HospitalInspections.org

Based on policy/procedure review, documentation review, and staff interviews, the hospital administrative staff failed to ensure Intensive Care Unit (ICU) staff, Behavioral Health Unit (BHU) staff, and Emergency Department (ED) staff followed:

1. Established hospital policies and procedures for the safe and appropriate use of seclusion/restraint in the care of patients

2. Requirement for reporting patient deaths, that involve a patient either in restraints or a recent history of being in restraints, to the Centers for Medicare and Medicaid Services (CMS)

3. Requirement for identified mandatory reporters (Physicians, Physician Assistants [PA], Registered Nurses [RN]) to report suspected child abuse to the appropriate state agency.


The following examples confirm this determination:

Staff in the Emergency Department (ED) failed to prohibit the use of a urinary catheter with patients with a psychiatric diagnosis who were restrained from physical/psychological abuse when not needed for medical reasons. (see A-145)

The Behavioral Health Unit (BHU) and Emergency Department (ED) staff failed to recognize that the use of handcuffs to prevent the acting out of violent/self destructive patients was, by definition, a restraint and failed to obtained an order from the authorized medical provider. (see A-0159)

The Behavioral Health Unit (BHU) failed to make a written modification to the patient's care plan after the use of restraint or seclusion. (see A-0166)

The Intensive Care Unit (ICU), BHU, and ED staff failed to obtain a physician or other authorized practitioner order for the use of restraints in accordance with hospital policy/procedure. (see A-0168)

The hospital administrative staff failed to ensure that orders for the use of restraint or seclusion were not written by a physician or authorized practitioner on an as needed basis (PRN). (see A-0169)

The hospital administrative staff failed to ensure that every order for restraint or seclusion, used for the management of violent or self-destructive behavior, only be written or renewed in accordance with the following limits for a total of 24 hours:
(A) 4 hours for adults 18 years of age or older;
(B) 2 hours for children and adolescents 9 to 17 years of age; or
(C) 1-hour for children under 9 years of age
and that these time frames are documented on each order written for the use of restraint or seclusion. (see A-0171)

The BHU and ED staff failed to document any/all interventions used to shorten the amount of time the patient required restraint/seclusion and the patient's response to the intervention(s), including the rationale for continued use restraints or seclusion. (see A-0188)

The hospital administrative staff failed to ensure that every patient death, that occurred while the patient was restrained or within 24 hours after the patient was removed from restraints, is reported to the Centers for Medicare and Medicaid Services (CMS). (see A-0214)

The cumulative effect of these systemic failures and deficient practices resulted in the facility's inability to ensure the effective, safe, and appropriate use of restraints or seclusion for its patients.

I. Based on medical record review and staff/physician interviews, the hospital administrative staff failed to protect Emergency Department (ED) patients with a psychiatric diagnosis who were restrained from physical/psychological abuse when it failed to implement a system that prohibited the use of urinary catheters in ED patients without documented medical necessity. Urinary catheter placement was found in 2 of 4 ED restrained psychiatric patient medical records reviewed. (Patient's #44 and 46) ED administrative staff reported approximately 1 restraint episode, used for the control of violent or self destructive behavior, per month.

A urinary catheter is a flexible tube inserted into a patient's bladder, through the urethra, used to drain the bladder of urine.

Insertion of a urinary catheter, without documented medical necessity, has the potential to cause physical/psychological damage to vulnerable patients with unknown psychiatric histories including a history of physical, psychological, or sexual abuse.


Findings include:

1. Review of Patient's #44 and 46's ED medical record revealed that nursing staff inserted a urinary catheter while the patients were in physical restraints for violent behavior. Both medical records lacked documentation of physician order or medical reason for the urinary catheter.

a. Review of Patient #44's medical record revealed an ED admission date of 6/21/11 for evaluation of psychosis and immediately placed in 4-point restraints to control the patient's violent behavior. (A 4-point restraint is one where each arm and each leg is individually restrained at the same time.)

Patient #44's medical record lacked evidence of a physician's order for insertion of a urinary catheter. Furthermore, the medical record lacked evidence of a physician's progress note that addressed the need for a urinary catheter.

Review of a nurses' note, dated/timed 6/21/11 at 12:03 PM, revealed, "Catheter discontinued due to restraints released, patient cooperating at this time."

During an interview, at the time of medical record review, Staff QQ, ED Supervisor, acknowledged nursing staff inserted a urinary catheter without a physician order. Staff QQ also acknowledged that the medical record lacked documentation of medical necessity for the catheter.

b. Review of Patient #46's medical record revealed an ED admission date of 10/18/11 for evaluation of aggressive behavior and psychoses. Patient #46's medical record revealed Patient #46 was placed in 4-point restraints to control the patient's violent behavior. Review of Patient #46's medical record found it did not include evidence of a physician's progress note that addressed the need for a urinary catheter. During an interview, at the time of medical record review, Staff QQ acknowledged that the medical record lacked documentation of medical necessity for the catheter.

3. During phone interview, Practitioner S, Emergency Department Physician, reported that it is not unusual for a physician to order a urinary catheter for a patient in restraints, especially if staff are giving medications that might cause the patient to be sedated. Staff may also use a urinary catheter to relieve a distended bladder and decrease agitation of the patient. Practitioner S also stated it is the physicians' judgement if a Foley (urinary catheter) is appropriate or not and, "No," not every patient in restraints has a catheter inserted.



II. Based on policies/procedures review, document review, medical record review, and staff interview, the Emergency Department (ED) nurses and physicians failed to notify the Department of Human Services (DHS) of suspected child abuse for 6 of 15 infants and/or minor patients (Patient's #11, 14, 15, 17, 18, and 20) reviewed..

The Director of Quality Services identified 15 cases of suspected infant and/or minor child abuse in the ED from 11/2010 to 11/2011.

Failure to notify DHS of suspected child abuse could place vulnerable children at risk for further abuse that may be life-threatening if not fatal.

Findings include:

1. Review of "Suspected Child Abuse or Neglect" policy, dated 6/11, revealed in part, "Great River Medical Center and their Mandatory reporters shall comply fully with the Iowa Code pertaining to child abuse or neglect...Mandatory reporters shall report and cooperate fully with the Iowa DHS in the reporting and in their investigations of child abuse or neglect... child - any person under the age of 18 years...The following classes of persons shall make a report of cases of child abuse or neglect within 24 hours...health practitioners."

2. Review of "Mandatory Provider Education" administrative policy, dated 6/17/09, revealed in part,..."A packet of educational materials will be generated and distributed to the providers (members of the medical staff) on a yearly basis...A list of those required educational items will be developed and updated yearly...The Providers will be asked to review the packet and sign the attestation included in the packet and return it to the Medical Staff Office...child abuse...sexual abuse; Note that when this involves any child under age 12, it must be reported to DHS, regardless of who the perpetrator is...."

3. Review of annual internet learning module curriculum titled "Recognizing Child Abuse and Dependent Adult Abuse" revealed in part, "Examples of mandatory reporters in a health care facility are: nurses, physicians...when child abuse...is suspected...a verbal report must be made immediately to the DHS...child...any person under the age of 18...information packets are located in the Emergency Department. These include: abuse reporting protocol, contact number, reporting, and documentation pages."

4. Review of Physician K's credential file revealed the document "Mandatory Provider Education 2011-2012." The document, signed and dated on 10/26/11 by Physician K, included the topic of Abuse/Neglect.

5. Review of Physician L's credential file revealed the document "Mandatory Provider Education 2010." The document, signed and dated on 2/2/11 by Physician L, included the topic of Abuse/Neglect.

6. Review of Physician M's credential file revealed the document "Mandatory Provider Education 2010." The document, signed and dated on 11/06/10 by Physician M, included the topic of Abuse/Neglect.

7. Review of Physician N's credential file revealed the document "Mandatory Provider Education 2011-2012." The document, signed and dated on 11/04/11 by Physician N, included the topic of Abuse/Neglect.

8. Review of Patient #11's medical record revealed:

- Patient #11, a 13-year-old child, arrived to the Emergency Department (ED) on 8/14/11 accompanied by his/her mother.
- On 8/14/11 at 4:48 PM, Physician K documented on the ED physician record; the patient complained of an alleged sexual assault involving "penile penetration".
- On 8/14/11 at 5:04 PM, Staff AA, Registered Nurse (RN), documented on the sexual examination report that Patient #11 admits to an 18-year-old male/female having sexual intercourse with him/her. An information packet was given to the patient's mother.
- On 8/14/11 at 6:50 PM, the patient transferred to a facility with child sexual assault specialist accompanied by the patient's mother.
- Patient #11's ED medical record lacked evidence of notification to DHS of suspected sexual assault by Physician K or Staff AA.


9. Review of Patient #14's medical record revealed:

- Patient #14, an 8-year-old child, arrived to the ED on 11/8/11 accompanied by his/her parents.
- On 11/8/11 at 12:38 PM, Physician N documented on the ED physician record that the patient complained a classmate touched him/her on the abdomen, both breasts, and genitalia region on two occasions.
- On 11/8/11 at 12:35 PM, Staff DD, RN, documented on the Abuse/Physical Assault notes; "child states...another classmate...unfastened [his/her] pants and...touched [his/her] buttocks." Additionally, the 8-year-old patient verbalized a detailed and graphic report of the incident and a repeated incident that occurred on school property on the same day.
- Patient #14's ED medical record lacked evidence of notification to DHS of suspected sexual assault by Physician N or Staff DD.


10. Review of Patient #15's medical record revealed:

- Patient #15, a 17-year-old adolescent, arrived to the ED on 11/16/11, accompanied by his/her father and two other relatives.
- On 11/16/11 at 6:42 PM, Physician M documented on the ED physician record that the patient complained of an alleged assault with penetration into the patient's body and ejaculation.
- On 11/16/11 at 7:16 PM, Staff EE, RN, documented on the Abuse/Physical Assault notes, "The assailant was an acquaintance and penetration took place with ejaculation."
- Patient #15's medical record lacked evidence of notification to DHS of suspected sexual assault by Physician M or Staff EE.


11. Review of Patient #17's medical record revealed:

- Patient #17, a 13-year-old child, arrived to the ED on 8/4/11 accompanied by his/her mother.
- On 8/4/11 at 4:20 PM, Physician M documented on the ED physician record, "Injury to perineum during a sexual assault."
- On 8/4/11 at 4:56 PM, Staff GG, RN, documented the patient account of assault notes, "Per patient and [parent] an assault approximately 2 weeks ago by a [male/female] assailant."
- Patient #17's medical record lacked evidence of notification to DHS of suspected sexual assault by Physician M or Staff GG.


12. Review of Patient #18's medical record revealed:

- Patient #18, a 16-year-old adolescent, arrived to the ED on 8/3/11 accompanied by a sibling and parent.
- On 8/3/11 at 4:38 PM, Staff HH, RN, documented on the ED triage assessment that patient complains of "being assaulted" sexually today.
- On 8/3/11 at 4:50 PM, Physician M documented on the ED physician record, "Chief complaint alleged sexual assault last [evening]."
- On 8/3/11 at 6:45 PM, Staff II, RN, documented on the ED discharge notes, "Patient sent with assault folder."
- Patient #18's medical record lacked evidence of notification to DHS of suspected sexual assault by Physician M or Staff II.


13. Review of Patient #20's medical record revealed:

- Patient #20, a 17-year-old adolescent, arrived to the ED on 2/1/11 accompanied by his/her grandparent.
- On 2/1/11 at 7:55 AM, Staff X, RN, documented on the ED Triage assessment, "Presents with [grandparent] stating [he/she] was 'raped' last night."
- On 2/1/11 at 8:03 AM, Staff X, RN, commented on the ED Abuse/Physical Assault notes, "Suspected situation; sexual assault, mandatory report; yes, case reportable; patient agreed to report."
- On 2/1/11 at 8:15 AM, Physician L documented on the ED physician record, "Chief complaint alleged sexual assault last night. Reported forced sex in car, patient said [he/she] said no."
- Patient #20's medical record lacked evidence of notification to DHS of suspected sexual assault by Physician L or Staff X.

14. During an interview on 11/16/11 at 4:00 PM, Staff BB, Clinical Facilitator of the Emergency Department (ED), stated the nurses received education on recognizing and reporting suspected child/dependant adult abuse. Staff BB, also confirmed the physicians received the recertification for mandatory reporting every 5 years. Staff BB confirmed the Emergency Department staff failed to notify Department of Human Services (DHS) of suspected child abuse for Patients #11, 14, 15, 17, 18, and 20.

15. During an interview on 11/16/11 at 4:15 PM, Staff CC, Chief Nursing Officer, confirmed the hospital policy required staff to notify Department of Human Services for all suspected child abuse. Staff CC confirmed the Emergency Department staff failed to notify Department of Human Services (DHS) of suspected child abuse for Patients #11, 14, 15, 17, 18, and 20.

16. During an interview on 11/17/11 at 9:05 AM, Staff DD, ED RN, stated policies for abuse are on the intranet and staff could access them at anytime for review. Staff DD confirmed the online computer-based learning modules for abuse instructed staff to contact DHS for all suspected child abuse immediately. Additionally, nurses and/or physicians are responsible to contact DHS for suspected child abuse. Staff DD confirmed he/she provided care for Patient #14. Staff DD stated he/she did not call DHS as the parents stated the school notified DHS; Staff DD did not call DHS to confirm this information.

17. During an interview on 11/17/11 at 10:45 AM, Staff FF, RN house supervisor, stated the ED staff is obligated to report, on the behalf of the child, to DHS for suspected child abuse. Staff FF stated as house supervisor he/she received training to contact the Social Worker and they would be responsible to notify DHS. Staff FF did not know of any procedure that would ensure the Social Worker contacted the appropriate agency.

18. During an interview on 11/17/11 at 12:05, Physician L, Medical Director of the ED, verified he/she completed the annual mandatory reporter training for child/dependent abuse. Physician L stated he/she instructs the nurses verbally to notify DHS if there is a suspected child abuse case identified. Physician L confirmed providing care to Patient #20 and stated he/she verbally told the nurse to notify DHS. Physician L stated the nurse would document in the patient's medical record if they notified DHS.

Based on policy/procedure review, medical record review, and staff interviews, hospital administrative staff failed to ensure Behavioral Health Unit (BHU) and Emergency Department (ED) staff recognized that the use of handcuffs to prevent the acting out of violent/self destructive patients was, by definition, a restraint and failed to obtained an order from the authorized medical practitioner. The BHU administrative staff reported that in the last 6 months, staff used handcuffs on 1 of 1 patients a mechanical restraint for the control of violent/self destructive behavior. The ED administrative staff reported that in the last 6 months, 2 patients had handcuffs used as a mechanical restraint for the control of violent/self destructive behavior.

Failure to recognize the use of handcuffs as a restraint device and to obtain a physician or mid-level practitioner order could potentially place patients at risk for physical and/or psychological harm from the inappropriate application of restraints.

Findings include:

1. Review of Clinical Policies and Procedures titled "Restraint and Seclusion", reviewed and revised December 2010, revealed the following:

"Operational Definitions: Restraint - Any manual method, 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."

"...3) Violent and Self Destructive Restraint and/or Seclusion - Behavioral Health...(1) As soon as possible, but no longer than one hour after the initiation of restraint or seclusion, the registered nurse shall consult with a physician about the patient's physical and psychological status and obtain an order (verbal or written)...."


2. Review of Patients #44 and 46's ED medical records and Patient #41's BHU medical record did not find evidence that nursing staff obtained physician or mid-level practitioner orders for the use of handcuffs when staff physically restrained these patients.

a. Review of Patient #44's medical record revealed an ED admission date of 6/21/11 "by the police in handcuffs" for evaluation of psychosis. The medical record revealed Patient #44 remained in handcuffs during triage and while in a patient treatment room. The medical record lacked evidence that an order for restraints was obtained for the use of handcuffs as a means of physical restraint to control the patient's violent behavior.

b. Review of Patient #46's medical record revealed an ED admission date of 10/18/11 "by the police in handcuffs" for evaluation for aggressive behavior and psychoses. The medical record revealed Patient #46 remained in handcuffs during triage and while in a patient treatment room. The medical record lacked evidence that an order for restraints was obtained for the use of handcuffs as a means of physical restraint.

c. Review of Patient #41's medical record revealed Patient #41 had a BHU admission date of 5/21/11 for treatment of dementia with severe behavioral changes including striking out at caretakers.
On 5/22/11 at 12:03 AM, nursing staff documented the following: "Patient refusing to cooperate and continued to swing and kick at staff whenever attempt was made to move [him/her]. West Burlington Police were called and placed patient in handcuffs. Patient was lifted from the floor and carried into seclusion room...."
Patient #41's medical record lacked evidence that nursing staff obtained an order for restraints for the use of handcuffs as a means of physical restraints to control the patient's violent behavior.

3. On 11/17/11 at 9:20 AM, during medical record review and interview, Staff QQ, Director of the ED, acknowledged the medical records for Patients #44 and 46 lacked evidence that nursing staff obtained a physician or mid-level practitioner order for the use of handcuffs as a means of physical restraint to control the patients' violent behavior.

4. On 11/17/11 at 9:20 AM, during medical record review and interview, Staff NN, Director of the BHU, acknowledged the medical record for Patient #41 lacked evidence that nursing staff obtained a physician or mid-level provider order for the use of handcuffs as a means of physical restraint to control the patients' violent behavior.

5. On 11/17/11 at 9:20 AM, during medical record review and interview, Staff LL, Vice President of Nursing, acknowledged the above findings and stated that nursing staff did not follow hospital policy/procedures regarding the use of restraints.

Based on policy/procedure review, medical record review, and staff interviews, hospital administrative staff failed to ensure Behavioral Health Unit (BHU) nursing staff updated patient care plans, in 3 of 3 medical records, where the patient was placed in seclusion (Patients #40, 41, and 42). The BHU administrative staff reported that an average daily census of 5 patients.

Failure to update a patient's plan of care after the use of seclusion or restraints could potentially fail to provide the patient's caretakers with information on methods or techniques to assist the patient and potentially avoid the use of seclusion or restraints.

Findings include:

1. Review of Clinical Policies and Procedures titled "Restraint and Seclusion," reviewed and revised December 2010, revealed it stated the following: "... 1) General Provisions...f) Care Plan (i) The patient's written plan of care shall be modified to initiate the type of restraint and the goals of the restraint episode."

The Policy/Procedure did not include evidence of requirements for nursing staff to modify the patient's written plan of care when staff implemented the use of seclusion of a patient.

2. Review of Patients #40, 41, and 42's BHU medical records lacked evidence that nursing staff modified or updated the patients' plan of care after the use of seclusion.

a. Review of Patient #40's medical record revealed a BHU admission date of 5/11/11 for treatment of Schizo-affective disorder. Staff placed Patient #40 in seclusion on 5/16/11, 5/19/11, 5/20/11, 5/22/11, 5/23/11, and 5/25/11 for control of violent behavior including striking out at staff members. However, nursing staff did not modify or update the patient's plan of care after the use of seclusion.

b. Review of Patient #41's medical record revealed Patient #41 a BHU admission date of 5/21/11 for the treatment of dementia with severe behavioral changes including striking out at caretakers. Medical record review revealed on 5/21/11 and 5/22/11, staff placed Patient #41 in seclusion for control of violent behavior including striking out at staff members. However, the medical record did not include evidence that nursing staff modified or updated the patients' plan of care after the use of seclusion to control the patient's violent behavior.

c. Review of Patient #42's medical record revealed Patient #42 a BHU admission date of 8/17/11 for the treatment of Intermittent Explosive Disorder and Schizoaffective Disorder. Medical record review revealed on 8/20/11, staff placed Patient #42 placed in seclusion for control of violent behavior including striking out at staff members. Nevertheless, Patient #42's medical record did nto include evidence that nursing staff modified or updated the patients' plan of care after the use of seclusion to control the patient's violent behavior.

3. On 11/17/11 at 9:40 AM, during medical record review and interview, Staff DD, BHU Supervisor, acknowledged the medical records for Patients #40, 41, and 42 lacked evidence that nursing staff modified or updated the patients' plan of care after the use of seclusion. Staff DD acknowledged that nursing staff failed to follow established hospital policies/procedures.

4. On 11/17/11 at 9:40 AM, during medical record review and interview, Staff NN, Director of the BHU, acknowledged the medical records for Patients #40, 41, and 42 lacked evidence that nursing staff modified or updated the patient's plan of care after the use of seclusion to control the patients' violent behavior. Staff NN acknowledged that nursing staff failed to follow established hospital policies/procedures.

5. On 11/17/11 at 9:40 AM, during medical record review and interview, Staff LL, Vice President of Nursing, acknowledged the medical records for Patients #40, 41, and 42 lacked evidence that nursing staff modified or updated the patient's plan of care after the use of seclusion to control the patients' violent behavior. Staff LL acknowledged that nursing staff failed to follow established hospital policies/procedures.

Based on policy/procedure review, medical record review, and staff interviews, hospital administrative staff failed to ensure Intensive Care Unit (ICU) nursing staff obtained an order from the authorized health care provider for the use of restraints to prevent patients from interfering with medical equipment needed to sustain the patient's life in 2 of 4 medical restraint records reviewed (Patients #37 and #9). The ICU administrative staff reported approximately 10 restraint episodes per month.

Failure to notify and obtain physician or providers' orders for the use of restraints could potentially place patients at risk for physical and/or psychological harm from the inappropriate application of restraints.

Findings include:

1. Review of Clinical Policies and Procedures titled "Restraint and Seclusion," reviewed and revised December 2010, revealed the following:

"Operational Definitions: Restraint Any manual method, 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."

"General Provisions: a) Orders i) Restraint or seclusion shall be ordered by a physician member of the medical staff who is responsible for the care of the patient.
...iv) The order shall specify the method of restraint and/or seclusion to be used. (Indications for the restraint may be documented in nursing or provider notes)."

"2.) Non-violent or Non-self Destructive Patient (Medical Restraint)
...b) Physician Order i) If the attending physician is not available, a registered nurse may initiate restraint in advance of a physicians' order.
(1) If restraint was necessary due to a significant change in the patients' condition, the attending physician shall be contacted immediately for an order.
(2) Otherwise, the attending physician must be notified as soon as possible, if the attending did not order the restraint or seclusion...."

2. Review of Patients #37 and 39's ICU medical records lacked evidence that nursing staff obtained physician or mid-level provider orders for the use of restraints as a means of physical restraint to prevent the disruption of life saving treatments.

a.) Review of Patient #37's medical record revealed in part, Patient #37 admitted to the Intensive Care Unit (ICU) on 9/5/11 after suffering an acute myocardial infarction (MI) with sustained low blood pressure. On 9/6/11 at 2:00 AM, nursing documentation revealed that Patient #37 was placed in bilateral wrist restraints.

Review of the hospital form titled "Restraint Initiation & Daily Physician Orders," dated 9/6/11, nursing staff documented a telephone/verbal order written at 6:00 AM for restraints, four hours after the patient was placed in restraints.

b. Review of Patient #39's medical record revealed in part, Patient #39 admitted to the Intensive Care Unit (ICU) on 10/25/11 for acute respiratory failure. On 10/25/11 at 11:11 AM, nursing documentation revealed staff placed Patient #39 in bilateral wrist restraints.

Review of the form titled "Restraint Initiation & Daily Physician Orders," dated 10/25/11, documented a physician order dated 10/25/11 and signed at 11:00 AM for bilateral wrist restraints. However, the form "Restraint Initiation & Daily Physician Orders," dated 10/26/11, documented nursing staff received a telephone/verbal order on 10/26/11. However, staff failed to document the time the telephone/verbal order was written.

3. On 11/17/11 at 10:00 AM, during medical record review and interview, Staff RR, ICU Nurse Manager, acknowledged the medical records for Patients #31 and 37 lacked complete (dated/timed) restraint orders. Staff RR agreed nursing staff failed to follow hospital policies/procedures.

4. On 11/17/11 at 9:20 AM, during medical record review and interview, Staff LL, Vice President of Nursing, acknowledged the above findings and stated that the nursing staff did not follow hospital policy/procedures regarding the documentation requirements for restraints.


II. Based on policy/procedure review, medical record review, and staff interviews, hospital administrative staff failed to ensure Emergency Department (ED) staff obtained an order from the authorized medical provider for the use of restraints to control violent or self destructive behavior. The ED administrative staff reported that in the last 6 months, 2 patients had handcuffs used as a mechanical restraint for the control of violent/self destructive behavior.

Use of handcuffs as a restraint device without a physician or mid-level providers' order could potentially place patients at risk for physical and/or psychological harm from the unnecessary and/or inappropriate application of restraints.

Findings include:

1. Review of Clinical Policies and Procedures titled "Restraint and Seclusion," reviewed and revised December 2010, stated the following: "Operational Definitions: Restraint Any manual method, 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."

"...3) Violent and Self Destructive Restraint and/or Seclusion Behavioral Health...(1) As soon as possible, but no longer than one hour after the initiation of restraint or seclusion, the registered nurse shall consult with a physician about the patient's physical and psychological status and obtain an order (verbal or written)...."

2. Review of Patients #44 and 46's ED medical records and Patient # 41's BHU medical record lacked evidence that nursing staff obtained physician or mid-level provider orders for the use of handcuffs as a means of physical restraint to control violent/self destructive behavior.

a. Review of Patient #44's medical record revealed Patient #44 was brought to the ED/on 6/21/11, by the police in handcuffs, for evaluation of psychosis. Patient #44's medical record revealed the patient remained in handcuffs during triage and while in a patient treatment room. The medical record lacked evidence that an order for restraints was obtained for the use of handcuffs as a means of physical restraints to control the patients' violent behavior.
b. Review of Patient #46's medical record revealed Patient #46 was brought to the ED on 10/18/11, by the police in handcuffs, for evaluation for aggressive behavior and psychoses. Patient #46's medical record revealed the patient remained in handcuffs during triage and while in a patient treatment room. The medical record lacked evidence that an order for restraints was obtained for the use of handcuffs as a means of physical restraints to control the patients' violent behavior.
c. Review of Patient #41's medical record revealed Patient #41 admitted to the BHU on 5/21/11, for treatment of Dementia with severe behavioral changes including striking out at caretakers.
On 5/22/11 at 12:03 AM, nursing staff documented the following: "Patient refusing to cooperate and continued to swing and kick at staff whenever attempt was made to move him. West Burlington Police were called and placed patient in handcuffs. Patient was lifted from the floor and carried into seclusion room...."
Patient #41's medical record lacked evidence that an order for restraints was obtained for the use of handcuffs as a means of physical restraints to control the patient's violent behavior.
3. On 11/17/11 at 9:20 AM, during medical record review and interview, Staff QQ, Director of the ED, acknowledged the medical records for Patient #44 and #46 lacked evidence that nursing staff obtained a physician or mid-level provider order for the use of handcuffs as a means of physical restraint to control the patients' violent behavior.

4. On 11/17/11 at 9:20 AM, during medical record review and interview, Staff NN, Director of the BHU, acknowledged the medical record for Patient #41 lacked evidence that nursing staff obtained a physician or mid-level practitioner order for the use of handcuffs as a means of physical restraint to control the patients' violent behavior.

5. On 11/17/11 at 9:20 AM, during medical record review and interview, Staff LL, Vice President of Nursing, acknowledged the above findings and stated that the nursing staff did not follow hospital policy/procedures regarding the use of restraints for the control of violent/self destructive behavior.

Based on policy/procedure review, medical record review, and staff interviews, hospital administrative staff failed to ensure physicians do not order and nursing staff does not accept written orders for the use of restraints as needed (PRN) in 1 of 4 Intensive Care Unit (ICU) restraint medical records reviewed. (Patient #46) The ICU administrative staff reported approximately 10 restraint episodes per month.

Failure to ensure no orders are written for staff to use restraints as needed potentially places patients at risk for physical and/or psychological harm from the inappropriate application of restraints.

Findings include:

1. Review of Clinical Policies and Procedures titled "Restraint and Seclusion," reviewed and revised December 2010, revealed the following:

"General Provisions: a) Orders ...iii) PRN restraint or seclusion orders or standing orders shall not be accepted and the ordering practitioner shall be contacted to order or discontinue the order...."

2. Review of Patient #46's medical record revealed the patient was brought to the ED on 10/18/11, then transferred to the intensive care unit for evaluation of possible drug overdose, aggressive behavior, and psychoses. Patient #46's medical record revealed in part:
- Physician Test - Medication Orders Sheet, "...Restraints as needed"
- Telephone Order written 10/18/11 at 9:58 PM, "Repeated and Verified"

3. On 11/17/11 at 10:15 AM, during medical record review and interview, Staff RR, ICU Nurse Manager, acknowledged nursing staff wrote and accepted an order for restraints to be used on an as needed basis for Patient #46. Staff RR agreed nursing staff failed to follow hospital policies/procedures.

4. On 11/17/11 at 10:15 AM, during medical record review and interview, Staff LL, Vice President of Nursing, acknowledged the above findings and stated that the nursing staff did not follow hospital policy/procedures regarding the documentation requirements for restraints.

Based on policy/procedure review, medical record review, and staff interviews, hospital administrative staff failed to ensure medical staff treating patients on the Behavioral Health Unit (BHU) wrote seclusion orders, used for the management of violent or self-destructive behavior, with specified time limits appropriate to the age of the patient in 3 of 3 medical records reviewed. (Patients #40, 41, and 42) The BHU administrative staff reported that the unit had an average daily census of 5 patients.

Failure to ensure that all orders for the use of seclusion are written with age appropriate time limits has the potential to place the patient at risk from physical or psychological harm from prolonged seclusion.

Seclusion refers to a room used to isolate a patient from all other individuals. The room has a door that is locked so the patient cannot leave and typically has no object or furniture in the room.

Findings include:

1. Review of Clinical Policies and Procedures titled "Restraint and Seclusion", reviewed and revised December 2010, stated the following:

"...3) Violent and Self Destructive Restraint and/or Seclusion Behavioral Health:
a) Requirements for all settings: ...(1) As soon as possible, but no longer than one hour after the initiation of restraint or seclusion, the registered nurse shall consult with a physician about the patient's physical and psychological status and obtain an order (verbal or written).
(2) The initial and all subsequent restraint orders shall expire in 4 hours for adults 18 years of age or older, 2 hours for children and adolescents 9 - 17 years of age, and 1 hour for children 8 years of age or younger...."

2. Review of Patients #40, 41, and 42's BHU medical records lacked evidence that age appropriate time limits were specified on the written seclusion orders.

a. Review of Patient #40's medical record revealed a BHU admission date of 5/11/11 for treatment of Schizo-affective disorder.
Medical record review revealed the patient was placed into seclusion on 5/16/11, 5/19/11, 5/20/11, 5/22/11, 5/23/11, and 5/25/11for control of violent behavior including striking out at staff members. However, Patient #40's medical records revealed seclusion orders, written by medical staff for each seclusion episode, did not include the time limit.

b. Review of Patient #41's medical record revealed a BHU admission date of 5/21/11 on for the treatment of Dementia with severe behavioral changes including striking out at caretakers. Medical record review revealed on 5/21/11 and 5/22/11, staff placed Patient #41 into seclusion for control of violent behavior including striking out at staff members. However, although Patient #41's medical record included seclusion orders written by medical staff for each seclusion episode, they lacked evidence of age appropriate time limits specified with the written seclusion orders.

c. Review of Patient #42's medical record revealed a BHU admission date of 8/17/11 for the treatment of Intermittent Explosive Disorder and Schizo-affective Disorder. Medical record review revealed on 8/20/11, staff placed Patient #42 into seclusion for control of violent behavior including striking out at staff members. However, although Patient #42's medical records revealed seclusion orders written by medical staff for this seclusion, it lacked evidence of specified age appropriate time limits.

3. On 11/17/11 at 9:50 AM, during medical record review and interview, Staff DD, BHU Supervisor, acknowledged the medical records for Patients #40, 41, and 42 lacked evidence that age appropriate time limits were specified with the written seclusion order.


4. On 11/17/11 at 9:50 AM, during medical record review and interview, Staff NN, Director of the BHU, acknowledged the medical records lacked evidence that age appropriate time limits were specified with the written seclusion order. Staff NN also acknowledged the hospitals' policy/procedure lacked requirements for age appropriate time limits for seclusion orders used for the management of violent and/or self destructive behavior.

Based on policy/procedure review, medical record review, and staff interviews, hospital administrative staff failed to ensure nursing staff documented patient response to interventions attempted while the patient was restained when the restraint was used for violent and/or self-destructive behavior in 4 of 4 Emergency Department (ED) medical records reviewed (Patients #43, 44, 45, and 6) and in 3 of 3 Behavioral Health Unit (BHU) medical records reviewed (Patients #40, 41, and 42). ED administrative staff reported approximately 1 restraint episode used for the control of violent or self-destructive behavior per month. The BHU administrative staff reported approximately 1 to 2 seclusion episodes, used for the control of violent or self-destructive behavior, per month.

Failure to document any or all interventions attempted while a patient is in seclusion or restraints could potentially fail to provide the patient's caretaker with information on methods and/or techniques to assist in reducing the time necessary to seclude and/or restrain the patient.

Findings include:

1. Review of Clinical Policies and Procedures titled "Restraint and Seclusion," reviewed and revised December 2010, lacked documentation of a requirement that nursing staff document interventions attempted to step-by-step/work the patient out of seclusion or restraints or to document the patient's response to the interventions attempted.

2. Review of the ED medical records for Patients #43, 44, 45, and 46 and the BHU medical records for Patients #40, 41, and 42 revealed that nursing staff failed to document interventions attempted to work the patient out of seclusion or restraints nor the patients' response to the interventions attempted.

a. Review of Patient #43's medical record revealed Patient #43 was brought to the ED on 6/8/11 for evaluation of suicidal ideation and aggressive behaviors. Patent #43 was placed in 4 point restraints (where each arm and each leg is individually restrained) from 10:30 PM to 12:07 AM for control of violent and self-destructive behaviors. However, Patient #43's medical record lacked documentation of interventions attempted by nursing staff, to work the patient out of restraints or the patients' response to the interventions.

b. Review of Patient #44's medical record revealed an ED on 6/21/11, for evaluation of psychosis. Patient #44's medical record revealed he/she was placed in 4 point restraints from 6:58 AM to 11:55 AM. Patient #44's medical record lacked documentation of interventions attempted by nursing staff to work the patient out of restraints or the patient's response to interventions attempted.

c. Review of Patient #45's medical record revealed an ED admission date of 7/30/11 for treatment of acute intoxication. Patient #45's medical record revealed he/she was placed in 4 point restraints from 8:00 PM to 10:26 PM. Patient #45's medical record lacked documentation of interventions attempted by nursing staff, to work the patient out of restraints or the patient's response to the interventions.

d. Review of Patient #46's medical record revealed an ED admission date of 10/18/11, for evaluation of psychosis and aggressive behaviors. Patient #46's medical record revealed he/she was placed in 4 point restraints from 9:00 PM to 10:30 PM.

However, review of Patient #46's medical record found it lacked documentation of interventions attempted by nursing staff to work the patient out of restraints or the patient's response to the interventions.

e. Review of Patient #40's medical record revealed a BHU admission date of 5/11/11, for treatment of Schizoaffective disorder.

Medical record review revealed on 5/16/11, 5/19/11, 5/20/11, 5/22/11, 5/23/11, and 5/25/11 that staff placed Patient #40 in seclusion for control of violent behavior that included striking out at staff members. However, review of the medical record revealed no documentation of interventions attempted by nursing staff to work the patient out of seclusion or the patients' response to the interventions.

f. Review of Patient #41's medical record revealed a BHU admission date of 5/21/11 for the treatment of dementia with severe behavioral changes including striking out at caretakers. Medical record review revealed on 5/21/11 and 5/22/11 that staff placed Patient #41 in seclusion for control of violent behavior including striking out at staff members. The medical record lacked documentation of interventions attempted by nursing staff, to work the patient out of seclusion or the patients' response to the interventions.

g. Review of Patient #42's medical record revealed a BHU admission date of 8/17/11 for the treatment of Intermittent Explosive Disorder and Schizo-affective Disorder. Medical record review revealed that on 8/20/11 staff placed Patient #42 placed in seclusion for control of violent behavior including striking out at staff members. Patient #42's medical record lacked documentation of interventions attempted by nursing staff to work the patient out of seclusion or the patients' response to the interventions.


3. On 11/17/11 at 9:20 AM, during medical record review and interview, Staff QQ, ED Supervisor, acknowledged nursing staff failed to document interventions attempted to work the patient out of restraints or the patients' response to the interventions.

4. On 11/17/11 at 9:20 AM, during medical record review and interview, Staff DD, BHU Supervisor, acknowledged nursing staff failed to document interventions attempted to work the patient out of seclusion or the patients' response to the interventions.

5. On 11/17/11 at 9:20 AM, during medical record review and interview, Staff NN, Director of the BHU, acknowledged nursing staff failed to document interventions attempted to work the patient out of seclusion or the patients' response to the interventions.

6. On 11/17/11 at 9:20 AM, during medical record review and interview, Staff LL, Vice President of Nursing, acknowledged nursing staff failed to document interventions attempted to work the patient out of seclusion or restraints, nor the patients' response to the interventions. Staff LL also acknowledged that hospital policy/procedure failed to address a requirement that nursing staff document patient response to interventions attempted during restraint and/or seclusion.

Based on policy review, document review, and staff interview, the hospital failed to ensure the each time a patient died in restraints or within 24 hours after the patient had been removed from restraints the death was reported to the Centers for Medicare and Medicaid Services (CMS) in 4 of 4 patient medical records reviewed. (Patients #36, 37, 38, and 39)

Failure to notify CMS of all patient deaths that occur while a patient is in restraints has the potential to deny regulatory agencies the opportunity to review and analyze restraint data that may impact and/or improve patient safety.

Findings include:

1. Review of Clinical Policies and Procedures titled "Restraint and Seclusion," reviewed and revised December 2010, revealed the following:
"...4) Reporting of Death in Restraints or Seclusion: a) The regulation at 42 CFR 482.13(G) specifically requires that a hospital must report the following information to the Centers for Medicare and Medicaid Services regional office in Kansas City, Missouri:

Reporting of Death During Week Day Shift:
vi). After completion and review of the death report the Quality representative will notify the CMS regional office in Kansas City.
vii). This death notification must occur within one business day.
viii) It must be documented in the patient's medical record the date and time the death was reported to CMS."

2. Review of the medical records for Patients #36, 37, 38, and 39 revealed that each medical record lacked evidence that nursing staff notified staff at the Centers for Medicare and Medicaid Services (CMS) of the death of the patients who were in restraints within 24 hours of death.

a. Review of Patient #36's medical record revealed an Intensive Care Unit (ICU) admission date of 6/21/11 after suffering an acute myocardial infarction (MI). Hospital form titled "Hospital Restraint/Seclusion Death Report Worksheet" for Patient #36 lacked evidence of a documented date/time that CMS was notified.

b. Review of Patient #37 's medical record revealed an ICU admission date of 9/5/11 after suffering an acute myocardial infarction (MI) with sustained hypotension. Hospital form titled "Hospital Restraint/Seclusion Death Report Worksheet" for Patient #37 lacked evidence of a documented date/time that CMS was notified.

c. Review of Patient #38's medical record revealed an ICU admission date of 10/4/11 for treatment of multilobular pneumonia and respiratory arrest. Hospital form titled "Hospital Restraint/Seclusion Death Report Worksheet" for Patient #38 lacked evidence of a documented date/time that CMS was notified.

d. Review of Patient #39's medical record revealed an ICU admission date of 10/25/11 for acute respiratory failure. Hospital form titled "Hospital Restraint/Seclusion Death Report Worksheet" for Patient #38 lacked evidence of a documented date/time that CMS was notified.

3. On 11/17/11 at 9:20 AM, during medical record review and interview, Staff LL, Vice President of Nursing, acknowledged hospital staff was aware of the regulation to report deaths that occurred while a patient was in restraints or within 24 hours after the patient had been removed from restraints to CMS. The Vice President of Nursing acknowledged that the Quality Representative failed to document the date/time CMS was contacted.

Based on review of the hospital's Performance Improvement Plan, documentation review, and staff interviews, the hospital failed implement changes regarding documentation of the seclusion and restraint of patients based on data collected.

Failure to evaluate and use quality indicators to impact patient care has the potential to submit patients to inappropriate and/or substandard care.

Findings include:

1. Review of Administrative Policy and Procedure titled "Organizational Performance Improvement Plan", approved 10/25/11, found it stated in part:

"Purpose: To provide a plan for monitoring and improving processes and outcomes of patient care and services provided by Great River Health Systems'.

"...3) Quality Measures and Use of Data: a) The organization identified performance improvement measures are to include but are not limited as directed by the board. The focus is on high risk, high volume, problem-prone areas, incidence, prevalence or severity problems in service areas. ... xiv) Restraint and seclusion."

"..d) Data will be analyzed for opportunities for improvement based on trends and comparisons to targets."

2. Review of restraints and seclusion data collected from May 2011 to November 2011 revealed that the Intensive Care Unit (ICU), Behavioral Health Unit (BHU), and the Emergency Department (ED) tracked the following quality indicators:
- Date of restraint/seclusion
- Date restraint discontinued
- Time restraint/seclusion initiate for BHU patients
- Time restraint/seclusion for BHU patients
- Number of minutes in restraint/seclusion for BHU patients

On 11/17/11 at 11:00 AM, Staff MM, Quality Coordinator, stated restraint/seclusion quality indicators are reported to the Quality and Safety Council quarterly.

3. Review of Quality Council meeting minutes for 2/11, 7/11, and 11/11 revealed that the Quality and Safety Council submitted restraint and seclusion indicators to the Quality Council as required by policy/procedures.

4. On 11/17/11 at 12:10 PM, Staff MM, Quality Coordinator, reported that the Quality and Safety Council has responsibility for review of quarterly restraint and seclusion indicators. Action items are discussed based on data trends, patient complaint, patient/staff issues, or patient/staff concerns. This information is then submitted to the Nursing Management Group for further study and action.

Staff MM also reported that from October 2010 to September 2011 restraint and seclusion indicators indicated to the committee that "restraint/seclusion documentation was a problem" although no actions were taken other than continued monitoring.

Based on review of policies and procedures, medical records, and staff interview, administrative staff failed to ensure Intensive Care Unit (ICU) staff monitored each patient's vital signs during the continuous renal replacement therapy (CRRT) treatments in accordance with the facility's policy and procedure. The facility's CRRT patient census was 0. However, problems were identified in 4 of 4 sampled closed medical records reviewed (Patients #1, 2, 3, and 4).

CRRT mimics the functions of the kidneys in regulating water, electrolytes, and wastes by continuing 24 hours a day and can continue for several days, slowly removing fluid and solutes. During CRRT, a patient's blood is outside the body and in contact with artificial tubing and filters.

Because fluid removal with CRRT is much slower than with intermittent hemodialysis, CRRT is an ideal therapy for critically ill patients in unstable conditions. However, a marked decrease in blood pressure, oxygen saturation; an increase in edema; or weight gain may indicate that the patient's therapy objectives are not being achieved or that the circuit is not functioning properly. In this instance, Staff should notify the physician and decrease or stop fluid removal until the patient's condition becomes more stable.

Failure to monitor a patient's vital signs, in accordance with facility policy, could potentially result in nursing staff failing to recognize deterioration in a patient's status and result in harm to the patient and/or the patient's death.

Findings include:

1. The hospital had a policy and procedure titled "Continuous renal Replacement Therapy (CRRT) Procedure" (revised: 3/08) which stated in part, "...TREATMENT...Vital signs every 15 minutes until stable, then every 30 minutes...."

2. Review of the CCRT standing order form revealed the following, in part, "...VITAL SIGNS Per Protocol: Minimum every 15 minutes until stable, then every 30 minutes and PRN. Call if:_____..."

During an interview, medical record review, and document review on 11/16/11 at 10:25 AM, Staff TT, Registered Nurse (RN), reported staff document the patient's vital signs on an ICU Flowsheet - not on the CRRT Flowsheet. Additionally, if more frequent documentation of vital signs is required staff document on the ICU Frequent Parameter Flowsheet.

3. Review of Patients #1, 2, 3, and 4's medical records showed nursing staff failed to document vital signs every 15 minutes at any time during the patient's CRRT and only sporadically documented every 30-minute vital signs. Patients #1, 2, 3, and 4's medical records contained no evidence of ICU Frequent Parameter Flowsheets in the hospital's electronic documentation system.

a. Patient #1's medical record showed staff initiated the CRRT on 8/18/11 at 11:00 P.M. and the treatment ran continuously until 8/22/11 at 2:45 P.M. Review of the ICU Flowsheet showed staff failed to document every 30-minute vital signs from 8/18/11 at 11:00 P.M. through the end of treatment on 8/22/11 (at least three days later). ICU staff reinitiated CRRT on 8/25/11 at 7:22 P.M. and the treatment ran continuously until 8/26/11 at 7:41 A.M. (approximately 12 hours). However, review of the ICU Flowsheet showed staff failed to document every 30-minute vital signs from 8/25/11 at 7:22 P.M. through 8/26/11 at 7:41 A.M.

b. Patient #2's medical record showed staff initiated the CRRT on 1/7/2011 at 4:00 P.M. and the treatment ran continuously until 1/10/11 at 8:25 A.M. (approximately 2 days and 16 hours). Review of the ICU Flowsheet showed staff failed to document every 30-minute vital signs from 1/7/11 at 4:00 P. M. through 1/10/11 at 7:00 A.M. Staff documented 2 sets of vitals for the 8 A.M. hour on 1/10/11.

c. Patient #3's medical record showed staff initiated the CRRT on 2/19/11 at 6:25 P.M. and the treatment ran continuously until 2/21/11 at 8:00 A. M. (approximately 37.5 hours). Review of the ICU Flowsheet showed staff failed to document every 30-minute vital signs on 2/19/11 for the 6:00 P.M. hour, from 2/20/11 at 8:00 A. M. through 8:00 P.M. and 2/21/11 for the 3:00 A.M. hour.

d. Patient #4's medical record showed staff initiated the CRRT on 3/3/11 at 3:00 P.M. and the treatment ran continuously until 3/10/11 at 1:10 A. M. (approximately 6 days and 10 hours). Staff restarted the CRRT at 1:55 A.M. and the treatment ran continuously until 3:17 P.M. (approximately 13 hours). Staff reinitiated the CRRT at 6:00 P.M. and the treatment ran continuously until 3/11/11 at 7:57 A.M. (approximately 14 hours). Staff resumed CRRT 3/11/11 at 9:00 P.M. and the treatment ran continuously until 3/15/11 at 8:30 A.M. (approximately another 3 days and 11.5 hours). Staff resumed CRRT at 11:40 A.M. and the treatment ran continuously through 3/16/11 at 1:00 P.M. (approximately another 13 hours). However, review of the ICU Flowsheet showed staff failed to document every 30-minute vital signs from 3/3/11 at 3:00 P.M. through 3/4/11 2:00 hour, 3/11/11 4:00 P.M. through 3/10/11 8:00 P.M. hour, 3/10/11 11:00 P.M. hour, and 3/11/11 1:00 A.M. through 3/16/1:00 P.M.

Based on observation, record review, and staff interview the acute care hospital failed to secure patient medical records from unauthorized users (housekeeping) in the nuclear medicine department and chemotherapy infusion department. The Nuclear Medicine staff reported completing approximately 100 studies per month.

Failure to secure patient medical records from unauthorized users could potentially result in the inappropriate use of a patient's identity or medical information.

Findings include:

1. An observation on 11/16/11 at 8:30 AM, with Staff J, Nuclear Medicine Coordinator, revealed the Hot Lab (the area where nuclear materials are stored until use) contained 2 doors, each with a combination keypad lock and a key lock. Nuclear medicine staff prepares the paper work for the nuclear medicine studies a day in advance and at the end of the day leaves the information containing patient information lying on the worktable. Nuclear Medicine staff secures the Hot Lab at the end of the workday. Housekeeping then cleans the Hot Lab during the night when no Nuclear Medicine staff ispresent. Housekeepers are unauthorized users for confidential patient medical records.

Review of the policy on 11/16/11 titled "Minimum Necessary Information", revised January 2009, found it states in part, "The following categories of staff are permitted unrestricted access to confidential healthcare information for the purpose of providing patient care: Attending physician, Consulting physicians (medical, surgical and specialists), Clinical staff who participate in care of patients in a confidential location."

During an interview on 11/16/11 at 8:30 AM, Staff J acknowledged the cleaning of the Hot Lab after hours by housekeeping with no Nuclear Medicine staff present. The Hot Lab does contain unsecured patient information.

During an interview on 11/16/11 at 9:45 AM, Staff K, Manager of Environmental Services, verified that housekeeping cleans the Hot Lab during the night with no supervision. The housekeepers have a key to open the Hot Lab.

2. Observation on 11/16/11 at 10:15 AM with Staff M, Clinical Nurse Supervisor of the Chemotherapy Infusion Unit, revealed unsecured storage for approximate 1500 patient medical records in the receptionist area. The Chemotherapy Infusion Unit is locked at the end of the day. Housekeeping staff cleans after business hours with no Chemotherapy staff present.

Review of the policy titled on 11/16/11, "Minimum Necessary Information "revised January 2009 states in part ... "The following categories of staff are permitted unrestricted access to confidential healthcare information for the purpose of providing patient care: Attending physician, Consulting physicians (medical, surgical and specialists), Clinical staff who participate in care of patients in a confidential location."

During an interview on 11/16/11 at 10:15 AM, Staff M acknowledged cleaning of the unit by housekeeping at the close of business with no chemotherapy staff present.

Staff L, Receptionist, verified cleaning of the reception area after hours with the patient medical records unsecured.

Based on review of policies/procedures, medication error reports, and staff interviews, hospital staff failed to notify physicians of medication errors for 6 of 20 medication error reports reviewed. (Patients #21, 22, 23, 24, 25 and 26).

The Compliance Officer reported an average daily census of approximately 8 Behavioral Health patients, 5 Intensive Care Unit patients, 5 inpatient rehabilitation patients, 33 acute care patients, 6 cardiac care patients, and 88 emergency room patients.

Failure to notify the physician of medication errors could result in delays in a physician ordering changes in the patient's care, if necessary.

Findings include:

1. Review of "Drug Administration Errors" policy, dated 6/11, revealed in part, "...Drug administration errors...are immediately reported to the attending physician...the person identifying the occurrence should immediately contact the physician with details...and the physician will determine the appropriate action to be taken...A red flag alert [medication error report] is to be completed...."

2. Review of "Red Flag Alert" policy, dated 11/3/11, revealed in part, "...Red Flag Alert is a documentation mechanism for an event which has caused harm, has the potential to cause harm, is identified as a breakdown in service or process at Great River Health Systems and include but not limited to: ...Medication error...If the event [medication error] has actually reached the patient or an omission or a physician medication order, the attending physician must be notified. The event should then be documented in the medical record following the guidelines below and complete a Red Flag Alert."

3. Review of Red Flag Alert reports revealed:

a. Nursing staff failed to administer Vancomycin 1 gram (gm) every 12 hours, on 3 consecutive doses to Patient #21 on 4/14/11 as ordered by the physician. Nursing staff failed to notify the physician of the error. Vancomycin is a medication that is frequently used to kill bacteria that cannot be killed by other antibiotics.

b. Nursing staff failed to administer Bisacodyl Suppository two times daily (bid), from 12/29/10 to 1/4/11, six days - 12 consecutive doses to Patient #22 as ordered by the physician. This suppository will usually result in a bowel movement by the patient. Nursing staff failed to notify the physician at the time the errors occurred. On 1/5/11 in the AM, the physician ordered a flat plate of Patient #22's abdomen due to distention (potentially due to lack of bowel movement) and ordered the suppositories to be given again.

c. Nursing staff failed to administer Insulin R for 7 consecutive doses to Patient #23, from 1/20/11 to 1/22/11, as ordered by the physician. Nursing staff failed to notify the physician of the error.

d. Nursing staff failed to administer Claforan, 2 consecutive doses to Patient #24 on 11/2/11. Nursing staff failed to notify the physician of the error.

e. Nursing staff administered Lopid and Tylenol on 3 consecutive doses to Patient #25 on 2/16/11 to 2/17/11. The physician discontinued Lopid and Tylenol on 2/16/11 at 7:10 AM. Nursing staff failed to notify the physician of the errors.

f. Nursing staff failed to administer an inhaler to Patient #26 on 3/11/11 at 10:30 PM. Nursing staff failed to notify the physician of the error.

4. During an interview on 11/16/11 at 3:08 PM, Staff Z, Registered Nurse (RN), Nursing Director of the Acute Care nursing floor acknowledged nursing staff failed to notify the physician of the medication errors for Patients #21, 22, 23, 24, 25, and 26. Staff Z said he/she was unable to find additional documentation validating physician notification in the patients ' medical record.

5. During an interview on 11/16/11 at 9:50 AM, Staff P, Pharmacist said the nursing staff "are probably not getting the physicians contacted" regarding medication errors.

6. During an interview on 11/16/11 at 10:25 PM, Staff Q, Pharmacist confirmed that the hospital policy directed nursing staff to contact the physician immediately after the medication error occurred.

Based on observation, document review, and staff interview the radiology staff failed to adequately monitor the safety of shielding devices used by patients and personnel during procedures that emit radiation. The radiology staff reported a monthly average of 3000 procedures that required shielding devices.

Failure to log and document evidence of each shielding device's maintenance and inspection could potentially result in the shielding device (such as an apron worn by a patient to prevent radiation exposure to reproductive organs) not stopping the exposure of the patient to radiation in that area of the body, increasing the potential of harmful exposure to radiation.

Findings include:

1. During tour of x-ray, fluoroscopy, mammogram and computed axial tomography (CAT scan) rooms on 11/15/11 at 2:00 PM with Staff Q, Director of Diagnostic Imaging, observation revealed shielding devices (lead aprons, skirts, collars, gloves, etc.) for patients and/or staff usage. Observation of the shielding devices revealed each lacked an identifying number or other identifier. Staff Q stated the staff did not keep a log of each shielding device to monitor for its continued ability to prevent radiation from penetrating the shield to reach a patient's body part. Staff Q stated the staff did not inventory the shielding device and confirmed there would not be documented evidence the staff inspected each shielding device.

2. Review of "Radiation Protective Apparel and Devices Policy," dated 3/1/2005, revealed in part, "All radiation protective apparel/devices will have a yearly visual inspection for defects in the integrity of the protective material...." Staff Q stated since the staff did not have an inventory of each shielding device, the staff could not document when staff inspected the shielding device. A visual inspection is not likely to find the microscopic cracks in the material that will allow radiation to penetrate.

3. During an interview on 11/16/11 at 9:30 AM, Staff R, Technical Radiology Supervisor, provided an inventory of shielding devices and confirmed prior to this inventory, the staff did not have knowledge of the number of shielding devices in each department. Staff R confirmed the hospital owned lead-lined gloves and the inventory list did not identify these. Staff R confirmed the hospital lacked a log of when staff inspected each shielding device.

Based on review of hospital documents, observation, and staff interviews, the Radiation Safety Officer failed to ensure surgical staff wore dosimetry badges in the operating room during surgical procedures involving C-Arm fluoroscopes. The Administrative staff reported an approximate monthly average of 169 procedures involving C-Arm fluoroscopes in surgery and 2-3 C-Arm fluoroscopes procedures in the Digestive Health surgical clinic.

A dosimeter badge is worn by an individual. The badge detects the presence and amount of radiation to which the individual is exposed. Failure to provide dosimetry badges to staff exposed to ionizing radiation could potentially result in the staff receiving an unknown and unrecognized quantity of ionizing radiation, potentially resulting in cancer and/or death.

Findings include:

1. Review of the following documents revealed:

a. "1st quarter 2011 Radiation Safety Committee Meeting Minutes" dated 3/3/11, "...It was decided based on the review of the previous 3 years exposure history that surgical personnel would no longer be issued dosimetry...."

b. Letter to Bureau of Radiological Health dated 9/19/11, "Great River Medical Center made the decision to stop providing dosimetry badges to personnel assigned to the surgical department...."

c. Reply to the above letter dated 9/12/11, "...The Iowa Department of Public Health (IDPH) has received employee complaints...regarding dosimetry badges. The complaints are specific to Great Medical River Center no longer providing dosimetry badges to employees for the purpose of monitoring radiation exposure...Each licensee...shall monitor exposures from sources of radiation...As a minimum...Individual working with medical fluoroscopic equipment."

d. "Radiation Safety", reviewed 1/2010, "Patients and employees shall be protected from unnecessary radiation....hospital employees who regularly assist in radiographic procedures (e.g. O.R. [operating Room] personnel) will also wear radiation-monitoring devices...."

2. Observation during the initial tour of the Digestive Health Surgical Clinic on 11/16/11 at 1:00 PM revealed a portable C-arm fluoroscope stored behind a curtain in a patient bay area. Staff P, Manager of Surgery, stated only the surgeons and anesthesia personnel wear the dosimetry badges during the C-arm fluoroscopes procedures. Staff P stated the staff did not wear dosimetry badges due to so few C-Arm fluoroscopes procedures performed. Staff P stated since the physicians performed only 2-3 C-arm fluoroscopes procedures per month, "This did not justify the cost of the dosimetry badges," for the Digestive Health Surgery staff.

Observation, during the initial tour of the general surgical department, on 11/16/11 at 2:45 PM, revealed 9 working operating rooms equipped with a C-Arm fluoroscopes. Staffs N, Director of Surgery stated only the surgeons and anesthesia staff wear the dosimetry badge; the rest of the surgery staff does not wear a dosimetry badge during the C-Arm fluoroscopes procedure. Staff N stated the Radiation safety Officer did research and staff stopped using the badge.

3. During an interview on 11/17/11 at 9:00 AM, Staff R, Supervisor of Radiology, stated the Radiation Safety Officer wrote to the Bureau of Radiological Health and is now waiting for an approval letter for surgical nursing/technician staff not to wear dosimetry badges. Staff R confirmed the hospital did not receive an approval letter to date.

During an interview on 11/17/11 at 11:00 AM, Staff V, Radiation Safety Officer, confirmed staff did not follow the hospital policy "Radiation Safety" at this time and the surgical staff, excluding the physician and anesthesia staff, as of July 1, 2011 did not wear dosimetry badges during surgical procedures involving C-arm fluoroscopes.

During a phone interview on 11/17/11 at 11:15 AM, with Staff R and Staff V in attendance, the Chief of the Iowa Bureau of Radiological Health stated all staff in the operating room during a surgical procedure involving C-arm fluoroscopes must wear a dosimetry badge.

The Compliance Officer on 11/17/11 at 12:30 PM identified 21 surgical nurses and 16 surgical technicians worked in the surgical department and had not wore a dosimetry badge since 7/1/2011.

Based on observation, document review, and staff interview, the hospital staff failed to ensure that employees followed their policy and manufacturer's instructions for use of the hospital approved testing and disinfection product MetriCide OPA Plus when cleaning and disinfecting patient care equipment for the Radiology and Surgery departments. The Radiology manager reported an approximate monthly average of 23 pelvis ultrasounds where this disinfectant would be used. The Director of Operating Room (OR) reported an approximate monthly average of 351 scope procedures in the Digestive Health surgical clinic where the disinfectant would be used.

Failure to use products that will kill bacteria and microorganisms that cause infections (i.e., disinfect)as directed by the manufacturer potentially puts patients at risk for exposure to infections and blood borne pathogens.

Findings include:

1. Review of the following documents revealed:

a. The product insert for MetriCide Solution Test Strips, provided by Staff T on 11/15/11, revealed in part, "MetriCide Solution Test Strips are semi-quantitative chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in MetriCide OPA Plus solution...It is recommended that MetriCide OPA Solution be tested before each usage with the MetriCide OPA Plus Solution Test Strips...When opening the bottle for the first time, record the date opened on the bottle label. Do not use any remaining strips 90 days after first opening the bottle. Improper storage or use of test strips may result in false readings...."

b. Hospital policy "Ultrasound/Probe Care and handling for Surgical Services" dated July 2004, "To ensure...probe is cleaned and disinfected prior to and post procedure. Effectiveness of MetriCide OPA Plus will be tested and documented prior to each usage...."

2. Observation on 11/15/11 at 1:00 PM, during the tour of the Radiology department with Staff U, Radiology Supervisor, revealed MetriCide OPA Plus disinfectant used to disinfect the Ultrasound trans-vaginal probes and an opened bottle of MetriCide Solution Test Strips. Observation revealed the staff failed to date the bottle of test strips when opened.

Review of the Ultra Sound "Cidex [MetriCide OPA Plus] Log", dated from August of 2011 thru Nov of 2011, revealed the Ultra Sound staff tested the MetriCide OPA Plus solution with the MetriCide test strips once in the morning, Monday thru Friday.

During an interview on 11/15/11 at 1:00 PM, Staff T, Ultrasound Technician, verified that he/she was unaware that the MetriCide OPA Solution Test Strips needed the date the staff opened the MetriCide Test Strip Bottle and that the strips outdated in 90 days after opening. Staff T confirmed the undated bottle and stated a new bottle has 100 strips and if testing solution once a day the staff could potentially use the strips past the recommended 90 days. Staff T verified there were no additional test strips in the Ultra Sound room available for use.

During an interview on 11/15/11 at 1:00 PM, Staff S, Ultrasound Technician, stated the staff checked the MetriCide OPA Plus solution once daily in the morning. Staff S provided a copy of the manufacturer's MetriCide OPA Plus insert and acknowledged the manufacturer recommends the staff check the MetriCide solution prior to usage.


3. Observation on 11/16/11 at 1:00 PM, during the tour of the Digestive Health surgical clinic revealed 3 Automated Endoscope Reprocessors used to clean the endoscopes. Staff opened the drawer and revealed the MetriCide Solution Test Strips.

Review of the "Quality Control log for Endoscope" dated September 2011 thru November 2011 noted a pass/fail test performed one time daily Monday thru Friday for each of the 3 Automated Endoscope Reprocessors.

During an interview on 11/16/11 at 1:00 PM, Staff O, Technician, stated the staff test the MetriCide with the MetriCide Test Strips prior to Automated Endoscope Reprocessor usage but only document the initial testing in the morning. Staff O confirmed the lack of documented evidence staff tested the 3 Automated Endoscope Reprocessors prior to each usage.

4. During an interview on 11/15/11 at 3:35 PM, Staff Q, Director of Diagnostic Imaging, stated the hospital policy confirmed staff needed to test the MetriCide solution prior to each usage. Staff Q stated the staff would have to change the current practice on only testing solution once a day.

I. Based on observation, staff interview, and document review, the hospital failed to ensure nursing staff followed the manufacturers' directions when using special wiping cloths that contain a disinfectant used by staff during 3 of 3 observations (Medical/Surgical floor, Day Hospital, and Acute Dialysis/Intensive Care Unit). The hospital has an average of 72 inpatients per day.

Failure to follow the manufacturers' directions for the use of disinfecting wipes could potentially result in the disinfecting wipe failing to kill microorganisms, potentially allowing the microorganism to spread to another patient, and potentially result in a life-threatening infection.

Findings include:

1. Observation on 11/15/11 at 8:07 AM in the Medical/Surgical unit revealed Registered Nurse (RN) Y used a PDI Sani-Wipe cloth to clean a computer workstation on a rolling cart. The PDI Sani-Wipe left liquid on the computer work station. The computer workstation stayed wet for approximately 1 minute 30 seconds.

During an interview on 11/15/11 at 10:30 AM, the Infection Control Practitioner stated the nurses should ensure the disinfecting liquid in the PDI Sani-Wipe cloth stayed wet on the surface of the computer workstation for the time recommended by manufacturer.

Review of the manufacturer's "TECHNICAL SUMMARY AND DATA" for the PDI Sani-Wipe cloths, copyright 2011, revealed in part, "Most ... organisms are killed within two (2) minutes by exposure to the liquid in the wipe."

2. Observation on 11/16/11 at 10:30 AM, in the Day Hospital unit, revealed Patient Care Technician YY used a PDI Sani-Wipe cloth to clean a computer workstation on a rolling cart. The PDI Sani-Wipe left liquid on the computer work station. The computer workstation stayed wet for approximately 1 minute.

Additionally, Patient Care Technician YY sprayed a blue recliner in the Day Hospital with HB Quat Disinfectant Cleaner. The HB Quat Disinfectant Cleaner stayed wet for approximately 2 minutes.

Review of the manufacturer's "Technical Data", version 7/11, for HB Quat Disinfectant Cleaner revealed in part, "Treated surfaces must remain wet for 10 minutes."

During an interview, at the time of the tour, the Director of the Day Hospital read the manufacturer's label on the PDI Sani-Wipe, and acknowledged the manufacturer required staff to leave the surface wet with the disinfecting liquid for 2 minutes, and Patient Care Technician YY did not leave the surface wet on the computer workstation for 2 minutes. Additionally, the Director of the Day Hospital acknowledged the manufacturer of the HB Quat Disinfecting Cleaner required staff to leave the surface wet with the disinfecting liquid for 10 minutes, and Patient Care Technician YY did not leave the surface on the blue recliner wet for 10 minutes.

3. Observation on 11/16/11 at 8:25 AM in the Intensive Care Unit showed Staff SS, Dialysis RN, used PDI Super Sani-Cloth Germicidal Disposable Wipes to clean the automated peritoneal dialysis (APD) machine and the patient's bedside table following a peritoneal dialysis treatment and dressing change. The surface of the APD machine and the bedside table remained wet for approximately 1 minute.

During an interview and review of the manufacturer's directions for use, with Staff SS at the time of the observation revealed the following in part, "...TO DISINFECT AND DEODORIZE: To disinfect nonfood contact surfaces only: ...thoroughly wet surface. Treated surface must remain visibly wet for a full two (2) minutes. Use additional wipe(s) if needed to assure continuous two (2) minute wet contact time...." Staff SS acknowledged she was unaware of the required wet contact time to ensure that the chemical would disinfectant by killing hepatitis B virus and other bacteria, tuberculosis, and virus'.



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II. Based on observation, policy review, FDA food code review, and staff interviews the hospital dietary staff failed to maintain a sanitary kitchen environment. The hospital administrative staff reported a census of 63 patients on entrance and the Director of Nutrition Services reported the dietary staff provided approximately 180-200 patient meals daily.

Failure to maintain the kitchen environment in a sanitary manner could potentially result in the contamination of the patient's food.

Findings include:

1. Observation during the tour of the kitchen environment on 11/14/11 beginning at 2:15 PM identified the following concerns, acknowledged by Staff A, Director of Nutrition Services:

a. A metal stand, utilized to hold a large Hobart mixer, had an open storage space underneath the mixer which contained a mixing bowl stored upside down. The bottom and side surfaces of the storage area had a covering of dust.

b. The southwest corner of the kitchen, to the right of the Beverage Air refrigerator (identification number GRM RF39), had an accumulation of food debris on the floor.

c. The back of the Market Forge steamer and the wall behind the steamer had a heavy accumulation of dust. The floor under and behind the steamer and the Groen steam kettle next to it, had an accumulation of scattered food debris.

d. The floor under and behind the grill and Vulcan stove had an accumulation of scattered food debris.

During an interview at the time of the tour, Staff A reported the cooks on each shift are directed to clean and sweep their work area prior to leaving for the day. Staff A further reported the entire department floor is mopped daily at the end of the day. He confirmed the noted concerns with dust and food debris represented an accumulation over a time period much more than a day.

e. Observation found 5 uncovered refuse containers in the cooks' area. The containers held food-related refuse and recyclables. All of the garbage containers remained uncovered during subsequent observations on 11/14/11 between 4:10 PM and 5:20 PM, 11/15/11 at 7:40 AM, 11/15/11 between 11:00 AM and 12:00 PM and 11/16/11 at 7:30 AM.

During an interview on 11/16/11 at 8:45 AM, Staff A confirmed the department refuse containers remained uncovered at all times and lacked knowledge of the Food and Drug Administration's Food Code requirements to keep refuse containers covered in foodservice areas.

Review of The Food Code, published by the Food and Drug Administration and considered a standard of practice for the food service industry, in both the 2005 and 2009 editions (section 5-501.113), revealed a requirement that receptacles and waste handling units for refuse, recyclables, and returnables be kept covered if the receptacles and units contain food residue and are not in continuous use or after they are filled.

2. Observations in the kitchen on 11/14/11 and 11/15/11 revealed the following concerns were identified with hair restraints:

a. During observation of meal preparation and meal trayline service on 11/14/11 from 4:10 PM to 5:20 PM, Staff C, dietary aide, passed through kitchen food preparation areas, equipment storage areas, and the trayline area with a beard that was not covered.

b. During observation of meal preparation and trayline on 11/14/11 from 4:10 PM to 5:20 PM, Staff F, cafeteria staff, passed through food preparation areas, equipment storage areas, and walked into a walk-in cooler with an ineffective hair restraint. Staff F wore a cap with an unrestrained ponytail through the back of the cap and loose hair on both sides of the face around the ears. Observation also found Staff F in the kitchen with the same ineffective hair restraint on 11/15/11 at 7:40 AM.

c. During the kitchen environment tour on 11/14/11 beginning at 2:15 PM, through observation of meal preparation and trayline on 11/14/11 from 4:10 PM to 5:20 PM, Staff E, evening supervisor, worked in the food preparation areas, equipment storage areas, and trayline area with an ineffective hair restraint. Staff E, wore a hair bonnet with loose, long, unrestrained hair at the sides of the face by the ears.

d. During observation of meal preparation and trayline on 11/15/11 from 11:00 AM to 12:00 PM, Staff D, cook, worked in the food preparation areas, equipment storage areas, and trayline area with an ineffective hair restraint. Staff D wore a cap with a hair net covering the hair in the back below the cap, but the bangs left loose on the forehead, out of the cap.

During an interview on 11/16/11 at 8:45 AM, Staff A reported dietary staff are allowed the choice of a hairnet, cap or bonnet for hair restraint. Staff A acknowledged some employees choose not to restrain all hair and attributed this to a "vanity issue."

Review of a Nutrition Services policy titled "Infection Control and Sanitation," with a review date of December 2010, revealed in part, "... Hair Restraints 1) Hair restraints such as hats, hair coverings or hair nets are to be worn at all times when preparing and serving food, when cleaning and when spending time in food preparation areas. Loose hair is to be kept tucked in under the hair restraint. The purpose is to effectively keep hair from contacting exposed food, clean equipment and utensils...."

Review of The Food Code, published by the Food and Drug Administration and considered a standard of practice for the food service industry, in both the 2005 and 2009 editions (section 2-402.11) revealed a requirement that food employees wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair that are designed and worn to effectively keep hair from contacting exposed food, equipment, utensils, and linen.

Based on observation and staff interview the hospital failed to integrate the patient's medical record from the Chemotherapy Infusion Unit into the hospital's medical record for the same patient. The Chemotherapy Infusion Unit provides chemotherapy for approximately 150-180 patients a month.

Failure to integrate patient medical records form the Chemotherapy Unit into the hospital's medical record system could potentially result in the lack of communication for the continuation of patient care.

Findings include:

Observation on 11/16/11 at 10:15 AM with Staff M revealed the patient's medical record from the Chemotherapy Unit was not integrated with the hospital medical records. Staff M reported the patient's chemotherapy medical record is paper and electronic. "The electronic medical record system that we use is not the same as the hospital system. They are two different systems and do not merge with each other. The paper record is kept in the department and old files are stored in the basement in a secure cage."

During an interview on 11/16/11 at 5:15 PM, Staff I, Director of Clinic Operations for Great River Clinics, verified the patient medical records form the Chemotherapy Infusion Unit were not integrated into the hospital's medical record system - the two systems are separate.