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Based on review of hospital policies/procedures, medical records, interviews and review of documents provided by the hospital, it was determined that the hospital failed to provide an organized nursing service 24-hours per day with an adequate number of registered nurses and competent nursing staff to assess patients' care needs and deliver, assign and supervise the care required by each patient as evidenced by:

(A395) failure to require that a registered nurse (RN) assess, evaluate and document nursing care needs and patient response to interventions for 1 of 1 patient who expired during dialysis; (Pt # 25)

(A397) failure to require that patients who require admission to the High Observation Unit be under the direct care of a Registered Nurse, as required by hospital policy; and

(A405) failure to require that registered nurses administer medications according to practitioners' orders.

The cumulative effect of these systemic problems resulted in the hospital's failure to provide an adequate, organized nursing service.

Based on review of hospital policy/procedure, medical records and interview, it was determined that the hospital failed to require that restraints be used in accordance with an order of a Licensed Independent Practitioner (LIP) for 1 of 3 patients (Pt # 23).

Findings include:

Review of hospital policy/procedure titled Restraints revealed: "A new order is required in the event restraints are reapplied after discontinuation...."

Review of Pt # 23's medical record revealed a physician order for Left wrist Mitt restraint on 12/3/13 at 1400. On 12/3/13 at 1400, an RN documented: "...pt pulls O2 off and pulling on trach collar... monitoring closely...."

On 12/3/13 at 1600, an RN documented: "...Received (sic) order for Mitt to LUE (Left Upper Extremity). Mitt off while daughter here will replace when daughter leaves...."

On 12/3/13 at 1800, an RN documented: "...resting quietly. LUE (with) Mitt in place...."

The restraint flow sheet contained documentation on 12/3/13, that the patient had a wrist restraint in place at 1300, "off" at 1400; Mitts in place at 1500 and 1600. Spaces for restraints were blank at 1700 and 1800. From 1900 on 12/3/13 through 0600 on 12/4/13, documentation indicated that Mitt restraints were in place.

The medical record did not contain a new order for reapplication of restraints.

On 12/4/13 at 1300, an RN documented: "...daughter here. Mitts off while daughter here. She will let me know when she is ready to leave so we can place the mitts back on...."

On 12/4/13 at 1630, an RN documented: "...left mitt off hand, watching pt from monitor, pt seems more alert...."

On 12/4/13 at 1800, an RN documented: 'Pt (with) mitts on again. Continues to pull on tubes...."

The restraint flow sheet for 12/4/13 contained documentation that Mitt restraint was in place at 0700. From 0800 through 1800, spaces for restraint type and location were blank. At 1500 and 1700 nursing documented "off". From 1900 on 12/4/13 through 0500 on 12/5/13 the flow sheet contained documentation that left Mitt restraint was in place.

Pt # 23's medical record contained one physician's order for Left Wrist Mitt Restraint on 12/4/13 at 1400.

The medical record did not contain a new order for the reapplication of restraints.

The Chief Clinical Officer and Director of Quality Management confirmed, during interview conducted on 1/29/14, that nursing applied restraints, discontinued restraints and reapplied restraints without a new order as required by hospital policy.

Based on review of hospital policy/procedure, medical records and interviews, it was determined that the hospital did not require the removal of restraints at the earliest possible time for 3 of 3 patients (Pts # 21, 22, and 23).

Findings include:

Review of hospital policy titled Restraints revealed: "...Restraint may not be used unless the use of restraint is necessary to ensure the immediate physical safety of the patient, a staff member, or others...Any use of restraint must be ended at the earliest possible time, regardless of the length of time stated in the order...Restraint may only be used while the unsafe situation continues...."

Review of Pt # 21's medical record revealed:

The form titled 24 Hour Patient Record and Plan of Care dated 9/12/13, contained a section for documentation of restraints. A nurse documented in the section for Narrative Justification for Restraint/Alternate Measures and Interventions used: 7 a: "...The pt is pulling apart her trach connections with her R hand-Unable to keep her from pulling the tubes. Had to restrain the r hand for her safety...7p: when mitten released/pt is combative (with) R arm/hand attempts to pull on trach/vent...."

The flow sheet contained check marks and/or initials in spaces for every 2 hours from 0800 on 9/12/13, through 0600 on 9/13/13, indicating that the patient was re-assessed for the need and alternatives to restraints. The patient remained in restraints.

Review of nursing narrative notes revealed:
On 9/12/32, at 2000: "...pt resting (with) eyes closed, (no) (signs/symptoms) distress...."
On 9/13/13, at 0000: "...pt resting comfortably, (no) change) in pt status...mitten remains on R hand...."
On 9/13/13, at 0200: "...(no) (signs/symptoms) distress (no) (change) in pt status...."
On 9/13/13, at 0400: "...Pt repositioned. Mitten remains on R hand (no) (signs/symptoms) distress...."
On 9/13/13, at 0600: "...Pt resting (with) eyes closed (no) (signs/symptoms) distress. (no) (change) in pt status. Mitten remains on R hand...."

The form titled 24 Hour Patient Record and Plan of Care dated 9/13/13 contained nursing documentation in the restraint section for Narrative Justification for Restraint/Alternate Measures and Interventions used: 7a: "...Agitated, Pulling @ trach & PICC line...7p: When mitten released, pt attempts to pull trach/vent/PEG/Foley...."

The flow sheet contained check marks and/or initials in spaces every hour from 0700 through 1900 and every 2 hours from 2100 on 9/13/13, through 9/14/13, at 0500, indicating that the patient was re-assessed for the need and alternatives to restraints. The patient remained in restraints.

Review of nursing narrative notes revealed:
On 9/14/13, at 0200: "...Pt resting (with) eyes closed, (no) (signs/symptoms) distress...."
On 9/14/13, at 0400: "...Pt resting comfortably, (no) (change) in pt status...(no) (signs/symptoms discomfort.
On 9/14/13, at 0600: "...pt resting (with eyes closed, (no) (signs/symptoms distress, (no) change) in pt status overnight. (no) (signs/symptoms) distress. R hand mitten remain (sic) on...."

The form titled 24 Hour Patient Record and Plan of Care dated 9/14/13 contained nursing documentation in the restraint section for Narrative Justification for Restraint/Alternate Measures and Interventions used: 7a: (blank)...7p: pt pulls on tubing for trach placed 9/10...."

The flow sheet contained check marks and/or initials in spaces every 2 hours on 9/14/13, from 0700 through 9/15/13, at 0500, indicating that the patient was re-assessed for the need and alternatives to restraints. The patient remained in restraints.

Review of nursing narrative notes revealed:

On 9/14/13, at 0730: "...Pt resting in bed (with) eyes closed. Does not respond to verbal stimuli. soft mitten restraint...."
On 9/14/13, at 2330: "...pt sleeping. breathing unlabored...."
On 9/15/13, at 0230: "...Pt sleeping. (no) (signs/symptoms) of Distress...."

Review of Pt 22's medical record revealed:

The form titled 24 Hour Patient Record dated 10/12/13 contained documentation in the restraint flow sheet section indicating that the patient was placed in bilateral soft wrist restraints; that she required restraints due to "Pulling at Invasive Tubes/Lines" and that she was re-assessed for continual restraints every 2 hours from 0700, on 10/12/13, through 0500, on 10/13/13. The patient remained in restraints.

Review of nursing narrative notes revealed:

On 10/13/13:
at 0000: "...Pt sleeping...."
at 0200: "...Pt sleeping...."
at 0400: "...Pt sleeping...."
at 0600: "...Pt sleeping...."

The form titled 24 Hour Patient Record dated 10/16/13, contained documentation in the restraint flow sheet section indicating that the patient was placed in bilateral soft wrist restraints; and that she was re-assessed for continual restraints every 2 hours from 0700, on 10/16/13, through 0500, on 10/17/13. Spaces were marked every 2 hrs on 10/16/13 from 0800 through 1800, indicating that she required restraints due to "Pulling at Invasive Tubes/Lines". Those spaces were blank from 1900 on 10/16/13 through 0600 on 10/17/13. The patient remained in restraints.

Review of nursing narrative notes revealed:

On 10/17/13:
at 0030: "...Pt sleeping...."
at 0330: "...Pt sleeping....
at 0545: "...pt sleeping in Bed...No (change) in Pt's status throughout the night. No signs of distress...."

The form titled 24 Hour Patient Record and Plan of Care dated 10/17/13, contained nursing documentation in the restraint section for Narrative Justification for Restraint/Alternate Measures and Interventions used: 7p: "...Pt pulls @ ET (endotracheal) tubes-Bilateral Soft Wrist restraints...."

The flow sheet contained check marks and/or initials in spaces every 2 hours on 10/17/13, from 1900, through 10/18/13, at 0600, indicating that the patient was re-assessed for the need and alternatives to restraints. The patient remained in restraints.

Review of nursing narrative notes revealed:

On 10/18/13:
at 0330: "pt sleeping soundly...."
at 0530: "Pt sleeping...."

The form titled 24 Hour Patient Record and Plan of Care dated 10/18/13 contained nursing documentation in the restraint section for Narrative Justification for Restraint/Alternate Measures and Interventions used: 7a: "...Soft restraints Due to Remind Pt Not to Pull at Tubes...."

The flow sheet contained initials in spaces every 2 hours on 10/18/13, from 0700 through 1700, indicating that the patient was re-assessed for the need and alternatives to restraints. The patient remained in restraints.

Review of nursing narrative notes revealed:

On 10/18/13 at 1100: "...Pt sleeping peacefully in bed...No (signs/symptoms) of distress...."

Review of Pt # 23's medical record revealed:

The form titled 24 Hour Patient Record dated 12/10/13, contained documentation in the restraint flow sheet section indicating that the patient was placed in "Mitts" and that he was re-assessed for continual restraints every 2 hours from 0700, on 12/10/13, through 0500, on 12/11/13. Spaces were marked every 2 hrs on 12/10/13 from 0700 through 12/11/13, at 0500, indicating that he required restraints due to "Pulling at Invasive Tubes/Lines". The patient remained in restraints.

Review of nursing narrative notes revealed:

On 12/11/13:
at 0100: "...Pt appears to be sleeping @ this time...."
at 0630: "...Pt appeared to sleep @ long intervals tonight...."

The Chief Clinical Officer and Director of Quality Management confirmed, during interview conducted on 1/29/14, that the nursing narrative notes contained documentation which indicated that restraints were not removed at the earliest possible time.

Based on review of the Medical Staff Bylaws and Rules and Regulations, hospital policy/procedure, hospital documents, medical records and interviews, it was determined that the medical staff failed to enforce the bylaws to carry out its responsibilities as evidenced by:

1. failing to require that physicians authenticate verbal orders as required by Medical Staff Rules and Regulations for 8 of 20 current patients, (Pt #'s 2, 5, 6, 9,11, 17, 15 and 20).

2. failing to require that physicians authenticate order for 1 of 2 patients who received titrated medication, (Pt # 8);

3. failing to require that physicians write and/or verbally give complete orders for 1 of 1 patients who received titrated sedation (Pt # 22).

Findings include:

Review of the hospital's Medical Staff Bylaws revealed: "...Responsibilities of the Medical Staff...As a condition of appointment...reappointment...and continued Medical Staff membership, each Medical Staff member and each Practitioner who exercises Clinical Privileges...must continuously fulfill all of the following responsibilities and obligations to:...Abide by the Bylaws and Rules, and all other lawful standards and policies of the Medical Staff and the Hospital, including without limitation the governing documents for the Hospital that may be amended from time to time...."

Review of the hospital's Medical Staff Rules and Regulations revealed: "...All orders for treatment shall be in writing, written clearly, legible and completely and shall be dated, timed and signed by a practitioner....A verbal order shall be considered to be in writing if dictated to a duly authorized person (including ...registered nurse...)...verbal orders must be authenticated within forty-eight (48) hours...by the responsible practitioner...Allied Health Professionals who have been granted the privilege of making entries in the medical record will properly date, time and authenticate such entries and such entries will be countersigned by the responsible medical practitioner...."

Review of hospital policy titled Physician Orders revealed: "...Medications, treatments and diagnostic testing shall not be be given without a written order signed by a physician...Orders must be written clearly, legibly and completely...All orders, including telephone orders must be dated, timed and authenticated by the ordering practitioner or another practitioner who is responsible for the care of the patient and authorized to write orders...Elements that must be included in the order to be considered complete are the following: c) Exact Strength or concentration..d). Dose...e) Frequency...Specific instructions for use...Quantity and/or duration...Order sets/Physician protocols may be used...b) The ordering practitioner/physician will indicate which orders to implement. Only the indicated orders will be implemented...telephone orders are necessary, they are to be used infrequently...order authentication: all orders, including verbal orders, are dated, timed, and authenticated promptly. The following expectation is utilized to define "promptly"...verbal/telephone orders: within 48 hours...."

1. Review of the medical record for patient # 2, admitted 1/17/14, six (6) verbal orders not signed as authenticated by a practitioner;

Review of the medical record for patient # 5, admitted 1/6/14, revealed between the dates 11/9/14 through 1/25/14, five (5) verbal orders not signed as authenticated by a practitioner and five (5) orders and one (1) progress note written by employee # 23 were not countersigned by a practitioner as of 1/28/14;

Review of the medical record for patient # 6, admitted 1/17/14, revealed between 1/20/14 through 1/27/14 four (4) orders and one (1) progress note not countersigned by a practitioner as of 1/28/14;

Review of the medical record for patient # 9, admitted 1/11/14, revealed one (1) order written by a nurse practitioner not countersigned by a practitioner;

Review of the medical record for patient # 11, admitted 1/12/14, revealed thirteen (13) verbal orders not signed as authenticated by a practitioner;

Review of the medical record for patient # 17, admitted 1/11/14, revealed one (1) verbal order not authenticated by a practitioner;

Review of the medical record for patient # 15, admitted 12/25/13, revealed between 1/1/14 through 1/26/14, sixteen (16) verbal orders not signed as authenticated by a practitioner; and

Review of the medical record for patient # 20, admitted 1/13/14, revealed between 1/14/14 through 1/24/14 seven (7) verbal orders and three (3) progress notes not authenticated and/or countersigned by a practitioner.

The Nurse Manager confirmed in an interview conducted on 1/28/14 and 1/29/14 verbal orders for patient #'s 2, 5, 6, 9, 11,15, 17 and 20 were not authenticated by a practitioner, and written orders/progress notes for patient #'s 5, 6, 9, and 20 were not countersigned by a practitioner.

2. Review of the hospital's Medical Staff Rules and Regulations revealed:
All standing orders and/or protocols must be signed, dated and timed by the responsible practitioner when utilized...."

Review of hospital policy titled Physician Orders revealed: "...Medications, treatments and diagnostic testing shall not be be given without a written order signed by a physician...order sets/physician protocols may be used...these order sets will be signed, dated and timed...order authentication: the following expectation is utilized to define "promptly", verbal/telephone orders: within 48 hours...."

Review of the medical record for patient # 8, admitted 1/2/14, revealed orders for admission and continuous intravenous Heparin were not authenticated by the practitioner.

The Nurse Manager confirmed in an interview conducted on on 1/28/14 confirmed the admission orders and the order for continuous Heparin were not authenticated by a practitioner.

3. Review of Pt # 22's medical record revealed:

On 10/11/13 at 1210, an RN recorded "TORB" (Telephone Order Read Back) on a Physician's Orders form titled Midazolam (Versed) PCA (Patient Controlled Analgesia) Protocol.

The space for PCA DOSE was blank. The RN recorded "3 mg/hr" in the space designated for "Physician to determine rate if titrating infusion." The RN recorded "-3" in the space designated for "Maintain a RASS (Richmond Agitated Sedation Scale) score of".

On 10/11/13 at 1730, a physician signed a Physician's Orders form titled Midazolam (Versed) PCA Protocol. The space for PCA DOSE was blank. The physician recorded a titration rate for infusion of "3 mg/hr".The physician recorded 1-2 in the space designated for "Maintain a RASS score of."

The Chief Clinical Officer confirmed during interview conducted on 1/29/14 the orders for Midazolam were incomplete.

Based on review of hospital policies/procedures, medical records and interviews, it was determined that the hospital failed to require that an RN assess, evaluate and document the nursing care needs and patient response to interventions for 1 of 1 patient who expired during dialysis (Pt # 25) as evidenced by:

1. failing to require that an RN review, read back and verify Hemodialysis Physician Orders with an ordering practitioner when recording them as a telephone order for 1 of 1 patient who expired during dialysis;

2. failing to document nursing assessment of a hypotensive patient during dialysis, after change in patient condition and after interventions, for 1 of 1 patient who expired during dialysis;

3. failing to follow orders for hypotension and communicate and consult with physician regarding patient status for 1 of 1 patient who expired during dialysis; and

4. administering medication to a patient whose medical record contained documentation that the patient was allergic to the medication for 1 of 1 patient (Pt # 22).



Findings include:

1. Review of hospital policy titled Physician Orders revealed: "...Order sets/Physician protocols may be used...The ordering practitioner/physician will indicate which orders to implement. Only the indicated orders will be implemented...If telephone orders are necessary, they are to be used infrequently...Telephone orders will be repeated/read back to the ordering person, who will verbally verify that it was repeated correctly...."

Review of Pt # 25's medical record revealed a Hemodialysis Physician Orders sheet dated 1/20/14 and signed by an RN as a Telephone order on 1/17/14 at 1500. A Provider's name was written in the space designated for the provider who gave the telephone order. The box to document that the telephone order was read back and verified, was blank. On 1/30/14, the order had not been signed by a Physician or other Provider.

On 1/30/14, RN # 1 confirmed that the RN did not speak with the provider via telephone and obtain the orders.The order set was completed by the RN who wrote Provider # 4's name in the space. The RN believed that Provider # 4 was on call.

On 1/30/14, Provider # 4 confirmed that s/he had not given a telephone order for Pt # 25's dialysis scheduled for 1/20/14.

2. Review of hospital policy titled Scope of Practice revealed: "...The Registered Nurse assesses plans, directs and evaluates nursing services provided to the patient...Use critical thinking and nursing judgment to analyze client assessment data to:...Determine the clinical implications of client signs, symptoms, and changes as either expected, unexpected, or emergent situations...Evaluate the impact of nursing care including the...Client's response to interventions;...Need for alternative interventions;...need to communicate and consult with other health team members...."

Review of hospital policy titled: Assessment-Reassessment revealed: "...Nursing will re-assess each patient...or as warranted by the patient's medical condition and documented on the Nursing Care Record...Reassessment...more frequently as indicated...More frequent observations and assessments may be recorded...depending on the status of the patient...Additional reassessment will also be conducted and documented in the following circumstances:...With any change in medical condition or status...Response to treatment...Before, during and immediately after invasive procedure or treatments (e.g. Hemodialysis)...Documentation; Entered into the medical record but not limited to the Nursing Care Notes and Progress Notes...."

Review of Pt #25's medical record revealed documentation on a form titled "Hospital Program Hemodialysis."

Page 1 contained an RN's Pre-Treatment Assessment of Pt #25 and was signed by the RN on 1/20/14 at 0700.

Pages 2 and 3 contained documentation of the patient's dialysis:

The patient's pre-dialysis blood pressure (BP) on 1/20/14, at 0701 was 81/41.

The Certified Clinical Hemodialysis Technician (CCHT) initialed the following documentation on 1/20/14:

"...0701...BP 104/31...NS (Normal Saline) Flush 250 ml...Tx (Treatment) started...
... 0715...BP 76/37...Stable/Resting...
...0716...Decrease goal 2800 BP low...Stable/Resting...
... 0730...BP 76/24...Goal (decreased) 2500 low BP...Stable/Resting...
... 0745...BP 79/23...Stable/Resting...
...0800...BP 81/33...NS Flush 100 ml...Low BP/Stable/Resting...
... 0815...BP 81/37...Stable Resting...
... 0830...BP 72/37...Stable Resting...
... 0845...BP 76/36...NS Flush 100 ml...Goal (decreased) 2300 Low BP...
... 0850...BP 80/39...BP increased...
...0900...BP 84/36...Stable/Resting...
...0915...BP 89/28...Stable/Resting...
...0930...BP 87/41...Stable /Resting...
...0945...BP 86/26...Stable/Resting...
...1000...Venous...clotted...New line set up...
...1030...BP 110/77...Stable Resting...
...1045...BP 84/39...Stable Resting...
...1100...BP 69/36...NS Flush 300 ml...Stable Resting...UF ( Ultra Filtration) min (minimum)low
BP...informed RN...
...1107...BP 83/35...BP increased...Stable/Resting...
...1115...pt noted to be unresponsive, code blue called...."

The bottom of Pages 2 and 3 contained spaces for "Inpatient Staff Signature(s)." The dialysis RN and CCHT signed the forms without date or time.

The dialysis RN recorded an assessment of Pt # 25 at 0700, on Page 1, prior to the start of dialysis. The RN did not document any re- assessment of the patient during dialysis, i.e, when the patient's blood pressure decreased and the CCHT administered saline; after administration of the saline to assess the patient's response to the intervention; when the CCHT lowered the target fluid removal goal or when the patient's line clotted and he required a "new line set up" which was accomplished by the CCHT.

The Chief Clinical Officer stated, during interview conducted on 1/30/14, that the dialysis RN's signature recorded at the bottom of Pages 2 and 3, indicated that the RN supervised the care of the patient throughout the dialysis. However, she confirmed that each entry made by the CCHT when the patient's BP was changing, when the patient received saline due to low BP, when the target fluid removal goal was lowered or when a new line was "set up", did not contain documentation by the RN that s/he had assessed the patient.

3. Review of the Hemodialysis Physician Orders dated 1/20/14, recorded as a telephone order by an RN on 1/17/14 at 1500, and noted by an RN on 1/20/14 at 0600 revealed the following:

"...Treatment of Hypotension: for...confirmed BP systolic 90 mm/HG and symptomatic:...(Yes) Turn UFR (Ultra Filtration Rate) to 300 cc/hour...(Yes) Normal saline 100 ml IV bolus, may repeat times two (for a total of 300 ml), if no response notify physician...(Yes) Administer oxygen @ 2 L per nasal cannula. Document reason for administration and response...(Yes) Lower machine dialysate temperature to 36 degrees C...(Yes) Albumin 25% 100 ml IV, may repeat times two. Do not administer if lab value > 3. Do not administer within last 30 minutes of treatment...."

Provider #4 confirmed, during interview conducted on 1/30/14, that a patient would be symptomatic of hypotension if he/she had a glazed look, was sweating, was nauseous, experienced popping in his/her ears or had a brief loss of consciousness.

Employee # 23 stated during interview conducted on 1/30/14, that Pt # 25 was diaphoretic throughout dialysis and his breathing "wasn't right". His systolic blood pressure was frequently below 80 and the CCHT administered saline.

Employee # 25 stated during interview conducted on 1/30/14, that Pt #25 had no complaints during dialysis on 1/20/14. S/he stated that a symptom of hypotension would be dizziness. S/he stated that Pt # 25 slept through most of his dialysis.

Employee # 26 stated that staff administered saline whenever the patient's systolic BP was lower than 80. S/he stated staff administered 300 ml of saline after they had already administered 200 ml. S/he did not identify any interventions from the order set which were considered other than administration of saline for hypotension. The hemodialysis RN did not contact the physician or nurse practitioner for consultation.

Employee # 25 stated that staff understood from Pt # 25's provider that the patient's BP was low and nothing could be done about it.

Review of Pt # 25's hemodialysis record for 1/20/14 revealed that he had received 200 ml of saline by 0845 and the maximum amount permitted by orders was 300 ml. The UFR recorded by the CCHT ranged from a starting rate, of 750, to 780 at 0715, 730 at 0730, 630 from 0745 through 0845, 530 from 0900 through 0930, 720 at 0945, and 740 from 1030 through 1100. The UFR was not reduced to 300 cc/hr as permitted by orders for hypotension. Pt # 25 did not receive Albumin and the record did not contain documentation that it was considered. He was on oxygen at 2L at the start of dialysis. Staff did not contact a provider during the patient's dialysis.

4. Review of hospital policy titled Medication Administration-ACU revealed:"...Any identified medication allergies will be noted on the MAR for reference...Once the medication ordered can be obtained for administration, the medication will be verified...with the physician order...The medication will also be verified against all patient noted allergies for contraindications...Any concerns regarding the medication to be administered should be directed back to the pharmacy PRIOR to administering the medication...."

Review of Pt # 22's medical record revealed:

The Admission Database: "...Allergies: Propofol...Ativan...." The patient's Medication Administration Record contained documentation of the patient's allergies to Propofol and Ativan.

On 10/11/13 at 1530, a physician completed the Physician's Orders for Propofol (Diprivan) Protocol. On 10/11/13 at 1608, an RN initiated titration of Propofol as ordered. The patient continued to receive titrated Propofol through 10/12/12 at 1406.

On 10/20/13 at 1530, a physician ordered Ativan 2 mg IV Now X 1...Ativan 1-4 mg IV Q 1 hr prn agitation...."

Nursing documented administration of the Ativan as ordered.

On 1/30/14, the Director of Pharmacy confirmed that Pt # 22's medical record contained documentation that the patient was allergic to Propofol and Ativan. She stated that the RN obtained Propofol from the Med Dispense on "override" on a Friday night. The pharmacy was not reviewing overrides on Saturday at the time and did not find the contraindication to the administration.

The Director of Pharmacy also confirmed that the Ativan was obtained by an RN via override on a Sunday. A pharmacist discovered the contraindication on Monday and spoke with the nurse. The nurse administered the Ativan as a comfort measure.

On 1/30/14, the Director of Quality confirmed that Pt # 22's medical record did not contain documentation that nursing clarified patient allergies prior to the administration of Propofol or Ativan.

Based on review of hospital policy/procedure, nursing assignment sheets and interview, it was determined that the hospital failed to require that patients who require admission to the High Observation Unit be under the direct care of a Registered Nurse, as required by hospital policy.

Findings include:

Review of hospital policy titled High Observation Unit revealed: "...Purpose: provide a higher level of care for the patient during an acute phase of the disease process...The High Observation unit is a designated area in the ACU to provide close monitoring. The patient could have, but is not limited to the following acute illness phase:...Total Care...Episodes of being physiologically unstable: post code...Multiple system failure...Acute GI Bleed...Acute altered neurological status...Pneumothorax...Ventilated with a FiO2 (Fraction of inspired oxygen) 60%, PEEP (Positive End Expiratory Pressure) greater than 5...Orally intubated...Hemodynamically unstable...Critical Drips...Active titration of Vasopressors or anti-arrhythmic...Sedation/paralytics...Patients in the High Observation Unit will be under the direct care of a Registered Nurse...If the patient is currently in-house and develops a condition requiring high observation, the patient will be moved into our High observation area...."

Review of the nursing assignment sheet for the 7P-7A shift on 1/11/14 revealed that 7 patients were residing in the High Observation Unit., including Pts # 5 and 17. An RN was not assigned to provide direct care to Patients # 5 and 17. Pts # 5 and 17 were assigned to LPN # 8.

Review of the nursing assignment sheet for the 7P-7A shift on 1/23/14, revealed that 7 patients were residing in the High Observation Unit, including Pts # 7, 20 and 6. An RN was not assigned to provide direct care to Pts # 7, 20 and 6. Pts # 7, 20 and 6 were assigned to an LPN.

Review of the nursing assignment sheet for the 7A-7P shift on 1/27/13, revealed that 7 patients were residing in the High Observation Unit, including Pts in rooms 323, 324 and 325. An RN was not assigned to provide direct care to Pts in room 323, 324 and 325. Pts in those rooms were assigned to an LPN.

On 1/29/14, the Nurse Manager confirmed that the hospital policy required that patients whose care needs require placement in the High Observation Unit are to receive direct care from a Registered Nurse. She confirmed that on the dates listed above, the patients listed above received direct care from LPN's.

Based on review of hospital policies and procedures, medical records, and interviews, it was determined that the hospital failed to require that registered nurses administer medications according to practitioners' orders, as evidenced by:

1. failing to clarify incomplete physician orders for Midazolam (Versed) per PCA Protocol for 1 of 1 patient who received Versed for sedation (Pt. # 22);

2. failing to document titration of Versed as ordered by physician for 1 of 1 patient (Pt # 22);

3. discontinuing Propofol without a physician's order for 1 of 1 patient who received titrated Propofol (Pt # 22);

4. failing to administer Versed in accordance with the desired sedation score specified in physician orders for one of one patient who received Versed (Pt # 22); and

5. failing to administer medication as ordered for 1 of 1 patient who expired during dialysis (Pt # 25).

Findings include:

1. Review of hospital policy/procedure titled Physician Orders revealed: "...Orders must be written clearly, legibly and completely...Elements that must be included in the order to be considered complete are the following:...Exact Strength or concentration...Dose...Quantity and/or duration...Specific instructions for use...if the order does not contain all of the above elements, the order must be clarified to include the missing components. Until the order is clarified...nursing staff will not administer the medication...."

Review of Pt # 22's medical record revealed:

On 10/11/13 at 1210, an RN recorded "TORB" (Telephone Order Read Back) on a Physician's Orders form titled Midazolam (Versed) PCA (Patient Controlled Analgesia) Protocol.

The space for PCA DOSE did not contain documentation of a PCA Dose. The RN recorded "3 mg/hr" in the space designated for "Physician to determine rate if titrating infusion." The RN recorded "-3" in the space designated for "Maintain a RASS (Richmond Agitated Sedation Scale) score of".

On 10/11/13, an RN recorded administration of a starting PCA Dose "4 mg". The medical record did not contain an order for the PCA Dose of 4 mg.

On 10/12/13 at 1730, a physician signed a Physician's Orders form titled Midazolam (Versed) PCA Protocol. The space for PCA DOSE did not contain documentation of PCA Dose. The space for Continuous Infusion (Basal) did not contain documentation of the Basal rate. The physician recorded a titration rate for infusion of "3 mg/hr".The physician recorded 1-2 in the space designated for "Maintain a RASS score of."

On 10/12/13 at 1820, an RN recorded administration of Versed at a Basal Rate of 3 mg/hr.

The Chief Clinical Officer confirmed, during interview conducted on 1/29/14, that the orders for Versed were incomplete; nursing had not clarified the incomplete orders, and nursing had administered the Versed without complete orders.

2. Review of hospital policy/procedure titled Scope of Practice revealed: "...RN Standards Related to Scope...Administers prescribed aspects of care including treatments, therapies, and medications...."

Review of Pt # 22's medical record revealed:

The Physician's Orders recorded on 10/11/13 at 1210 for titration of Versed contained a titration rate of 3 mg/hr as described in # 1 above. The RN documented administration of 4 mg at 1253, 5 mg, at 1325, 6 mg at 1418, 7 mg at 1506 and 7 mg at 1608. The patient's level of sedation was "1".

The Physician's Orders recorded on 10/12/13 at 1730 for titration of Versed contained a titration rate of 3 mg/hr as described above. The RN documented administration of 3 mg/hr at 1820, 3 mg/hr at 1925, and 5 mg at 1945. The patient's level of sedation was "0" at 1820, 1925 and "+1" at 1945.

The Chief Clinical Officer confirmed, during interview conducted on 1/29/14, that nursing did not titrate the Versed as ordered.

3. Review of hospital policy/procedure titled Scope of Practice revealed: "...RN Standards Related to Scope...Administers prescribed aspects of care including treatments, therapies, and medications...."

Review of Pt # 22's medical record revealed:

On 10/11/13 at 1530, a physician signed a Physician's Orders form titled Propofol (Diprivan) Protocol. The order set included "...Initiate infusion a 5 mcg/kg/min....Maintain a RASS score of -3...."

On 10/11/13, at 1608, the RN initiated titration of the Propofol as ordered..

A Frequent Monitoring/Critical Medication Flowsheet dated 10/11/13, contained documentation of the Propofol infusing from 10/11/13 at 1608 through 10/12/13 at 1406. It contained documentation that the Propofol was not infusing from 1418 through 1731. At 1600, an RN documented: "...On Propofol vacation since 1436...." At 1831, an RN noted Propofol infusion rate as 3 mg/hr. An RN did not document any further infusion of Propofol. The medical record did not contain a physician's order to discontinue the Propofol.

The Chief Clinical Officer confirmed, during interview conducted on 1/29/14, that nursing discontinued the Propofol infusion without a physician's order.

4. Review of hospital document revealed a Level of Sedation (LOS) scale including: "S"=sleep, "1"= alert, through "5"= Unreactive to verbal/tactile stimuli. The LOS scale did not contain any negative numbers, such as -3.

Review of hospital document revealed "...Feature 4 (RASS)... Altered Level of Consciousness...." The RASS scale contained numbers from +4: "Combative, violent, immediate danger to staff" through -5: "Unarousable; No response to voice or physical stimulation."

Review of Pt # 22's medical record revealed:

On 10/11/13 at 1210, an RN recorded "TORB" (Telephone Order Read Back) on a Physician's Orders form titled Midazolam (Versed) PCA (Patient Controlled Analgesia) Protocol.

The RN recorded "-3" in the space designated for "Maintain a RASS (Richmond Agitated Sedation Scale) score of".

Nursing recorded administration of the Versed on 10/11/13 from 1253 through 1618, recording the "Level of Sedation" score.

On 10/12/13 at 1730, a physician signed a Physician's Orders form titled Midazolam (Versed) PCA Protocol. The physician recorded 1-2 in the space designated for "Maintain a RASS score of."

Nursing recorded Versed titration and LOS scores on the PCA Flow Sheet from 1820 on 10/12/12, through 0220 on 10/20/13. Scores entered included "-1" .
Nursing also recorded Versed titration on the Frequent Monitoring/Critical Medication Flowsheet, utilizing RASS scores.

The Chief Clinical Officer confirmed, during interview conducted on 1/29/14, that nursing utilized the LOS scale when the physician order required use of the RASS scale. She stated that she did not know that nursing was recording medication titration on two flowsheets.

5. Review of hospital policy/procedure titled Scope of Practice revealed: "...RN Standards Related to Scope...Administers prescribed aspects of care including treatments, therapies, and medications...."

Review of hospital policy/procedure titled Medication Administration-ACU revealed: "...If possible, the prescribed medication should be obtained from the Med Dispense system and administered as soon as possible...Administer the prescribed medication and record the administration on the MAR (Medication Administration Record)...."

Review of Pt # 25's medical record revealed:

On 1/10/14 at 1845, a physician wrote orders: "...3. Midodrine 5-10 mg po (by mouth) tid (three times a day) wm (with meals) prn SBP <110 (for systolic blood pressure less than 110)...4. Midodrine 5 mg 30 min prior to HD (Hemodialysis) and 5-10 mg q (every) 30-60 min on HD prn SBP <110...."

On 1/13/14 at 1925, a physician wrote orders:

"...1. (change) Midodrine to 10 mg po (by mouth) tid meal (three times a day with meals)...2. Also give 10 mg Midodrine 30-60 min prior to HD then additional 5 mg q 60 min X 2 on HD prn...."

Pharmacy entered the orders in the MAR as follows: "Midrodrine HCL po 2 Tab x 5 mg/ea prn with meals for hypotension prn SBP <110." and "Midodrine HCL 5 mg po 1 Tab x 5 mg/ea prn every Mon, Wed, and Fri for Hypotension...Give 30 minutes prior to HD and 5-10 mg Q 30-60 minutes on HD prn SBP < 110."

On 1/15/13, a physician documented: "...Did not receive Midodrine today. Ref (Refused) HD today...."

The MAR dated 1/15/14 at 0700 through 1/16/14 at 0659 contained documentation that the patient received 10 mg Midodrine on 1/15/14 at 2100.

The patient received dialysis on 1/16/14 from 1000 until 1400. An RN documented administration of 10 mg Midodrine at 0900 on 1/16 and 10 mg at 0255 on 1/17 in the spaces designated for administration with meals and documented administration of 5 mg at 1115 in a space designated for 30 minutes prior to HD and during HD. The patient's systolic blood pressure was less than 110 when recorded every 15 minutes during dialysis from 1000 through 1100 and from 1130 through 1400 and nursing did not administer a second dose of Midodrine during the dialysis as ordered.

The patient received dialysis on 1/17/14 from 0645 until 1045. His pre-treatment blood pressure was 83/43. The MAR contained documentation that the patient received 10 mg Midodrine with meals at 0730, 1200 and 1700. The Med Dispense documentation from pharmacy indicated that the medication was removed from the Med Dispense at 0535, 1301 and 1729. The patient's systolic blood pressure was less than 110 when recorded every 15 minutes during dialysis from 0645 through 1015. Neither the MAR, the Hemodialysis documentation nor the Med Dispense print out contained documentation that the Midodrine was removed from the Med Dispense or administered to the patient during dialysis as ordered.

The patient received dialysis on 1/20/14 from 0701 until 1115, when he was noted to be unresponsive. The patient's systolic blood pressure was less than 110 when recorded every 15 minutes during dialysis from 0701 through 0945 and from 1045 through 1107. Neither the MAR, the Hemodialysis documentation nor the Med Dispense print out contained documentation that the Midodrine was removed from the Med Dispense or administered to the patient during dialysis as ordered.

Provider # 4 confirmed during interview conducted on 1/29/14, that nursing did not administer medication to Pt # 25 as prescribed.

The Chief Clinical Officer confirmed during interview conducted on 1/29/14, that nursing did not administer medication to Pt # 25 as prescribed.