The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

LOMA LINDA UNIVERSITY MEDICAL CENTER-MURRIETA 28062 BAXTER ROAD MURRIETA, CA 92563 July 30, 2014
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to provide care in a safe setting, for one patient (Patient 8) who sustained a burn injury to the left calf during surgery, by failing to:

1. Ensure the Operating Room Staff was inserviced on the use of the surgical device;

2. Ensure the Operating Room Staff thoroughly assessed Patient 8's left calf prior to leaving the Operating Room (OR); and,

3. Ensure hospital staff were aware and instructed on the care to be provided to the burn injury to Patient 8's left calf.

These failures were the direct cause of Patient A sustaining a full thickness thermal burn to the left calf and for the wound not being treated until post-op day 3.


Findings:


1. During an interview with the Process Integrity Manager (PIM), on June 9, 2014, at 12:45 p.m., the PIM stated a facility investigation revealed Patient 8 sustained a burn to the left calf from an "Aquamantys Bipolar Handpiece" (a single use disposable instrument, part of the Aquamantys System) used during a surgical procedure.

The "Aquamantys System" was a surgical device that included a handpiece which used an electric current that generated heat to seal tissues in order to help prevent blood loss.

The PIM stated the facility's practice was to inservice all Operating Room Staff on devices used during surgical procedures.

The record for Patient 8 was reviewed. Patient 8 was admitted on [DATE], with the diagnosis of osteoarthritis of both knees (inflammation of the joint cartilage of the knees). The perioperative report dated April 29, 2014, indicated Patient 8 had knee replacement surgery for both knees.

The document indicated an "Aquamantys System" was used during Patient 8's surgery.

A review of the document titled, "Aquamantys System and Bipolar Sealers," dated January 9, 2013, indicated " Precautions. Surgery should be performed by persons with adequate training and preparation. Personnel should fully understand the nature and use of RF (radio frequency-electrical current) before performing electrosurgical procedures to avoid the risks of shock and burn hazards to both patient and operator..."

During an interview with the PIM, on June 9, 2014, at 2 p.m., the PIM was asked to provide documentation that indicated Operating Room Staff had training in the use of the Aquamantys System.

The PIM was unable to provide the documentation.

During a follow up visit on June 30, 2014, at 9:40 a.m., an interview was conducted with the PIM. The PIM stated the investigation of the incident involving Patient 8 sustaining a burn during surgery was completed. The PIM stated, the results of the investigation indicated there was a "lack of competency" of staff on the use of the Aquamantys device.

2. During an interview with the Process Integrity Manager (PIM), on June 9, 2014, at 12:45 p.m., the PIM stated a facility investigation revealed Patient 8 sustained a burn to the left calf from an "Aquamantys Bipolar Handpiece" during a surgical procedure.

On June 9, 2014, at 1:20 p.m., an interview was conducted with Operating Room Technician (ORT) 1. ORT 1 stated on April 29, 2014, he was the relief ORT during Patient 8's surgery. ORT 1 stated approximately 15 minutes after entering the operating room, he observed a "plume" of steam coming from underneath Patient 8's left leg. ORT 1 stated he said "stop, stop" to alert the staff, and he removed the Aquamantys Bi-polar handpiece that was positioned underneath Patient 8's left leg.

ORT 1 stated the device was positioned underneath Patient 8's leg with the on/off switch in the on position. ORT 1 stated Patient 8 had a surgical dressing on the left leg, and the area of the left leg that had contact with the device, was warm to touch.

ORT 1 stated he did not observe Operating Room Staff remove the dressing to check the area that came in contact with the activated device.

During a record review and concurrent interview, with Circulating Registered Nurse (CRN) 1, on June 9, 2014, at 2:05 p.m., CRN 1 stated, she was the Circulating Nurse for Patient 8's surgery, on April 29, 2014.

A Circulating Nurse is a Registered Nurse who manages the overall nursing care in the operating room, and helps maintain a safe environment (reference from Association Of Perioperative Nurses).

CRN 1 stated she did not remember what happened during Patient 8's surgical procedure.

CRN 1 stated she did not remove the dressing from Patient 8's left leg to assess the area that was in contact with the activated Aquamantys device.



3. A review of the record and concurrent interview with the CRN 1, was conducted on June 9, 2014, at 2:05 p.m.

The physician document titled, "Progress Notes", dated May 1, 2014, indicated, "Left calf blistering."

The physician document titled, "Progress Notes", dated May 2, 2014, indicated "Left calf blister..."

The physician document titled, "Progress Notes", dated May 3, 2014, indicated "Large blister over the calf with serous drainage."

The physician document titled, "Progress Notes", dated May 4, 2014, indicated "Large blister over the calf dressing still intact....Consider d/c (discharge) to home...in AM tomorrow."

The physician document titled "Progress Notes" dated May 5, 2014, indicated "Left calf blister with mild serous drainage."

The nursing document titled, "General Comments" entry date May 6, 2014, indicated, "Dr...(Physician A's name) aware of wound on left calf. New order for Santyl (a topical medication used to treat severe burns), declined order for ...(Physician's name) wound consultant."

The document titled "Initial inpatient wound care consult" dated May 9, 2014, indicated "On POD #7 (Patient Observation Day), nurse noted a large L (left) posterior calf wound post op(after surgery)...Large Left posterior calf full thickness wound...presumably caused by thermal burn injury from OR (Operating Room) Aquamantys hemostasis sealer."

CRN 1 reviewed the record and was unable to find documentation Physician A had informed nursing staff regarding Patient 8's left leg contact with Aquamantys device during the surgical procedure.

CRN 1 was unable to find documentation to indicate Physician A had ordered any treatment for the burn injury to Patient 8's left calf until the sixth day following the incident.
VIOLATION: MEDICAL STAFF CREDENTIALING Tag No: A0341
Based on interview and record review, the facility failed to ensure Ongoing Professional Practice Evaluations (OPPE's) were completed, for six of nine Medical Staff (Physicians' 3,4,5,6,7, and 9) credential files reviewed. This failed practice had the potential to place patients receiving services from these physicians, at risk for substandard healthcare.

Ongoing Professional Evaluations (OPPE) are documented summaries of ongoing data collection for the purpose of assessing a practioner's clinical competence.

Findings:

A review of the medical staff files was conducted on July 28, 2014. Six of the nine physician credential files did not contain completed OPPE.

During an interview with the Director of Medical Staff (DMS) on July 28, 2014, at 1:56 p.m., the DMS reviewed the files. The DMS was unable to find evidence the Department Chairs completed current OPPE for Physicians' 3, 4, 5, 6, 7, and 9. The DMS stated OPPE were to occur every six months.

During a concurrent interview with the Chief of Staff (CS) on July 28, 2014 at 1:56 p.m., the CS agreed that the OPPE were not current, and stated they are working on getting them up to date.

The facility policy titled, "Professional Practice Evaluation," (revised November, 2013), was reviewed on July 28, 2014. The policy defined ongoing professional practice evaluation as "The routine monitoring and evaluation of current competency for members of the medical staff, and the use of that information for ongoing evaluation for the purposes of determining whether to continue, limit or revoke any existing privileges and reappointment." The criteria listed included, "... review of operative and other clinical procedures performed and their outcomes, blood and pharmaceutical usage, requests for tests and procedures, and length of stay patterns."

The policy further indicated, "The Quality and Safety Department will generate OPPE profiles for a defined 6-month period-generally January through June and July through December."
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on interview and record review, the facility failed to ensure nursing assessments were implemented prior to and following the administration of pain medication in order to determine the effectiveness of the medication for five sampled patients (Patients 26, 27, 31, 13 and 18). This failure may lead to inadequate pain management for those patients.

Findings:

A review of the facility policy, "Pain Management Standards (Reviewed/Revised:12/04/2012)," was conducted. The policy indicated, "Pain management is a fluid and dynamic process, requiring screening/triage, diagnosis, treatment, reassessment and adjunct therapies to reach the patient's tolerable pain level...Management of pain is a patient right...Assessments and reassessments are to occur at regular intervals with routine vital signs, change in condition, new reports of pain/exacerbation of pain and within a clinically appropriate amount of time after interventions. Reassessments should include a new pain rating and should be recorded in the clinical documentation. Reassessment shall take place within a clinically appropriate time frame, depending on the type of intervention and the route of medication administration."

a. A review of Patient 26's record was conducted. Patient 26 was admitted to the facility on on July 25, 2014, for a total hip replacement.

A review of the Medication Administration Record indicated Patient 26 was receiving Toradol (pain medication) 15 mg. (milligrams) I.V. (intravenously) every 6 hours for pain and Norco (pain medication) 10 mg. 2 tablets orally every 4 hours for pain from a level 4 to 6.

An interview was conducted with Registered Nurse (RN) 4 on July 28, 2014, at 12:15 p.m. RN 4 stated when pain medication is administered the level of pain, on a scale from 1 to 10 (with 10 being the highest level of pain) must be assessed prior to and after administering the medication.

RN 4 further stated when a patient receives an oral medication the reassessment of pain should be done in one hour and with an IV pain medication, the reassessment should be done in 15 minutes to a half hour after the patient received the medication.

The following reflects when Patient 26 received Toradol and when pre-assessments of pain were implemented and when pain reassessments were implemented following medication administration;

-July 26, 2014, 12:37 p.m., pre: level 5, no reassessment,
-July 26, 2014, 5:50 p.m., pre: level 5, no reassessment,
-July 26, 2014, 11:38 p.m., no pre or post reassessment,
-July 27, 2014, 5:50 a.m., no pre or post reassessment,
-July 27, 2014, 12:32 p.m., no pre or post reassessment,
-July 27, 2014, 6:12 p.m., no pre or post reassessment.

The following reflects when Patient 26 received Norco and when pre-assessments of pain were implemented and when pain reassessments were implemented following medication administration;

-July 26, 2014, 10:49 p.m., pre: level 4, no reassessment,
-July 27, 2014, 6:12 p.m., pre: level 5, no reassessment,
-July 28, 2014, 1 a.m., pre: level 8, no reassessment,
-July 28, 2014, 9 a.m., pre: level 8, no reassessment.


b. A review of Patient 27's record was conducted. Patient 27 was admitted to the facility on on July 25, 2014, for right knee surgery.

A review of the Medication Administration Record indicated Patient 27 was receiving Toradol (pain medication) 15 mg. I.V. every 6 hours for pain, and Tramadol (pain medication) 100 mg, 2 tablets orally every 6 hours as needed for pain from a level 7 through 10.

An interview was conducted with Registered Nurse (RN) 4 on July 28, 2014, at 12:15 p.m. RN 4 stated when pain medication is administered the level of pain, on a scale from 1 to 10 (with 10 being the highest level of pain) must be assessed prior to and after administering the medication.

RN 4 further stated when a patient receives an oral medication the reassessment of pain should be done in one hour with an oral medication and with an IV pain medication, the reassessment should be done in 15 minutes to a half hour after the patient received the medication.

The following reflects when Patient 27 received Toradol and when pre-assessments of pain were implemented and when pain reassessments were implemented following medication administration;

-July 25, 2014, 11:13 p.m., no pre or post reassessment,
-July 26, 2014, 5:20 a.m., no pre or post reassessment,
-July 26, 2014, 12:49 p.m., pre: 7, no post reassessment,
-July 26, 2014, 5:28 p.m., pre: 10, no post reassessment,
-July 27, 2014, 12:49 a.m., pre: 5, no post reassessment,
-July 27, 2014, 7:07 a.m., pre: 4, no post reassessment,
-July 27, 2014, 12:25 p.m., pre 5, no post reassessment,
-July 27, 2014, 5:38 p.m., no pre or post reassessments,
-July 27, 2014, 11:14 p.m., no pre or post reassessments,
-July 28, 2014, 5:34 a.m., no pre or post reassessments.

The following reflects when Patient 27 received Tramadol and when pre-assessments of pain were implemented and when pain reassessments were implemented following medication administration;

-July 27, 2914, 2:23 p.m., pre: 5, no post reassessment.

c. A review of Patient 31's record was conducted. Patient 31 was admitted to the facility on on July 19, 2014, secondary to shortness of breath, which required surgical placement of chest tubes to drain fluid from the patient's lungs.

A review of the physician's progress note dated July 27, 2014, at 10:11 a.m., indicated Patient 31 was, "still having a lot of pain at the site of the chest tubes."

A review of the Medication Administration Record indicated Patient 31 was receiving Tramadol (pain medication) 50 mg, 1 tablet orally every 6 hours and Dialudid (pain medication) .5 mg. I.V. (intravenously), for pain indicated at a level from 7 to 10.

An interview was conducted with Registered Nurse (RN) 4 on July 28, 2014, at 12:15 p.m. RN 4 stated when pain medication is administered the level of pain, on a scale from 1 to 10 (with 10 being the highest level of pain) must be assessed prior to and after administering the medication.

RN 4 further stated when a patient receives an oral medication the reassessment of pain should be done in one hour with an oral medication and with an IV pain medication, the reassessment should be done in 15 minutes to a half hour after the patient received the medication.

The following reflects when Patient 31 received Tramadol and when pre-assessments of pain were implemented and when pain reassessments were implemented following medication administration;

-July 21, 2014, 6:04 a.m., no pre or post reassessment,
-July 21, 2014, 12:06 p.m., no pre or post reassessment,
-July 21, 2014, 11:10 p.m., no pre or post reassessment,
-July 22, 2014, 5:12 a.m., no pre or post reassessment,
-July 22, 2014, 12:30 p.m., no pre or post reassessment,
-July 23, 2014, 2:15 a.m., no pre or post reassessment,
-July 23, 2014, 6:02 a.m., no pre or post reassessment,
-July 23, 2014, 12:30 p.m, no pre or post reassessment.

The following reflects when Patient 31 received Dilaudid and when a pre-assessment of pain was implemented and when pain reassessment were implemented following medication administration;

July 21, 2014, 8 p.m., pre: 10, no post assessment.





d. On July 28, 2014, the record for Patient 13 was reviewed. Patient 13 was admitted to the facility on on July 9, 2014, with the diagnosis of fibroids and a hysterectomy (removal of uterus) was performed.

A review of the Medication Administration Record indicated Patient 13 was to receive Norco (pain medication) 5 mg/325 mg, two tablets orally every four hours as needed for a pain level of 7 to 10 (with 10 being the highest level of pain).

Patient 13 received Norco 5 mg/325 mg, two tablets on:
- July 13, 2014, at 7:32 p.m., with a pre-assessment pain level of 7 and no pain reassessment following the administration of the pain medication.
- July 14, 2014, at 12:20 a.m., with a pre-assessment pain level of 7 and no pain reassessment following the administration of the pain medication.
- July 14, 2014, at 4:57 a.m., with a pre-assessment pain level of 9 and no reassessment following the administration of the pain medication.

e. On July 28, 2014, the record for Patient 18 was reviewed. Patient 18 was admitted to the facility on on July 27, 2014, with the diagnosis of term pregnancy in labor.

A review of the Medication Administration Record indicated Patient 18 was to receive Norco 5 mg/325 mg, one tablet orally every four hours as needed for a pain level of 4 to 6.

Patient 18 received Norco 5 mg/325 mg, one tablet on:
- July 28, 2014, at 9:02 p.m., with a pre-assessment pain level of 5 and no pain reassessment following the administration of the pain medication.
- July 29, 2014, at 3:45 a.m., with no pre-assessment pain level and no pain reassessment following the administration of the pain medication.

During an interview with the Director of Medical/Surgical (DMS), on July 30, 2014, at 10:50 a.m., she stated a pain assessment/numeric value should be obtained prior to the administration of pain medication. The DMS stated post administration of pain medication reassessment involves medication effective - yes or no, and then a "quick/rapid pain assessment" where a numeric value was assigned. The DMS stated the pre and post pain medication administration assessments should include an assessment/numeric value of the patient's pain level.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure plans of care were initiated and/or updated for six sampled patients (Patients 9, 11, 12, 27, 28 and 29). This had the potential to result in the patient, the patient's representative, and interdisciplinary team being unaware of the plan of care for the patient.

Findings:

a. On July 28, 2014, the record for Patient 9 was reviewed. Patient 9 was admitted to the facility Intensive Care Unit (ICU) on July 27, 2014, at 9:44 a.m., with diagnoses including chest pain and bleeding.

Patient 9 had an esophagogastroduodenoscopy (EGD - procedure in which a thin scope with a light and camera at its tip is used to look inside of the esophagus, stomach, and first part of the small intestine, to identify and treat conditions such as upper digestive system bleeding) performed on July 27, 2014.

Patient 9 received blood transfusions on July 27 and 28, 2014.

There was no indication a plan of care had been initiated for Patient 9.

b. On July 28, 2014, the record for Patient 11 was reviewed. Patient 11 was admitted to the facility ICU on July 27, 2014, at 3:01 p.m., with the diagnosis of [DIAGNOSES REDACTED]

Patient 11 had a bilateral pulmonary embolism (BPE - embolism of a [DIAGNOSES REDACTED] or one of its branches produced by foreign matter and most often a blood clot originating in a vein of the leg or pelvis and marked by labored breathing, chest pain, fainting, rapid heart rate, cyanosis, shock, and sometimes death).

Patient 11 was transferred to acute care Facility B on July 28, 2014, at 5 p.m.

There was no indication a plan of care had been initiated for Patient 11.

c. On July 28, 2014, the record for Patient 12 was reviewed. Patient 12 was admitted to the facility ICU on July 22, 2014, with the diagnosis of [DIAGNOSES REDACTED]

Patient 12 received a blood transfusion on July 24, 2014.

There was no indication a plan of care had been initiated for Patient 12.

During an interview with Registered Nurse (RN) 1, on July 28, 2014, at 10:10 a.m., he reviewed the records for Patient 9, 11, and 12 and was unable to find documentation of plans of care being initiated. RN 1 stated plans of care should be initiated by the nurse "upon admission." RN 1 stated he did not know why plans of care were not initiated for Patients 9, 11, and 12.

During an interview with the Director of Critical Care (DCC), on July 30, 2014, at 11:20 a.m., she stated plans of care should be initiated within eight (8) hours of admission.

d. A review of Patient 27's record was conducted. Patient 27 was admitted to the facility on on July 25, 2014. On July 25, 2014, the patient had right knee surgery secondary to osteoarthritis.

A review of the Medication Administration Record indicated Patient 27 was receiving Toradol (pain medication) 15 mg, (milligram) intravenously every 6 hours for pain, and Tramadol (pain medication) 100 mg, 2 tablets orally every 6 hours as needed for pain from a level 7 through 10 (the highest level of pain).

A review of the interdisciplinary care plans indicated care plans initially addressed the patient's alteration in comfort (pain). The care plans however were not updated during the night shifts (7 p.m. to 7 a.m.) on July 26 and 27, 2014, to address the patient's pain and other potential issues.

An interview was conducted with Registered Nurse (RN) 4 on July 28, 2014, at 2 p.m. RN 4 stated care plans need to be updated every shift to reflect the patients condition, changes and updates.

e. A review of Patient 28's record was conducted. Patient 28 was admitted to the facility on on July 24, 2014, with a diagnosis of [DIAGNOSES REDACTED]

A review of the interdisciplinary care plans failed to show that the patient's care plan was updated on July 25, 2014, to address his urinary catheter or his anemia.

An interview was conducted with Registered Nurse (RN) 4 on July 28, 2014, at 2 p.m. RN 4 stated care plans need to be updated every shift to reflect the patients condition, changes and updates.

f. A review of Patient 29's record was conducted. Patient 29 was admitted to the facility on on July 25, 2014, with diagnosis of [DIAGNOSES REDACTED]

Patient 29 received blood transfusions on July 25 and 27, 2014.

A review of the interdisciplinary care plans failed to show that the patient's care plan was updated on July 26, 2014, to address his blood transfusions.

An interview was conducted with Registered Nurse (RN) 4 on July 28, 2014, at 2 p.m. RN 4 stated care plans need to be updated every shift to reflect the patients condition, changes and updates.

The facility policy and procedure titled "Standards of Care for Acute and Critical Care" dated March 9, 2011, revealed "... The RN caring for acute and critically ill patients develops a plan of care that prescribes interventions to attain expected outcomes in Care Plan Orders section. ... Initiated within 8 hours of admission. Re-evaluated each shift. ... Plan of care will be reviewed and updated as necessary every shift. ..."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on observation, interview and record review, the facility failed to:

1. Ensure medication preparation and administration were performed per accepted standards of practice for one sick neonate (Patient 15). In addition, the facility did not have a policy and procedure in place which addressed the preparation and administration of medications to sick neonates per acceptable standards of practice.

This had the potential to result in the incorrect medication/dosage being administered to a fragile, sick neonate.

2. Ensure medication was administered per the physician's order for Patient 31. This failure resulted in a pain medication, Tramadol, being administered one hour and 49 minutes early, which could lead to medical instability.

Findings:

The National Association of Neonatal Nurses position statement for medication safety, dated July 2011, revealed "... Clear, specific policies and procedures that outline how medications are ordered, processed, dispensed, administered, and monitored have been established and are accessible to all healthcare professionals involved in the medication use process in the NICU (Neonatal Intensive Care Unit). ... All medications and their calculations are checked by another licensed professional prior to administration. ..."

1. On July 28, 2014, at 11:15 a.m., a tour of Perinatal Services was conducted.

Patient 15 was observed in the nursery with her parents and during a concurrent interview with Registered Nurse (RN) 2, she stated Patient 15's mother had been discharged the previous day and Patient 15 was in the nursery for antibiotic (medications used to treat bacterial infections) treatment.

On July 28, 2014, the record for Patient 15 was reviewed. Patient 15 was admitted to the facility on on July 25, 2014, at 10:27 p.m. Patient 15 was delivered vaginally, had a tight nuchal cord times two (umbilical cord wrapped around the neonates neck twice), and had apgars of 6 at one minute and 7 at five minutes (on a 0 to 10 scale, indicates fetal well being by assessing color, heart rate, reflexes, muscle tone and respiratory effort).

On July 26, 2014, Patient 15's white blood cell count (disease fighting cells) was elevated, C-reactive protein (CRP - non-specific blood test used if a high suspicion of tissue injury or infection was suspected) was elevated, and transcutaneous bilirubin (non-invasive measurement of bilirubin, substance made as red blood cells break down) was elevated.

The physician ordered Ampicillin, Gentamicin, and phototherapy as treatment.

On July 27, 2014:
- at 12:47 a.m., Patient 15 was given Ampicillin (an antibiotic) 100 milligrams (mgs) per kilogram (kg) of body weight via intravenous (directly into a vein) injection which was performed by a nurse and verified/witnessed by another nurse.
- at 12:54 a.m., Patient 15 was given Gentamicin (an antibiotic) 4 mgs/kg via intravenous infusion which was performed by a nurse and verified/witnessed by another nurse.
- at 1 a.m., Patient 15 was started on continuous phototherapy (light treatment which turns bilirubin into products that can be eliminated by the body).
- at 12:56 a.m., Patient 15 was given Ampicillin 281 mgs via intravenous injection which was performed by a nurse and verified/witnessed by another nurse.

On July 28, 2014:
- at 2:15 a.m., Patient 15 was given Ampicillin 281 mgs via intravenous injection which was performed by a nurse. There was no indication the Ampicillin preparation/administration was verified/witnessed by another nurse.
- at 2:30 a.m., Patient 15 was given Gentamicin 11.24 mg via intravenous infusion which was performed by a nurse. There was no indication the Gentamicin administration was verified/witnessed by another nurse.

During an interview with Registered Nurse (RN) 2, on July 28, 2014, at 11:30 a.m., she reviewed the record and was unable to find documentation of a nurse verifying/witnessing the Ampicillin preparation/administration at 2:15 a.m. and the Gentamicin administration at 2:30 a.m., on July 28, 2014. RN 2 stated the neonatal nurse prepared the Ampicillin based on the neonates weight and this was verified/witnessed by another neonatal nurse. She stated the Gentamicin did not need to be verified/witnessed because the Gentamicin was prepared by pharmacy but usually the neonatal nurses would verify/witness medications administered to a sick neonate.

During an interview with the Director of Pharmacy (DP) and the Medication Safety Pharmacist (MSP), on July 30, 2014, at 8:50 a.m., they stated for all medications prepared for neonates, the medications were checked by two pharmacists, and there was no policy but this was the standard of practice. When the DP was asked if the pharmacy prepared the intravenous Ampicillin, the DP stated the Ampicillin was prepared by nursing and currently nursing did not have a practice of double checking neonatal medications which were prepared and administered by nursing.

The facility does not have a policy and procedure addressing the preparation and administration of medications to sick neonates.

2. A review of Patient 31's record was conducted. Patient 31 was admitted to the facility on on July 19, 2014, secondary to shortness of breath, which required surgical placement of chest tubes to drain fluid from the patient's lungs.

A review of the Medication Administration Record indicated Patient 31 was receiving Tramadol (a pain medication) 50 milligrams orally every 6 hours.

A review of the Medication Details indicated on July 23, 2014, Patient 31 refused the midnight dose of Tramadol. The Tramadol was subsequently administered to Patient 31 at 2:16 a.m.

Further review of the Medication Administration Record indicated Patient 31 received the next dose of Tramadol at 6:02 a.m., 1 hour and 49 minutes before the scheduled 6 hour time span per the physician's order for the medication to be administered every 6 hours.

An interview was conducted with the DP on July 30, 2014, at 8:50 a.m. The DP stated when a re-timing of a medication was needed the physician had to be notified in order to modify or change the timing of the medication. The DP stated the pharmacy was not notified about the Tramadol being administered early. He further stated administering a medication too early was considered a medication error and an incident report needed to be documented.
VIOLATION: BLOOD TRANSFUSIONS AND IV MEDICATIONS Tag No: A0409
Based on interview and record review, the facility failed to ensure patient consents were complete and vital signs were taken when blood transfusions were administered, per facility policy and procedure, for four sampled patients (Patients 9, 12, 29, and 30). This failure had the potential to result in the patients not being informed of the risks, benefits, and alternatives to blood transfusions, and a delay in the recognition of a transfusion reaction.

Findings:

a. On July 28, 2014, the record for Patient 9 was reviewed. Patient 9 was admitted to the facility on on July 27, 2014, with diagnoses including chest pain and bleeding.

The "Blood Transfusion Informed Consent" document, dated July 27, 2014, and signed by Patient 9, did not indicate if the patient accepted blood transfusions, accepted the administration of alternatives, or refused blood products.

The "Blood Bank Transfusion Form" dated July 28, 2014, indicated 306 milliliters (mls) of red blood cells was given to Patient 9, by intravenous infusion (directly into a vein), from 1:50 a.m. until 3:50 a.m.

The record indicated patient vital signs were documented at 1 a.m., 2 a.m., 3 a.m., and 4 a.m.

There was no indication Patient 9's vital signs were taken prior to the transfusion beginning (1:50 a.m.), 15 minutes after the transfusion had been started (2:05 a.m.), and post transfusion (3:50 a.m.).

b. On July 28, 2014, the record for Patient 12 was reviewed. Patient 12 was admitted to the facility on on July 22, 2014, with the diagnosis of chest pain.

The "Blood Transfusion Informed Consent" document, dated July 22, 2014, did not indicate the "Risks and Benefits/Informed Consent of blood transfusion were discussed with the patient/surrogate" by the physician and recorded in the record; and, "If not recorded the physician must complete and sign form."

There was no indication in the record the physician discussed the risks and benefits of blood transfusions with Patient 12, or the physician signed the "Blood Transfusion Informed Consent" form.

The "Blood Bank Transfusion Form," dated July 24, 2014, indicated 350 mls of red blood cells were given to Patient 12, by intravenous infusion, from 10:40 a.m. until 11:34 a.m.

The record indicated patient vital signs were documented at 10 a.m., 11 a.m., 11:16 a.m., 12 p.m., 1 p.m., and 1:20 p.m.

There was no indication Patient 12's vital signs were taken prior to the transfusion beginning (10:40 a.m.), 15 minutes after the transfusion was started (10:55 a.m.), and post transfusion (11:34 a.m.).

The "Blood Bank Transfusion Form," dated July 24, 2014, indicated 350 mls of red blood cells were given to Patient 12, by intravenous infusion, from 12 p.m. until 12:55 p.m.

There was no indication Patient 12's vital signs were taken 15 minutes after the transfusion started (12:15 p.m.) and post transfusion (12:55 p.m.).

During an interview with Registered Nurse (RN) 1, on July 28, 2014, at 10:10 a.m., he reviewed the record and was unable to find documentation of complete blood transfusion consents for both Patients 9 and 12. RN 1 stated the physician explained the risks and benefits of blood transfusion to the patient or the patient's responsible party, and the consent should be completed prior to obtaining blood from the laboratory. In addition, RN 1 stated the patient's vital signs should be taken and recorded just prior to the administration of blood, 15 minutes after the start of the transfusion, and at the end of the transfusion per facility policy and procedure.

During an interview with the Director of Critical Care (DCC), on July 30, 2014, at 10:50 a.m., she stated the vital sign monitors in the Intensive Care Unit (ICU) were automatic and were generally set at a one hour interval. The DCC stated the automatic interval could be adjusted by the nurse or the machine could be triggered to take a set of vital signs. In addition, the DCC stated vital signs for patients receiving a blood transfusion should be taken prior to the transfusion starting, 15 minutes after the transfusion has begun, and post transfusion, which was the facility's policy and procedure.







c. A review of Patient 29's record was conducted. Patient 29 was admitted to the facility on on July 25, 2014, with rectal bleeding and renal failure.

Patient 29 received one unit of red blood cells on July 27, 2014. The transfusion began at 5:40 a.m. and concluded at 8:50 a.m.

The documentation failed to show vital signs were taken prior to the transfusion or after the transfusion concluded.

An interview was conducted with Registered Nurse (RN) 5, on July 28, 2014, at noon. RN 5 stated when transfusing blood, the vital signs have to be taken prior to the administration of the unit, 15 minutes into the transfusion, and at the end of the transfusion. RN 5 further stated, when there are no baseline vital signs, it was difficult to determine if the patient had a transfusion reaction.

d. A review of Patient 30's record was conducted. Patient 30 was admitted to the facility on on July 23, 2014. On July 24, 2014, the patient had a surgical incision and drainage of fluid from his left knee.

Patient 30 received one unit of red blood cells on July 27, 2014. The transfusion began at 2:30 p.m. and concluded at 5 p.m.

The documentation failed to indicate vital signs were taken prior to the transfusion or after the transfusion concluded.

An interview was conducted with Registered Nurse (RN) 5, on July 28, 2014, at noon. RN 5 stated when transfusing blood, the vital signs have to be taken prior to the administration of the unit, 15 minutes into the transfusion, and at the end of the transfusion. RN 5 further stated when there were no baseline vital signs it was difficult to determine if the patient had a transfusion reaction.

The "Blood Transfusion Informed Consent," dated July 27, 2014, did not indicate the "Risks and Benefits/Informed Consent" of blood transfusion were discussed with the patient/surrogate by the physician and recorded in the record; and, "If not recorded the physician must complete and sign form."

There was no indication in the record which showed the physician discussed the risks and benefits of blood transfusions with Patient 30.

The facility policy and procedure titled, "Administration of Blood and Blood Products," reviewed/revised July 30, 2013, revealed, "... The "Consent to Transfusion" form is to be used for documenting patient consent for transfusion. The physician shall discuss the need for, risk of and alternatives to blood transfusion with the patient or patient's surrogate decision-maker prior to completing the transfusion consent form and the transfusion. ... Additionally, vital signs must be recorded before, 15 minutes after the start and post-transfusion. ..."
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure surgical services were consistent with needs and resources for one patient (Patient 8), by failing to:

1. Implement and enforce their policy and procedure regarding safety in the operating room;

2. Develop and implement a policy and procedure regarding the surgical care for a bilateral knee surgical procedure; and

3. Develop and implement a policy and procedure regarding the use of a surgical device (Aquamantys Bi-polar handpiece).


These failures resulted in:


1. Patient 8 sustaining a full thickness thermal burn injury to the left calf.


Thermal burns are burns to the skin caused by an external heat source. A full thickness burn is the most severe burn involving all layers of skin. Nerve endings, small blood vessels, hair follicles, sweat glands are all destroyed. Subcutaneous fat tissue, muscle and bone may also be involved (Referenced from Derm Net NZ (December 29, 2013)-a resource for general practioners and dermalogists).


2. The Surgical Staff to be unaware of what surgical care was to be provided during a surgical procedure, and


3. The Surgical staff to be unaware of what precautions and safeguards were needed for a surgical device.


Findings:


1. An interview was conducted with the Operating Room Director (ORD), on June 9, 2014, at 1:45 p.m. The ORD stated, the facility had policies and procedures regarding the safety of patients during surgical procedures.

The ORD stated some surgeons used an Aquamantys Bi-polar handpiece (a surgical device which used an electrical current that generated heat to seal skin tissue, in order to help prevent blood loss). The ORD stated the device was used by the surgeon when an incision (cut) was made into the skin.

The ORD stated when the surgeon was not using the device, the device was removed from the operating table.

The record for Patient 8 was reviewed. Patient 8 was admitted on [DATE], with the diagnosis of osteoarthritis of both knees (inflammation of the joint cartilage of the knees). The perioperative report dated April 29, 2014, indicated Patient 8 had knee replacement surgery for both knees.

The document indicated the surgeon used an "Aquamantys System" during Patient 8's surgery.

During an interview with the ORD, on June 9, 2014, at 1:45 p.m., the ORD stated she was informed by the Wound Care Nurse, on May 6, 2014, Patient 8 had sustained a burn injury to the left calf.

The ORD stated the facility's investigation of the incident, revealed the surgeon placed the device under Patient 8's left leg, after using the device.

During a follow up visit conducted on July 30, 2014, the record for Patient 8 were reviewed. The records indicated Patient 8 received extensive wound treatments to the left calf following discharge from the facility on May 9, 2014. The records further indicated, Patient 8 was readmitted on [DATE], for a surgical procedure to remove large areas of necrosis (dead tissue) from the burn injury site.

On July 30, 2014, at 9:40 a.m., an interview was conducted with the Process Integrity Manager (PIM). The PIM stated, the facility's investigation of the incident was completed. The PIM stated Patient 8 sustained a full thickness thermal burn to the left calf from the Aquamantys device.

Thermal burns are burns to the skin caused by an external heat source. A full thickness burn is the most severe burn involving all layers of skin. Nerve endings, small blood vessels, hair follicles, sweat glands are all destroyed. Subcutaneous fat tissue, muscle and bone may also be involved (Referenced from Derm Net NZ (December 29, 2013)-a resource for general practioners and dermalogists).

The PIM stated staff did not follow the facility's policy and procedures regarding safety during Patient 8's surgical procedure on April 29, 2014.

The facility policy and procedure titled, "Fire Prevention in the Operating Room...," dated November 12, 2013, indicated, "All staff entering the Perioperative, Procedural/Invasive areas will demonstrate knowledge...of safety and prevention."

The policy further indicated, "Controlling Heat Sources...Never place the cautery pencil on the patient..."

Patient 8 sustained a full thickness thermal burn to the left calf which required extensive follow up wound treatments and surgical intervention.

2. During an interview with the ORD, on June 9, 2014, at 1:45 p.m., the ORD stated facility policies and procedures were used to inform staff of what appropriate protocols (rules) to follow during surgical procedures.

The ORD stated Patient 8 had a bilateral knee (both knees) surgical procedure completed on April 29, 2014. The ORD stated, "We (the facility) have never done bilateral knees (procedure) before."

The ORD stated, during the procedure, Patient 8 sustained a burn injury to the left calf.

During the Quality Assessment Performance Improvement (QAPI) interview conducted on July 30, 2014, at 10:50 a.m., the Director of Quality (DQ) stated the incident involving Patient 8 was reviewed.

The DQ stated the review revealed the facility did not have a policy and procedure regarding the surgical care required during a bilateral knee surgical procedure.

3. During an interview with the Process Integrity Manager (PIM), on June 9, 2014, at 12:45 p.m., the PIM stated a facility investigation revealed Patient 8 sustained a burn to the left calf from an "Aquamantys Bipolar Handpiece"during a surgical procedure, on April 29, 2014.

A review of the record with the admitted [DATE], indicated the surgeon used the "Aquamantys System" during Patient 8's surgery.

The "Aquamantys System" was a surgical device that included a handpiece which used an electric current that generated heat to seal tissues in order to help prevent blood loss.

The document titled, "Initial Inpatient wound Care Consult," dated May 9, 2014, indicated, "On POD #7 (Patient Observation Day), nurse noted a large L (left) posterior calf wound post op(after surgery)...Large Left posterior calf full thickness wound...presumably caused by thermal burn injury from OR (Operating Room) Aquamantys hemostasis sealer."

During a follow up visit on June 30, 2014, at 9:40 a.m., an interview was conducted with the PIM. The PIM stated the facility did not have a policy and procedure for the Aquamantys Bi-polar Device.

A review of the document titled, "Aquamantys System and Bipolar Sealers," dated January 9, 2013, indicated, "Precautions. Surgery should be performed by persons with adequate training and preparation. Personnel should fully understand the nature and use of RF (radio frequency-electrical current) before performing electrosurgical procedures to avoid the risks of shock and burn hazards to both patient and operator..."
VIOLATION: OPERATIVE REPORT Tag No: A0959
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure an operative report included complications that occurred during a surgical procedure, for one patient (Patient 8).

This failure had the potential for other healthcare providers to not have an accurate accounting of the surgical procedure in order to identify complications. In addition, the facilities failure to document the patient's complications had the potential to result in a delay of treatment for Patient 8.

Findings:

During an interview with the Process Integrity Manager (PIM), on June 9, 2014, at 12:45 p.m., the PIM stated Patient 8 sustained a burn injury from a surgical device (an Aquamantys Bi-polar handpiece- a surgical device which used an electrical current that generated heat to seal skin tissue in order to help prevent blood loss during a bilateral knee replacement procedure.

The record for Patient 8 was reviewed. Patient 8 was admitted on [DATE], with the diagnosis of osteoarthritis of the knee (inflammation of the knee joint cartilage). The perioperative report indicated Patient 8 had knee replacement surgery for both knees.

On June 9, 2014, at 1:20 p.m., an interview was conducted with Operating Room Technician (ORT) 1. ORT 1 stated on April 29, 2014, he was the relief ORT during Patient 8's surgery. ORT 1 stated, approximately 15 minutes after entering the operating room, he observed a "plume" of steam coming from underneath Patient 8's left leg. ORT 1 stated he said, "Stop, stop," to alert the staff, and removed the Aquamantys Bi-polar handpiece that was positioned underneath Patient 8's left leg.

ORT 1 stated the device was positioned underneath Patient 8's leg with the on/off switch in the on position. ORT 1 stated Patient 8 had a surgical dressing on the left leg, and the area of the left leg that had contact with the device was warm to touch.

The physician document titled, "Progress Notes," dated May 1, 2014, (two days after surgery) indicated, "Left calf blistering."

The document titled, "Progress Notes," dated May 8, 2014, indicated, "Discussed with patient the wound may be secondary to a thermal burn secondary to the Aquamantys heated water..."

On June 9, 2014, at 2:05 p.m., the operative reports were reviewed with Circulating Room Nurse 1 (CRN) 1. CRN 1 was unable to find documentation on the operative reports that indicated what complications occurred during Patient 8's bilateral knee replacement surgical procedure.