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Based on review of Patient Rights information, grievance files, Medical Staff Bylaws, hospital policies, PI/QI meeting minutes, medical records, and staff interview it was determined the agency failed to provide an effective grievance resolution process and appropriate restraint usage in accordance with hospital policies and regulations. These failures impacted 7 of 7 patients ( #12, #13, #17, #18, #19, #20, and #21) whose complaint/grievance information was reviewed, and 4 of 7 restrained patients (#5, #6, #8, and #9) whose records were reviewed. Failure to provide and effective grievance process had the potential to interfere with quality and coordination of investigation and resolution of all patient/family grievances, as well as the integration of grievances into the PI/QI program. Failure to ensure restraints were utilized and monitored in accordance to valid orders and hospital policy had the potential to negatively impact patient care and safety. Findings include:

1. Refer to A119 as it relates to the failure of the hospital to ensure the grievance process operated effectively.

2. Refer to A121 as it relates to the failure of the hospital to establish a clearly explained procedure for the submission of patients' written grievance to the hospital.

3. Refer to A123 as it relates to the failure of the hospital to provide written notices of the resolutions of grievances.

4. Refer to A168 as it relates to the failure of the hospital to ensure restraint use was in accordance with the order of LIPs in accordance with hospital policy.

5. Refer to A169 as it relates to the failure of the hospital to ensure staff did not order PRN restraints or re-start restraints, after discontinuation, under the same order.

6. Refer to A175 as it relates to the failure of the hospital to ensure trained staff monitored restrained patients in accordance with hospital policy.

The cumulative effect of these negative systemic practices seriously impeded the ability of the hospital to provide services of adequate quality.

Based on staff interview and review of hospital policies, grievance files, and PI/QI meeting minutes, it was determined the hospital failed to ensure the grievance process operated effectively. This impacted 7 of complainants/patients (#12, #13, #17, #18, #19, #20, and #21) whose grievance files were reviewed. It had the potential to interfere with quality and coordination of investigation and resolution of all patient/family grievances. It also had the potential to impact integration of grievance findings into the quality improvement process. Findings include:

1. The hospital did not have a procedure for submission of written grievances. "Patient Right's" information did not instruct the patient/caregiver how to file a written complaint/grievance. This was confirmed during a telephone interview with the CEO on 12/07/10 at 9:30 AM. When asked about written procedures, the CEO stated "What is there to know? You pick up a pen and paper and write a letter."

2. Complaints/grievances were not documented on incident reports to allow for trending, analysis and report through the quality improvement structure. The hospital policy, "Resolution of Patient Complaints/Grievances," dated 1/09, stated it was the role of the employee to complete an incident report at the time of the identification of a patient grievance. Incident reports were reviewed for January of 2009 through November of 2010. No incident reports were completed related to 7 of 7 complaints/grievances (#12, #13, #17, #18, #19, #20, and #21) reviewed. During a telephone interview on 12/07/10 at 2:00 PM, administrative staff were asked provide evidence of completion of incident reports. None were provided.

In addition, communication with complainants, steps of investigation, and efforts at resolution were not documented and attached to hospital incident reports. This was not done because incident reports were not completed. The hospital policy, "Resolution of Patient Complaints/Grievances," dated 1/09, stated "documentation regarding the communication, steps, and efforts at resolution will be documented and attached to the hospital incident report."

During an interview on 12/01/10 at 9:00 AM, the Director of Quality/Risk Management stated they do not always document analysis on incident reports. He stated "If you know anything about Risk Management you know less is more."

3. The hospital did not log grievances clearly as grievances. The hospital had a binder labeled "Complaints/Grievances 2010." The complaints were not separated from grievances or labeled to identify which incidents were handled as complaints and which were handled as grievances. This impacted follow-up, as grievances required resolution letters be sent to complainants while complaints did not require resolution letters.

The hospital policy, "Resolution of Patient Complaints/Grievances," dated 1/09, stated "the administrator will provide a written notice of the decision involving the grievance." Hospital staff did not provide written notice to patients/complainants related to grievance decisions, in accordance with hospital policy or regulation. This was the case for 5 patients/complainants (#12, #13, #17, #18, and #20) whose complaints met the definition of grievances.

4. According to the hospital's policy, "Resolution of Patient Complaints/Grievances," dated 1/09, the governing body delegated the responsibility for the resolution of patient grievances to the administrator of the hospital. The hospital failed to ensure the responsible party (the administrator) provided effective oversight of the grievance process and ensured assigned roles were completed as required by hospital policy. The following roles were identified in the policy:

> Role of employee: Complete an incident report at the time of the identification of a patient grievance: forward the incident report to their immediate supervisor for action. This was not done (as described in #1 above).

> Role of the employee's supervisor: Document on, or in an attachment to, the incident report actions taken. This was not done (as described in #2 above).

> Role of administration: Provide the written follow-up at the completion of the investigation to the patient and family. This was not done (as described in #3 above).

> Role of the Risk Manager: Log the grievance. Grievances were not clearly logged as grievances (as described in #3 above).

During a telephone interview on 12/07/10 at 9:30 AM, the CEO confirmed he was the delegated administrator, and responsible for the grievance operation, although he delegated tasks to others.

The hospital failed to ensure effective operation of the grievance process.

Based on review of "Patient Rights" information and staff interview, it was determined the hospital failed to establish a clearly explained procedure for the submission of patients' written grievances to the hospital. This had the potential to act as a hindrance to the submission of grievances and had the potential to impact all patients admitted to the hospital. Findings include:

The packet of information provided to patients at admission was reviewed. The information explained the hospital's grievance procedures. A form, "Patient's Rights," contained within the packet, had a section subtitled "Your Right to File a Grievance Please let us know..." It stated "if you wish to file a formal complaint or grievance during or after your discharge, please contact the Hospital Administrator." A telephone number to the hospital was provided. There was no information provided in the "Patient's Rights" information explaining how a patient could submit a written grievance (e.g. whom to address a letter, the address or email where to send the grievance, if any grievance form was available to complete).

This was confirmed during a telephone interview with the CEO on 12/07/10 at 9:30 AM, who stated "What is there to know? You pick up a pen and paper and write a letter."

The hospital failed to establish a clearly explained procedure for the submission of a patient's written grievance to the hospital.

Based on staff interview and review of grievance files and hospital policy, it was determined the hospital failed to provide written notice of the resolution of grievances for 5 of 7 patients (#12, #13, #17, #18, and #20) whose complaint/grievance information was reviewed. This had the potential to result in a lack of clarity for complainants as to the steps taken to resolve the grievances, the resolution of the grievances, and who the complainant could contact for further information or communication. Findings include:

A hospital policy, "Resolution of Patient Complaints/Grievances," dated 1/09, described a patient grievance as a formal or informal written or verbal complaint made to the hospital by a patient or family/representative regarding the patient's care (when the complaint was not resolved at the time of the complaint by staff present). Staff present was defined as any hospital staff present at the time of the complaint or who could quickly be at the patient's location to resolve the patient complaint. The policy stated the following circumstances indicated a grievance:

> When staff present are unable to resolve the issue. If a patient care complaint cannot be resolved at the time of the complaint by staff present, is postponed for later resolution, is referred to other staff for later resolution, requires investigation, and/or requires further actions for resolution, then the complaint is a grievance.

> When patient/family call or write to the hospital about concerns related to patient care or services. A written complaint is "ALWAYS" considered a grievance. An e-mail or fax is considered "written."

> All verbal or written complaints regarding abuse, neglect, patient harm, or hospitals compliance with Medicare Conditions of Participation are considered grievances.

The following complaints were included in a binder labeled "Complaints/Grievances 2010." They all met the definition of grievances according to hospital policy and regulation. None of the complainants identified below were provided with written responses to the grievances.

1. An e-mail communication from a CM to the Director of Quality/Risk Management, dated 7/26/10 at 10:04 AM, documented a complaint from a family member regarding the staff not coming into Patient #13's room for over 2 hours.

During an interview on 12/03/10 at 9:45 AM, the Director of Quality/Risk Management stated in order to investigate the complaint he reviewed call light logs but did not document his investigation.

No letter of resolution was provided to the complainant. Because the complaint required follow-up investigation, it met the definition of a grievance and required written notice in response as part of the grievance process.

2. An e-mail communication from an RN to the Director of Quality/Risk Management, dated 8/03/10 at 11:01 AM, documented complaints a family member made regarding investigation and management of Patient #17's pain.

A CM entry, on an "INTERDISCIPLINARY PROGRESS NOTE," dated 8/05/10 at 3:00 PM, documented involvement of multiple staff, including the CEO, DCS, an LPN, and 2 physicians, to address family concerns about care.

No letter of response was provided to the complainant. Because the complaints required follow-up investigation and interventions, they met the definition of grievances and required written notice from the hospital regarding its decision as part of the grievance process.

3. An e-mail, dated 3/10/10 at 8:28 AM, addressed to hospital staff from a family member, expressed concerns regarding Patient #18's care.

No letter of resolution was written to the complainant. Because the complaint was received in writing, it met the definition of a grievance and required written notice of the hospital's decision.

4. A letter, dated 1/08/10, documented multiple complaints a family member had regarding Patient #20's care. The letter did not document the author of the letter.

CM entries, dated 1/08/10 and 1/14/10, in "INTERDISCIPLINARY PROGRESS NOTES," documented multiple staff (i.e. CEO, DCS, DNO, MSW, and House Supervisor) were involved in the investigation and resolution of the complaints.

A handwritten note, dated 1/21/10 at 4:50 PM, stated "discussed complaint management status was 100% satisfied." The note was signed by the Director of Quality/Risk Management.

No letter of resolution was provided to the complainant. Because the complaints required follow-up investigation and later actions, the complaint met the definition of a grievance and required written notice of the hospital's decision.

5. A DNO entry, dated 6/30/10, documented concerns family members had regarding Patient #12's nursing care, alleging lack of nursing responsiveness to cleanliness needs, use of chemical restraints, and negative attitude of a nursing staff member. An "INTERDISCIPLINARY PROGRESS NOTE," dated 6/30/10" referenced a Care Conference that addressed some of the family concerns6. Additionally, an e-mail communication between the DNO and Director of Quality/Risk Management, dated 8/05/10 (36 days after receipt of the complaint), documented a follow-up telephone call to the family. The e-mail stated "I hope this helps in closing out the complaint."

No letter of resolution was provided to the complainant. Because the complaints were not resolved at the time and required follow-up, the complaints met the definition of a grievance and required written notice of its decision as part of the grievance process.

The Director of Quality/Risk Management, along with the CEO and DNO, were interviewed on 12/03/10 at 9:45 AM. During the interview, the complaints included in the "Complaints/Grievance 2010" binder were discussed. The Director of Quality/Risk Management explained the grievances (listed above) were designated as complaints because the hospital was able to resolve the complaints to the patients' satisfaction.

The hospital did not classify complaints as grievances in accordance with hospital policy and regulation. As a result, the hospital failed to provide written notice to patients/family members who had grievances.

Based on staff interview and review of medical records, hospital policies and bylaws, it was determined the hospital failed to ensure restraint use was in accordance with the order of LIPs and hospital policy for 7 of 7 restrained patients (#2 #5, #6, #8, #9, #10 and #11) whose records were reviewed. This resulted in restraint use without valid orders. Findings include:

1. The hospital policy, "Restraint Use," dated 01/09, stated an order for medical restraints expired each calendar day. This statement implied restraint orders would expire at 11:59 PM on the calendar day restraints were ordered. However, the records of 6 patients who were restrained (#2, #5, #6, #8, #9, and #10) showed the patients continued to be restrained after 11:59 PM when orders expired.

During a telephone interview on 12/07/10 at 2:00 PM, corporate staff confirmed orders for medical restraints expired per calendar day rather than after 24 hours.

Examples include, but are not limited to, the following:

> Patient #2: Restraint orders, dated 7/10/09 at 1:00 PM, expired 7/10/09 at 11:59 PM. Nursing documentation on a "Restraint Flow Sheet," indicated restraints were removed on 7/11/09 at 7:40 AM (7.5 hours after expiration).

> Patient #5: Sixteen restraint orders reviewed expired at 11:59 PM and were not renewed in accordance with hospital policy. As an example, restraint orders, dated 10/28/10 at 9:30 AM, expired 10/28/10 at 11:59 PM. Restraint orders were renewed on 10/29/10 at 3:00 PM (15 hours after expiration)

> Patient #6: Thirteen restraint orders reviewed expired at 11:59 PM and were not renewed in accordance with hospital policy. As an example, restraint orders, dated 10/06/10 at 8:19 AM expired 10/06/10 at 11:59 PM. Restraint orders were renewed on 10/07/10 at 2:40 PM (14+ hours after expiration).

> Patient #8: Four restraint orders reviewed expired at 11:59 PM and were not renewed in accordance with hospital policy. As an example, restraint orders, dated 11/28/10 at 12:30 PM expired 11/28/10 at 11:59 PM. Restraint orders were renewed on 11/29/10 at 9:30 AM (9.5 hours after expiration).

> Patient #9: Eight restraint orders reviewed expired at 11:59 PM and were not renewed in accordance with hospital policy. As an example, restraint orders, dated 11/22/10 at 3:00 PM expired 11/22/10 at 11:59 PM. Restraint orders were renewed on 11/23/10 at 9:30 AM (9.5 hours after expiration).

> Patient #10: Restraint orders, dated 11/17/10 at 8:00 AM expired 11/17/10 at 11:59 PM. Restraint orders were renewed on 11/18/10 at 7:00 AM (7 hours after expiration).

2. A policy, "Restraint Use," dated 01/09, defined an LIP as a MD, DO, DPM, or other professional licensed by the State of Idaho as an independent practitioner and credentialed as a member of the Medical Staff.

"DELINEATION OF PRIVELEGES" documents identified NPs as Allied Health Practitioners, rather than LIPs. Undated Medical Staff Bylaws 2.3 stated Allied Health Practitioners worked in collaboration with a member of the Medical Staff and could not be members of the Medical Staff.

During a telephone interview on 12/07/10 at 10:00 AM, the HIM Manager confirmed NPs were considered Allied Health Practitioners and not members of the Medical Staff.

The hospital allowed NPs to order restraints. The following are examples of patients who had restraints ordered by an NP:

> Patient #5: NP ordered restraints on 10/22/10 at 4:30 PM, 10/25/10 at 8:00 AM, 10/26/10 at 8:00 AM, 10/28/10 at 9:30 AM, 10/29/10 at 3:00 PM, 10/30/10 at 3:00 PM, 11/01/10 at 8:00 AM, and 11/02/10 at 8:00 AM.

> Patient #6: NP ordered restraints on 10/09/10 at 3:30 PM.

> Patient #9: NP ordered restraints on 11/23/10 (time illegible), 11/25/10 at 8:00 AM, 11/26/10 at 9:00 AM, 11/27/10 at 8:00 AM, 11/28/10 at 8:00 AM, and 11/29/10 at 8:00 AM. The DNO reviewed Patient #9's medical record during an interview on 12/03/10 at 8:45 AM. She reviewed the restraint order forms and verified the NP signature.

> Patient #11: NP ordered restraints on 12/02/10 at 7:30 AM.

Administrative staff provided a "Signature Log" showing the names and signatures of the NPs. The orders discussed above were compared to the "Signature Log" to verify NPs wrote the orders.

Allowing NPs to order restraints was not in accordance with hospital policy which required credentialing as a member of the Medical Staff.

Based on record review, policy review, and staff interview, it was determined the hospital failed to ensure staff did not order PRN restraints or re-start restraints, after discontinuation, under the same order for 5 of 7 restrained patients (#5, #6, #8, #9 and #10) whose records were reviewed. This resulted in one patient being chemically restrained on a PRN basis and four patients being restrained without valid orders after discontinuation of restraints. Findings include:

1. Patient #8 was an 80 year old patient admitted to the hospital on 11/15/10. A "NURSING PROGRESS NOTE," dated 11/28/10 at 4:20 AM, described Patient #8 as "uncooperative and combative." Physician orders were obtained, dated 11/28/10 at 4:20 AM, for Haldol IV 0.5 - 1 milligram every 2 hours as needed for agitation. A "PRN INTERVENTION FORM" documented administration of Haldol IV for agitation on 11/28/10 at 4:45 AM, 11/28/10 at 1:00 PM, and 12/01/10 at 9:55 PM. During an interview on 12/02/10 at 1:10 PM, the DNO reviewed the record and confirmed the order.
According to "drugs.com," injectable Haldol, also known as Haloperidol, is indicated for the treatment of schizophrenia and control of Tourette disorder. These conditions were not documented in Patient #8's record. According to the Family Practice Notebook (fpnotebook.com), Haldol can be used as a chemical restraint to manage violent behavior.

The physician's order constituted a PRN order for a chemical restraint.

2. Patient #10 was a 55 year old male who was admitted on 11/07/10. Patient #10's medical record contained NP orders, dated 11/18/10 at 7:00 AM, for bilateral wrist restraints for BiPAP at night. According to a "Restraint Flow Sheet," dated 11/18/10, nursing staff initiated restraints (type not stated) at midnight on 11/19/10. The restraints were initiated based on an order obtained 17 hours prior. The order constituted a PRN order. During an interview on 12/03/10 at 9:25 AM, the DNO reviewed the record, confirmed the documentation, and stated she agreed the order constituted a PRN order.

The physician's order constituted a PRN order for wrist restraints.

3. The policy, "Restraint Use," dated 1/09, stated after a patient is released from restraints, a new order must be obtained for each additional encounter. In the following examples, restraints were removed from patients while family members were in the rooms and then and re-started under existing orders. This constituted PRN use of restraint orders.

a. Patient #6 was a 26 year old female who was admitted to the hospital on 10/01/10 after sustaining injuries in a motor vehicle accident. The medical record contained a physician's order, dated 10/05/10 at 8:00 AM, for bilateral wrist restraints. According to documentation on a "Restraint Flow Sheet," dated 10/05/10, restraints were off from 11:00 AM until 7:00 PM, while family members were present in Patient #6's room. An RN entry on the flow sheet stated "will have to replace when family leaves." The flow sheet indicated the restraints were re-started at 7:00 PM. A new order to re-start restraints was not present in the record.

During an interview on 12/01/10 at 2:45 PM, the DNO reviewed the record and confirmed a new order was not obtained. She stated she did not think a new order was required since the mother had been serving as a replacement for the restraints.

During a second interview on 12/03/10 at 9:00 AM, the DNO explained that staffing levels did not always allow for sitters in order to avoid restraints.

b. Patient #5 was a 73 year old male who was admitted to the hospital on 10/22/10. An RN entry in a "NURSING PROGRESS NOTE," dated 11/03/10 at 12:00 PM, documented restraints were off for approximately one hour until Patient #5 removed his CPAP. Restraints were restarted without a new order.

During an interview on 12/01/10 at 11:00 AM, the DNO reviewed Patient #5's record. She confirmed there was no order for restraints obtained after the trial release.



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c. Patient #9 was a 77 year old female admitted to the hospital on 11/22/10 for continued wound care and rehabilitation therapy. The medical record contained a physician's order, dated 11/24/10 at 3:45 PM, for bilateral wrist restraints to prevent Patient #9 from pulling at her Foley catheter and her abdominal wound dressing. According to documentation on a "Restraint Flow Sheet," dated 11/24/10, restraints were off at the 9:00 AM and 1:00 PM restraint monitoring times while Patient #9 was "out of bed," and not monitored for restraint usage. Documentation on the "Restraint Flow Sheet" indicated restraints were back in place for Patient #9 at 11:00 AM and 3:00 PM. No additional restraint orders for 11/24/10 were present in the medical record.

In addition, the medical record contained an NP order, dated 11/26/10 at 9:00 AM, for bilateral wrist restraints. According to documentation on a "Restraint Flow Sheet," dated 11/26/10, restraints were off at the 9:00 AM and 3:00 PM restraint monitoring times while the family was at the bedside. Documentation on the "Restraint Flow Sheet" indicated restraints were back in place for Patient #9 at 11:00 AM and 5:00 PM. No additional restraint orders for 11/26/10 were present in the medical record.

The DNO was interviewed on 12/03/10 at 8:45 AM. She reviewed Patient #9's medical record and confirmed the documentation in the "Restraint Flow Sheet" probably meant Patient #9 was not in restraints as there was no evidence of continued restraint monitoring. She stated the facility had not considered the need for a new restraint order in the above situations. She agreed if a patient was placed back into restraints after being out of them while family was present, a new assessment of the need for restraints should be completed. She stated this included the assessment of use of the least restrictive measures, an assessment of the behaviors which required a restraint, and a new restraint order.

Orders for the use of restraint were written as standing orders or on a PRN basis.

Based on record review, policy review, and staff interview it was determined the hospital failed to ensure an RN evaluated and appropriately addressed skin care needs upon admission and on an ongoing basis in accordance with accepted standards of nursing practice and hospital policy for 3 of 7 patients (#1, #2, and #9) who had documented skin breakdown whose records were reviewed. This resulted in the development of Stage III ulcers in one patient. It had the potential to result in skin breakdown in all patients at risk of skin breakdown. Findings include:

1. Patient #1 was a 50 year old female who was admitted to the hospital on 7/03/09 and transferred to another acute care facility on 7/13/10. An RN "Admission Assessment," dated 7/03/09 at 4:00 PM included a section describing the assessment of Patient #1's skin, including a description of redness and breakdown in the perianal area. An RN entry in a "NURSING PROGRESS NOTE," dated 7/03/09 at 4:30 PM described the perianal skin as red and excoriated with some bleeding open areas. The number, sizes, or staging of the breakdown was not documented in either nursing entry. Patient #1's Braden Score was identified as 15 (a score of 16 or less indicated a high risk for skin breakdown).

An Interdisciplinary Plan of Care was initiated on 7/03/10 and included monitoring of skin and measures to reduce the risk of breakdown.

Three days later, on 7/06/10, a CWOCN documented pictures and an assessment of Patient #1's wounds. The wounds on Patient #1's buttocks were described as partial thickness wounds with scant sero-sanguineous, brown, odorless drainage. The number of areas of breakdown was not indicated. The CWOCN documented recommending miconazole powder, 3m No Sting Spray, Calazime ointment and a rectal tube.

A hospital policy, "Interdisciplinary Wound Prevention Assessment & Treatment," revised 6/08 stated existing areas of skin breakdown would be assessed for appearance, approximation, drainage/exudates, and stage/depth. In addition, every patient's skin integrity would be reassessed every 12 hours and/or as needed and the Braden scale assessment every 24 hours. Pressure ulcers were classified utilizing a scale: Suspected Deep Tissue Injury; Stage I,; Stage II; Stage III; Stage IV:, and Unstageable. Other wounds/breakdown would be classified as Superficial, Partial Thickness, or Full Thickness.

RN documentation of assessment of the skin of the buttocks on the "ICU FLOW SHEET" was missing or incomplete , as follows:

> No documented skin assessment related to buttocks on 7/04/09 7:30 AM;
> Buttocks described as "red" on 7/05/09 at 7:30 AM;
> Buttocks described as bruising, red/excoriated on 7/06/09 (untimed);
> Buttocks described as red and excoriated on 7/07/09 (untimed);
> Buttocks described as perianal redness on 7/11/09 (untimed)
> No documented skin assessment related to buttocks on 7/12/09 at 8:00 AM.

The Interdisciplinary Plan of Care, dated 7/03/10, included changing Patient #1's positions every 2 hours. In reviewing nursing documentation of positioning on "ICU Flow Sheets," it was determined Patient #1 was not repositioned every 2 hours. Examples of times where positioning was not documented included:

> 7/05/10 from 6:00 PM to midnight;
> 7/06/10 from midnight to midnight;
> 7/08/10 from 1:00 AM to 6:00 AM;
> 7/09/10 from 1:00 AM to midnight.

During an interview on 11/30/10 at 10:10 AM, the DNO reviewed the record and confirmed the incomplete documentation of nursing assessment and repositioning of Patient #1.

On 7/13/10 at 8:00 AM, an RN entry on "ICU FLOW SHEET" documented Patient #1 had developed multiple Stage II-III excoriated ulcers in the perianal area.

The CWOCN was interviewed on 11/30/10 at 10:35 AM. She reviewed Patient #1's record and stated she did not recall the patient. However, she stated, after reviewing the record, she thought the RN documentation on 7/13/09 was not accurate because the skin breakdown looked to her like viral lesions and not pressure ulcers. She explained pressure ulcers were not supposed to be staged as was done by the RN on 7/13/10. She stated there may be a need to further educate nurses in the difference between pressure ulcers and other types of ulcers.

Records were obtained from the secondary acute care facility where Patient #1 transferred to on 7/13/10. Wound care notes from the receiving facility, dated 7/13/09 at 4:06 PM, documented Patient #1's right buttock had 13 Stage III pressure ulcers, all 1 centimeter or less in size. Patient #'1s left buttock had 9 Stage III pressure ulcers, all 1 centimeter or less in size.

The hospital failed to ensure consistent wound assessment and repositioning resulting in patient injury.



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2. Patient #2 was an 86 year old male admitted to the hospital on 7/10/09 for recurrent pneumonia and chronic respiratory failure. The day shift RN documented on the "Summary of Findings 7A-7P" form, dated 7/26/10 at 9:00 AM, Patient #2 had a red coccyx. However, the night shift RN indicated on the "Summary of Findings 7P - 7A" form, dated 7/26/10 at 8:30 PM, Patient #2 had skin breakdown on the coccyx. There was no additional information to describe the skin breakdown noted. The following day the RN indicated on the "Summary of Findings 7A-7P" form, dated 7/27/10 at 9:00 AM, Patient #2 had skin breakdown on his coccyx. There was no additional documentation to further describe what the breakdown was.

The DNO was interviewed on 11/30/10 at 10:30 AM. She reviewed the above documentation found in Patient #2's medical record. She stated she preferred more specific documentation regarding the skin assessment and any potential skin breakdown.

The hospital did not thoroughly and effectively assess and document Patient #2's skin breakdown.

3. Patient #9 was a 77 year old female admitted to the hospital on 11/22/10 for continued wound care and rehabilitation therapy. An "Admission Assessment," completed by an RN on 11/22/10, contained a section for the skin assessment. On a diagram of the human body the RN indicated a large wound in the center of Patient #9's abdomen, with vertical incisions at the top and the bottom of this wound which was labeled as sutured with staples. In addition, a vertical line with hash marks was separate from, and to the left side of, the above wound. There was no description of the wounds, i.e. measurements of the wounds, what the tissue involved looked like, or if there was any odor or drainage. A wound addendum was completed by the CWOCN on 11/22/10. The CWOCN documented measurements and a detailed description of the large open wound in the center of Patient #9's abdomen. There was no documentation of an assessment of the wounds sutured with staples.

The DNO was interviewed on 12/03/10 at 8:45 AM. She confirmed the absence of a description of the wound sites containing the staples. She stated on occasion the House Supervisor initiated the admission assessment and turned it over to the RN caring for the patient for completion when that RN was available. The DNO stated, however, it is the responsibility of the RN caring for the patient to ensure the wound assessment is complete.

During an interview on 12/01/10 at 8:55 AM, the Director of Quality/Risk Management stated they had some work to do regarding nursing documentation related to wound assessments. He stated they work with this issue at least once a year.

The hospital failed to ensure an RN evaluated and appropriately addressed skin care needs upon admission and on an ongoing basis in accordance with accepted standards of nursing practice and hospital policy.

Based on record review, policy review, and staff interview, it was determined the hospital failed to ensure nursing staff developed and/or kept current care plans for 2 of 7 patients (#1 and #8) who had risk for skin breakdown whose records were reviewed. This had the potential to impact quality and coordination of patient care. Findings include:

1. Patient #8 was an 80 year old patient admitted to the hospital on 11/15/10. An RN entry documented the presence of a black decubitus ulcer of the right heel on the "ADMISSION ASSESSMENT," dated 11/15/10 at 2:55 PM. A diagram noted the presence of a "scratch" right buttock, a scab in the right groin, and a dressing on the right chest. The Braden Scale score was documented to be 12. An area next to the score documented "If score 16 or less, patient is at high risk. Incorporate into care plan."

A hospital policy, "Interdisciplinary Wound Prevention Assessment and Treatment," dated 6/08, stated for those patients at high risk (Score 16 or less), a plan would be initiated and care provided using treatment standards based upon the individual needs of the patient. It also stated based on the identification of skin integrity issues during assessment and reassessment, the plan of care would include interventions for care.

There were no planned skin care interventions documented on the initial POC, dated 11/15/10, or the weekly updates, dated 11/18/10 through 11/22/10, and 11/26/10 through 12/02/10.

The following interventions are examples of nursing care interventions and physician orders documented in the record.

> A "Wound Care Documentation" sheet documented wound care instructions as follows: 1) Betadine to first metatarsal site daily after cleansing with normal saline. Hydrate feet with Remedy cream; 2) Triple antibiotic ointment to R [right] Chest skin tear with gauze. Cover dressing daily. Nursing staff documented the interventions (11/18/10 at 9:00 AM, 11/19/10 at 8:00 AM, 11/22/10 at 12:00 PM, 11/24/10 at 1:00 PM, 11/25/10 at 11:00 AM, 11/26/10 at 10:00 AM, 11/29/10 at 2:02 PM, and 11/30/10 at 3:00 PM). These recommendations/interventions were not included in the POC, nor provided daily as stated.

> "PHYSICIAN'S ORDERS," dated 11/27/10 at 1:55 PM included orders for miconazole (anti-fungal) powder to peri-rectal area two times per day. These orders were not included in the POC.

> An RN entry on a "NURSING PROGRESS NOTE," dated 11/24/10 at 2:30 PM, stated patient repositioned in bed often with assist and heels in antipressure boots. These interventions were not included in the POC.

During an interview on 12/02/10 at 1:10 PM, the DNO reviewed Patient #8's record and confirmed skin care interventions were not listed on the POC.

2. Patient #1 was a 50 year old female who was admitted to the hospital on 7/03/09 and transferred to another health care facility on 7/13/10. An RN "Admission Assessment," dated 7/03/10 at 4:00 PM included a section describing the assessment of Patient #1's skin. The RN documented Patient #1's perianal skin was red and broken down. Her Braden Score was 15 (a score of 16 or less indicated a high risk for skin breakdown). The extent or size or appearance of the breakdown was not described.

Wound care being provided or recommended was not included in the POC. Failure to include activities in the POC had the potential to lead to inconsistent and uncoordinated nursing care. Examples follow:

a. Nursing progress note, dated 7/03/09 at 4:30 PM, stated Calazine ointment applied liberally.
b. Nursing progress note, dated 7/06/09 at 9:30 AM, stated powder and cream applied.
c. CWOCN documentation, dated 7/06/09 at 10:40 AM, documented recommending Miconazole powder, 3 M No Sting Spray, Calazine ointment, and rectal tube.

The nursing plan of care was not kept current.

Based on medical record review, review of incident reports and grievance documentation, and staff interview it was determined the facility failed to document, analyze, and monitor adverse patient events and patient/complaint grievance processes. This failure directly impacted 3 of 16 patients (#1, #8, and #13) whose records were reviewed and for 7 of 7 patients (#12, #13, #17, #18, #19, #20, and #21) whose grievance documentation was reviewed. This resulted in the inability of the facility to analyze the data appropriately and develop performance improvement processes. Findings include:

1. The hospital's "Incident Reporting" policy, effective 10/07, was reviewed. The policy indicated an incident report was to be completed for every occurrence or event not consistent with routine care or treatment.

Incident reports were not completed for the following examples of adverse events:

a. Patient #13 was a 66 year old female admitted to the hospital on 7/02/10 with diagnoses including, among other things, acute respiratory failure, encephalopathy (generalized brain dysfunction), diabetes, and a urinary tract infection. The following incidents were documented in Patient #13's medical record without corresponding incident reports:

i. The RN documented in the nursing notes on 7/14/10 at 9:30 AM, Patient #13 pulled a mitten (a less restrictive measure than the bilateral wrist restraints otherwise utilized for Patient #13) off and pulled out her Keo feeding tube. On 12/02/10 at 11:00 AM, the House Supervisor for the day explained a Keo feeding tube was weighted at the end which was inserted through the patient's nostril, down the esophagus, and into the stomach. An x-ray was required to confirm placement before using the tube for feeding. The RN also documented in the nursing notes on 7/14/10 at 9:30 AM, wrist restraints were reapplied. The RN documented, on 7/14/10 at 10:30 AM, the Keo feeding tube was replaced and Patient #13 was placed in restraints while up in her wheelchair, and was "pulling at restraints." The RN documented, on 7/14/10 at 10:45 AM, Patient #13 pulled off a restraint and pulled out the Keo feeding tube again. At this time, the RN indicated the physician was notified, restraints were reapplied, and the plan was for Patient #13 to have a PEG (Percutaneous Endoscopic Gastrostomy) feeding tube placed the next day.

ii. The RN documented in the nursing notes on 8/02/10 at 1:00 PM, Patient #13 pulled out her trach. The RN noted a new trach was placed, Patient #13 remained in restraints, and the NP was notified. At 4:30 PM on 8/02/10, the RN documented Patient #13 again pulled out her trach. The RN documented the NP was aware and authorized the trach to be left out and a dressing placed over the site.

Incident reports were reviewed for July 2010 through November 2010. There were no incident reports completed for the Keo feeding tube decannulations on 7/14/10 at 9:30 AM and 10:45 AM, or the trach decannulations on 8/02/10 at 1:00 PM and 4:30 PM.

During an interview on 12/07/10 at 2:00 PM, the Director of Quality/Risk Management was asked to provide all incident reports for Patient #13 for July of 2010. These reports were received on 12/15/10 and failed to include reports for the above decannulations.





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b. Patient #1 was a 50 year old female who was admitted to the hospital on 7/03/09 and transferred to another acute care facility on 7/13/09. An RN "Admission Assessment," dated 7/03/09 at 4:00 PM included a section describing the assessment of Patient #1's skin, including a description of redness and breakdown in the perianal area. An RN entry in a "NURSING PROGRESS NOTE," dated 7/03/09 at 4:30 PM described the perianal skin as red and excoriated with some bleeding open areas.

On 7/13/10 at 8:00 AM, an RN entry on "ICU FLOW SHEET" documented Patient #1 had multiple Stage II-III excoriated ulcers. No incident report was found to have been completed that reported Patient #1 developed Stage II-III excoriated ulcers during hospitalization.

During an interview on 11/30/10 at 10:10 AM, the DNO confirmed an incident report had not been completed. She stated an incident report should have been generated.

c. A PT session with Patient #8 was observed on 12/02/10 at 11:45 AM until 12:05 PM. Patient #8's catheter tubing was noted to be filled with blood. The PT commented Patient #8 had pulled out her catheter a couple of days prior and "medical was aware" of the blood in the catheter.

No incident report was found indicating Patient #8 had pulled out her catheter.

During an interview on 12/07/10 at 2:00 PM, the Director of Quality/Risk Management was asked to provide any incident reports that were completed for Patient #8 during her current hospitalization. None were provided.

2. A hospital policy, "Resolution of Patient Complaints/Grievances," dated 1/09, stated it was the role of the employee to complete an incident report at the time of the identification of a patient grievance and forward the incident report to their immediate supervisor for action.

Staff provided surveyors with a binder titled "Patient/Complaints/Grievances 2010." Nine complaints/grievances were selected for review (#12, #13, #17, #18, #19, #20, and #21). Entries were not delineated as specifically complaints or grievances.

No incident reports were completed for the complaints/grievances, as required per hospital policy. During the telephone exit interview on 12/07/10 at 2:00 PM, surveyors asked staff to forward incident reports associated with the complaints/grievances in the 2010 log. None were forwarded as of 12/20/10.

Grievances were not tracked on incident reports per hospital policy.

Based on staff interview and review of incident reports, meeting minutes, quality assurance data, and medical records it was determined the hospital failed to analyze the causes of adverse events for 5 of 5 patients (#12, #13, #14, #15, and #16) whose incident reports were reviewed and for whom documentation of the analysis of the event was requested. This failure had the potential to affect all patients who received care at the facility. Failure to analyze each adverse event resulted in the inability of the hospital to develop and implement preventive measures. Findings include:

The hospital's "Incident Reporting" policy, effective 10/07, was reviewed. The policy indicated, "At the time of receipt of the report, the department manager should review and investigate the incident within one working day of the event." In addition, "Any findings related to the incident should be documented either on the incident report or on an addendum to the report...The investigation should include any follow up with staff, a review of the medical record, and a review of the processes that were involved in the incident."

The Director of Quality/Risk Management was interviewed on 12/01/10 at 9:00 AM regarding incident report investigation and analysis, specifically related to reports documenting inadvertent removal of a patient line or tubing (called decannulation). (Examples of lines or tubing which were decannulated include Foley catheters, central intravenous lines, trachs, and feeding tubes.) The Director of Quality/Risk Management stated analysis for each event was completed. However, the incident report may not contain documentation of the analysis. He further stated the analysis was discussed in detail at the quarterly meetings of the Safety Committee, Quality Council, Medical Executive Committee, and the Governing Body. He subsequently provided additional quality assessment documentation and minutes from several of the above committee meetings for review.

A "PI/QI Measurement Report" was presented for the first 3 quarters of 2010. This report analyzed incidents and falls and was reviewed specifically for evidence of analysis of decannulations. Under the "Check" portion of the report the following information was documented for each quarter:

> 1st Quarter: "Trach decannulations are down from previous quarters (N=2). No patient injuries were noted."

> 2nd Quarter: "Self removal of lines and tubes (N=10) accounted for 13% of all incidents while 3 tracheotomy decannulations (N=3) accounted for 4%."

> 3rd Quarter: "Trach decannulations (2) are not showing any evidence of increasing even though restraint use this quarter was minimal."

The "PI/QI Measurement Report" did now show documentation of analysis of individual incidents or their potential causes.

The following meeting minutes were reviewed for discussion of decannulations and the analysis of the incidents:

> 2nd quarter Safety Meeting on 7/22/10

> 3rd quarter Safety Meeting on 11/01/10

> 2nd quarter Quality Council Meeting on 8/19/10

> 3rd quarter Quality Council Meeting on 11/12/10

> 2nd quarter Medical Executive Committee Meeting on 9/09/10

> 2nd quarter Governing Body Meeting on 9/23/10

The meeting minutes contained no documentation of discussion regarding decannulations.

Incident reports from July 2010 through November 2010 were reviewed. During this time frame, 16 of the incident reports documented the inadvertent removal of a patient line or tubing in some fashion other than under the control of nursing staff. The CEO, DNO, and Director of Quality/Risk Management were interviewed together on 12/03/10 at 10:10 AM regarding analysis of these incidents. The Director of Quality/Risk Management again stated the analysis was done, it was just not documented with the incident report. During the interview the CEO, DNO, and Director of Quality/Risk Management were asked to provide the documentation of the incident analysis for five selected incidents out of the 16 incident reports mentioned above.

The selected incident reports and subsequent documentation provided relating to investigation and analysis of the incidents included the following:

1. Staff completed an incident report for Patient #13 for an incident on 7/14/10 at 3:00 AM. Staff documented Patient #13 was able to get out of mittens (a less restrictive measure than the bilateral wrist restraints otherwise utilized for Patient #13) and pulled her Keo feeding tube out. On 12/02/10 at 11:00 AM, the House Supervisor for the day explained a Keo feeding tube which was weighted at the end inserted through the patient's nostril, down the esophagus and into the stomach. An x-ray was required to confirm placement before using the tube for feeding. The section of the report titled "Additional Investigation and Actions Taken," contained documentation that the "Nursing staff instrucTEd [sic] to make every attempt to keep patients out of restraints per policy. Will continue to keep patient safe. Trial and release every 2 hours. Will instruct night shift to sit close to patient while patient out of restraints to keep from having lines pulled." The "Follow Up" section was blank.

The additional documentation provided as evidence of analysis of the incident included nursing and physician progress notes from 7/12/10 through 7/15/10. The RN documented on 7/13/10 at 10:00 PM and 12:00 AM, Patient #13 was out of restraints and continued to be monitored closely. On 7/13/10 at 1:30 AM, the RN documented Patient #13 was restless but remained out of restraints and monitoring continued. At 3:00 AM on 7/13/10, the RN documented Patient #13 pulled out the Keo feeding tube and the Charge Nurse was notified. There was no documentation related to an assessment of Patient #13, or whether Patient #13 continued to be free from restraints.

On 7/14/10 at 7:30 AM, the RN documented Patient #13 had mittens on after "night shift replaced Keo tube." The RN documented on 7/14/10 at 9:30 AM, Patient #13 pulled a mitten off and pulled out her Keo feeding tube (for a second time). The RN further documented restraints were reapplied. The RN documented, on 7/14/10 at 10:30 AM, the Keo feeding tube was replaced and Patient #13 was placed in restraints in her wheelchair, and Patient #13 was "pulling at restraints." The RN documented, on 7/14/10 at 10:45 AM, Patient #13 pulled off a restraint and pulled out the Keo feeding tube (a third time). At this time, the RN indicated the physician was notified, restraints were reapplied, and the plan was for Patient #13 to have a PEG (Percutaneous Endoscopic Gastrostomy) feeding tube placed the next day.

The Pulmonologist documented in the physician progress notes on 7/12/10, "[Patient #13] Remains delirious & mildly agitated," and on 7/13/10, "Continues [with] agitated delirium." The NP documented in the progress notes on 7/14/10 at 4:00 PM, that Patient #13, "Continues with periods of agitation, pulled keo [sic] out x2."

There was no evidence in the information submitted the incident had been investigated or analyzed by management in accordance with hospital policy. There was no indication staff were interviewed or the medical record reviewed. There were no incident reports completed for the Keo feeding tube decannulations on 7/14/10 at 9:30 AM and 10:45 AM. There was no documented evidence Patient #13 was assessed for the need of possible alternatives, besides restraints, to keep her safe from pulling out additional lines and tubing in the future. There was no evidence the facility reviewed the processes involved in the incidents for Patient #13.

A second incident report for Patient #13 documented incidents which occurred on 8/02/10. Staff documented Patient #13 removed her trach 3 times, at 11:00 PM, 2:30 AM, and 4:30 AM, despite being in restraints and mittens. Staff also documented the trach was replaced without complications. In the "Additional Investigation and Actions Taken," section, it was documented that this information was forwarded to "nursing leadership for f/u [follow up] and corrective action prn [as needed]. To DCS for f/u and corrective action prn. Document review demonstrates hourly checks per restrain policy. Nursing continues to follow restraint guidelines and using restraint flow sheet per policy. Will continue to monitor patient and keep patient safe. Family not available to sit with patient." The "Follow Up" section was left blank.

The additional documentation provided as evidence of analysis of the incident included physician progress notes for 8/02/10 and 8/03/10, case management documentation from 7/20/10 through 8/11/10, and nursing progress notes from day shift on 8/01/10 through night shift on 8/02/10. The NP documented in the physician progress notes on 8/02/10 at 3:00 PM, "Pt has pulled out trach 4 times last noc [night] while restrained...Will keep trach out if pt redecannulates self...likely hallucinating or delusional, frequently calling out and increase aggitation [sic]." The following morning, 8/03/10 at 9:00 AM, the NP documented further medication adjustment in response to the "delusional/hallucinating type activity."

The RN documented on 8/01/10 at 11:30 PM, the Respiratory Therapist found Patient #13 with her trach completely out, while in bilateral wrist restraints. The trach was inserted and restraints reapplied. Patient #13 was then medicated for pain. On 8/02/10 at 2:30 AM, the RN documented that Patient #13, "Decannulated self [with] restraints applied. RT [Respiratory Therapy] was able to pass a new trach back into place. Will continue to monitor closely." The RN documented, on 8/02/10 at 4:30 AM, Patient #13, "Decannulated self after removing own restraints for a third time. RT replaced." The RN documented that pain medication was again given for pain as a result of the trach reinsertions.

The RN documented on 8/02/10 at 1:00 PM, Patient #13 self decannulated. The RN noted a new trach was placed, Patient #13 remained in restraints, and the NP was notified. At 4:30 PM on 8/02/10, the RN documented Patient #13 again pulled out her trach. The RN documented the NP was aware and authorized the trach to be left out and a dressing placed over the site.

There was no evidence of a thorough investigation or analysis into the events described above. There was no documentation that nursing leadership, or the DCS, received the information in the incident report or attempted to follow up on the incident as indicated on the incident report. The incident report contained documentation the medical record had been reviewed for appropriateness of the documentation of monitoring, however, there was no evidence staff were interviewed. There were no incidents reports filed for the trach decannulations on 8/02/10 at 1:00 PM and 4:30 PM, and review of the medical record by facility staff failed to correct this error. The NP addressed a possible need for a change in one of Patient #13's medications. However, it was not until after Patient #13 removed her own trach 4 times while in restraints, that this was noted. The incident report noted that family members were not available to sit with Patient #13. There was no evidence the facility evaluated the situation to determine if a sitter should have been arranged for Patient #13, or documentation of the reason this was not possible. There was no evidence to show other alternatives had been discussed if bilateral wrist restraints and mittens were not effective in keeping Patient #13 safe.

During an interview on 12/07/10 at 2:00 PM, the Director of Quality/Risk Management was asked to provide all incident reports for Patient #13 for July of 2010. These reports were received on 12/15/10 and failed to include reports for the Keo feeding tube decannulations on 7/14/10 at 9:30 AM and 10:45 AM, or the trach decannulations on 8/02/10 at 1:00 PM and 4:30 PM. .

There was no evidence of a review of the processes involved with the care of Patient #13, even after the first incident of decannulation on 7/14/10. As a result the hospital was unable to develop and implement measures to attempt to prevent further decannulation.

2. Staff completed an incident report for Patient #16 for an incident which occurred on 11/23/10 at 10:00 PM. The incident report indicated Patient #16 pulled out a Keo feeding tube while in bilateral wrist restraints. A section of the incident report form was titled, "Additional Investigation and Actions Taken." Documentation in this section read, "To nursing leadership as fyi [for your information] No patient harm." The section of the report titled "Follow Up" was left blank.

The additional documentation provided as evidence of analysis of the incident included nursing progress notes from 11/23/10 from 9:00 PM through 11/26/10 at 7:00 AM. The RN for Patient #16 documented on 11/23/10 at 10:00 PM, "Pt [patient] pulled Keo feeding tube out while in restraints. Pt denies that he pulled tube out point [sic] to 'that man' in the corner of the room. Nods yes that 'he' did it. Pt remains in restraints."

There was no documentation of an investigation or an analysis of the incident. There was no evidence nursing leadership was aware of the incident and, at a minimum, reviewed the medical record and interviewed staff to evaluate appropriateness of monitoring and restraints. There was no evidence of a review of the processes that were involved in the incident in accordance with hospital policy.

3. Staff completed an incident report for Patient #15 for an incident which occurred on 7/14/10 at 6:00 AM. The incident report indicated Patient #15 pulled out a femoral central line while in restraints (bilateral wrist restraints). According to documentation in the report, the site was cleaned, a pressure dressing was applied, and Patient #15 remained in restraints. Documentation in the section, "Additional Investigation and Actions Taken," included, "Staff instructed to make every attempt to keep patients out of restraints. Trial and release every 2 hours. Nursing will be instructed to stay close to patient so that lines and tubes will not be pulled out." The "Follow Up" section was left blank.

The additional documentation provided as evidence of analysis and investigation of the incident included nursing progress notes from 7/13/10 through 8/02/10. The RN for Patient #15 documented, on 7/13/10 at 6:00 AM, "IV [intravenous] meds [medications] completed, pt [patient] pulled femoral line out, cleaned and drsg [dressing] applied, remains in restraints. pt confused & aggitated [sic]."

There was no documentation of an investigation or analysis of the incident. There was no explanation regarding how the femoral line was pulled out, or where the nurse was when the line was pulled out (documentation was not clear and the incident appeared to happen relatively close to the time medications were administered). No evidence of a record review or staff interview to support an analysis of the incident was provided. There was no evidence of evaluation or assessment of Patient #15 to determine if measures other than restraints would have been beneficial to keep Patient #15 safe.

4. Staff completed an incident report for Patient #14 for an incident which occurred on 9/27/10 at 3:00 AM. The incident report indicated Patient #14 pulled out a PEG tube. According to the American Society for Gastrointestinal Endoscopy, at www.asge.org, a PEG tube is placed through a small incision in the skin directly into the stomach and required the patient to undergo an upper endoscopy to guide the tube placement. The incident report indicated the charge nurse was notified and the tube was replaced. The report also indicated the tube would not be accessed until x-ray confirmed placement. The section of the incident report titled, "Additional Investigation and Actions Taken," indicated the information went to nursing leadership for follow up and corrective action as needed. The section titled "Follow Up" was left blank.

The additional documentation provided as evidence of analysis of the incident included case management notes for Patient #14, from 9/28/10 through 10/28/10, along with nursing progress notes for 9/27/10 from 7:00 AM to 7:00 PM. Patient #14's RN documented on 9/27/10 at 8:15 AM, "Pt [patient] had pulled PEG last shift. X-ray to check if placement is still good to be done. Meds [medications] per PEG held @ this time." Additional documentation at 12:30 PM indicated, "Pt scheduled to go to [local hospital] to have PEG replaced [after] pulling it last night."

There was no evidence of an investigation or analysis of the incident in the documentation provided. The portion of the medical record provided for review did not document the actual incident. There was no evidence to indicate the medical record had been reviewed for appropriate supervision and assessment of Patient #14 in the event modifications to care would have been beneficial. There was no documentation the staff involved in the incident were interviewed, and no evidence nursing leadership evaluated the incident and followed up as needed. There was no evidence of the review of the processes involved in order to assist in the potential development and implementation of measures to keep all patients safe from self-decannulation.

5. Staff completed an incident report for Patient #12 for an incident which occurred on 7/19/10 at 8:00 PM. Staff indicated during the 8:00 PM rounds, the RN noted Patient #12's PICC [Peripherally inserted central catheter] lying next Patient #12. The incident report indicated the catheter was intact and there was no bleeding or bruising noted at the insertion site. The section of the incident report, "Additional Investigation and Actions Taken," noted the information went to "nursing leadership as fyi [for your information]." The "Follow Up" section of the report was blank.

The additional documentation provided as evidence of analysis and investigation of the incident included nursing notes from 7/19/10, 8:00 PM to 12:00 AM, and care conference notes from 6/30/10 through 7/28/10. The RN taking care of Patient #12 documented on 7/19/10 at 8:00 PM, "...pt [patient] sitting in bed, Picc [sic] is on [right] side of pt in sheets & is completely out. Tip intact site of pull [without] s/s [signs/symptoms] of bleeding or bruising. Pt is alert & denies pain. [No] other aggitation [sic] observed." The RN documented, on 7/19/10 at 8:30 PM, the RN Supervisor for the night shift would notify the physician and obtain an order to change medication administration from via the PICC to the feeding tube.

There was no evidence of an investigation of the incident or analysis of the event. There was no documentation of a review of the medical record to determine if supervision prior to the event was appropriate, or documentation of interviews with staff. There was no investigation to indicate how the PICC was decannulated, if Patient #12 was responsible for pulling it out directly, or it was pulled out accidentally.

During an interview on 12/07/10 at 2:00 PM, the Director of Quality/Risk Management confirmed the nursing progress notes, physician progress notes, and the case management notes were provided as evidence supporting the analysis of the individual incident reports.

The facility failed to analyze or investigate individual incident reports in accordance with their policy. Failure to analyze each event prevented the facility from developing and implementing measures to improve patient safety.