HospitalInspections.org

Based on personnel record review, policy review, document review and staff interview, it was determined that service letters were not obtained as required for 1 of 14 hospital employees in the sample (Employee #1). Findings include:

The hospital policy entitled "Conducting a Background Record Check" stated, "...All candidates for employment will be required to undergo the following standard background checks...Delaware State Service Letters to validate previous employment...All information related to pre-employment/employment background investigation shall be retained in the respective personnel files..."

The Department of Labor's Delaware Special Employment Practices for Health Care and Child Care Facilities Regulations stated, "Health care facility" is "any custodial or residential facility where health, nutritional or personal care is provided for persons, including...hospitals...No employer who operates a health care facility...shall hire any person seeking employment...without obtaining one or more service letter(s) for that person..."

A. Employee #1 (date of hire 2/14/05)
Personnel file review revealed documentation that a service letter was requested 1/28/05. However, there was no documentation indicating the receipt of a service letter or of any further attempts to request service letters.

This finding was confirmed with Human Resources Recruitment Manager A on 12/19/12 at 2:18 PM.

Based on personnel record review, policy review, document review and staff interview, it was determined that service letters were not obtained as required for 2 of 2 contracted dietary staff in the sample (Contracted Employee #'s 1 and 2). Findings include:

The hospital document entitled "Management Services Agreement" stated, "...(name of contractor) will comply with all known laws, regulations and standards applicable to its provision of the Management Services...These include, but are not limited to...Delaware Department of Labor...(name of contractor) will provide Bayhealth with all relevant personnel information required by the law..."

The hospital policy entitled "Employee Personnel Files" stated, "...The policy of Bayhealth is to establish a...personnel file on each individual at the time of hire...personnel files will...be maintained on contract employees..."

The hospital policy entitled "Conducting a Background Record Check" stated, "...All candidates for employment will be required to undergo the following standard background checks...Delaware State Service Letters to validate previous employment...All information related to pre-employment/employment background investigation shall be retained in the respective personnel files..."

The Department of Labor's Delaware Special Employment Practices for Health Care and Child Care Facilities Regulations stated, "Health care facility" is "any custodial or residential facility where health, nutritional or personal care is provided for persons, including...hospitals...No employer who operates a health care facility...shall hire any person seeking employment...without obtaining one or more service letter(s) for that person..."

Review of personnel files for Contracted Employee #1 (date of hire 8/4/08) and Contracted Employee #2 (date of hire 8/24/09) revealed no evidence that either the hospital and/or contractor requested service letters from previous employers.

These findings were confirmed with Director of Accreditation Services A on 12/20/12 at 2:22 PM.

Based on observation, policy review and staff interview, it was determined that staff failed to ensure a safe environment for 6 of 6 pediatric unit patients (Patient #'s 4, 49, 50, 51, 52 and 53). Findings include:

The hospital policy entitled "Environment of Care Safety and Security Management Plan" stated, "...Bayhealth identifies safety and security risks associated with the environment of care that could affect patients, staff, and other people coming to the hospital's facilities...takes action to minimize or eliminate identified safety and security risks in the physical environment..."

During a tour of the pediatric unit on 12/13/12 at 9:28 AM with Nurse Manager B, an unlocked cabinet containing multiple pairs of scissors and bottles of glue was discovered in the playroom which was accessible to the 6 current patients and his/her families. Nurse Manager B confirmed this finding and reported that the cabinet was to be locked at all times.

Based on medical record review, policy review and staff interview, it was determined that the medical records for 2 of 6 restrained inpatients (Restrained Patient #'s 3 and 4) in the sample, lacked a written modification to the plan of care addressing the use of restraints. Findings include:

The hospital policy entitled "Restraint and Seclusion" stated, "...Restraint...use will be a part of the patient's plan of care when this intervention is utilized..."

A. Restrained Patient #3

Review of the "Restraint/Seclusion Physician Order Form" revealed staff obtained a verbal order for bilateral wrist restraints (mitts) on 6/17/12 at 3:50 AM to prevent the patient from pulling on/out the nasogastric tube (drainage tube).

Review of the "Restraint/Seclusion Physician Order Form" revealed staff obtained a verbal order for the renewal of mitts on 6/17/12 at 11:15 PM.

Review of the restraint "Flowsheet" documentation revealed that the patient was restrained from 3:00 AM on 6/17/12 until 7:13 PM on 6/18/12.

Review of the "Plan of Care" failed to provide documented evidence to support that the plan of care was modified to include the implementation and use of restraints.

On 12/20/12 at 10:20 AM, Director of Patient Care Services A reviewed the medical record and confirmed that the plan of care had not been modified to reflect the use of restraints, which was the expectation.

B. Restrained Patient #4

Review of "Doctor's Orders" dated 10/26/12 at 2:40 AM, included an order for 2 point restraints for 24 hours - patient on a mechanical ventilator.

Review of the "Restraint/Seclusion Physician Order Form" revealed an order dated 10/27 (no identified year) at 8:40 AM, for the application of soft restraints to the right and left wrist.

Review of the restraint "Flowsheet" documentation revealed:

10/26/12
- 3:30 AM - 5:59 AM: Restrained with soft wrist restraints

10/28/12
- 11:07 AM: Restrained with soft wrist restraints

Review of the "Plan of Care" included an undated entry that referenced a physician order for restraints. However, the "Plan of Care" failed to provide documented evidence to support that the plan of care was modified to include the implementation and use of restraints.

On 12/20/12 at 12:05 PM, Director of Accreditation Services A reviewed the medical record and confirmed this finding.

Based on medical record review, policy review and staff interview, it was determined that staff failed to obtain an order for the use of restraints for 1 of 10 restrained patients (Restrained Patient #4) in the sample. Findings include:

The hospital policy entitled "Restraint and Seclusion" stated, "...physician's verbal order must be co-signed within 24 hours after the initial use of restraint...Should a patient be released in advance of the order expiring, a new order will be required to reapply restraints..."

A. Restrained Patient #4

Review of "Doctor's Orders" dated 10/26/12 at 2:40 AM, included an order for 2 point restraints for 24 hours - patient on a mechanical ventilator.

Review of the "Restraint/Seclusion Physician Order Form" revealed a renewal order dated 10/27 (no identified year) at 8:40 AM, for the application of soft restraints to the right and left wrist.

Review of the restraint "Flowsheet" documentation revealed the following:

10/26/12
- 3:30 AM - 5:59 AM: Restrained with soft wrist restraints

10/27/12
- No restraints used

10/28/12
- 11:07 AM: Restrained with soft wrist restraints

Review of "Doctor's Orders" and other medical record documentation failed to provide evidence to support that staff obtained a new physician's order on 10/28/12 for the re-application of restraints.

Interview with Director of Accreditation Services A on 12/20/12 at 12:30 PM confirmed this finding.

Based on medical record review, policy review and staff interview, it was determined that for 7 of 41 patients in the sample (Patient #'s 3, 4, 5, 6, 8, 10 and 15), nursing staff failed to conduct patient assessments per physician's orders and/or hospital protocol. Findings include:

The hospital policy entitled "24 Hour Chart Check" stated, "...verify that all physician and essential nursing functions/orders are initiated..."

The hospital policy entitled "Flagging of Physician Orders" stated, "...After the physician writes the order...alert the nursing staff...The orders should then be...initiated..."

The hospital document entitled "2012 Plan for the Provision of Patient Care 2N IMC" stated, "...2 North Intermediate Care Unit (IMC)...The RN (registered nurse) or assigned staff will assess the patient every 4 hours or more frequently...Heart rate, blood pressure, respiratory rate and urine output will be recorded with each assessment..."

The hospital policy entitled "Pain Management" stated, "...A pain score of 4 or above...requires intervention...Pain will be assessed/reassessed as follows: On admission...with any new report of pain...following any pain producing procedures...1 hour after a pain management intervention...At routine intervals as defined by the individual unit's established assessment...a minimum of every 8 hours for adults...pain scale...'0' indicating no pain to a level of '10' which indicates the worst pain imaginable..."

Review of medical records revealed:

A. Patient #3 (Unit 2N)

Review of the medical record failed to provide evidence of nursing assessments every 4 hours as per protocol on the following days:

- 12/16/12: After 9:14 AM until 7:10 PM (9 hours 56 minutes without a documented assessment)
- 12/17 at 3:32 PM through 12/18/12 at 12:25 AM: No documented evidence that heart rate, blood pressure and respiratory rate were assessed (8 hours 53 minutes without assessments)

Nurse Manager A confirmed these findings on 12/18/12 between 1:50 PM and 2:20 PM and reported that nursing assessments were to be completed every 4 hours.
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B. Patient #4 (Pediatrics Unit)

1. 12/12/12: Physician order for vital signs to be assessed every 4 hours

Review of the medical record failed to provide evidence that staff obtained the patient's temperature as ordered on the following days:

- 12/12 at 7:50 PM through 12/13/12 at 9:24 AM: No documented temperatures recorded and/or patient/family refusal (13 hours 34 minutes without temperature assessment)

During an interview on 12/13/12 at 10:10 AM, Nurse Manager B and RN M confirmed that the medical record lacked documentation of a temperature every 4 hours as ordered by the physician.
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C. Patient #5 (CV-SICU)

1. 12/11/12 at 4:23 PM: "Cardiac Surgery Post-Op Orders" included a physician's order to turn patient "side to side" every 2 hours and prn (as needed)

a. Review of the medical record failed to provide evidence of turns at least every 2 hours at the following times:

- 12/11/12 between 4:55 PM and 11:09 PM (6 hours 15 minutes between turns)
- 12/11 between 11:09 PM and 12/12/12 at 7:38 AM (8 hours and 29 minutes between turns)
- 12/12/12 between 7:38 AM and 10:53 AM (3 hours and 20 minutes between turns)

b. Review of "Nursing Assessment" documentation revealed that the patient was positioned on his/her back (rather than being turned on side) at the following times:

- 12/11/12: 4:50 PM, 6:28 PM, 8:17 PM and 11:09 PM
- 12/12/12: 3:52 AM, 7:58 AM, 9:00 AM and 10:53 AM

2. 12/11/12 at 4:23 PM: Physician's Order for Oral Care Q4H (every 4 hours) and brush teeth twice a day while on ventilator

a. Review of the medical record failed to provide evidence of oral care as ordered by the physician at the following times:

- 12/11 4:23 PM (time of order) until 12/11/12 at 11:09 PM (6.75 hours after order)
- 12/11 between 11:09 PM and 12/12/12 at 1:15 PM (12.75 hours without oral care)

3. 12/11/12 at 4:35 PM: Physician's order for pacemaker (mode): "DDD"

a. Review of the medical record revealed the following:

- No evidence that the cardiac pacemaker was set to the "DDD" mode or that the pacemaker mode order was changed between 12/11/12 at 4:35 PM and 12/12/12 at 1:15 PM
- 12/11/12 at 7:49 PM: RN C documented that the pacemaker mode was set as "Aai"
- 12/12/12 11:09 PM: RN B documented that the pacemaker mode was "Vvi"

On 12/12/12 at 1:20 PM, Nurse Manager A and Director of Patient Care A reviewed the medical record and confirmed these findings. Director of Patient Care A reported that if the nurse noted that the pacemaker settings were not as ordered, the physician/physician assistant was to be notified of the discrepancy between actual and ordered settings.
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D. Patient #6 (Unit 3-E)

1. 12/10/12 at 5:34 PM: "General Doctor's Admission Orders" included an order for vital signs every 4 hours

Review of "Vital Signs" documentation revealed that the nurse failed to obtain vital signs every 4 hours as ordered on the following days:

- 12/11/12: After 4:00 AM until 10:00 AM (6 hours later)
- 12/12/12: After 6:00 AM until 12:00 PM (6 hours later)

Nurse Manager F reviewed the medical record on 12/13/12 at 2:15 PM and confirmed these findings.
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E. Patient #8 (Transitions Unit)

1. 12/11/12 at 1:28 PM: "General Doctor's Admission Orders" included an order for vital signs every 4 hours

Review of "Vital Signs" documentation revealed that the nurse failed to obtain vital signs every 4 hours as ordered on the following days:

- 12/11: After 9:10 PM until 12/12/12 at 6:08 AM (9 hours later)
- 12/12: After 9:53 PM until 12/13/12 at 6:42 AM (8.75 hours later)

Nurse Manager F reviewed the medical record on 12/13/12 at 12:45 PM and confirmed these findings.
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F. Patient #10 (Unit 4B)

1. 12/13/12: Physician orders for vital signs every 6 hours and pulse oximetry checks every 4 hours

a. Review of the medical record failed to provide evidence that vital signs were obtained every 6 hours as ordered on the following days:

12/14/12
- 2:00 AM - 10:00 AM (8 hours between assessments)
- 2:00 PM - 10:00 PM (8 hours between assessments)
- 12/14 at 10:00 PM through 12/15/12 at 6:00 AM (8 hours between assessments)

12/15/12
- 2:30 PM - 9:30 PM (7 hours between assessments)
- 12/15 at 9:30 PM through 12/16/12 at 5:44 AM (8 hours 14 minutes between assessments)

12/16/12
- 9:07 PM - 6:15 AM (9 hours 8 minutes between assessments)

b. Review of the medical record failed to provide evidence that pulse oximetry checks were obtained every 4 hours as ordered on the following days:

12/13/12
- 1:44 AM - 9:04 AM (7 hours 20 minutes between assessments)
- 9:04 AM - 3:47 PM (6 hours 43 minutes between assessments)
- 12/13 at 5:05 PM through 12/14/12 at 12:00 AM (6 hours 55 minutes between assessments)

12/14/12
- 2:00 AM - 10:00 AM (8 hours between assessments)
- 12/14 at 4:00 PM through 12/15/12 6:00 AM (14 hours between assessments)

12/15/12
- 2:30 PM - 9:30 PM (7 hours between assessments)
- 12/15 at 9:30 PM through 12/16/12 5:44 AM (8 hours 14 minutes between assessments)

12/16/12
- 5:44 AM - 2:20 PM (8 hours 36 minutes between assessments)
- 2:20 PM - 9:07 PM (6 hours 47 minutes between assessments)
- 12/16 at 9:07 PM through 12/17/12 at 6:15 AM (9 hours 8 minutes between assessments)

During an interview on 12/17/12 between 9:30 AM and 9:55 AM, Clinical Nurse Specialist B confirmed that the medical record lacked documentation of vital signs every 6 hours and pulse oximetry checks every 4 hours as ordered by the physician.
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G. Patient #15 Emergency Department (ED)

1. Review of the "Emergency Department Chart" failed to provide evidence that staff provided Patient #15 with adequate pain control on 12/17/12 at the following times:

3:56 AM: "...R (right) flank pain...seen here Thursday for ruptured ovarian cyst..."
3:56 AM: Pain 10/10
5:55 AM: Pain 10/10

2. "Nursing Assessment" documented by the ED nurse:
4:14 AM: "...right flank pain seen here this past week for ovarian cyst rupture, no relief with meds at home...pain localized to below ribs in back right side..."

3. Physicians' examination notes:
5:32 AM - "Primary symptom...right flank pain...not well described...is crampy...is sharp...Severity of symptoms is severe...symptoms are constant..."
5:32 AM - "...Anxious...moderate distress..."

4. Physician's Orders for pain control/management included:
5:44 AM - a one time "Stat" dose of Toradol 30 milligrams (mg) IV
5:44 AM - a one time "Stat" dose of Morphine Sulfate 2 mg IV

The medical record failed to provide evidence that nursing staff:

- Communicated with the physician regarding the patient's need for pain control after the patient reported a pain level of 10/10 between 3:56 AM and 5:32 AM
- Provided timely pain intervention: Not medicated until 5:44 AM, 2 hours 12 minutes after the patients report of 10/10 pain level

Emergency Department Clinical Nurse Specialist (CNS) C was interviewed on 12/17/12 at 10:19 AM and stated that:
- if a patient had pain, the expectation was that the pain be addressed
- "...the expectation is treatment within 15-20 minutes maximum for severe pain..."

Director of Emergency and Trauma Services A and CNS C reviewed the medical record on 12/17/12 at 10:49 AM and confirmed these findings. Director of Emergency and Trauma Services A stated that the medical record lacked evidence that the nurse followed the hospital's policy, to manage the patient's pain in a timely manner.

Based on observation, policy review, medical record review and staff interview, it was determined that for 4 of 16 inpatient units toured and for 1 of 6 outpatient units toured, hospital staff failed to prepare medications according to established hospital policies. Findings include:

I. The hospital policy entitled "Infection Control for Pharmacy" stated, "...Single-use unit dose vials will be used whenever possible...Multi-dose vials will be discarded 28 days after opening the vial..."

A. During a tour of the Birthing Center Triage Area #2, on 12/13/12 at 11:22 AM, the following observation was made and confirmed by Clinical Coordinator A:

1. One 20 milliliter (ml) multi-dose vial of Lidocaine with "opened 10/3/12" written on the label

On 12/20/12 at 8:45 AM, Director of Pharmacy A confirmed that the multi-dose vial should have been discarded 28 days after it was opened.

B. During a tour of the Outpatient Medical Oncology Unit Pod #1, on 12/14/12 at 11:08 AM, the following observation was made and confirmed by Clinical Coordinator B:

1. One opened 5 ml single dose vial of Xylocaine-MPF 1%

On 12/14/12 at 11:08 AM, Clinical Coordinator B confirmed that a single dose vial should not be used more than one time. In addition, on 12/20/12 at 8:45 AM, Director of Pharmacy A reported that there was not a specific policy that addressed single dose vials; however, he/she believed "single dose" was "self-explanatory".

II. The hospital policy entitled "Medication Access from the Automated Distribution Cabinets" stated, "...Medications removed from the ADC (automated distribution cabinets) and not administered to the patient...will be either returned to the ADC return Bin or returned to the ADC pocket as prompted by the cabinet functionality..."

A. A tour of the medication room on the west side of Women's Services was conducted on 12/13/12 at 2:02 PM with Nurse Manager B and Clinical Coordinator C. The following observation was made and acknowledged at the time of finding:

1. One plastic medicine cup was found in an overhead cabinet with three (3) oral medications:
a. One Prenatal vitamin tablet
b. One Docusate sodium 100 milligram (mg) capsule
c. One ferrous sulfate 325 mg tablet

B. On 12/17/12 at 8:45 AM, during a tour of the medication area on the hospital unit 4A with Clinical Nurse Specialist D, the following observation was made and acknowledged at the time of finding:

1. One plastic bag labeled as "Insulin Humulin R" was found in a patient medication bin; however, there was one tablet of Metronidazole 250 mg located in the plastic bag.

C. During an interview on 12/20/12 at 8:45 AM, Director of Pharmacy A confirmed the following:
- medications were not to be stored in packages not labeled for that specific medication or in medication cups in cabinets
- if medications could not be given or were refused, staff were expected to return the medications to the ADC

III. The hospital policy entitled "Control of Medications" stated, "...The Pharmacy shall follow all Federal and State regulations defining a medication label..."

A. On 12/18/12 at 9:25 AM, during a tour of the medication area on the hospital unit 3 West with Nurse Manager C, the following observation was made and acknowledged at the time of finding:

1. An unlabeled one (1) gram unit dose tube of Erythromycin ophthalmic ointment 0.5% was found in the medication bin labeled for Patient #7.

2. Review of the "Medication Profile" for Patient #7 revealed no evidence of an order for Erythromycin Opthalmic Ointment.

During an interview on 12/18/12 at 9:25 AM, Nurse Manager C confirmed the following:
- the medication should have been in a plastic bag labeled with the necessary information and a bar code to scan
- Patient #7 did not have an order for Erythromycin Opthalmic Ointment
- the medication should have been placed in the pharmacy pick-up bin

Based on observation, medical record review, policy review and staff interview, it was determined that for 1 of 2 patients (Patient #5) in the sample receiving blood/blood product transfusions, staff failed to administer the transfusion in accordance with approved policies. Findings include:

The hospital policy entitled "Administration of Blood and Blood Products" stated, "...for the safe and accurate administration of blood products...tubing must be discarded after 8 hours or 2 full units given...Identification of the Patient with the blood component...must be verified by two (2) licensed nurses and/or physicians...must be done at the patient's bedside. One of the identifying individuals must be the transfusionist...Allergic reactions...must be documented on the Transfusion Record...Double check all documentation on Transfusion Record before placing on the patient's chart..."

The hospital policy entitled "Management of Venous Access Devices" stated, "...All IV tubings are to be labeled with start and discard dates and times..."

1. Patient #5 (CV-SICU Unit)
On 12/12/12 from 11:58 AM - 12:05 PM, Patient #5 was observed receiving medications from registered nurse (RN) A. During this observation, the patient's completed blood transfusion (one unit of packed red blood cells) was observed hanging from an intravenous (IV) pole.

a. The blood transfusion tubing lacked a label (with date/time) noting when the tubing was initiated or was to be discarded. Director of Patient Care A, present during the observation, confirmed this finding.

b. Review of Patient #5's medical record with Director of Patient Care A revealed:
1. 12/12/12 4:15 AM "Blood Bank Order and Transfusion Justification" documented the verbal order received by RN B from the Physician Assistant (PA-1) for transfusion of 1 unit of red blood cells.

2. 12/12/12 4:52 AM "Transfusion Record" - lacked the following information in the "Issued To" and "Transfusion Record" sections of the form:
- Date of the transfusion (time entered as "4:32")
- Transfusionist's Name
- Date/Time (the Transfusion was) started
- Date/Time (the Transfusion was) stopped
- Amount Transfused
- Yes/No response to the Question: "Transfusion Reaction"

Director of Patient Care A confirmed the above findings on 12/12/12 at 1:15 PM, and stated the transfusionist did not complete the "Transfusion Record" as required by policy.

Based on medical record review, policy review and staff interview, it was determined that for 1 of 3 (Patient #32) medical records reviewed in the hospital's free standing emergency center (FSEC), the patient's medical record was found to be incomplete. Findings include:

The hospital policy entitled "Charting Guidelines" stated, "...Entries must be dated and timed..."

The FSEC policy entitled "Transferring Patients from the Smyrna Emergency Center" stated, "...the Emergency Center (EC)...Registered Nurse will contact the receiving facility...and provide hand-off report...Document..."

I. Patient #32 (FSEC Visit Date 12/18/12)
Review of the patient's medical record revealed:

12/18/12 - "Emergency Department Chart" documented that Patient #2 was cared for by the Emergency Center on 12/18/12 from 12:53 PM until the patient was transferred to another hospital by ambulance at 5:19 PM.

12/18/12 - "Acute Care Transfer Order and Physician Certification" lacked the following:
- Documentation that the nurse called report to the receiving facility
- Registered nurse's signature and date of signature

Patient #32's medical record was reviewed with Director of Emergency and Trauma Services A and this finding was confirmed on 12/19/12 at 9:38 AM.

I. Based on medical record review, policy review and staff interview, it was determined that for 2 of 10 restrained patients (Restrained Patient #'s 3 and 4) in the sample, the medical record failed to contain restraint documentation. Findings include:

The hospital policy entitled "Restraint and Seclusion" stated, "...family will be notified promptly of the initiation of restraint...Notification of family will be documented on the Physician's Order sheet...Alternative or less restrictive interventions will be tried, when feasible, and found to be ineffective...Documentation of the alternatives that were tried but failed prior to the use of restraint is required...Restraint...use will be a part of the patient's plan of care when this intervention is utilized...physician's verbal order must be co-signed within 24 hours after the initial use of restraint...Should a patient be released in advance of the order expiring, a new order will be required to reapply restraints...Documentation...Document which family member was notified, how the person (s) was notified, and the rationale for the restraint...If the patient is restrained...documentation of regular, recorded observation and assessments of the patient during the period of restraint...will be completed...Safety observations were made every 30 minutes for acute/surgical patients in restraint..."

A. Restrained Patient #3

Review of the "Restraint/Seclusion Physician Order Form" revealed staff obtained a verbal order for bilateral wrist restraints (mitts) on 6/17/12 at 3:50 AM to prevent the patient from pulling on/out the nasogastric tube (drainage tube).

Review of the "Restraint/Seclusion Physician Order Form" revealed staff obtained a verbal order for the renewal of mitts 6/17/12 at 11:15 PM.

Review of the restraint "Flowsheet" documentation revealed that the patient was restrained from 3:00 AM on 6/17/12 until 7:13 PM on 6/18/12.

The medical record failed to include:

1. The authentication of verbal orders for restraint use on 6/17/12 at 3:50 AM and 11:15 PM.

2. Documented evidence to support that the plan of care was modified to include the implementation and use of restraints.

3. Documented evidence of patient assessments every 30 minutes while patient was restrained.

4. Documented evidence of family notification when restraints were initiated and/or continued to be used.

On 12/19/12 at 1:17 PM, Director of Accreditation Services A reviewed the medical record and confirmed that the verbal orders for restraint use had not been authenticated by the physician as required by policy and confirmed that there was no documentation to support that staff had notified the family regarding the use of restraints.

On 12/20/12 at 10:20 AM, Director of Patient Care Services A reviewed the medical record and confirmed that the plan of care had not been modified to reflect the use of restraints as expected and that every 30 minute safety checks were not documented as completed for an acute medical-surgical patient in restraints.
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B. Restrained Patient #4

Review of "Doctor's Orders" dated 10/26/12 at 2:40 AM, included an order for 2 point restraints for 24 hours - patient on a mechanical ventilator.

Review of the "Restraint/Seclusion Physician Order Form" revealed an order dated 10/27 (no identified year) at 8:40 AM, for the application of soft restraints to the right and left wrist.

Review of the restraint "Flowsheet" documentation revealed that the patient was restrained on:

10/26/12
- 3:30 AM - 5:59 AM: Restrained with soft wrist restraints

10/27/12
- No restraints used

10/28/12
- 11:07 AM: Restrained with soft wrist restraints

Medical record review revealed the following:

1. Review of "Doctor's Orders" and other medical record documentation failed to provide evidence to support that staff obtained a new physician's order on 10/28/12 for the re-application of restraints.

2. The "Plan of Care" included an undated entry that referenced a physician order for restraints. However, the "Plan of Care" failed to provide documented evidence to support that the plan of care was modified to include the implementation and use of restraints.

3. Review of the "Record of Admission" confirmed that the patient identified his/her spouse as an emergency contact. The "Restraint/Seclusion Physician Order Form" failed to provide documented evidence of family notification when restraints were initiated and/or continued to be used.

On 12/20/12 at 12:05 PM and 12:30 PM, Director of Accreditation Services A reviewed the medical record and confirmed these findings.
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II. Based on medical record review, policy review, document review and staff interview, it was determined that the medical record failed to contain pertinent information related to the patient's (Patient #27) medical status for 1 of 5 closed medical records in the sample. Findings include:

The hospital policy entitled "Safety/Variance Reporting" stated, "...All members of the hospital staff will report any variance constituting harm or potential harm to patients...When an incident occurs there are some initial measures that must be taken...If a patient is involved, the facts of the incident...will be documented in the medical record..."

The hospital policy entitled "Charting Guidelines" stated, "...Documentation of patient care shall be pertinent...will reflect patient status regarding needs, problems...nursing interventions and patient response..."

A. Patient #27

Review of the "Interdisciplinary - Progress Notes" documentation dated 10/30/12 at 8:30 AM included an entry by the physician regarding a fall - "...Pt. (patient) fell on floor over foley (drainage) bag, After getting up to Bathroom - will keep for observation."

Review of "Doctor's Orders" dated 10/30/12 at 8:30 AM, included no reference to discharge or cancellation of discharge due to a fall or orders for nursing staff to observe the patient post-fall.

Review of the "Nursing Assessment" documentation revealed that Patient #27 was identified as being at risk for falls. There was no documented evidence that nursing staff was aware of the fall; no reference to fall or specific observations related to an actual fall.

Review of the "Discharge Summary" dictated on 10/30/12 at 1:46 PM, included Patient #27's hospital course. The physician documented:

- "...Progressed well and was scheduled to be discharged to home on October 30, 2012, however, had slipped and fell in the bathroom. He stated he did not hit his head. We told the patient that he was going to stay in the hospital today on the day of discharge for observation..."

Review of the medical record and other hospital documents failed to provide evidence to support that the physician was:

- Notified and/or communicated to nursing staff that the patient had reported a fall to him/her
- Notified and/or communicated to nursing staff that the patient required additional observation as a result of the fall

Director of Accreditation Services A reviewed the medical record on 12/13/12 at 9:22 AM and 2:32 PM and confirmed the following:

- It was the expectation that the physician report a fall to licensed nursing staff
- With knowledge of a fall, the High Risk Fall Protocol should have been initiated
- Safety Report should have been completed by the physician
- No physician's order in the medical record for post-fall observation of patient by nursing
- No documentation in "Interdisciplinary - Progress Notes" to provide evidence that nursing was aware of the fall and/or documentation to support that the patient required additional observation related to the fall
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III. Based on medical record review, policy review and staff interview, it was determined that for 2 of 5 closed medical records (Patient #27 and Restrained Patient #4) in the sample, entries were illegible or failed to contain the year of medical record entry. Findings include:

The hospital policy entitled "Charting Guidelines" stated, "...Entries must be dated...legible..."

A. Patient #27

Review of "Interdisciplinary - Progress Notes" revealed signed entries that were illegible on:

10/27/12 at 9:10 AM
10/28/12 at 8:30 AM
10/30/12 at 8:30 AM
10:30/12 at 11:40 AM
10:30/12 at 12:18 PM

On 12/12/12 at 1:30 PM, Clinical Nurse Specialist D reviewed the medical record and confirmed these findings.

B. Restrained Patient #4

Review of the "Restraint/Seclusion Physician Order Form" revealed an order dated 10/27 at 8:40 AM, for the application of soft restraints to the right and left wrist. The year of order entry was not documented.

On 12/20/12 at 12:05 PM, Director of Accreditation Services A reviewed the medical record and confirmed this finding.

Based on closed medical record review, medical staff rules and regulations review and staff interview, it was determined that the medical record for 1 of 5 discharged patients (Patient #27) in the sample, failed to contain a final diagnosis within 30 days of discharge. Findings include:

The hospital document entitled "Bayhealth Medical Staff Rules and Regulations" stated, "...A discharge diagnosis shall be entered in the medical record upon discharge of the patient...Discharge Diagnosis...attending Physician is responsible for completion of the medical record, including...final diagnosis...within thirty (30) days of the discharge of the patient from the Hospital..."

Review of the "History & Physical" revealed Patient #27 was admitted to the hospital on 10/26/12.

Review of the "Discharge Summary" dictated on 10/30/12 at 1:46 PM, included Patient #27's hospital course. The physician documented:

- "...Progressed well and was scheduled to be discharged to home on October 30, 2012, however, had slipped and fell in the bathroom. He stated he did not hit his head. We told the patient that he was going to stay in the hospital today on the day of discharge for observation...nurses went to check on the patient...found unresponsive...rapid response initiated...quickly converted to code blue...intubated (artificial airway)...full ACLS (Advanced Cardiac Life Support) protocol and CPR (cardiopulmonary resuscitation) were initiated for 47 minutes...despite all efforts...no return of spontaneous circulation and code was called after 47 minutes. Date and time of death was October 30, 2012 at 1300 (1:00 PM)."

- The medical record failed to include evidence of a final diagnosis.

Director of Accreditation Services A reviewed the medical record on 12/13/12 at 9:22 AM and 12/17/12 at 2:56 PM and confirmed that the medical record failed to include a final diagnosis.

Based on observation, policy review, and staff interview, it was determined that there was a mislabeled drug stored in the refrigerator for 1 of 13 intensive care unit (ICU) patients in the sample. Findings include:

The policy entitled "Administration of Medications On and Off the Sterile Field" stated, "...All medications...that are not immediately administered must be labeled even if there is only one medication being used...Labeling occurs when any medication or solution is transferred from the original packaging to another container...Labels must include drug name, strength, quantity, expiration date...and expiration time..."

A. Patient #41 (ICU)

Review of Patient #41's medical record revealed:

12/10/12 "Doctors Orders" - The physician ordered Clorpactin (used to clean debris from wounds) dressing to the patient's leg twice each day.
12/13/12 "Scheduled Medications" stated, "...Clorpactin...stir contents of vial in 1 liter of sterile lukewarm water expires 1 week after reconstitution..."

On 12/13/12 at 10:00 AM, the ICU refrigerator was opened and contents were inspected with ICU Nurse Manager A and Patient Care Director A. The refrigerator contained a brown paper bag with a 1 liter bottle of sterile water inside; approximately 850 of the 1000 milliliters (ml) remained in the previously opened bottle which was labeled with Patient #41's name and the date/time. There was no information on the bottle to indicate that the bottle contained anything other than sterile water.

During review of Patient #41's medical record with Clinical Nurse Specialist (CNS) A on 12/13/12 at 10:15 AM, CNS A confirmed that she/he had reconstituted Clorpactin into the sterile water bottle found in the refrigerator at 10:00 AM, and had failed to properly label the medication bottle as required by hospital policy.

Based on observation and staff interview, it was determined that the hospital failed to maintain the building in a manner to ensure compliance with Life Safety Code for the safety of 221 of 221 inpatients and for 3 of 4 off-campus designated provider-based entities. The hospital failed to meet the applicable provisions of the 2000 edition of the Life Safety Code (LSC) of the National Fire Protection Association (see the attached CMS-2567s referencing LSC deficiencies).

Based on observation, staff interview and policy review, it was determined that the hospital failed to maintain environmental surface cleanliness and integrity in a manner to assure patient safety and well-being in 21 of 40 patient care/support areas on the environmental tour. Findings include:

The hospital policy entitled "Environment of Care Safety and Security Management Plan" stated, "Bayhealth establishes a safe, functional environment. Interior spaces meet the needs of the patient population and are safe and suitable to the care, treatment, and services provided..."

The hospital policy entitled "Infection Prevention Guidelines for Environmental Services" stated, "To reduce the risk of healthcare associated infections that may occur as the result of exposure to contaminated surfaces...maintain a thoroughly clean environment throughout the hospital by reducing the pathogens on the many fomites in patient environments..."

The instruction sheet entitled "Maintenance of Scienceware Eye Wash Bottles" stated, "Wash the Eye Wash Bottle and all accessory parts...in mild detergent solution...Rinse well...Under clean conditions, fill Eye Wash bottle completely...Replace top, close cap and return to emergency station..."

Hospital staff accompanied the surveyor during environmental tours at the hospital, and four (4) off-campus outpatient care areas. The following was observed and confirmed at the time of discovery:

I. Main Hospital on 12/12/12

A. 6th Floor (Mother/Babies) from 11:30 AM to 12:38 PM
a. Room 629 (unisex restroom) - baby changing station with dried yellow liquid stains
b. Room 626 (medication room) - surfaces with adhesive residue and dried fluid stains
c. Isolation room (hearing testing area) - sign and file taped to wall
d. Room 647 (patient room) - 6 screw holes in drywall
e. Room 669 (ultrasound testing room)
- eye wash solution refill bottle, only
- no eye wash station mounted on wall
- no eye wash bottle present
- Cidex, a high level disinfectant with eye irritating potential, was used in this area
f. Vaginal ultrasound transducer lying unprotected on counter
g. Patient pantry/family kitchen - interior of microwave oven soiled with dried dark liquid, chipped laminate

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A and Clinical Coordinator C.

B. 5th Floor (Labor & Delivery/Special Care Nursery) from 1:35 PM to 2:37 PM
a. Room 503 - taped sign
b. Soiled utility room (Formalin, a tissue preservative with the potential to cause eye damage and blindness, was used in this area)
- eye wash solution refill bottle not removed from cardboard box
- no eyewash bottle present
c. Room 555 (soiled utility) - damaged wall board
d. Room 581 (soiled utility) - four (4) taped signs

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A, Director of Women's and Children's Services A, and Nurse Manager H.

C. 4th Floor (Medical/Surgical) from 2:48 PM to 3:25 PM
a. Room 444 (family convenience area) - black hair on changing table, tape on door enclosing washer/dryer, tape on washer/dryer
b. Taped signs outside/inside the following rooms: 403, 406, 411, 413, 414, 419, 420, 423, 430, 440, 455, 462 and stretcher/supply room
c. Rooms 462 and 403 - drywall damage

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A, Nurse Manager I and Clinical Nurse Specialist B.

II. Main Hospital on 12/13/12

A. 3rd Floor (from 8:15 AM to 11:05 AM)

1. Intensive Care Unit (ICU)
a. Room 320g (soiled utility) - cabinet doors did not completely close, damaged wall board
b. Handwashing sink (wall opposite nurses station) - moist wall board above damaged grout
c. Room 328 - taped signs outside/inside, 5 in clean supply room
d. Nurses station - taped signs on exteriors of refrigerators, cabinets and ice machine; soiled grout at handwashing sink

2. Intermediate Care Unit (IMC)
a. Room 320m (housekeeping closet) soiled air vent, sign taped to wall
b. Nurses station - taped sign on ice machine
c. Window sills (facing the nursing station core) - very dusty
d. Rooms 306, 300m - taped signs outside/inside (2 on refrigerator, 6 on cabinets)

3. 3 West (3W)
a. Room 370p (patient/family kitchen) - turntable of microwave oven soiled with dried food
b. Handwashing sink - unsealed, damaged wooden edge trim
c. Room 370L - taped signs outside/inside (2 signs and roll of tape stuck to wall); medication room (taped sign and 8 stickers on cabinets)
d. Room 391 (tub room used as equipment storage room) - with open drains, cracked ceramic tiles

4. 3 East (3E)
a. Patient/family kitchen - interior of microwave oven soiled with dried food
b. Room 370F (medication room) - tape and tape residue
c. Room 370C - eight (8) taped signs
d. Room 370G - two (2) taped signs, two (2) soiled (previously wetted) ceiling tiles

5. 3 North (3N)
a. Room 369 - five (5) screw holes in drywall
b. Sink opposite Room 353A - soiled caulk

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A, Nurse Manager E (ICU), Nurse Manager G (IMC), Nurse Manager C (3W) and Nurse Manager F (3E & 3N).

B. 2nd Floor (2 North) from 11:10 AM to 11:26 AM
a. 2 North hallway - soiled fabric upholstery on bench seat
b. Medication room and patient/family kitchen refrigerators - taped signs and adhesive residue
c. Room 201L - four (4) holes in dry wall
d. Patient/family kitchen - interior of microwave oven soiled with dried food

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A and Plant Operations Manager A.

C. 5th Floor (Caesarean Section Delivery Suite) from 1:07 PM to 1:20 PM
a. Soiled utility room - eyewash solution refill bottle stored on shelf with isopropyl alcohol and cleaning agents; no eyewash bottle present

This finding was confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A and Director of Women's and Children's Services A.

D. 2nd Floor (from 1:33 PM to 2:55 PM)

1. Wound Care Center (WCC)
a. Clean utility room - taped sign, sticker on cabinet, taped sign on ice machine

2. 2 North (2N)
a. Patient/family kitchen - cabinets did not close completely
b. 2N entry way - soiled fabric upholstery on bench seat
c. Room 266 D (medication room) - adhesive stickers on cabinets and drawers, tape on door

3. CV-SICU
a. Room 295E (medication room) - six (6) taped signs

4. Pediatrics (Peds)
a. Room 271K (medication room) - refrigerator with taped sign

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A, Director of Wound Care Center A (WCC), Nurse Manager A (CV-SICU) and RN L (Peds).

III. Ambulatory Care Services on 12/14/12

A. Middletown Medical Center (from 9:00 AM to 9:30 AM)
a. Mammography room - two (2) stained ceiling tiles

This finding was confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A, Administrative Director of Ambulatory Care Services A and Manager of Outpatient Services Centers A.

B. Bayhealth Outpatient Rehabilitation Services from 1:36 PM to 2:22 PM
a. Outpatient physical therapy treatment cubicle area - damaged counter laminate
b. Six (6) treatment cubicles - screws protruding (at chest height) in the walls

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A and Plant Operations Manager A.

IV. Main Hospital on 12/17/12 (from 10:30 AM to 2:43 PM)

A. Radiation Oncology
a. Radiation treatment room - moderate collection of dust on parts of an imaging unit

B. Emergency Department (ED)
a. Medication rooms - Accudose units (automated medication dispensing equipment) and refrigerators with taped signs
b. Nutrition stations - refrigerators with unlabeled, undated open food containers, microwave ovens soiled with dried food
c. Soiled utility and housekeeping rooms - signs taped to walls

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A, Director of Operations for Oncology Services A and Director of Emergency & Trauma Services A.

V. Main Hospital on 12/18/12 (from 8:55 AM to 2:39 PM)

A. Peri-operative services - endoscopy
a. Endoscope processing room - eyewash station was not assembled to be functional, staff was unclear how to use it

B. Diagnostic imaging - delaminating cabinet in computerized tomography (CT) room

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A, Director of Peri-Operative Services and Manager of Diagnostic Imaging A.

I. Based on observation, document review, policy review and staff interview, it was determined that for 3 of 19 patient care units, staff failed to ensure an acceptable level of safety and quality for emergency box/crash carts. Findings include:

The hospital policy entitled "Neonatal Emergency Box" stated, "...Each day the Neonatal Emergency Box will be checked to verify the seal (lock) is still intact and the listed expiration dates on the top are not exceeded. This will be recorded on the Neonatal Emergency Box Checklist..."

The hospital policy entitled "Crash Cart Daily Inspection" stated, "...done to verify presence of designated equipment...to assure that all equipment functions properly...The clinical coordinator or his/her designee will examine the crash cart daily. Document time of inspection on the check list...All equipment must be clean and without damage...Nothing should obstruct access to the crash cart..."

A. During tours of individual hospital units at Kent General Hospital, emergency boxes/crash carts were checked to ensure that staff was performing daily checks. Review of the "Neonatal Emergency Box Checklist" and the "Defibrillation/Crash Cart Checklist" revealed emergency boxes/crash carts were not checked daily on the following dates:

1. Neonatal Intensive Care Unit (NICU) - 11/29/12

NICU Nurse Manager A confirmed this finding on 12/14/12 at 10:30 AM.

2. Outpatient Medical Oncology - 12/4, 12/5 and 12/11/12

Clinical Coordinator B confirmed this finding on 12/14/12 at 1:15 PM.

B. During a tour of the intensive care unit (ICU) on 12/13/12 between 9:20 AM and 10:15 AM, Surveyor C and registered nurse (RN) D made several attempts to open the bottom two (2) drawers of Crash cart #60. RN D confirmed that the drawers of the crash cart did not open due to content and quantity of supplies stored in the cart's drawers.

Nurse Manager E and Director of Patient Care A, present at the time of observation, confirmed this finding.

II. Based on observation, staff interview and policy review, it was determined that the hospital failed to ensure an acceptable level of safety, quality and cleanliness of patient care equipment and supplies in 19 of 40 patient care/support areas. Findings include:

The hospital policy entitled "Infection Prevention Guidelines for Environmental Services" stated, "To reduce the risk of healthcare associated infections that may occur as the result of the exposure to contaminated surfaces, equipment, air, dust...maintain a thoroughly clean environment throughout the hospital by reducing the pathogens on the many fomites in patient environments...Sanitation within the hospital environment depends upon cleaning thoroughness and frequency. There are...procedures for cleaning...beds, furniture...carpets...equipment...special patient-care departments, and other non-patient areas..."

The hospital policy entitled "Cleaning of Equipment" stated, "...Cleaning and disinfecting high-touch areas play a major role in providing a clean, safe, sanitary environment for patients, visitors, and staff...Cleaning of specific equipment...collaborative responsibility between Staff caring for the patient and Environmental Services..."

The hospital policy entitled "Non-Electrical Rolling Stock Cleaning" stated, "...Cycle clean and disinfect all non-electrical rolling patient care equipment on a scheduled basis..."

Hospital staff accompanied the surveyor during environmental tours of the hospital, and four (4) off-campus outpatient care areas. The following was observed and confirmed at the time of discovery:

A. Main Hospital on 12/12/12

1. 6th Floor (Mother/Babies) from 11:30 AM - 12:38 PM
a. Room W04 -- rolling base of intravenous (IV) pole soiled with dust and dried liquid splashes
b. Sonography Room 1 -- dusty bottom shelf of stretcher
c. Room 688 (clean utility) -- "Intellishelf" supply bin sitting on the floor
d. Southeast side floor 6 -- two (2) soiled fabric-upholstered chairs
e. Room 657 -- portable commode with cracked plastic arm rest and adhesive/stain on lid

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A and Clinical Coordinator C.

2. 5th Floor (Labor & Delivery/Special Care Nursery) from 1:35 PM - 2:37 PM
a. Family break room -- four (4) soiled fabric-upholstered chairs

This finding was confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A, Director of Women's and Children's Services A and Nurse Manager H.

3. 4th Floor (Medical/Surgical) from 2:48 PM - 3:25 PM
a. Room 442 -- tape residue on stretcher mattress
b. Room 441-- rolling bases of six (6) IV poles soiled with dust and dried liquids
c. Stretcher/supply room -- lower shelf of stretcher with noted debris
d. Room 430 -- recliner with adhesive residue, damaged vinyl upholstery on armrests
e. Room 462 -- one (1) soiled fabric-upholstered chair

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A, Nurse Manager I and Clinical Nurse Specialist B.

B. Main Hospital on 12/13/12

1. 3rd Floor from 8:15 AM - 11:05 AM
a. ICU
- Crash cart #14 -- hair and dust accumulation on top surface
- Room 332 -- soiled rolling base of one (1) IV pole
- Opposite Room 330 -- soiled tape residue on recliner
- Philips electrocardiogram machine -- dusty shelf
b. Intermediate Care Unit (IMC)
- Portable x-ray machine -- very dusty
- Stretcher/chair -- tape residue, torn mattress
- Crash cart #31 -- dust accumulation on top surface
- Room 341 -- soiled rolling base of Dinamap (machine that records blood pressure)
- Wheelchair -- damaged vinyl on calf rest and arm
- Crash cart #51 -- dust accumulation on top surface
- Two (2) Z carts (support computers) -- taped signs and soiled edges
- Three soiled linen carts -- signs taped to lids
- Family resource center -- office chair with soiled fabric upholstery
c. Dialysis Unit
- Curtain protecting clean supplies in Intellishelf (immediately adjacent to a dialysis station) not pulled to protect stored items from possible contamination
d. 3 West (3W)
- Room 392 -- one (1) soiled fabric-upholstered chair and foot rest
- Room 393 -- isolation ante-room being used as storage containing three (3) Dinamaps, one (1) sit-to-stand lift, one (1) computer on wheels
- Room 391 -- tub room used as storage (with 2 open drains and toilet), fabric covered spreader bar for patient lift was found to be stored on the tile floor
e. 3 East (3E)
- Room 370D -- severely damaged table top finish
- Room 370G -- one (1) soiled fabric-upholstered chair
f. 3 North (3N)
- Sitting area between 3E and 3N -- one (1) soiled fabric-upholstered chair seat

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A, Nurse Manager E (ICU), Nurse Manager G (IMC), Nurse Manager C (3W) and Nurse Manager F (3E & 3N).

2. 2nd Floor (2 North) from 11:10 AM to 11:26 AM
- Crash cart #36 and defibrillator -- dusty
- Clean utility room -- uncovered clean linen cart, soiled rolling bases of nine (9) IV poles

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A and Plant Operations Manager A.

3. 5th Floor (Caesarean Section Delivery Suite) from 1:07 PM to 1:20 PM
- Operating Room #1 -- labels and tape on front shelf of blue anesthesia cart, fluid warmer with rusty base
- Anesthesia work room -- items stored in under sink cabinet include two (2) large yellow bins, two (2) small blue bins, five (5) suction canisters
- Obstetric recovery -- two (2) soiled fabric-upholstered chairs
- Fluid warmer -- rusty base

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A and Director of Women's and Children's Services A.

4. 2nd Floor -- 2 North (2N) from 1:53 PM to 2:08 PM
- Room 266D (medication room) -- paper towels were stacked on counter, not in protective towel dispenser
- Room 263 -- one (1) soiled fabric-upholstered chair seat

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A and Plant Operations Manager A.

C. Ambulatory Care Services on 12/14/12

1. Middletown Medical Center -- from 9:00 AM to 9:30 AM
- Sonography room -- foam positioning cushion with damaged, uncleanable cover

This finding was confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A and Manager of Outpatient Services A.

2. Bayhealth Medical Center Pain Treatment Center -- from 10:45 AM to 11:25 AM
- Procedure room -- damaged mattress cover

This finding was confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A and Plant Operations Manager A.

3. KGH Women's Center -- from 11:30 AM to 11:55 AM
- Gowned patient waiting room -- five (5) soiled fabric-upholstered chair seats

This finding was confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A and Women's Center Coordinator A.

4. Bayhealth Outpatient Rehabilitation Services -- from 1:36 PM to 2:22 PM
- Pool area -- tear in vinyl treatment table cover
- Occupational therapy area -- rusted table legs

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A and Director of Rehabilitation Services A.

D. Main Hospital on 12/17/12

1. Emergency Department (ED) -- from 11:23 AM to 12:16 PM
- Computerized tomography room -- damaged vinyl on knee support

This finding was confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A.

E. Main Hospital on 12/18/12

1. Peri-operative services -- from 9:43 AM to 11:42 AM
- Operating Room 6 -- anesthesia side cart with dust and hair on surface

This finding was confirmed at the time of observation by Director of Peri-Operative Services A and Chief CRNA A.

2. Diagnostic imaging -- from 2:22 PM to 2:39 PM
- Sonography waiting room -- stained/soiled carpeting
- Main waiting area -- four (4) soiled fabric-upholstered chair seats

These findings were confirmed at the time of observation by Corporate Compliance Clinical Risk Specialist A, Plant Operations Manager A and Manager of Diagnostic Imaging A.

Based on review of documentation and staff interview, it was determined that staff failed to log temperature and humidity data in central services for 4 of 17 days. Findings include:

On 12/19/12 at 10:50 AM, review of the central services document entitled "Daily Temperature and Humidity Log" revealed that there had been no entries for 4 of 17 days (on 12/16, 12/17, 12/18 or 12/19/12). This finding was confirmed at the time of discovery by Supervisor of Central Services A.

I. Based on observation, policy review, job description review and staff interview, it was determined that for 10 of 25 patient care observations (Patient #'s 5, 9, 33, 41, 42, 44, 45, 46, 47 and 48) in the sample, staff failed to follow the hospital's infection control policies. Findings include:

The hospital job description entitled "Manager, Infection Control" stated, "...responsible for ongoing oversight and continuous improvement of the...Infection Control program of surveillance, prevention, and clinical response regarding infectious disease exposures and hazards...Ensure ongoing compliance with...CMS requirements...Ensures for all areas of responsibility that employees are aware of...policies and procedures and that corrective action is taken to achieve fair, timely and consistent enforcement..."

The hospital's policy entitled "Hand Hygiene" stated, "...Hand hygiene is required...Before, between and after contact with patients...After touching any source that is likely to be contaminated with pathogens...after touching any secretions such as...respiratory secretions even if gloves were worn...Before preparing and accessing medications station...Before touching a patient...Before clean/aseptic procedure...After touching a patient...After touching patient surroundings...Use of gloves during procedures does not eliminate the need for hand hygiene before glove application and following glove removal...Change gloves during patient care if moving from a contaminated body site to a clean body site..."

The hospital's policy entitled "Management of Venous Access Devices" stated, "...Dressings on vascular access devices...will be changed...the sterile 'CVAD (central venous access device) Dressing Change Kit' will be utilized...open sterile central line dressing change kit. Apply mask. Don non-sterile gloves. Position patient...mask patient if needed. Remove old dressing and non sterile gloves and dispose...Observe the site...Don sterile gloves...Begin cleansing site with Chlorate...apply...benzoin...center the dressing over the insertion site..."

The hospital's job description entitled "RN, Vascular Access Specialist" stated, "...Utilizes national practice standards, including...CDC's (Centers for Disease Control and Prevention) Guidelines for the prevention of Intravascular-Catheter Related Infections..."

The hospital's policy entitled "Isolation Guidelines" stated, "...To assure the proper isolation of patients as recommended by the Centers for Disease Control and Prevention...Standard precautions are to be used with all patients receiving care and apply to blood, body fluids, secretions and excretions...Clean non-sterile gloves are worn when touching...body fluids, secretions, excretions, contaminated items...Change gloves between procedures on the same patient after contact with materials that may contain high concentrations of microorganisms and when moving from a contaminated body site to a clean body site...Patient Care Equipment...Reusable equipment must be cleaned or reprocessed between patients..."

A. Patient #5 (CV-SICU Unit)

The following was observed during a medication administration pass and care provided by registered nurse (RN) A on 12/12/12 between 11:58 AM and 12:05 PM:

- Wheeled mobile computer cart (MCC) into room to patient bedside
- Washed hands
- Touched keyboard of MCC; Retrieved scanner from top of MCC and scanned patient's wrist band
- Donned gloves
- Removed patient's oxygen mask
- Placed medication cup to patient's lips and administered oral medication
- Gave the patient a cup with water and allowed the patient to sip from the cup
- Retrieved emesis basin and container holding mouthwash and administered mouthwash
- Held emesis basin to patient's mouth while RN A coughed into his/her right forearm
- Opened a tube containing Bacitracin ointment
- Applied ointment to two cotton swabs
- Applied the ointment to the patient's left and right nostrils, each with a separate swab
- Discarded supplies
- Removed gloves, washed hands

RN A failed to perform hand hygiene:
- Before touching the patient
- Before donning gloves
- After touching inanimate objects
- After coughing into his/her right forearm, before touching patient again

Director of Patient Care A, present during the observation, confirmed these findings.

During an interview with Infection Preventionist A on 12/19/12 at 1:11 PM, the medication administration observation was discussed. Infection Preventionist A confirmed that RN A failed to follow the hospital's hand hygiene policy and CDC guidelines for infection prevention during the provision of care.
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B. Patient #44 (Unit 3-E)

The following was observed during a medication administration pass by RN E on 12/13/12 from 11:35 AM to 11:40 AM:

- Performed hand hygiene
- Donned gloves
- Scanned patient's ID bracelet with the MCC scanner at patient's bedside
- Placed scanner back on top of cart
- Retrieved a 500 milliliter (ml) intravenous (IV) medication bag containing levofloxacin (Levaquin - a drug used to treat infections) and a secondary IV medication tubing set from the top of the cart
- Removed the cap covering one end of the tubing and spiked the medication bag with the end point of secondary medication (tubing) set
- Removed the cap from the other end of the secondary medication tubing set and connected the tubing set to the IV tubing (already connected to the patient) and to a 1 liter bag of normal saline hanging from the patient's bedside IV pump and pole

RN E failed to:
- Perform hand hygiene and change gloves before spiking the IV medication bag and after touching inanimate objects
- Swab the port of the primary IV tubing with alcohol, before connecting the medication bag and tubing to the port

3E Nurse Manager A, present during the observation, confirmed these findings.

During an interview with Infection Preventionist A on 12/19/12 at 1:48 PM, the medication administration observation was discussed. Infection Preventionist A confirmed that RN E failed to follow the hospital's hand hygiene policy and CDC guidelines for infection prevention during the provision of care.
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C. Patient #41 (IMC unit)

The following was observed during a nursing procedure to replace the huber needle in Patient #41's vascular access port (an implanted device under the patient's skin used to provide long term IV access and therapies) by the vascular access RN F on 12/14/12 from 8:50 AM to 9:30 AM:

- Washed hands
- Donned gloves
- Touched the MCC and patient tray table located at patient's bedside
- Retrieved face mask from across room, approached patient and placed the mask on the patient
- Removed gloves
- Washed hands
- Donned gloves
- Opened sterile dressing change kit (on top of patient tray table)
- Removed occlusive dressing over patient's venous access port on patient's chest
- Performed hand hygiene
- Donned gloves
- Donned a face mask, touched both his/her face and hair
- Touched patient's chest within 4 inches of vascular access device (VAD) site
- As RN F reached to touch the huber needle access site surveyor prompted RN F to perform hand hygiene/glove change
- Removed gloves
- Performed hand hygiene
- Donned gloves
- Wiped port of micro bore extension tubing set from connected needle with alcohol, attached syringe and verified blood return
- Removed gloves
- Performed hand hygiene
- Reached into opened sterile dressing change packet
- Removed envelope containing sterile gloves and touched other contents in the sterile kit with bare hands
- Opened envelope containing sterile gloves
- Touched tray table
- Donned sterile gloves
- Snapped Chlorate applicator to activate, applied solution in back and forth motion across VAD area several times
- Retrieved and inserted new huber needle with extension set into VAD, touching VAD site with both gloved hands
- Attempted to obtain blood return with 10 ml syringe
- When unable to obtain blood return, requested new needle/extension set from assisting RN
- New needle set dropped on sterile field and second Chlorate applicator provided (sterility maintained)
- Re-applied Chlorate for 2 minutes
- Attached syringe to new single lumen 3/4 needle extension set and inserted huber needle into VAD
- Obtained blood return and requested a second 10 ml syringe of normal saline to flush the port
- Took the syringe of normal saline from the assisting nurse, touching the assisting nurse's clean (but not sterile) blue glove
- Obtained and applied benzoin ointment over VAD site
- Opened Tegaderm occlusive dressing and applied over VAD site

RN F failed to perform hand hygiene and/or change gloves:
- Before touching patient
- After contact with inanimate objects
- When moving from a contaminated site to a clean/sterile site

Nurse Manager G, present during the observation, confirmed these findings. The findings were reviewed at 9:30 AM with RN F and Clinical Nurse Specialist (CNS) B who both confirmed that the RN F had not completed hand hygiene and glove changes as required.

The vascular access observation was discussed with Infection Preventionist A during an interview on 12/19/12 at 1:30 PM. Infection Preventionist A reported that RN F failed to follow the hospital's hand hygiene policy and CDC guidelines for infection prevention.
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D. Patient #45 (Neonatal Intensive Care Unit (NICU))

The following was observed during patient care performed by RN H on 12/14/12 at 10:14 AM:

- Administered an oral medication
- Discarded the oral medication syringe
- Unfastened the tape on both sides of the diaper
- Opened the bassinet drawer and retrieved a Vaseline packet and gauze
- Opened Vaseline packet and placed the Vaseline ointment on the gauze
- Wiped the perianal area with the Vaseline and gauze
- Applied a new diaper
- Wrapped Patient #45 in a blanket
- Washed hands

RN H failed to wear gloves during the diaper change when there was a potential contact with bodily fluids.

Nurse Manager D and Clinical Practice Leader A were present during the observation and confirmed this finding. The patient care observation was discussed with Infection Preventionist A during an interview on 12/19/12 at 10:25 AM. Infection Preventionist A reported that RN H failed to follow OSHA Blood Borne Pathogen guidelines and the CDC Transmission Based Precautions for Isolation, both of which the hospital follows.
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E. Patient #46 (Unit 4B)

The following was observed during the medication administration pass performed by RN I on 12/17/12 from 8:50 AM - 9:00 AM:

- Administered oral medication with gloves on both hands
- Removed gloves and discarded
- Touched computer

RN I failed to perform hand hygiene:
- After removing gloves

Director of Patient Care Services A, Nurse Manager I and Clinical Nurse Specialist B, present during the observation, confirmed this finding. The medication administration observation was discussed with Infection Preventionist A during an interview on 12/19/12 at 10:25 AM. Infection Preventionist A reported that RN I failed to follow the hospital's hand hygiene policy.
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F. Patient #9 (Unit 4A)

The following was observed during the tracheostomy (surgical opening of airway in neck) care performed by RN J on 12/17/12 from 11:30 AM - 11:40 AM:

- Donned gown and gloves
- Prepared clean field and equipment for suctioning on the bedside table
- Removed gloves
- Washed hands
- Donned sterile gloves
- Suctioned patient's tracheostomy
- Retrieved gauze from the top of the cart
- Opened the gauze and placed on the clean field
- Unfastened the tracheostomy collar
- Removed the soiled dressing from the tracheostomy and discarded
- Touched the gauze on the clean field
- Removed gloves
- Touched a bottle of liquid on the bedside table
- Sanitized hands
- Donned gloves
- Cleansed tracheostomy area with moistened gauze
- Applied clean gauze to the tracheostomy site
- Fastened the tracheostomy collar
- Discarded trash
- Removed gloves
- Washed hands

RN J failed to perform hand hygiene and/or change gloves:
- After removing gloves
- After removing the soiled tracheostomy dressing /before touching the clean field

Clinical Nurse Specialist B, present during the observation, confirmed this finding. The patient care observation was discussed with Infection Preventionist A during an interview on 12/19/12 at 10:25 AM. Infection Preventionist A reported that RN J failed to follow the hospital's policies regarding glove use and hand hygiene.
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G. Patient #42 (ICU isolation room):

The following was observed during a respiratory therapy treatment (nebulizer) provided by Respiratory Therapist (RT) C on 12/18/12 from 9:45 AM to 9:52 AM:

- RT C used own stethoscope to auscultate (listen to) the patient's lung sounds prior to and at the end of the nebulizer treatment
- At the completion of the treatment, RT C placed his/her stethoscope around his/her neck
- Wiped down the MCC
- Removed the yellow isolation gown worn during the treatment
- Wheeled the cart out of the patient's room into the hospital hallway
- When asked, RT C confirmed that he/she had completed all tasks associated with the treatment and was ready to move to the next patient

At 9:55 AM, RT C confirmed that he/she had failed to sanitize his/her personal stethoscope at the end of the patient's treatment.

Director of Respiratory Care and Neurodiagnostics A and Respiratory Therapy Manager A, both present during the observation, confirmed these findings. Director of Respiratory Care and Neurodiagnostics A stated that a disposable stethoscope should have been dedicated to the patient and that RT C should have sanitized his/her personal stethoscope with an alcohol wipe when removing his/her yellow contact isolation gown.
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H. Patient #47 (Unit 2N-IMC)

The following was observed during medication administration performed by RN K on 12/18/12 at 11:05 AM:

- Sanitized hands
- Donned gloves
- Administered oral medications
- Removed gloves
- Discarded trash
- Reached into pocket for a pen
- Wrote on a medication patch
- Sanitized hands

RN K failed to perform hand hygiene:
- After removing gloves

Director of Patient Care Services A, present during the observation, confirmed this finding. The patient care observation was discussed with Infection Preventionist A during an interview on 12/19/12 at 10:25 AM. Infection Preventionist A reported that RN K failed to follow the hospital's hand hygiene policy.
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I. Patient #48 (Unit 2N-IMC)

The hospital policy entitled "Cleaning of Equipment" stated, "...Equipment/Computers are to be cleaned between patients..."

The following was observed during the respiratory treatment performed by RT D on 12/18/12 at 11:22 AM:

- Retrieved medication
- Rolled computer on wheels into patient room
- While verifying patient identification, stretched computer scanner cord across patient's bedside table
- Administered medication
- Removed computer from the patient room

RT D failed to:
- Clean the computer after contact with the patient's bedside table

Director of Patient Care Services A, present during the observation, confirmed that the computer was not cleaned after touching the patient's bedside table. The observation was discussed with Infection Preventionist A during an interview on 12/19/12 at 11:05 AM. Infection Preventionist A reported that the computer should have been cleansed after contact with the patient's bedside table.
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J. Patient #33 - Free Standing Emergency Center (FSEC) Smyrna

The policy entitled "Infection Control Guidelines for the Smyrna Freestanding Emergency Center" stated, "...Shared patient equipment will be cleaned with an approved disinfectant immediately after use..."

The following was observed during a patient care assessment in examination room #5 on 12/19/12:

9:45 AM to 9:58 AM
- Employee #1 placed the blood pressure cuff and the pulse oximetry monitor on Patient #33 to record vital signs
- After use, the cuff and pulse oximetry monitor were hung by their cords, over the IV pump and pole

10:24 AM to 10:28 AM:
- Patient #33 was escorted out of the exam room
- Employee #2 entered the room and removed linens and cleaned the stretcher
- Employee #2 exited the examination room and confirmed that he/she had completed cleaning the room and that it was ready for the next patient

Employee #2 failed to clean the:
- Blood pressure cuff
- Pulse oximetry monitor
- Cords to which these were attached
- IV pump and pole over which the equipment was draped

Employee #2 confirmed on 12/19/12 at 10:28 AM that he/she had failed to clean the blood pressure cuff/cord, pulse oximetry monitor probe/cord, and the IV pump and pole over which they were draped.

The observation was reviewed with Director of Emergency and Trauma Services A on 12/19/12 at 10:36 AM and confirmed that staff did not properly clean the examination room, and that all of the patient used equipment should have been disinfected immediately after the patient exited the room, in accordance with policy.

The observation and findings were also reviewed with Infection Preventionist A on 12/19/12 at 1:40 PM. Infection Preventionist A confirmed that staff should have disinfected all patient used equipment and that failure to do this was a breach in the hospital's infection control guidelines.
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II. Based on observation, policy review and staff interview, it was determined that for 2 of 2 food temperature testing observations, staff failed to follow the hospital's policy for infection control. Findings include:

The hospital policy entitled "Infection Prevention Guidelines for Food Services" stated, "...Hand-washing Policy is enforced...before starting to work...Disposable gloves must be changed with each activity or whenever gloves become...contaminated...All...equipment will be cleaned and sanitized after each use..."

A. The following was observed during food temperature testing by Dietitian A on 12/18/12 from 11:35 AM - 11:50 AM in the hospital kitchen:

With gloved hand wiped digital thermometer probe with alcohol swab and tested temperature of:
- Green beans
- Stuffing
- Potatoes
- Turkey
- Jello

With same gloved hand, touched thermometer probe and then placed probe in:
- Macaroni salad
- Fruit salad

- Gloves removed, left room

Dietitian A failed to:
- Disinfect the temperature probe between each food tested
- Disinfect the temperature probe after touching with gloved hand and prior to inserting probe into food
- Perform hand hygiene after glove removal

Director of Accreditation Services A, who was present at the time of observation, confirmed these findings.

During an interview with Infection Preventionist A on 12/19/12 at 11:17 AM, the hand hygiene observations during food temperature testing were discussed. Infection Preventionist A confirmed that Dietitian A had failed to meet the hospital's expectation for hand hygiene and infection prevention.
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B. The following was observed during food temperature testing by Dietitian B on 12/18/12 from 1:55 PM - 2:10 PM in the hospital kitchen:

Hands washed, donned gloves; With gloved hands:

- Opened and removed tray from refrigerator unit
- Dropped digital thermometer unit on floor
- Picked up thermometer unit from floor with gloved hands
- Opened alcohol prep pad and disinfected unit and thermometer probe
- Picked up opened alcohol prep pad and packaging and discarded
- Placed thermometer probe in orange jello, removed and disinfected probe
- Removed gloves, washed hands

- Donned gloves; With gloved hands temperature tested:

- Macaroni salad, disinfected probe
- Removed fruit salad tray from refrigerator unit
- Disinfected probe, temperature tested three (3) fruit salads (probe disinfected each time)
- Disinfected digital thermometer unit and probe
- Picked up coffee cup lid, alcohol prep pad and packaging from floor
- Placed thermometer unit in drawer
- Removed gloves

Dietitian B failed to:
- Change gloves/perform hand hygiene after contact with contaminated surfaces and prior to testing food
- Perform hand hygiene after glove removal

Director of Accreditation Services A, who was present at the time of observation, confirmed these findings.

During an interview with Infection Preventionist A on 12/19/12 at 11:25 AM, the hand hygiene observations during food temperature testing were discussed. Infection Preventionist A confirmed that Dietitian B had failed to meet the hospital's expectation for hand hygiene and infection prevention.
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III. Based on observation, policy review, job description review and staff interview, it was determined that for 1 of 41 medical records reviewed (Medical Record #24), staff failed to ensure that potentially contaminated substances were isolated to protect other staff from possible infection. Findings include:

The hospital policy entitled "OSHA Exposure Control/Blood Borne Pathogens" stated, "...for the prevention of occupational exposure of employees to blood borne pathogens as required by the Occupational Safety and Health Administration (OSHA)...employees must comply with procedures for Standard Precautions..."

Code of Federal Regulations, Title 29 Labor, Part 1910, Occupational Safety and Health Standards, effective 5/20/2010, stated, "...Contaminated means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface...all human blood and certain human body fluids are treated as if known to be infectious...Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials...minimize spattering and generation of droplets of these substances...Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with...potentially infectious materials...and when handling or touching contaminated items...Contaminated work surfaces shall be decontaminated with an appropriate disinfectant...Place in a secondary container if leakage is possible..."

A. Medical Record #24

During a review of the medical record with Nurse Manager E, a 12/13/12 document, which Nurse Manager E identified as page 1 of the "Critical Care Flow Sheet", contained vital sign assessments for 4:00 AM and 5:00 AM. The document was observed to have multiple darkish red brown spots consistent with blood stains on the paper.

This finding was confirmed upon observation by Nurse Manager E and Director of Patient Care Services A on 12/13/12 at 10:25 AM. Upon discovery, Nurse Manager E reported that:
- The soiled document should not have been placed/kept in the chart
- The page should have been removed and placed in a plastic page protector
- Infection Control Department and Medical Records Department should have been contacted for further guidance

I. Based on closed medical record review, policy and contract review and staff interview, it was determined that for 1 of 5 patients (Patient #27) in the sample that had expired in the hospital, staff failed to provide timely notification to the Organ Procurement Organization (OPO). Findings include:

The hospital policy entitled "Organ and Tissue Identification" stated, "...This policy assures that all potential organ, tissue and eye donors are identified, and that all potential donor families are provided the option of donation...At or near the time of every patient death, the nurse responsible for the patient's care, shall contact (name of OPO) Program..."

The hospital had a contract with the (name of OPO) program. Review of the contract entitled "Donor Institution Memorandum of Agreement" revealed, "...Donor Institution shall...implement and maintain current policies and procedures to provide for organ and tissue referral...establish a procedure for notification to (name of OPO) at or near time of death of every patient at Donor Institution..."

A. Patient #27
Review of the "Discharge Summary" dictated on 10/30/12 at 1:46 PM revealed that Patient #27 was pronounced dead at 1:00 PM on 10/30/12.

The "Certificate of Referral/Request for Anatomical Donations" document completed by the nurse, failed to include the date and time of referral to the (name of OPO) program. The document was signed off as completed by the nurse on 10/30/12 at 6:52 PM (5 hours and 52 minutes after Patient #27 was pronounced dead).

Review of medical record entries revealed no documented evidence to support that the date and/or time of referral to the (name of OPO) program was "timely".

Interview with Director of Accreditation Services A on 12/13/12 at 9:30 AM confirmed these findings.

II. Based on contract review and staff interview, it was determined that the contract with the (name of OPO) program failed to address all of the required criteria in the agreement. Findings include:

Review of the OPO document entitled "Donor Institution Memorandum of Agreement" revealed that the Agreement failed to define "imminent death" and "timely notification".

Interview with Director of Accreditation Services A on 12/13/12 at 10:05 AM confirmed this finding.

Based on observation, medical record review, job description review and staff interview, it was determined that respiratory therapy staff failed to provide the mechanical ventilatory and oxygen support that was ordered by the physician for 1 of 1 patients in the sample requiring ventilatory support. Findings include:

The hospital's job description for the respiratory therapist stated, "...Accountability...Accurately administers...respiratory care and protocols as ordered by the physician or respiratory protocols..."

Patient #24 - Intensive Care Unit (ICU)

A. Review of "Doctors Orders" dated 12/13/12 at 2:00 AM, included the following ordered ventilator settings:

- AC (Assist/Control): 16
- TV (Tidal Volume): 500
- Oxygen: 60%
- Peep (Positive End-Expiratory Pressure): +5

B. Review of Flowsheet & Ventilator Flow Sheet documentation revealed:

Both Respiratory Therapists (RT) A and RT B documented the patient was receiving mechanical ventilator support at a rate of AC 14, instead of the physician ordered rate of AC 16 on:

- 12/13/12 at 2:19 AM and 5:00 AM (documented by RT A)
- 12/13/12 at 9:40 AM (documented by RT B)

C. During a ventilator check on 12/13/12 at 11:00 AM, Patient #24's ventilator was observed to be set at:

- AC 14 (instead of AC 16 as ordered by the physician)
- Peep of +3 (instead of Peep +5 as ordered by the physician)

ICU Manager A, present at the time of observation, confirmed that the patient's ventilator settings were not in accordance with the physician's orders.

On 12/13/12 at 11:10 AM, the patient's observed ventilator settings and orders were reviewed with Respiratory Therapist B who stated the patient had been on the observed settings since 6:00 AM on 12/13/12 and that the pulmonologist would be advised.

Director of Respiratory Care and Neurodiagnostics A was interviewed on 12/18/12 at 8:45 AM and reported that:
- Respiratory Therapists were to implement mechanical ventilator settings in accordance with the physician's order
- Respiratory Therapists were to monitor ventilated patients every 4 hours and as needed
- Ventilator setting checks were included in monitoring.

On 12/18/12 at 9:15 AM, Director of Respiratory Care and Neurodiagnostics A confirmed that the Respiratory Therapist had not followed the physician's orders or hospital policy, as required.