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Based on review of medical records, observation, and staff interview, it was determined the hospital failed to ensure patients' were protected from self harm. This resulted in a patient experiencing 24 self-decannulations without aggressive intervention to prevent further incidents. This placed the health and safety of the patient in immediate jeopardy. Findings include:

1. Refer to A 144 as it relates to the facility's failure to ensure patients' right to receive care in a safe setting was upheld by protecting them from self injury.

The cumulative effect of these negative systemic practices resulted in the inability of the hospital to keep patients safe from harm.

On Thursday 10/18/12 at 1:30 PM, the CEO was notified in person of the immediate jeopardy related to the facility's failure to ensure a patient, who repeatedly decannulated himself, was assessed and measures were taken to protect him from injury.

A plan of correction was received, reviewed, and accepted on 10/18/12 at 4:30 PM. The plan included assigning a staff member to monitor a patient on a 1 to 1 basis in order to protect him from harm. The staffing schedule was adjusted for the following week, with provisions for sick calls, etc. Education for the entire clinical staff was initiated regarding incident reporting of unplanned events, i.e., pulling out tubes, catheters, tracheostomy tubes, etc. The facility planned to provide staff inservices until all clinical staff had been educated. An interdisciplinary team meeting was held on 10/18/12 at 2:00 PM to discuss interventions to ensure the safety of the patient. A root cause analysis was initiated in order to identify ways to protect this and other patients from harm.

Implementation of the above plan was verified and the CEO was notified in person on 10/18/12 at 4:30 PM, that the immediate jeopardy was abated.

Based on staff interview and review of facility policies and medical records, it was determined the hospital failed to ensure 1 of 20 patients (#16) whose records were reviewed was under the care of a physician. The lack of physician involvement also had the potential to affect all patients admitted to the hospital. The failure of a physician to supervise and manage patient care had the potential to result in substandard care provided to patients. Findings include:

1. Patient #16's medical record documented an 85 year old male who was initially admitted to the facility on 6/12/12, at 1:06 PM, for care related to clostridium difficile colitis (a contagious infection of the colon that is typically associated with the use of antibiotics resulting in symptoms such as fever, abdominal pain, and severe diarrhea.) Additional diagnoses included cancer of the prostate with recent prostatectomy (surgical removal of the prostate) and radiation therapy, mixed urinary tract infection, severe protein calorie malnutrition, urinary outlet obstruction with Foley catheter in place, CHF, CAD, hypertension, and chronic pain. He was transferred to an acute care hospital and discharged on 6/15/12.

"ADMISSION ORDERS" for Patient #16 were signed by an NP on 6/12/12 at 3:00 PM. On 6/12/12 at 6:00 PM, the NP ordered Heparin, an anticoagulant. The "HISTORY & PHYSICAL" was dictated by an NP on 6/13/12 at 12:18 PM and co-signed by the physician on 7/01/12 at 11:30 AM. The H&P stated Patient #16 had a history of anemia and required transfusion prior to admission to NIACH. The examination did not mention if the patient was bleeding from his bladder or not, but it did state "He will continue with bladder irrigation." No order for bladder irrigation was documented. "PHYSICIAN PROGRESS NOTES" included 4 entries by mid-level providers (NPs and PAs). The entries included documentation by the NP on 6/13/12 at 11:00 AM, that indicated the NP had dictated the history and physical. Another progress note by the NP, dated 6/14/12 at 1:30 PM, stated Patient #16 had anemia and ordered 2 units of red blood cells transfused the following morning. The progress note stated Patient #16 had bleeding post bladder radiation. No progress notes by a physician were documented.

"NURSING PROGRESS NOTES" documented problems with the urinary catheter and documented it required manual irrigation to remove clots on 6/14/12 at 12:30 AM, 6:30 AM, and 11:45 AM. The progress note by the NP, dated 6/14/12 at 1:30 PM, did not mention problems with the catheter. No further progress notes by the NP, PA, or physician were documented.A "NURSING PROGRESS NOTE," dated 6/14/12 at 5:00 PM, stated "call placed to [NP's name] re: [regarding] continued inability to aspirate clots, foley not draining and patient's c/o [complaint of] severe pain."

A telephone order by the NP, dated 6/14/12 at 6:00 PM, stated to replace the urinary catheter and continue to irrigate it as needed for clots. The order stated to transfer Patient #16 to a nearby ED if there was no resolution.

A "NURSING PROGRESS NOTE," dated 6/14/12 at 7:15 PM, stated "patient transported to [the ED], report called to [ED]." A "NURSING PROGRESS NOTE," dated 6/14/12 at 11:50 PM, stated "pt back from [the ED] via EMS transport. Foley in place draining red urine. Monitoring Foley irrigated 10 cc."

A telephone order by the PA, dated 6/14/12 at 11:30 PM, stated to irrigate Patient #16's catheter as needed if it was not draining. The continuous irrigation was not restarted. A "NURSING PROGRESS NOTE," dated 6/15/12 at 3:00 AM, stated staff were not able to irrigate the catheter. A telephone order by the PA, dated 6/15/12 at 4:20 AM, stated to increase Patient #16's Morphine but did not mention the catheter. A telephone order by the physician, dated 6/15/12 at 5:35 AM, stated to transfer Patient #16 to a nearby hospital. A "NURSING PROGRESS NOTE," dated 6/15/12 at 5:35 AM, stated one unit of blood had been transfused and Patient #16 was being transferred to another hospital.

Patient #16's "DISCHARGE SUMMARY," dated 7/14/12, was written by the NP. It did not recap the problems with the catheter or Patient #16's course of treatment.
The NP was interviewed on 10/19/12 beginning at 10:30 AM. She stated she admitted Patient #16 and followed him. She stated she dictated the H&P and the Discharge Summary. She reviewed the medical record and stated Patient #16 was not seen by a physician while at the hospital. She stated physicians rounded on patients on Tuesdays and either Saturdays or Sundays. She stated patients were followed by mid-level providers the rest of the time.

Patient #16 was not under the care of a physician.

2. The policy "Medical Staff Clinical privileges-Allied Health Practitioner," revised 5/12, stated "...Activities performed by the allied health practitioner will be performed under the supervising physician's direction." The policy stated the NP or PA "...will communicate daily with the supervising physician regarding the status of patients under that physician's care. Documentation of this communication will be evident in the medical record." The policy also said "...Admission orders and orders for discharge and/or transfer may be completed by the AAPN or PA but with evidence that the supervising physician was involved in the decisions."

The NP was interviewed on 10/19/12 beginning at 10:30 AM. She stated there was no documentation of communication between the physician and the mid-level providers caring for Patient #16.

The President of the Medical Executive Committee, a physician, and the CEO were interviewed on 10/18/12 beginning at 3:35 PM. They confirmed Patient #16 was not examined by a physician during his hospital stay. They stated the nephrologists saw their patients on Tuesdays and either Saturdays or Sundays. They stated patients were followed by mid-level providers the rest of the time. They confirmed that a patient could be admitted on a Tuesday afternoon and be discharged as many as 5 days later without seeing a physician.

The hospital had not developed policies to ensure all patients were under the care of a physician.

Based on staff interview and review of facility policies and medical records, it was determined the hospital failed to ensure 1) the medical staff enforced written policies and procedures for appraisal of emergencies, initial treatment, and referral of patients and 2) that hospital policies related to emergencies matched the expectations of hospital management and medical staff. This affected the care for 1 of 3 patients (#16) who were transferred to acute care hospitals for emergency care. The absence of direction to staff created the potential for delays in emergency care or in unnecessary transfers. Findings include:

1. Patient #16's medical record documented an 85 year old male who was initially admitted to the facility on 6/12/12 at 1:06 PM for care related to clostridium difficile colitis (a contagious infection of the colon that is typically associated with the use of antibiotics resulting in symptoms such as fever, abdominal pain and severe diarrhea.) Additional diagnoses included cancer of the prostate with recent prostatectomy (surgical removal of the prostate) and radiation therapy, mixed urinary tract infection, severe protein calorie malnutrition, urinary outlet obstruction with Foley catheter in place, CHF, CAD, hypertension, and chronic pain. He was transferred to an acute care hospital and discharged on 6/15/12.

"ADMISSION ORDERS" for Patient #16 were signed by an NP on 6/12/12 at 3:00 PM. On 6/12/12 at 6:00 PM, the NP ordered Heparin, an anticoagulant. The "HISTORY & PHYSICAL" was dictated by an NP on 6/13/12 at 12:18 PM and co-signed by the physician on 7/01/12 at 11:30 AM. The H&P stated Patient #16 had a history of anemia and required transfusion prior to admission to NIACH. A progress note by the NP, dated 6/14/12 at 1:30 PM, stated Patient #16 had anemia and ordered 2 units of red blood cells transfused the following morning. The progress note stated Patient #16 had bleeding post bladder radiation. No progress notes by a physician were documented during his stay.

"NURSING PROGRESS NOTES" documented problems with the urinary catheter and documented it required manual irrigation to remove clots on 6/14/12 at 12:30 AM, 6:30 AM, and 11:45 AM. The progress note by the NP, dated 6/14/12 at 1:30 PM, did not mention problems with the catheter. No further progress notes by the NP, PA, or physician were documented.A "NURSING PROGRESS NOTE," dated 6/14/12 at 5:00 PM, stated "call placed to [NP's name] re: [regarding] continued inability to aspirate clots, foley not draining and patient's c/o [complaint of] severe pain."

A telephone order by the NP, dated 6/14/12 at 6:00 PM, stated to replace the urinary catheter and continue to irrigate it as needed for clots. The order stated to transfer Patient #16 to a nearby ED if there was no resolution.

A "NURSING PROGRESS NOTE," dated 6/14/12 at 7:15 PM, stated "patient transported to [the ED], report called to [the ED]." A "NURSING PROGRESS NOTE," dated 6/14/12 at 11:50 PM, stated "pt back from [the ED] via EMS transport. Foley in place draining red urine. Monitoring Foley irrigated 10 cc."

A telephone order by the PA, dated 6/14/12 at 11:30 PM, stated to irrigate Patient #16's catheter as needed if it was not draining. The continuous irrigation was not restarted. A "NURSING PROGRESS NOTE," dated 6/15/12 at 3:00 AM, stated staff were not able to irrigate the catheter. A telephone order by the PA, dated 6/15/12 at 4:20 AM, stated to increase Patient #16's Morphine but did not mention the catheter. A telephone order by the physician, dated 6/15/12 at 5:35 AM, stated to transfer Patient #16 to a nearby hospital. A "NURSING PROGRESS NOTE," dated 6/15/12 at 5:35 AM, stated one unit of blood had been transfused and Patient #16 was being transferred to another hospital.

Documentation that Patient #16 had been examined by a practioner to determine whether he required transfer or if the hospital could effectively meet his needs, was not found in his medical record.

The NP was interviewed on 10/19/12 beginning at 10:30 AM. She stated she admitted Patient #16 and followed him. She stated she dictated the H&P and the Discharge Summary. She reviewed the medical record and stated Patient #16 was not seen by a practitioner prior to transferring him to the ED.

The President of the Medical Executive Committee, interviewed on 10/18/12 beginning at 3:35 PM, stated Patient #16's medical record had been reviewed following discharge but the lack of assessment of the patient prior to transfer had not been identified.

Patient #16 was not examined by a practitioner prior to transferring him to the ED.

2. The policy "Medical Staff Availability & Consultations," dated 2/06, stated "Changes in patient condition or patient need will be communicated to the physician utilizing the physician contact mechanism provided by the medical staff member. The physician will respond to calls within 30 minutes." The policy continued, "Should the patient require urgent or emergent assessment and treatment, the attending physician (or on call designee) will respond to the hospital within 45 minutes of the communication of the urgent/emergent patient care need." The policy allowed a practitioners to wait up to 1 hour and 15 minutes prior to presenting to the hospital to evaluate emergencies.

The President of the Medical Executive Committee and the CEO were interviewed on 10/18/12 beginning at 3:35 PM. They stated practitioners on call were expected to present to the hospital within 20 minutes to evaluate emergencies.

The hospital's policy for the emergency assessment and evaluation of patients did not match the expectations of the hospital.

Based on review of medical records, observation, and staff interview, it was determined the hospital failed to ensure 1 of 6 patients with tracheostomy tubes (Patient #3) received care in a safe setting. The hospital failed to ensure measures were taken to prevent Patient #3 from pulling out his tracheostomy tube and Foley catheter. These failures left Patient #3 vulnerable to decannulation and placed him in immediate jeopardy of serious harm, impairment, or death. Findings include:

Patient #3's medical record documented a 75 year old male who was admitted to the hospital on 9/05/12 with diagnoses of acute respiratory failure, myocardial infarction, post resection of laryngeal cancer, severe end-stage Parkinson's Disease, and a drug resistant lung infection. He was currently a patient as of 10/19/12. At time of admission, Patient #3 had a tracheostomy tube and a PEG tube.

Nursing notes documented incidents where Patient #3 had decannulated (accidentally or purposely pulled out a tube) 24 times between 9/12/12 and 10/15/12. These included:

9/12/12-Foley catheter
9/15/12-tracheostomy tube
9/16/12-tracheostomy tube
9/18/12-tracheostomy tube
9/19/12-tracheostomy tube
9/21/12-PICC
9/22/12-tracheostomy tube
9/24/12-tracheostomy tube
9/24/12-tracheostomy tube
9/26/12-tracheostomy tube
9/26/12-tracheostomy tube
9/29/12-tracheostomy tube
9/29/12-tracheostomy tube
9/29/12-tracheostomy tube
9/30/12-tracheostomy tube
10/02/12-tracheostomy tube
10/02/12-tracheostomy tube
10/03/12-tracheostomy tube
10/07/12-tracheostomy tube
10/11/12-Foley catheter
10/12/12-tracheostomy tube
10/13/12-Foley catheter
10/14/12-tracheostomy tube
10/15/12-Foley catheter

Patient #3's "INTERDISCIPLINARY PHYSICIAN LED PLAN OF CARE," page 6, dated 10/10/12-10/16/12, stated "ALTERATION IN PULMONARY STATUS...Pt [patient] pulled out trach X2 today." The same POC, page 15, stated "ALTERATION IN SAFETY AND BEHAVIOR" instructed staff to "Supervise pt for safety while restraints off, bilateral soft wrist restraints, confused pulling at lines, up with assistance, bed alarm, call light within reach, reinforce compliance with compensatory safety strategies, side rails X2, [bilateral wrist restraints with mittens]."

Patient #3 was observed on 10/16/12 beginning at 9:05 AM. He was alone when the surveyor and his RN entered the room. He was laying on his left side. His left wrist was restrained and he had a protective mitten on his left hand. However, the wrist was restrained with his elbow bent leaving his left hand inches from his face. He was observed to reach up and scratch his forehead with his mittened hand. Even with the restraint and mitten, he was able to reach and could have dislodged his tracheostomy tube. Patient #3 did not have any kind of monitor or alarm that would alert staff if he pulled his tracheostomy tube or if his oxygen level dropped.

The CEO, the Director of Respiratory Therapy, and the Clinical Compliance Specialist were interviewed together on 10/18/12 beginning at 10:05 AM. They confirmed the number of times Patient #3 had decannulated himself. They stated the hospital could not prevent Patient #3 from pulling out his tracheostomy tube. They stated he had pulled his tracheostomy tube out when his wife was in the room and again when the physical therapist was in the room. They stated Patient #3 had not had a one to one staff member assigned to prevent him from decannulating. They stated Patient #3 was restrained with his hand close to his face for comfort. The CEO stated she had observed Patient #3 without mittens two times on 10/17/12.

Patient #3's physician was interviewed on 10/18/12 beginning at 10:25 AM. He stated Patient #3 required the tracheostomy tube. He stated Patient #3 had consistently shown acute respiratory failure without the airway (tracheostomy tube) present. He also stated Patient #3's surgeon was very adamant that the tracheostomy tube remain in place.

The hospital had not taken steps to prevent Patient #3 from decannulating himself. This placed Patient #3's health and safety at risk of serious harm or death from respiratory failure if the decannulation events continued.

Based on review of medical records and incident reports and staff interview, it was determined the facility failed to track and analyze adverse patient events for 2 of 2 current patients (#3 and #6) who were identified to have experienced self-decannulations. Failure to track and analyze adverse events impeded the facility's ability to improve patient care and safety. Findings include:

1. The facility failed to track adverse events as follows:

a. Patient #3's medical record documented a 75 year old male who was admitted to the hospital on 9/05/12 with diagnoses of acute respiratory failure, myocardial infarction, post resection of laryngeal cancer, severe end-stage Parkinson's Disease, and a drug resistant lung infection. He was currently a patient as of 10/19/12.

Nursing notes documented incidents where Patient #3 had self-decannulated 24 times between 9/12/12 and 10/15/12. These included:

9/12/12-Foley catheter
9/15/12-tracheostomy tube
9/16/12-tracheostomy tube
9/18/12-tracheostomy tube
9/19/12-tracheostomy tube
9/21/12-PICC
9/22/12-tracheostomy tube
9/24/12-tracheostomy tube
9/24/12-tracheostomy tube
9/26/12-tracheostomy tube
9/26/12-tracheostomy tube
9/29/12-tracheostomy tube
9/29/12-tracheostomy tube
9/29/12-tracheostomy tube
9/30/12-tracheostomy tube
10/02/12-tracheostomy tube
10/02/12-tracheostomy tube
10/03/12-tracheostomy tube
10/07/12-tracheostomy tube
10/11/12-Foley catheter
10/12/12-tracheostomy tube
10/13/12-Foley catheter
10/14/12-tracheostomy tube
10/15/12-Foley catheter

Only 8 incident reports were documented that noted Patient #3 had decannulated. These included:

9/21/12-PICC
9/24/12-tracheostomy tube
9/24/12-tracheostomy tube
10/02/12-tracheostomy tube
10/03/12-PEG tube
10/03/12-tracheostomy tube
10/04/12-tracheostomy tube
10/13/12-Foley catheter

The Clinical Compliance Specialist was interviewed on 10/17/12 beginning at 3:35 PM. She stated she collected and compiled incident reports at the hospital. When asked why incident reports were not completed for all episodes of decannulation for Patient #3, she stated nurses did not always complete incident reports when patients decannulated.

b. Patient #6's medical record documented a 67 year old male who was admitted to the hospital on 10/01/12 with diagnoses of respiratory failure and renal failure. He was currently a patient as of 10/19/12.

Nursing notes documented incidents where Patient #6 had decannulated 2 times. These included:

10/13/12-keofeed tube (a small feeding tube, weighted at the end, inserted via the nostril through the stomach, and may be advanced into the small intestine)
10/14/12-PICC

No incident reports were documented that Patient #6 had decannulated.

The Clinical Compliance Specialist was interviewed on 10/17/12 beginning at 3:35 PM. She stated no incident reports had been completed documenting decannulation events for Patient #6. She stated incident reports were tracked and trended through the QAPI program. She acknowledged the numbers of decannulations for the QAPI program were not accurate.

The facility failed to accurately track adverse patient events.

2. The facility failed to ensure adverse events were analyzed as follows:

a. Only 8 incident reports were documented that noted Patient #3 had decannulated. These included:

9/21/12-PICC
9/24/12-tracheostomy tube
9/24/12-tracheostomy tube
10/02/12-tracheostomy tube
10/03/12-PEG tube
10/03/12-tracheostomy tube
10/04/12-tracheostomy tube
10/13/12-Foley catheter

The incident reports were reviewed and documented the following related to analysis and implementation of steps to prevent further decannulations:

i. On 9/24/12 at 8:15 PM, the author of the incident report documented that Patient #3 was unrestrained at the time of decannulation and restraints were applied to "prevent him from decannulating himself again."

ii. On 9/24/12 at 9:50 PM, the author of the incident report documented initiation of mitten to Patient #3's hands in addition to wrist restraints to "keep him from pulling out his trach again." The DON documented on the form, on 9/25/12, that Patient #3 was placed in a chair as a diversionary tactic.

iii. On 10/02/12 the Director of Respiratory Therapy reviewed the incident and evaluated the size of tracheostomy tube in place and the mechanism by which it was easily removed when Patient #3 lifted his chin. There was documentation of discussion with the physician and a change in the tracheostomy tube was initiated.

iv. In response to the tracheostomy decannulation on 10/03/12, the Director of Respiratory Therapy documented, on 10/04/12, "Will let staff know to keep an eye out for this and help to prevent decannulations."

The incident reports did not include documentation the medical record was reviewed for the events surrounding each decannulation, such as ensuring staff were checking in on Patient #3 frequently or that reasons for potential agitation (such as pain, positioning, toileting, etc.) had been addressed. There was no indication that staff were routinely interviewed to determine that restraints or the mittens were applied appropriately.

The CEO, the Director of Respiratory Therapy, and the Clinical Compliance Specialist were interviewed together on 10/18/12 beginning at 10:05 AM. They confirmed the number of times Patient #3 had decannulated himself. They stated the hospital could not prevent Patient #3 from pulling out his tracheostomy tube. They stated he had pulled his tracheostomy tube out when his wife was in the room and again when the physical therapist was in the room. They stated Patient #3 had not had a one to one staff member assigned to prevent him from decannulating. They explained that several interventions had been implemented to deter him from decannulating, such as placing him close to the nursing station for improved observation, involving him in therapy activities, and attempting to wean him from the need of the tracheostomy tube and Foley catheter.

The Clinical Compliance Specialist was interviewed on 10/19/12 at 11:15 AM. She confirmed that components of an investigation of adverse events were not thoroughly documented, and were not routinely completed in order to implement preventative actions to keep patients safe.

The facility failed to ensure decannulations were tracked and analyzed.

Based on review of medical records and facility policies and staff interview it was determined the facility failed to ensure wound care orders were signed by a physician for 3 of 11 patients with orders written by the wound care nurse (#2, #5 and #17) whose records were reviewed. This failure resulted in implementation of medications for wound care without a physician order. Findings include:

1. Patient #2 was a 63 year old male admitted to the facility on 10/11/12 for treatment of chronic respiratory failure and pneumonia. The wound care nurse examined Patient #2 and recommended "Miconazole powder to perianal and scrotal skin twice a day and as needed after stools. Calazine barrier cream to perianal skin after powder." The recommendations were written on a "PHYSICIAN'S ORDERS" form and dated 10/11/12 at 3:20 PM. The recommendations were not signed by a physician. The recommendations were noted by the RN on 10/11/12 at 4:30 PM. The Unit Clerk indicated the order was processed on 10/11/12 at 3:25 PM. Patient #2's medication administration record indicated the order for Miconazole powder was added to his medication list on 10/11/12 at 4:00 PM.

The DRG Coordinator was interviewed on 10/18/12 at 2:35 PM. She reviewed Patient #2's medical record and confirmed the wound care order should have been cosigned by the physician prior to implementation.

The facility failed to ensure wound care orders were signed by a physician.



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2. Patient #17 was a 62 year old female admitted to the facility on 8/01/12, 8/14/12 and 8/21/12 for treatment related to an infected hernia repair and renal failure. The wound care nurse completed an examination of Patient #17 and entered the following recommendations on the "PHYSICIAN'S ORDERS:"

a. 8/07/12 at 7:20 AM: "Skin/Wound Care Recommendation: 1. Please change silvadene order to BID to buttock and ischial [lower back portion of the hip] wound q shift after cleansing [with] NS gauze. Use minimal amount to cover wound beds. Place Interdry Ag+ over sites. No tape. 2. Turn patient q 2 hours. 3. Stat 3 low air loss mattress. 4. Xenaderm to L abdominal wound [with] VAC dressing (change) MWF. Cover [with] foam dressing [after] 3M No Sting Spray to peri wound skin."

b. 8/07/12 at 10:00 AM: "Skin/Wound Care Recommendation: 1. Xenaderm to R back lesion daily after gently cleansing. Skin prep to peri wound skin gauze drsg [dressing] [with] minimal tape to secure."

c. 8/08/12 at 3:45 PM: "Skin/Wound Care Recommendation: 1. Change dressing on L abdomen daily instead of MWF. DC foam dressing. Apply Xenoderm then cover [with] Interdry Ag+."

d. 8/27/12 at 12:45 PM: "Skin/Wound Care Recommendation: 1.Bacitracin ointment to old L picc site and RUE lesion daily [after] cleansing [with] NS."

e. 9/03/12 at 3:30 PM: "Skin/Wound Care Recommendation: 1. DC Hydrocolloid dressings to buttocks & ischials [lower, back part of pelvis], Begin Xeroform gauze to open lesions, 3M No Sting Spray to peri wound skin then cover [with] non bordered Optifoam. Minimal Medipore tape to secure. Change Optifoam daily and Xeroform every other day if it is intact."

f. 9/11/12 at 10:30 AM: "Skin/Wound Care Recommendation: 1.DC foam dressings to ischial & buttock wounds. Begin Stoma powder, 3M No Sting Spray then Calazine barrier cream q shift and PRN. 2. Continue to turn patient q 2 hours. 3. Begin white foam to undermined areas at 3:00 and 9:00 on abdominal wound."

g. 9/15/12 at 10:25 AM: "Skin/Wound Care Recommendation: 1. Do not send VAC [with] patient to [name of transfer facility] on Monday. Clamp tubing [with] a glove on the end of the tubing. DC VAC."

The wound care recommendations were noted by an RN for each entry by the wound care nurse, but the recommendations were not signed by a physician.

During an interview on 10/18/12 beginning at 3:40 PM, the Clinical Compliance Specialist reviewed Patient #17's medical record and confirmed the wound care recommendations were not signed by a physician. She stated they were considered to be orders and should have been cosigned by the physician prior to implementation.

The facility failed to ensure wound care orders were signed by a physician.

3. Patient #5 was a 57 year old male admitted to the facility on 10/08/12 for treatment related to respiratory failure and paraplegia resulting from a motor vehicle accident. The wound care nurse completed an examination of Patient #5 and entered the following recommendations on the "PHYSICIAN'S ORDERS," dated 10/12/12 at 12:45 PM: "Skin/Wound Care Recommendations: 1. Please change gauze and ABD dressing to posterior neck incision q shift and PRN."

The wound care recommendations were noted by an RN 10/12/12 at 3:30 PM. The recommendations were not signed by a physician.

During an interview on 10/19/12 beginning at 10:12 AM, the DRG Coordinator reviewed Patient #5's medical record and confirmed the wound care recommendations were not signed by a physician. She stated they were considered to be orders and should have been cosigned by the physician prior to implementation.

The facility's policy titled, "Medication Administration," revised 8/12, was reviewed. According to the policy, medication orders must include the physician's signature.

The facility failed to ensure wound care orders were signed by a physician.

Based on record review, staff interview and review of policies, it was determined the facility failed to obtain patient or POA consent for treatments and transfers to another facility for 3 of 20 (#4, #11 and #18) patients whose records were reviewed. The failure to obtain patient or patient designee consent before the transfer or treatment was provided had the potential for procedures or transfers to occur without the patients' or designees' approval. Findings include:

A policy, "Informed Consent," revised 02/2012, stated: "A general authorization and consent, such as that obtained at the time of admission is sufficient under those circumstances in which the proposed treatment or examination and its inherent risks and hazards are commonly known." The policy also stated: "In all other instances, a procedure specific consent should be obtained and documented." The policy included such procedures as venous access catheter insertion and blood administration, as examples of procedures needing specific consents. The policy also stated the consent form should be completed by a professional hospital staff member with the content of the discussion documented in detail in the medical record. In the case of an incapacitated patient, the consent would be given by a guardian, or person designated in writing to make decisions for the patient. The patient's reason for incapacity should be listed in the appropriate section.

A policy, "Transfer of Patients," revised 08/12, stated: "The patient will be informed of the risks and benefits of any transfer. The patient's physician/LIP will provide this information and will document this informed consent. The patient will be asked to sign a document indicating his/her understanding."

1. Patients were transferred to facilities without completed consents. Examples include:

a. Patient #11 was a 26 year old female, admitted to the facility on 9/11/12 for care related to respiratory failure and injuries from a motor vehicle accident. Patient #11 was transferred to an acute care hospital on 9/19/12 for a surgical procedure. A "TRANSFER FORM," dated 9/19/12 contained a statement "The above risks and benefits indicated above have been explained to me and I understand my right to refuse transfer and/or tests." The statement was followed with a line under which was "Signature Patient/Representative and Date." There was no signature or date.

Patient #11 was transferred to an acute care hospital for a surgical procedure on 9/28/12. A "TRANSFER FORM," signed by the physician and dated 9/27/12, contained a statement "The above risks and benefits indicated above have been explained to me and I understand my right to refuse transfer and/or tests." The statement was followed with a line under which was "Signature Patient/Representative and Date." There was no signature or date.

During an interview on 10/18/12 beginning at 4:40 PM, the DRG Coordinator reviewed Patient #11's medical record and confirmed the transfer form was not signed by the patient.

Twice Patient #11 was transferred to another facility without his written consent.

b. Patient #4 was a 66 year old male, admitted to the facility on 9/12/12 for care related to respiratory failure. Patient #4 was transferred to an acute care hospital for a CT scan. A "TRANSFER FORM," signed as a verbal order by an RN and dated 10/12/12, contained a statement "The above risks and benefits indicated above have been explained to me and I understand my right to refuse transfer and/or tests." The statement was followed with a line under which was "Signature Patient/Representative and Date." There was no signature or date.

During an interview on 10/19/12 beginning at 9:35 AM, the DRG Coordinator reviewed Patient #4's medical record and confirmed the transfer form was not signed by the patient.

Patient #4 was transferred to another facility without his written consent.

2. A blood transfusion was initiated without a properly executed consent:

a. Patient #18 was a 74 year old male admitted to the facility on 10/13/12 for care related to respiratory failure and heart disease. Patient #18 had a tracheostomy, was on a ventilator and was non-verbal. The general admission consent had been signed by Patient #18's wife on the day of admission. A consent for blood transfusion dated 10/15/12, at 10:45 AM, contained a physician's signature at 10:30 AM, and two RN's signatures. The "Patient Signature" section was blank, the "Authorized Representative" section contained the written statement "verbal consent" and the "Relationship to Patient" section was blank. The consent did not indicate who had given a verbal consent. The progress notes for 10/15/12, as well as the nursing notes, were reviewed and there was no documentation of discussion of the need for administration of blood with Patient #18 or his wife. A "NURSING PROGRESS NOTE," dated 10/15/12, at 12:00 PM, described Patient #18 as confused with his legs out of bed, and the bed alarm was activated.

During an interview on 10/18/12 at 2:45 PM, the RN providing care to Patient #18 reviewed his medical record. The RN stated she had not provided care for Patient #18 on 10/15/12, and was not sure who the consent had been obtained from. She confirmed there was no documentation in the nursing notes to validate who the consent had been discussed with.

The facility did not ensure patient consents were fully executed before procedures and transfers occurred.