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Based on interview and documentation in 3 of 3 medical records of inpatient Medicare beneficiaries reviewed for the "Important Message from Medicare (IM)" (Patients 6, 8 and 9), it was determined the hospital failed to ensure the following:
* Inpatient Medicare beneficiaries were not provided the "Important Message from Medicare" form and/or were not provided the form within required timeframes.

The CMS Interpretive Guideline for this requirement at CFR 482.13(a)(1) reflects "...according to the regulation at 42 CFR 489.27(a), (which cross references the regulation at 42 CFR 405.1205), each Medicare beneficiary who is an inpatient (or his/her representative) must be provided the standardized notice, "An Important Message from Medicare" (IM), within 2 days of admission...The IM is a standardized, OMB-approved form and cannot be altered from its original format. The IM is to be signed and dated by the patient to acknowledge receipt...Furthermore, 42 CFR 405.1205(c) requires that hospitals present a copy of the signed IM in advance of the patient's discharge, but not more than two calendar days before the patient ' s discharge. In the case of short inpatient stays, however, where initial delivery of the IM is within 2 calendar days of the discharge, the second delivery of the IM is not required."

Findings include:

1. The medical record of Patient 6 was reviewed and reflected the patient was an inpatient Medicare beneficiary admitted on 11/11/2019 at 1712.
* The record contained a copy of one IM form. The IM form was signed and dated by the patient on 11/13/2019 at 1430.
* A "Care Manager Reassessment" note dated 11/15/2019 at 1159 reflected "IMM form given to [name] to get signed by patient or family."
- The record reflected the patient was discharged on 11/16/2019 at 1551.

The record contained no documentation that reflected the hospital presented the patient or patient's representative a copy of the signed IM form in advance of discharge.

During an interview and review of the medical record with the EA on 01/07/2020 at 1710, the EA confirmed the record contained no documentation that reflected the patient was presented a copy of the signed IM form in advance of discharge.

2. The medical record of Patient 8 was reviewed and reflected the patient was an inpatient Medicare beneficiary admitted on 11/23/2019 at 1031.
* The record contained a copy of one IM form. The IM form was not signed or dated by the patient or patient's representative.
* The "Care Manager Discharge Summary" reflected "IMM Provided? [blank space] Last Date Given: [blank space]"
* The patient was discharged on 12/01/2019 at 1137.

The record contained no documentation that reflected the patient or patient representative was provided with an IM form within 2 days of admission.
The record contained no documentation that reflected the patient or patient representative was presented a copy of a signed IM prior to discharge.

During an interview and review of the medical record with the CC on 01/07/2020 at 1715, the CC confirmed there was no documentation that the patient or patient representative was presented with an IM form.

3. The medical record of Patient 9 was reviewed and reflected the patient was an inpatient Medicare beneficiary admitted on 11/26/2019 at 2318.
* The record contained a copy of one IM form. The form was not signed by the patient or patient representative. The section on the form for "Signature of Patient or Patient Representative" contained the following handwritten entry "verbal - spouse [name]." The form was dated 11/27/2019 at 1445.
* The "Care Manager Discharge Summary" reflected "IMM Provided? [blank space] Last Date Given: [blank space]"
* The patient was discharged on 12/06/2019 at 1640.

The record contained no documentation that reflected the reason the patient or patient representative did not sign the IM form, or that further attempts were made to provide the IM form to the patient or patient representative within two days of admission, and obtain their signature and date to acknowledge receipt of it.

The record contained no documentation that reflected the hospital presented the patient or patient's representative a copy of an IM form in advance of discharge.

During an interview and review of the medical record with the CC on 01/07/2020 at 1735, the CC confirmed the record contained no documentation that reflected the patient or patient representative was presented with a copy of an IM form prior to discharge.

Based on interview, review of grievance documentation for 7 of 7 patients selected from the grievance log or other grievance documents (Patients 1, 2, 4, 5, 7, 10 and 11), and review of policies and procedures, it was determined that the hospital failed to fully develop and implement policies and procedures that ensured patients' rights were recognized, protected and promoted as follows:
* A written response to the complaint/grievance was not submitted to patients/patient representatives in all cases.
* Written responses to patients'/patient representatives' complaints/grievances did not contain all of the required elements including the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

Findings include:

1. The hospital policy and procedure titled "Patient Grievance Process," dated last revised "12/2011" reflected:
* "Mercy has established a process for the prompt resolution of patient grievances and complaints...Mercy informs patients of their rights, including the internal grievance process and who to contact to file a grievance upon admission..."
* "Procedure...When a complaint cannot be resolved promptly to the patient's satisfaction by available staff...the Patient Grievance Process may be invoked. Examples include complaints about...availability or promptness of care or ancillary services...quality of care provided by employees and/or medical staff...patient rights and confidentiality, including the use and disclosure of PHI..."
* "...When a patient communicates a Patient Grievance (orally or in writing) to the Designated Representative, to an employee or other representative of Mercy, or to a physician, the Patient Grievance Process begins."
* "...The Designated Representative will, as soon as reasonably possible, but ideally within seven business days of the communication of a Patient Grievance of a Patient Grievance, begin an investigation by contacting the patient either in writing or orally, acknowledging receipt of the Patient Grievance, describing the Patient Grievance process steps, and estimating the time to reach Mercy's conclusion of the Process. The patient/representative will be asked to sign the grievance acknowledgement of receipt form...If resolution has been reached within that time then final written notice is sent to the patient."
* "...Except in unusual circumstances, the investigation and subsequent processing of a Patient Grievance following the contact described above should occur as follows..."
- "Investigation and its Conclusion: The Designated Representative has the authority to interview the patient, Mercy's employees...other individuals as necessary to complete the investigation. The Designated Representative shall complete the investigation by either a. resolving the grievance by agreement with the patient, and providing written notice to the patient, or b. making recommendations to the Patient Grievance Committee in the absence of agreement with the patient. The Designated Representative shall forward the Patient Grievance investigation, resolution materials and recommendations...to the Patient Grievance Committee."
- "Patient Grievance Committee Action. In the event a Patient Grievance remains unresolved, the Patient Grievance Committee shall review the investigation file, conduct an additional investigation...and draft a written response to the patient within 14 days from the Committee's receipt of the investigation file. The patient must have already received written notice of the investigation within seven days of Mercy's receipt of the grievance. The Patient Grievance Committee response will outline the steps taken to investigate the grievance with the amount of detail appropriate to the circumstances, the results of the Process, and the date of completion."

The policy and procedure was not fully developed as it did not include a process that ensured:
* The written response, when provided to the patient/patient representative by the Designated Representative, included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.
* The written response, when provided to the patient/patient representative by the Patient Grievance Committee, included the name of the hospital contact person.

2. Patient 1: Grievance documentation for the patient was reviewed and reflected the grievance was submitted to the hospital by the patient on 09/05/2019. The documentation reflected "Patient concerned about rough handling by doctor."

A written notice provided to the patient dated 09/20/2019 was reviewed and reflected "Thank you for sharing your concerns with me...I have moved your concerns forward to the Director of the Surgical Floor, the Medical Staff office and the Quality Improvement department...I can assure you the appropriate follow up with the physician has occurred...I will be forwarding your...concerns to...Director of Risk Management...This review may require you to submit additional information...[Director of Risk Management] will contact you directly if more information is needed."

* There was no documentation in the written notice that reflected the steps taken to investigate the grievance.
* There was no documentation that the grievance was submitted to the grievance committee and the grievance committee further investigated the patient's grievance and submitted a written response to the patient/patient representative within 14 days that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.
* There were no further written responses submitted to the patient.

3. Patient 2: Grievance documentation for the patient was reviewed and reflected the grievance was submitted to the hospital by the patient on 09/25/2019. The documentation reflected "Patient concerned that nurse drawing blood did not wear gloves or wash hands."

A written notice provided to the patient dated 10/11/2019 was reviewed and reflected "Your concerns and comments were sent to the Nursing Director of the Emergency Room who has reviewed you (sic) concerns for areas of improvement...the appropriate action with the staff member has occurred...If I can be of further assistance to you in the future, please do not hesitate to contact me."

* There was no documentation in the written notice that reflected the steps taken to investigate the grievance.
* There was no documentation that the grievance was submitted to the grievance committee and the grievance committee further investigated the patient's grievance and submitted a written response to the patient/patient representative within 14 days that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.
* There was no further written response submitted to the patient.

4. Patient 4: Grievance documentation for the patient was reviewed and reflected the grievance was submitted to the hospital by the patient on 10/30/2019. An entry on the grievance log dated 10/30/2019 reflected "Patient concerned about pain in [unit or department]...& attitude of nurse."

* There was no written response provided to the patient/patient representative, including no written response that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

5. Patient 5: Grievance documentation for the patient was reviewed and reflected the grievance was submitted to the hospital by the patient's family member on 11/05/2019. An entry on the grievance log dated 11/05/2019 reflected "Patient's [family member] concerned about the way [his/her] [son/daughter] was treated in the ED. Following discharge, [family member] took patient to Medford's ER and [he/she] was there for 4 days."

A written response provided to the patient dated 11/27/2019 was reviewed and reflected "I am responding to the results of my review, related to the concerns you expressed...regarding the care of your [son/daughter] while in our Emergency Room...I have moved your concerns forward...for further review...I can assure you appropriate follow up...has occurred."

* There was no documentation in the written response that reflected the steps taken to investigate the grievance.
* There was no documentation that the grievance was submitted to the grievance committee and the grievance committee further investigated the patient's grievance and submitted a written response to the patient/patient representative within 14 days that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.
* There was no further written response submitted to the patient following the 11/27/2019 response.

6. Patient 7: Grievance documentation for the patient was reviewed and reflected the grievance was submitted to the hospital by the patient on 11/12/2019. An entry on the grievance log dated 11/12/2019 reflected "Patient felt [he/she] was mistreated in ED, and nurse placed tourniquet too tightly on [his/her] arm, which resulted in nerve damage."

A written response provided to the patient dated 11/26/2019 was reviewed and reflected "Thank you for sharing your concerns with me...I am forwarding your letter and concerns to...Director of Risk Management...This review may require you to submit additional information..."

* There was no documentation in the written response that reflected the steps taken to investigate the grievance, the results of the grievance process, and the date of completion.
* There was no documentation that the grievance was submitted to the grievance committee and the grievance committee further investigated the patient's grievance and submitted a written response to the patient/patient representative within 14 days that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.
* There was no further written response submitted to the patient following the 11/26/2019 response.

7. Patient 10: Grievance documentation for the patient was reviewed and reflected the grievance was submitted to the hospital by the patient on 12/20/2019. The grievance documentation reflected "Patient...states that this nurse [name] treated me very wrong...when I told [him/her] I was in pain, [he/she] didn't seem concerned and didn't help get me comfortable...left [me]...in feces..."

* There was no written response provided to the patient/patient representative, including no written response that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.
* Additionally, the grievance was not entered into the hospital's grievance log.

8. Patient 11: Grievance documentation for the patient was reviewed and reflected the grievance was submitted to the hospital by the patient on 12/12/2019. The grievance documentation reflected "Patient describes to me confidential information was told to [his/her] [ex-spouse]. Patient states that...[he/she] didn't give permission to speak to [him/her]...[He/she] would like me to move [his/her] concerns forward to the appropriate department heads."

* There was no written response provided to the patient/patient representative, including no written response that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.
* Additionally, the grievance was not entered into the hospital's grievance log.

9. Findings 2, 3, 4, 5, 6, 7 and 8 were confirmed with the PAS on 01/07/2020 at 1440 during a review of the grievance documentation.

Based on interview, review of staff training records for 10 of 10 physician and LP staff authorized to order restraints and seclusion (Staff 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10), review of staff training content, review of medical staff bylaws, review of policies and procedures, and other documentation it was determined that the hospital failed to fully develop and implement policies and procedures as follows:
* Hospital policies did not specify restraint and seclusion training requirements for physician and LP staff who were authorized to order restraints and seclusion.
* Physician and LP staff authorized to order restraints and seclusion were not trained related to restraints and seclusion.

Findings included:

1. During an interview on 1/08/2020 at 1640, the EA stated that physicians, NPs and PAs were authorized to order restraints and seclusion.

2. The policy and procedure titled "Restraints & Seclusion," dated last reviewed "01/2018" was reviewed and reflected:
* "All hospital staff who has direct patient contact receives education and training in...The proper and safe application and use of restraints...Initial and ongoing training...Alternative methods of handling behavior, symptoms, and situations that have traditionally been managed through the use of restraints or seclusion...Staff that work in areas with the highest risk for violent/self destructive restraint and/or seclusion procedures will receive annual restraint and seclusion training." The policy and procedure did not specify restraint and seclusion training requirements for physician and LP staff.

3. During a telephone interview with the CNO and EA during the exit conference on 01/17/2020 at 1000 they confirmed the hospital's restraint and seclusion policy and procedure did not include restraint and seclusion training requirements for physician and LP staff.

4. The following medical staff orientation, training, and other documents were provided and did not include restraint and seclusion training content, or stipulate restraint and seclusion training requirements for physician and LP staff:
* "Mercy Medical Center Orientation Guide for Medical Staff," dated revised 01/23/2014.
* An undated handbook titled "Signing On For Safety A Primer for Practitioners."
* An undated presentation document titled "Physician Safety First Training: High Reliability and Error Prevention."
* Hospital medical staff bylaws dated approved 09/18/2018.

5. During an interview on 01/08/2020 at 1545 the DMS stated there was no information in the medical staff rules and regulations related to physician and LP staff training requirements for restraint and seclusion.

6. Review of physician and LP staff training records reflected the following:

a. Staff 1, a NP with hire date 08/01/2019 reflected:
* No documentation of restraint and seclusion training or evidence that he/she was provided the hospital's restraint and seclusion policies or documentation that he/she had a working knowledge of the hospital's restraint and seclusion policies.

b. Staff 2, a NP with hire date 05/01/2018 reflected:
* No documentation of restraint and seclusion training or evidence that he/she was provided the hospital's restraint and seclusion policies or documentation that he/she had a working knowledge of the hospital's restraint and seclusion policies.

c. Staff 3, a physician with hire date 07/18/2018 reflected:
* No documentation of restraint and seclusion training or evidence that he/she was provided the hospital's restraint and seclusion policies or documentation that he/she had a working knowledge of the hospital's restraint and seclusion policies.

d. Staff 6, a physician with hire date 01/08/2014 reflected:
* No documentation of restraint and seclusion training or evidence that he/she was provided the hospital's restraint and seclusion policies or documentation that he/she had a working knowledge of the hospital's restraint and seclusion policies.

e. Similar findings were identified related to lack of documentation of restraint and seclusion training or evidence staff were provided the hospital's restraint and seclusion policies or other documentation that reflected they had a working knowledge of the hospital's restraint and seclusion policies for the following staff:

Staff 4, a physician with hire date 09/27/1994;
Staff 5, a physician with hire date 09/17/1998;
Staff 7, a physician with hire date 09/01/2008;
Staff 8, a physician with hire date 11/16/2015;
Staff 9, a physician with hire date 04/19/2017; and
Staff 10, a physician with hire date 12/30/2009;

7. During an interview and review of physician and LP training records with the DMS on 01/08/2020 at 1445, the DMS confirmed there was no documentation in the staff training records that reflected Staff 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 were trained related to restraint and seclusion or were provided and received the hospital's restraint and seclusion policies.

Based on interview, documentation in the medical record of 1 of 1 patient reviewed for application of violent/self destructive restraints (Patient 3), and review of policies and procedures, it was determined the hospital failed to ensure policies and procedures were fully implemented as follows:
* One hour face-to-face evaluations following application of violent or self destructive restraints did not include the need to continue or terminate the restraint in all cases.

Findings include:

Refer to the findings cited at Tag A182 related to Patient 3 that reflected one hour face-to-face evaluations following application of violent/self destructive restraints did not include the need to continue or terminate the restraints in accordance with hospital policy.

Based on interview, documentation in the medical record of 1 of 1 patient reviewed for application of violent/self destructive restraints (Patient 3), and review of policies and procedures, it was determined the hospital failed to ensure policies and procedures were fully developed and enforced as follows:
* RNs who conducted one hour face-to-face evaluations following application of violent/self destructive restraints did not consult with the attending physician or LP following the evaluation; and
* Policies and procedures did not specify the time frame "as soon as possible" for RN consultations with the attending physician or LP following one hour face-to-face evaluations.

Findings include:

1. The policy and procedure titled "Restraints & Seclusion," dated last revised "01/2018" was reviewed and reflected:
* "Violent/Self Destructive Restraint And/Or Seclusion...Indications: Restraint and/or Seclusion are used only when it can be clinically justified or when warranted by patient behavior that threatens the physical safety of the patient, or others."
- "A registered nurse who had completed additional face-to-face evaluation training may conduct the in-person evaluation within one hour of the initiation of restraint or seclusion. When the in-person evaluation (performed within one hour of the initiation of restraint or seclusion) is done by a trained registered nurse, he or she consults with the physician responsible for the care of the patient as soon as possible."
- "The in-person evaluation, conducted within one hour of the initiation of restraint or seclusion for the management of violent or self-destructive behavior that jeopardizes the physical safety of the patient, staff, or others, includes the following...An evaluation of the patient's immediate situation...The patient's reaction to the intervention...The patient's medical and behavioral condition...The need to continue or terminate the restraint or seclusion."
- "If the face-to-face evaluation is performed by a registered nurse or physician assistant, the evaluator must consult with the attending physician as soon as possible following the face-to-face evaluation."
The policy and procedure did not specify "as soon as possible" related to when RNs who conducted the face-to-face evaluations must consult the attending physician or LP responsible for the patient's care after completion of the evaluation.

2. The medical record of Patient 3 reflected he/she was admitted to the hospital on 09/25/2019 with shortness of breath, weakness, and altered mentation.

* RN notes dated 10/20/2019 at 0645 reflected "Pt becoming increasingly aggressive. Security called to room...Pt asked to sit down by staff...Becomes violent and hits staff member. Pt placed in restraints..."

* RN notes dated 10/20/2019 at 0645 on the "Restraint Management" form reflected bilateral soft wrist and vest restraints were initiated on 10/20/2019 at 0645 for "High Risk Behaviors (Violent)." The RN documentation reflected the physician was consulted on 10/20/2019 at 0700 and "Reviewed with staff patient's physical and psychological status; whether restraint or seclusion should be continued, and guidance on ways to help the patient gain control? Y"

* RN notes dated 10/20/2019 at 0715 on a "Restraint Management" form reflected a one hour face-to-face evaluation was conducted by the RN.
- The "Rationale to continue or terminate the restraint/seclusion:" section was not completed and was blank.
- The following sections on the form were not completed and were blank: "Date/Time physician responsible for the care of the patient consulted (as soon as possible but not more than 1 hour) after face to face evaluation:," "Physician:," "Date:," and "Time:"

Although the record reflected the RN consulted with the physician at 0700, there was no documentation he/she consulted with the physician or LP after the face-to-face evaluation was conducted at 0715.

There was no documentation that reflected the face-to-face evaluation included the need to continue or terminate the restraints in accordance with hospital policy. This was confirmed during an interview and review of the medical record with the RM on 01/08/2020 at 1000.

* RN notes dated 10/20/2019 at 1806 reflected "1735 Pt was observed while sitting up in chair that [he/she] was finished eating and had broken [his/her] plastic spoon and was scratching/cutting [his/her] L wrist. While attempting to control the situation there was a skin tare (sic) noted on the R wists (sic) as well. A code gray was called....[he/she] attempted to head butt one of the nurses...the pt was lifted into bed and soft wrist and posey in place..."

* RN notes dated 10/20/2019 at 1745 on a "Restraint Management" form reflected Violent/self destructive restraints were initiated on 10/20/2019 at 1745 and included side rails, soft wrist restraints and vest restraint.

* RN notes dated 10/20/2019 at 1813 on a "Restraint Management" form reflected a one hour face-to-face evaluation was conducted by the RN.
- The "Rationale to continue or terminate the restraint/seclusion:" section was not completed and was blank.
- The following sections on the from were not completed and were blank: "Date/Time physician responsible for the care of the patient consulted (as soon as possible but not more than 1 hour) after face to face evaluation:," "Physician:," "Date:," and "Time:"

There was no documentation that reflected the one hour face-to-face evaluation included the need to continue or terminate the restraints in accordance with hospital policy.

There was no documentation that reflected the RN consulted with the physician following the completion of the one hour face-to-face evaluation. This was confirmed during an interview and review of the medical record with the CNO and EA on 01/08/2020 at 1715.

Based on interview, review of restraint training documentation for 5 of 5 hospital staff (Employees 11, 12, 13, 14 and 15), review of policies and procedures, and review of restraint training materials and other documentation it was determined that the hospital failed to fully develop and implement policies and procedures as follows:
* Staff were not trained and did not demonstrate competency in the safe application and use of all types of restraints available for use in the hospital.

Findings include:

1. The policy and procedure titled "Restraint & Seclusion," dated last revised "01/2018" was reviewed and reflected:
* "All hospital staff who have direct patient contact receives education and training in...The proper and safe application and use of restraints...Initial and ongoing training...Alternative methods of handling behavior, symptoms, and situations that have traditionally been managed through the use of restraints or seclusion...Staff that work in areas with the highest risk for violent/self destructive restraint and/or seclusion procedures will receive annual restraint and seclusion training."
* "Placement of a Patient in Restraint...Trained staff members will apply restraints following specific restraint manufacturer's guidelines."

2. The policy and procedure titled "Orientation," dated last revised "06/2018," reflected:
* "...Human Resources will...Assist the Staff Development Department in ensuring that competency requirements during the Orientation Process are met..."
* "Staff Development will...Provide general nursing orientation...which will include...Restraint and Seclusion..."
* "Manager will...Ensure that new employees attend the next scheduled New Employee Orientation from date of hire...Departmental orientation includes...Completion of the Department Orientation Checklist...Completion of Skills Checklist...Review of job responsibilities and required competencies...Completed checklists are maintained in the employee's personnel file."

3. An undated, untitled document was provided by the EA on 01/07/2020 at 1140 in response to a request for a list of units/departments where restraints are available for use, and the type of restraints. The document was reviewed and reflected the following:
* "Emergency Department"
- "Type Of Restraints...TAT, Soft Wrist/Ankle; 3 Seclusion Rooms (Crisis Unit)"
- "Application...RN (Team Leader), Charge RN, NC, then can be assisted by ED Techs & Security"
* "Family Birthplace"
- "Type Of Restraints...Soft Wrist/Ankles"
- "Application...RN (Team Leader), Charge RN, NC, then can be assisted by ED Techs & Security"
* "ICU"
- "Type Of Restraints...Soft Wrist/Ankle, TAT, Vests"
- "Application...RN (Team Leader), Charge RN, NC, then can be assisted by PCTs, CNAs, & Security"
* "Medical Floor"
- "Type Of Restraints...Vests, Soft Wrist/Ankle, TAT"
- "Application...RN (Team Leader), Charge RN, NC, then can be assisted by CNAs & Security"
* "PCU"
- "Type Of Restraints...Soft Wrist/Ankle, TAT, Vests"
- "Application...RN (Team Leader), Charge RN, NC, then can be assisted by PCTs, CNAs, & Security"
* "Surgical/Peds"
- "Type Of Restraints...Soft Wrist/Ankle, Vests"
- "Application...RN (Team Leader), Charge RN, NC, then can be assisted by CNAs & Security"

4. During a tour of the Medical Unit on 01/07/2019 at 1320 with the DMU and EA, hand mitts were observed in the equipment storage room. At the time of the observation, the DMU stated the hand mitts were a restraint.

5. An interview was conducted with the SOT on 01/08/2020 at 1310. The SOT stated the hospital had a "posey net" restraint that was available for use and kept on the "second floor" of the hospital. The SOT stated the "posey net" restraint was a "full body restraint" and it could be "initiated by anyone clinical but security and a nursing supervisor must be present when it is used because it is so restrictive."

a. A manufacturer "Application Instruction Sheet" for "Posey Restraint Net" dated 2007 was provided on 01/08/2020 in response to a request for manufacturer instructions for the "posey net" restraint. The manufacturer instructions reflected:
* "Description of Product: A full body restraint for total immobilization in a supine position. For bed application only."
* "Patients wearing this product must be monitored constantly. They should never be left alone or unobserved. Often times these patients are psychotic and/or suicidal, and must receive intensive supervision. If left alone, they could do themselves or others serious harm."
* The manufacturer instructions included additional information related to the "Posey Restraint Net" including but not limited to: Contraindications, Adverse Reactions, Laundering, Warnings, and Application Instructions.

b. During an interview with the EA on 01/08/2020 at 1330, the EA confirmed the "Posey Restraint Net" was not included on the list of hospital restraints available for use above.

6. The restraints identified on the list of restraints available for use were inconsistent with the restraints observed, those staff stated were available for use, and the hospital policy and procedure titled "Restraint & Seclusion." For example:
* The list of restraints available for use and the hospital policy did not include a posey net restraint, whereas staff stated a posey net restraint was available for use.
* The list of restraints available for use and the hospital policy did not include hand mitt restraints, whereas hand mitts were observed available for use on the Medical Unit and staff stated hand mitts were a restraint.
* The list of restraints available for use included vest restraints, whereas the hospital policy did not reference vest restraints.

7. Staff restraint/seclusion training materials provided were reviewed and were inconsistent and did not include staff training and demonstrated competencies for the restraint types identified on the list of restraints available for use, those observed available for use, and those staff stated were available for use. For example:
* Documentation in skills day training materials titled "Safe Use Of Restraints 2019 Skills Day" for RN and CNA staff referenced use of "Non Violent Restraint" and "Violent/Self-Destructive Restraint" and included pictures of wrist and/or ankle restraints, and an individual in a wheelchair with an upper body restraint, but did not include all of the specific restraint devices available for use. For example, the training documentation did not include a posey net restraint.
* Documentation in the annual training materials titled "Lesson 4: Patient Care and Protection" provided for RN, CNA, SO and other staff referenced "Limb restraints," "Therapeutic hold," "Restraint vest," "Waist restraint," "supine restraints," "prone restraints," and "Restraint or seclusion for violent patients." The training documentation was inconsistent with or did not include information related to all of the specific restraint types available for use. For example, the training documentation did not include a posey net restraint or hand mitts; and the training documentation referenced "Therapeutic hold" and that was not included on the list of restraints available for use.
* Documentation in the annual staff training materials provided for SO staff included no reference to hand mitt restraints.
* Documentation of a "Nursing Orientation Checklist" document used to demonstrate restraint training and competencies for RNs and CNAs included no reference to seclusion, posey net restraint, or hand mitt restraints.

Due to the unclear and inconsistent information related to the types of restraint devices available for use at the hospital, there was no assurance staff were appropriately trained and demonstrated competency in the specific types of restraints used.

8. Review of staff training documentation reflected the following:

a. Employee 11, a Medical Unit CNA with hire date 07/16/2018 reflected:
* No documentation of restraint education specific to the hospital's available restraint devices on hire. The "Nursing Orientation Checklist" signed by the instructor and employee and dated 08/16/2018 reflected "Restraints Patient Rights and Fall Safety" with a check mark next to it but did not include restraint education specific to the hospital's available restraint devices.

* No documentation of demonstrated restraint competency for mitt restraints or posey net restraint on hire. The "Skill" (demonstrated competency) section on the "Nursing Orientation Checklist" dated 08/16/2018 included "Application of soft wrist/ankle restraint," "Application of Twice-As-Tough (TAT) Locking Restraints," and "Application of Posey Vest" but did not include mitt restraints or posey net restraint.

* No documentation of restraint education specific to the hospital's available restraint devices annually. The "Medical CNA Annual Competency Checklist 2019" dated 12/18/2018 reflected "Skills Day...Restraint Application/Documentation...Classroom Training 11/18/19." However, there was no documentation of restraint education specific to the hospital's available restraint devices and the "Validator (Initials)" space was blank.

* No documentation of demonstrated restraint competency for mitt restraints or posey net restraint annually. The annual "Med/Surg/PCU/ICU Skills Day 2019" CNA "Competency Checklist" signed by the employee and dated 11/18/2019 reflected "Restraint Application - Demonstrates the correct application and removal of the Twice-As-Tough locking restraints, soft wrist/ankle restraints, and soft vest restraint..." but did not include mitt restraints or posey net restraint. Further the "Training Complete:" section was signed by a Staff Development Educator but not dated. It was unclear when the competency was completed.

During an interview and review of Employee 11's training records with the RNE on 01/08/2020 at 1415, the RNE confirmed there was no documentation of annual posey net restraint training or competency.

b. Employee 12, a Medical Unit RN with hire date 02/05/2018 reflected:
* No documentation of restraint education specific to the hospital's available restraint devices on hire. The "Nursing Orientation Checklist" signed by the instructor and employee and dated 02/16/2018 reflected "Restraints Patient Rights and Fall Safety" with a check mark next to it but did not include restraint education specific to the hospital's available restraint devices.

* No documentation of demonstrated restraint competency for mitt restraints or posey net restraint on hire. The "Skill" (demonstrated competency) section on the "Nursing Orientation Checklist" signed by the employee and dated 02/16/2018 included "Application of soft wrist/ankle restraint," "Application of Twice-As-Tough (TAT) Locking Restraints," and "Application of Posey Vest" but did not include mitt restraints or posey net restraint.

* No documentation of restraint education specific to the hospital's available restraint devices annually. The "Medical RN Annual Competency Checklist 2019" dated 11/15/2019 reflected "Skills Day...Restraint Application/Documentation..." However, there was no documentation of restraint education specific to the hospital's available restraint devices.

A second "Medical RN Annual Competency Checklist 2019" was provided. It was dated 01/08/2020 and reflected "Skills Day...Restraint Application/Documentation...Classroom Training 10/21/19." However, there was no documentation of restraint education specific to the hospital's available restraint devices and the competency checklist was not signed by the employee; and was not dated by the employee, the Validator or the Director/Clinical Coordinator.

* No documentation of demonstrated restraint competency for mitt restraints or posey net restraint annually. The annual "Med/Surg Skills Days 2019 RN Competency Checklist" signed by the employee and dated 10/21/2019 reflected "Restraint Application - Demonstrates the correct application and removal of the Twice-As-Tough locking restraints, soft wrist/ankle restraints, and soft vest restraint..." but did not include mitt restraints or posey net restraint. Further the "Training Complete:" section was signed by a Staff Development Educator but not dated. It was unclear when the training was completed.

c. Employee 15, a SO with hire date 08/05/2019 reflected:
* No documentation of restraint education and competency specific to the hospital's available restraint devices on hire. The "New Employee On The Job Training Checklist Safety & Security" with "Date Started: 08/13/2019" reflected:
- "Competency...Restraints"
- "Evaluation Method (Observation, Simulation, Test)...Sim" followed by initials and "8/15/19."
However, the documentation did not include education and competencies specific to the hospital's available restraint devices. In addition the bottom section of the form reflected "By signing this form both Employee/Evaluators agree that the employee understands and can perform duties. The spaces for "Employee Signature:" and "Date:," "Evaluators Signature:" and "Date:," and "Department Supervisor's Signature:" and "Date." were blank.

d. Similar findings related to incomplete and/or lack of restraint training and/or competency documentation on hire and/or annually were identified during review of training records for the following employees:
* Employee 13, a Medical Unit RN with hire date 07/26/2016; and
* Employee 14, a SO with hire date 09/28/2017.

Based on interview, review of restraint training documentation for 5 of 5 hospital staff who participate in patient restraint or seclusion (Employees 11, 12, 13, 14 and 15), and review of policies and procedures and restraint training materials, it was determined that the hospital failed to fully develop and implement policies and procedures that ensured staff were trained and demonstrated knowledge in the use of immediate interventions and first aid to be provided to a restrained or secluded patient who is in distress or injured.

Findings include:

1. The policy and procedure titled "Restraints & Seclusion," dated last revised "01/2018" was reviewed and reflected:
* "All hospital staff who have direct patient contact receives education and training in...The proper and safe application and use of restraints...Initial and ongoing training...Alternative methods of handling behavior, symptoms, and situations that have traditionally been managed through the use of restraints or seclusion...Staff that work in areas with the highest risk for violent/self destructive restraint and/or seclusion procedures will receive annual restraint and seclusion training."
The policy and procedure did not include that appropriate staff received education, training, and would demonstrate knowledge in the use of first aid techniques to be provided to a restrained or secluded patient who is in distress or injured; and certification in the use of cardiopulmonary resuscitation, including required periodic recertification.

2. Restraint training materials provided were reviewed and lacked documentation of training and demonstrated competency related to first aid techniques for patients who were restrained or in seclusion. For example:
* Documentation in skills day training materials titled "Safe Use Of Restraints 2019 Skills Day" for RN and CNA staff referenced did not include training and demonstrated competency content related to first aid techniques for patients who were restrained or in seclusion. This was confirmed during an interview with the RNE on 01/08/2020 at 1330.
* Documentation in the annual training materials titled "Lesson 4: Patient Care and Protection" provided for RN, CNA, SO and other staff reflected "Staff must be trained and competent in the following...Use of first aid techniques and certification in the use of cardiopulmonary resuscitation." However, there was no further documentation of training provided and competencies related to first aid techniques and certification in the use of cardiopulmonary resuscitation. This was confirmed during an interview with EC on 01/07/2020 at 1605.
* Documentation in the annual staff training materials provided for SO staff included no reference to training and demonstrated competency related to first aid techniques for patients who were restrained or in seclusion. This was confirmed during and interview with the SOT on 01/08/2020 at 1310.
* Documentation on a "Nursing Orientation Checklist" used to demonstrate restraint training and competencies for RNs and CNAs included no reference to training and demonstrated competency related to first aid techniques for patients who were restrained or in seclusion.
* Documentation on a "Medical CNA Annual Competency Checklist" used to demonstrate restraint training and/or competencies for CNAs included no reference to training and demonstrated competency related to first aid techniques for patients who were restrained or in seclusion.

3. Review of staff training documentation for the following employees reflected no evidence of training and competency related to first aid techniques for patients who were restrained or secluded, including appropriate first aid required if a restrained or secluded patient was in distress or injured:

Employee 11, a Medical Unit CNA with hire date 07/16/2018.
Employee 12, a Medical Unit RN with hire date 02/05/2018.
Employee 13, a Medical Unit RN with hire date 07/26/2016.
Employee 14, a SO with hire date 09/28/2017.
Employee 15, a SO with hire date 08/05/2019.

4. During an interview with RNE on 01/08/2020 at 1400, he/she confirmed Employee 11 had no training or competencies related to first aid techniques for patients who were restrained or in seclusion.

5. During an interview with SOT on 01/08/2020 at 1310, he/she confirmed Employees 14 and 15 had no training or competencies related to first aid techniques for patients who were restrained or in seclusion.

Based on interview, documentation reviewed in the medical record of 1 of 1 patient for provision of nursing services (Patients 3), and review of nursing policies and procedures, it was determined that the hospital failed to ensure the RN supervised and evaluated patients to ensure care was provided in a safe and appropriate manner in accordance with hospital policies and procedures as follows:
* Patients who experienced falls were not appropriately evaluated by the RN after the fall.
* Post fall huddles were not conducted in accordance with hospital policy.

Findings include:

1. The policy and procedure titled "Standards of Nursing Practice," dated last revised "08/2019," was reviewed and reflected:
- "Assessment is the identification and collection of information concerning the health status of assigned patients on the Unit. Assessment is continuous and systematic as evidenced by...A documented needs assessment addressing physical...fall risk, self care ability, age specific needs...This is accomplished through interviews, observations, inspection, auscultation, palpation, and reports..."
- "Assessment information is maintained for availability..."
- "Planning involves determining the patient problems and desired outcomes...This is evidenced by...A written plan of care...based on the analysis of information obtained from the assessment. This plan of care includes the patient's present and potential problems from information gathered in the assessment."

2. The policy and procedure titled "Fall Prevention Program," dated last revised "07/2018," was reviewed and reflected:
* "After a fall, the Post-Fall Debrief form...must be filled out as soon as possible and returned to Risk Management where information will be tallied and discussed at the Fall Prevention Committee and the Quality Improvement Committee (QIC). Areas of opportunity from the debrief form will be noted and passed on to Department Leaders."

3. Review of the medical record of Patient 3 reflected:
* RN notes dated 11/01/2019 at 1736 reflected "A/O to self by name. Pt status is comfort care now. Pt has been restless and constantly moving in bed, pt pulled and broke nasal cannula...kept pulling on tele wires...Speech garbled...Medicated for pain x 2...Medicated for anxiety x 1...Medicated once PRN for hypertension..."

* A RN "Post Fall Assessment" dated 11/01/2019 at 2058 reflected "Paitent (sic) had slid [him/herself] out of bed to where [his/her] legs and buttocks were sitting on the floor. [His/her] upper torso was still on [his/her] bed and [he/she] was holding onto the side rail of [his/her] bed. Patient had no apparent injuries from the incident. Vitals WNL."
- It was unclear what time the fall occurred as there were no other notes related to a fall on 11/01/2019 at 2058.
- There was no documentation of what the "WNL" vital signs were or when they were taken.
- There was no assessment for injuries aside from "No apparent injuries," including but not limited to no neurological assessment, no skin assessment for bruising or other potential injuries, no assessment of physical functioning and range of motion to extremities, and no assessment for pain.
- There was no documentation of a post fall huddle.

* The RN notes dated 11/01/2019 at 2108, 10 minutes after the fall assessment above reflected "Camera Tech reports patient legs on side of bed. RN came in from another room. Patient sitting on floor and holding on to bed rail with head up. Charge nurse notified. Second Charge came into room. O2 put back 4L NC that fell off. No injuries noted. Four person transfer back into bed...Will continue to monitor."
- There was no assessment for injuries aside from "No injuries noted," including but not limited to no neurological assessment, no skin assessment for bruising or other potential injuries, no assessment of physical functioning and range of motion to extremities, and no assessment for pain.
- There was no documentation of a post fall huddle.

4. During an interview and review of the medical record with the DMU on 01/08/2020 at 1000, the DMU confirmed the lack of post fall RN assessments. The DMU stated after a fall the normal process was to ask the patient if he/she hit his/her head and do a visual assessment of the head and if there were signs/symptoms of injury the nurse would do pupil checks. The DMU stated the RN would also check the patient's extremities for injuries. The DMU acknowledged there was no documentation that was done.

5. During an interview with the RM on 01/08/2020 at 0815, the RM stated he/she had no documentation of a post fall huddle. The RM stated "we haven't kept the forms."