHPR for Hospital Consult

CMS recently published a survey and certification memo containing the final interpretive guidelines for hospital outpatient services.

These guidelines were based on the federal regulations that went into effect last July. The medical staff and board can decide who is eligible to order outpatient tests. Hospitals can decide what can be ordered by physicians and other practitioners who are both privileged and which tests can be ordered by those who are not.

An order is required for any outpatient test or procedure. The language now reads that an order is needed by a practitioner who is responsible for the care of the patient who is licensed in the state where he or she provides care to the patient. For example, an Ohio patient spends the winters in Florida and has a prescription to have outpatient lab tests such as an INR because the patient is on warfarin (Coumadin). The Florida hospital can decide if they will honor the prescription and perform the lab test for the patient.

The hospital could accept orders of other practitioners as allowed within their state scope of practice. This must be authorized by the medical staff and approved by the board. Many states allow other practitioners, such as Nurse Practitioners (NP) and Physician Assistants (PA) to order a test or procedure. The state board of nursing usually sets forth the scope of practice for a NP and this information is generally contained on their website. Likewise, the state medical board generally sets forth the scope of practice for the PA and lists this on their website. This makes it easier for hospitals to verify the scope of practice for practitioners from other states when they decide to honor these orders. License can be verified online also. Hospital should consider what else should be verified such as if the person is on the Office of Inspector General’s (OIG) list of excluded individuals.

The list of excluded individuals can be searched here. The order should also be consistent with any state law requirements.

These changes affect tag number 1076, 1080, and 1081. The CMS manual will be amended to reflect these changes. The current CMS manual is available here.

Hospitals should review these three revised tag numbers and have a list of what orders can be accepted in the outpatient area. This includes practitioners with privileges and those who do not. The hospital should have a clear policy of what staff should do, such as the outpatient registration personnel and outpatient staff when they receive an outpatient orders. There should be documentation of the verification process. Outpatient orders could include things like lab tests, physical therapy, occupational therapy, speech pathology services, rehabilitation, blood, outpatient chemotherapy, nuclear medicine study, or outpatient procedures. This process should be authorized by the medical staff and approved by the board. The Medical Executive Committee is often empowered to approve policies on behalf of the Medical Staff. Hospitals should ensure they are meeting the needs of their patients and that these are provided in accordance with standards of care and practices, with appropriate equipment, trained staff and an appropriate facility. Hospitals must ensure compliance with the CMS conditions of participation if they provide outpatient services.

You can find all the survey memos on the CMS website.


CMS Dietary Update

CMS recently published three changes to the hospital condition of participations (CoPs) under Appendix A.

Appendix A is the manual for larger hospitals. CMS first published the final regulation changes in the federal register that became effective July 11, 2014. These interpretive guidelines explain the changes were published in a CMS survey memo dated January 30, 2015. The manual will be amended to include these changes.

CMS has a separate manual for critical access hospitals under Appendix W. CMS has also rewritten all of the dietary standards for critical access hospitals in an advance memo dated Jan. 16, 2015.

CMS made changes to tag number 629 and 630 and tag 628 was deleted. The tag numbers appear in the upper hand corner in the manual.

The primary reason for the change was to allow the board and medical staff to have the option to credential and privilege (C&P) the dietician or qualified nutrition specialist to write an order for a patient’s diet. Diet includes whatever the patient’s diet is such as therapeutic diet, supplemental feedings, or TPN (enteral or parenteral nutrition).

Therapeutic diet refers to a diet ordered as part of the patient’s treatment for a disease or clinical condition to eliminate, decrease, or increase certain substances in the diet, such as potassium or sodium, or to provide mechanically altered food when indicated.

In the past, many physicians would order a consult with the dietician for a recommendation of a therapeutic diet. The dietician would then write a recommendation as a consult. If the nurse on duty or the dietician did not call the physician, the hospital could be at risk for a deficiency if it simply waited until the next day when the physician made rounds. The practitioner would generally adopt the recommendation. This process involved interrupting the physician. The verbal order then needed to be signed off. Now the dietician who is C&P to write orders can simply write the diet order. If the physician disagrees the order can always be amended.

So if C&P, the dietician or qualified nutritional specialist could order diet, which they are trained to do, without supervision or the approval of the physician or practitioner. However, it is important to note that this cannot be done by policy and procedure only. The qualified dietician must be credentialed and privileged by the medical staff and this must be approved by the board. The order must be documented in the medical record.

CMS notes that in some states this person may be referred to as a licensed dietician or a registered dietician. Registered dieticians may be defined to include one who is registered with the Commission on Dietetic Registration or as defined by state law.

The state must also not prohibit the practice of ordering the patient’s diet. The American Dietetics’ Association has a map showing the states that may prohibit this at

Tag 629 now states that the individual patient nutritional needs must be met in accordance with recommended dietary practices. Patients must be assessed for risk of nutritional deficiencies. If present then this may be in the patient’s plan of care. It could include the need to monitor intake, I&O, daily weights, or lab values.

CMS discusses the Institute of Medicine’s food and nutrition board’s dietary reference intake. This includes four reference values including the Recommended Dietary Allowance or the recommended dietary allowances, which is the average dietary intake of nutrition sufficient for healthy people.

Tag 629 also discusses when a patient may need a comprehensive assessment. In many hospitals, the RN does an admission assessment which includes a nutritional screen. This may prompt the dietician to do a nutritional assessment when indicated by the patient’s condition. This may include if the patient has a medical or surgical condition that interferes with the ability to digest and absorb nutrients. The patient may have symptoms indicating a risk for malnutrition, such as anorexia nervosa, bulimia, electrolyte imbalance, or end stage renal disease. The patient’s medical condition could be adversely affected by intake and need a special diet as those patients with heart failure, diabetes, or renal disease. Patient may be at risk if receiving artificial nutrition such as tube feedings, TPN, or peripheral parental nutrition.


Critical Access Hospital CoP Update

Critical access hospitals (CAH) should be aware of an important survey memo published by CMS on Jan. 16, 2015. This is an advance memo to provide extra time for CAHs to review before it becomes final.

CMS reserves the right to make changes or tinker with the changes. When the changes are final, CMS will publish a transmittal and then update the CAH manual. The current manual is dated October 10, 2014. The CAH manual is located under Appendix W at

The Jan. 16 survey memo can be found here. This 93-page memo changes many changes. The sections on rehabilitation, nursing, drugs and biologicals, pharmacy, dietary, and infection control were completely rewritten. There has been a section added on IV medication, blood, contract management, and safe opioid use.

Many of these changes may look familiar to larger hospitals with many similarities noted in the Appendix A manual. This may be good news to hospitals in systems as the manuals will be more closely cross walked. It will make it a little easier for hospitals in system to adopt policies and procedures. It will also be easier for the CMS surveyors since there will be less differences between the two manuals.

The survey memo also provides the final interpretive guidelines for three changes that became effective July 11, 2014. CAHs no longer need an outside person to be a member of the hospital’s policy and procedure committee.

There is no longer a requirement that a physician, such a MD or DO, be present in the hospital at least once every two weeks. Some of the larger CAHs may have 25 patients, observation patients, and an active outpatient department and may have physicians present on a daily basis. The CAH just needs to ensure that the physicians are present for sufficient periods of time to provide medical direction.

The third section addressed the issue of when a physician had to review the outpatient orders of a non-physician practitioner such as a nurse practitioner or a physician assistant. A physician would only need to co-sign outpatient orders to the extent required under state law if there is a state law that requires such a review and co-signature.

Every CAH should take a look at the Jan. 16 memo. Hospitals should assemble a team to review the standards and do a gap analysis. Hospitals should start working on revised policies and education that will need to take place. Hospitals should watch for the final revisions by monitoring the CMS manual website so that all CAHs are aware of when these advanced changes are final.



Keep an eye out for the CAH COP Series Coming in July!





MAY 2015

5/1/15 - 2 CNE
Avoiding Legal Hazards in Documentation: CMS and TJC Requirements for Hospitals and Nurses 

5/5/15 - 1.5 CNE, 1.5 CME & 1.5 ACEP
Advancing Patient Safety in the ED:
Risks, Challenges and Corrective Initiatives

5/6/15 - 2 CNE, 2 CME & 2 ACEP
The Capricious ED:
How to Avoid CMS, TJC and Legal Liability

5/12/15 - 1.5 CNE
CMS Medical Records: What You Need to Know 

5/13/15 - 2 CNE
Clarifying the Confusing CMS Hospital Surgery, PACU, and Anesthesia Standards 

5/19/15 - 1.5 CNE
IV Medication & Blood Administration:
Did Your Hospital Get The Memo?

5/20/15 - 1.5 CNE
CMS Requirements on Order Sets,
Protocols, Preprinted and Standing Orders

5/27/15 - 1.5 CNE
Complying With New CMS Nursing Services CoPs 

JUNE 2015

6/2/15 - 1.5 CNE
Grievances and Complaints:
Compliance with CMS
and TJC Standards

6/3/15 - 1.5 CNE
The Final CMS Worksheet
on Infection Control

6/9/15 - 1.5 CNE & 1.5 CME 
Restraint And Seclusion:
The Most Problematic
Of All CMS Standards

6/10/15 - 1.5 CNE
New CMS QAPI Standards and
Revised QAPI Worksheet

6/16/15 - 1.5 CNE
Hospital Utilization Review Programs:
Current CMS CoPs

6/23/15 - 1.5 CNE
Contracted Hospital Services:
Certifying Compliance with

6/24/15 - 1.5 CNE
The New CMS Worksheet and Discharge Planning Standards 

6/29/15 - 1.5 CNE
Ensuring Compliance with CMS Anesthesia Standards