The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

GEISINGER MEDICAL CENTER 100 NORTH ACADEMY AVENUE DANVILLE, PA 17822 July 11, 2011
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0186
Based on review of facility documents, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to attempt a less restrictive intervention before spraying cayenne pepper spray at a patient in the behavioral health unit (MR2).

Findings include:

Review on July 1, 2011, of the facility's "Cayenne Pepper Self Defense Spray" policy, last reviewed March 31, 2011, revealed "Purpose: A. To assure that security staff members are able to protect themselves with non-lethal force in the event of a personal attack. B. to assure that this protection mechanism is used only under extreme circumstances where an officer's life or safety may be in danger. Policy: A. Only the cayenne pepper product approved and issued by the Department of Security shall be carried by security officers on duty. B. Use of the cayenne pepper product shall only be permitted for the purpose of self-protection or the protection of others, not for the protection of property. C. Use of cayenne pepper defense spray is limited to the exterior of hospital buildings except in extreme cases where, regardless of the location, the officer's life or the life of another is in danger. ... Procedure: A. Self-protection/protection of others. 1. Reasonably evaluate the potential danger to yourself and the possibility of contamination of the atmosphere by the cayenne pepper self-defense spray. ... 3. If possible or practical, retreat or comply with a reasonable demand. 4. If possible, call for backup by fell ow officers and/or help from the [name of local police]. 5 If absolutely necessary, to protect the officer's life or the life of another person, direct the cayenne pepper self-defense spray toward the face of the actor from a three (3) foot distance. ... "

Review on July 8, 2011, of the facility's "Inpatient Psychiatry Manual - Procedure for Potentially Assaultive or Acting Out Patient," last reviewed February 11, 2011, revealed "Purpose: To maintain a safe environment for the patient and other patients. To prevent injury to the patients and personnel. To prevent occurrence or reoccurrence of acting out behavior. ... Essential Steps in Procedure: 1. Method: 1. Reduce environmental stimuli as much as possible. 2. Never approach a potentially assaultive or acting out patient alone; approach as a group. 3. Psychological interventions: Assign one staff member as spokesperson to interact with patient. Try to talk to patient to calm the patient. Present expectations and limits. ... Documentation: 1. Factors precipitating behavior. 2. How behavior was displayed. 3. Methods used to control behavior. 4. Medications and effectiveness. 5. Any other pertinent information."

Review on July 1, 2011, of MR2 revealed the patient was admitted to the facility's behavioral health unit (BHU). BHU staff asked MR2 to return to their bedroom. MR2 refused and went to obtain a cup of coffee. When facility security staff approached MR2, the patient began to swing a cane at the BHU and security staff. Hospital security staff then sprayed cayenne pepper spray at MR1.

Review on July 1, 2011, of nursing documentation revealed there were tables and chairs between MR2 and the security staff and the BHU staff that prevented security staff and BHU from physically restraining MR2. There was no documentation that the BHU staff or hospital security staff attempted alternative interventions with MR2 before deploying the cayenne pepper spray.

Interview with EMP1, EMP2, EMP3 and EMP4 on July 1, 2011, at 9:30 AM confirmed that security staff sprayed MR2 with pepper spray because MR2 was swinging a cane. Interview with EMP1, EMP2, EMP3 and EMP4 confirmed that the facility staff did not attempt alternative intervention before spraying MR1 with the cayenne pepper spray.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on review of facility policies and procedures, facility documents, medical records (MR) and interview with staff (EMP), it was determined that the Governing Body failed to ensure that the Chief Executive Officer maintained a safe environment for patients (A057); failed to protect and promote each patient's rights (A115); failed to ensure patients were not subjected to being handcuffed or sprayed with cayenne pepper spray by hospital staff(A144); failed to ensure the least restrictive interventions were determined to be ineffective before restraints or seclusion were applied (A164); failed to ensure the least restrictive intervention was utilized to protect the patient or others from harm (A165); failed to discontinue a four point leather restraint at the earliest possible time (A174); failed to evaluate and monitor a patient in a four point leather physical restraints (A175); and failed to attempt a less restrictive intervention before spraying cayenne pepper spray at a patient in the behavioral health unit (A186).

Findings include:

Review on July 1, 2011, of the facility's "Patients Rights and Responsibilities" policy, last reviewed February 24, 2011, revealed "Purpose: To ensure that patients are informed of their rights, which are referred to in the Patient Rights and Responsibilities brochure. ..."

Review on July 1, 2011, of the facility's "Patient Rights and Responsibilities April 2011" brochure, last revised April 2011, revealed "Patient Rights: ... 7. The patient has the right to good quality care and high professional standards that are continually maintained and reviewed. ... 16. The patient has the right to expect good management techniques to be implemented within the hospital considering effective use of the time of the patient and avoid the personal discomfort of the patient. ... 29. A patient has the right to receive care in a safe setting. ... 31. A patient has the right to be free from restraints of any forms [sic] for acute medical and surgical care that are not medically necessary or are used as a means of coercion, discipline, convenience or retaliation of staff. ... 33. A patient has the right to be free from seclusion and restraints of any form for behavioral management imposed as a means of coercion, discipline, convenience or retaliation by staff. ..."

Review on July 1, 2011, of the facility's "Restraint/Seclusion" policy, last reviewed November 10, 2010, revealed "Purpose: Geisinger Health System is committed to; 1. Reducing the frequency of restraint use, striving to eliminate the use of restraints. 2. Limiting restraint use by defining the terms restraint, seclusion, and pharmacologic restraint. 3. Using these protective measures in accordance with regulatory standards. Policy: It is the policy of Geisinger Health System to; 1. Limit the use of restraints/seclusion to emergencies where there is a risk of patient harming himself/herself or others, using the least restrictive method. 2. Preserve the rights, safety, well being, and dignity of the patient when restraints are used. 3. Use restrain/seclusion only to improve the patient's well being and when other less restrictive interventions have been determined to be ineffective. ... Definitions: 1. Physical restraint is defined as any manual, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. ... 5. A violent or self destructive patient is defined as a patient who is not cognitively impaired and knowingly intends to attempt to harm themselves, others, the environment, or has a primary psychiatric diagnosis. ... Responsibilities: ... Staff; Are responsible for: Employing less restrictive alternatives to restraint use ..." The use of restrictive devices such as handcuffs and Cayenne Pepper spray are not governed by this policy.

Review on July 6, 2011, of the facility's "Handcuffs, Carrying and Use" policy, last reviewed March 16, 2011, revealed "Purpose: Handcuffs are carried and used by security staff members ... Use of handcuffs is limited to instances where physical intervention is necessary to detain and initiate criminal complaints on people that have exhibited behavior harmful to themselves or others. Handcuffs are not to be used to restrain a patient. Policy: ... Handcuffs are a law enforcement restraint device/tool and may not be used by hospital security staff members as a restraint tool on patients. ... Handcuffs may only be applied on patients by law enforcement and forensic/correctional staff - this does not include hospital security. A patient that elopes would also still be considered a patient and we would also be restricted from using handcuffs as a restraint device. Handcuffs may be used in restraining and protecting a non-patient that has been disorderly and exhibited harmful behavior resulting in the use of Cayenne pepper Spray on the Medical Center campus."

Review on July 1, 2011, of the facility's "Cayenne Pepper Self Defense Spray" policy, last reviewed March 31, 2011, revealed "Purpose: A. To assure that security staff members are able to protect themselves with non-lethal force in the event of a personal attack. B. to assure that this protection mechanism is used only under extreme circumstances where an officer's life or safety may be in danger. Policy: A. Only the cayenne pepper product approved and issued by the Department of Security shall be carried by security officers on duty. B. Use of the cayenne pepper product shall only be permitted for the purpose of self-protection or the protection of others, not for the protection of property. C. Use of cayenne pepper defense spray is limited to the exterior of hospital buildings except in extreme cases where, regardless of the location, the officer's life or the life of another is in danger. ... Procedure: A. Self-protection/protection of others. 1. Reasonably evaluate the potential danger to yourself and the possibility of contamination of the atmosphere by the cayenne pepper self-defense spray. ... 3. If possible or practical, retreat or comply with a reasonable demand. 4. If possible, call for backup by fell ow officers and/or help from the [name of local police]. 5 If absolutely necessary, to protect the officer's life or the life of another person, direct the cayenne pepper self-defense spray toward the face of the actor from a three (3) foot distance. ... "

Review on July 1, 2011, of MR1 revealed this patient had a behavioral dyscontrol event and was handcuffed by the hospital security staff. There was no documentation that hospital security staff or the emergency department (ED) staff implemented a less restrictive alternative to restrain MR1 prior to applying the handcuffs. Further review of MR1 revealed no documentation that a less restrictive intervention or a determination that a less restrictive intervention was ineffective was completed by the hospital security staff or the ED staff prior to the application of the handcuffs.

Interview with EMP2 on July 1, 2011, at approximately 10:30 AM confirmed that the facility's security department was approved to use handcuffs. Further interview with EMP2 confirmed that MR1 was a patient in the hospital; hospital security staff applied handcuffs to MR1; and hospital security staff used the handcuffs as a restraint. EMP1 confirmed that hospital security staff and the Behavioral Health Unit (BHU) staff did not implement a less restrictive alternative to restrain MR1, and that the hospital security staff and the BHU staff did not use a less restrictive intervention or determine that a less restrictive intervention was ineffective prior to the application of the handcuffs.

Review on July 1, 2011, of MR2 revealed this patient had a behavioral dyscontrol event and was sprayed with Cayenne Pepper spray on the facility's behavioral health unit by hospital security staff. There was no documentation that hospital security staff or the ED staff implemented a less restrictive alternative to restrain MR2. Further review of MR2 revealed no documentation that a less restrictive intervention or a determination that a less restrictive intervention was ineffective was completed by the hospital security staff or the ED staff prior to the application of the Cayenne Pepper spray.

Interview with EMP2 on July 1, 2011, at approximately 10:30 AM confirmed that the facility's security department was approved to use Cayenne pepper spray. Further interview with EMP2 confirmed that MR2 was a patient in the hospital; hospital security staff sprayed Cayenne Pepper spray on MR2; and hospital security staff used the Cayenne Pepper spray as a restraint. EMP1 confirmed that hospital security staff and the BHU staff did not implement a less restrictive alternative to restrain MR2, and that the hospital security staff and the BHU staff did not use a less restrictive intervention or determine that a less restrictive intervention was ineffective prior to the application of the Cayenne Pepper spray.

Telephone interview with EMP1 on July 8, 2011, at approximately 8:30 AM confirmed there was no documentation in the Governing Body meeting minute of approval by the Governing Body for the use of handcuffs or Cayenne Pepper spray by the hospital staff.


Cross Reference:

482.12(b) Chief Executive Officer
482.13 Patient Rights
482.13(c)(2) Patient Rights: Care in Safe Setting
482.13(e)(2) Patient Rights: Restraint or Seclusion
482.13(e)(3) Patient Rights: Restraint or Seclusion
482.13(e)(9) Patient Rights: Restraint or Seclusion
482.13(3)(10) Patient Rights: Restraint or Seclusion
482.13(3)(16)(iii) Patient rights: Restraint or Seclusion
VIOLATION: CHIEF EXECUTIVE OFFICER Tag No: A0057
Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined the Chief Executive Officer (CEO) failed to ensure hospital patients were safe and not subjected to the use handcuffs and Cayenne Pepper spray by hospital staff for two of two medical records reviewed (MR1 and MR2).

Findings include:

Review on July 1, 2011, of the facility's "Patients Rights and Responsibilities" policy, last reviewed February 24, 2011, revealed "Purpose: To ensure that patients are informed of their rights, which are referred to in the Patient Rights and Responsibilities brochure. ..."

Review on July 1, 2011, of the facility's "Patient Rights and Responsibilities April 2011" brochure, last revised April 2011, revealed "Patient Rights: ... 7. The patient has the right to good quality care and high professional standards that are continually maintained and reviewed. ... 16. The patient has the right to expect good management techniques to be implemented within the hospital considering effective use of the time of the patient and avoid the personal discomfort of the patient. ... 29. A patient has the right to receive care in a safe setting. ... 31. A patient has the right to be free from restraints of any forms [sic] for acute medical and surgical care that are not medically necessary or are used as a means of coercion, discipline, convenience or retaliation of staff. ... 33. A patient has the right to be free from seclusion and restraints of any form for behavioral management imposed as a means of coercion, discipline, convenience or retaliation by staff. ..."

Review on July 1, 2011, of the facility's "Restraint/Seclusion" policy, last reviewed November 10, 2010, revealed "Purpose: Geisinger Health System is committed to; 1. Reducing the frequency of restraint use, striving to eliminate the use of restraints. 2. Limiting restraint use by defining the terms restraint, seclusion, and pharmacologic restraint. 3. Using these protective measures in accordance with regulatory standards. Policy: It is the policy of Geisinger Health System to; 1. Limit the use of restraints/seclusion to emergencies where there is a risk of patient harming himself/herself or others, using the least restrictive method. 2. Preserve the rights, safety, well being, and dignity of the patient when restraints are used. 3. Use restrain/seclusion only to improve the patient's well being and when other less restrictive interventions have been determined to be ineffective. ... Definitions: 1. Physical restraint is defined as any manual, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. ... 5. A violent or self destructive patient is defined as a patient who is not cognitively impaired and knowingly intends to attempt to harm themselves, others, the environment, or has a primary psychiatric diagnosis. ... Responsibilities: ... Staff; Are responsible for: Employing less restrictive alternatives to restraint use ..." The use of restrictive devices such as handcuffs and Cayenne Pepper spray are not governed by this policy.

Review on July 6, 2011, of the facility's "Handcuffs, Carrying and Use" policy, last reviewed March 16, 2011, revealed "Purpose: Handcuffs are carried and used by security staff members ... Use of handcuffs is limited to instances where physical intervention is necessary to detain and initiate criminal complaints on people that have exhibited behavior harmful to themselves or others. Handcuffs are not to be used to restrain a patient. Policy: ...Handcuffs are a law enforcement restraint device/tool and may not be used by hospital security staff members as a restraint tool on patients. ... Handcuffs may only be applied on patients by law enforcement and forensic/correctional staff - this does not include hospital security. A patient that elopes would also still be considered a patient and we would also be restricted from using handcuffs as a restraint device. Handcuffs may be used in restraining and protecting a non-patient that has been disorderly and exhibited harmful behavior resulting in the use of Cayenne pepper Spray on the Medical Center campus."

Review on July 1, 2011, of the facility's "Cayenne Pepper Self Defense Spray" policy, last reviewed March 31, 2011, revealed "Purpose: A. To assure that security staff members are able to protect themselves with non-lethal force in the event of a personal attack. B. to assure that this protection mechanism is used only under extreme circumstances where an officer's life or safety may be in danger. Policy: A. Only the cayenne pepper product approved and issued by the Department of Security shall be carried by security officers on duty. B. Use of the cayenne pepper product shall only be permitted for the purpose of self-protection or the protection of others, not for the protection of property. C. Use of cayenne pepper defense spray is limited to the exterior of hospital buildings except in extreme cases where, regardless of the location, the officer's life or the life of another is in danger. ... Procedure: A. Self-protection/protection of others. 1. Reasonably evaluate the potential danger to yourself and the possibility of contamination of the atmosphere by the cayenne pepper self-defense spray. ... 3. If possible or practical, retreat or comply with a reasonable demand. 4. If possible, call for backup by fell ow officers and/or help from the [name of local police]. 5 If absolutely necessary, to protect the officer's life or the life of another person, direct the cayenne pepper self-defense spray toward the face of the actor from a three (3) foot distance. ... "

Review of MR1 and MR2 on July 1, 2011, revealed these patients had a behavioral dyscontrol event at the facility on June 16, 2011. Review of MR1 revealed the patient had a behavioral dyscontrol event and was subject to handcuffing by hospital security staff. Review of MR2 revealed the patient had a behavioral dyscontrol event and was sprayed with Cayenne Pepper spray on the facility's behavioral health unit by hospital security staff.

Interview with EMP2 on July 1, 2011, at approximately 10:30 AM confirmed that the security department was approved to use handcuffs and Cayenne Pepper spray. Further interview with EMP2 confirmed that MR1 was handcuffed and MR2 was sprayed with Cayenne Pepper spray by hospital security staff; that there was no documentation that less restrictive restraints or seclusion were implemented prior to the use of the handcuffs or the Cayenne Pepper spray. EMP1 and EMP2 also confirmed that hospital security staff and hospital staff did not implement a less restrictive alternative to restrain MR1 and MR2 and that the hospital staff did not use a less restrictive intervention or determined that a less restrictive intervention was ineffective prior to the application of the handcuffs or Cayenne Pepper spray.

Telephone interview with EMP1 on July 8, 2011, at approximately 8:30 AM confirmed there was no documentation in the Governing Body Meeting Minutes that the Governing Body had approved the use of handcuffs or Cayenne Pepper spray by hospital staff.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on review of facility policies and procedures, facility documents, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to protect and promote each patient's rights for patients; failed to ensure patients were not subjected to being handcuffed or sprayed with cayenne pepper spray by hospital staff (A144); failed to ensure the least restrictive interventions were determined to be ineffective before restraints or seclusion were applied (A164), failed to ensure the least restrictive intervention was utilized to protect the patient or others from harm (A165); failed to discontinue a four point leather restraint at the earliest possible time (A174); failed to evaluate and monitor a patient in a four point leather physical restraint (A175); and failed to attempt a less restrictive intervention before spraying cayenne pepper spray at a patient in the behavioral health unit (A186).

Findings include:

Review on July 1, 2011, of MR1 revealed that this patient had a behavioral dyscontrol event and was subject to handcuffing by hospital security staff on June 16, 2011. There was no documentation that facility staff implemented a less restrictive alternative to restrain MR1. Further review of MR1 revealed no documentation that a less restrictive intervention or a determination that a less restrictive intervention was ineffective was completed by the hospital security staff or the ED staff prior to the application of the handcuffs.

Review on July 1, 2011, of MR2 revealed that this patient had a behavioral dyscontrol event and was subject to spraying of cayenne pepper spray on the facility's behavioral health unit by hospital security staff on June 16, 2011. There was no documented evidence that facility staff implemented a less restrictive alternative to restrain MR2. Further review of MR2 revealed no documentation that a less restrictive intervention or a determination that a less restrictive intervention was ineffective was completed by the hospital security staff or the ED staff prior to the application of the Cayenne Pepper spray.

Interview with EMP2 on July 1, 2011, at approximately 10:30 AM confirmed that the facility utilized handcuffs on MR1 and Cayenne Pepper spray on MR2 as a restraint. There was no documentation that restraints or seclusion were implemented prior to the use of the handcuffs and Cayenne Pepper spray. EMP2 further confirmed that "if the staff is threatened with harm, then Security takes over and that the use of handcuffs or Cayenne Pepper spray may be warranted."

Cross Reference

482.13(c)(2) Patient Rights: Care in Safe Setting
482.13(e)(2) Patient Rights: Restraint or Seclusion
482.13(e)(3) Patient Rights: Restraint or Seclusion
482.13(e)(9) Patient Rights: Restraint or Seclusion
482.13(3)(10) Patient Rights: Restraint or Seclusion
482.13(3)(16)(iii) Patient rights: Restraint or Seclusion
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined that the facility failed to ensure that patients were not subjected to being handcuffed or sprayed with cayenne pepper spray by hospital staff for two of two medical records reviewed (MR1 and MR2).

Findings include:

Review on July 1, 2011, of the facility's "Patients Rights and Responsibilities" policy, last reviewed February 24, 2011, revealed "Purpose: To ensure that patients are informed of their rights, which are referred to in the Patient Rights and Responsibilities brochure. ..."

Review on July 1, 2011, of the facility's "Patient Rights and Responsibilities April 2011" brochure, last revised April 2011, revealed "Patient Rights: ... 7. The patient has the right to good quality care and high professional standards that are continually maintained and reviewed. ... 16. The patient has the right to expect good management techniques to be implemented within the hospital considering effective use of the time of the patient and avoid the personal discomfort of the patient. ... 29. A patient has the right to receive care in a safe setting. ... 31. A patient has the right to be free from restraints of any forms [sic] for acute medical and surgical care that are not medically necessary or are used as a means of coercion, discipline, convenience or retaliation of staff. ... 33. A patient has the right to be free from seclusion and restraints of any form for behavioral management imposed as a means of coercion, discipline, convenience or retaliation by staff. ..."

Review on July 1, 2011, of the facility's "Restraint/Seclusion" policy, last reviewed November 10, 2010, revealed "Purpose: Geisinger Health System is committed to; 1. Reducing the frequency of restraint use, striving to eliminate the use of restraints. 2. Limiting restraint use by defining the terms restraint, seclusion, and pharmacologic restraint. 3. Using these protective measures in accordance with regulatory standards. Policy: It is the policy of Geisinger Health System to; 1. Limit the use of restraints/seclusion to emergencies where there is a risk of patient harming himself/herself or others, using the least restrictive method. 2. Preserve the rights, safety, well being, and dignity of the patient when restraints are used. 3. Use restrain/seclusion only to improve the patient's well being and when other less restrictive interventions have been determined to be ineffective. ... Definitions: 1. Physical restraint is defined as any manual, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. ... 5. A violent or self destructive patient is defined as a patient who is not cognitively impaired and knowingly intends to attempt to harm themselves, others, the environment, or has a primary psychiatric diagnosis. ... Responsibilities: ... Staff; Are responsible for: Employing less restrictive alternatives to restraint use ..." The use of restrictive devices such as handcuffs and Cayenne Pepper spray are not governed by this policy.

Review on July 6, 2011, of the facility's "Handcuffs, Carrying and Use" policy, last reviewed March 16, 2011, revealed "Purpose: Handcuffs are carried and used by security staff members ... Use of handcuffs is limited to instances where physical intervention is necessary to detain and initiate criminal complaints on people that have exhibited behavior harmful to themselves or others. Handcuffs are not to be used to restrain a patient. Policy: ...Handcuffs are a law enforcement restraint device/tool and may not be used by hospital security staff members as a restraint tool on patients. ... Handcuffs may only be applied on patients by law enforcement and forensic/correctional staff - this does not include hospital security. A patient that elopes would also still be considered a patient and we would also be restricted from using handcuffs as a restraint device. Handcuffs may be used in restraining and protecting a non-patient that has been disorderly and exhibited harmful behavior resulting in the use of Cayenne pepper Spray on the Medical Center campus."

Review on July 1, 2011, of the facility's "Cayenne Pepper Self Defense Spray" policy, last reviewed March 31, 2011, revealed "Purpose: A. To assure that security staff members are able to protect themselves with non-lethal force in the event of a personal attack. B. to assure that this protection mechanism is used only under extreme circumstances where an officer's life or safety may be in danger. Policy: A. Only the cayenne pepper product approved and issued by the Department of Security shall be carried by security officers on duty. B. Use of the cayenne pepper product shall only be permitted for the purpose of self-protection or the protection of others, not for the protection of property. C. Use of cayenne pepper defense spray is limited to the exterior of hospital buildings except in extreme cases where, regardless of the location, the officer's life or the life of another is in danger. ... Procedure: A. Self-protection/protection of others. 1. Reasonably evaluate the potential danger to yourself and the possibility of contamination of the atmosphere by the cayenne pepper self-defense spray. ... 3. If possible or practical, retreat or comply with a reasonable demand. 4. If possible, call for backup by fell ow officers and/or help from the [name of local police]. 5 If absolutely necessary, to protect the officer's life or the life of another person, direct the cayenne pepper self-defense spray toward the face of the actor from a three (3) foot distance. ... "

Review on July 1, 2011, of MR1 revealed that this patient had a behavioral dyscontrol event and was subject to handcuffing by hospital security staff on June 16, 2011. There was no documented evidence that facility staff implemented a less restrictive alternative to restrain MR1.

Review on July 1, 2011, of MR2 revealed that this patient had a behavioral dyscontrol event and was sprayed with cayenne pepper spray on the facility's behavioral health unit by hospital security staff on June 16, 2011. There was no documented evidence that facility staff implemented a less restrictive alternative to restrain MR2.

Further review of MR1 and MR2 revealed no documentation that the facility staff attempted to implement restraints or seclusion when less restrictive interventions were determined to be ineffective to protect the patient, a staff member, or others from harm, and failed to implement safe and appropriate restraint and seclusion techniques by using handcuffs and Cayenne Pepper spray.

Interview with EMP2 on July 1, 2011, at approximately 10:30 AM confirmed the facility security staff utilized handcuffs on MR1 and Cayenne Pepper spray on MR2 as restraints, and there was no documentation that restraints or seclusion were implemented prior to the use of the handcuffs and Cayenne Pepper spray.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0164
Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined that the facility failed to ensure the least restrictive interventions were determined to be ineffective before restraints or seclusion were applied to protect the patient, a staff member, or others from harm in two of two medical records reviewed (MR1 and MR2).

Findings include:

Review on July 1, 2011, of the facility's "Patients Rights and Responsibilities" policy, last reviewed February 24, 2011, revealed "Purpose: To ensure that patients are informed of their rights, which are referred to in the Patient Rights and Responsibilities brochure. ..."

Review on July 1, 2011, of the facility's "Patient Rights and Responsibilities April 2011" brochure, last revised April 2011, revealed "Patient Rights: ... 7. The patient has the right to good quality care and high professional standards that are continually maintained and reviewed. ... 16. The patient has the right to expect good management techniques to be implemented within the hospital considering effective use of the time of the patient and avoid the personal discomfort of the patient. ... 29. A patient has the right to receive care in a safe setting. ... 31. A patient has the right to be free from restraints of any forms [sic] for acute medical and surgical care that are not medically necessary or are used as a means of coercion, discipline, convenience or retaliation of staff. ... 33. A patient has the right to be free from seclusion and restraints of any form for behavioral management imposed as a means of coercion, discipline, convenience or retaliation by staff. ..."

Review on July 1, 2011, of the facility's "Restraint/Seclusion" policy, last reviewed November 10, 2010, revealed "Purpose: Geisinger Health System is committed to; 1. Reducing the frequency of restraint use, striving to eliminate the use of restraints. 2. Limiting restraint use by defining the terms restraint, seclusion, and pharmacologic restraint. 3. Using these protective measures in accordance with regulatory standards. Policy: It is the policy of Geisinger Health System to; 1. Limit the use of restraints/seclusion to emergencies where there is a risk of patient harming himself/herself or others, using the least restrictive method. 2. Preserve the rights, safety, well being, and dignity of the patient when restraints are used. 3. Use restrain/seclusion only to improve the patient's well being and when other less restrictive interventions have been determined to be ineffective. ... Definitions: 1. Physical restraint is defined as any manual, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. ... 5. A violent or self destructive patient is defined as a patient who is not cognitively impaired and knowingly intends to attempt to harm themselves, others, the environment, or has a primary psychiatric diagnosis. ... Responsibilities: ... Staff; Are responsible for: Employing less restrictive alternatives to restraint use ..." The use of restrictive devices such as handcuffs and Cayenne Pepper spray are not governed by this policy.

Review on July 6, 2011, of the facility's "Handcuffs, Carrying and Use" policy, last reviewed March 16, 2011, revealed "Purpose: Handcuffs are carried and used by security staff members ... Use of handcuffs is limited to instances where physical intervention is necessary to detain and initiate criminal complaints on people that have exhibited behavior harmful to themselves or others. Handcuffs are not to be used to restrain a patient. Policy: ...Handcuffs are a law enforcement restraint device/tool and may not be used by hospital security staff members as a restraint tool on patients. ... Handcuffs may only be applied on patients by law enforcement and forensic/correctional staff - this does not include hospital security. A patient that elopes would also still be considered a patient and we would also be restricted from using handcuffs as a restraint device. Handcuffs may be used in restraining and protecting a non-patient that has been disorderly and exhibited harmful behavior resulting in the use of Cayenne pepper Spray on the Medical Center campus."

Review on July 1, 2011, of the facility's "Cayenne Pepper Self Defense Spray" policy, last reviewed March 31, 2011, revealed "Purpose: A. To assure that security staff members are able to protect themselves with non-lethal force in the event of a personal attack. B. to assure that this protection mechanism is used only under extreme circumstances where an officer's life or safety may be in danger. Policy: A. Only the cayenne pepper product approved and issued by the Department of Security shall be carried by security officers on duty. B. Use of the cayenne pepper product shall only be permitted for the purpose of self-protection or the protection of others, not for the protection of property. C. Use of cayenne pepper defense spray is limited to the exterior of hospital buildings except in extreme cases where, regardless of the location, the officer's life or the life of another is in danger. ... Procedure: A. Self-protection/protection of others. 1. Reasonably evaluate the potential danger to yourself and the possibility of contamination of the atmosphere by the cayenne pepper self-defense spray. ... 3. If possible or practical, retreat or comply with a reasonable demand. 4. If possible, call for backup by fell ow officers and/or help from the [name of local police]. 5 If absolutely necessary, to protect the officer's life or the life of another person, direct the cayenne pepper self-defense spray toward the face of the actor from a three (3) foot distance. ... "

Review on July 1, 2011, of MR1 revealed the patient was in the facility's behavioral health unit (BHU), was discharged , and returned to the emergency department (ED) on June 16, 2011, with a drug overdose and suicidal thoughts. MR1 agreed to and was presented with voluntary admission papers for admission to the facility's BHU unit while in the ED. ED staff explained to MR1 that MR1 could be held for 72 hours. MR1 refused admission, tore up the paper work and was eloping from the ED. The ED staff called for hospital security support. The hospital staff followed MR1 from the examination room to the waiting room. Hospital documentation revealed that when MR1 saw the presence of hospital security, MR1 began to throw punches at the security officer which resulted in the hospital security officer applying handcuffs to MR1. Hospital security then placed MR1 on a stretcher, applied four point leather restraints and removed the handcuffs. The facility was unable to provide documentation that hospital staff or hospital security attempted to de-escalate the situation, or that other less restrictive interventions were implemented and determined to be ineffective.

Review on July 1, 2011, of MR2 revealed the patient was admitted through the hospital ED as an involuntary commitment to the facility's BHU. The hospital security staff escorted MR2 to the BHU. Facility documentation revealed that MR2 was defiant and agitated upon arrival. During the admission process, MR2 was threatening to kill staff while swinging a four point metal cane. Further review of facility documentation revealed the facility staff made attempts to calm MR2 for approximately 15 minutes. These attempts were unsuccessful. The BHU staff requested that the hospital security staff escort MR2 to the bedroom. MR2 moved into a corner which increased MR2's behavior. The hospital security staff warned MR2 that Cayenne Pepper spray would be used. MR2's behavior escalated. Hospital security released a short spray from the pepper can which resulted in MR2 becoming 'immediately submissive'.

Interview with EMP2 on July 1, 2011, at approximately 10:30 AM confirmed that handcuffs were used on MR1 and that Cayenne Pepper spray was used on MR2. Further interview confirmed there was no documentation that restraints or seclusion was attempted prior to the use of the handcuffs or the Cayenne Pepper spray. When questioned as to why restraints or seclusion was not implemented, EMP2 stated, "... MR1 and MR2's behavior escalated, we wanted to ensure that hospital staff was not harmed and that if staff feels threatened, then security takes over."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0165
Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined that the facility failed to ensure the least restrictive intervention was implemented to protect the patient or others from harm in two of two medical records reviewed (MR1 and MR2).

Findings include:

Review on July 1, 2011, of the facility's "Patients Rights and Responsibilities" policy, last reviewed February 24, 2011, revealed "Purpose: To ensure that patients are informed of their rights, which are referred to in the Patient Rights and Responsibilities brochure. ..."

Review on July 1, 2011, of the facility's "Patient Rights and Responsibilities April 2011" brochure, last revised April 2011, revealed "Patient Rights: ... 7. The patient has the right to good quality care and high professional standards that are continually maintained and reviewed. ... 16. The patient has the right to expect good management techniques to be implemented within the hospital considering effective use of the time of the patient and avoid the personal discomfort of the patient. ... 29. A patient has the right to receive care in a safe setting. ... 31. A patient has the right to be free from restraints of any forms [sic] for acute medical and surgical care that are not medically necessary or are used as a means of coercion, discipline, convenience or retaliation of staff. ... 33. A patient has the right to be free from seclusion and restraints of any form for behavioral management imposed as a means of coercion, discipline, convenience or retaliation by staff. ..."

Review on July 1, 2011, of the facility's "Restraint/Seclusion" policy, last reviewed November 10, 2010, revealed "Purpose: Geisinger Health System is committed to; 1. Reducing the frequency of restraint use, striving to eliminate the use of restraints. 2. Limiting restraint use by defining the terms restraint, seclusion, and pharmacologic restraint. 3. Using these protective measures in accordance with regulatory standards. Policy: It is the policy of Geisinger Health System to; 1. Limit the use of restraints/seclusion to emergencies where there is a risk of patient harming himself/herself or others, using the least restrictive method. 2. Preserve the rights, safety, well being, and dignity of the patient when restraints are used. 3. Use restrain/seclusion only to improve the patient's well being and when other less restrictive interventions have been determined to be ineffective. ... Definitions: 1. Physical restraint is defined as any manual, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. ... 5. A violent or self destructive patient is defined as a patient who is not cognitively impaired and knowingly intends to attempt to harm themselves, others, the environment, or has a primary psychiatric diagnosis. ... Responsibilities: ... Staff; Are responsible for: Employing less restrictive alternatives to restraint use ..." The use of restrictive devices such as handcuffs and Cayenne Pepper spray are not governed by this policy.

Review on July 6, 2011, of the facility's "Handcuffs, Carrying and Use" policy, last reviewed March 16, 2011, revealed "Purpose: Handcuffs are carried and used by security staff members ... Use of handcuffs is limited to instances where physical intervention is necessary to detain and initiate criminal complaints on people that have exhibited behavior harmful to themselves or others. Handcuffs are not to be used to restrain a patient. Policy: ...Handcuffs are a law enforcement restraint device/tool and may not be used by hospital security staff members as a restraint tool on patients. ... Handcuffs may only be applied on patients by law enforcement and forensic/correctional staff - this does not include hospital security. A patient that elopes would also still be considered a patient and we would also be restricted from using handcuffs as a restraint device. Handcuffs may be used in restraining and protecting a non-patient that has been disorderly and exhibited harmful behavior resulting in the use of Cayenne pepper Spray on the Medical Center campus."

Review on July 1, 2011, of the facility's "Cayenne Pepper Self Defense Spray" policy, last reviewed March 31, 2011, revealed "Purpose: A. To assure that security staff members are able to protect themselves with non-lethal force in the event of a personal attack. B. to assure that this protection mechanism is used only under extreme circumstances where an officer's life or safety may be in danger. Policy: A. Only the cayenne pepper product approved and issued by the Department of Security shall be carried by security officers on duty. B. Use of the cayenne pepper product shall only be permitted for the purpose of self-protection or the protection of others, not for the protection of property. C. Use of cayenne pepper defense spray is limited to the exterior of hospital buildings except in extreme cases where, regardless of the location, the officer's life or the life of another is in danger. ... Procedure: A. Self-protection/protection of others. 1. Reasonably evaluate the potential danger to yourself and the possibility of contamination of the atmosphere by the cayenne pepper self-defense spray. ... 3. If possible or practical, retreat or comply with a reasonable demand. 4. If possible, call for backup by fell ow officers and/or help from the [name of local police]. 5 If absolutely necessary, to protect the officer's life or the life of another person, direct the cayenne pepper self-defense spray toward the face of the actor from a three (3) foot distance. ... "

Review on July 1, 2011, of MR1 revealed the patient was a patient in the facility's behavioral health unit (BHU), was discharged and returned to the emergency department (ED) on June 16, 2011, with a drug overdose and suicidal thoughts. MR1 agreed to and was presented with voluntary admission papers for admission to the facility's BHU unit while in the ED. The ED staff explained to MR1 that MR1 could be held for 72 hours. MR1 refused admission, tore up the paper work and was eloping from the ED. The ED staff called for hospital security support. The hospital staff followed MR1 from the examination room to the waiting room. Hospital documentation revealed that when MR1 saw the presence of hospital security, MR1 began to throw punches at the security officer which resulted in the hospital security officer applying handcuffs to MR1. Hospital security then placed MR1 on a stretcher, applied four point leather restraints and removed the handcuffs. The facility was not able to provide documentation that the hospital staff or the hospital security attempted to de-escalate the situation, or that other less restrictive interventions were implemented and determined to be ineffective.

Review on July 1, 2011, of MR2 revealed the patient was admitted through the hospital ED as an involuntary commitment to the facility's behavioral health unit (BHU) and that hospital security staff escorted MR2 to the BHU. Facility documentation revealed that MR2 was defiant and agitated upon arrival and during the admission process and that MR2 was threatening to kill staff while swinging a four point metal cane. Further review of facility documentation revealed that facility staff made attempts to calm MR2 for approximately 15 minutes and that these attempts were unsuccessful. The BHU staff requested that hospital security staff escort MR2 to the bedroom. MR2 moved into a corner which increased MR2's behavior. The hospital security staff warned MR2 that Cayenne Pepper spray would be used. MR2's behavior escalated. Hospital security released a short spray from the pepper can which resulted in MR2 becoming 'immediately submissive'.

Interview with EMP2 on July 1, 2011, at approximately 10:30 AM confirmed that handcuffs were used on MR1 and that Cayenne Pepper spray was used on MR2 and that there was no documentation that restraints or seclusion was attempted prior to the use of the handcuffs or the Cayenne Pepper spray. When questioned as to why restraints or seclusion was not implemented, EMP2 stated, "... MR1 and MR2's behavior escalated, we wanted to ensure that hospital staff was not harmed and that if staff feels threatened, then security takes over."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0174
Based on review of facility documents, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to discontinue a four point leather restraint at the earliest possible time for one of one medical records reviewed (MR1).

Findings include:

Review on July 1, 2011, of the facility's "Restraint/Seclusion" policy, last reviewed November 10, 2010, revealed "... Staff; Are responsible for: Employing less [sic] restrictive alternatives to restraint use until deemed unsafe for patient and or staff. ... Monitor and evaluate patient's need for restraint and ADL's ... Discontinuing restraints as soon as the behavior requiring the restraint is resolved or controlled using an alternative to restraint. ..."

Review on July 1, 2011, of MR1 revealed that MR1 had a behavioral dyscontrol event while a patient in the facility's emergency department (ED) and that hospital security applied handcuffs to MR1 while in the ED. Further review of MR1 revealed that hospital staff and security then placed MR1 on a stretcher, removed the handcuffs and applied four point leather restraints (restraints applied to each extremity and secured to a bed or stretcher to prevent a patient from moving). MR1's physician ordered continuous observation of MR1's mood and behavior checks, respiratory and circulation checks, food, fluid and elimination checks, and signs of injury checks, every 15 minute while in leather restraints. MR1's four point restraints were applied on June 16, 2011, at 3:30 AM. The ED staff administered Haldol (an antipsychotic medication used to treat and manage mania and agitation) 5 milligrams (mg)/millimeter (ml) inject 10 mg intramuscular (IM) STAT (immediately) at 3:20 AM. MR1 was transported and admitted to the BHU at 4:20 AM in four point restraints on a gurney and accompanied with hospital security. Nursing documentation revealed that MR1 was lethargic. There was no documentation that the facility assessed and removed MR1 four point leather restraints as soon as the behavior requiring the restraint was resolved.

Interview with EMP1 and EMP4 on July 1, 2011, at approximately 11:30 AM confirmed the facility did not remove MR1's four point leather restraints as soon as the behavior requiring the restraint was resolved.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
Based on review of facility documents, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to evaluate and monitor a patient in a four point leather physical restraint for one of one medical records reviewed (MR1).

Findings include:

Review on July 1, 2011, of the facility's "Restraint/Seclusion" policy, last reviewed November 10, 2010, revealed "... Staff; Are responsible for: Employing less [sic] restrictive alternatives to restraint use until deemed unsafe for patient and or staff. ... Monitor and evaluate patient's need for restraint and ADL's ... Discontinuing restraints as soon as the behavior requiring the restraint is resolved or controlled using an alternative to restraint. Staff must document on the Restraint flow sheet under Physical Restraint Type/select "Discontinued." Equipment/supplies: ... 4. Leather/vinyl restraint i.e. wrist and/or ankle. ... Procedure: ... Violent or self Destructive/Seclusion ... 2. Staff are [sic] responsible to use the least restrictive form of restraint. ... 10. Staff will monitor patient by observation, interaction or direct examination for, but not limited to, signs of injury from restraint use as appropriate, hunger and/or thirst if applicable and as appropriate, breathing, circulation, provide range of motion as appropriate, meet the patients toileting need, provide comfort by repositioning as appropriate, emotional support if needed, and readiness for discontinuation every 15 minutes. ..."

Review on July 1, 2011, of MR1 revealed that MR1 had a behavioral dyscontrol event while a patient in the facility's emergency department (ED) and that hospital security applied handcuffs to MR1 while in the ED. Further review of MR1 revealed that hospital staff and security then placed MR1 on a stretcher, removed the handcuffs and applied four point leather restraints (restraints applied to each extremity and secured to a bed or stretcher to prevent a patient from moving). MR1's physician ordered continuous observation of MR1's mood and behavior checks, respiratory and circulation checks, food, fluid and elimination checks, and signs of injury checks, every 15 minute while in leather restraints. MR1's four point restraints were applied on June 16, 2011, at 3:30 AM. The ED staff documented MR1's blood pressure and respiratory rate at 4:00 AM, one-half hour after the leather restrains were applied. There was no documentation that the ED staff continuously monitored MR1 while restrained in four point restraints. There was no evidence that the ED staff monitored MR1's mood and behavior checks, respiratory and circulation checks, food, fluid and elimination checks, and signs of injury checks every 15 minutes as ordered by MR1's physician. There was no documentation that the ED staff monitored MR1's safety while in the four point leather restraints.

Interview with EMP1 and EMP4 on July 1, 2011, at approximately 11:30 AM confirmed there was no physician's order for handcuffs to be applied to MR1. EMP1 and EMP4 confirmed the ED staff did not continuously observe or monitor MR1 while restrained in leather restraints, and that the ED staff did not monitor MR1's mood and behavior, respiratory and circulation, food, fluid and elimination and signs of injury every 15 minute as ordered by MR1's physician. EMP1 and EMP4 also confirmed there was no documentation by the ED staff that MR1's safety was monitored while in the four point leather restraints.