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Based on observation, interview, and record review, the hospital failed to protect and promote patients' rights as evidenced by:

1. The hospital failed to ensure patients received care in a safe setting. Cross reference to A0144.

2. The hospital failed to identify the use of a mechanical device, material, or equipment that immobilized or reduced the ability of one patient to move freely. Cross reference to A0159.

3. The hospital failed to ensure care plans were developed to address the use of restraints and bedrails for four patients. Cross reference to A0166.

4. The hospital failed to ensure the physician's orders were obtained for the use of restraints and bedrails for three patients. Cross reference to A0168.

5. The hospital failed to ensure restraint orders were only initiated when documented behaviors warranted and physician's orders were obtained daily for their use for one patient. Cross reference to A0169.

6. The hospital failed to ensure the physician's orders for restraints used for one patient were renewed every 24 hours. Cross reference to A0173.

7. The hospital failed to ensure assessment, monitoring, and interventions were provided every two hours for two patients regarding the use of restraints and bedrails. Cross reference to A0175.

The cumulative effect of these systemic practices resulted in the hospital's inability to provide high quality healthcare in a safe environment.

Based on observation, interview, and record review, the hospital failed to provide privacy or confidential information to patients admitted to the hospital as evidenced by:

* For patients admitted to the behavioral health in-patient services. Pre-printed menus that include patients full name and room number were found on a hallway table in the common area. Additionally, menus with patient names were also found in an unlocked dining room drawer.

* A container of breastmilk with a label of the patient's identification was found in regular trash can in the MBU.

Findings:

1. Review of hospital's P&P titled Tray Identification, CN-016, showed patients in the Behavioral Health Services receive meals at designated times. Each patient tray is identified by a room service tray ticket. Menus show patient names, room number, date of birth, allergies (if any) and diet order.

On 2/23/15 at 0900 hours, the BHU was toured. Ten patient menus were observed in a unsecured location. The menus included the full name of the patient and their room number on the BHU.

In a common area of the dining room, approximately 30 menus were found stored in a unlocked drawer. All 30 menus contained the full names of patients who were former in-patients on the BHU.

An interview with the BHU Director was conducted. The Director stated the menus should be stored in a more secure location. The Director stated the menus found in the BHU hallway were for patient's currently hospitalized on the BHU; however, the menus found stored in the drawer should have been shredded.


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2. A random inspection was conducted on 2/24/15 at 1400 hours in the MBU, accompanied by the Executive Director Women's Services & Med/Sur, and RN O.

A container of breastmilk of Patient 26 was observed stored in a refrigerator. A label was observed sticked on the container of breastmilk. The label included the patient's name, patient's date of birth, patient's gender, patient's admission date, patient's medical record number, and physician's name. The label dated 2/23/15 at 0830 hours.

RN O stated the container of breastmilk was stored more than 24 hours. The RN was observed taking the container of breastmilk out of the refrigerator and gave to RN P.

On 2/24/15 at 1415 hours, RN P was asked where she put the above container of breastmilk. The container of breastmilk with the above label was found in a regular trash can by the RN.

Based on observation, interview, and record review, the hospital failed to ensure patients received care in a safe setting as evidenced by:

1. Failure to ensure six of eight sampled patients (Patients 1, 10, 20, 22, 23, and 29) reviewed for restraints were free from the use of restraints. This failure restricted the patients from moving freely and created unsafe environment for the patients. Cross reference to A0154.

2. Failure to provide surgical services to meet the needs of the patients in regards to emergency supplies and medications, proper surgical attire, safe injection practices, hand hygiene, proper dilution of an enzymatic detergent, cleaning of patient care equipment and OR areas, and actions taken to address out of range temperature and humidity. These failures increased the risk of poor outcomes for surgical patients. Cross reference to A0951.

Based on observation, interview, and record review, the hospital failed to ensure six of eight patients (Patients 1, 10, 20, 22, 23, and 29) reviewed for restraints were free from the use of restraints. This failure restricted the patients from moving freely and created an unsafe environment for the patients.

Findings:

According to FDA, many deaths and injury reports related to entrapment and falls for both adult portable bed rail products and hospital bedrails have been reported. The entrapment events occurred in openings within the bedrails, between the bedrails and mattresses, under bedrails and at the end of the rail, between split rails, and between the bedrails and head or foot boards.

Entrapments have occurred in a variety of patient care settings including hospitals. Patient entrapment may result in deaths and serious injuries. The FDA states all bedrails should be used with caution, especially with older adults and people with altered mental status, physical limitations, and certain medical conditions.

Review of the hospital's P&P titled Restraints and Seclusion reviewed/revised 7/14, showed physical restraint is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. Devices may include soft cloth jacket vests, soft wrist/ankle restraints, hard restraints, or other devices such as using side rails to prevent a patient from voluntarily getting out of bed.

Review of the hospital's P&P titled Restraints and Seclusion reviewed on 7/14, showed the intent of this policy is to assess for appropriate use and application of restraints. The use of hand mitts would not be considered restraint; however, if the mitts are applied so tightly that the patient's hand or fingers are immobilized, this would be considered a restraint and the requirements would apply. If the mitts are so bulky that the patient's ability to use their hands is significantly reduced this would be considered restraint.

For Non-violent restraints each written order is time limited to 24 hours. The RN conducts reassessment for continuation of a restraint every two hours, the PCT or sitter obtain vital signs and circulation checks every two hours, the physician conducts a face-to-face, and the physician or RN conducts continuous assessments of the need for restraints.

Review of the hospital's P&P titled Fall Risk Assessments and Interventions revised 9/14, showed Standard Fall Risk Interventions are to orient patient/family to environment and routines and their role in fall prevention, place call light within reach and remind patient to call for assistance, ensure bed is in a low position with brake on, personal items are within reach, additional lighting as needed, provide non-skid footwear for patients as needed, minimize trip or slip hazards, round frequently and assess for safety and comfort.

1. Tour rounds were conducted on the DSU Unit on 2/23/15 at 1050 hours, accompanied by the Manager of DSU and the Executive Director of Critical Care, Telemetry and Renal Services. Patient 22 was observed in bed. The patient's two upper bedrails and two lower bedrails were elevated. The Manager confirmed the observation. The Manager stated four bedrails were elevated for the patient's safety; the patient climbed out of her bed.

Review of Patient 22's medical record was initiated on 2/23/15. The patient was admitted to the hospital on 2/15/15.

Review of the Physical Assessment Med/Surg (Medical/Surgical) dated 2/14/15 at 0510 hours, showed Patient 22 exhibited generalized weakness.

Review of The Physical Therapy Evaluation dictated on 2/15/15 at 0844 hours, showed Patient 22 reported her previous level of functions was independent with her ADL care; the patient was independent with limited community ambulation.

The assessment indicated the patient was supervised ambulating 350 feet in hall with no device, occasionally reaching our to the hall rail for stability; the patient was functioning at prior level of mobility; and the RN was advised to ambulate the patient in the hall three to four times daily for hospital protocol.

Review of documentation for Patient 22 for Patient Safety and Positioning dated 2/15/15 at 2021 hours, and on 2/16/15 at 0020 and at 0516 hours, showed four bedrails were elevated for "Patient Safety."

Review of the Physical Assessment Med/Surg dated 2/17/15 at 0742 hours, showed Patient 22 exhibited general weakness. The patient required minimal assist for ambulation and mobility.

Review of documentation for Patient 22 for Patient Safety and Positioning showed four bedrails were elevated for the patient on 2/17, 2/18, 2/19, 2/20, 2/21, 2/22, and 2/23/15.

Review of the Physical Therapy Evaluation dictated on 2/20/15 at 0844 hours, showed Patient 22 had impairment in bed mobility, balance, transfers, and ambulation. The patient required minimal assistant in/out of bed and to ambulate with no device.

Review of documentation for Patient 22 by a CCT for Patient Safety and Positioning dated 2/22/15 at 0725 hours, showed four bedrails were elevated for Patient 22 per the patient's request. The patient was able to use the call light.

Review of Patient Safety and Positioning dated 2/23/15 at 0740, at 0800, and at 0938 hours, showed four bedrails were elevated for Patient 22. The patient requested four bedrails up per safety. The patient was able to use the call light.

However, there was no documentation to show nursing staff conducted an individualized assessment of Patient 22 and specified the reasons for the use of four bedrails from 2/15/15 at 2021 hours to 2/22/15 at 0600 hours, with documentation of any less restrictive methods used.

In addition, there was no physician's order for the use of four bedrails for Patient 22. There was no documented evidence to show nursing staff developed a care plan to address the use of four bedrails for Patient 22.

An interview and concurrent medical record review was conducted with the Manager of DSU and the Executive Director of Critical Care, Telemetry and Renal Services on 2/23/15 at 1055 hours. The Manager stated four bedrails was elevated for Patient 22 due to safety reasons. When the Manager was asked what "safety" meant, she stated Patient 22 fell out of bed. The Manager acknowledged the use of four elevated bedrails was a restraint for Patient 22 and a physician's order should be obtained for their use.

When asked, the Manager was unable to find documented evidence to show nursing staff assessed and specified the reason for use of four elevated bedrails for Patient 22, a care plan was developed, or a physician's order was obtained for their use.

During an interview with CCT 1 on 2/23/15 at 1150 hours, the CCT was asked the reason for the use of four bedrails for Patient 22. The CCT stated the patient requested to elevate four bedrails.

An observation and concurrent interview was conducted with Patient 22 on 2/23/15 at 1155 hours, accompanied by the Executive Director of Critical Care, Telemetry and Renal Services. Patient A was observed sitting in a chair. The patient was asked about the use of four bedrails and whether she requested to elevate four bedrails. The patient stated she was not sure; she did not ask to elevate four bedrails; and her mind was not there now.

2. Review of Patient 23's medical record was initiated on 2/23/15. The patient was admitted to the hospital on 2/16/15.

Review of the physician's History & Physical dictated on 2/16/15 at 1616 hours, showed Patient 23 was alert and oriented times three (to person, place, and time).

Review of the section of the nursing Physical Assessment Med/Surg of the Care Activity-Assessment showed the following:

* On 2/16/15 at 1642 hours, at 2015 hours, Patient 23's neurological parameters were "WDL" (within normal limits). The patient had weakness with resistance to the right and left arms and to the right and left legs. The patient had difficulty in hearing on the right side and the left side. The patient was anxious and restless.

* On 2/17/15 at 0728 hours, documentation showed Patient 23's neurological parameters was "WDL Except." Further review showed the patient had weakness with resistance to the right arm, left arms, and right and left legs.

Review of documentation on the section for Initiate Restraint, Non-Violent showed a vest restraint was initiated for Patient 23 on 2/17/15 at 1148 hours. The non-violent restraint justification included attempts to get out of bed. Further review showed a soft restraint was initiated on 2/17/15 at 1350 hours.

Review of documentation on the section for Monitor Restraint, Non-Violent of the Care Activity-Assessments, showed the following:

* On 2/17/15 at 1200, 1600, and 1800 hours, a vest restraint was applied for Patient 23.

* On 2/17/15 at 0200, 0400, 1400, 1949, and 2200 hours, Patient 23's hands and lower extremities were restrained with soft restraints in addition to a vest restraint.

* On 2/18/15 at 0600 and 1200 hours, Patient 23's hands and lower extremities were restrained with soft restraints. The vest restraint was removed.

* On 2/18/15 at 0800, 1000, 1400, 1600, and 1800 hours, Patient 23's hands and lower extremities were restrained with soft restraints and a vest restraint was used.

* On 2/18/15 at 2000 and at 2200 hours; on 2/19/15 at 0000, 0200, 0400, 0600, 0759, 1004, 1200, 1400, 1600, 1810, 2000, and 2200 hours; and on 2/20/15 at 0003, 0201, and 0400 hours, Patient 23's hands and lower extremities were restrained with soft restraints, a vest restraint was used and the patient's hands were restrained with mittens.

* On 2/20/15 at 0603 hours, Patient 23's hands were restrained with mittens and the patient's four bedrails were elevated.

* On 2/20/15 at 0801 and 1000 hours, Patient 23's hands and lower extremities were restrained with soft restraints, a vest restraint was used, and the patient's hands were restrained with mittens.

* On 2/20/15 at 1200, 1400, 1600, and 1800 hours, Patient 23's hands and lower extremities were restrained with soft restraints and the patient's hands were restrained with mittens. The patient's four bedrails were elevated

* On 2/20/15 at 2000 and 2200 hours and on 2/21/15 at 0000 hours, Patient 23's hands and lower extremities were restrained with soft restraints and the patient's hands were restrained with mittens.

* On 2/21/15 at 0200, 0400, 0600, 0800, 1000, 1200, 1400, 1600, 1800, and 2000 hours, Patient 23's hands and lower extremities were restrained with soft restraints and the patient's hands were restrained with mittens. The patient's four bedrails were elevated.

* On 2/21/15 at 2200 hours, Patient 23's left upper extremity was restrained with a soft restraint. The patient's four bedrails were elevated.

* On 2/21/15 at 2347 hours, Patient 23's bilateral upper extremities and his left lower extremity were restrained with a soft restraint. The patient's four bedrails were elevated. However, the form showed the patient was "quiet."

* On 2/22/15 at 0746, 1000, 1200, 1600, 1800, 2000, and 2200 hours; on 2/23/15 at 0000, 0200, 0400, 0800, 1100, and 1200 hours, Patient 23's hands and lower extremities were restrained with soft restraints and the patient's hands were restrained with mittens. The patient's four bedrails were elevated.

Review of the Hospitalist Progress Note dated 2/22/15 at 1524 hours, showed the physician documented Patient 23 was restrained secondary to "getting out of bed unsafely."

A physician's order was not obtained for the use of soft restraint when soft restraints were initiated for Patient 23 until 16 hours after their application. In addition, the physician's orders were not obtained for the use of hand mittens and the four bedrails for Patient 23. Cross reference to A0168, example #2.

A physician's order for the use of vest restraints and soft restraints exceeded 24 hours, contrary to the hospital's P&P. Cross reference to A0173.

Patient 23 was not assessed, monitored, and provided interventions every two hours by the nursing staff when restrained as per hospital's P&P. Cross reference to A0168, example #2.

During an interview and concurrent medical record review with the Manger of DSU and RN S on 2/23/15 at 1315 hours, RN S was asked the reasons for the use of four bedrails, soft restraints, mittens, and vest restraint for Patient 23. The RN stated the patient was confused and pulling out the lines, the patient threw his legs out of the bed, and the staff worried the patient would fall.

The Manager stated Patient 23 was restrained due to attempts to get out of bed while also confirming the patient was restrained with vest, hand mittens, or elevated four bedrails in addition to the use of soft restraints to his upper and lower extremities.

3. During an observation on 2/26/15 at 1000 hours, Patient 29 was observed lying in bed. The patient's two upper bedrails and two lower bedrails were elevated. The patient's family member was at the bedside. The Manager of the Pulmonary, Renal/Observation Unit confirmed the observation.

A concurrent interview and Patient 29's medical record review was conducted with RN T on 2/26/15 at 1010 hours. The patient was admitted to the hospital on 2/23/15.

Review of the section for documentation of Patient 29's Patient Safety and Positioning showed four bedrails were elevated on 2/25 and on 2/26/15.

There was no documentation to show Patient 29 of an assessment and there was no physician's order for the use of four bedrails.

There was no documentation to show nursing staff developed a care plan to address the use of four bedrails for Patient 29.

During an interview with RN T on 2/26/15 at 1005 hours, the RN was asked the reason for the use of four bedrails for Patient 29. The RN stated Patient 29 did not need four bedrails elevated and they should not be elevated. The patient and/or the patient's family member did not request to elevate the four bedrails. The RN stated the patient was able to ambulate and was able to get out of bed. When asked, the RN stated the patient was unable to lower the bedrails.

RN T confirmed four bedrails were elevated for Patient 29 on 2/25 and 2/26/15. The RN stated Patient 29 should be assessed for the use of four bedrails; a physician's order should be obtained, and a care plan should be developed to address the use of four bedrails; however, the RN was unable to locate evidence this was done.


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4. During a tour of the third floor medical unit on 2/26/15 at 0930 hours, Patient 20 was observed in bed with all four bedrails elevated. An air mattress appeared to be in place on the bed.

Review of Patient 20's medical record on 2/26/15, did not show a physician's order for four bedrails was obtained.

The nurse caring for Patient 20, RN A, was interviewed on 2/26/15 at 0940 hours. RN A stated she would need to call the doctor for an order to have four bedrails elevated if needed. RN A stated the Lift Team was recently in the room to care for the patient and put up the bedrails.

In an interview with the Lift Team Staff on 2/26/15 at 1020 hours, he stated he believed all bedrails were to be elevated on the beds, especially if the bed was slippery (as with the use of an air mattress); however, he would leave the bedrails down if instructed. The staff stated when an air bed was in use, they always left four bedrails up and with other mattresses, he put four bedrails up unless he was told otherwise.

During an interview with the Ergonomic Coordinator for the Lift Team on 2/26/15 at 1025 hours, he stated he trained the Lift Team; usually the bedrails went back up when leaving the patient, but it was not the Lift tech's responsibility to decide if the bedrails were to be up or down.

A falls precaution poster at the 3rd floor nursing station listed actions to take to prevent falls. The list included, "bedrails up for safety if needed."

The sign was reviewed with RN E. The RN stated the sign referred to the use of bedrails for falls prevention.

The Patient Falls Risk Assessment and Prevention training for 2015, was reviewed and did not show bedrails were to be used for falls prevention.


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5. Observation of a sign posted at the Pulmonary Unit nurses' station for Instructions for staff on Fall Prevention Interventions showed to assist patients with ambulation when needed, keep the patient care area well lit and free of clutter, keep patient's belongings/equipment within reach of the patient, do not leave patients unattended whenever possible, keep wheelchairs/gurneys in the locked & low position, apply safety devices during procedures when needed, and "bedrails up for safety when needed."


On 2/23/15, medical record review for Patient 10 was initiated. Patient 10 was admitted to the hospital on 2/20/15.


Review of the nurses' note dated 2/20/15, showed Patient 10 climbed out of bed with all four bedrails up. The patient was found on the hallway floor; he was alert and confused, but no bruises or open wounds were noted. Patient 10 denied any pain. His head and body were checked and no 'bumps" were found.


Review of the Hospitalist Progress Note dated 2/22/15, showed the physician documented, due to Ativan (medication used to treat anxiety) now discontinued, Patient 10 was still somewhat confused but better than yesterday. The patient still had soft restraints but was now alert and oriented times three. The physician documented a patient family member confirmed this always happened with Ativan.


During the tour rounds on the Pulmonary Unit, accompanied by the Executive Director of Women's Services & Medical Surgical Units on 2/23/14 at approximately at 1000 hours, Patient 10 was observed lying in bed. The patient appeared alert and was able to make his needs known. All four bedrails of the patient's bed were raised (two upper and two lower) and he was in a vest (type of medical restraint used to restraint the patient to his bed) restraint tied on both sides of the bed frame.


Review of a physician's order dated 2/20/15, showed an order for restraint for Patient 10, location: hands and waist, non-violent restraint: vest. The non-violent restraint justification was: pulling drain/line/tubes, and attempting to get out of bed. Additional order instructions were for a soft vest restraint and hand mittens (type of medical soft restraint designed to restrict had movement, it is bulky, made of soft fabric, fastened tightly the wrist with Velcro) PRN (as needed) to prevent the patient from falling.


There was no daily physician's order and/or documentation to support the restraint intervention needs to continue or to end the restraint as soon as possible.


During an interview with RN N on 2/23/15 at 0900 hours, the RN stated the four bedrails were elevated for Patient 10's safety; the patient had climbed out of his bed.

RN Q was interviewed on 2/23/15 at 1015 hours. The RN explained Patient 10 became increasingly confused during his first night in the hospital and fall prevention measures were implemented around 1500 hours on 2/20/15. RN Q stated measures for fall prevention included posting a star sign outside of Patient 10's room, keeping the room free of clutter, activation of the bed alarm, wearing rubber-soled socks, and elevating all four bedrails when needed for the patient's safety.

During an interview with the Executive Director of Women's Services and Med Surg on 2/23/15 at 1020 hours, she confirmed the use of four bedrails was considered a restraint by the hospital's P&P and was not a fall prevention measure.

Patient 10 was interviewed on 2/23/15 at 1020 hours. The patient stated when he fell he had to go to the bathroom and was trying to get out of bed. Patient 10 stated he was not sure if he had requested assistance before attempting to get out of bed.

6. On 2/23/15, medical record review for Patient 1 was initiated. Patient 1 was admitted to the hospital on 2/20/15.

During the tours rounds on the Pulmonary Unit, accompanied by the Executive Director Women's Services & Medical Surgical Units on 2/23/14 at approximately at 1030 hours, Patient 1 was observed lying in bed. The patient appeared confused and unable to make her needs known. There was a sling placed on her right shoulder.

A sitter was by her side (companion) who was holding the patient's left hand down to prevent her from moving her arm. All four bedrails were raised on the bed. A hand mitten was tightly attached to her left wrist.


During an interview with the PCT 1 on 2/23/15 at 1035 hours, she stated Patient 1 fell at home and broken her right shoulder. The patient was unable to move the arm due to pain or remove the hand mitten by herself. The PCT was asked to remove the patient's left hand mitten. An IV catheter was observed on the dorsum of the patient's left hand.

Review of a History and Physical Report dated 2/20/15, showed the patient was brought in to the hospital after it was noticed she was confused and had fever episodes. The patient was awake and alert, somewhat lethargic, but able to answer questions. The patient reported she had a fall and sustained a right shoulder fracture. The patient underwent a surgical repair of her right shoulder.

During an interview with RN M on 2/23/15 at 1040 hours, he stated a hand mitten was not classified as a restraint by the hospital's P&P and a physician's order was not necessary. When asked the reason for Patient 1's hand mitten, he stated Patient 1 was pulling the IV line and was confused. RN M stated the patient had the mittens on when he started his shift. When RN M was asked about an order for the restraint, a face to face assessment, and a nurse rounding on the patient for restraints, he stated the patient "can take them off, if she needed to." RN M stated these were not documented as restraints.

During an interview and demonstration of the hand mitten on 9/23/15 at 1030 hours, the Executive Director Women's Services and Med Surg provided the surveyor a sample of the mitten used by Patient 1. The mittens covered the entire hand of the Executive Director.

The mitten contained a large foam padding, larger than a hand size and about three inches thick, which could decrease the ability to move fingers, and was secured tightly around the wrist with a Velcro strap. The mitten also contained a flap that allowed the fingers to be either exposed or enclosed in the mitten. When the fingers were enclosed, the ability to grab items was diminished and the patient's hands and fingers were visible to staff members.


During the same interview the Director stated this type of mitten was not considered a restraint and therefore, it was not necessary for a nurse to have a physician's order, nurse rounding, and a face to face assessment when using these devices.

However, further medical record review showed Patient 1 was confused and disoriented. Observation of the patient showed her left shoulder and arm were immobilized, and in addition, she had a 1:1 sitter holding her right hand, which might prevent the patient from removing the mitten. There was no documentation to show the hand mitten was assessed to not be a restraint for this patient.

Based on observation, record review, and interview, the hospital failed to identify the use of a mechanical device, material, or equipment that immobilized or reduced the ability of one of eight sampled patients (Patient 1) reviewed for restraints to move freely. A hand mitten (bulky, glovelike covering for the hand, with no divided fingers, tightly fastened to the wrist with Velcro) was used on the patient without an order, a face to face assessment, and nurse rounding for safety. This created the risk of poor health outcomes to this patient.

Findings:

Review of the hospital's P&P titled Restraints and Seclusion reviewed on 7/14, showed the intent of this policy is to assess for appropriate use and application of restraints. Physical restraint is any manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move. The use of hand mitts would not be considered restraint; however, if the mitts are applied so tightly that the patient's hand or fingers are immobilized, this would be considered a restraint and the requirements would apply. If the mitts are so bulky that the patient's ability to use their hands is significantly reduced this would be considered a restraint. For Non-violent restraint each written order is time limited to 24 hours, RN conducts reassessment for continuation of restraint every two hours, PCT or sitter obtain vital signs circulation checks every two hours, physician conducts face-to-face, the physician or RN conducts continuous assessments of the need for restraints.

On 2/23/15, medical record review for Patient 1 was initiated. Patient 1 was admitted to the hospital on 2/20/15.

During the tours rounds on the Pulmonary Unit, accompanied by the Executive Director Women's Services & Medical Surgical Units on 2/23/14 at approximately at 1030 hours, Patient 1 was observed lying in bed. The patient appeared confused and was unable to make her needs known. There was a sling placed on her right shoulder.

A sitter was by her side (companion) who was holding the patient's left hand down to prevent her from moving her arm. All four bedrails were raised on the bed. A hand mitten was tightly attached to her left wrist.

During an interview with the PCT 1 on 2/23/15 at 1035 hours, she stated Patient 1 fell at home and broken her right shoulder. The patient was unable to move the arm due to pain or remove the hand mitten by herself. The PCT was asked to remove the patient's left hand mitten. An IV catheter was observed on the dorsum of the patient's left hand.

Review of a History and Physical Report dated 2/20/15, showed the patient was brought in to the hospital after it was noticed she was confused and had fever episodes. The patient was awake and alert, somewhat lethargic, but able to answer questions. The patient reported she had a fall and sustained a right shoulder fracture. The patient underwent a surgical repair of her right shoulder.

During an interview with RN M on 2/23/15 at 1040 hours, he stated a hand mitten was not classified as a restraint by the hospital's P&P and a physician's order was not necessary. When asked the reason for Patient 1's hand mitten, he stated Patient 1 was pulling the IV line and was confused. RN M stated the patient had the mittens on when he started his shift. When RN M was asked about an order for the restraint, a face to face assessment, and a nurse rounding on the patient for restraints, he stated the patient "can take them off, if she needed to." RN M stated these were not documented as restraints.

During an interview and demonstration of the hand mitten on 9/23/15 at 1030 hours, the Executive Director Women's Services and Med Surg provided the surveyor a sample of the mitten used by Patient 1. The mittens covered the entire hand of the Executive Director.

The mitten contained a large foam padding, larger than a hand size and about three inches thick, which could decrease the ability to move fingers and was secured tightly around the wrist with a Velcro strap. The mitten also contained a flap that allowed the fingers to be either exposed or enclosed in the mitten. When the fingers were enclosed, the ability to grab items was diminished and the patient's hands and fingers were visible to staff members.

During the same interview, the Director stated this type of mitten was not considered a restraint and therefore, it was not necessary for a nurse to have a physician's order, nurse rounding, and a face to face assessment when using these devices.

However, medical record review showed Patient 1 was confused and disoriented. Observation of the patient showed her left shoulder and arm were immobilized, and in addition, she had a 1:1 (one to one) sitter holding her right hand, which might prevent the patient from removing the mitten. There was no documentation to show the hand mitten was assessed to not be a restraint for this patient.

Based on interview and record review, the hospital failed to ensure care plans were developed to address the use of restraints and bedrails for four of eight sampled patients (Patients 1, 10, 22, and 23) reviewed for restraints and bedrails. This failure resulted in the lack of documentation of the process of assessment, intervention, and evaluation of the restraint use for these patients.

Findings:
The hospital's P&P titled "Restraints and Seclusion" revised on 7/14, showed
Restraint or Seclusion documentation will be recorded on the 24 hours Restraint or Seclusion Documentation/Care Plan Form, Restraint or Seclusion Use Physician Order Form, and Daily logs. Documentation should contain the patients' written care plan as follows:

1) An assessment of the identified behavior and its related circumstances requiring restraints or seclusion.
2) Outcome oriented goal related to restraints or seclusion use.
3) Criteria for discontinuation of restraints or seclusion, patient and family notification when appropriated.
4) Description of interventions.
5) Person responsible for implementation of restraints or seclusion.
6) Incorporation of the physician order into the care plan.
7) Discontinuation of the restraints or seclusion.1.a. On 2/23/15, medical record review for Patient 10 was initiated. Patient 10 was admitted to the hospital on 2/20/15.

Review of the nurses' note dated 2/20/15, showed Patient 10 climbed out of bed with all four bedrails up. The patient was found on the hallway floor; he was alert and confused, but no bruises or open wounds were noted. Patient 10 denied any pain. His head and body were checked and no 'bumps" were found.

Review of the Hospitalist Progress Note dated 2/22/15 showed the physician documented, due to Ativan (an antianxiety medication) now discontinued, Patient 10 was still somewhat confused but better than yesterday. The patient still had soft restraints but was now alert and oriented times three. The physician documented a patient family member confirmed this always happened with Ativan.

During the tour rounds on the Pulmonary Unit, accompanied by the Executive Director of Women's Services & Medical Surgical Units on 2/23/14 at approximately at 1000 hours, Patient 10 was observed lying in bed. The patient appeared alert and was able to make his needs known. All four bedrails of the patient's bed were raised (two upper and two lower) and he was in a vest (type of medical restraint used to restraint the patient to his bed) restraint tied on both sides of the bed frame.

Review of a physician's order dated 2/20/15, showed an order for restraint for Patient 10, location: hands and waist, non-violent restraint: vest. The non-violent restraint justification was: pulling drain/line/tubes, and attempting to get out of bed. Additional order instructions were for a soft vest restraint and hand mittens (type of medical soft restraint designed to restrict had movement, it is bulky, made of soft fabric, fastened tightly the wrist with Velcro) PRN (as needed) to prevent the patient from falling.

Review of the Patient 10's care plan dated 2/20/15, showed no documented evidence that interventions and goals were developed and implemented for the use of multiple restraints.

During an concurrent interview and medical record review with RN L on 2/23/15 at 1015 hours, she was asked if Patient 10 had a care plan to address the use of restraints, RN 1 stated, "No."

Patient 10's care plan did not accurately reflect modifications of the patient's plan of care based on the physician's orders and actual implemented restraints and did not provide individualized interventions to attempt restraint reduction or the least restrictive means to attempt to maintain the patient's safety. The plan of care was not updated to reflect changes in the restraint use when the type of restraint was changed.

b. RN Q in the Pulmonary Unit was interviewed on 2/23/15 at 1015 hours. The RN stated Patient 10 became increasingly confused during his first night in the hospital and fall prevention measures were implemented around 1500 hours on 2/20/15. RN Q stated measures for fall prevention included posting a star sign outside of Patient 10's room, keeping the room free of clutter, activation of the bed alarm, wearing rubber-soled socks, and placing all four bedrails in the elevated position when needed for the patient's safety.

During an interview with the Executive Director Women's Services and Med Surg on 2/23/15 at 1020 hours, she confirmed the use of four bedrails was considered a restraint by the hospital's P&P, not as a fall prevention.

Patient 10 was interviewed on 2/23/15 at 1020 hours. The patient stated when he fell he had to go to the bathroom and was trying to get out of bed. Patient 10 stated he was not sure if he requested assistance before attempting to get out of bed.

There was no documentation found in the medical record to show the use of the four elevated bedrails used for safety or restraint was included in Patient 10's care plan.

2. Review of the hospital's P&P titled Restraints and Seclusion revised on 7/14, showed any manual method, physical or mechanical device material or equipment that immobilizes or reduces the ability of a patient to move his arms, hands, legs etc. freely or restrict the patient's freedom of movement meets the definition of restraint.

During the tours rounds on the Pulmonary Unit, accompanied by the Executive Director Women's Services & Medical Surgical Units on 2/23/14 at approximately at 1030 hours, Patient 1 was observed while lying in bed. The patient appeared confused and was unable to make her needs known. There was a sling placed on her right shoulder.

A sitter was by her side (companion) who was holding the patient's left hand down to prevent her from moving her arm. All four bedrails were raised on the bed. A hand mitten was tightly attached to her left wrist.

During an interview with the PCT 1 on 2/23/15 at 1035 hours, she stated Patient 1 fell at home and broken her right shoulder. The patient was unable to move the arm due to pain or remove the hand mitten by herself. The PCT was asked to remove the patient's left hand mitten. An IV catheter was observed on the dorsum of the patient's left hand.

During an interview with RN M on 2/23/15 at 1040 hours, he stated the hand mitten was not classified as a restraint by the hospital's P&P and a physician's order was not necessary. When asked the reason for the hand mitten, he stated Patient 1 was pulling the IV line and was confused.

Review of Patient 1's care plan failed to show the use of a hand mitten and four bedrails. The care plan did not show individualized interventions were developed for their use, a plan was developed to release the restraints frequently, or the use of less restrictive interventions were used to reduce the use of restrains.


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3. Review of Patient 22's medical record was initiated on 2/23/15. The patient was admitted to the hospital on 2/15/15.

Review of the Patient Safety and Positioning showed four bedrails were elevated for Patient 22 for seven days, from 2/16 through 2/22/15.

There was no documented evidence to show nursing staff developed a care plan to address the use of four bedrails for Patient 22.

An interview and concurrent medical record review was conducted with the Manager of DSU and the Executive Director of Critical Care, Telemetry and Renal Services on 2/23/15 at 1055 hours. When asked, the Manager was unable to find documented evidence to show a care plan was developed to address the use of four bedrails for Patient 22.

4. Review of Patient 23's medical record was initiated on 2/23/15. The patient was admitted to the hospital on 2/16/15.

Review of the section for documentation of Monitor Restraint, Non-Violent of the Care Activity-Assessments showed four bedrails were elevated for Patient 23 for four days, from 2/20 through 2/23/15.

There was no documented evidence to show nursing staff developed a specific care plan to address the use of four bedrails for Patient 23.

An interview and concurrent medical record review was conducted with the Manager of DSU on 2/23/15 at 1315 hours. When asked, the Manager was unable to find documented evidence to show a care plan was developed to address the use of four bedrails for Patient 23.

Based on record review and interview, the hospital failed to ensure the physician's orders were obtained for the use of restraints and bedrails for three of eight sampled patients (Patients 1, 20, and 23) reviewed for restraints and bedrails. This failure could result in providing inappropriate care to the patients.

Findings:

Review of the hospital's P&P titled Restraints and Seclusion reviewed/revised 7/14, showed the following:

* In an emergency situation, the least restrictive, yet effective restraint may be initiated by a RN, without a prior order by a physician, based on an appropriate assessment of the patient. Then the physician must be contacted immediately to issue a verbal or written order covering the emergency use of restraint. This must take place within minutes. Continuation of restraints beyond a 24 hours period must be accompanied by an order from the physician. The physician must base the order on an examination of the patient.

* For safety non-violent restraint (medical restraint) the RN conducts reassessment for continuation of restraint, vital signs circulation checks by the Patient Care Technician (PCT) or sitter every two hours, and the each restraint written order is time limited to 24 hours. Only a physician may order restraints or seclusion.

The Medical Staff Clinical Rules approved 6/2014) showed "Restraints shall be used only when alternative methods are not sufficient to protect the patient or others from injury. A practitioner's order must be obtained for each use of restraints."

1. During the tour rounds on the Pulmonary Unit, accompanied by the Executive Director Women's Services & Medical Surgical Units on 2/23/14 at approximately at 1030 hours, Patient 1 was observed lying in bed. The patient appeared confused and was unable to make her needs known. There was a sling placed on her right shoulder.

A sitter was by her side (companion) who was holding the patient's left hand down to prevent her from moving her arm. All four bedrails were raised on the bed. A hand mitten was tightly attached to her left wrist.

During an interview with the PCT 1 on 2/23/15 at 1035 hours, she stated Patient 1 fell at home and broken her right shoulder. The patient was unable to move the arm due to pain or remove the hand mitten by herself. The PCT was asked to remove the patient's left hand mitten. An IV catheter was observed on the dorsum of the patient's left hand.

During an interview with RN M on 2/23/15 at 1040 hours, he stated a hand mitten was not classified as a restraint by the hospital's P&P and a physician's order was not necessary. When asked the reason for Patient 1's hand mitten, he stated Patient 1 was pulling the intravenous line and was confused.

Review of Patient 1's physician's order sheet showed no physician's orders were written for the use of a hand mitten or the use of four side rails.

This information was shared with the Manager of the Pulmonary Unit.


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2. Review of Patient 23's medical record was initiated on 2/23/15. The patient was admitted to the hospital on 2/16/15.

a. Review of the section of Initiate Restraint, Non-Violent showed a vest restraint was initiated for Patient 23 on 2/17/15 at 1148 hours. The non-violent restraint justification included an attempt to get out of bed. Further review showed a soft restraint was initiated on 2/17/15 at 1350 hours.

Review of the section of Monitor Restraint, Non-Violent of the Care Activity-Assessments, showed Patient 23 was restrained to his hands and his lower extremities by using soft restraints on 2/17/15 at 1400, 1949, and 2200 hours; on 2/18/15 at 0019, 0200, and 0400 hours.

Review of the Restraint Justification Non Violent Daily showed a physician's order to use soft restraints to Patient 23's upper extremities and lower extremities, starting on 2/18/15 at 0601 hours.

There was no documentation to show the physician's order was obtained for the use soft restraints when soft restraints were initiated for Patient 23 on 2/17/15 at 1350 hours. There was no documentation to show the physician ordered the use of soft restraint while the patient was restrained for 16 hours (from 2/17 at 1350 hours to 2/18/15 at 0601 hours).

b. Review of the section of Monitor Restraint, Non-Violent of the Care Activity-Assessments showed Patient 23 had mittens to his hands on 2/18/15 at 2000 and 2200 hours, and on 2/19, 2/20, 2/21, 2/22, and 2/23/15.

However, no physician's order was obtained for the use of hand mittens for Patient 23.

c. Review of the section of Monitor Restraint, Non-Violent of the Care Activity-Assessments showed Patient 23's four bedrails were elevated on 2/20/15 at 0603, 1200, 1400, 1600, and 1800 hours; on 2/21/15 at 0200, 0400, 0600, 0800, 1000, 1200, 1400, 1600, 1800, 2000, 2200, and 2347 hours; on 2/22/15 at 0746, 1000, 1200, 1600, 1800, 2000, and 2200 hours; and on 2/23/15 at 0000, 0200, 0400, 0800, 1100, and 1200 hours.

However, there was no physician's order obtained for the use of four bedrails for Patient 23.

During an interview and concurrent medical record review with the Manager of DSU on 2/23/15 at 1315 hours, the Manager confirmed the above findings.


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3. During a tour of the third floor medical unit on 2/26/15 at 0930 hours, Patient 20 was observed in bed with all four bedrails elevated. An air mattress appeared to be in place on the bed.

During a review of Patient 20's medical record, no physician's order for four elevated bedrails was found.

The nurse caring for Patient 20, RN A, was interviewed on 2/26/15 at 0940 hours. RN A stated she would need to call the doctor for an order to have four bedrails elevated if needed. RN A stated the Lift Team was recently in the room to care for the patient and put up the bedrails. RN A stated the patient was weak and might not be able to ambulate.

In an interview with the Lift Team Staff on 2/26/15 at 1020 hours, he stated he believed all bedrails were to be elevated on the beds, especially if the bed was slippery (as with the use of an air mattress); however, he would leave the rails down if instructed. The staff stated when an air bed was in use, they always left four bedrails up and with other mattresses, he put four bedrails up unless he was told otherwise.

During an interview with the Ergonomic Coordinator for the Lift Team on 2/26/15 at 1025 hours, he stated he trained the Lift Team; usually the bedrails went back up when leaving the patient, but it was not the Lift tech's responsibility to decide if the bedrails were to be up or down.

In an interview with the Unit Manager on 2/25/15 at 1025, she concurred that there was no physician's order to have the four bedrails up in Patient 19's record.

Based on record review and interview, the hospital failed to ensure restraint orders were only initiated when documented behaviors warranted and physician's orders were obtained daily for their use for one of eight sampled patients (Patient 10) reviewed for the use of restraints and bedrails. This created the risk of unnecessary restraint use for this patient.
Findings:

Review of the hospital's P&P titled Restraints and Seclusions revised on 7/14, showed for safety non-violent restraint (medical restraint), each restraint written order is time limited to 24 hours. Only a physician may order restraints or seclusion. Standing and PRN (as needed) order are NOT acceptable. The order will include the specific reason for restraints or seclusion, the type of restraints, body location of restraints, and specific time period. An order continuing restraints must be obtained no less often than once each calendar day, and must be based upon an examination of the patient by the physician.

Review of the medical record for Patient 10 showed a physician's order dated 2/20/15, for hands and waist, non-violent restraint: vest. Non-Violent Restraints justification: pulling drain/line/tubes and attempting to get out of bed.

Additional order instructions showed a soft vest restraint and hand mittens (type of medical soft restraint designed to restrict had movement, it a bulky, made of soft fabric, fastened tightly the wrist with Velcro) PRN (as needed) to prevent the patient from falling.

Review of the nurses' restraint monitoring log for restraint use dated from 2/22 to 2/23/15, showed staff stopped documenting the use of hand mittens for Patient 10 on 2/22/15 at 1755 hours.

During an interview with the Executive Director of Women's Services and Med Surg on 2/23/15 at 1045 hours, the hospital's P&P for Restraints was reviewed. The Director confirmed restraint orders needed a renewal daily by the physician and should not be ordered on "as needed" basis.

Based on interview and record review, the hospital failed to ensure the physician's orders for restraints used for one of eight sampled patients (Patient 23) were renewed every 24 hours, creating the increased risk of the loss of freedom of movement for this patient.

Findings:

Review of Patient 23's medical record was initiated on 2/23/15. The patient was admitted to the hospital on 2/16/15.

a. Review of the section of Initiate Restraint, Non-Violent showed vest restraint was initiated for Patient 23 on 2/17/15 at 1148 hours.

Review of the Restraint Justification Non Violent Daily showed an physician's order to use a vest to the patient's chest was started on 2/17/15 at 1148 hours.

According to the hospital's P&P, the physician's order for the use of vest restraint for Patient 23 must not exceed 24 hours from 2/17/15 at 1148 hours; or the physician must order for the use of vest restraint by 2/18/15 at 1148 hours, for continuing the use of vest restraint.

However, there was no physician's order for the use of a vest restraint for Patient 23 for 46 hours (from 2/18 at 1148 hours to 2/20/15 at 1000 hours) as per hospital's P&P.

During an interview and concurrent medical record review with the Manager of DSU on 2/23/15 at 1315 hours, the Manager confirmed the above findings.

b. Review of the Restraint Justification Non Violent Daily showed the physician ordered to use soft restraints to Patient 23's upper extremities and lower extremities, starting on 2/18/15 at 0601 hours.

According to the hospital's P&P, the physician's order for the use of soft restraint for Patient 23 must not exceed 24 hours from 2/18/15 at 0601 hours; or the physician must order for the use of soft restraint on 2/19/15 at 0601 hours, for continuing the use soft restraint.

Further review of the Restraint Justification Non Violent Daily showed a physician's order to use soft soft restraints to Patient 23's upper extremities and lower extremities started on 2/19/15 at 0936 hours. However, this physician's order was canceled.

There was no physician's order for the use of soft restraint while Patient 23 was restrained for 26 hours (from 2/19 at 0601 hours to 2/20/15 at 0836 hours) as per the hospital's P&P.

c. Review of a Restraint Justification Non Violent Daily showed the physician ordered to use soft restraints to Patient 23's hands and lower extremities, starting on 2/20/15 at 0836 hours.

According to the hospital's P&P, the physician's order for the use of soft restraints for Patient 23 must not exceed 24 hours from 2/20/15 at 0836 hours; or the physician must order for the use of soft restraint on 2/21/15 at 0836 hours for continuing the use soft restraint.

However, there was no physician's order for the use of soft restraints for Patient 23 for 25 hours (from 2/21 at 0836 hours to 2/22/15 at 1013 hours) as per the hospital's P&P.

During an interview and concurrent medical record review with the Manager of DSU on 2/23/15 at 1315 hours, the Manager confirmed the above findings.

Based on interview and record review, the hospital failed to ensure assessment, monitoring, and interventions were provided every two hours for two of eight sampled patients (Patients 23 and 24) reviewed for the use of restraints and bedrails. These failures could lead to provision of inappropriate patient care to the patients in the hospital.

Findings:

Review of the hospital's P&P titled Restraints and Seclusion reviewed/revised 7/14, showed the RN assesses the patient's medical condition at the time the restraints are initiated, or when possible, prior to application of restraints. Patients will be assessed at least every two hours or more frequently, if necessary for the use of safety/non-violent/Non-Self Destructive behavior restraint. Reassessment included the physical and emotional well-being of the patient, vital signs, circulation, all patient hydration, hygiene, elimination, range of motion, comfort needs, skin integrity, level of distress and agitation, mental status, cognitive functioning, maintenance of patient's rights, dignity, and safety, assessment for less restrictive measures as soon as possible, changes in the patient's behavior or clinical condition requiring removal of restraints, and appropriate application, removal and reapplication of restraints.

1. Review of Patient 23's medical record was initiated on 2/23/15. The patient was admitted to the hospital on 2/16/15.

a. Review of the section of Monitor Restraint, Non-Violent of the Care Activity-Assessments showed Patient 23 was assessed for the use of restraints on 2/21/15 at 2000, 2200, and 2347 hours; and on 2/22/15 at 0746 hours.

However, there was no documentation to show Patient 23 was monitored and provided interventions every two hours while the patient was restrained for eight hours from 2/21 at 2347 hours to 2/22/15 at 0746 hours, as per hospital's P&P.

b. Review of the section of Monitor Restraint, Non-Violent of the Care Activity-Assessments showed Patient 23 was assessed for the use of restraints from 2/22/15 at 1000 hours to 2/23/15 at 1200 hours.

However, there was no documentation to show Patient 23 was monitored and provided interventions every two hours while the patient was restrained for four hours (from 1200 to 1600 hours) on 2/22/14, as per hospital's P&P.

An interview and concurrent medical record review was conducted with the Manager of DSU on 2/23/15 at 1315 hours. The Manager confirmed the findings.

2. Review of Patient 24's medical record was initiated on 2/23/15. The patient was admitted to the hospital on 2/20/15.

Review of a physician's order dated 2/22/15 at 1930 hours, showed to use soft restraints to the left and right upper extremities for Patient 24 due to removing devices and attempting to get out of bed.

Review of the restraint assessment failed to show Patient 23 was assessed and provided interventions for four hours on 2/23/15 (from 0400 to 0600 hours) while the patient was restrained as per hospital's P&P.

During an interview and concurrent medical record review with the Manager of DSU on 2/23/15 at 1405 hours, the Manager confirmed the finding.

Based on interview and record review, the hospital's quality program failed to collect data regarding the use of bedrails and post-discharge outcomes from the BHU, creating the risk of persistent poor practices and substandard patient care.

Findings:

1. During an interview with the Director Regulatory &Privacy Compliance on 2/25/15 at 1350 hours, he stated hard restraints were tracked by type, location, and associated injuries; the goals were to limit the use of hard restraints to designated areas, to ensure an order was provided within 24 hours, an assessment occurred every two hours, the type and reason for the restraint was documented, and no injuries occurred with the use of restraints.

The Director stated safety rounds and environment of care rounds were completed frequently; however, he did not expect staff to pick up on the use of the four bedrails during patient safety rounds. The Director stated data were collected from the computer system and tracked regarding the use of restraints. The Director stated the use of four bed side rails as a restraint was not tracked.

During tours of the hospital from 2/24 through 2/16/15, the use of four bedrails was observed to be used for seven of eight sampled patients reviewed for restraints, in several areas of the hospital and in some cases without physician's orders, care plans, assessments or valid reasons for their use. Cross references to A0154, A0166, A0169, and A0173.

2. During interviews with RN C on 2/25/15 at 0940 and 1250, the RN stated they were aware not all patients who were discharged from the BHU with plans for outpatient therapy attended the therapy. She stated someone provided follow up with individual patients discharged from the BHU who did not attend the outpatient treatment program as planned; however, there was no follow up data collected regarding BHU patients who did not go to the day treatment program to try to determine why the discharge plan had not worked.

During an interview with the Clinical Educator on 2/26/15 at 1022, she stated she provided education to staff in the BHU. She stated further she had not been asked to provide any education regarding discharge planning to BHU staff.

Based on interview and record review, the hospital failed to conduct a complete investigation of one type of surgical site infection and performed a complete analysis and response to review of falls data, creating the risk of substandard healthcare outcomes.

Findings:

1. During an interview with the Infection Control Coordinator on 2/25/15 at 1030 hours, she stated when there was a trend in surgical site infections, the cases were subject to increased scrutiny. The Coordinator stated breast surgery infections spiked in one quarter of 2013 and 2014, and both times an investigation was completed.

Review of the investigations for the 2013 surgical site infections showed peri-operative antibiotics were not documented as being administered correctly in three of the 13 cases reviewed.

However, when a second spike in breast surgical site infections occurred in the second quarter of 2014, the correct administration of peri-operative antibiotics was not reviewed.

Review of the 12/1/14 Quality Safety Committee Minutes showed an update was presented regarding the breast surgical site infections. However, the section of the minutes for "plan" was blank and the report was accepted as presented.

During a continuing interview with the Infection Control Coordinator, she concurred the correct use of peri-operative antibiotics was not reviewed for the 2014 cases. The Coordinator stated there were no specific guidelines followed for the review of surgical site infections.

2. The falls precaution poster observed in the third floor nursing station listed actions to take to prevent falls. The list included "Side rails up for safety if needed."

The sign was reviewed with RN E who stated the sign referred to using the bedrails for falls prevention.

The Patient Falls Risk Assessment and Prevention training for 2015, was reviewed; however, documentation failed to show the use of bedrails for falls prevention.

During an interview with the Director of Regulatory and Privacy on 2/25/15 at 1330 hours, he identified falls with injuries as a high risk issue that was analyzed and tracked by the QAPI program.

During an interview with the Patient Safety Officer on 2/25/15 at 1400 hours, she stated the goal was to have no falls with associated harm.

The falls data from the first and second half of 2014, were reviewed. The data showed an increase in the number of falls resulting in moderate injury in the second half of 2014.

The Patient Safety Officer discussed interventions put in place in 2013 and June 2014, to reduce falls. The Patient Safety Officer stated individual cases were reviewed; however, she was not able to show analysis of the data or to specify new interventions were implemented in response to the 2014, data showing an increase in injury associated with falls in the second half of 2014.

Based on interview and record review, the hospital failed to ensure one new physician had proctoring of his initial cases per department policy, creating the increased risk of substandard patient care by that physician.

Findings:

The credential file of DR 2 was reviewed on 2/25/15. Documentation showed the physician was a recent residency graduate, appointed on 9/1/14 and was to receive proctoring; however, there was no evidence of proctoring found in the file.

During an interview with the Director of Medical Staff Services on 2/25/15 at 1530 hours, she stated DR 2 was to undergo proctoring the first six cases for which he served as the admitting and attending physician. The Director stated DR 2 was to report the cases within 24 hours in order to obtain proctoring; however, the proctoring had not occurred.

The cases for DR 2 for the period of 9/1/14 through 2/25/15, were reviewed on 2/26/15. Documentation showed for 104 cases, he was both the admitting and attending physician on the cases and for 218 other cases, he was either the admitting or attending physician.

Based on interview and record review, the hospital failed to ensure medical staff were included in the influenza vaccine program as recommended by the CDC and stated in the hospital's P&P. In addition, the hospital failed to ensure the medical staff by-laws followed CDC guidelines for immunizations of health care workers. This created the risk of transmitting a preventable disease to the patients cared by the medical staff.

Findings:

Review of the hospital's P&P Influenza Vaccination Program reviewed 12/13, showed "These guidelines are based on the Centers for Disease Control and Preventions (CDC) definition of healthcare personnel (HCP) and applies to all employees (clinical and non-clinical), licensed independent practitioners, temporary workers, students, clergy, and volunteers working in the following settings: acute care hospitals and outpatient clinics" and "All healthcare personnel should be offered the seasonal vaccination free of charge by the Employee Health; or provide annual written proof of having received the required influenza vaccine ..." and "Those healthcare providers who do not receive the influenza vaccine for any reason must complete a written declination form, in accordance with state law (CASB 1058), and will be required to wear the required surgical mask at all times in specified departments and locations, during the period deemed by the Infection Control Committee as the 'influenza season."

During an interview with the Director of Medical Staff Services on 2/25/15 at 1530 hours, she stated the influenza vaccine program was administered through employee health; however, it was not required for medical staff.

The hospital did not follow the facility's adopted, nationally recognized CDC guidelines for immunizations of health care workers that states:

* "Healthcare workers include physicians, nurses, emergency medical personnel, dental professionals and students, medical and nursing students, laboratory technicians, pharmacists, hospital volunteers, and administrative staff."

* "(...recommends that health care providers receive vaccinations for diseases for which routine vaccination or documentation of immunity is recommended because of risks in the workplace."

* "Healthcare organizations should review health care provider vaccination and immunity status at the time of hire and at least annually thereafter."

During an interview with the Infection Control Coordinator on 2/26/15 at 0830 hours, she stated it was not mandated for physicians to participate in the influenza and immunization program; however, when asked, the Coordinator concurred physicians were considered healthcare providers.

Based on interview and record review, the hospital failed to ensure the Medial Staff Rules were implemented when a reference was not provided from each of the facilities for one physician (DR 1) who provided services prior to reappointment, creating the risk of substandard patient care.

Findings:

Review of the Medical Staff Rules dated 2/14, showed on page 33, "The applicant shall fill out and deliver an application form to the Medical Staff Office, which shall seek to verify the information submitted. The application will be deemed complete when all necessary verifications have been obtained, including current and past licenses, licensing board disciplinary records, specialty board certification status, National Practitioner Data Bank information, DEA (Drug Enforcement Administration) certification if privileges to prescribe will be sought, record of exclusion from federal programs, verification of all practice from professional school through the present, current and past malpractice liability insurance, and reference letters."

During a review of the credential file of DR 1 on 2/25/15, three facilities were listed on the application dated 9/19/14, for reappointment in 2015. However, there was only one letter found indicating the physician was in good standing from one of the three facilities. No evidence of communication with the other two facilities was found.

The credential file showed that DR 1 was reappointed on 2/1/15.

In an interview with the Director of Medical Staff Services on 2/25/15 at 1530 hours, she stated it was the standard to query other facilities where the physician provided services; however, she was not able to find evidence the other two facilities where Dr 2 practiced were queried.

Based on observation, interview, and record review, the hospital failed to ensure nursing care was provided to meet the needs of three of 30 sampled patients (Patients 21, 24, and 17) as evidenced by:

* Nursing staff failed to obtain a physician's order for Patient 21 for insertion of an indwelling urinary catheter (a flexible tube passed through the urethra into the bladder to drain urine into a collection bag) and failed to assess the necessity for the use of catheter prior to reinsertion. In addition, the nursing staff failed to conduct an initial fall assessment when Patient 21 was admitted to the hospital and failed to assess and specify the reason for the use of four bedrails.

* Nursing staff failed to assess Patient 24 for sedation level on 2/22/15 at 2200 hours, when the patient was receiving Propofol (a sedative medication).

* Nursing staff failed to follow the physician's order for an indwelling urinary catheter placement for Patient 17. The hospital could not demonstrate the catheterization was necessary, and a patient who was incontinent of bladder received appropriate treatment and services to prevent UTI and restore as much normal bladder function as possible.

These failures created the risk of substandard health outcomes for the patients in the hospital.

Findings:

Review of the hospital's P&P titled Urinary Catheter (Foley), Care of: Indications for and Care of the Patient with an Indwelling Urinary Catheter, Including the use of a Bladder Scanner reviewed/revised 2/14, showed the following:

* All indwelling urinary catheters require a physician's order for placement.

* An indwelling urinary catheter may be indicated based on an individual clinical situation and the physician's order. Discontinuation should occur as soon as the clinical situation resolves.

* The RN assessed the need for the indwelling urinary catheter every shift using the criteria and documented in the plan of care.

1. Review of Patient 21's medical record was initiated on 2/23/15. The patient was admitted to the hospital on 2/22/15 at 1334 hours.

a. Review of the Physical Assessment ICU dated 2/22/15 at 1413 hours, showed Patient 21 had an indwelling urinary catheter present on admission. The insertion date of the indwelling urinary catheter was unknown.

Review of the Physical Assessment ICU dated 2/22/15 at 2000 hours, showed Patient 21's indwelling urinary catheter was reinserted. The section to show the patient was assessed for "indwelling catheter removal" showed "no."

There was no documentation to show the reason why the patient required an indwelling urinary catheter.

Further review of the medical record failed to show a physician's order was obtained to reinsert Patient 21's indwelling urinary catheter.

A concurrent interview and medical record review was conducted with RN N and the Executive Director of Critical Care, Telemetry & Renal Services on 2/23/15 at 0950 hours. When asked, RN N was unable to find documented evidence to show a physician's order was obtained for reinsertion of Patient 21's indwelling urinary catheter. RN N was also unable to find documentation to show the reason Patient 21 required an indwelling urinary catheter.

The Executive Director stated a physician's order should be obtained prior to reinsertion of Patient 21's indwelling urinary catheter.

b. Review of the hospital's P&P for Fall Risk Assessments and Interventions reviewed/revised 9/14, showed patients will be assessed for fall risk by the RN upon admission and every shift.

Review of Patient 21's medical record showed Patient 21 was assessed at high fall risk on 2/22/15 at 2000 hours, and on 2/23/15 at 0800 hours. However, further review failed to show nursing staff conducted a fall assessment for Patient 21 when the patient admitted to the hospital on 2/22/15 at 1334 hours.

A concurrent interview and medical record review was conducted with RN N and the Executive Director of Critical Care, Telemetry & Renal Services on 2/23/15 at 0950 hours. RN N stated an initial assessment was conducted for Patient 21 on 2/22/15 at 1413 hours; however, the RN was unable to find documented evidence to show nursing staff conducted initial fall assessment upon admission.

c. Review of the Patient Safety and Positioning showed four bedrails were elevated for "Patient Safety" on 2/22/15 at 1330, 1611, 1703, 2000, 2100, and 2200 hours; on 2/23/15 at 0000, 0400, 0601, 0731, and 0933 hours.

Review of the Fall Risk dated 2/22/15 at 2000 hours, and on 2/23/15 at 0800 hours, showed Patient 21 was assessed at high fall risk. The section of Standard Interventions and Moderate/High Risk Falls Intervention did not show to use four bedrails for the patient.

There was no documented evidence to show nursing staff assessed and specified the rationale for the use of four bedrails for the patient.

A concurrent interview and medical record review was conducted with RN N and the Executive Director of Critical Care, Telemetry & Renal Services on 2/23/15 at 0950 hours. When asked the reason for the use of four bedrails for Patient 21, the RN stated they were used for patient safety; Patient 21 was assessed as high fall risk and four bedrails were elevated for the patient.

2. Review of Patient 24's medical record was initiated on 2/23/15. The patient was admitted to the hospital on 2/20/15.

Review of the Anesthesia Record showed Propofol was started by an anesthesiologist on 2/22/15 at 1345 hours. At 1420 hours, the care was handed off to the ICU nurse.

Review of the physician's order showed to start Propofol on 2/22/15 at 1656 hours.

Review of the Patient's Plan of Care-Additional Problem/Intervention showed the Richmond Agitation Sedation Scale RASS would be done every two hours.

Review of the section of the Richmond Agitation Sedation Scale RASS of the Care Activity-Assessments showed Patient 24 was not assessed for sedation level every two hours for four hours on 2/22/15 (from 2000 to 0000 hours).

During an interview and medical record review with the Manager of DSU on 2/24/15 at 0930 hours, the Manger confirmed the patient was not assessed for sedation level as the above.


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3. Review of the hospital's P&P titled Nurse-Driven Indwelling Urinary Catheter Removal showed alternatives for incontinence: ultrasorb pad (may be weighed for Intake and Output), condom catheter, and adult brief with tabs for bedbound patients, provide skin care every 2-3 hours or as need.

On 2/25/15 at 1100 hours, Resident 17 was observed while lying in bed. The patient had an indwelling urinary catheter.

On 2/25/15, medical record review for Patient 17 was initiated. Patient 17 was admitted to the hospital on 2/24/15, with chief of complaint of altered mental status due to a UTI.

Review of the Emergency Department Adult Triage Assessment dated 2/24/15, showed according to Patient 17's family member, the patient did not talk, had history of dementia, and was disoriented to person, time, place, and situation/event.

A physician's order dated 2/24/15, showed laboratory testing for a UA.

Review of the ED Urinary Catheter Insertion dated 2/24/15 at 1123 hours, showed a straight catheter (insert and remove right after) was used to collect urine for the UA specimen.

The UA results form dated 2/24/15, showed Patient 17's urine was yellow (concentrated), cloudy (indicative of white blood cells/infection) and contained many bacteria. Patient 17 was diagnosed with UTI and admitted to the Telemetry Unit.

Review of the admission written telephone order dated 2/24/15 at 2020 hours, and transmitted to the electronic record by the unit secretary included "Urine culture (lab test to check for bacteria or other germs in a urine sample) if not already done, Foley (indwelling urinary drainage catheter) catheter if unable to void."

However, review of the transcribed electronic physician's order dated 2/24/15, showed to insert a urinary catheter to gravity drainage for Patient 17 due to the criteria of "urinary retention" (inability to empty the bladder completely).

Review of the nurses' interventions dated 2/24/15 at 2100 hours, showed a urinary catheter to gravity was inserted for Patient 17.

On 9/15/11 at 0945 hours, during an interview with RN R, she stated she did not know if Patient 17 was continent or incontinent of urine. The RN stated in order to verify if the patient had urinary retention the patient should be assessed for voiding ability every two hours for eight hours. If the patient was unable to void and complained of discomfort a bladder scanner ultrasound (non-invasive method for determining bladder emptying) should be performed. RN R confirmed the patient was not assessed for urinary retention.

Based on observation, interview, and record review, the hospital failed to ensure the care plans for three of 30 sampled patients (Patient 21, 11, and 17) were developed specific to the needs of the patients as evidenced by:

1. For Patient 21, the nursing staff failed to develop a care plan to address the use of four bedrails.

2. For Patient 17, the hospital failed to develop care plans to address the patient's altered mental status due to a UTI and address the rational for the use of indwelling urinary catheter.

3. For Patient 11, the hospital failed to develop a comprehensive care plan with goals and approaches to address the patient's dehydration/fluid maintenance status.

Lack of comprehensive care plan development might result in interventions not developed which could further compromise the patient's medical status.

Findings:

1. Review of Patient 21's medical record was initiated on 2/23/15. The patient was admitted to the hospital on 2/22/15 at 1334 hours.

Review of documentation of Patient 21's Patient Safety and Positioning showed four bedrails were elevated for "Patient Safety" on 2/22/15 at 1330, 1611, 1703, 2000, 2100, and 2200 hours; on 2/23/15 at 0000, 0400, 0601, 0731, and 0933 hours.

A concurrent interview and medical record review was conducted with RN N and the Executive Director of Critical Care, Telemetry & Renal Services on 2/23/15 at 0950 hours. RN N stated Patient 21 was assessed as a high fall risk and four bedrails were elevated for the patient. When asked, the RN was unable to find a care plan was developed for the use of four bedrails for Patient 21.


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2. On 2/25/15 at 1100 hours, Resident 17 was observed lying in bed. The patient had an indwelling urinary catheter.

On 2/25/15, medical record review for Patient 17 was initiated. Patient 17 was admitted to the hospital on 2/24/15, with chief of complaint of altered mental status and UTI.

During an interview with RN R on 2/25/15 at 0945 hours, she was asked to provide the rational for the use of the indwelling urinary catheter as the diagnosis for urinary retention was not listed by the physician. RN R stated the physician's order to insert the urinary catheter might have been misinterpreted by the unit secretary when the order was transcribed to the electronic record.

Review of Patient 17's care plan initiated on 2/24/15, did not show a care plan was developed for altered mental status due to the UTI, for the IV therapy the patient received due to fluid volume/imbalance and for monitoring of the labs.

3. On 2/15/15, medical record review for Patient 11 was initiated. Patient 11 was admitted to the hospital on 2/20/15, with diagnoses including dehydration.

Review of the physician's order dated 2/20/15, showed an order for IV fluid: 1000 ml of Sodium Chloride 0.9 % (Normal Saline) at a rate of 75 ml/hour (to be infused for approximately 13 hours and 20 minutes).

Review of the Patient 11's comprehensive care plan dated 2/24/15, failed to address the patient's increased risk for dehydration. There were no approaches/interventions developed from 2/20 through 2/24/15, to ensure the patient's estimated fluid requirement was met to prevent dehydration.

During an interview with RN Q on 2/25/15 at 0930 hours, the lack of a care plan to address Patient 11's dehydration/fluid maintenance with goals and interventions was discussed. The RN acknowledged a care plan was not developed.

Based on observation and interview, the hospital failed to ensure nursing staff administered an IV solution per the physician's order and labeled the IV fluid bag per the hospital's P&P for one of 30 sampled patients (Patient 11). These failures posed the risk for dehydration for the patient.

Findings:

Review of the hospital's P&P titled Medication/IV Administration revised on 10/14, showed IV lines and IV medications that require a label are labeled with the patient name, location, date, drug name, concentration, and /or dosage, diluent if appropriate, expiration date and time and initials of RN preparing.

On 2/15/15, Patient 11's medical record review was initiated. Patient 11 was admitted to the hospital on 2/20/15, with diagnoses including dehydration.

On 2/24/15 at approximately 1000 hours, an observation of Patient 11's medication pass was conducted. Patient 11 was receiving an IV solution of sodium chloride (NaCl) 0.9 % at a rate of 75 ml/hour via an electronic infusion pump. No identification label was found on the IV bag to identify the patient, the date the bag was hung, or the infusion rate. The IV tubing was not labeled with the date and time to show when the tubing needed to be changed. Approximately 250 ml of fluid still remained in the IV bag.

Review of the physician's order for Patient 11 dated 2/20/15, showed an order for an IV fluid: 1000 ml of Sodium Chloride 0.9 % (Normal Saline) at a rate of 75 ml/hour (to be infused for approximately 13 hours and 20 minutes).

Review of the Medication Administration Record - Current Medications dated 2/24/15, showed RN Q hung the bag of Normal Saline 1000 ml at 75 ml/hour on 2/23/15 at 1400 hours. According to the physician's ordered rate, the IV infusion bag should have been completed at approximately 0320 hours on 2/24/15, but was still hanging when observed at 1000 hours, six hours and 40 minutes later.

On 2/24/15 at 0910 hours, RN Q confirmed the IV fluid was not labeled with a patient name and the tubing was not labeled. The RN stated the IV fluid have a sticker on the bag identifying when the bag was opened and when the tubing needed to be changed.

Based on observation and interview, the hospital failed to ensure medications were securely stored when a medication cart was found unlocked in an empty OR. This posed the potential for unlicensed staff to have access to the unsecured medications.

Findings:

Review of the hospital's P&P titled Floor Stock Medications, RX-429, showed drugs shall be stored in an orderly manner in any cabinet, drawers, carts, or Pyxis (Automated Medication Dispensing Machine) to prevent overcrowding.

On 2/24/15 beginning at 0920 hours, the Surgical Services area was toured with the OR Manager.

A medication cart used for eye surgical patients was found unlocked in an OR.

The OR Manager stated all medication carts were to be locked when the room was not in use.

Based on observation, interview, and record review, the hospital failed to ensure five expired bag of IV fluids were removed from the Telemetry Unit medication room and were not available for patient use. In addition, a premixed IV bag of Magnesium Sulfate (an electrolyte supplement) was found stored in the medication cart on the Stepdown Unit. The premixed IV bag of Magnesium sulfate did not have an outer wrapper and was not labeled for a patient with a date opened. These failures created the potential for decreased efficacy for any patient who could have received the expired and/or opened medications.

Findings:

Review of the hospital's P&P titled Inspections of Drug Storage Areas reviewed/Revised 8/12, showed all medication storage areas will be inspected monthly for proper conditions. Unusable drugs" would be removed from stock and sequestered by pharmacy when the following criteria are met:
* Outdated drugs.
* Mislabeled drugs & drugs with illegible labels.
* IV bags removed from their original wrapper with no expiration date sticker.

1. On 2/23/15 at 1350 hours, the Telemetry Unit medication room was inspected with the Telemetry Charge Nurse and Telemetry Manager.

Four IV 100 ml bags of 0.9 % Sodium Chloride were found in a storage container. Three IV bags showed an expiration date of 11/20/14, and one IV bag showed an expiration date of 5/13.

The Telemetry Manager stated the pharmacy stocked the medication room with all the IV fluids and were responsible for the disposal of outdated fluids.


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2. An inspection of a medication cart in the Stepdown Unit was conducted on 2/23/15 at 0940 hours, accompanied by the Executive Director of Critical Care, Telemetry and Renal Services.

A premixed IV bag of Magnesium Sulfate was observed stored in the medication cart. The premixed IV bag of Magnesium sulfate did not have a wrapper, was not labeled with patient's name, and was not dated. The Executive Director confirmed the finding.

Based on observation, interview, and record review, the hospital failed to ensure the facility and equipment were maintained for an acceptable level of safety and quality as evidenced by:

* Temperature of a refrigerator stored breastmilk was out of an acceptable range in the MBU.

* Visual inspection was not done for an ESU (Electrosurgical Unit) every six months in accordance to the manufacturer's recommendations.

* PM was not done on a weight scale.

These failures created risk for an unsafe environment to the patients receiving care in the hospital.

Findings:

1. Review of the hospital's P&P titled Breastfeeding reviewed/revised 9/14, showed the hospital was not licensed to store breastmilk beyond 24 hours. Temporary refrigeration was available on MBU until milk was transported. Breastmilk may be stored in the designated refrigerators for up to 24 hours; add the 24 hour expiration date and time to the labeled container and place in an individual bag in the refrigerator.

A random inspection was conducted on 2/24/15 at 1400 hours in the MBU, accompanied by the Executive Director Women's Services & Med/Sur, and RN O.

A refrigerator was observed where a container of breastmilk was stored. The refrigerator's temperature was noted as 46 degrees Fahrenheit.

Review of the HACCP (Hazard Analysis and Critical Control Points) Refrigerator Temperature Log-Critical Control Point form for the Breastmilk refrigerator showed to check temperatures twice a day. The acceptable temperature ranged was listed as between 34 and 38 degrees Fahrenheit.

Further review showed the Breastmilk refrigerator's temperature was 38 degrees Fahrenheit on 2/23/15 at 0700 hours, and 35 degree Fahrenheit on 2/24/15 at 0800 hours. However, there was no documented evidence to show the refrigerator's temperature was checked on the evening shift of 2/23/15.

RN O stated the refrigerator's temperature should be checked twice a day. The RN confirmed there was no documented evidence to show the refrigerator was checked in the evening shift on 2/23/15.

RN O stated an acceptable range of the refrigerator's temperature would be between 34 to 38 degrees Fahrenheit. The RN confirmed the refrigerator's temperature was not within the acceptable range.

2. Review of the manufacturer's instructions for use of an ESU showed the ESU should be visually inspected at least every six months. This inspection should include the following checks:

* Damage to the power cord and plug.

* The proper mating and absence of damage to the accessory connectors.

* Any obvious external or internal damage to the unit.

* An accumulation of lint or debris within the unit or heatsink.

* Control Panel cuts, punctures or dents.

During an interview and document review with the Director of BioMed on 2/24/15 at 1130 hours, the Director stated an ESU would be tested every year for preventive maintenance. However, when asked, the Director was unable to provide documented evidence to show the ESU was visually inspected at least every six months in accordance to the manufacture's recommendations.

3. During an observation on 2/23/15 at 0940 hours, in the Stepdown Unit, accompanied by the Executive Director of Critical Care, Telemetry and Renal Services, a weight scale did not have a sticker to indicate PM was done. The Executive Director confirmed the finding.

On 2/26/15 at 1540 hours, there was no further documentation provided to show the PM was done for above weight scale.

Based on observation, interview, and record review, the hospital failed to provide surgical services to meet the needs of the patients as evidenced by:

1. Failure to ensure the preparation of supplies and medications for a MH emergency was complete and followed the hospital's checklist.

2. Failure to implement the P&P for surgical attire in the OR.

3. Failure to ensure staff followed safe injection practices.

4. Failure to ensure the hand hygiene P&P was implemented when two employees did not wash hands after removing gloves.

5. Failure to ensure staff followed the manufacturer's recommendations for contact time when cleaning the gurneys.

6. Failure to document the BI vials and record the results in the STERRAD Sterilization log.

7. Failure to ensure staff were inserviced on the manufacturer's recommendations for proper dilution of an enzymatic detergent.

8. Failure to ensure implementation of the P&P for Surgical Department Cleaning for the daily cleaning, terminal cleaning, and evaluation of the cleaning services integrated into the QAPI program.

9. Failure to ensure the instrumentation carts in the SPD were clean.

10. Failure to ensure implementation of the P&P for documentation of actions taken to address out of range temperature and humidity.

11. Failure to ensure staff in the Outpatient Surgery Center were inserviced on the manufacturer's recommendations for proper dilution of an enzymatic detergent and to ensure one of the OR rooms was properly cleaned.

These failures increased the risk of poor healthcare outcomes to surgical patients in the hospital.

Findings:

1. On 2/24/15 at 0941 hours, the hospital's main OR pre-operative area was toured. A MH cart was observed.

a. The hospital's P&P titled Malignant Hyperthermia reviewed 5/13, showed for the departments staffed 24/7, the staff should inspect the integrity and expiration dates of the MH cart every shift and document in the appropriate logbook.

Review of the Malignant Hyperthermia Cart Content List revised 11/10, showed two feeding tubes, size 8 Fr (French) were on the cart; however, only one feeding tube was found.

Further inspection of the cart showed the following items were found in the cart but were not on the checklist:

* Cysto set
* Two 10 Fr suction catheters
* One of two IV infusion tubings
* Three 3-way stopcocks
* Ten 18 gauge needles
* Ten 16 gauge needles
* One of bag Decanter II

The Malignant Hyperthermia Cart Content List indicated items were stored in three drawers in the cart; however, the cart had only two drawers.

In a concurrent interview with RN J, RN J stated the RNs checked the cart daily to ensure the lock on the Malignant Hyperthermia Cart was intact; however, the Central Supply Department was responsible for preparing the cart.

b. Continued review of the Malignant Hyperthermia Cart Content List revised 11/10, showed one bag of IV Sterile Water 1000 ml bag was on the cart.

However, the Malignant Hyperthermia Cart Medication List revised 7/12, found on the top of the Malignant Hyperthermia Cart, showed two IV Sterile Water 1000 ml bags were required.

During a concurrent interview with RN J, RN J stated pharmacy was responsible for preparation of the medication for the cart, RN J was not aware the differing requirement for IV Sterile Water 1000 ml bags.

2. The hospital's P&P for Surgical Attire, reviewed 12/13, showed all possible head and facial hair must be covered.

On 2/24/15 at 1130 hours, the main OR was toured. DR 3 (Anesthesiologist) was observed in the operating room. The physician's hair was not fully covered with the surgical hat.

3. According to APIC position paper: Safe injection, infusion, and medication vial practices in health care, 2010 by the Association for Professionals in Infection Control and Epidemiology, showed to:

* Never store or transport syringes in clothing or pockets.

* Cleanse the access diaphragm of vials (rubber stopper where the needle if injected to withdraw medication) using friction and a sterile 70% isopropyl alcohol, ethyl alcohol, iodophor, or other approved antiseptic swab.

* Disinfect IV ports and vial stoppers by wiping and using friction with a sterile 70%isopropyl alcohol, ethyl/ethanol alcohol, iodophor, or other approved antiseptic swab. Allow the port to dry before accessing.

a. On 2/23/15, during an observation in the hospital's outpatient procedure area, DR 1 withdrew four medications from four individual vials for a pain management injection. DR 1 was not observed to clean the access of the vial diaphragms with an approved antiseptic swab.

b. On 2/24/15 at 1120 hours, DR 3 was observed visiting a patient in the pre-op area. A syringe was observed stored in the physician's top scrub pocket.

c. On 2/24/15 at 1120 hours, DR 3 was observed administering the IV medications for a patient in the pre-op area. DR 3 did not clean the diaphragms of the medication vials with an approved antiseptic swab prior to access with a needle.

d. On 2/24/15 at 1125 hours, DR 3 was observed with a patient in the OR. The MD was observed not to disinfect the IV port when administering the IV medications two separate times.

On 2/25/15 at 1050 hours, during an interview, the hospital's Infection Control Coordinator stated the hospital adapted the APIC safety injection position for their standards practices.

4. The hospital's P&P titled Bloodborne Pathogen Control Plan reviewed 7/13, showed employees shall wash their hands immediately or as soon as feasible after removal of gloves or other personal protective equipment.

a. On 2/24/15 at 1120 hours, RN I was observed providing patient care in the pre-operative area. RN I removed gloves patient care; however, no hand hygiene was performed.

b. On 2/24/15 at 1527 hours, the outpatient Interventional Radiology Post Procedural Area was toured with the Surgical Services Clinical Manager. One EVS staff was observed to remove gloves after cleaning a gurney. No hand hygiene observed after the gloves were removed.

5.a. On 2/23/15 at 1345 hours, during a tour in the hospital Outpatient GI lab Preoperative area, RN H was cleaning a gurney after discharging a patient. RN H wiped the gurney pad with disinfectant wipes and then immediately wiped the gurney dry with a towel.

Review of the manufacturer's recommendations for the disinfectant wipes showed a wet time of two minutes was required.

b. On 2/24/15 at 1527 hours, the Interventional Radiology Post Procedural Area was toured with the Surgical Services Clinical Manager. An EVS staff was cleaning a gurney and pillows after a patient's discharge. The EVS staff wiped the gurney and pillows with disinfectant wipes; however, the EVS staff placed the wet pillows together on top of the wet gurney pad before the items were dry.

6. The hospital's P&P titled Sterrad biological Testing, reviewed 12/12, showed to utilize a CycleSure BI for monitoring the sterilization process on all STERRAD sterilizers. After 48 hours, check the processed BI and control BI vials and record the results in the STERRAD Sterilization log.

On 2/23/15 at 0845 hours, the SPD was toured with the Executive Director of Surgical Services and Endoscopy. In a concurrent interview with the SPD Manager, he stated the hospital utilized three STERRAD sterilizers for sterilization services: STERRAD #1, #3, and #4.

Review of the documentation STERRAD Bio, the sterilization record dated February 2015, showed the following:

* STERRAD #1- documentation for processed and control BI for the date, time, and 24 hours check mark were not complete on 2/1, 2/10, 2/11, 2/12, 2/16, 2/17, 2/18, and 2/19/15; however, the results were read by (staff initials).

* STERRAD #3- documentation for processed and control BI for the date, time, and 24 hours check mark were not complete on 2/16, 2/17, and 2/18/15; however, the results were read by (staff initials).

* STERRAD #4, documentation for processed and control BI for the date, time, and 24 hours check mark were not complete on 2/11, 2/12, 2/16, 2/17, 2/18, 2/19, 2/20, 2/21, and 2/22/15; however, the results were read by (staff initials).

In further interview with the SPD Manager, he stated the SPD staff monitored the BI results in 24 hours and 48 hours. The Manager stated his further review of the manufacturer's recommendations for the monitoring of the BI results showed a 24 hours reading; he could not see a recommendation for performing a 48 reading result check.

7. According to CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008, cleaning is the removal of foreign material (e.g., soil, and organic material) from objects and is normally accomplished using water with detergents or enzymatic products. Enzyme solutions should be used in accordance with manufacturer's instructions, which include proper dilution of the enzymatic detergent and contact with equipment for the amount of time specified on the label.

On 2/23/15 at 0845 hours, the SPD decontamination area was toured. The Instrumental Technician was interviewed regarding the dilution of the enzymatic solutions for cleaning of the surgical instruments.

The Instrumental Technician stated there was a water fill mark in the sink and a machine delivered the amount of required enzymatic solution to the water. When asked to state the manual dilution of the enzymatic solution, the Instrumental Technician stated she used eight 30 ml (240 ml) syringes of enzymatic solution and added water to the line in the sink.

Review of the manufacturer's instructions showed to use 1/2 to 1 ounce (15-30 ml) of enzymatic solution to each one gallon of water.

In a concurrent interview with the SPD Manager, he stated the water fill mark in the sink equaled six gallons; therefore, the amount of the enzymatic solution for dilution required would be from 90-80 ml.

8. Review of the hospital's P&P titled Surgical Department Cleaning, reviewed 2/14, showed the Environmental Services Department will adhere to established daily, end of day cleaning, and terminal cleaning schedules and procedures to insure an aseptically clean environment for patients and staff in the sterile processing area, which is in part of the Surgical Department.

On 2/24/15 at 1445 hours, the CVOR services areas were toured with the Executive Director of Surgical Services and Endoscopy and the Surgical Services Clinical Manager. The following was observed:

a. In the general services area, a difficult intubation cart was inspected. At the base of the clear cabinet, there was visible blue debris. Four flexible intubation scopes were sterilized and ready for use.

The Executive Director of Surgical Services and Endoscopy stated the Anesthesia Department technicians were responsible for the cleaning of the cart. The Director had no further information as to when the cart was last cleaned.

b. In CVOR #23:

* A cart located next the perfusion machine was inspected. A vial of magnesium showed an expiration date of 1/11. In three drawers of the cart, there was paper trash, dust, broken Q-tips, and assorted miscellaneous items. Most of the items appeared old.

The Director of Surgical Services and Endoscopy stated the hospital perfusionists were responsible for cleaning the cart. The Director had no further information as to when the cart was last cleaned.

* A pair of gloves and paper trash was found on the floor behind the perfusion cart.

* The anesthesia cart had rusty erosion on the outside and the top of the cart. There was debris between the supply storage compartments. A compartment for stored individually packed 10 ml syringes had yellow to brown residues.

* One black linen suture was found on the floor.

The Director of Surgical Services and Endoscopy stated the last time the OR was used was 1/20/15.

b. In CVOR #24:

* A blue linen suture was found on the floor.

* Baseboards around the room had an accumulation of dust.

* A cart located next the perfusion machine was inspected. The cart's three drawers contained paper trash, dust, and assorted miscellaneous items.

The Director of Surgical Services and Endoscopy stated the hospital perfusionists were responsible for cleaning the cart. The Director had no further information as to when the cart was last cleaned.

* The heart-lung bypass machine exterior showed considerable dust residue on the machine.

Additionally, a ice reservoir on the machine contained melting ice and water. A clear, plastic drainage tube from the ice reservoir showed considerable sediment and buildup of particulate matter. Trash debris, dirt, and particulate matter build was also noted in the cavities and spaces on the equipment.

Review of the Perfusion Maintenance Checklist for the heart-lung machines showed the checklist was to be completed on date surgery was performed.

The Perfusion Maintenance Checklist for the machine also showed instructions to note date when water in heater cooler and MPS (myocardial protection system) units was changed and cleaned with disinfectant (monthly or as needed).

For January 2015, the Perfusion Maintenance Checklist showed cleaning was performed twelve times.

During an interview with the Surgical Services Clinical she stated the perfusionist assumed full responsibility for the preventative maintenance monitoring and cleaning of the heart-lung equipment.

* The anesthesia cart had rusty erosion on the outside and the top of the cart.

The Director stated the OR was used a couple of hours ago. The EVS staff had completed the cleaning of the room.

The EVS weekly verification sheet for cleaning of CVOR Operating Rooms and Cath Labs was requested and reviewed. The weekly verification sheet showed a total of 10 rooms were included: Cath lab 1-4, CVOR 21-24, a hybrid room and a combo room.

Documentation of cleaning for three weeks in January (1/12 to 1/28/15) and four weeks in February (2/2 to 2/23/15) was reviewed. No documented evidence was found to show all the rooms were cleaned weekly.

Review of the documentation for the Supervisor Verification showed, except for 2/23/15, the documentation was either initialed by the same person who signed for cleaning or was left blank.

For CVOR #23 (observed with dust and trash on 2/24/15), there was no documented evidence the room was cleaned weekly since 1/12/15.

For CVOR #24, there was no documentation of weekly cleaning for four of the seven weeks.

c. In an OR, clean and ready for use, an antibiotic IV solution bag 50/ml was noted draped over OR equipment. IV tubing was attached to the bag and the tubing was primed (solution filled the tubing) for use. Upon inspection, there was no patient name or date of acquisition on the bag.

The Surgical Services Clinical Manager stated the bag was from a prior surgery and during the room cleaning procedure the bag was inadvertently left behind.

The EVS Operating Room Terminal Cleaning Weekly Verification Sheet for the week of 1/13 to 1/31/15, was reviewed further. Documentation for Supervisor Verification of cleaning of the hospital's main OR 1-10, Cysto room, Sub sterile, Litho, and Mini Minor room was initialed by the same person.

On 2/25/15 at 1440 hours, the Director of EVS was interviewed. The Director stated he reviewed the above Operating Room Terminal Cleaning Weekly Verification Sheet documents before the interview.

The Director of EVS stated he was not aware there was no documentation a Supervisor's verification. The Director stated EVS had a system to oversee and evaluate the staff's work; however, he could not locate documented evidence to show the supervision and evaluating system was implemented by the supervisors and the manager. The Director also stated he was unable to identify the initials found on the EVS Operating Room Terminal Cleaning weekly Verification Sheet for the hospital's main OR 1-10, Cysto room, Sub sterile, Litho, and Mini Minor room.

On 2/25/15 at 1500 hours, the Infection Control Coordinator was interviewed regarding how the EVS services reports were integrated into the hospital's Infection Control Committee. The Infection Control Coordinator reviewed the EVS report for the 2nd quarter 2014, and stated there was documented evidence of EVS data collection for the cleaning services in the Surgical Services area; however, for the IC meeting minutes for January 2015, EVS was "deferred."

9. The SPD was toured on 2/23/15 at 0845 hours. The following was noted:

* Three instrumentation carriers (carts that carried instruments to the autoclave for sterilization) were observed in the assembly area with dust and loose sterile package sterilization labels stocked on the carriers.

In a concurrent interview with SPD Manager, the Manager stated the hospital had a contracted service which was responsible for cleaning and preventive maintenance of the carts once a year. The Manager was not aware of the accumulated dust on the carts.

* In the decontamination area, two feeder washers (the area to load the cart of dirty instruments to the autowasher) had gaps around the feeders with heavy visible dust and paper trash noted.

The case cart washer doors were noted to have erosion wearing off the surfaces of the doors.

When asked, the SPD Manager was unable to recall the cleaning schedule for the feeders and was not aware of the dust and trash.

10. Review of the hospital's P&P titled Temperature, Humidity, and Pressure Relationship Monitoring for Procedural Suites reviewed 11/14, showed :

- The temperature, humidity, and pressure relationship is recorded for every suite in the department on days of operation by a designated person.

- If the temperature recording is out of range at time of daily check, adjust the thermostat to 68-73 degrees Fahrenheit.

- If the temperature does not re-adjust within 30 minutes call engineering immediately for buildings 1 and 2.

- The humidity for each suite is recommended between 20-60% Relative Humidity.

- If a humidity recording is out of range at time of daily check, call Engineering immediately

- When the temperature, humidity, and/or pressure relationship are corrected and was within range, the procedural suite may be used.

- Document all actions taken in the "ACTION TAKEN" column on the log sheet. For instance, document what action was taken due to the temperature, humidity, and/or pressure relationship being out of range.

- At any time during daily operations the temperature (unless indicated for optimal patient care), humidity, and /or the pressure relationship is identified to be out of acceptable range, the above actions should be initiated without interruptions of ongoing cases.

Review of the hospital's P&P titled Temperature and Humidity for Plant Services Department reviewed 10/14, showed:

- Departments check the temperature and humidity in procedural areas and sterile processing daily. Temperature and humidity readings are noted in the department's log.

- If the reading is out of range, the department must notify extension 15000 to place a request for service.

- When a reading is reported out of range:
a) Maintenance Machine is notified of an out of range condition.
b) Maintenance Machine notifies Plant Operations who makes an adjustment on the equipment.
c) Maintenance Machine rechecks the temperature or humidity in 30 minutes.
d) If the reading continues to read out of range, the machine will follow up with Plant Operations for additional adjustments. Maintenance Machine rechecks the temperature or humidity in another 30 minutes.

- Maintenance Machine is required to document each step in ISIS Pro (a documentation system) for the following:
a) Maintenance Machine must update the work code "problem," to "T&H Verification."
b) Under the "statuses" tab, each step must be documented. This includes actions taken, re-checks and notification to management
c) Work orders are "Completed" when the desired temperature/humidity had been achieved or upon further intervention from management.

a. Review of the log sheet for documentation of temperature, humidity, and pressure for the SPD area showed for out of range readings document all activity, including time of call and name of person at extension 15000.

The actions included: #1 call 15000 and 18022; #2 recheck in one hour; #3 document repeat reading; and #4 repeat as necessary until corrected.

The log sheet showed the normal humidity reading was 30-60%.

Review of the log sheet for February 2015, was conducted on 2/23/14. The log showed on 2/12/15, the humidity reading was out of range in both the decontamination and the assembly areas. On 2/13 and 2/14, the humidity reading was out of range for the assembly area. Documentation showed staff called extension 15000 (step #1); however, there was no further documentation to show the actions for steps #2, #3 and #4.

On 2/23/15 at 0845 hours, the SPD Manager reviewed the above documentation. The Manager stated the SPD staff made a call to Plant Operations. The staff checked the humidity on the following day as the follow up action. The Manager confirmed there was no further documentation to show further corrective actions and a recheck of the humidity.

b. Review of the OR Room Temperature Log showed the log sheet indicated for temperatures out of range to adjust the thermostat to range (if no thermostat available, call extension 15000), and recheck in 30 minutes; if still out of range, call extension 15000. Do not use the room until the range is within normal limits.

The temperature log for February 2015, was reviewed on 2/23/15. Documentation showed on 2/4/15, OR room 6's temperature reading was 62 degrees Fahrenheit. Documentation in comment section failed to show actions for adjusting the thermostat to range and a recheck in 30 minutes. The documentation only showed "call 15000."

On 2/25/15 at 1110 hours, during an interview the Director of Facility provided documentation of the work order for OR 6 on 2/4/15. Documentation showed staff called at 0728 hours, and the work was completed at 0813 hours. However, there was no documentation to show each step was taken, who made an adjustment, and Maintenance Machine was rechecked for the temperature or humidity in 30 minutes.

c. Review of the L&D Temperature and Pressure Relationship Log showed the log sheet indicated for temperature out of range to adjust the thermostat to range (if no thermostat available, call extension 15000) and recheck in 30 minutes (if still out of range, call extension 15000). Do not use room until range is within normal limits.

A review of the L&D Temperature and Pressure Relationship Log was conducted on 2/23/15. For 13 of 23 days for February 2015, there was no documentation to show L&D staff adjusted the thermostat to range and rechecked in 30 minutes. Documentation in the action section showed "called 15000."

On 2/25/15 at 1110 hours, during an interview, the Director of Facility stated he could not find documentation of work orders for those calls from the L&D staff for February 2015. The Director stated if Facility staff received calls for out of range of temperature and/or humidity, they would act on the problems. Facility staff did not document the details of the actions on the department's log sheet; the department's staff should document the actions.

The Director stated the Facility staff documented on the Facility's documentation only if the problem was not resolved. The Facility staff did not track or trend the work orders for out of range temperature and/or humidity.


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11. The outpatient surgery center was toured on 2/24/15 beginning at 1035 hours. The following was observed:

a. An ultrasound machine was observed in the utility room associated with OR 9. During a concurrent interview with Surgical Tech 1, she stated the ultrasound machine was used by the surgical techs to clean the diamond blades. The Tech stated a packet of enzymatic cleaner was mixed with a liter bottle of sterile water in the ultrasound.

Review of the enzymatic cleaner packet showed it should be diluted with one gallon, not one liter of water.

b. In OR 9, tape residue was observed to cover an approximately 16 inch long area of the microscope handle. Fragments of tape were also seen adherent to several areas of the floor and several areas of the floor had hard brown or yellow residue. A damp paper towel was used to swipe the floor in two locations; some of the brown residue was removed, while others were not.

During an interview with RN U on 2/24/15 at 1040 hours, she stated terminal cleaning occurred each evening; OR had not been used that day.

c. In the outpatient surgery sterile processing area, two Steris System One scope processers were seen.

In a concurrent interview with the SPD Manager, he stated the machines were sometimes used for processing scopes. When asked about daily maintenance of the machines, he stated he was not aware of any required daily maintenance.

Review of the operator's manual for the machines showed there should be daily cleaning of the chambers with alcohol.

d. The IP rounds report for the fourth quarter of 2014 was reviewed. The report contained the name of the area reviewed, specific items reviewed, and an indication of "yes," "no" or "NA (not applicable)."

The reports showed for some areas, a notation of "NA" was seen opposite an item known to exist and that should be assessed. On other parts of the report, "yes" was opposite an item known not to exist. Some areas of the hospital, such as the outpatient surgery center were not listed on the report.

Rounding sheets with handwritten notations were provided for review for some other areas on 2/26/15 at 1350 hours, by the Infection Control Coordinator. The Coordinator stated not all of the areas of the hospital reviewed had made it on to the typed report.

One of the documents provided, Infection Prevention & Control Unit Environmental Surveillance - 2014, was for the surgery center dated 7/2/14. The pre-printed document had handwritten notations for a review of the Outpatient Surgery OR. Again, there were the possible responses of "yes," "no," and "NA." There was an item for compliance with use of glutaraldehyde with the response of "yes;" however, the surveillance document did not indicate which of outpatient ORs was toured.

The Infection Control Coordinator reviewed the documents and concurred "NA" was not appropriate for some of the items on the typed report. The Coordinator stated glutaraldehyde was not used in the OR, so it should not have been a "yes." In addition, the Coordinator concurred there was no information to indicate which outpatient surgery OR or ORs were observed for the report.

Based on interview and record review, the hospital failed to ensure a comprehensive H&P examination was complete for one of 30 sampled patients (Patient 19) prior to surgery, creating the risk of a substandard healthcare outcome to this patient.

Findings:

Review of the Medical Staff Clinical Rules regarding outpatient surgery pre-op evaluations, page 29, showed "Each patient shall be evaluated pre-operatively by the surgeon, who shall be responsible for determining what surgical intervention is necessary and for securing the patient's informed consent for the surgery."

Review Patient 19's medical record on 2/24/15, showed the patient had a cataract surgery in the outpatient surgery center; however, the medical record did not contain a pre-operative H&P.

The medical record contained a "Transplant Progress note" dated 2/18/15, which contained information about Patient 19's readiness for surgery from the perspective of the transplant program physician. However, the document did not contain information about medications, allergies, surgical history, social history, chief complaint, or a medical history, including a history of vision problems leading up to the need for the proposed cataract surgery. There was no documentation to show which of Patient 19's eye was affected.

A second document, the Surgery Center Progress Note, showed the surgeon checked a box on the day of surgery to indicate "No Change from H&P."

A review of the Pre-Op Nursing Record showed the patient was allergic to penicillin (an antibiotic) and was taking multiple medications.

During an interview with RN B on 2/24/15 at 0940 hours, she concurred there was no other document resembling an H&P in Patient 19's medical record; the Transplant Progress Note did not contain information about Patient 19's vision.

During an interview with the Director Regulatory &Privacy Compliance on 2/25/15 at 1520 hours, he concurred there were no medications or allergies listed on the Transplant Progress Note.

Based on interview and record review, the hospital failed to ensure the post-operative monitoring P&P was fully implemented for one of 30 sampled patients (Patient 19), creating the increased risk of a poor post-surgical outcome to this patient.

Findings:

Review of Patient 19's medical record showed the patient came to the hospital on 2/24/15, for a surgery. The physician selected the order to "Discharge by criteria" on the PACU (Post Anesthesia Care Unit) Orders.

The hospital's P&P Discharge Criteria for Phase II Post Anesthesia Care reviewed 8/14, showed "Patients may be considered ready for discharge when they meet the following criteria as assessed by the RN: ...SaO2 (oxygen saturation-a measure of the amount of oxygen in the blood) a minimum of 95% on room air or return to baseline status.

For the adult patient, if the SaO2 falls below 95% on room air, apply nasal O2 at 2 liters/minute. If the SaO2 cannot be maintained at 95% with nasal O2 at 2 liters/minute, notify the anesthesiologist for orders."

Review of Patient 19's Perioperative Clinical Record showed she was assessed in the PACU from 0845 to 0915 hours. The patient's last SaO2 was documented at 0910 hours, as 87.8%.

A nursing note written at 0915 hours, indicated the patient's "O2 Sat > (greater than) 92% on RA (room air);" however, there was no documentation to show her oxygen saturation level was rechecked after the 87.8% reading. The Patient was discharged from the PACU at 0917 hours.

During an interview with RN B on 2/24/15 at 0940 hours, she stated she believed the pulse oximeter (device to measure SaO2) was just off the patient's finger; however, she stated she should have rechecked the SaO2.