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Based on interview and record review, the facility's governing body failed to:

1. Ensure Patient 1 had fire safety preventative measures implemented in the Operating Room prior to and during an operative procedure for one patient, (Patient 1).
(reference A 940, A951, A144, A115)

2. Ensure quality of care was provided when a cardiologist requested a noncredentialed, former echocardiogram ( Echo-ultrasound conducted on the heart) student to perform a test for one patient, Patient 2. (reference A49, A115)

3. Ensure six of the ten members of the medical staff reviewed did not cooperate with the TB (Tuberculosis- a contagious disease) screening policy for medical staff, creating the increased risk of the spread of infection to patients in the facility. (reference A49)

4. Ensure the forms for Consent For Treatment for patients admitted to the Emergency Department (ED), were complete. This failure may lead to confusion regarding the provision of medical care required for those individuals.(reference A131)

The cumulative effect of these systemic failures resulted in failure of the governing body to ensure patients were receiving quality care in a safe and effective manner.

Based on interview and record review, the medical staff failed to enforce its rules and regulations when:

1. A facility cardiologist requested a noncredentialed, former Echo Technician Student (ETS) to perform a test for one patient, Patient 2. This failed practice resulted in the potential for misinterpretation of test results, and subjected Patient 2 to undergo a test performed by an unqualified individual..

2. The Medical Staff failed to ensure six of ten members of the medical staff reviewed cooperated with the TB (Tuberculosis- a contagious disease) screening policy for medical staff, creating the increased risk of the spread of infection to patients in the facility.

Findings:

1. The record for Patient 2 was reviewed on November 3, 2015. Patient 2 was admitted to the facility on August 14, 2015, with the following diagnoses: syncope (fainting), left ventricular dysrhythmia (abnormal heart rate), and coronary artery disease (heart disease).

An interview was conducted with the Director of Cardiopulmonary Services (DCPS) on November 3, 2015, at 3 p.m. The DCPS stated on August 15, 2015, Patient 2 was being treated in the Intensive Care Unit (ICU). Physician (MD) 1 was the patient's primary physician. A cardiologist, (MD) 2, was consulting on the case.

The DCPS stated on August 19, 2015, the Patient 2's condition changed, and MD 2 had ordered an echocardiogram for the evaluation of the patient's left ventricular function (a check for flow of blood through the heart).

The DCPS further stated the Cardio-Pulmonary Department had an EchoTechnician (ET)who was on call August 19, 2014, for overnight emergencies. The DCPS stated, the ET received no calls the evening of August 19, 2015.

The DCPS stated MD 2 arrived at the patient's ICU bedside around 8 p.m. on August 19, 2015. The DCPS stated MD 2 had made arrangements to have a former ETS come into the hospital to perform an echocardiogram for Patient 2.

The DCPS stated he was informed by a facility ET that a note was left on the ET's desk dated August 19, 2015, at 9:17 p.m. The note indicated the ETS had completed an echocardiogram for Patient 2.

The DCPS stated the former student completed her clinical hours at the facility but she should not have been here. The DCPS stated the student was not an employee of the hospital.

The DCPS stated, he reported this information to the Chief Executive of Operations (CEO) immediately the next day.

The DCPS further stated the facility required an experienced Echo technician to have one of two credentials in order to work at the facility. The credentials included: the American Registry of Diagnostic Medical Sonography (ARDMS) and Cardiovascular Credentialing Internal (CCI). The former student was not credentialed by either service.

An interview was conducted with the facility's Chief Executive Officer (CEO) on November 4, 2015, at 11:40 a.m. The CEO stated MD 2 informed him (The CEO) MD 2 had authorized a family member (the former ETS) to perform the test.

The CEO stated the former student entered the main entrance of the facility, went to the Radiology Department where the Echo equipment was kept, and then went to the ICU to perform the test for Patient 2.

The CEO stated MD 1 and MD 2 were aware the former ETS completed the test.

The CEO stated MD 1 and MD 2 did not follow the facility rules and regulations.

The CEO stated the former ETS did not have the credentials to perform the test at the facility.

A record review of MD 2's progress note regarding Patient 2, dated, August 19, 2015, indicated "Critical care of two hours from 7 to 9 p.m. The Echo technician was not available and it would have taken time, but I wanted to be sure how the left ventricle is doing, particularly because the ejection fraction (percentage of blood flow) was already low even at time of admission...At my request, (former echocardio student), Echo extern technician (name withheld) whom I knew...she conducted the Echocardiogram under my supervision...in spite of the heart condition being the same as before..."

An interview was conducted with a facility Governing Board Member (GBM) on November 3, 2015, at 2 p.m. The GBM stated he was made aware of a patient having a test completed by the former ETS, and the ETS was not credentialed or affiliated with the hospital. The GBM stated the rules and regulations of the facility (of the Medical Staff Bylaws) were not followed.

Review of the facility Medical Staff Bylaws approved and revised by the Chief of Staff and the Governing Body on January 2015, indicated, the Basic Responsibilities of Medical staff Membership included:

"3.8 Basic responsibilities of Medical Staff Membership:

A. Providing patients with care and coordinating care, treatment and services with other medical staff practitioners and hospital personnel as relevant to the care, treatment, and services of each patient to ensure that all patients admitted to the hospital or treated in any outpatient department are provided with the quality of care meeting the professional standards of the Medical Staff of this hospital.

B. Abiding by the medical Staff Bylaws, medical Staff Rules and regulations and other established rules and policies of the hospital as approved by the Medical Staff...

E. Abiding by the lawful ethical principles established by his or her profession...

H. Refusing to engage in improper inducements for patient referrals..."

2. A review of six medical staff (MD 1, 2, 3, 4, 7, 10) was conducted on November 3, 2015. The health data for TB (Tuberculosis- a contagious disease) screening test for the six physicians was not found within the past year.

A review of the "2010 Hospital Policy and Procedure: Annual TB Screening for Medical Staff, Section III", indicated, "All physicians, as a part of the initial credentialing and thereafter annually must provide documentation of TB screening or testing. TB screening may be accomplished in the following ways dependent upon the skin test status of the physician. 1) Tuberculin Skin Testing (TST) is required for all those physicians who have no previous history of positive TST or unknown reaction. 2) A baseline CXR (chest x-ray) and a completed symptom questionnaire will be accepted for those physicians with a history of positive TST for the initial credentialing."

On November 3, 2015, at 1:35 p.m., an interview was conducted with the Chief of the Medical Staff. The Chief of the Medical Staff stated he was aware of the TB policy concerning the Medical Staff was not followed, and would bring this matter to the next Medical Executive meeting to ensure the policy will be enforced.

On November 3, 2015, at 3:35 p.m., an interview was conducted with the Director of Medical Staff Services. The Director of Medical Staff Services agreed physician compliance of the TB screening process should be improved and all physicians should be screened and followed the rules and regulations set forth by the Medical Staff and Hospital.

Based on interview and record review, the facility failed to ensure patient's rights were protected by failing to ensure:

1. Patient 1 had fire safety preventative measures implemented prior to the use of electrocautery (a heat source) near oxygen during a surgical procedure. (refer to A144);

2. Patient 2 had received care in a safe setting, when a former Echocardio Technician Student (ETS), not credentialed and affiliated with the hospital, performed a test for Patient 2 (refer to A144);

3. An echocardio student, not credentialed and affiliated with the hospital, did not have access to Patient 2 medical record (refer to A146), and

4. The Consent For Treatment for five patients admitted to the Emergency Department (ED), (Patients 13, 14 15, 16 and 23) was completed (refer to A931).

The cumulative effect of these problems resulted in the failure of the facility to ensure patients received quality care in a safe setting, and in the failure of the facility to ensure confidentiality of medical records.

Based on interview and record review, the facility failed to ensure the Consent For Treatment for five patients admitted to the Emergency Department (ED), (Patients 13, 14 15, 16 and 23) were complete. This failure had the potential to lead to confusion regarding the provision of medical care required for those patients.

Findings:

An interview was conducted with the ED Technician (EDT) on November 2, 2015, at 10 a.m. The EDT was stationed at the inner entrance to the ED. The EDT stated when patients presented to the ED she had the patient sign a Consent For Treatment. The EDT further stated the date or time was not documented on the consents, but the consents would be witnessed at that time.

A review of the facility's Consent For Treatment document was conducted. The document indicated, "Consent For Treatment: I give consent for Emergency Treatment. I understand that these services may include laboratory tests, x-rays, medical or surgical treatment and procedures including anesthesia."

A review of Patient 13's record was conducted. Patient 13 presented to the ED on October 31, 2015, with a chief complaint of blood in her sputum. A review of Patient 13's Consent for Treatment was conducted. Patient 13 signed the consent, but the consent was not witnessed, dated or timed.

A review of Patient 14's record was conducted. Patient 14 presented to the ED, accompanied by her spouse on November 1, 2015, with a chief complaint of weakness, nausea and vomiting. A review of Patient 14's Consent for Treatment was conducted. The document was blank. Patient 14 did not sign the consent, nor did the patient's spouse. The document was not witnessed, dated or timed.

A review of Patient 15's record was conducted. Patient 15 presented to the ED on November 1, 2015, with complaints of stomach pain. A review of Patient 15's Consent for Treatment was conducted. Patient 15's responsible party signed the consent, but the consent was not witnessed, dated or timed.

A review of Patient 16's record was conducted. Patient 16 presented to the ED on October 27, 2015, with a chief complaint of abdominal distension. A review of Patient 16's Consent for Treatment was conducted. Patient 16 signed the consent, but the consent was not dated or timed.

A review of Patient 23's record was conducted. Patient 23 presented to the ED on October 26, 2015, with a chief complaint of a fever. A review of Patient 23's Consent for Treatment was conducted. Patient 23 signed the consent, but the consent was not dated or timed.

A review of the facility policy, "Consent/Informed Consent (Date Revised: 4/15)," was conducted. The policy indicated, "Consent for General Medical Care: consent is required for the general medical care provided to patients admitted to the hospital for inpatient or outpatient services, including services provided in the Emergency Department."

An interview was conducted with the Patient Access Manager on November 2, 2015, at 2 p.m. The Patient Access Manager stated all consents have to be signed, dated, timed, and witnessed.

Based on interview, and record review the facility failed to ensure:

1. A patient (Patient 1) had fire safety preventative measures implemented in the Operating Room prior to and during a surgical procedure.

2. A patient (Patient 2) received care in a safe setting when an Echocardiogram test (Echo-ultrasound test for heart function) was conducted by a former Echocardio Technician Student (ETS), not a credentialed employee of the facility.

Findings:

1. A review of Patient 1's record was conducted on November 3, 2015. The record indicated the following:

Patient 1 was admitted to the facility on August 26, 2015, with a diagnosis of right forehead lipoma (fatty, non-cancerous tumor). The "Informed Consent to Surgery Operating Room Special Procedure," dated August 26, 2015, indicated the procedure to be performed was an excision of the right forehead lipoma. The type of anesthetic to be performed was monitored anesthesia care (MAC).

A review of the document titled, "Pre-anesthesia Evaluation," dated August 27, 2015, indicated, "Monitored anesthesia care (MAC)...The patient wants MAC only and will take general anesthesia only if needed as a last choice. I suggested general anesthesia and will do MAC since the patient (Patient 1) wants it that way and the patient understands the risks of doing facial surgery under MAC and possibly of increased fire hazard compared to general anesthesia with endo tracheal tube (a tube connected to a ventilator)...spoke with surgeon and he wants MAC and he wants it particularly because the patient wants it that way and it's doable."

The Operative Report indicated, "Lipoma was identified and dissected from the surrounding tissues using a combination of Bovie cautery (heated blade with an electrical source) and metzenbaum (type of) scissors. During this portion of the procedure while cauterizing (applying heat to stop bleeding) a vessel, a spark occurred with ignition of the patient's hair. This was extinguished with gauze. Smoke was noted to be coming from under the drapes (sterile blue drapes) which were immediately pulled open. Burns were noted and drapes were completely removed. No active fires were noted under the drape. Moist laps (sponges used in surgery) were then placed over the patient's face and neck areas."

The operative report further indicated, "There appeared to be a combination of both first and second degree burns involving the left side of the face and neck. There appeared to be no injury to the eyes. The patient was inspected for any other areas of injury....the burns were treated with Silvadene cream (medicine). The lipoma then removed using metzenbaum scissors and the incision closed...At the end of the procedure, the patient was taken to recovery room in stable condition."

A review of the document, "Operative Report," dated, August 26, 2015, indicated, "Pre-operative diagnosis-lipoma right forehead." The post-operative diagnosis indicated, "Lipoma, right forehead, first and second degree burns, left side of face and neck."


According to the Mayo Clinic's web site- http://www.mayoclinic.org/first-aid/first-aid-burns/basics/ART-20056649, Patient 1's burns were classified as:

"1st-degree burn
A first-degree burn is the least serious type, involving only the outer layer of skin. It may cause:
· Redness
· Swelling
· Pain...
·
2nd-degree burn
A second-degree burn is more serious. It may cause:
· Red, white or splotchy skin
· Swelling
· Pain
· Blisters...
If the burned area is larger or covers the hands, feet, face, groin, buttocks or a major joint, treat it as a major burn... to get medical help immediately."

A review of the "Anesthesia Record," dated, August 27, 2015, indicated, "Oxygen at five liters a minute per face mask. The patient positioning at 11:40 a.m., oxygen by...mask. At 12:15 p.m., fire from closeness of the surgery to the airway and recognized immediately and oxygen shut off. Saline poured on top of the fire area and patient burnt skin and surgeon treating fire injury with cooling measures and completed surgery and applied Silvadene...cream at he burnsite."

A review of the Nurses Progress Note dated August 26, 2015, at 12:30 p.m., indicated, "Burns: eyebrows, eyelashes, left side of neck, face, and left ear...Dressing: Silvadene cream applied to eyebrows, forehead, face neck, and ear. Covered with wet gauze. Intra-op(erative) Outcomes: Eyebrows gone, eyelashes gone, left side of face and neck burned on left side of face and left ear."

An interview was conducted with the Director of Nurses (DON) on November 3, 2015, at 9 a.m. The DON stated the operating room staff could have utilized preventative measures to reduce the risk of the operating room fire by: offering bipolar (coagulation device-produces less heat) instead of the cautery, including the bovie setting in the time out (verbal notice before the first cut of surgery), reducing the concentration of oxygen by mixing it with air, and using nasal cannula (nasal prongs directing the flow of oxygen into the nose) instead of face mask.

The DON further stated the physician's preference card said (amount of heat) 30 but the bovie was set at 35. The DON stated,"The bovie was set too high". The DON further stated the surgical field did not have wet towels.

During an interview with the DON on November 3, 2015, at 10 a.m., the DON stated the facility used the Anesthesia Patient Safety Foundation Guidelines. The DON stated the guidelines indicated the type of surgical procedure Patient 1 underwent was a fire level three or high risk for fire.

The DON stated according to the guidelines a patient having facial surgery equals one point, oxygen mask equals one point, and supplemental oxygen used near the bovie equals one point, making the total score of three, indicating a high fire risk.

The DON further stated the Association of Perioperative Nurses (AORN) standards were also used by the facility regarding prevention of operating room fires.

An interview was conducted with the Circulating Nurse (CN) on November 3, 2015, at 9:45 a.m. The CN stated she assisted with the circulating duties for (Patient 1), and used aquasonic gel (water soluble gel-nonflammable) on the right side of the hairline The CN stated, "I should have used it on the entire hairline." The CN stated she did announce with the time out that the patient's surgical fire risk was a three (high fire risk).

The CN stated, "We (staff) need to start out at a lower bovie setting. (The) bovie was set at 35, it should have been started lower." The CN further stated, "I think there was not enough communication between the surgeon and the anesthesiologist."

An interview was conducted with the Scrub Technician (ST) on November 3, 2015, at 10 a.m. The ST stated he saw smoke and a flash immediately (with the start of surgery). The ST stated he announced the bovie settings as 35 (cut heat) and 35 (coagulation heat) prior to the first cut but the surgeon did not respond. The ST stated,"In retrospect, I should have repeated the bovie settings to the surgeon.

The ST stated that the surgical field did not contain wet towels. The ST further stated," There could have been improved communication with the anesthesiologist and the surgeon."

An interview was conducted with the Anesthesiologist on November 3, 2015, at 10:40 a.m. The Anesthesiologist stated," General anesthesia is better with these cases...next time (I would) communicate with the surgeon when cautery was in use and reduce the oxygen concentration, use wet sponges (around the field), and check and lower the cautery level."

The Anesthesiologist stated, "There must have been a leak (of oxygen) around the drape." The Anesthesiologist further stated, the patient (Patient 1) and the surgeon preferred MAC.

The Anesthesiologist stated the initial burns (facial) were doused (with saline) but the burns to the lower face, ear, and neck were seen five minutes after the surgery was completed. The Anesthesiologist stated, "The surgical staff should have assessed the burns immediately."

An interview was conducted with the Surgeon on November 3, 2015, at 1:20 p.m. The Surgeon stated Patient 1 did sustain second and third degree burns requiring skin grafting (a surgical procedure in which donor skin is transplanted to the burn areas) to the left side of his face and neck.

The Surgeon stated he gave the patient an option of receiving general anesthesia versus MAC, Patient 1 decided on MAC. The Surgeon stated,"Usually, it is a joint decision to decide the type of anesthesia between the surgeon and the anesthesiologist." The surgeon stated he requested general anesthesia but anesthesiologist went with MAC.

The Surgeon stated, "I think the drapes were too low and the bovie setting was not announced (prior to use)."

A review of the facility's operating room policy and procedure titled,"Electro-Surgical Unit, Use Of," was reviewed on November 3, 2015. The policy indicated, "Procedure: ...Set the surgical eletrocautery unit (SEU) at the lowest level required to perform...as directed by the doctor/surgeon."

A review of the facility policy titled, "Fire Prevention and Response," revised August 2015, indicated the following surgical fire prevention measures:
"Policy:
The Surgical Services Department shall plan for and practice fire response for fires within the patient care areas and all areas surrounding the direct patient care areas.

All staff members will participate and respond to fire drills and all related specific fire safety rules and regulations with competency...

If oxygen...is being administered during head and neck surgery, coat the entire hairline near the surgical site (eyebrows, mustaches, and beards) by applying water-soluble jelly.

Minimize the buildup of oxygen ...by tenting (the surgical drapes)to allow for dissipation of gasses...

If the procedure and patient condition permit, anticipate by one minute (stopping) the use of ...electrosurgical unit..Re-administer the oxygen following the use of...electrosurgical unit.

During surgery have available saline soaked sponges on the surgical field."

A review of the Association of Perioperative Nurses, Guideline for a Safe Environment of Care, Part 1, dated December 15, 2012, indicated the following: The fire prevention and management plan should include: Perioperative team members' responsibilities include(ing) communication; Methods of prevention and, Processes to safely manage different fire scenarios...

The patient's hair is a fuel source, and covering facial hair with a water soluble gel decreases the risk of combustion because it raises the temperature that is required for ignition...water soluble gel should be used to cover the patient's facial hair...

The lowest possible concentration of oxygen that provides adequate patient oxygen saturation should be used for a patient who requires supplemental oxygen...

A laryngeal mask or endo tracheal (devices in which oxygen is directed down the throat) tube should be used when the patient requires supplemental oxygen greater than 30% unless using the tube is contraindicated by the procedure (example given-the patient is required to respond verbally during the procedure.

Use of a laryngeal mask airway or endotracheal tube decreases the risk of fire by decreasing the oxygen concentration under the drapes and in the patient's upper airway...

Drapes should be placed over the patient's head in a manner that allows the oxygen to flow freely and prevents accumulation under the drapes...

A second delivery system that administers five liters/minute to ten liters/minute of medical air should be used when supplemental oxygen is administered under the drapes...minimizing oxygen with nonflammable gases, such as medical air, reduces the risk of fire by preventing an oxygen rich environment...

Extinguishing a fire as soon as possible decreases the risk of injury to the patient and personnel..."

2. The record for Patient 2 was reviewed on November 3, 2015. Patient 2 was admitted to the facility on August 14, 2015, with the following diagnoses: syncope (fainting), left ventricular dysrhythmia (abnormal heart rate), and coronary artery disease (heart disease).

A review of MD 2's progress note dated, August 19, 2015, "Critical care of two hours from 7 to 9 p.m.," indicated, "The Echo technician was not available and it would have taken time, but I wanted to be sure how the left ventricle is doing, particularly because the ejection fraction (percentage of blood flow) was already low even at time of admission...At my request, (former student), Echo extern technician (name withheld) whom I knew...she conducted the Echocardiogram under my supervision...in spite of the heart condition being the same as before..."

An interview was conducted with the Director of Cardiopulmonary Services (DCPS) on November 3, 2015, at 3 p.m. The DCPS stated on August 15, 2015, Patient 2 was being treated in the Intensive Care Unit (ICU). Physician (MD) 1 was the patient's primary physician. A cardiologist, (MD) 2, was consulting on the case.

The DCPS stated, on August 19, 2015, the Patient 2's medical condition began to deteriorate. MD 2 had ordered an echocardiogram for the evaluation of the patient's left ventricular function (a check for flow of blood through the heart).

The DCPS stated, MD 2 arrived at the patient's ICU bedside around 8 p.m., on August 19, 2015. and made arrangements to have a former Echocardio Technician Student (ETS) come into the hospital to perform an echocardiogram for Patient 2.

The DCPS stated, the facility had a EchoTechnician (ET) who was on call for overnight emergencies. The technician received no calls the evening of August 19, 2015.

The DCPS stated the facility employed ET (ET 1), informed him a note was left on his desk from the former ETS, that indicated the student had completed an echocardiogram for Patient 2. The DCPS stated the former student completed clinical hours at the facility but she should not have been at the facility. The DCPS stated the Echo technician student was not an employee of the hospital.

The DCPS stated, he reported this information to the Chief Executive of Operations (CEO) the following day.

The DCPS further stated an experienced Echo technician hired by the facility was required to have one of two credentials in order to work independently at the facility. The credentials included: the American Registry of Diagnostic Medical Sonography (ARDMS) and Cardiovascular Credentialing Internal (CCI). The former Echo student was not credentialed by either service.

An interview was conducted with the facility's Chief Executive Officer (CEO) on November 4, 2015, at 11:40 a.m. The CEO stated MD 2 informed him (the CEO) MD 2 had called his family member (ETS) to come to the facility to perform the test. She (the former student) had come into the facility, went to the Radiology Department, took the Echo equipment, went to the ICU, and completed the test for Patient 2.

The CEO stated MD 1 and MD 2 did not follow the facility's rules and regulations according to the facility's bylaws.

The CEO stated the former ETS did not have the credentials to perform the test at the facility.

Review of the facility Medical Staff Bylaws approved and revised by the Chief of Staff and the Governing Body on January 2015, indicated, the Basic Responsibilities of Medical staff Membership included:

"Providing patients with care and coordinating care, treatment and services with other medical staff practitioners and hospital personnel as relevant to the care, treatment, and services of each patient to ensure that all patients admitted to the hospital or treated in any outpatient department are provided with the quality of care meeting the professional standards of the Medical Staff of this hospital."

Based on interview and record review, the facility failed to ensure patient Protected Health Information (PHI) was kept confidential for one patient, Patient 2. Patient 2's PHI was accessed by a former Echo Technician Student (ETS) who was not credentialed, and not employed by the facility.

Findings:

The record for Patient 2 was reviewed on November 3, 2015. Patient 2 was admitted to the facility on August 14, 2015, with the following diagnoses: syncope (fainting), left ventricular dysrhythmia (abnormal heart rate), and coronary artery disease (heart disease).

A review of MD 2's progress note dated, August 19, 2015, "Critical care of two hours from 7 to 9 p.m.," indicated, "The Echo technician was not available and it would have taken time, but I wanted to be sure how the left ventricle is doing, particularly because the ejection fraction (percentage of blood flow) was already low even at time of admission...At my request, (former student), Echo extern technician (name withheld) whom I knew...she conducted the Echocardiogram under my supervision...in spite of the heart condition being the same as before..."

An interview was conducted with the Director of Cardiopulmonary Services (DCPS) on November 3, 2015, at 3 p.m. The DCPS stated on August 15, 2015, Patient 2 was being treated in the Intensive Care Unit (ICU). Physician (MD) 1 was the patient's primary physician. A cardiologist, (MD) 2, was consulting on the case.

The DCPS stated, on August 19, 2015, Patient 2's medical condition began to deteriorate.

The DCPS stated, MD 2 arrived at the patient's ICU bedside around 8 p.m., on August 19, 2015. and made arrangements to have a former ETS come into the hospital to perform an echocardiogram for Patient 2.

The DCPS stated, the facility had a Echo Technician (ET) on call for overnight emergencies. The technician received no calls the evening of August 19, 2015.

The DCPS stated the facility employed ET (ET 1), informed him a note was left on his desk from the former ETS that indicated the student had completed an echocardiogram for Patient 2. The DCPS stated the former student completed clinical hours at the facility but she should not have been at the facility. The DCPS stated the ETS was not an employee of the hospital.

The DCPS stated, he reported this information to the Chief Executive of Operations (CEO) the following day.

The DCPS further stated an experienced ET hired by the facility was required to have one of two credentials in order to work independently at the facility. The credentials included: the American Registry of Diagnostic Medical Sonography (ARDMS) and Cardiovascular Credentialing Internal (CCI). The former Echo student was not credentialed by either service.

An interview was conducted with the facility's Chief Executive Officer (CEO) on November 4, 2015, at 11:40 a.m. The CEO stated MD 2 informed him (the CEO) MD 2 had called his family member (ETS) to come to the facility to perform the test. She (the student) had come into the facility, went to the Radiology Department, took the Echo equipment, went to the ICU, and performed the test for Patient 2.

The CEO stated the former ETS did not have the credentials to perform the test at the facility.

The CEO stated, "The former student did not have the credentials to create and/ or access a patient record..."

A review of the form titled "Echocardiographic Worksheet," indicated the following PHI information:

Patient 2's Name,

Date of birth,

Medical Record Number,

Reason for test,

Patient Identification Number, and

Echocardiogram results.

A review of the facility policy titled,"Affiliation Agreement," indicated, the facility is to:
"Notify all (echo) program students that he/she is required to; Perform their functions in accordance with all the Affiliate's policies and rules and with the rules and policies of the specific department..."

Based on interview, and record review, the facility failed to ensure Patient 1 had fire safety preventative measures implemented in the Operating Room (OR) prior to and during an operative procedure (refer to A951).

The cumulative effect of this systemic failure resulted in Patient 1 sustaining a burn injury during an operative procedure, and had the potential to result in the failue to ensure safe and quality care was provided for all patients undergoing operative procedures.

Based on interview, and record review the facility failed to ensure prevention of surgical fire policy and procedure, and perioperative standards were implemented in the surgical setting for one patient, Patient 1. Patient 1 suffered second and third degree burns during a surgical procedure.

Findings:

A review of Patient 1's record was conducted on November 3, 2015. The record indicated the following:

Patient 1 was admitted to the facility on August 26, 2015, with a diagnosis of right forehead lipoma (fatty, non-cancerous tumor). The "Informed Consent to Surgery Operating Room Special Procedure," dated August 26, 2015, indicated the procedure to be performed was an excision of the right forehead lipoma. The type of anesthetic to be performed was monitored anesthesia care (or MAC-monitored anesthesia care-medications given to reduce loss of consciousness and oxygen given to supplement reduced respirations).


A review of the document titled, "Pre-anesthesia Evaluation," dated August 27, 2015, indicated, "Monitored anesthesia care (MAC)...The patient wants MAC only and will take general anesthesia only if needed as a last choice. I suggested general anesthesia and will do MAC since the patient (Patient 1) wants it that way and the patient understands the risks of doing facial surgery under MAC and possibly of increased fire hazard compared to general anesthesia with endo tracheal tube (a tube connected to a ventilator)...spoke with surgeon and he wants MAC and he wants it particularly because the patient wants it that way and it's doable."


The Operative Report indicated, "Lipoma was identified and dissected from the surrounding tissues using a combination of Bovie cautery (heated blade with an electrical source) and metzenbaum (type of) scissors. During this portion of the procedure while cauterizing (applying heat to stop bleeding) a vessel, a spark occurred with ignition of the patient's hair. This was extinguished with gauze. Smoke was noted to be coming from under the drapes (sterile blue drapes) which were immediately pulled open. Burns were noted and drapes were completely removed. No active fires were noted under the drape. Moist laps (sponges used in surgery) were then placed over the patient's face and neck areas."

The operative report further indicated, "There appeared to be a combination of both first and second degree burns involving the left side of the face and neck. There appeared to be no injury to the eyes. The patient was inspected for any other areas of injury....the burns were treated with Silvadene cream (medicine). The lipoma then removed using metzenbaum scissors and the incision closed...At the end of the procedure, the patient was taken to recovery room in stable condition."

A review of the document, "Operative Report," dated, August 26, 2015, indicated, Pre-operative diagnosis-lipoma right forehead. The post-operative diagnosis indicated, "Lipoma, right forehead, first and second degree burns, left side of face and neck."


According to the Mayo Clinic's web site- http://www.mayoclinic.org/first-aid/first-aid-burns/basics/ART-20056649, Patient 1's burns were classified as:

"1st-degree burn
A first-degree burn is the least serious type, involving only the outer layer of skin. It may cause:
· Redness
· Swelling
· Pain...
·
2nd-degree burn
A second-degree burn is more serious. It may cause:
· Red, white or splotchy skin
· Swelling
· Pain
· Blisters...
·
If the burned area is larger or covers the hands, feet, face, groin, buttocks or a major joint, treat it as a major burn... to get medical help immediately."

A review of the "Anesthesia Record," dated, August 27, 2015, indicated, "Oxygen at five liters a minute per face mask. The patient positioning at 11:40 a.m., oxygen by...mask. At 12:15 p.m., fire from closeness of the surgery to the airway and recognized immediately and oxygen shut off. Saline poured on top of the fire area and patient burnt skin and surgeon treating fire injury with cooling measures and completed surgery and applied Silvadene...cream at he burnsite."

A review of the Nurses Progress Note dated August 26, 2015, at 12:30 p.m., indicated, "Burns: eyebrows, eyelashes, left side of neck, face, and left ear...Dressing: Silvadene cream applied to eyebrows, forehead, face neck, and ear. Covered with wet gauze. Intra-op(erative) Outcomes: Eyebrows gone, eyelashes gone, left side of face and neck burned on left side of face and left ear."

An interview was conducted with the Director of Nurses (DON) on November 3, 2015, at 9 a.m. The DON stated the operating room staff could have utilized preventative measures to reduce the risk of the operating room fire by: offering bipolar (coagulation device-produces less heat) instead of the cautery, including the bovie setting in the time out (verbal notice before the first cut of surgery), and reducing the concentration of oxygen by mixing it with air, and using nasal cannula (nasal prongs directing the flow of oxygen into the nose) instead of face mask.

The DON further stated the physician's preference card said (amount of heat) 30 but the bovie was set at 35. The DON stated,"The bovie was set too high". The DON further stated the surgical field did not have wet towels.

During an interview with the DON on November 3, 2015, at 10 a.m. The DON stated the facility used the Anesthesia Patient Safety Foundation Guidelines. The DON stated the guidelines indicated the types of surgical procedure Patient 1 underwent was a fire level three or high risk for fire.

The DON stated according to the guidelines a patient having facial surgery equals one point, oxygen mask equals one point, and supplemental oxygen used near the bovie equals one point, making the total score of three, indicating a high fire risk.

The DON further stated the Association of Perioperative Nurses (AORN) standards were also used for the facility regarding prevention of operating room fires.

An interview was conducted with the Circulating Nurse (CN) on November 3, 2015, at 9:45 a.m. The CN stated she assisted with the circulating duties for (Patient 1) and used aquasonic gel (water soluble gel-nonflammable), on the right side of the hairline The CN stated, "I should have used it on the entire hairline." The CN stated she did announce with the time out that the patient's surgical fire risk was a three (high fire risk).

The CN stated, "We (staff) need to start out at a lower bovie setting." (The) bovie was set at 35, it should have been started lower. The CN further stated, "I think there was not enough communication between the surgeon and the anesthesiologist."

An interview was conducted with the Scrub Technician (ST) on November 3, 2015, at 10 a.m. The ST stated he saw smoke and a flash immediately (with the start of surgery). The ST stated he announced the bovie settings as 35 (cut heat) and 35 (coagulation heat) prior to the first cut but the surgeon did not respond. The ST stated,"In retrospect, I should have repeated the bovie settings to the surgeon."

The ST stated that the surgical field did not contain wet towels. The ST further stated," There could have been improved communication with the anesthesiologist and the surgeon."

An interview was conducted with the Anesthesiologist on November 3, 2015, at 10:40 a.m. The Anesthesiologist stated," General anesthesia is better with these cases...next time (I would) communicate with the surgeon when cautery was in use and reduce the oxygen concentration, use wet sponges (around the field), and check and lower the cautery level."

The Anesthesiologist stated, "There must have been a leak (of oxygen) around the drape." The Anesthesiologist further stated, the patient (Patient 1) and the surgeon preferred MAC (reduced consciousness by anesthetic medication given intravenously with oxygen support).

The Anesthesiologist stated the initial burns (facial) were doused (with saline) but the burns to the lower face, ear, and neck were seen five minutes after the surgery was completed. The Anesthesiologist stated, "The surgical staff should have assessed the burns immediately."

An interview was conducted with he Director of Plant Operations (DPO), on November 3, 2015, at 11:10 a.m. The DPO stated the cautery machine was checked by two independent companies, and it was determined the fire was not an equipment issue. The DPO stated surgical fire drills were conducted quarterly but anesthesia was not involved with the drills.

An interview was conducted with the Surgeon on November 3, 2015, at 1:20 p.m. The Surgeon stated Patient 1 did sustain second and third degree burns requiring skin grafting (a surgical procedure in which donor skin is transplanted to the burn areas) to the left side of his face and neck.

The Surgeon stated he gave the patient an option of receiving general anesthesia versus MAC, Patient 1 decided on MAC. The Surgeon stated,"Usually, it is a joint decision to decide the type of anesthesia between the surgeon and the anesthesiologist." The surgeon stated he requested general anesthesia but anesthesiologist went with MAC.

The Surgeon stated he did not refute the decision to proceed with MAC anesthesia before the start of surgery and/or the surgical time out.

The Surgeon stated, "I think the drapes were too low and the bovie setting was not announced (prior to use)."

A review of the facility's operating room policy and procedure titled,"Electro-Surgical Unit, Use Of," was reviewed on November 3, 2015. The policy indicated, "Procedure: ...Set the surgical eletrocautery unit (SEU) at the lowest level required to perform...as directed by the doctor/surgeon."

A review of the facility policy titled, "Fire Prevention and Response," revised August 2015, indicated the following surgical fire prevention measures:
"Policy:
The Surgical Services Department shall plan for and practice fire response for fires within the patient care areas and all areas surrounding the direct patient care areas.

All staff members will participate and respond to fire drills and all related specific fire safety rules and regulations with competency...

If oxygen...is being administered during head and neck surgery, coat the entire hairline near the surgical site (eyebrows, mustaches, and beards) by applying water-soluble jelly.

Minimize the buildup of oxygen ...by tenting (the surgical drapes)to allow for dissipation of gasses...

If the procedure and patient condition permit, anticipate by one minute (stopping) the use of ...electrosurgical unit..Re-administer the oxygen following the use of...electrosurgical unit.

During surgery have available saline soaked sponges on the surgical field."

A review of the Association of Perioperative Nurses, Guideline for a Safe Environment of Care, Part 1, dated December 15, 2012, indicated the following: The fire prevention and management plan should include: Perioperative team members' responsibilities include(ing) communication; Methods of prevention and, Processes to safely manage different fire scenarios...

The patient's hair is a fuel source, and covering facial hair with a water soluble gel decreases the risk of combustion because it raises the temperature that is required for ignition...water soluble gel should be used to cover the patient's facial hair...

The lowest possible concentration of oxygen that provides adequate patient oxygen saturation should be used for a patient who requires supplemental oxygen...

A laryngeal mask or endo tracheal (devices in which oxygen is directed down the throat) tube should be used when the patient requires supplemental oxygen greater than 30% unless using the tube is contraindicated by the procedure (example given-the patient is required to respond verbally during the procedure.

Use of a laryngeal mask airway or endotracheal tube decreases the risk of fire by decreasing the oxygen concentration under the drapes and in the patient's upper airway...

Drapes should be placed over the patient's head in a manner that allows the oxygen to flow freely and prevents accumulation under the drapes...

A second delivery system that administers five liters/minute to ten liters/minute of medical air should be used when supplemental oxygen is administered under the drapes...minimizing oxygen with nonflammable gases, such as medical air, reduces the risk of fire by preventing an oxygen rich environment...

Extinguishing a fire as soon as possible decreases the risk of injury to the patient and personnel..."