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Based on review of 1 of 3 open medical records of patients who were administered blood (patient #1) in a total sample of 23, review of policy titled "Blood and Blood Components" (Effective 11/2009) and interview with the DON (director of nursing services), the hospital failed to have documented evidence that the patient or the patient's representative was allowed to make an informed decision regarding administration. of 2 units of packed red blood cells to patient #1. There failed to be a consent in the medical record giving the hospital permission to administer blood or blood products to the patient. Findings:

Review of the open medical record revealed patient #1 was a 58 year-old admitted on 7/12/2010 at 4:45 PM with diagnoses of Klebsiella pneumonia, skin infection, Hepatitis C and anemia. Further review revealed a 7/17/2010 at 4:50 PM physician order to type, cross match and transfuse 2 units of Rbcs (packed red blood cells). Review of nurses notes revealed the first unit of blood was administered on 7/17/2010 at 8:45 PM and the second was transfused on 7/18/2010 at 12:15 AM and completed on 7/18/2010 at 9:00 AM. There failed to be a consent in the medical record giving staff permission to transfuse the blood to patient #1. The DON stated in an interview on 8/16/2010 at 3:00 PM that she and the ADON (assistant director of nursing services) would review all open records to try to find patient #1's consent for the blood. On 8/19/2010 at 1:30 PM the DON and ADON confirmed that a consent for blood and blood products was not in any of the open medical records.

Review of the Blood and Blood Components policy and procedure revealed before administering blood "a physician order shall be written for all transfusions". Further review revealed to "obtain informed consent;" and "provide patient teaching concerning procedures".

Based on closed record review, staff interview, and review of hospital's policy Restraint or Seclusion Policy and Procedure, the hospital failed to ensure qualified staff performed a comprehensive assessments on 2 of 2 patients in a total sample of 23 (patient #21 and #23). Staff failed to failed to identify problems that would contribute to behavior changes in the patient prior to applying soft wrist restraints. (Patient #21 and 23) Findings:

1. Review of the closed medical record for patient #21 revealed an admission date of 5/12/2010 with diagnoses that included congestive heart failure, acute respiratory failure, status post tracheostomy and status post percutaneous endoscopic gastrostomy tube. Patient #21 was ventilator dependent.

Further review of the medical record revealed documentation in the nurse notes dated 5/23/10 that patient #21 pulled out the tracheostomy and had it replaced by the(RRT) Registered Respiratory Therapist at 3:30 PM.

Review of physician orders dated 5/23/10 at 10:00 PM for restraints for non-violent or non-self-destructive behavior revealed a soft limb holder for right and left upper extremity was ordered because patient #1 was unable to respond to direct requests or follow specific instructions and was intubated.

Review of nurse documentation on the Restraint or Seclusion: Less Restrictive Interventions record dated 5/23/10 revealed no documented evidence of patient #21's responses to less restrictive interventions. Further review revealed documentation that patient #1 was becoming more aware, more responsive, and bilateral wrist restraints were applied for safety.

Review of nurse notes dated 5/23/10 revealed no documented evidence of a comprehensive assessment to support the use of wrist restraints. The nurse notes failed to reveal patient #21 was agitated or pulling at the tracheostomy tube.

Review of Restraint or Seclusion Policy and Procedure 9-3.4.0 approved by the Governing Body effective 11/2009 and revised 1/2010 revealed "Before restraint is implemented, a comprehensive assessment of the patient is conducted and documented by an RN, and the risks associated with the use of restraint will be evaluated."

Interview with S4 RN on 8/19/10 at 10:20 AM revealed when a patient had a tracheostomy and became anxious, agitated or was pulling at tubes, and wrist restraints were applied, the patient's wrist were tied down by their side to prevent the patient from pulling the tubes out. S4 confirmed she was responsible for the care of patient #21 on 5/24/10. When reviewing the hourly restraint monitoring record S4 stated the restraints were removed every hour and each time patient #21's hand would immediately go for the tracheostomy tube. S4 confirmed the monitoring record did not reflect that assessment. After review of the medical record, S4 confirmed there was no documented evidence that a comprehensive assessment was performed prior to the application of the bilateral wrist restraints.

Interview with S1 RN DON on 8/19/10 at 1:00 PM confirmed a comprehensive assessment was not performed on patient #21 prior to applying the wrist restraint.

2. Review of the closed medical record revealed patient #23 was a 100 year old admitted 4/23/10 with diagnoses that included mononeuritis, cellulitis of trunk, acute respiratory failure, and acute kidney failure.

Further review of the medical record revealed patient #23 had an acute onset of shortness of breath with hypoxia and was intubated on 5/25/10. Further review revealed soft wrist restraints were applied bilaterally.

Review of the Restraint or Seclusion: Less restrictive interventions record dated 5/25/10 revealed the wrist restraints were applied due to patient #23 being intubated-pulls at ET (endotracheal) tube and nasogastric tube.

Review of nurse note documentation on 5/25/10 revealed bilateral soft wrist restraints to prevent pulling ET tube. The nurse notes failed to indicate patient behavior of agitation, anxiety, or pulling at the ET tube.

Further review of the medical record revealed no documented evidence of a comprehensive assessment prior to applying the bilateral wrist restraints to identify medical problems that may be causing behavior changes in the patient.

Interview on 8/19/10 at 2:30 PM with S2 RN ADON confirmed there was no documented evidence of a comprehensive assessment prior to the use of bilateral wrist restraints.

Based on review of the medical record, hospital policy, procedure for Restraint or Seclusion, and staff interview, the facility failed to ensure restraints are only applied to patients with a physician order by not obtaining an order prior to, during or immediately after the application of wrist restraints for 1 of 1 patients in a total sample of 23. (Patient #21) Findings:

Review of the medical record for patient #21 revealed an admission of 5/12/2010 with diagnoses that included congestive heart failure, acute respiratory failure, status post tracheostomy and status post percutaneous endoscopic gastrostomy tube. Patient #21 was ventilator dependent. Further review of the medical record revealed documentation in the nurse notes dated 5/23/10 that patient #21 pulled out the tracheostomy and had it replaced by the Registered Respiratory Therapist at 3:30 PM.

Review of physician orders dated 5/23/10 at 10:00 PM for restraints for non-violent or non-self-destructive behavior revealed a soft limb holder for right and left upper extremity was ordered and the physician signed the order 5/25/10 at 3:00 PM. Further review revealed the nurse documented there was not an order given by the attending physician and that the physician was notified on 5/24/10 with no time indicated. Review of nurse notes dated 5/24/10 failed to reveal documented evidence of physician notification of the restraint use or to obtain an order.

Review of Restraint or Seclusion Policy and Procedure 9-3.4.0 approved by the Governing Body effective 11/2009 and revised 1/2010 revealed "An order for restraint or seclusion will be obtained as soon as possible from the physician or the LIP (licensed independent practitioner) who is responsible for the care of the patient."

Interview with S4 RN on 8/19/10 at 10:20 AM revealed she was assigned to care for patient #21 the second day the restraints had been applied. S4 RN indicated it was common to use restraints when a patient had a tracheostomy but that an order had to be obtained prior to or immediately after if it was an emergent situation. S4 confirmed the restraint was applied prior to obtaining an order and that the physician was not notified immediately.

Interview with S1 RN DON on 8/19/10 at 1:00 PM confirmed wrist restraints were applied to patient #21 prior to obtaining an order and that there was no documented evidence the physician was notified as soon as possible after the application to obtain an order.

I. Based on review 1 of 13 closed medical records, review of policy and procedure for Patient Assessment/Reassessment, and staff interview, the hospital failed to ensure the RN performed an on going assessment, evaluated and supervised the nursing care of patient #9 when it was determined by the LPN that the patient had a decline in condition. The LPN (Licensed Practical Nurse) failed to reassess patient #9 and notify the RN, which resulted in the transfer of the patient to the host hospital (acute care hospital) and admission to the intensive care unit. Findings:

Review of the closed medical record revealed patient #9 was admitted to the hospital on 6/21/10 with diagnoses that included cellulitis right arm, status post incision and drainage with MRSA cultured, diabetes mellitus type II, cerebrovascular accident, parathyroidectomy, a heart transplant in the year 20000 and chronic renal and ureteral disease secondary to immunosuppressants following the transplant.

Review of assessments documented on the nurses daily flow sheet from 7/1/10 through 7/7/10 revealed an entry every twelve hours indicating that patient #9 was alert, confused, and exhibited generalized weakness.

Review of nurse notes dated 7/07/10 at 9:20 AM by S7 LPN revealed the nurse had to arouse patient #9 to administer his oral medications. The nurse documented she had to shake and call patient #9 by name to complete medication administration. The nurse noted after the medications were given, the patient immediately fell back asleep.

Continued review of the 7/07/10 notes revealed documentation at 10:30 AM that patient #9 aroused to verbal stimuli "momentarily". Documentation at 11:00 AM revealed patient #9 was not eating or drinking except for medication administration; "Glucerna offered-fell asleep with liquid in his mouth; kept arousing until all swallowed".

Further review revealed no further documentation until 5:20 PM (6hrs 20 minutes later) when patient #9 was found without a palpable or audible blood pressure, his skin was cool to touch, oxygen saturation was 79-81%, heart rate 60, respirations 20, doppler blood pressure was 80. According to documentation patient #9 was stabilized and transferred to the intensive care unit of the host facility.

Review of hospital policy Patient Assessment/Reassessment (reference #9-1.1.0 effective 11/09) revealed "Based on the initial assessment of the patient and established plan of care, reassessments are performed and documented throughout the care process. A reassessment of the patient shall be performed at least every 12 hours by the nursing staff. An RN's signature on the daily reassessment indicates that the care of the patient has been supervised and evaluated by a registered nurse. Any significant change in the patient's condition should elicit a reassessment of the patient (documented in the narrative notes) within one hour. The registered nurse is responsible for ensuring that the physician is notified of all significant changes in the patient's condition."

Interview with S2 RN ADON on 8/18/10 at 2:30 PM confirmed there was a 6 hour gap in reassessment of patient #9 as evidenced by lack of documentation of the patient's declining condition until he was found unresponsive. S2 also confirmed that the RN was not notified of patient #9's decline. During that interview, S2 revealed the LPN responsible for patient #9's care was unavailable for interview.


II. Based on review of the medical records, policy titled "Patient Assessment/Reassessment" (effective 11/2009), policy titled "Blood And Blood Components" (effective 11/2009) and staff interviews the hospital failed to ensure the RN assessed and evaluated the nursing care of each patient by failing to ensure: 1) 1 of 3 patients (patient #1) was assessed prior to initiating a blood transfusion, 2) 1 of 3 patients (patient #1) was assessed and evaluated 15 minutes after a blood transfusion was started as per hospital policy and 3) the dressings for 3 of 4 patients (patients #5, #6, #8) were assessed and evaluated each 12 hour shift and the wound of 1 of 4 (patient # 7) patient was assessed and evaluated each 12 hour shift in a total sample of 23 patients. Findings:

1. Review of the medical record revealed patient #1 was a 58 year-old admitted on 7/12/2010 at 4:45 PM with diagnoses of Klebsiella pneumonia, skin infection, Hepatitis C and anemia. Further review revealed a 7/17/2010 at 4:50 PM physician order to type, cross match, and transfuse 2 units of PRBCs. Review of the nurses notes revealed the first unit of blood was administered on 7/17/2010 at 8:45 PM, the second on 7/18/2010 at 12:15 AM and completed on 7/18/2010 at 9:00 AM. There failed to be documentation in the medical record that the RN assessed the patient or obtained a set of vital signs before the transfusion was initiated. Further review revealed the nurse failed to obtain vital signs 15 minutes after the blood transfusion was started as per hospital policy. The DON confirmed in an interview on 8/16/2010 at 3:00 PM and again on 8/19/2010 at 1:30 PM that the RN failed to have documented evidence that patient #1 was evaluated before and after the PRBCs were administered on 7/17/2010 at 8:45 PM and 7/18/2010 at 12:15 AM.

Review of hospital policy for administering blood and blood products revealed that prior to the transfusion the RN should "obtain complete set of pre-vital signs (blood pressure, pulse, respiration, temperature)". Further review revealed "the registered nurse will stay with the patient for the first 15 minutes of the transfusion" and "obtain a complete set of vital signs 15 minutes after the initiation of the transfusion".

2. Review of the medical record revealed patient #5 was admitted on 7/14/2010 at 8:51 PM with diagnoses of acute respiratory failure, Klebsiella pneumonia, a wound to the right medial calf and a wound to the nasal septum. Review of wound assessment forms revealed there was one assessment made by the wound care nurse, RNS4 on 8/10/2010 (no time documented) for the right medial calf wound. The assessment at that time for the right medial calf wound revealed an "intact blister" with "closed wound edges". S4 documented the wound to the septum was due to a previous endotracheal tube "cutting into septum". Documentation on the nurses daily flow sheet (from 8/10/2010 through 8/16/2010) under the skin assessment sections revealed a check mark indicating to "See Wound Care Flow Sheet".

Review of the 8/10/2010 Wound Care Treatment Flow Sheet revealed an order by the S4, wound care nurse, to apply a 2x3 Tegaderm patch (a thin, clear sterile dressing that keeps out water, dirt and germs, and let skin breathe) to the blister on the patient's right medical calf and to change the Tegaderm dressing every 5 days when needed. This pre-printed wound care treatment flow sheet has 2 sections one for the AM nurse and one for the PM nurse to document when he/she assesses the dressing to the patient's wound. Review of these sections from 8/10/2010 through 8/16/2010 failed to reveal the PM nurses acknowledged whether or not the patient had a dressing. Further review failed to reveal documentation that the PM nurses assessed and evaluated patient #5's dressing.

3. Review of the medical record revealed patient #6 was admitted on 7/27/2010 at 10:00 AM with diagnoses of probable sepsis, an un-stageable pressure ulcer to the coccyx, and Coronary artery disease. Review of the Wound assessment form revealed RN S4 assessed the coccyx wound on 7/27/1010, 8/05/10 and 8/13/2010. Documentation from 7/27/2010 through 8/16/2010 on the nurses daily flow sheet under each skin assessment revealed a check mark indicating to "See Wound Care Flow Sheet".

Review of the 7/27/2010 through 8/16/2010 Wound Care Treatment Flow Sheets revealed patient #6 had a pressure ulcer on the coccyx. Further review revealed S4 ordered "Rinse the wound with DWC (a skin pep that contains seaweed), apply Sensicare (a cream that protects irritated skin) to the immediate peri-wound, apply 1/4 strength Dakin solution (used to prevent the growth of germs), moistened Kerlix (gauze dressing) to fill the wound". Further orders revealed to cover the wound with 1/2 ABD pad and secure with a minimal tape. S4 further ordered this treatment to be done daily and as needed.

Review of this pre-printed wound care treatment flow sheet revealed 2 time sections one for the AM nurse to document assessments and the other for the PM. There failed to be documented evidence from 7/27/2010 through 8/16/2010 that the PM nurses assessed and evaluated patient #6's dressing on the coccyx from 7/29/2010- 7/31/2010, 8/04/2010- 8/08/2010, 8/10/2010, 8/13/2010-8/15/2010.

4. Review of the open medical record for patient # 7 revealed an admission date of 8/3/10 with diagnoses that included diabetes type II, noninsulin dependant, status post right femoral-popliteal bypass surgery, left below the knee amputation, peripheral vascular disease, and coronary artery disease. Review of the risk for pressure ulcer development Braden Scale dated 8/3/10 revealed patient #7 was at moderate risk for pressure ulcer development. Review of August 2010 physician orders revealed orders dated 8/6/10 for Sensicare protective ointment to the area daily and as needed.

Observation on 8/16/10 at 9:30 AM revealed patient #7 was in her bed with the right leg elevated on a pillow with her heel not touching the bed. Interview with the patient at that time revealed she was able to shift her weight in the bed and was able to push her self up in the bed. Patient #7 stated she went to therapy daily and that staff encouraged her to move.

Review of the hospital Wound Assessment Form revealed documentation on 8/3/10 that patient #7 had a Stage III pressure ulcer to the coccyx/buttocks that measured 10.0 centimeters long by 5.0 centimeters wide and had a depth of less than 0.1. Further review revealed 100 % of the ulcer wound bed was purple, had no odor, the wound edges were open, had serosanguinous drainage and the tissue surrounding the ulcer was discolored. The assessment was signed by S4 RN Wound Care Nurse.

Review of nurses daily flowsheet record dated 8/6/10 through 8/16/10 revealed documentation on the skin assessment section to "See Wound Care Flow Sheet". Review of the Wound Care Treatment Flow Sheet revealed documentation on 8/6/10, 8/7/10, 8/9/10, 8/10/10, 8/14/10, 8/15/10, and 8/16/10 that a treatment was administered but there was no documentation of an assessment of the wound every 12 hours including each day treatment was administered .

Interview on 8/16/10 at 10:45 AM with S1 DON confirmed there was no evidence of on going evaluation of patient #9's wounds.

5. Review of the medical record revealed patient #8 was admitted on 8/12/2010 at 4:09 PM with diagnoses of perforated ulcer, thoracotomy as a result of empyema, ulcers to the coccyx, buttocks, and left posterior calf. Review of the wound care treatment flow sheet from 8/12/2010 revealed there were no PM assessments of the wounds or the dressings by the nurses from 8/12/2010 through 8/14/2010.

Review of the policy for Patient Assessment/Reassessment policy revealed that "based on the initial assessment of the patient and established plan of care, reassessment are performed at least every 12 hours by nursing staff. The reassessment of the patient will be supervised and evaluated by a registered nurse. An RN's signature on the daily assessments indicates that the care of the patient has been supervised and evaluated by a registered nurse".

Based on observation, review of policy titled "Daily Patient Isolation Room Cleaning" (Reference #5004), policy titled "Notification Procedure for Contact Isolation", form titled "Isolation Orders", policy titled Guidelines for Isolation Precautions" (Policy #8-2.0.0), and staff interviews, the infection control officer failed to ensure all staff adhered to infection control policies and procedures to prevent the spread of infections as evidenced by: 1) the failure of housekeeping staff (contracted service from the host hospital) to adhere to hospital policies and procedures for cleaning isolation rooms and 2 ) the failure of nursing staff to adhere to hospital policies and procedures for isolation. Findings:

1. On 8/18/2010 at 8:55 AM CNA (certified nursing assistant) S5 was observed removing a gown, mask, and gloves from an isolation set-up outside the door to room a. Further observation revealed S5 put on the personal protective gear (gown, mask, gloves), walked down the hall way to the uncovered linen cart and removed sheets and pillow cases. In the process of removing the linen CNA S5 dropped the linen on the floor, picked it up and proceeded to room a. Review of the sign on the door to room a revealed this patient (patient #1) was on droplet isolation precautions. Review of the medical record revealed patient #1 was a 58 year-old admitted on 7/12/2010 at 4:45 PM with diagnoses of Klebsiella pneumonia, skin infection and Hepatitis C.

On 8/18/2010 at 9:15 AM CNA S5 walked out of the room into the hall way wearing the same personal protective gear, placed the contaminated linen in the regular dirty linen hamper and went back into room a. At 9:17 AM on 8/18/2010 S5 came out of room a wearing her gloves and mask, walked down the hall near the nurses station and opened the dietary cart. After closing the food cart she walked to the nurses station, pulled off her gloves and mask and placed them in the trash bin inside the nurses station. At that time CNA S5 stated that she left the gown she wore in the room but confirmed that she opened the food cart with the contaminated gloves and disposed of the mask and gloves in the trash bin at the nurses station. In an interview on 8/18/2010 at 9:30 AM the DON confirmed that S5 failed to use correct isolation techniques after providing care for patient #1.

Review of policy Guidelines For Isolation Precautions revealed, "Handling and disposal of used patient-care equipment and articles are prudent or required, including the likelihood of contamination with infective material. Some used articles are enclosed in containers or bags to prevent inadvertent exposures to patients, personnel and visitors and to prevent contamination of the environment. Although soiled linen may be contaminated with pathogenic microorganisms, the risk of disease transmission is negligible if it is handled, transported and laundered in a manner that avoids transfer of microorganisms to patients, personnel and environments".

Further review of the policy revealed to "change gloves between task and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. Remove gloves promptly after use, before touching non contaminated items and environmental surfaces, and before going to another patient, and wash hands immediately to avoid transfer of microorganisms to other patients and environments. Remove gloves before leaving the patient's room and wash hands immediately. Handle, transport, and process used linen soiled with blood, fluids, secretions, and excretions in a manner that prevents skin and mucous membranes exposures and contamination of clothing that avoids transfer of microorganisms to other patients and environments".

2. On 8/18/2010 at 1:00 PM, the housekeeper was observed cleaning room b which had a sign on the outside of the door indicating the patient was in contact isolation. After cleaning the room the housekeeper failed to clean all supplies and equipment on the housekeeping cart and failed to change the dust mop head. The housekeeper also failed to use gloves while emptying the contaminated mop water. Review of the medical record revealed patient #5 was admitted on 7/14/2010 at 8:51 PM with diagnoses of acute respiratory failure, Klebsiella pneumonia and MRSA (methicillin resistant staph aureus).

An interview with the housekeeper at this time revealed she works for the host hospital. She stated that she did not use the dust mop to clean the room and confirmed that she did not use gloves to handle the pail while emptying the contaminated mop water. In an interview on 8/18/2010 at 2:00 PM, the administrator and DON stated that housekeeping services are contracted through the host hospital and they would contact that hospital. On 8/19/2010 at 2:45 PM, the director of house keeping services of the host hospital stated in an interview that he was aware that the host hospital had problems with cleaning isolation rooms but he had a plan of action to take care of this. He further stated that he had gone over the plan with this housekeeper.

Review of the host policy "Daily Patient Isolation Room Cleaning" revealed "When leaving Isolation Room, remove gown, mask and dispose of in trash liner. Do not remove gloves at entrance to room. Wash down supplies and equipment with germicidal solution. Bag the mop head and soiled linen. Dump out solution in bucket. Remove gloves and discard in trash liner. Double bag into liner outside of room. Tie off bag".