HospitalInspections.org

Based on observation, staff assignment review, staff interview, policy review, medical record review, physician interview, and observations as referenced in the Life Safety Report of Survey completed June 22, 2010, the Governing Body failed to provide oversight and have systems in place to ensure the protection of patients' rights, an effective quality assurance program, an organized nursing service and to ensure the physical plant was maintained to provide the safety of patients.

The findings include:

1. The hospital failed to protect and promote patients' rights by failing to provide care in a safe setting, ensure a physician's order for the use of restraint, ensure restraints were not ordered on an as needed basis, ensure restraint patients were monitored per policy, and develop and maintain the facilities in a manner to ensure the health and safety of patients, staff, and visitors.

~cross refer to 482.13 Patient Rights' Condition: Tag A0115

2. The hospital failed to implement and maintain an effective quality assessment and performance improvement program to ensure the safety of patients.

~cross refer to 482.21 QAPI Condition: Tag A0263

3. The hospital failed to have effective Nursing Services providing oversight of day to day operations to ensure adequate staffing in the dialysis unit to provide continuous visualization and monitoring of patients during hemodialysis treatments and to ensure nursing supervision to provide the delivery of patient care in a safe and therapeutic environment.

~cross refer to 482.23 Nursing Services Condition: Tag A0385

4. The hospital failed to develop and maintain the facilities in a manner to ensure the health and safety of patients, staff and visitors.

~ cross refer 482.41 Physical Environment Condition: Tag A0700

Based on observation, staff assignment review, staff interview, policy review, medical record review, physician interview and observations as referenced in the Life Safety Report of Survey completed June 22, 2010, the hospital failed to protect and promote patients' rights by failing to provide care in a safe setting, ensure a physician's order for the use of restraint, ensure restraints were not ordered on an as needed basis, ensure restraint patients were monitored per policy, and develop and maintain the facilities in a manner to ensure the health and safety of patients, staff, and visitors.

The findings include:

1. The hospital failed to provide care in a safe setting by failing to ensure nursing staff continuously visualized and monitored patients dialyzing in isolation rooms of the dialysis unit throughout dialysis treatments for 4 of 6 dialysis patients observed dialyzing in isolation rooms.

~cross refer to 482.13(c)(2) Patients' Rights Standard: Tag A0144

2. The hospital failed to ensure a physician's order for the use of restraint for 2 of 5 sampled restraint patients.

~cross refer to 482.13(e)(5) Patients' Rights Standard: Tag A0168

3. The hospital failed to ensure restraints were not ordered on an as needed basis for 2 of 5 sampled restraint patients.

~cross refer to 482.13(e)(6) Patients' Rights Standard: Tag A0169

4. The hospital failed to ensure 3 of 5 sampled restraint patients were monitored per policy.

~cross refer to 482.13(e)(10) Patients' Rights Standard: Tag A0175

5. The hospital failed to develop and maintain the facilities in a manner to ensure the health and safety of patients, staff, and visitors.

~cross refer to 482.41 Physical Environment Condition: Tag A0700.

Based on observation, staff assignment review, staff interview, personnel record review, and physician interview, the hospital failed to provide nursing care in a safe manner ensuring patients dialyzing in the isolation rooms of the hemodialysis unit could be continuously visualized and monitored throughout the dialysis treatment for 4 of 6 (#22, 25, 71, 23) patients observed dialyzing in isolation rooms on the dialysis unit.

The findings include:

1. Observation in the dialysis unit on 06/18/2010 at 1150 revealed the dialysis unit had 4 isolation rooms: #7762; #7761, #7759, #7757. Observation revealed that each of these rooms were separate, private rooms with the inability to see patients from one isolation room to the other isolation room.

Observation in the dialysis unit on 06/18/2010 at 1150 revealed patient #22 was receiving hemodialysis in room #7762; patient #25 was receiving hemodialysis in room #7761; patient #71 was receiving hemodialysis in room #7759 and patient #23 was receiving hemodialysis in room #7757.

Observation in the dialysis unit on 06/18/2010 at 1150 revealed intervals of time when staff was not able to continuously visualize and monitor the patient during dialysis treatment. Observation on 06/18/2010 at 1150 revealed from 1208-1220 (12 minutes) RN #1 left patient #25 dialyzing in room #7761 unattended to provide care for patient #22 dialyzing in room #7762, her other assigned patient. Observation on 06/18/2010 at 1150 revealed from 1235-1259 (24 minutes) RN #2 left patient #23 dialyzing in room #7757 unattended to provide care for patient #71 dialyzing in room #7759, her other assigned patient. Observation revealed staff left one patient's line of sight to provide care to another patient dialyzing in another isolation room.

Review of the 06/18/2010 staff assignment revealed 2 registered nurses were assigned to care for 4 isolation patients. RN #1 was assigned to care for patient #22 (room #7762) and #25 (room #7761) from 0848-1208 (3 hours and 20 minutes), and RN #2 was assigned to care for patients #71 (room #7759) and #23 (room #7757) from 1035-1235 (2 hours).

Interview on 06/18/2010 at 1230 with the Charge Nurse revealed the dialysis unit was staffed on a 2:1 patient/staff ratio and had staffed this way since before 2005. Interview also revealed the Charge Nurse voiced concerns of the inability to continuously visualize and monitor patients during hemodialysis treatment when the new unit opened on 10/31/2005.

Observation in the dialysis unit on 06/21/2010 at 1249 revealed RN #3 sitting in the ante room outside isolation room #7762 where patient #22 was dialyzing. Observation revealed patient #22 was located on a bed in the room with the patient's vascular access site not visible from where RN #3 was sitting. Observation revealed the patient's access site and blood line connection was positioned out of the nurses line of sight towards the back wall of the isolation room. Observation revealed the patient's bed was in the highest position obstructing RN #3's line of vision of the access and blood line connection.

Interview 06/21/2010 at 1255 with the RN #3 monitoring patient #22 revealed staff was informed late on 06/18/2010 that isolation patients would now be a one patient to one staff assignment. Interview revealed this staff was not aware that the patient's access site and blood line connection had to be continuously visible and monitored by staff.

Interview with the Clinical Operation Director (COD) on 06/22/2010 at 1040 revealed she had concerns regarding the staffs "limited" ability to view and monitor patients continuously during dialysis treatment. Interview revealed patient safety concerns during dialysis treatment included hypotensive episodes, unresponsiveness and needle dislodgement resulting in exsanguination in a matter of minutes. Interview revealed the nurse may be out of the room as long as 10-25 minutes at any given time based on the needs of the other patient that staff is also responsible for. Interview revealed that no safety measures had been implemented after the new unit with the four isolation rooms opened in 2005 to ensure patients were continuously visualized and monitored during hemodialysis treatment.

Based on policy review, medical record review and staff and physician interview the hospital failed to ensure a physician's order for the use of restraint for 2 of 5 sampled restraint patients (#33 and #34).

The findings include:

Review of current hospital policy entitled "Restraint Utilization for Acute Medical-Surgical (non-violent) Indications" dated 08/2009 revealed, "...Restraint interventions require a written Physician's, NP (Nurse Practitioner) or PA (Physician Assistant) order....In instances where restraint(s) are applied emergently, a verbal order may be taken....Physician/NP/PA Responsibilities: Documentation of a written order for the initiation of a restraint intervention within 24 hours of initiation and daily thereafter. (must have a verbal order written by an RN (Registered Nurse)/ALPN (Licensed Practical Nurse) if MD/PA/NP is not immediately available...."

1. Open record review on 06/15/2010 for Patient #33 revealed a 59 year-old male admitted on 05/29/2010 at 2320 with cryptococcal meningitis (fungal infection of the membranes covering the brain and spinal cord) and status post surgical repair of perforated and necrotic bowel at a community hospital on 05/25/2010. Record review revealed the patient was intubated and on a ventilator at the time of admission. Record review revealed the patient was extubated on 06/01/2010. Record review revealed the patient was placed in bilateral soft wrist restraints on 05/30/2010 at 0000. Record review revealed the first documentation of a physician's order for the patient to be restrained was dated 05/30/2010 at 0821 (8 hours and 21 minutes after the patient was restrained). Record review revealed the patient remained in restraints until 06/04/2010 at 1700, when staff removed them. Review of physician's orders revealed no documentation of an order for the patient to be restrained on 06/02/2010 between 1011 and 1941 (9 hours and 40 minutes) and between 1940 on 06/03/2010 and 0714 on 06/04/2010 (11 hours and 34 minutes). Further record review revealed the patient pulled out his nasogastric tube on 06/05/2010 at 0202 and was placed in bilateral soft wrist restraints again. Record review revealed the next documentation of a physician's order for the patient to be restrained was dated 06/05/2010 at 0714 (5 hours and 12 minutes after the patient was restrained). Record review revealed staff removed the restraints on 06/05/2010 at 1800. Record review revealed documentation on 06/05/2010 at 2000 the patient was placed in bilateral soft wrist restraints again. Record review revealed the next documentation of a physician's order for the patient to be restrained was dated 06/06/2010 at 0714 (11 hours and 14 minutes after the patient was restrained).

Interview on 06/16/2010 at 1000 with administrative nursing staff revealed a physician's order for restraints must be documented in the medical record when a patient is restrained or immediately after the emergent application of restraints. Interview revealed restraint orders must be renewed by the physician each day. Interview revealed nursing staff may remove restraints when a patient's condition warrants, but must obtain another physician's order for restraints if restraints are reapplied. Interview confirmed there was no available documentation of a physician's order for restraints for the following times when the patient was in restraints: on 05/30/2010 between 0000 and 0821 (8 hours and 21 minutes); on 06/02/2010 between 1011 and 1941 (9 hours and 40 minutes); between 1940 on 06/03/2010 and 0714 on 06/04/2010 (11 hours and 34 minutes) and between 2000 on 06/05/2010 and 0714 on 06/06/2010 (11 hours and 14 minutes).

2. Open medical record review on 06/16/2010 for Patient #34 revealed a 67 year-old male admitted on 05/18/2010 with diarrhea and a history of myasthenia gravis (autoimmune disease characterized by weakness of skeletal muscles). Record review revealed the patient was restrained with bilateral hand mitts from 06/04/2010 at 0400 until 06/08/2010 at 1605. Review of physician's orders revealed no documentation of an order for the patient to be restrained between 1934 on 06/05/2010 and 0648 on 06/06/2010 (11 hours and 14 minutes).

Interview on 06/16/2010 at 1000 with administrative nursing staff revealed a physician's order for restraints must be documented in the medical record when a patient is restrained or immediately after the emergent application of restraints. Interview revealed restraint orders must be renewed by the physician each day. Interview confirmed there was no available documentation of a physician's order for restraints when the patient was restrained between 1934 on 06/05/2010 and 0648 on 06/06/2010 (11 hours and 14 minutes).

Based on policy review, medical record review and physician and staff interview the hospital failed to ensure restraints were not ordered on an as needed basis for 2 of 5 sampled restraint patients (#33 and #34).

The findings include:

Review of current hospital policy entitled "Restraint Utilization for Acute Medical-Surgical (non-violent) Indications" dated 08/2009 revealed, "...Restraint Orders: Restraint interventions require a written Physician's, NP (Nurse Practitioner) or PA (Physician Assistant) order....The order will be:...may not be written as a 'PRN (as needed)' or as a standing order. Must include clinical justification for the restraint(s)....Physician/NP/PA Responsibilities:...All restraint orders will be renewed daily based on the patient's assessed needs, as determined via a Physician's, NP's, or AP's face-to-face assessment, will be clinically justified, and will be time-limited. (Not to exceed one-calendar day in duration)....Assessing the need for Restraint(s): The Registered Nurse's assessment is used to determine the need for restraint intervention...."

1. Open record review on 06/15/2010 for Patient #33 revealed a 59 year-old male admitted on 05/29/2010 at 2320 with cryptococcal meningitis (fungal infection of the membranes covering the brain and spinal cord) and status post surgical repair of perforated and necrotic bowel at a community hospital on 05/25/2010. Record review revealed the patient was in bilateral soft wrist restraints due to the patient pulling on his tubes and lines from 05/30/2010 at 0000 until 06/04/2010 at 1700, from 06/05/2010 at 0202 until 1800 and from 06/05/2010 at 2000 until 06/12/2010 at 0600. Record review revealed the patient had a sitter 24 hours per day since 06/11/2010 at 1700. Record review revealed documentation the restraints were removed on 06/12/2010 at 0738. Further record review revealed documentation of physician's orders for bilateral wrist restraints for pulling on tubes and lines on 06/12/2010 at 0842 (4 minutes after the patient was last restrained), on 06/13/2010 at 1028 (1 day after the patient was last restrained) and on 06/14/2010 at 0651 (2 days after the patient was last restrained).

Interview on 06/16/2010 at 1600 with the Registered Nurse (RN #12) that was assigned to Patient #33 from 0700-1900 on 06/12/2010 revealed the patient had restraints on because he pulled at his tubes and lines. Interview revealed the patient's wife removed the wrist restraints during the morning on 06/12/2010. Interview revealed, "She stayed with him for a while and then he had a sitter that came in between 2 and 3 (PM). He didn't have restraints the rest of the day."

Interview on 06/16/2010 at 1000 with administrative nursing staff revealed restraints should only be ordered and used when patients pull at medical tubes and lines and other interventions have failed to stop them. Interview revealed restraints should not be ordered if the patient's current condition and behavior don't warrant their use. Interview confirmed there was documentation of physician's orders for restraints on 06/12/2010 at 0842 (4 minutes after the patient was last restrained), on 06/13/2010 at 1028 (1 day after the patient was last restrained) and on 06/14/2010 at 0651 (2 days after the patient was last restrained).

Interview on 06/16/2010 at 1445 with the Resident Physician (Physician A) that ordered restraints for Patient #33 on 06/12/2010, 06/13/2010 and 06/14/2010 revealed the physician renewed restraint orders each morning during patient rounds. Interview revealed, "We always evaluate patients before entering a restraint order....We see patients a minimum of 3 to 4 times a day....At the time of the order entry I know he will need restraints for the next 24 hours, so I renew the orders for that time period....There were times with him (Patient #33) that the wife was in and removed the restraints without us knowing and staff had to put them back on when she left....He had the restraints around his wrists, but not tied to the bed, several times." Interview revealed the physician was unaware the patient was not restrained on 06/12/2010 at 0842, on 06/13/2010 at 1028 and on 06/14/2010 at 0651 when the physician renewed orders for restraint.

2. Open medical record review on 06/16/2010 for Patient #34 revealed a 67 year-old male admitted on 05/18/2010 with diarrhea and a history of myasthenia gravis (autoimmune disease characterized by weakness of skeletal muscles). Record review revealed the patient was restrained with bilateral hand mitts due to the patient pulling on his tubes and lines from 06/04/2010 at 0400 until 06/08/2010 at 1605. Review of nurse's notes on 06/09/2010 at 1550 revealed, "0 (No) use of restraints so far. Pt (patient) not agitated/pulling tubes." Further record review revealed documentation of physician's orders for bilateral hand mitt restraints for pulling on tubes and lines on 06/09/2010 at 1631 (1 day after the patient was last restrained), 06/10/2010 at 1631(2 days after the patient was last restrained) and 06/11/2010 at 1631 (3 days after the patient was last restrained).

Interview on 06/17/2010 at 1430 with administrative nursing staff revealed restraints should only be ordered and used when patients pull at medical tubes and lines and other interventions have failed to stop them. Interview revealed restraints should not be ordered if the patient's current condition and behavior don't warrant their use. Interview confirmed there was documentation of physician's orders for restraints on 06/09/2010 at 1631 (1 day after the patient was last restrained), 06/10/2010 at 1631(2 days after the patient was last restrained) and 06/11/2010 at 1631 (3 days after the patient was last restrained).

Interview on 06/18/2010 at 1115 with the Resident Physician (Physician B) that ordered restraints for Patient #34 on 06/10/2010 and 06/11/2010 revealed restraints were ordered for the patient because he "intermittently pulled at tubes and lines throughout his stay". Interview revealed the physician did not recall if the patient was restrained on 06/10/2010 and 06/11/2010 (when he ordered restraints). Interview revealed, "I didn't expect it to be a PRN (as needed) order." Interview revealed the physician was unaware the patient was not restrained on 06/10/2010 and 06/11/2010 when the physician renewed orders for restraint.

Based on medical record review and administrative staff interview the hospital staff failed to report the death of a patient that occurred within 24 hours after the patient had been removed from restraints to the Centers for Medicare Services (CMS) for 1 of 1 sampled patients that expired within 24 hours of restraint (#20).

The findings include:

Review of hospital policy entitled "Restraint and Seclusion", last revised on 6/11/2009, revealed, "...REPORTING DEATHS ASSOCIATED WITH RESTRAINT/SECLUSION...Hospitals must report deaths associated with the use of restraint or seclusion for the following situations: 1. Each death that occurs while patient is in restraint or seclusion. 2. Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion; or 3. Each death known to the hospital that occurs within on week after restraint or seclusion where it is reasonable to assume that the use of restraint or seclusion contributed directly or indirectly to the patient's death....Documenting Death Report...The staff must document in the patient's medical record the date and time the patient death was reported to the Centers for Medicare & Medicaid Services (CMS)."

Closed record review for Patient #20 revealed a 61 year old female admitted on 01/07/2010 for treatment of CVA (stroke) and CHF (congestive heart failure). Medical record review revealed the patient had been placed in SPD (soft protective device) bilateral wrist restraints to prevent patient from pulling at IV (intravenous tubings) per physician's order on 01/08/2010 at 0948. Review revealed the patient remained in restraints until 1500 on 01/09/2010, when restraints were removed. Review revealed at 1555 on 01/09/2010 the patient expired. Further record review failed to reveal any available documentation of the date and time the death of Patient #20 was reported to CMS.

Interview with the Risk Manager on 01/14/2010 at 1410 revealed nursing staff on the units were supposed to fill out an incident report regarding deaths of patients within 24 hours of restraint and send it to Risk Management. Interview revealed Risk Management is responsible for reviewing the incident report and notifying CMS of all deaths associated with the use of restraints. Interview with the Risk Manager on 01/14/2010 at 1415 revealed an incident report had not been filled out, so Risk Management was not aware of the death of the patient who had been in restraints. Interview confirmed there was no available documentation that Patient #20's death was reported to CMS.

2. Open medical record review on 06/16/2010 for Patient #34 revealed a 67 year-old male admitted on 05/18/2010 with diarrhea and a history of myasthenia gravis (autoimmune disease characterized by weakness of skeletal muscles). Record review revealed the patient was in bilateral soft wrist restraints from 05/24/2010 at 1700 until 06/04/2010 at 0400. Further record review revealed the patient was restrained in bilateral hand mitts from 06/04/2010 at 0400 until 06/08/2010 at 1605. Record review revealed no documentation nursing staff monitored the skin integrity and circulation of the patient's restrained limbs (wrists or hands) or the patient's response to being restrained on 05/26/2010 between 1200 and 1600 (4 hours), on 05/30/2010 between 1600 and 2000 (4 hours), on 06/07/2010 between 2000 and 0000 (4 hours) and on 06/08/2010 between 0400 and 0800 (4 hours).

Interview on 06/16/2010 at 1400 with administrative nursing staff revealed nursing staff must monitor skin integrity and circulation of restrained limbs and the patient's response to restraints at least every 2 hours while a patient is restrained. Interview confirmed there was no available documentation nursing staff monitored the skin integrity and circulation of the patient's restrained limbs (wrists or hands) or the patient's response to being restrained on 05/26/2010 between 1200 and 1600 (4 hours), on 05/30/2010 between 1600 and 2000 (4 hours), on 06/07/2010 between 2000 and 0000 (4 hours) and on 06/08/2010 between 0400 and 0800 (4 hours).

3. Open medical record review on 06/16/2010 for Patient #35 revealed a 44 year-old female admitted on 06/04/2010 with thrombocytopenia (low platelets) and Perm Cath pain and thrombosis (pain and blood clotting at the venous access used for the patient's hemodialysis). Record review revealed the patient was in bilateral soft wrist restraints from 06/15/2010 at 0500 until 1300. Record review revealed no documentation nursing staff monitored the skin integrity and circulation of the patient's restrained limbs (wrists) or the patient's response to being restrained on 06/15/2010 between 0500 and 0800 (3 hours).

Interview on 06/16/2010 at 1500 with administrative nursing staff revealed nursing staff must monitor skin integrity and circulation of restrained limbs and the patient's response to restraints at least every 2 hours while a patient is restrained. Interview confirmed there was no available documentation nursing staff monitored the skin integrity and circulation of the patient's restrained limbs (wrists) or the patient's response to being restrained on 06/15/2010 between 0500 and 0800 (3 hours).

Based on staff interview and policy review the hospital failed to implement and maintain an effective quality assurance and performance improvement program to ensure the safety of patients.

The findings include:

1. The hospital failed to set priorities for performance improvement that affect patient safety and quality of care in the inpatient dialysis unit.

~cross refer to 482.21(c)(1) QAPI Standard: Tag A0285

Based on staff interview and policy review, the hospital failed to set priorities for performance improvement that affect patient safety and quality of care in the inpatient dialysis unit.

The findings include:

1. Interview on 06/18/2010 at 1230 with the dialysis unit Charge Nurse revealed the dialysis unit was staffed on a 2:1 patient/staff ratio. Interview revealed the hospital built and opened a new dialysis unit in October 2005 that had private patient isolations rooms. Interview revealed dialysis staff voiced concerns regarding the inability to constantly observe and monitor isolation patients during hemodialysis treatments in the new isolation rooms. Interview revealed no actions were taken to address the patient safety concerns related to constant patient visibility in the isolation rooms after the new unit opened.

Interview with the clinical operations director of dialysis on 06/22/2010 at 1040 revealed she had voiced concerns to upper management regarding the staff's "limited" ability to view and monitor patients continuously during dialysis treatment. Interview revealed patient safety concerns during dialysis treatment included hypotensive episodes, unresponsiveness and needle dislodgement resulting in exsanguination in a matter of minutes. Interview further revealed that the nurse may be out of the patient's room as long as 10-25 minutes at any given time based on the needs of the other patient that staff is also responsible for. Interview revealed patient dialysis treatments were started in the new unit on 10/31/2005 without implementation of safety measures to assure patients were continuously observed and monitored by staff during hemodialysis treatment.

2. Review of hospital policy, "Infection Control Policy Dialysis Center", revised 07/15/2009, revealed "...It is recognized that patients who undergo dialysis are at high risk for the development of infections. Given the inherent risk, it is imperative that a practical and effective infection control policy be developed to protect patients and staff...".

Interview on 06/24/2010 at 1245 with the clinical operations director of dialysis revealed "we are currently not looking at infection rates in our inpatient unit. We are not tracking infection rates on the inpatient side because they're counted on their unit". Interview further revealed "any infections are high risk. We haven't figured out how to track this. We need to work with infection control to work this out".

Based on observation, medical record reviews, policy and procedure reviews, staff interview and staffing assignment reviews, the hospital failed to have effective Nursing Services providing oversight of day to day operations to ensure adequate staffing in the dialysis unit to provide continuous visualization and monitoring of patients during hemodialysis treatments and to ensure nursing supervision to provide the delivery of patient care in a safe and therapeutic environment.

The findings include:

1. Nursing staff failed to provide adequate staff to ensure continuous visualization and monitoring for 4 of 6 observed patients dialyzing in four isolation rooms on the dialysis unit throughout the dialysis treatment.

~cross refer to 482.23(b) Nursing Services Standard: Tag A0392

2. Nursing staff failed to continuously supervise and monitor patients, their vascular access sites and blood lines during hemodialysis treatments for 4 of 6 patients observed receiving dialysis in the dialysis isolation rooms.

~cross refer to 482.23(b) (3) Nursing Services Standard: Tag A0395

3. Nursing staff failed to assess and implement care for 1 of 1 hemodialysis patients that experienced a hypoglycemic event during dialysis treatment

~cross refer to 482.23(b)(4) Nursing Services Standard: Tag A0395

4. Nursing staff failed to provide hemodialysis as ordered by the physician for 1 of 10 dialysis patients reviewed.

~cross refer to 482.23(b)(4) Nursing Services Standard: Tag A0395

5. Nursing staff failed to assess and implement safety measures for 2 of 13 sampled patients at high risk for falls.

~cross refer to 482.23(b)(4) Nursing Services Standard: Tag A0395

6. Nursing staff failed to monitor a patient's weight as ordered by the physician for 1 of 6 sampled dietary reviews.

~cross refer to 482.23(b)(4) Nursing Services Standard: Tag A0395

7. Nursing staff failed to assess and reassess pain for 1 of 10 inpatient surgical records reviewed.

~cross refer to 482.23(b)(4) Nursing Services Standard: Tag A0395

8. Nursing staff failed to administer medication in accordance with a physician's order and per accepted standards of practice as evidenced by failing to obtain a physician's order prior to administering medication for 2 of 2 outpatient pain clinic patients; failing to administer medication per the physician's order in 1 of 10 surgery inpatients; and failing to protect a patient from a known allergen in 1 of 10 surgery inpatients.

~cross refer to 482.23(c) Nursing Services Standard: Tag A0404

Based on observation, staff assignment review, and staff interview, nursing staff failed to provide adequate staff to ensure continuous visualization and monitoring throughout the dialysis treatment for 4 of 6 (#22, 25, 71, 23) observed patients dialyzing in four isolation rooms on the dialysis unit.

The findings include:

Observation in the dialysis unit on 06/18/2010 at 1150 revealed the dialysis unit had 4 isolation rooms: #7762; #7761, #7759, #7757. Observation revealed that each of these rooms were separate, private rooms with the inability to see patients from one isolation room to the other isolation room.

Observation in the dialysis unit on 06/18/2010 at 1150 revealed patient #22 was receiving hemodialysis in room #7762; patient #25 was receiving hemodialysis in room #7761; patient #71 was receiving hemodialysis in room #7759 and patient #23 was receiving hemodialysis in room #7757.

Observation in the dialysis unit on 06/18/2010 at 1150 revealed intervals of time when the staff was not able to continuously visualize and monitor the patient during dialysis treatment. Observation on 06/18/2010 at 1150 revealed that from 1208-1220 (12 minutes) patient #25 dialyzing in room 7761 was left unattended by staff. Observation revealed RN #1 left patient #25 unattended to provide care for patient #22, her other assigned dialysis patient in room #7762. Observation on 06/18/2010 at 1150 revealed that from 1235-1259 (24 minutes) patient #23 dialyzing in room 7757 was left unattended by staff. Observation revealed RN #2 left patient #23 unattended to provide care for patient #71, her other assigned dialysis patient in room #7759. Observation revealed the staff left the patients line of sight in order to provide care to other patients who were dialyzing in other isolation rooms.

Review of the 06/18/2010 staff assignment revealed 2 registered nurses were assigned to care for 4 isolation patients. RN #1 was assigned to care for patient #22 (room #7762) and #25 (room #7761) from 0848-1208 (3 hours and 20 minutes), and RN #2 was assigned to care for patients #71 (room #7759) and #23 (room #7757) from 1035-1235 (2 hours).

Interview on 06/18/2010 at 1230 with the Charge Nurse revealed the dialysis unit was staffed on a 2:1 patient/staff ratio and had staffed this way since before 2005. Interview revealed the Charge Nurse voiced concerns of the inability to continuously visualize and monitor patients during hemodialysis treatment when the new unit opened on 10/31/2005.

Observation in the dialysis unit on 06/21/2010 at 1249 revealed RN #3 sitting in the ante room outside isolation room #7762 where patient #22 was dialyzing. Observation revealed patient #22 was located on a bed in the room with the patient's vascular access site not visible from where RN #3 was sitting. Observation revealed the patient's access site and blood line connection was positioned out of the nurses line of sight towards the back wall of the isolation room. Observation revealed the patient's bed was in the highest position obstructing RN #3's line of vision of the access and blood line connection.

Interview 06/21/2010 at 1255 with RN #3 monitoring patient #22 revealed staff was informed late on 06/18/2010 that isolation patients would now be a one patient to one staff assignment. Interview revealed this staff was not aware that the patient's access site and blood line connection had to be continuously visible and monitored by staff.

Interview with the Clinical Operation Director (COD) on 06/22/2010 at 1040 revealed she had concerns when the new unit opened in 10/31/2005 regarding the staffs "limited" ability to view and monitor patients continuously during dialysis treatment . Interview revealed patient safety concerns during dialysis treatment included hypotensive episodes, unresponsiveness and needle dislodgement resulting in exsanguination in a matter of minutes. Interview revealed that the nurse may be out of the room as long as 10-25 minutes at any given time based on the needs of the other patient that staff is also responsible for. Interview revealed that no safety measures related to continuous visualization during dialysis treatment had been implemented since the new unit opened in 2005.

Consequently, nursing staff were not available to provide continuous visualization and monitoring of patients dialyzing in four isolation rooms on the dialysis unit. Inability to have adequate staff available to provide continuous monitoring has the potential to result in serious harm or death.

Based on observation, staff assignment review, staff interview, policy review and medical record review, nursing staff failed to assess, supervise and evaluate the delivery of patient care as evidenced by failing to continuously observe and monitor patients during hemodialysis treatments for 4 of 6 (#22, 25, 71, 23) patients observed receiving dialysis in the dialysis isolation rooms; evaluate and provide care for 1 of 1 (#24) hemodialysis patients that experienced a hypoglycemic event during dialysis treatment; provide heparin during hemodialysis as ordered by the physician for 1 of 10 (#22) dialysis patients reviewed; assess and implement safety measures for 2 of 13 (#77, 50) sampled patients at high risk for falls; monitor patient's weight as ordered by the physician for 1 of 6 sampled dietary reviews (#50); and assess and reassess pain for 1 of 10 inpatient surgical records reviewed (#16).

The findings included:
1. Observation in the dialysis unit on 06/18/2010 at 1150 revealed the dialysis unit had 4 isolation rooms: #7762; #7761, #7759, #7757. Observation revealed that each of these rooms were separate, private rooms with the inability to see patients from one isolation room to the other isolation room. Observation revealed patient #22 was receiving hemodialysis in room #7762; patient #25 was receiving hemodialysis in room #7761; patient #71 was receiving hemodialysis in room #7759 and patient #23 was receiving hemodialysis in room #7757.

Observation in the dialysis unit on 06/18/2010 at 1150 revealed intervals of time when staff was not able to continuously visualize and monitor the patient during dialysis treatment. Observation on 06/18/2010 at 1150 revealed from 1208-1220 (12 minutes) RN #1 left patient #25 dialyzing in room #7761 unattended to provide care for patient #22 dialyzing in room #7762, her other assigned patient. Observation on 06/18/2010 at 1150 revealed from 1235-1259 (24 minutes) RN #2 left patient #23 dialyzing in room #7757 unattended to provide care for patient #71 dialyzing in room #7759, her other assigned patient. Observation revealed staff left one patient's line of sight to provide care to another patient dialyzing in another isolation room.

Review of the 06/18/2010 staff assignment revealed 2 registered nurses were assigned to care for 4 isolation patients. RN #1 was assigned to care for patient #22 (room #7762) and #25 (room #7761) from 0848-1208 (3 hours and 20 minutes), and RN #2 was assigned to care for patients #71 (room #7759) and #23 (room #7757) from 1035-1235 (2 hours).

Interview on 06/18/2010 at 1230 with the dialysis unit Charge Nurse revealed the dialysis unit was staffed on a 2:1 patient/staff ratio. Interview also revealed the hospital opened a new dialysis unit that had private patient isolations rooms and dialysis staff voiced concerns regarding the inability to constantly observe and monitor isolation patients during hemodialysis.

Observation in the dialysis unit on 06/21/2010 at 1249 revealed RN #3 sitting in the ante room outside isolation room #7762 where patient #22 was dialyzing. Observation revealed patient #22 was located on a bed in the room with the patient's vascular access site not visible from where RN #3 was sitting. Observation revealed the patient's access site and blood line connection was positioned out of the nurses line of sight towards the back wall of the isolation room. Observation revealed the patient's bed was in the highest position obstructing RN #3's line of vision of the access and blood line connection.

Interview 06/21/2010 at 1255 with RN #3 monitoring patient #22 revealed staff had been informed late on 06/18/2010 that isolation patients would now be a one patient to one staff assignment. Interview revealed this staff was not aware that the patient's access site and blood line connection had to be continuously visible and monitored by staff.

Interview with the Clinical Operation Director (COD) on 06/22/2010 at 1040 revealed she had concerns regarding the staff's "limited" ability to view and monitor patients continuously during dialysis treatment. Interview revealed patient safety concerns during dialysis treatment included hypotensive episodes, unresponsiveness and needle dislodgement resulting in exsanguination in a matter of minutes. Interview revealed that the nurse may be out of the room as long as 10-25 minutes at any given time based on the needs of the other patient that staff is also responsible for. Interview revealed patient dialysis treatments were started in the new unit on 10/31/2005 without implementation of safety measures to assure patients were continuously observed and monitored by staff during hemodialysis treatment.

2. Review of the hospital's "Insulin Therapy Management in Hospitalized Adult Protocol" effective 10/1998, last revised 9/2008, "Hypoglycemia-BG )<70 mg/dl or >70 mg/dl with symptoms:"..."Follow Hypoglycemia Treatment Algorithm"..."give 1/2 cup fruit juice or 1/2 cup regular soft drink and call provider...Repeat BG 30 minutes after oral treatment...if BG <70 repeat treatment and call provider."

Open record review for Patient #24 revealed a 54 year old male admitted on 06/02/2010 with complaints of back pain who had a medical history that included end stage renal disease secondary to insulin dependent diabetes mellitis. Record review revealed a physicians order dated on 06/14/2010 that directed staff to obtain the patient's blood glucose (BG) every two hours. Record review revealed on 06/21/2010 this patient received hemodialysis from 0800-1212 and returned from dialysis to the 8300 unit at 1330. Record review revealed the RN #4 responsible for this patient in the dialysis unit on 06/21/2010 obtained BG as ordered at 0850, 1105 and 1300. Record review revealed the following results for the patient's BG while in dialysis: 0850=110; 1105=103; 1300=57. Record review revealed this patient experienced a hypoglycemic event on 06/21/2010 at 1300.

Interview on 06/21/2010 at 1515 with the Nurse Manager of the 8300 unit revealed the patient's BG result of 57 warranted initiation of the hospital's "hypoglycemic" protocol for patient #24 while in the dialysis unit.

Record review revealed no documented evidence that indicated the dialysis RN notified the physician or assessed/reassessed this patient's hypoglycemic status on 06/21/2010.

3. Open record review for Patient #22 revealed this 53 year old male had been admitted from the emergency department on 06/11/2010 to rule out cerebral vascular accident after becoming "somnolent" in the out patient dialysis facility parking lot post dialysis treatment. Record review revealed the following medical history: renal failure, myocardial infarction (2002, 2005, 2008); diabetes mellitis; congestive heart failure; hypertension; depression; gout; peripheral neuropathy, left foot transmetatarsal amputation. Record review revealed this patient had been seen by a physician on an outpatient basis for a possible left lower leg amputation secondary to osteomyelitis which caused a chronic ulcer on left foot stump.

Record review revealed this patient had hemodialysis in the dialysis unit on 06/13, 06/14, 06/16, 06/18, 06/19, 06/21 and 06/23/2010. Record review revealed this patient had a physician's order for 1000 unit bolus of heparin (anticoagulant) on 06/22/2010 for his dialysis treatment that was scheduled for 06/23/2010. Medical record review revealed this patient did not receive the 1000 unit bolus dose of heparin in dialysis on 06/23/2010 as ordered.

Interview on 06/23/2010 at 1450 with the dialysis Charge Nurse revealed the heparin had not been administered to the patient as ordered because the patient was already receiving a "heparin drip on the floor". Interview revealed staff had not contacted the physician to clarify the need for the additional heparin during dialysis on 06/23/2010. Interview revealed staff should have contacted the physician to clarify or verify the need for the additional heparin.

4. Review of hospital policy "Patient Transport Policy" review/revision 01/29/2010, revealed "Licensed or unlicensed personnel may transport the patient only after the patient's clinical information has been reviewed for appropriateness of safe travel and the inpatient RN has verified the mode of travel and equipment needs"..."This is part of the hand-off process"...Transporter provides care RN with TTR (ticket to ride) for completion and insures nurse prepared patient for transport...Care RN completes unshaded boxes on the TTR and prints name legibly on the TTR after determination that transporter can safely accompany patient without medical personnel and that it is safe for patient to be transported off unit/department by vehicle of transportation brought by transporter"...

Observation in the dialysis unit on 06/18/2010 at 1320 revealed patient #77 a thin, frail appearing male with bilateral above the knee amputations was leaving dialysis treatment transported via wheel chair by a transporter. Observation revealed the patient was seated in the wheelchair with his arms by his torso and upper body leaning forward away from the back of the wheelchair. Observation revealed as staff #13, the transporter, wheeled the patient from the dialysis unit, the patient's head flung back and the patient's torso rapidly moved back against the back support of the wheelchair. The patient was observed to have poor balance control while sitting in the wheelchair. Observation revealed the patient had not been secured in the wheel chair prior to transport.

Open record review on 06/23/2010 of Patient #77 revealed a 65 year-old male that presented to the dialysis unit on 06/18/2010 for dialysis treatment prior to outpatient surgery to amputate his right index finger. Review of the medical record revealed a past medical history that included: bilateral above the knee (AKA) amputations, cardiomyopathy; current left AKA wound, right index finger wound and sacral decubitis. Medical record review revealed this patient had been assessed in pre op on 06/15/2010 as a high risk for falls.

Medical record review for patient #77 revealed dialysis was provided on 06/18/2010 from 0837-1220, report was given to charge nurse (in OR) and a transporter would be sent by OR to transport patient to surgery.

Review of the 06/18/2010 TTR for patient #77 from dialysis revealed the nurse assessed this patient as high risk for falls but the mode of travel had been left blank.

Interview on 06/24/2010 at 1030 with staff #13 (the transporter that transported this patient from dialysis on 06/18/2010) revealed he was aware that patient #77 was a bilateral above the knee amputee, and transported the patient to the OR without securing the patient in the wheelchair. Interview revealed the transporter used a wheelchair from the OR inventory that did not have a seatbelt attached or a means of securing the patient in the wheelchair. Interview revealed the nurse had not directed the transporter to secure the patient into the wheelchair.

Interview on 06/24/2010 at 1055 with the dialysis RN #1 responsible for patient #77 on 06/18/2010 revealed she was aware that he was a high risk for falls, but did not direct the transporter to secure the patient in the wheelchair.



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5. Review of the "Falls Prevention Protocol" effective July 1998, reviewed March 2010 revealed "Assessments on inpatients will be performed by the RN (registered nurse) using the (hospital) Fall Assessment Tool. Based on the assessment, the RN will initiate the Fall Plan of Care when the patient is determined to be at high risk for falls." Review of the hospital's "Fall Assessment Tool (Adult)" revealed an assessment for "Fall in the Last 12 mos (months) (ask only on admission)" with a box to check "yes" or "no." The assessment tool states "Any yes or Hx (history) of fall in the last 12 mos=HIGH RISK, need falls POC (plan of care)." Further review of the policy revealed "When a patient is determined to be at high risk for falls based on the (Hospital) Fall Assessment Tool, initiate the pre-printed 'Plan of Care: Fall Prevention.' Interventions include: a. Communication of high risk status for falls to all (hospital) staff: Place Falls armband on patient. Place Falling Star label near the patient's name outside the room and on the name board at the main desk. Have patient wear YELLOW Fall Risk slippers....Documentation: (Hospital) Falls Assessment Tool to be completed: a. upon admission (on flowsheet). b. every shift (on flowsheet)...."

Open record review on 06/16/2010 and 06/21/2010 of Patient #50 revealed a 63 year-old female admitted 06/13/2010 for further evaluation and treatment of Myasthenia Gravis, weakness and urinary tract infection. Review of the physician's admission history and physical dated 06/13/2010 revealed the patient was transferred from another hospital for increased weakness and was hypotensive (low blood pressure) in the emergency department. Physician's notes recorded "She has had several falls over the last few months secondary to L>R (left greater than right) weakness most recently about a month ago falling on her right side...." Further review revealed "Ant R (anterior right) rib pain - likely musc (muscular) in nature given recent falls. Check rib imaging to r.o fx (rule out fracture)." Review of the nursing admission flowsheet dated 06/13/2010 revealed the section on the "Fall Assessment Tool" for "Fall in the last 12 mos" was blank. Review of the "Fall Assessment Tool" for "Fall in the last 12 mos" dated 06/14/2010, 06/15/2010, 06/16/2010, 06/17/2010, 06/18/2010, 06/19/2010 and 06/20/2010 revealed the assessment was documented each shift (once during a 12 hour shift). Review of the "Fall Assessment Tool" for these dates revealed the patient's history of falls was blank or recorded "no" falls. Review of the patient's care plan dated 06/14/2010 at 0900 revealed a pre-printed "Falls Prevention Plan of Care." Review of the interventions recorded "1. Communication of High Risk for falls includes: Place falls armband on patient. Place Falls falling star label on patient's name card at/near patient's room..."

Observation of Patient #50 on 06/16/2010 at 1520 revealed the patient was in bed in the hallway outside her room and a transporter (staff #11) was taking the patient to radiology. Observation revealed the patient did not have a yellow armband in place and there was no falling star outside the room indicating the patient was identified as high risk for falls.

Interview on 06/22/2010 at 1345 with administrative nursing staff revealed the patient was assessed for falls every shift. The staff member reviewed the patient's medical record and revealed that nursing staff failed to identify the patient's history of falls on the recorded assessments (2 times a day for 9 days) and failed to place the patient on high risk falls precautions. Interview revealed the patient should have a yellow armband on and a falling star outside the door to communicate to all staff that the patient was identified as high risk for falls. Interview confirmed that the nursing staff failed to follow the hospital policy for falls prevention by failing to identify the patient was high risk and failing to put safety interventions in place to prevent falls.

6. Open record review on 06/16/2010 and 06/21/2010 of Patient #50 revealed a 63 year-old female admitted 06/13/2010 for further evaluation and treatment of Myasthenia Gravis, weakness, dysarthria (motor speech disorder, difficult to understand due to muscle weakness) and dysphagia (difficulty swallowing). Review of physician's orders dated 06/13/2010 at 2306 revealed an order to "Measure weight on admission." Further review revealed a physician's order dated 06/13/2010 at 2306 to "Measure weight every other day." Review of the patient's record revealed the patient's weight was recorded as 61.8 Kg (kilograms) on 06/14/2010 at 1400. Record review revealed the patient's weight was recorded as 66.2 Kg on 06/21/2010 (not timed). Further record review revealed no further documentation of the patient's weight.

Interview on 06/22/2010 at 1345 with a nursing administrative staff member revealed there were no further weights done. Interview confirmed the physician had ordered patient weights to be measured on admission and every other day. Interview confirmed the patient was weighed on 06/14/2010 and 06/21/2010 (7 days since prior weight obtained). The interview revealed nursing staff failed to follow the physician's order for obtaining weights.



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7. Review of hospital policy "Pain Management Protocol for Adult and Pediatric Patients", effective 2000 revealed "A. Frequency...6. Reassessment:...4) Within 1 hour following any intervention ( i.e. scheduled or prn analgesia medication, change in treatment plan, or non-pharmacological action)...B. Reassessment: 1) Within 1 hour after a pain intervention (pharmacological and/or non-pharmacological) or patient is not satisfied with pain management".

Closed medical record review of Patient #16 revealed the patient was admitted on 01/29/2010 and expired on 03/16/2010. Record review revealed the patient was admitted with Clinical Stage III esophagus cancer with a Tracheo-esophageal fistula requiring surgery. Record review revealed a physician's order on 02/08/2010 for Dilaudid (narcotic pain medication) 2 - 4 mg via tube every 4 hours as needed for pain and for pain greater than 6 /10 (numeric pain scale with 10 being the severe level of pain) give 4 mg. Record review revealed on the Medication Administration Record (MAR) on 02/07/2010 documentation the patient was administered Dilaudid 4mg at 0940 and an undocumented amount at 1600. Record review revealed no documentation a reassessment of the patient after the interventions. Record review revealed on the Medication Administration Record (MAR) on 02/08/2010 documentation the patient was administered Dilaudid 4mg at 0300 and at 1835. Record review revealed no documentation a reassessment of the patient after the interventions.

Interview with administrative staff on 06/24/2010 at 1630 revealed there was no documentation available of reassessments of the patient's pain after the administration of medication for 02/07/2010 at 0940 and 1600 and 02/08/2010 at 0300 and 1835.

Based on policy review, medical record review and staff interview the hospital's nursing staff failed to administer medication in accordance with a physician's order and per accepted standards of practice as evidenced by: failing to obtain a physician's order prior to administering medication for 2 of 2 outpatient pain clinic patients (#48, 49); failing to administer medication per the physician's order in 1 of 10 surgery inpatients (#16); and failing to protect a patient from a known allergen in 1 of 10 surgery inpatients (#17) .

The findings include:

Review of the hospital's policy, "Administering Medications to Patients in Clinics", effective 01/2000, revealed "... Policy or Procedure 1. Medications administered to patients in the clinics must be ordered by a physician, Nurse Practitioner or Physician's Assistant...Order is documented either on a Clinic Encounter Form, an All Purpose Form or doctor's order sheet. The elements of a complete medication order are: Medication name, Medication dose, Medication route, Medication frequency and Provider Signature...".

Review of the hospital's policy, "Medication Order Writing and Processing", effective 03/2007, revealed "...B. Procedures...2. A complete medication order includes all of the following elements. ...a. Patient Name and History Number (can be accomplished with addressograph plate)...7. The prescriber will include date, time, signature (first initial, last name) and title...".

Review of the hospital's policy, "Assessment of Patients Procedures", effective 04/2007, revealed "All patients in any setting are initially assessed by a member of the medical staff who possesses the appropriate clinical privileges. Designated physician extenders, nurse practitioners, physician assistants, and others, may participate in the assessment process: the age-appropriate assessment and reassessment process includes the medical and drug history including allergies...The nursing age-appropriate assessment and reassessment includes a health and psychosocial history, allergies...The initial screening of a patient presenting to a hospital based clinic will include: Specialty/focused assessment-allergies".

1. Open record review of Patient #48 revealed a 57 year-old female admitted to the hospital's outpatient pain clinic (Clinic #1) on 06/17/2010 with chronic back pain. Review of a progress note written by a registered nurse 06/17/2010 at 1040 revealed "10mg (milligrams) SL (sublingual) Valium (controlled anti-anxiety drug) given per order...". Record review revealed no documentation of a physician's order to administer the Valium.

Interview on 06/17/2010 at 1130 with a staff registered nurse (RN #6) revealed "we use the Lidocaine infusion protocol for an order". The staff registered nurse showed the surveyor a typed (not dated, not signed) "Lidocaine Infusion Protocol". Review of the form revealed a handwritten addition to the protocol, "Valium 10 mg SL- 30 min prior to starting infusion of Lidocaine". Interview confirmed the form did not contain the patient's name, history number, date, time and signature of the physician. Interview further revealed, "I think I got a verbal order this morning but I did not write it down. Then I told another nurse to give it".

Interview on 06/17/2010 at 1445 with the director of pharmacy for outpatient clinics revealed "this Lidocaine protocol is not an order. An order for a medication should have the patient specific name with date, time and signature of the ordering physician". Interview confirmed the nurse administered Valium without an order.

2. Closed record review of Patient #49 revealed a 58 year-old female admitted to the hospital's outpatient pain clinic (Clinic #1) on 06/16/2010 with chronic back pain. Review of the "Clinic Monitoring Record/Pre-Procedure Record" revealed the nurse administered Valium (controlled anti-anxiety drug) 10 mg (milligrams) sublingually at 1045. Record review revealed no documentation of a physician's order to administer the Valium.

Interview on 06/17/2010 at 1130 with a staff registered nurse (RN #6) revealed "we use the Lidocaine infusion protocol for an order". The staff registered nurse showed the surveyor a typed (not dated, not signed) "Lidocaine Infusion Protocol". Review of the form revealed a handwritten addition to the protocol, "Valium 10 mg SL- 30 min prior to starting infusion of Lidocaine". Interview confirmed the form did not contain the patient's name, history number, date, time and signature of the physician.

Interview on 06/17/2010 at 1445 with the director of pharmacy for outpatient clinics revealed "this Lidocaine protocol is not an order. An order for a medication should have the patient specific name with date, time and signature of the ordering physician". Interview confirmed the nurse administered Valium without an order.



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3. Closed medical record review of Patient # 16 revealed the patient was admitted on 01/29/2010 and expired on 03/16/2010. Record review revealed the patient was admitted with Clinical Stage III esophagus cancer with a Tracheo-esophageal fistula requiring surgery. Record review revealed a physician's order on 02/08/2010 for Dilaudid (narcotic pain medication) 2 - 4 mg via tube every 4 hours as needed for pain and for pain greater than 6 /10 (numeric pain scale with 10 being the severe level of pain) give 4 mg. Record review revealed on the Medication Administration Record (MAR) on 02/08/2010 documentation by nursing the patient was administered Dilaudid at 1600. Record review revealed no documentation of the patient's complaint of pain, rating of pain per the pain scale or the amount administered to the patient.

Interview with administrative nursing staff on 06/25/2010 at 1030 revealed there was no documentation available of an assessment of the patient's complaint of pain and for the rating of pain per the physician's order. The interview revealed the staff did not follow the physician's order.

4. Open medical record review on 06/21/2010 of Patient #17 revealed the patient was admitted on 06/18/2010 with a rectovaginal fistula requiring surgery. Record review revealed hand written documentation on the "Preoperative Patient Checklist" dated 06/15/2010 "Allergic: Betadine". Review of the "General Surgery Posting Form" revealed documentation "Betadine allergy". Record review of the "Perioperative Nursing Plan of Care" dated 06/18/2010, revealed "Allergies Betadine". Record review revealed on the "Universal Preadmission Data" form dated 06/15/2010, allergy to Betadine. Record review revealed on the "Order Conformation report" dated 06/19/2010 documentation "Betadine Drug allergy Rash Severe". Review of all the Medication Administration Records (MAR) revealed documentation of Allergy to Betadine. Review of the Admission orders hand written documentation twice of allergy to Betadine. Review of the preanesthesia evaluation dated 06/18/2010, revealed "Allergies...Betadine rash". Review of the 'Universal Patient discharge instructions" revealed "Allergy Betadine reaction rash Severe reported by self'". Record review revealed on 06/18/2010 documentation on the Perioperative Nursing Plan of Care during the postoperative phase a 4 x 4 Benzoin Op site dressing was applied to the patient's right leg. Review of physician orders revealed an order on 06/19/2010 for "Betadine paint to perineum daily by nursing". Review of the physician's progress notes dated 06/21/2010 documentation "Betadine paint to perineum daily".

Interview with administrative nursing staff on 06/21/2010 at 1330 revealed each physician/staff member is to ask the patient about allergies when completing any assessment requiring allergy information. The staff and physicians are not to copy allergy documentation over from other parts of the medical record. The interview did not reveal why the patient was given a known documented allergen.

Based on the hospital's policy review, hospital's pharmacy activity report review, closed medical record review and staff interview, the hospital failed to ensure accurate records for scheduled drug waste by registered nurses in order to minimize the risks of diversion or actual loss of the drugs (Patients #85, #60)

The findings include:

A review of the hospital's policies and procedures for pharmacy "Automated Dispensing Cabinet Medication Management" (effective date of 02/2010) revealed that "The wasted medication is documented in the automated dispensing cabinet at the time the medication is wasted. The policy also revealed that "if a controlled substance is wasted, another licensed user must witness the wastage."

A review of the hospital's emergency department automated drug dispensing machine activity reports for wasting of controlled substance drugs dated 05/01/2010 through 05/31/2010 revealed a list of controlled substances scheduled drugs that were removed from the automated drug dispensing machine by registered nurses for medication administration. The computerized documentation on the record also revealed the date and times of the removed drugs along with the waste times that were automatically documented when the nursing staff wasted any leftover amounts of the scheduled drugs.

1. A review of the hospital's emergency department automated drug dispensing machine activity reports for wasting of controlled substance drugs revealed that a emergency department registered nurse (RN) removed a controlled substance medication "Dilaudid 2 milligram/1 milliliter tubex" for patient #85 on 05/03/2010 at 1934. The documentation revealed that on 05/04/2010 at 0526 (total of 9 hours and 52 minutes after removed) that the entire "Dilaudid" medication was wasted by the nursing staff with none administered to the patient. The review of the documentation revealed no documentation of where the scheduled drugs waste was kept during from the time of the patient administration to the time that the controlled substance was documented as wasted by the nursing staff.

An interview on 06/18/2010 at 1325 with the hospital's pharmacy director and administrative nursing staff revealed that there is a concern for the long amount of time that the controlled substances are kept out and wasted by the nursing staff. The interview did confirm that the nursing staff needs to waste the medications as soon as possible after removing from the medication machines. The interview revealed that the hospital had not reviewed the waste reports closely for the emergency department. The interview also revealed that no explanation could be given as to why the RN kept the Dilaudid medication out before wasting it over 9 hours. The interview revealed that the RN witnessing the waste, could not be sure what was being wasted.

2. A closed medical record review on 06/18/2010 for patient #60 revealed that the patient presented to the hospital's emergency department on 04/30/2010. The review revealed that the patient was ordered by the emergency department physician at 2303 to receive the medication "Dilaudid 1 milligram" (controlled substance medication) intravenously for pain. Documentation in the medical record review revealed that a hospital emergency department registered nurse (RN) administered the ordered medication on 04/30/2010 at 2316. The documentation in the medical record revealed that the RN administered "Dilaudid 0.5 milligrams" to the patient intravenously over 2 minutes in length.

The review of the hospital's emergency department automated drug dispensing machine activity reports for wasting of controlled substance drugs revealed that the hospital had "Dilaudid 2 milligrams/1 milliliter injectables" kept in the machine for removal by the emergency department staff that needed the medication for patients. The review for 05/01/2010 of the report revealed that the emergency department RN administered Dilaudid 0.5 milligrams to the patient and wasted Dilaudid 1.5 milligrams on 05/01/2010 at 0400 (total of 4 hours and 44 minutes after administering the medication on 04/30/2010 at 2316). The review of the documentation revealed no documentation of where the scheduled drugs waste was kept during from the time of the patient administration to the time that the controlled substance was documented as wasted by the nursing staff.

An interview on 06/18/2010 at 1325 with the hospital's pharmacy director and administrative nursing staff revealed that there is a concern for the long amount of time that the controlled substances are kept out and wasted by the nursing staff. The interview did confirm that the nursing staff needs to waste the medications as soon as possible after removing from the medication machines. The interview revealed that the hospital had not reviewed the waste reports closely for the emergency department.

Based on hospital policy and procedure review, observations during tours, and staff interviews the hospital failed to ensure medications were kept in a secure area and locked when not in use by staff on the 6100, 6300, and 3100 patient care units.

The findings include:

Review of hospital policy "Drug Distribution Medication Order Writing and Processing," Page 3, Effective March 2007, revealed "...II. MEDICATION ORDERS - GUIDELINES FOR PROCESSING ...8. ...All medications should remain in a safe and secure storage area until ready to be directly administered to a patient."

1. Observations during tour of the 6100 Unit on 06/18/2010 at 1000 revealed an Omnicell automated dispensing cabinet (ADC) located at nurse's station A. Observation revealed the ADC was located to the right of a counter top work space. Observation revealed the counter top work space and ADC created a "V" pattern (counter top on the left leg, ADC on the right leg). Observation revealed when standing at the counter top work space the nursing staff does not have a direct line of sight and visualization of the ADC doors or control panel (a blind spot is created). Further observation revealed the door to the upper middle storage cabinet was unsecured and easily opened by the surveyor. Observation revealed the upper middle storage cabinet contained individual medication storage bins. Observation revealed eight (8) bins contained medications for patient use. Observation revealed the shelving units of the unsecured cabinet displayed rapidly flashing green lights (warning). Observation of the touch screen control panel revealed the ADC was currently "logged in" by a staff nurse. Observation revealed the staff nurse who logged into the ADC was located at the counter top work space adjacent to the ADC. Observation revealed when standing in front of the ADC control panel and unsecured cabinet door with the green lights flashing, the staff nurse did not have a direct line of sight and visualization of the ADC. Observation revealed the ADC was not supervised by a licensed/authorized staff member. Observation revealed the staff nurse failed to secure the ADC by "logging out." Further observation during tour revealed nurse's station B. Observation revealed the door to the upper left medication cabinet that contained the patient specific medication bins for rooms 6117 to 6131 was unsecured and easily opened by the surveyor. Observation revealed medications being stored in the individual bins of the cabinet. Observation revealed the ADC was unsupervised by licensed/authorized staff.

Interview during tour of the 6100 Unit on 06/18/2010 at 1000 with nursing management staff revealed the Omnicell (an ADC) is used to store medications for the nursing unit. Interview revealed only licensed nursing staff and pharmacy staff have access to the ADC. Interview revealed the cabinet doors to the Omnicell should be locked and secured at all times when not in use by authorized staff. Interview revealed the staff should always log out of the ADC when not in use and left unattended.

Interview on 06/21/2010 at 1000 with the Associate Chief Pharmacy Officer revealed the Omnicell ADC are new to the facility. Interview revealed the facility started using them in November 2009. Interview revealed the facility has approximately 130. Interview revealed all nursing and pharmacy staff have been trained on proper use of the new ADCs. Interview revealed the doors to the ADC should be kept secured at all times when not in use. Interview revealed the staff should be checking the doors after use to make sure the ADC is secured. Interview revealed the staff should be logging out of the ADCs when not in use or left unattended. Interview revealed all medications should be supervised by licensed/authorized staff and/or kept in a secure location when not in use at all times.

2. Observation during tour of the 6300 Unit on 06/18/2010 at 1000 revealed an Omnicell automated dispensing cabinet (ADC) located at nurse's station #1. Observation revealed the door to the upper right and lower right medication cabinet that contained respiratory medications was unsecured and easily opened by the surveyor. Observation revealed medications being stored in the individual bins of the cabinet. Observation revealed the ADC was unsupervised by licensed/authorized staff.

Interview during tour of the 6300 Unit on 06/18/2010 at 1000 with nursing management staff revealed the Omnicell (an ADC) is used to store medications for the nursing unit. Interview revealed only licensed nursing staff and pharmacy staff have access to the ADC. Interview revealed the cabinet doors to the Omnicell should be locked and secured at all times when not in use by authorized staff. Interview revealed the staff should always log out of the ADC when not in use and left unattended.

Interview on 06/21/2010 at 1000 with the Associate Chief Pharmacy Officer revealed the Omnicell ADC are new to the facility. Interview revealed the facility started using them in November 2009. Interview revealed the facility has approximately 130. Interview revealed all nursing and pharmacy staff have been trained on proper use of the new ADCs. Interview revealed the doors to the ADC should be kept secured at all times when not in use. Interview revealed the staff should be checking the doors after use to make sure the ADC is secured. Interview revealed all medications should be supervised by licensed/authorized staff and/or kept in a secure location when not in use at all times.

3. Observation during tour of the 3100 Unit on 06/16/2010 at 1400 revealed one vial of humulin R insulin being stored on the counter top adjacent to the automated dispensing cabinet (ADC) located at nurse's station #2. Observation revealed the medication was in close proximity and visible from the main hallway used by staff/patients/visitors. Observation revealed unlicensed staff/patients/visitors present in the hallway. Observation revealed the medication was unsecured and unsupervised by authorized licensed staff.

Interview with nursing management staff during tour of the 3100 Unit on 06/16/2010 at 1400 revealed the medication should have been placed back into the ADC. Interview revealed the medication should not have been left unsupervised and unsecured.

Interview on 06/21/2010 at 1000 with the Associate Chief Pharmacy Officer revealed all medications should be supervised by licensed/authorized staff and/or kept in a secure location when not in use at all times.

Based on hospital policy and procedure review, observations during tour, and staff interviews the hospital failed to ensure Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 were kept locked within a secure area on the 4300 unit.

The findings include:

Review of hospital policy "Drug Distribution Medication Order Writing and Processing," Page 3, Effective March 2007, revealed "...II. MEDICATION ORDERS - GUIDELINES FOR PROCESSING ...8. ...All medications should remain in a safe and secure storage area until ready to be directly administered to a patient."

Observation during tour of the 4300 Unit on 06/22/2010 at 1417 revealed two 5 milligram Oxycodone (Schedule II Controlled Substance) tablets in a white paper medication cup stored on top of a yellow isolation cart located in the main hallway outside of patient room 4306. Observation revealed the patient room was located across the hallway from the automated dispensing cabinet (ADC) storage area of the nurse's station. Observation revealed the two oxycodone tablets were left unsupervised and unsecured. Further observation revealed a staff nurse bending over in front of an ADC with her back turned toward the isolation cart removing a medication syringe. Observation revealed the staff nurse was approximately 10 feet from the isolation cart and did not maintain a direct line of sight and constant visualization of the two 5 milligram oxycodone tablets. Observation revealed non licensed staff/visitors/patients in the main hallway.

Interview during tour of the 4300 Unit on 06/22/2010 at 1417 with the staff nurse (RN #7) revealed she had removed the oxycodone and placed it on the isolation cart to don a gown when she realized she needed a "flush." Interview revealed she left the oxycodone on top of the isolation cart and returned to the nurse's station to remove a "flush" from the Omnicell (an ADC). Interview revealed she should not have left the medication unsupervised and unsecured. Interview revealed "It was not a good practice, I was rushed."

Interview during tour of the 4300 Unit on 06/22/2010 at 1417 with nursing management staff revealed once a medication is removed form the ADC it should be taken directly from the nurse's station to the patient. Interview revealed the nurse should have taken the medication with her back to the nurse's station and not left the medication on the isolation cart. Interview confirmed the medication was left unsecured and unsupervised.

Interview on 06/21/2010 at 1000 with the Associate Chief Pharmacy Officer revealed all medications should be supervised by licensed/authorized staff and/or kept in a secure location when not in use at all times.

Based on policy and procedure reviews, observations during tour, and staff interviews the hospital's dietary staff failed to carry out their respective duties in a competent manner to ensure that cookware was stored in a safe and sanitary manner for 9 of 9 pieces of cookware stored on clean storage racks for later use for food preparation.

The findings include:

Review of hospital policy "Manual Pot, Pan, and Tray Sanitation" Policy V3-5-R, Effective July 1, 2001 and Revised 1-2004, revealed "PROCEDURE: ...3. Pots, pans, and trays will be air dried prior to stacking."

Observations during tour of the hospital's main kitchen on 06/17/2010 at 1100 revealed two large multi-shelved storage racks used to store clean and dried cookware for later use to prepare food. Further observation revealed visible clear liquids on the outer and inner surfaces of 9 of 9 sampled metal cookware pans stacked and stored on the two storage racks.

Interview with dietary management staff during tour on 06/17/2010 at 1100 revealed the cookware on the dry storage racks were considered clean and ready for use. Interview confirmed the presence of visible clear liquids on the 9 pieces of metal cookware sampled from the two clean storage racks. Interview revealed the dietary staff are to allow the cookware to completely air dry before being stacked and stored on the clean storage racks. Interview revealed the 9 pieces of metal cookware was not acceptable for food preparation. Interview confirmed the dietary staff failed to follow the hospital's policy and procedures.

Based on hospital policy and procedure reviews, staff interviews, observations during tours and observations as referenced in the Life Safety Report of Survey completed June 22, 2010, the hospital staff failed to develop and maintain the facilities in a manner to ensure the health and safety of patients, staff, and visitors.

The findings include:

1. The hospital failed to develop and maintain the facilities in a manner to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association (NFPA).

~cross-refer to 482.41(a) Physical Environment: Maintenance of Physical Plant - Standard Tag A0701

2. The hospital failed to ensure the essential electrical system was maintained to provide emergency power and lighting to critical and appropriate areas of the hospital during outages of normal power.

~cross-refer to 482.41(a)(1) Physical Environment: Emergency Power and Lighting - Standard Tag A0702

3. The hospital failed to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association assuring the safety and well being of patients.

~cross-refer to 482.41(b)(1)(2)(3) Physical Environment: Life Safety from Fire - Standard Tag A0710

4. The hospital failed to ensure emergency lighting was provided at all exit discharges and fixtures are properly connected to the Essential (emergency) Electrical System.

~cross-refer to 482.41(b)(4) Physical Environment: Emergency Lighting/Batteries - Standard Tag A0711

5. The hospital failed to discontinue the usage of roller latches on the 4th floor electroconvulsive therapy (ECT) unit.

~cross-refer to 482.41(b)(5) Physical Environment: Roller Latches Prohibited - Standard Tag A0712

6. The hospital failed to ensure staff were familiar with procedures for special locking arrangement release devices and emergency air handler shutdown switches.

~cross-refer to 482.41(b)(7) Physical Environment: Fire Control Plans - Standard Tag A0714

7. The hospital failed to conform with the Firefighter's Service Requirements of ASME/ANSI A17.3, Safety Code for Existing Elevators and Escalators 19.5.3, 9.4.3.2.

~cross-refer to 482.41(b)(8) Physical Environment: Regular Fire and Safety Inspections - Standard Tag A0715

8. The hospital failed to ensure the emergency defibrillator/crash carts for the 3300 Unit, Outpatient Clinic #3, Outpatient Clinic #4 and the blood glucose control solutions for Unit 3100, were maintained at an acceptable level of safety and quality.

~cross-refer to 482.41(c)(2) Physical Environment: Facilities, Supplies, Equipment Maintenance - Standard Tag A0724

9. The hospital failed to maintain and provide a multi-use outpatient clinic with adequate heart monitors to monitor a patient during treatment (Clinic #2).

~cross-refer to 482.41(c)(3) Physical Environment: Complexity of Facilities - Standard Tag A0725

10. The hospital failed to ensure emergency air handler shutdown switches were installed, identified, and functioned properly in buildings 02 and 06 and the relative humidity was maintained and documented in the fifth floor operating rooms 1-3 of building 02.

~cross-refer to 482.41(c)(4) Physical Environment: Ventilation, Light, Temperature Control - Standard Tag A0726

Based on observations as referenced in the Life Safety Report of Survey completed June 22, 2010, the hospital staff failed to ensure the safety and well-being of patients by failing to maintain the facility in a manner to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association (NFPA).

The findings include:

Building 02:
1. Based on observations, on June 16, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Lack of exit directional sign in corridor area in front of dust barrier - construction zone near room 5541.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 022

2. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Oxygen cylinders free standing on the floor of room 9000A. There were no carts, bases or other secure device to support cylinders.

b. There were unsecured oxygen bottles at the entry to main operating rooms located on third floor.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 076

3. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include: full and empty oxygen cylinders were stored together without signage. If stored within the same enclosure, empty cylinders shall be segregated and designated (with signage) from full cylinders. Empty cylinders shall be marked to avoid confusion and delay if a full cylinder is needed hurriedly [NFPA 99 4-3.5.2.2b(2)] (6300 unit, 6214A, and radiology & main diagnostics).

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 076

4. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Medical gas piping is not labeled in 9100 DDS shaft.

b. Lack of a canopy or other enclosure to protect nitrous oxide bank from extremes of weather.

c. Unsecured oxygen cylinders in room 0063 - near loading dock.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 077

5. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Medical gas piping is not labeled in 6100 shaft, across from room 6131, at nurses station.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 077

6. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Electrical junction box knockout was not equipped with a knockout plug - lighting circuit adjacent to Helicopter pad exit.

b. The pyxis machine was not verified as being on the emergency circuit at the Short Stay nurses station

c. There was an open electrical junction box above the cross corridor doors near room 7505.

d. There was an open electrical junction box above ceiling tile and near the exit sign at room 7461.

e. There was an open electrical junction box in the mechanical room 1818.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 147

7. Based on observations, on June 16, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. There is no protective bushing between fixture wires and electrical junction box - wall mounted light fixture located in patient room 5717.

b. There is a multi outlet power tap used in patient care area - room 5509.

c. Medication refrigerator is wired to a branch circuit protected by a twenty amp overcurrent protection device - manufacturer's specifications require a maximum fifteen amp overcurrent protection device. Medication preparation area located near room 5327, and other similar spaces throughout North Building.

d. Electrical circuit supplying the medication refrigerator, referenced in item(c) above, is not identified in the critical branch panel board of the Essential Electrical System.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 077

Building 03
8. Based on observations, on June 18, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Exit discharge is incomplete to the publicway - lack of solid, slip-resistant surface other than soil and grass (beside stair #4).

b. Incomplete electromagnetic locking arrangement installation at stair near registration desk #2, exit access door from roof area courtyard, and exit discharge near room #142. System as installed fails to comply with delayed egress locking as defined in the Life Safety Code or special locking arrangements as defined in the NC State Building Code.

c. Exit sign posted over door to fitness room near room #1418 - the referenced door is exit access from the room, not egress through the room from the corridor area.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 032

Building 05
9. Based on observations, on June 18, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Lack of more than a single bulb fixture at required exit discharges.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 045

10. Based on observations, on June 18, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Visual indicator is not functioning on automatic transfer switch.

b. Exposed bulb incandescent fixtures used above storage areas in basement.

c. Standing water in front of electrical switchgear in the basement level - equipment is not listed for wet locations.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 147

Building 06
11. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Exit discharges from stairways are equipped with single fixtures.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 045

12. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following item was noncompliant, specific finding include:

a. Dry-pipe sprinkler system alarm valve is closed with no means provided for monitoring the valve (valve & fire pump room at North Pavilion).

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 061

13. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Sprinkler system gauges upstream and downstream of the sprinkler fire pump are not listed for fire protection service (North Pavilion, main sprinkler valve room).

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 062

14. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following item was noncompliant, specific finding include:

a. Chain link fence, enclosure gate, is not secured against access by other than ambulatory health care center staff (liquid oxygen tank area - located near loading dock area).

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 076

15. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Receptacles supplying power to the heaters in the main sprinkler hot box are not identified as emergency power receptacles - receptacles were verified by hospital staff as connected to normal power distribution system.

b. Forty-two pole electrical panelboard is equipped with a twenty-seven pole circuit directory - all devices are not identified in panelboard LH2 (located in room 2015).

c. Panelboard LSP2 - circuit directory is not completely labeled to show devices served.

d. Panelboard located in generator set enclosure - circuit directory is not completely labeled to show devices served.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 147

Building 07
16. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following item was noncompliant, specific finding include:

a. Unsecured oxygen cylinders in room 154ST.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 076

Based on observations as referenced in the Life Safety Report of Survey completed June 22, 2010 the hospital staff failed to assure the safety of patients, staff, and visitors by failing to ensure the essential electrical system was maintained to provide emergency power and lighting to critical and appropriate areas of the hospital during outages of normal power.

The findings include:

Building 02
1. Based on observations, on June 16, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Medication refrigerator is not connected to a critical branch circuit - medication room located near room 5222B.

b. Means of egress lighting in the PACU area can be switched off by wall-mounted snap switches. Means of egress lighting connected to the Life Safety Branch of the essential electrical system must not be switched from wall switches within the means of egress.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 145

Building 06
2. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Duplex receptacle providing power to heaters in sprinkler valve box is not connected to the critical branch of the essential electrical system (located beside emergency generator - North Pavilion).

b. There is no unitary light with battery backup located at the generator set.

c. There are no lights identified as connected to the essential electrical system - generator set location.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 106

3. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Circuit supplying power to the main fire alarm control panel could not be verified as connected to the Life Safety Branch panelboard of the essential electrical system (Panelboard ERT, circuit #2, in North Pavilion).

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 145

Based on observations as referenced in the Life Safety report of survey completed June 22, 2010, the hospital staff failed to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association assuring the safety and well being of patients.

The findings include:

Building 01
1. Based on observations, on June 17, 2010 at approximately 1:20 P.M. onward, a standard lockset is provided on cross corridor door opening in the following area:

a. G-1 neurology area near room 15(1640A)

Door locking arrangement is locked against egress with no means for unlocking the door - this constitutes an immediate jeopardy condition, the team. leader for the health survey was notified at approximately 1:30 P.M. and hospital administration was notified at approximately 3:10 P.M. of the immediate jeopardy condition. The immediate jeopardy was abated at approximately 1:40 P.M. by complete removal of deficient locking device.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 032

2. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following item was noncompliant, specific findings include:

a. There was an unsealed penetration in the smoke wall above the cross corridor doors at the separation of G1 and FI near room 1692.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 025

3. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include exit sign from 2J to 2K to the exit had an arrow in the incorrect direction.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 047

Building 02
4. Based on observations, on June 17, 2010 at approximately 1:20 P.M. onward, incomplete electromagnetic locking arrangements are provided in cross corridor door openings in the following areas:

a. First floor Children's Health Center near room 1902.

b. Fifth floor corridor from Children's Health Center to PACU corridor near room 5817.

Door locking arrangements are not equipped with required switching arrangements and did not release during activation of the fire alarm system at approximately 1:20 P.M. - this constitutes an immediate jeopardy condition, the team leader for the health survey was notified at approximately 1:30 P.M. and hospital administration was notified at approximately 3:10 P.M. of the immediate jeopardy condition. The immediate jeopardy for all referenced locks was abated at approximately 1:40 P.M., and 2:00 P.M. by complete removal of deficient electromagnetic locking devices.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 032

5. Based on observations, on June 16, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Incomplete delayed egress lock in the ED -Main exit - lock will rearm with card swipe after initiation of irreversible process. This action will cause excessive delay in exiting facility if action is done prior to complete removal of all occupants in an emergency.

b. Dead-end corridor greater than thirty feet in area near room 5271A.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 032

6. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. The door to room 9106 and 9262 and throughout the facility had keyed dead bolts, located above 48" (inches) above the finished floor, and a separate positive latching device that did not open with a single range of motion (north tower).

b. The door to room 4920 and 4921 had keyed dead bolts, located above 48" above the finished floor, and a separate positive latching device that did not open with a single range of motion (4th floor Childrens Hospital).

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 018

7. Based on observations, on June 16, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

c. Exit access door, from pediatric intensive care unit, is not equipped with positive latching hardware - door 5408.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 018

8. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Non-rated vision panel or door protecting light closet near 9200 nurse's station.

Note: the building is not equipped with a complete automatic sprinkler system

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 019

9. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Lack of complete fire damper installation for mechanical duct penetrating ninth floor mechanical chase in central core shaft. There were no visible steel support angles and breakaway connection from the inside of shaft.

b. Lack of self-closing and latching fire door for mechanical chase near Unit 7200 corridor and fire alarm control panel.

c. Unsealed penetrations in one hour shaft wall at room 5636.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 020

10. Based on observations, on June 16, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Unsealed conduit penetration in mechanical chase located in room 5262M.

b. Unsealed conduit penetration in DDS shaft behind tube station - third floor operating room entrance.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 020

11. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Wall penetration in the 8000B vertical chase.

b. Latching hardware missing in the vertical chase door near AHU 7-3, next to stairwell 13.

c. Latching hardware missing in the vertical chase door near 8403E electrical room 8th floor interstitial space.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 020

12. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Smoke barrier, located above ceiling, in room 7602A is not complete to the underside of deck.

b. There was an unsealed penetration in room number 9143 at an unused conduit on the smoke wall.

c. There was an unsealed penetration in the ceiling above the cross corridor doors near room 7131.

d. There was an unsealed penetration in the smoke wall above the ceiling between rooms 7316 and 7315.

e. There was an unsealed penetration in the ceiling above door near room 7505.

f.. There was an unsealed penetration above the ceiling tile above cross corridor doors near room 7459 .

g. There was an unsealed penetration in the smoke wall above the ceiling tile near room 6223.

h. There was an unsealed penetration in the smoke wall in room 6214A above the ceiling tile at the acid waste vent piping.

i. There was an unsealed penetration in the smoke wall above the ceiling tile near room 4120.

j. There was an unsealed penetration in the smoke wall above the ceiling tile near room 2350.

k. There was an unsealed penetration in the smoke wall in the interstitial area near air handling unit number 8.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 025

13. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Door 100619 between zone 5 and zone 6 in the 8th floor interstitial space did not form a smoke tight seal when closed.

b. Electrical room wall above panel EMC 68, in room 6402E interstitial space, had a penetration the smoke wall that was not sealed in order to maintain the required fire resistance rating of the smoke barrier.

c. Half door, near door 10260, in the 6th floor interstitial space did not properly close to form a smoke tight seal.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 025

14. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following item was noncompliant, specific findings include:

a. Smoke door in radiology, near room 1547, did not have an astrigal and was not smoke tight.

b. The fire door on the fourth floor interstitial area near stairwell number 5 had a gap greater than 1/8 of an inch.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 027

15. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Fire door to room 9221 (clean utility) is tied in the open position.

b. Room 7603 is used as a storage room with less than forty-five minute door and listed hardware. The room is greater than one hundred square feet area.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 029

16. Based on observations, on June 16, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Lack of fire dampers for duct penetrations of large respiratory storage room 5000C.

b. Lack of one hour fire resistive enclosure for large sterile core supply room - room 3557.

c. Lack of one hour fire resistive enclosure for induction room #18, and #25 - rooms are used for storage.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 029

17. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include after activation of the facility fire alarm system the 3rd floor fire curtain did not retract with object placed under door.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 033

18. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Excessive latching hardware on door to room 9106 - latch is located greater than forty-eight inches above the finished floor level. Door hardware should not require greater than a single motion of the hand to release door latch.

b. Incomplete electromagnetic locking arrangement on access door to purchasing, and receiving department. There is no release switch adjacent to door, and master release switch located at a supervised station.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 038

19. Based on observations, on June 16, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Required eight feet corridor, as originally constructed, is reduced to six feet width in area of construction zone near room 5541.

b. Stair S055 is identified as a required exit - corridor width leading to stairway door is much less than eight feet in width.

Note: The 1967 New Life Safety Code required a minimum eight feet corridor width in Hospitals - the level of Life Safety may not be reduced below this requirement or NC Building Code requirements.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 039

20. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. There was not an exit sign in the MRI hallway near the radiology patient waiting room
(looking from the reception desk).

b. There was not an exit sign in the exit discharge from radiology toward the front entrance of the hospital.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 047

21. Based on observations, on June 17, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. There was not an exit sign in the exit area located near room 5817 and cross corridor fire doors.

b. There was not an exit sign in the exit area near cross corridor fire doors and fifth floor stairway in Children's Health Center.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 047

22. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Lack of sprinkler inside shower stall - located in room 9254T.

b. Lack of sprinkler coverage for space beside nurse's station - across hall from room 9331.

c. Lack of sprinkler in room 7614E.

d. Lack of sprinkler coverage for shower stall 5535, and 5534.

e. Walk-in coolers and freezers are not equipped with sprinklers (kitchen area).

f. Lack of sprinklers in blood gas room - located near room 3511 and operating room #16.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 056

23. Based on observations, on June 16, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Sprinkler tamper switch would not sound an audible alarm during test - hospital pump house #1-1008715-16.

b. Sprinkler tamper switch would not sound an audible alarm during test - helipad room #1008785-30.

c. Sprinkler system post indicator valve, located near front entrance, did not activate an audible signal during test.

d. Tamper switch audible signals can be permanently silenced - switches can use an intermittent signal (all switches that produced a sound with the valves closed).

e. Sprinkler valve upstream of sprinkler pressure switch is not electrically supervised - stair #23.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 061

24. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Sprinkler is obstructed by suspended ceiling signage - corridor area near room 7459.

b. Main sprinkler valves, located in outside hot box, are wrapped with heat tape - NFPA 13 sprinkler systems must be provided with a heat source other than heat tape; and capable of maintaining a minimum forty degree temperature inside enclosure (entrance to Children's Health Center).

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 062

25. Based on observations, on June 16, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Sprinkler in storage room is obstructed by solid wood shelves - located across corridor from room 5830.

b. Sprinklers in storage closets 5200C, and 5200D are obstructed by solid wood shelves.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 062

26. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Corridor impediments near room 9205 - computers on wheels, and soiled linen carts were left unattended and were not in immediate and continuous use.

b. Pedestal sign located in required means of egress near Unit 71 entrance area.

c. Unattended equipment in corridor area between rooms 7302, and 7303.

d. Equipment unattended in corridor area near Cath Lab #1 - 7434.

e. Bulk supplies are impeding exit discharge at basement level - near loading dock.

f. Corridor obstructed by dry wall compound, carts, and other construction supplies in area near room 5406.

g. Furniture stored in corridor area - in front of ICN waiting area (fifth floor).

h. Impediments in the means of egress near stair S073.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 072

27. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Cabinet and sink doors on the 9100, 9300, 6300 units swing into the corridor without a listed closure and the door does not swing 180 degrees but leaves a projection of approximately 12" into the corridor. NFPA 7.2.1.4.4 states during its swing, any door in a means of egress shall leave not less than one-half of the required width of an aisle, corridor, or landing unobstructed and shall not project more than 7 in. (17.8 cm) into the required width of an aisle, corridor, passageway, or landing, when fully open.

b. Wall mounted chart holders on the 6100 unit did not fully retract.

c. Door 1420 to storage room was not equipped with a listed closure device.

d. Corridor impediments in the 1400 exit at Radiology- six large cameras, trash can and other storage items were left unattended and were not in immediate and continuous use.

e. Corridor impediments in the round hallway 8th floor near the four bank and the transport elevators. On Tuesday at 1500 hours there was 2 dirty beds, 2 clean beds & a clean cart. On Thursday at 1100 hours there was 2 dirty beds, 1 dirty storage & a large materials cart.

f. Corridor impediments in the loading dock hallway exit, at stair 5, including two tables and four chairs (Childrens hospital).

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 072

Building 03
28. Based on observations, on June 18, 2010 at approximately 8:00 A.M. onward, the following item is noncompliant, specific finding include:

a. The use of an area beneath the stairway as a storage room - stair enclosures may not be used as hazardous area enclosures.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 029

Building 05
29. Based on observations, on June 18, 2010 at approximately 8:00 A.M. onward, the following item is noncompliant, specific finding include:

a. Lack of one hour enclosure or sprinklers for storage room #130.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 029

Building 06
30. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Unsealed holes in smoke barrier located adjacent to room 2008 (consult #2) - located above corridor ceiling in ambulatory health care center.

b. Unsealed hole in cross corridor smoke barrier adjacent to room 2123 - located above ceiling in ambulatory health care center.

c. Non-rated vision panel in smoke barrier wall beside preoperative area entrance(ambulatory health care center - near room 2008).

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 025

31. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. There large gaps between meeting edges of smoke barrier doors - preoperative area in ambulatory health care center.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 027

32. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following item was noncompliant, specific finding include:

a. During loss of normal power to the main fire alarm panel, there was no audible trouble signal at the remote fire alarm annunciator panel located in the ambulatory health care center (North Pavilion).

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 051

33. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. There are no smoke detectors located not greater than five feet from both sides of cross corridor smoke barrier in ambulatory health center.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 054

34. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Storage of impediments in stairway #1.

b. Storage of impediments in stairway #2.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 072

Building 07
35. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Unsealed holes in enclosing walls of mechanical room #167.

b. Lack of one hour enclosures or sprinklers for two soiled linen storage rooms.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 029

Building 09
36. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant; specific findings include:

a. Three office spaces are used as storage rooms without sprinkler coverage or one hour rated enclosures.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 029

Based on observations as referenced in the Life Safety Report of Survey completed June 22, 2010 the hospital staff failed to assure the safety of patients, staff, and visitors by failing to ensure emergency lighting was provided at all exit discharges and fixtures are properly connected to the Essential Electrical System.

The findings include:

Building 05
1. Based on observations, on June 18, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Lack of emergency lighting at all exit discharges.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 046

Building 06
2. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Exit discharges from stairways are not equipped with fixtures connected to the Life Safety Branch of the essential electrical system (North Pavilion - exits serving ambulatory health care center).

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 046

Building 07
3. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Lack of emergency lighting provided for the exits and exit discharges - existing lights are wired to switched circuits.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 046

Based on observations as referenced in the Life Safety Report of Survey completed June 22, 2010, the hospital staff failed to develop and maintain the facilities in a manner to ensure the safety of patients as evidenced by failure to discontinue the usage of roller latches on the 4th floor electroconvulsive therapy (ECT) unit.

The findings include:

Building 01
1. Based on observations on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include roller latches were on patient bedroom doors located on the 4th floor ECT Unit.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 018

Based on policy and procedure reviews, staff interviews, and observations as referenced in the Life Safety Report of Survey completed June 22, 2010, the hospital leadership failed to ensure the safety of patients, personnel and guests by failing to ensure staff were familiar with procedures for special locking arrangement release devices and emergency air handler shutdown switches.

The findings include:

Building 02
1. Based on observations, on June 16, and 17, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Staff were not familiar with special locking arrangement release devices in labor/delivery unit (fifth floor).

b. Fire safety policies and procedures manual did not address the use of emergency shutdown switches for air handlers.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 048

2. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include the policy and procedure written plan did not include air handling unit shut down switches.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 048

Based on documentation review and observations as referenced in the Life Safety Report of Survey completed June 22, 2010, the hospital staff failed to conform with the Firefighter's Service Requirements of ASME/ANSI A17.3, Safety Code for Existing Elevators and Escalators 19.5.3, 9.4.3.2. to ensure the safety and well-being of patients, staff, and visitors.

The findings include:

Building 02
1. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include inspections on four elevators are dated 2/20/08 (Children's Hospital).

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 160

Based on policy and procedure review, observation during tours, and staff interviews, the hospital staff failed to ensure the emergency defibrillator/crash carts for the 3300 Unit, Outpatient Clinic #3, Outpatient Clinic #4 and the blood glucose control solutions for Unit 3100, were maintained at an acceptable level of safety and quality.

The findings include:

Review of hospital policy "Defibrillator Functional Checks and Operation Procedure," Effective 02/2008, revealed "...Manual defibrillator functional checks are to be performed as outlined on the 'Defibrillator Operator's Checklist' appropriate to the particular defibrillator every shift the area/location of operation is open. ..."

Review of a "LifePak 20 -- Operator's Checklist" observed to be secured (taped) to the inside bottom of a drawer located on the storage cart for the 3300 Unit defibrillator revealed "...4. Perform 'User Test' a. Unplug the defibrillator from the wall power..."

1. Observation during tour of the 3300 Unit on 06/16/2010 at 1530, revealed an emergency defibrillator being stored on a metal storage cart. Observation revealed a log that documented daily shift checks being maintained. Observation of the log revealed the Charge Nurse (CN) had tested the defibrillator on 06/16/2010 for the day shift. Observation of the CN performing a defibrillator check revealed her testing the defibrillator while still plugged into wall power. Observation revealed the CN failed to unplug the defibrillator from wall power to perform the check according to manufacturer's instructions.

Interview during tour of the 3300 Unit on 06/16/2010 at 1530 with the Charge Nurse (CN) revealed "this is how I normally test the defibrillator." Interview revealed "I was taught to test the defibrillator plugged in." Further interview revealed "I do not know what the policy states." Interview revealed the CN was unaware of the manufacturer's instructions to unplug the defibrillator from the wall power in order to test the device.

Interview during tour of the 3300 Unit on 06/16/2010 at 1530 with nursing management staff revealed the nursing staff should be unplugging the defibrillators from the wall power and testing them on battery power according to the manufacturer's instructions. Interview revealed the CN failed to follow the hospital policy.



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2. Observation on 06/17/2010 at 1115 during tour of outpatient Clinic #3 revealed the crash cart/defibrillator was not checked by the nursing staff on 06/08/2010, 06/09/2010 and 06/10/2010.

Interview on 06/17/2010 at 1120 with administrative staff revealed "the crash cart/defibrillator should be checked every morning prior to seeing patients". Interview confirmed the crash cart was not checked the morning of 06/08/2010, 06/09/2010 and 06/10/2010.

3. Observation on 06/16/2010 at 1430 during tour of the wound clinic in the outpatient unit of the hospital (Clinic #4) revealed the crash cart/defibrillator was not checked by the nursing staff on 06/15/2010 and 06/16/2010.

Interview on 06/16/2010 at 1435 with administrative staff revealed "the crash cart/defibrillator should be checked every morning prior to seeing patients". Interview confirmed the crash cart was not checked the morning of 06/15/2010 and 06/16/2010.

4. Review of hospital policy "Nursing Process Standards Blood Glucose Testing Procedure..." Page 3 of 10, Revised/Reviewed 02/2010, revealed "...The glucose controls expire 90 days after first opening the bottles or the manufacturer's expiration date printed on the label, whichever comes first. When opening a new box of....Controls, record the open date, expiration date, and your initials on each bottle's label."

Observation during tour of the 3100 Unit on 06/16/2010 at 1530 revealed two blood glucose meters available for use stored at nurse's station #2. Observation revealed the glucose meter control solutions were stored in a cabinet above a sink. Observation of the Level 1 and Level 2 control solution bottle(s) revealed each bottle was not dated or labeled when opened.

Interview with nursing management staff during tour of the 3300 Unit on 06/16/2010 at 1530 revealed, the two blood glucose meters stored at nurse's station #2 were available for patient use. Interview revealed the glucose meters required quality control checks every 24 hours. Interview revealed once opened, the quality control solutions are good for 90 days. Interview revealed the staff are suppose to date and label the quality control solutions when they are opened. Interview confirmed the Level #1 and Level #2 quality control solutions being stored in the cabinet at nurse's station #2 were not dated and labeled when opened. Interview revealed the nursing staff was unable to determine if the control solutions had expired after 90 days. Interview revealed the nursing staff failed to follow hospital policy.

Based on observation during tour and staff interview the hospital failed to maintain a multi-use outpatient clinic with adequate heart monitors to monitor a patient during treatment (Clinic #2).

The findings include:

Observation during tour of Clinic #2 on 06/17/2010 at 1130 revealed a physical therapy clinic, speech and audiology clinic, psychology diagnostic laboratory, behavioral physiology laboratory and a pain, memory and movement disorders clinic housed in this outpatient location. Observation during tour of the pain clinic revealed a patient receiving a Lidocaine infusion intravenously. Observation revealed the patient was connected to the heart monitor/defibrillator located on the top of the crash cart.

Interview on 06/17/2010 at 1145 with a staff registered nurse (RN #8) revealed the crash cart being used to monitor the patient was the only crash cart in the facility. Interview further revealed "if we needed the crash cart for another patient, we would have to stop the Lidocaine infusion and remove the patient from the cardiac monitor on top of the crash cart". Interview further revealed "I don't know how long we'd need to monitor the patient if we stopped the Lidocaine".

Interview on 06/17/2010 with administrative clinic staff revealed "the crash cart should not be used to routinely monitor a patient during a procedure. It's the only crash cart in the building".

Interview on 06/17/2010 at 1445 with the director of pharmacy for the outpatient clinics revealed "Lidocaine's action does not stop immediately once the infusion is stopped. Lidocaine has a half-life of 90 to 120 minutes so the patient would need to be on the cardiac monitor after the infusion is complete".

Based on observations as referenced in the Life Safety Report of Survey completed June 22, 2010, the hospital staff failed to ensure emergency air handler shutdown switches were installed, identified, and functioned properly in buildings 02 and 06 and the relative humidity was maintained and documented in the fifth floor operating rooms 1-3 of building 02.

The findings include:

Building 02
1. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. Lack of emergency shutdown switch for air handler serving 9100 unit and beyond.

b. Lack of label to identify air handler shutdown switch located near 7614 nurse's station(children's cath lab).

c. Lack of emergency shutdown switch for air handler serving fifth floor operating rooms 1-3.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 067

2. Based on observations, on June 16, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. Test of air handler shutdown switch would not shut down unit 5-7 in PICU.

b. Lack of an emergency shutdown switch for air handlers serving the pharmacy, and kitchen area.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 067

3. Based on observations, on June 15, 2010 at approximately 11:30 A.M. onward, the following items were noncompliant, specific findings include:

a. No records or backup measuring devices to confirm required relative humidity levels in fifth floor operating rooms 1-3. Room is equipped only with sensing devices connected to an automated system.

Note: Relative humidity was measured with a sling psychrometer and confirmed to be approximately 67%. This exceeds licensure requirement of 60% maximum in NC.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 078

Building 06
4. Based on observations, on June 21, 2010 at approximately 8:00 A.M. onward, the following items were noncompliant, specific findings include:

a. There is no emergency shutdown switch(s) for air handler(s) serving the ambulatory health care center.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 067

Based on hospital policy review, observations, staff interviews, medical record review, and personnel/credential file review, the hospital infection control program failed to have oversight of the prevention and control of infections and communicable diseases as evidenced by failure of staff to adhere to hospital policy standard precautions while providing hands on care to patients during dialysis treatment; ensure staff used personal protective equipment (PPE) and handwashing/sanitization per to policy for 1 of 5 sampled patients on contact isolation precautions (#50); store clean supplies per policy; and ensure 3 of 15 (Personnel/Credential File #1, 2, 3) medical staff members were current with required annual Tuberculosis Skin Testing (TST).

The findings include:

1. Review of the hospital "Infection Control Policy Dialysis Center dated 06/04/2003-revised 07/15/2009 revealed "It is recognized that patients who undergo dialysis are at high risk for the development of infections"..."Gloves are mandatory for all patient care procedures and dialysis machine contact. Gloves are changed and hands washed between patients"..."There is a designated clean area where all handling of clean & unused supplies will occur"...

Observation in the hemodialysis unit on 06/21/2010 at 1242 revealed a gloved RN #4 touched the contaminated equipment at station #6 where a patient was dialyzing. Observation revealed the RN documented on the patients dialysis flow sheet without removing the her contaminated gloves or sanitizing her hands.

Interview with the Clinical Operations Director (COD) of the dialysis unit on 06/21/2010 at 1245 indicated that documenting on the dialysis flow sheet is a clean task (gloves should have been removed and hands sanitized prior to initiation of this task).

Observation in the hemodialysis unit on 06/21/2010 at 1250 revealed RN #4 with only one of her hands gloved, touched the contaminated equipment with the gloved hand at station #6 where a patient was dialyzing. Observation revealed the RN documented on the patient's dialysis flow sheet without removing the her contaminated glove or sanitizing her hands. The RN removed her contaminated glove and obtained clean supplies from the clean supply area without sanitizing her hands.



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2. Review of the Infection Control "Contact Isolation" policy effective June 1, 2008 revealed contact isolation procedures are used in addition to standard precautions for patients "known or suspected to be infected or colonized with epidemiologically important microorganisms that can be transmitted by direct contact with the patient when performing care activities or indirect contact (touching) with environmental surfaces or patient care items." Review revealed "Common infections and conditions requiring contact isolation" included "multi-drug resistant organisms (e.g., MRSA, VRE)." Further policy review revealed staff should "wear gloves when entering the room, during the course of care change gloves after having contact with infective material, remove gloves before leaving patients environment, wash hands immediately or use alcohol gel."..." Patient Transport...Clean gloves can be used to transport patients if handling equipment such as beds, pumps, wheelchairs etc."

Observation during tour of the 4300 unit on 06/16/2010 at 1520 revealed a sign outside Patient #50's room that stated the patient was on contact precautions. Staff were observed in the patient's room with yellow gowns and gloves on. A transporter staff member (staff #11) arrived and was observed to don a gown and gloves before entering the patient's room. The transporter was observed touching the patient and surface items in the patient's room to ready the patient for transport. The transporter staff member was observed to remove the gown and place it in the container inside the patient's room before rolling the stretcher with the patient on it into the hallway. The transporter did not remove the gloves that were donned when the staff member entered the patient's room. The staff member did not wash his hands or sanitize his hands with alcohol gel before leaving the patient's room. The staff member was observed to go to the supply cabinet outside of the patient's room and obtain a clean gown from the cabinet while still wearing the contaminated gloves. The staff member wrapped the patient's medical record in the clean gown while still wearing the contaminated gloves and left the unit transporting the patient on the stretcher. Observation revealed the transporter staff member did not remove the contaminated gloves or wash or sanitize his hands before leaving the patient's room or unit.

Interview on 06/16/2010 at 1520 with administrative staff that were present during the observation revealed "He should have removed his gloves in the patient's room and washed his hands. He did not follow policy and procedure for contact isolation."

Open record review on 06/16/2010 of Patient #50 revealed a 63 year-old female admitted 06/13/2010 for further evaluation of Myasthenia Gravis, weakness and urinary tract infection. Record review revealed a physician's order dated 06/14/2010 at 1146 for contact isolation for rule out VRE and MRSA. Review revealed the patient was placed on contact precautions on 06/14/2010 at 0930.

Interview on 06/18/2010 at 1105 with the transporter staff (staff #11) revealed "I should have removed my gloves before I left the patient's room. I should have left the gloves in the room and washed my hands. It was a mistake."



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3. A review of the hospital's policy under Infection Control "Materials Management" (revised 09/30/2009) revealed "All supplies are stored on shelves that position the goods at least 8 inches from the floor and 18 inches of clearance from the ceiling."

Observation on 06/17/2010 at 1320 during a tour of the hospital's main pharmacy "Oral Hazard Room" revealed that a cardboard box containing filter devices was located directly on the floor. Further observation during the tour at 1325 at the pharmacy's "Sterile Preparation Room" area revealed that a total of four (4) cardboard boxes with supplies were also located directly on the floor. The observation revealed that the cardboard boxes in both areas were not positioned at least 8 inches off of the floor in the hospital's main pharmacy.

An interview during the observation and tour on 06/17/2010 at 1335 with the pharmacy administrative staff revealed that the cardboard boxes should not be placed directly on the floor according to the hospital's policy. The interview revealed that the pharmacy is short of space for supplies and it does get tight sometimes.



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4. A review of the hospital's policy under Infection Control "Materials Management" (revised 09/30/2009) revealed "All supplies are stored on shelves that position the goods at least 8 inches from the floor and 18 inches of clearance from the ceiling."

During tour of the Inpatient Endoscopy and Bronchoscopy unit on 06/21/2010 at 1245 the following clean supplies were observed in the clean supply room on the floor: Four (4) medivac-nonconductive suction tubings, one (1) box of exam gloves, two (2) 30 cc syringes, twenty-one (21) 5 ml syringes, three(3) argyle 40 ml specimen containers, three (3) suction catheters, nineteen (19) three way stopcocks, one (1) arm sling, three (3) paper gowns, six (6) 3 ml syringes, six (6) 10 ml syringes, one (1) pack of powder free exam gloves, one (1) multidose access spike, one (1) micron filter, seven (7) prep kits, three (3) 500 cc bags of Sodium Chloride intravenous solution, two (2) spectraps, one, (1) high pressure extension set, one (1) eclipse needle, oxygen tubing, four (4) Chux pads, two (2) claves stopcocks, two (2) Styrofoam cups, one (1) Tegaderm dressing, one (1) nasal cannula, one (1) oxygen mask and two (2) 60 cc syringes.

Interview during observation with administrative staff and supervisory nursing staff revealed the supplies are available for patient use. The interview revealed the material management staff are responsible for the par levels in the clean supply room. The interview revealed the materials management staff are to ensure the clean supply room does not have supplies on the floor. The interview revealed the state that the clean supply room was observed in was not per the expected hospital's guidelines for clean supply rooms.



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5. Review of the "TUBERCULOSIS CONTROL PLAN (Revision Date 2/2010)" revealed "...IV. Responsibilities...V. TUBERCULIN SKIN TESTING: A. Tuberculin skin testing is used for new employee screening, for periodic employee surveillance, and after potential employee exposures to TB..." Further document review revealed "...J. Annual TB Surveillance Groups 2010: Personnel assigned to work in the following areas...Emergency Department....MD Faculty working in the following specialty groups/programs...Emergency Department, Infectious Diseases, Pulmonary Medicine, Hospitalist..."

Personnel file review of an Emergency Department Physician Assistant (#1) revealed the date of the most current Tuberculin Skin Testing (TST) was 09/12/2008 and was past due on 09/14/2009. Credential file review of the Respiratory Therapy Medical Director (#2) revealed the date of the most current TST was 12/18/2008 and was past due on 12/21/2009. Credential file review of the Infection Control Medical Director (#3) revealed the date of most current TST was 06/02/2008 and past due on 06/04/2009.

Interviews with administrative staff on 06/24/2010 at 1115 revealed attending physicians in Pulmonary, Infectious Diseases, Emergency Departments and Hospitalist must have annual Tuberculin Skin Testing. Interview confirmed that no annual TST had been performed on the above personnel/credential files reviewed (#1, #2, #3).

Based on review of the register of surgical procedures in the Women's Unit and staff interviews the unit failed to maintain a surgical register for surgical procedures performed in Women's unit.

The findings include:

Review of the operating room register on 06/15/2010 did not reveal any surgical procedures performed on the Women's Unit. Interview with administrative operating room staff on 06/15/2010 at 1600 revealed the Women's Unit maintains a register separate from the hospital's North operating room register. The interview revealed scheduled and urgent Cesarean Sections, Tubal ligations, and Hysterectomies are procedures performed in the Women's Unit.

Review of the Women's Unit surgical register on 06/18/2010 revealed only Cesarean Sections listed. Interview with administrative staff on 06/18/2010 at 1445 revealed this register had been "pulled" together for review. The interview revealed the Women's Unit does not maintain a register of the surgeries performed. The interview revealed there was no further documentation available of a register for the surgical procedures performed in the Women's Unit.