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The facility failed to ensure the Condition of Participation: CFR 482.12 Governing Body was met by failing to ensure:

1a. Eight (8) GI scopes were stored in accordance with infection control (IC) standards and in a manner to prevent cross contamination. (Refer to A-0749)

b. The GI scopes were stored in a compliant storing cabinet per manufacturer recommendations. (Refer to A-0749)

c. Terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed in the GI lab procedure room. (Refer to A-0749)

2. The GI scope accessories were stored with their perspective scopes. (Refer to A-0749)

3. GI procedures were not being performed in the same room where the scopes are reprocessed and are stored.
(Refer to A-0749)

4. The Trophon (a high level disinfection system for vaginal ultrasound probes) was maintained per manufacturer recommendations. (Refer to A-0749)

5. There was documented evidence that terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed in the sterile processing department (the area in the facility where they clean and sterilize the surgical instruments) (Refer to A-0749)

6. One of two steam sterilizer machines (used to sterilize surgical instruments) did not have a brown stain located in the left bottom lower part of the cylinder. (Refer to A-0749)

7. A sterile processing department technician (SPDT 1) was wearing gloves, when he prepared one small bone tray (where sterilized surgical instruments are placed in the tray) (Refer to A-0749)

8. Documented evidence that the temperatures and humidity (amount of moisture in the air) were monitored in the sterile processing department and where sterilized surgical instruments were stored. (Refer to A-0749)

9. The call light system was functioning in one of two restrooms located in the emergency department main lobby. (Refer to A-0091)

10. There was documented evidence of physician orders for Patient 3. (Refer to A-0144)

11. There was documented evidence of physician orders for Patient 19. (Refer to A-0144)

12. The hospital staff appropriately monitored Patient 1, conducted a contraband search of Patient 1's personal belongings when Patient 1 presented to the Emergency Department (ED) with suicidal ideations (thoughts of killing oneself). (Refer to A-1104)

13. The Registered Nurse (RN 3) triage suicide risk screening for Patient 1 was accurate. (Refer to A-1104)

14. There was documented evidence Patient 1 received a Social Services consult as ordered by the physician. (Refer to A-1104)

15. The Registered Nurse (RN 4) conducted a complete triage assessment for Patient 2. (Refer to A-1104)

16. Vital signs were obtained per policy and procedure for Patient 2. (Refer to A-1104)

17. Verbal orders for a medication was documented for Patient 2. (Refer to A-1104)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: Governing Body.

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

1a. Eight (8) GI scopes were stored in accordance with infection control (IC) standards and in a manner to prevent cross contamination.

b. The GI scopes were stored in a compliant storing cabinet per manufacturer recommendations

c. The GI scope accessories were stored with their perspective scopes.

2. Terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed in the GI lab procedure room.

3. GI procedures were not being performed in the same room where the scopes are reprocessed and are stored.

4. The Trophon (a high level disinfection system for vaginal ultrasound probes) was maintained per manufacturer recommendations.

5. Terminal cleaning was performed in the sterile processing department (the area in the facility where they clean and sterilize the surgical instruments).

6. One of two steam sterilizer machines (used to sterilize surgical instruments) did not have a brown stain located in the left lower part of the cylinder.

7. A sterile processing department technician (SPDT 1) was wearing gloves, when he prepared a small bone tray (where sterilized surgical instruments are placed in the tray)

8. The temperatures and humidity (amount of moisture in the air) were monitored in the sterile processing department and where sterile surgical instruments were stored.

9. The call light system was functioning in one of two restrooms located in the emergency department main lobby.

10. There was documented evidence of physician orders for Patient 3.

11. There was documented evidence of physician orders for Patient 19.

12. The hospital staff appropriately monitored Patient 1, conducted a contraband search of Patient 1's personal belongings when Patient 1 presented to the Emergency Department (ED) with suicidal ideations (thoughts of killing oneself).

13. The Registered Nurse (RN 3) triage suicide risk screening for Patient 1 was accurate.

14. There was documented evidence Patient 1 received a Social Services consult as ordered by the physician.

15. The Registered Nurse (RN 4) conducted a complete triage assessment for Patient 2.

16. Vital signs were obtained per policy and procedure for Patient 2.

17. Verbal orders for a medication was documented for Patient 2.

These deficient findings had the potential to affect the health and safety of patients in a universe of 64 patients..


Findings:

1. During a tour of the Gastrointestinal (GI-referring collectively to the stomach and the small and large intestine) lab room, the following observations were made:

a. Eight (8) GI scopes hanging in a white cabinet touching each other.

b. A white scope storing cabinet with a fan located in the right lower side of the cabinet containing eight (8) scopes. The cabinet was not intended to be a scope storage cabinet, it did not have a HEPA filter and was not a drying cabinet.

c. All scope accessories were stored separate form their perspective scopes and stored in a urine specimen cup adjacent to the decontamination sink. The accessories also stored in a drawer in a rolling work station that is used to perform the pre-cleaning of the GI scopes and is used by the physician during the procedure.

During an interview with a GI LAb technician (GILT) on November 15, 2017, at 9:30 AM, he stated the GI scope cabinet stored eight (8) scopes and the cabinet was not a HEPA filter or an air drying cabinet. The GILT stated the GI scopes should not be touching each other and it was the hospital's practice to store the scope accessories separate from their perspective scopes. The GILT stated the scope accessories located adjacent to the decontamination sink were clean and were left overnight to dry.

During an interview with the Infection Control Preventionist (ICP) on November 15 , 2017, at 10:13 AM, she stated the GI scope cabinet was made by the facilities department and there was no instructions for use (IFU). The ICP stated the GI scopes are touching and they are not suppose to be touching and are potentially contaminated.

During an interview with the ICP on November 15, 2017 at 10:13 AM, she stated the hospital adopted and followed the Nationally Recognized Infection Control guidelines

During a concurrent interview with the ICP on November 15, 2017 at 10:13 AM, she stated that the hospital adopted and followed the Nationally Recognized Infection Control guidelines from:

a. APIC - Association for Professionals in Infection Control

b. AORN - Association of Perioperative Registered Nurses

c. CDC -Centers for Disease Control

d. SGNA - Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal
Endoscopes

According to the "AORN Journal, May 2016, Vol. 103, No. 5, Back to Basics Flexible Endoscope Processing" stipulates, "Endoscopes should be stored in a manner which prevents them from contamination and protects them from damage...If no drying cabinet is available, personnel should store the endoscopes in a closed cabinet with a High-Efficiency Particulate Arrestance (HEPA), filtered air that provides positive pressure and allows air circulation ...Flexible endoscopes should be stored with all valves opened and detached parts stored with the endoscope.

According to SGNA, "Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes":

"Key consideration in storage include: a. Use storage cabinets that are made of a material that can be disinfected ...Reusable buttons and valves should be reprocessed and stored together with the endoscope as a unique set for tracking purposes ...SGNA supports a 7-day storage interval for reprocessed endoscopes-but only if they were reprocessed and stored according to professional guidelines and manufacturer instructions ..."

2. During an interview with the Infection Control Preventionist (ICP) on November 15, 2017 at 10:13 AM, she stated the hospital followed the Nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation-an organization for advancing and development, and safe and effective use of medical technology, CDC (Center for Disease Control), APIC (Association of Professionals in Infection Control and Epidemiologist) and AORN (Association of perioperative practice and healthcare).

During a review of the "Terminal Cleaning Checklist," dated July 26, 2017, completed by Environmental Services Staff (EVS 1), indicated, "...Using germicidal damp dust ceilings, AC return/vents...clean all cabinets and check to ensure all surfaces are clean, dusted and spot free."

During an interview with EVS 1 on November 15, at 10:30 AM, she stated she was responsible for the terminal cleaning of the GI lab procedure room. EVS 1 stated she signed and completed the "Terminal Cleaning Checklist," dated July 26, 2017. EVS 1 stated she documented that she completed the tasks but did not dust the vents, cabinets or the ceiling because she could not reach. EVS 1 stated she should have thoroughly terminally cleaned the GI lab procedure room but did not.

During an interview with the Environmental Services Manager (EVSM) on November 15, 2017 at 9:05 AM, she reviewed the terminal cleaning log for the GI lab procedure room and was not able to find documented evidence of terminal cleaning for the months of August 2017, September 2017 and October 2017. The EVSM stated she was not aware of the issues identified in the GI lab procedure room.

The facility's policy and procedure titled, "Environmental Cleaning and Disinfecting of Procedural Practice Settings," dated March 2017, indicated, "...C. Terminal cleaning: Terminal cleaning is done in each procedure room...once in each 24-hour period during the workweek."

AORN, one of the nationally recognized infection control guidelines the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of the day when the area is being used."

3. During a tour of the of the GI lab room on November 15, 2017 at 9:30 AM, an observation was made of a Medivators processor (a machine used for cleaning and disinfecting reusable patient equipment), and a white cabinet storing eight (8) scopes located within the room.

During a concurrent interview with the GI lab Technician (GILT), he stated GI (Gastrointestinal-referring collectively to the stomach and the small and large intestine) procedures were being performed in the same room where the Medivators processor is located, the reprocessing of scopes takes place, and the scopes are stored.

During an interview with the Director of Quality and Risk Management (QORM) on November 15, 2017 at 10:07 AM, she stated It was her understanding that it was okay to reprocessed scopes in the same room were procedures are performed and where the scopes are stored because it was licensed that way.

During an interview with the ICP on November 15, 2017 at 10:13 AM, she stated the hospital followed the Nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation-an organization for advancing and development, and safe and effective use of medical technology, CDC (Center for Disease Control), APIC (Association of Professionals in Infection Control and Epidemiology) and AORN (Association of perioperative practice and healthcare). The ICP stated the scopes are currently stored in a non-compliant storing cabinet in the same room that is used as a procedure room and a decontamination room where the scopes are reprocessed. The ICP stated the scopes are potentially contaminated. The ICP stated the issues that were identified in the GI lab procedure room included procedures being performed in the same room where the scopes are reprocessed and where the scopes are stored has been elevated to administration and awaiting a response.

AORN, one of the nationally recognized infection control guidelines the hospital followed indicated, "Cabinets used for storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area close to, but not within, the endoscopy procedure room."

4. During a review of the "Trophon User Manual, indicated, "Section B6: Routine Care and Maintenance...B6.2 Service Once the service interval of 12 months..."

During an interview with the Director of Quality and Risk Management (DOQRM) on November 16, 2017 at 9:43 AM, she stated she was not able to find documented evidence of the preventative maintenance for the Trophon (a machine used for cleaning and disinfecting reusable vaginal ultrasound probes). The DOQRM stated the Trophon machine was purchased by the hospital in 2014. The DOQRM stated the Trophon was not in the hospital system therefore, a preventative maintenance schedule was not developed.

During an interview with the Director Imaging Services (DIS) on November 17, 2017, at 2:40 PM, he stated he could not find documented evidence of preventative maintenance for the Trophon. The DIS stated the manufacturer recommendations for annual preventative maintenance was not being followed.

5. During an interview with the Manager of Environmental Services (MOES) on November 16, 2017 at 9:05 AM, the MOES stated that they never had a separate terminal cleaning log to document that terminal cleaning was performed in the sterile processing department.

During an interview with the Director of Quality and Risk Management (DOQRM) on November 16, 2017 at 9:14 AM, the DOQRM stated that there was no documentation proof that terminal cleaning was performed in the sterile processing department from January 1, 2017 to November 14, 2017.

AORN, one of the nationally recognized infection control guidelines the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of each day when the area is being used." Both AORN and AAMI (Association for the Advancement of Medical Instrumentation) ST79 recommend that sterile processing be terminally cleaned the same as the operating, delivery, and invasive procedure rooms. AAMI ST79 (Section 3.4) states that the best practice is to provide separate housekeeping facilities for the decontamination and clean areas to avoid transferring contaminates from dirty to clean "areas."

The facility policy and procedure titled, "Environmental Cleaning and Disinfecting of Procedural Practice Setting", dated September 2017, indicated: "Terminally cleaning is done in each procedure room, scrub, and utility room once in each twenty-four period during the regular work week. Mechanical frictions, Environmental Protection Agency, and hospital approved cleaning agents shall be used for terminal cleaning following the same procedure used for between surgery procedures cleaning including, but not limited to the following: surgical lights, external tracks, fixed ceiling mounted equipment, all furniture, equipment including wheels, casters, step stools, foot pedals, telephones and light switches. Hallways, floors, handles of cabinets, push plates, ventilation faceplates, horizontal surfaces including tops of counters, sterilizers, fixed cabinetry, utility areas, and scrub sinks. Relocate furniture to one side of the room or into the hallway, mop the floor with hospital approved neutral floor cleaning solutions, one half of the floor at a time, move furniture to newly cleaned side of the room, and mop the remaining of the floor area..."

6. During a tour of the hospital sterile processing department area on November 15, 2017 at 3:09 PM, one of two sterilizer machines (used to sterilize surgical instruments) had a brown stain located in the left lower part of the cylinder.

During a concurrent interview with the Lead Sterile Processing Technician (LSPT 1), he confirmed there was a brown stain located in the left lower part of the cylinder.

The facility policy and procedure titled, "Operation, Maintenance, and Cleaning of Sterilizers" dated September 2017, indicated: "Cleaning and maintenance of sterilizers must be completed according to the manufacturer's recommendations..."

7. During a tour of the hospital sterile processing department area on November 15, 2017 at 3:15 PM, a Sterile Processing Department Technician (SPDT 1) was observed not wearing gloves while assembling surgical instruments (instruments used for surgical procedures).

During a concurrent interview with the Lead Sterile Processing Technician (LSPT 1), he confirmed the SPDT 1 should have been wearing gloves when assembling surgical instruments.

The facility policy and procedure titled, "Processing Contaminated Instruments and Equipment for Sterilization" dated February 2013, indicated: "Care and handling of surgical instruments and powered equipment should follow the manufacturers recommendations. Employees must wear personal protective equipment during the process. The personal protective equipment includes gown, gloves, eye, and face protection..."

8. During an interview with the Facilities Manager (FM 1) on November 16, 2017 at 10:17 AM, the FM 1 stated that the facility was not monitoring temperatures and humidity in the sterile processing department since two years ago.

During an interview with the Infectionist Perfectionist (IP) on November 16, 2017 at 10:34 AM, the IP stated that there was not a thermostat (regulates the room temperature) located in the clean room area where they stored sterilized surgical instruments. The IP also stated there was no monitoring of the temperatures and humidity since construction began in the sterile processing department.

During an interview with the Director of Quality and Risk Management (DOQRM) on November 17, 2017 at 8:10 AM, the DOQRM stated there was no monitoring of the temperatures and humidity since May 2, 2016 when construction began in the sterile processing department.

The facility policy and procedure titled,"Scope of Service Central Sterilization" dated May 2009, indicated: "Sterile packages should be stored under environmentally controlled conditions..."

9. During initial tour of the emergency department with the Facilities Manager (FM 1) on November 15, 2017 at 9:35 AM, it was observed the call light system in the restroom located in the emergency department was not working. When the call light was activated, there was no loud noise from the annunciator (a bell, light, or other devices that provides information on the state or condition of something by indication which of several electrical circuits has been activated) located in the emergency department nurses station.

During a concurrent interview with FM 1, he confirmed there should have been a loud noise coming from the annunciator located in the nurses station when the call light from the restroom was activated.

During an interview with the Emergency Technician (ET 1) on November 15, 2017 at 9:36 AM, ET 1 stated the call light should have made a loud noise.

The facility policy and procedure titled, "Call Lights", dated March 2016, indicated: "Call systems are maintained at each bed station and in the bathrooms. Pressing the call button may activate the call system. Activation shall result in a flashing light over the entrance to the patient care area involved. A flashing light at the control sole indicating the specific room or station involved. An interrupted beep tone shall be heard throughout the Emergency Department. If the alarm has been activated, all available Emergency Department staff shall respond to the area where the alarm originated..."

10. During a review of Patient 3's face sheet (demographics) indicated, Patient 3 was admitted to the facility on November 2, 2017, with a diagnosis of constipation.

During a review of Patient 3's clincal record the, "Pre-Procedure Assessment Report," dated November 2, 2017, indicated Patient 3 was aministered Versed (a medication used to sedate a person who is having a minor surgery, dental work, or other medical procedures) 9 MG (milligrams), Fentanyl (a fast acting narcotic analgesic and sedative) 200 MCG (micrograms) and Benadryl (used as a sleep aid) 50 MG.

During an inteview with the Chief Nursing Officer (CNO) on November 17, 2017 at 11:01 AM, she reviewed the clinical record and was unable to find documentation of physician orders for the medications that were administered.

The facility policy and procedure titled, "Procedural Sedation", dated May 2014, indicated: "Obtain and verify physician's order for procedural sedation medications to be administered..."

11. During a review of Patient 19's face sheet (a form with health and medical information) indicated, Patient 19 was admitted to the facility on September 25, 2017, with diagnoses which included rectal bleeding (bleeding from the rectum often noted as a small amount of bright red blood) and abdominal pain (often related to pain coming from the digestive tract).

During a review of Patient 19's medical record review dated September 25, 2017, indicated the Registered Nurse (RN 5) administered Versed (is used to sedated a person who is having a minor surgery, dental work, or other medical procedures) 6 milligrams and Fentanyl (a fast acting narcotic analgesic and sedative) 150 micrograms, and Benadryl (used as a sleep aid) 50 milligrams. Also, there was no documentation proof that the physician ordered Versed 6 mg, Fentanyl 150 micrograms and Benadryl 50 mg.

During a concurrent interview with the Supervisor of Ambulatory Services (SA), he confirmed that there was no documentation proof that the physician wrote an order for the administration of Versed 6 milligrams, Fentanyl 150 micrograms, and Benadryl 50 milligrams that was given to Patient 19.

The facility policy and procedure titled, "Procedural Sedation", dated May 2014, indicated: "Obtain and verify physician's order for procedural sedation medications to be administered..."

12. During a review of Patient 1's clinical record, indicated Patient 1 presented to the Emergency Department on August 11, 2017 with a chief complaint (the patient's reported reason for seeking medical care) of suicidal ideations (thoughts of killing oneself).

During a review of the "Triage Report," dated August 11, 2017, indicated, "Pt (Patient) BIBA (brought in by ambulance) with SI (suicidal ideations). Pt was found in middle of highway waiting to get hit by car with intent to die. Pt (Patient) HX (history) SI, depression, bipolar (a mental illness that causes dramatic shifts in a person's mood, energy and ability to think clearly), Schizo (Schizophrenia- a severe mental disorder that affects how a person thinks, feels, and behaves), Meth (Methamphetamine an illegal drug that is abused for its euphoric high that provides increased energy).

During an interview with a Registered Nurse (RN 1) on November 17, 2017 at 8:35 AM, RN 1 stated she was the assigned night shift nurse for Patient 1 on August 11, 2017. RN 1 stated Patient 1 verbalized she had suicidal ideations and attempted to kill herself in the past. RN 1 stated she attempted to conduct a contraband search on Patient 1, however Patient 1 refused and she did not document her attempt. RN 1 stated she visualized the metal belt on Patient 1 but did not attempt to conduct another contraband search.

A review of the "Daily Focus Assessment Report," completed by RN 1 dated August 11, 2017 at 11:34 PM, indicated the following:

History of suicide Attempts-Yes

Ideations-Suicidal thoughts now

Patient at Risk-Yes

A review of Patient 1's "Application for Assessment, Evaluation, and Crisis Intervention or Placement for Evaluation and Treatment," dated August 12, 2017 at 8:47 AM, indicated, "Based upon the above information, there is probable cause to believe that said person is, as a result of mental disorder: A danger to herself."

During an interview with Registered Nurse 2 (RN 2) on November 16, 2017 at 12:16 PM, she stated she was the assigned day shift nurse for Patient 1 on August 12, 2017 [the day of the incident]. RN 2 stated the nursing staff was responsible to conduct a contraband search for patients who present to the ED with suicidal ideations. RN 2 stated a contraband search was not conducted for Patient 1 and her personal belongings were not removed and the facility's policy and procedure was not followed. RN 2 stated Patient 1's clothes should have been removed and Patient 1 should have been placed in a hospital gown or paper scrubs but she did not know why it was not done. RN 2 stated CCRT (Community Crisis Response Team-a crisis response program for those experiencing a psychiatric emergency utilizing specially trained mobile crisis response teams to provide crisis interventions, and assessments) evaluated Patient 1 and Patient 1 was deemed to be a danger to herself but the information was not communicated with her.

RN 2 stated on August 12, 2017 at 9:40 AM, Patient 1 requested to use the restroom, Patient 1 ambulated to the restroom by herself. RN 1 stated she was timing Patient 1 and after some time went by [approximately 10 minutes], she went to check on Patient 1. RN 1 stated she knocked on the restroom door and called out Patient 1's name but there was no answer. RN 1 attempted to open the restroom door but it was locked. RN 1 retrieved the restroom key and unlocked the door. RN 1 stated she opened the door and Patient 1 was found lying on the restroom floor tied to the side rail with her belt around her neck. RN 1 stated "she [Patient 1] was blue I thought she was dead." RN 1 stated she palpated for a pulse. RN 1 stated she released the belt around Patient 1's neck and Patient 1 gasped for air and Patient 1 was angry she was still alive. RN 1 stated Patient 1 was assisted on the gurney and was transported to bed 3. RN 1 stated once Patient 1 was in bed 3 she was observed to have jerking movements, the physician was notified of the incident and Patient 1 was administered Ativan (a medication used to treat seizures).

A review of Patient 1's "Physician Emergency Department Record," indicated "I was called by the nursing staff because the patient [Patient 1] had hung herself in the bathroom and turned blue. Shortly after the patient was removed from the bathroom and placed in the room 3, she [Patient 1] began to have a seizure, she was administered Ativan 1 MG (milligrams). She will now have one-on-one supervision/monitoring ..."

During an interview with the Emergency Department Director (EDD) on November 16, 2017 at 10:27 AM, he stated a contraband check was not conducted on Patient 1, she was not given a hospital gown, and she remained in her street clothes. The EDD stated the process was not followed. The EDD stated Patient 1 was deemed a danger to herself and was not monitored by the ED staff. The EDD stated the expectation was for Patient 1 to have a safety attendant.

The facility's policy and procedure titled, "Emergency Department 5150 Procedures," dated November 2010, indicated, "...All psychiatric patients who are admitted to a nursing unit must submit to a contraband search by Public Safety and/or hospital staff.

The facility's policy and procedure titled, "Emergency Department Scope of Service," dated December 2015, indicated, "...H. Psychiatric patients...including suicidal patients, shall receive careful considerations of both physical and psychosocial needs...1. A definite follow-up plan to ensure safety of the patient...shall be arranged as needed."

13. During a review of Patient 1's clinical record, the facesheet (demographics) indicated Patient 1 presented to the Emergency Department on August 11, 2017 with a chief complaint (the patient's reported reason for seeking medical care) of suicidal ideations (thoughts of killing oneself).

During a review of the "Triage Report," dated August 11, 2017, indicated, "Pt (Patient) BIBA (brought in by ambulance) with SI (suicidal ideations). Pt was found in middle of highway waiting to get hit by car with intent to die. Pt (Patient) HX (history) SI, depression, bipolar (a mental illness that causes dramatic shifts in a person's mood, energy and ability to think clearly), Schizo (Schizophrenia- a severe mental disorder that affects how a person thinks, feels, and behaves), Meth (Methamphetamine an illegal drug that is abused for its euphoric high that provides increased energy). Suicide Risk: Screened-No Risk."

During an interview with Registered Nurse 3 (RN 3) on November 17, 2017 at 8:20 AM, she stated she completed the Triage Report for Patient 1. RN 3 stated Patient 1 was a suicide risk. RN 3 stated the "Suicide Risk," question was answered incorrectly, it was an error.

During an interview with the Emergency Department Director (EDD) on November 16, 2017 at 10:27 AM, he stated Patient 1's triage suicide screening question was incorrect. The EDD stated RN 3 documented incorrectly.

14. During a review of Patient 1's clinical record, the facesheet (demographics) indicated Patient 1 presented to the Emergency Department on August 11, 2017 with a chief complaint (the patient's reported reason for seeking medical care) of suicidal ideations (thoughts of killing oneself).

A review of the physician orders dated August 12, 2017, indicated "Consult Social Services."

During an interview with Social Services (SS) on November 17, 2017 at 9:23 AM, he reviewed the clinical record and was unable to find documented evidence of a social service consult. The SS stated he evaluated Patient 1 but did not have time to document his consult.

During an interview with the Interim Director Case Manager (IDCM) on November 17, 2017 at 9:25 AM, she stated her expectation was for her staff to document the Social Services assessment and plan.

The facility's policy and procedure titled, "It is the policy of (name of facility) to make social services available to patients, families and hospital personnel."

15. During a review of Patient 2's clinical record, indicated Patient 2 presented to the Emergency Department (ED) on August 27, 2017 with a chief complaint of shortness of breath.

A review of Patient 2's "Triage Report," dated August 27, 2017 at 6:19 PM, indicated, Vital Signs as follow:

BP (Blood Pressure) 205/130 (normal ranges are between 120/80 and 140/90)

Temperature 97.8

Pulse 111 (normal ranges are between 60-100)

Respirations 24

SpO2 84 % (amount of oxygen in the blood-normal ranges are between 95 to 100)

Acuity 3 (triage algorithm that categorizes emergency department patients by evaluating both patient acuity and resource needs- acuity 3=urgent).

During an interview with Registered Nurse 4 (RN 4) on November 15, 2017 at 4:17 PM, she stated she was the triage nurse who completed Patient 2's triage assessment. RN 4 stated Patient 2's vital signs were abnormal, Patient 2's BP was high 205/130, pulse of 111 was high, and his oxygen saturation level was low at 84%. RN 4 stated she did not listen to Patient 2's lung sounds, therefore Patient 2 did not receive a complete triage assessment and the process was not followed. RN 2 stated the acuity of 3 she assigned to Patient 2 was inappropriate. RN 2 stated Patient 2 should have been assigned a more appropriate acuity of 2 (Emergent-conditions that require immediate evaluation and treatment to prevent further complications or deterioration).

During an interview with the Emergency Department Director (EDD) on November 16, 2017 at 10:27 AM, he stated Patient 2's assigned triage acuity level of 3 was inappropriate. The EDD stated Patient 2's low oxygen level of 84% and high blood pressure of 205/130 should have been an indication to assign a higher acuity. The EDD stated an acuity level of 1 or 2 would have been appropriate.

The facility's policy and procedure titled, "Emergency Department Assessment," dated May 2009, indicated, "...Patients shall receive a physical assessment ..."

16. During a review of Patient 2's clinical record, indicated Patient 2 presented to the Emergency Department(ED) on August 27, 2017 with a chief complaint of shortness of breath.

A review of Patient 2's "Triage Report," dated August 27, 2017 at 6:19 PM, indicated, Vital Signs as follow:

BP (Blood Pressure) 205/130 (normal ranges are between 120/80 and 140/90)

Temperature 97.8

Pulse 111 (normal ranges are between 60-100)

Respirations 24

SpO2 84 % (amount of oxygen in the blood-normal ranges are between 95 to 100)

A review of Patient 2's "Vital Sign Report," dated August 27, 2017, indicated the following:

At 6:24 PM (Triage vital signs)

BP 205/130

02 sats 84%

Pulse 111

Resp (Respirations) 24

Temp (Temperature) 97.8

No documentation of vital signs between 6:24 PM and 8:28 PM.

At 8:28 PM

BP 123/83

02 sats 91%

Pulse 98

Resp 20

During an interview with Registered Nurse 6 (RN 6) on November 17, 2017 at 8:40 AM, she stated she was the assigned nurse for Patient 2 on August 27, 2017. RN 6 reviewed the clinical record and was unable to find documentation of Patient 2's vital signs from the time of triage at 8:24 PM to 8:28 PM (a total of 1.5 hours).

A review of Patient 2's "Order Report," dated August 27, 2017, indicated, "Labetalol (a medication to treat high blood pressure) 20 MG (milligrams) intravenous (in the vein)."

RN 6 stated Patient 2's BP and pulse maintained high at 220's/130's and pulse 110's but she did not document. RN 6 stated the physician was notified of Patient 2's high blood pressure and high pulse and new orders were received. RN 6 stated she administered Labetalol 20 MG IV (intravenous-in the vein) as ordered. RN 6 stated she obtained vital signs prior to administering Labetalol to Patient 2 but did not document.

During an interview with the Emergency Department Director (EDD) on November 16, 2017, at 10:27 AM, he stated Patient 2's vital signs should have been obtained more frequently. The EDD stated the expectation was for Patient 2 to have vital signs taken every 30 minutes since Patient 2's vital signs were abnormal in triage. The EDD stated the blood pressure was not taken prior to the administration of Labetalol and the expectation was for RN 6 to obtain vital signs prior to administering medications that treat blood pressure.

The facility's policy and procedure titled, "Emergency Department Assessment," dated May 2009, indicated, ... Patient's shall receive a physical assessment including vital signs...2. All patients shall have vital signs taken to include: blood pressure, heart rate, respiratory rate, temperature ...4. Frequency of assessment shall be dictated by the patient's condition and shall be adequately monitored to assure patient safety. a. Minimum stan

Based on observation and interview, the facility failed to ensure the call light system was functioning in one of two restrooms located in the emergency department main lobby. This failure had the potential for patients not to receive help in a timely manner if an emergency occurred in the restroom which could result in accidents, injuries, and death for a universe of 64 patients.

Findings:

During initial tour of the emergency department with the Facilities Manager (FM 1) on November 15, 2017 at 9:35 AM, it was observed the call light system in the restroom located in the emergency department was not working. When the call light was activated, there was no loud noise from the annunciator (a bell, light, or other devices that provides information on the state or condition of something by indication which of several electrical circuits has been activated) located in the emergency department nurses station.

During a concurrent interview with the (FM 1), he confirmed there should have been a loud noise coming from the annunciator located in the nurses station when the call light from the restroom was activated.

During an interview with the Emergency Technician (ET 1) on November 15, 2017 at 9:36 AM, ET 1 stated the call light should have made a loud noise.

The facility policy and procedure titled, "Call Lights", dated March 2016, indicated: "Call systems are maintained at each bed station and in the bathrooms. Pressing the call button may activate the call system. Activation shall result in a flashing light over the entrance to the patient care area involved. A flashing light at the control sole indicating the specific room or station involved. An interrupted beep tone shall be heard throughout the Emergency Department. If the alarm has been activated, all available Emergency Department staff shall respond to the area where the alarm originated..."

Based on interview and record review, the facility failed to ensure they had documented evidence of physician orders (orders written by a physician that are implemented by nursing staff) for two out of 30 sampled patients (Patient 3, and Patient 19). This failure had the potential for Patients 3, and 19, to be at risk for side effects from having unnecessary medications.

Findings:

1. During a review of Patient 3's face sheet (demographics) indicated, Patient 3 was admitted to the facility on November 2, 2017, with a diagnosis of constipation.

During a review of Patient 3's clinical record the, "Pre-Procedure Assessment Report," dated November 2, 2017, indicated Patient 3 was administered Versed (a medication used to sedate a person who is having a minor surgery, dental work, or other medical procedures) 9 MG (milligrams), Fentanyl (a fast acting narcotic analgesic and sedative) 200 MCG (micrograms) and Benadryl (used as a sleep aid) 50 MG.

During an interview with the Chief Nursing Officer (CNO) on November 17, 2017 at 11:01 AM, she reviewed the clinical record and was unable to find documentation of physician orders for the medication that were administered to Patient 3.

The facility policy and procedure titled, "Procedural Sedation", dated May 2014, indicated: "Obtain and verify physician's order for procedural sedation medications to be administered..."

2. During a review of Patient 19's face sheet (a form with health and medical information) indicated, Patient 19 was admitted to the facility on September 25, 2017, with diagnoses which included rectal bleeding (bleeding from the rectum often noted as a small amount of bright red blood) and abdominal pain (often related to pain coming from the digestive tract).

During a review of Patient 19's medical record review dated September 25, 2017, indicated the Registered Nurse (RN 5) administered Versed (is used to sedated a person who is having a minor surgery, dental work, or other medical procedures) 6 milligrams and Fentanyl (a fast acting narcotic analgesic and sedative) 150 micrograms, and Benadryl (used as a sleep aid) 50 milligrams. Also, there was no documentation proof that the physician ordered Versed 6 mg, Fentanyl 150 micrograms and Benadryl 50 mg.

During a concurrent interview with the Supervisor of Ambulatory Services (SA), he confirmed that there was no documentation proof that the physician wrote an order for the administration of Versed 6 milligrams, Fentanyl 150 micrograms, and Benadryl 50 milligrams that was given to Patient 19.

The facility policy and procedure titled, "Procedural Sedation" dated May 2014, indicated: "Obtain and verify physician's order for procedural sedation medications to be administered..."

The facility failed to ensure the Condition of Participation: CFR 482.21 Quality Assessment and Performance Improvement was met by failing to ensure:

1a. Eight (8) GI scopes were stored in accordance with infection control (IC) standards and in a manner to prevent cross contamination. (Refer to A-0747)

b. The GI scopes were stored in a compliant storing cabinet per manufacturer recommendations. (Refer to A-0747)

c. The GI scope accessories were stored with their perspective scopes. (Refer to A-0747)

2. Terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed in the GI lab procedure room. (Refer to A-0747)

3. GI procedures were not being performed in the same room where the scopes are reprocessed and are stored.

4. The Trophon (a high level disenfection system for vaginal ultrasound probes) was maintained per manufacturer recommendations. (Refer to A-0747)

5. Terminal cleaning was performed in the sterile processing department (the area in the facility where they clean and sterilize the surgical instruments). (Refer to A-0747)

6. One of two steam sterilizer machines (used to sterilize surgical instruments) did not have a brown stain located in the left lower part of the cylinder. (Refer to A-0747)

7. A sterile processing department technician (SPDT 1) was wearing gloves, when he prepared a small bone tray (where sterilized surgical instruments are placed in the tray). (Refer to A-0747)

8. The temperatures and humidity (amount of moisture in the air) were monitored in the sterile processing department and where sterile surgical instruments were stored. (Refer to A-0747)

9. The call light system was functioning in one of two restrooms located in the emergency department main lobby. (Refer to A-0091)

10. There was documented evidence of physician orders for Patient 3. (Refer to A-0144)

11. There was documented evidence of physician orders for Patient 19. (Refer to A-0144)

12. The hospital staff appropriately monitored Patient 1, conducted a contraband search of Patient 1's personal belongings when Patient 1 presented to the Emergency Department (ED) with suicidal ideations (thoughts of killing oneself). (Refer to A-1104)

13. The Registered Nurse (RN 3) triage suicide risk screening for Patient 1 was accurate. (Refer to A-1104)

14. There was documented evidence Patient 1 received a Social Services consult as ordered by the physician. (Refer to A-1104)

15. The Registered Nurse (RN 4) conducted a complete triage assessment for Patient 2. (Refer to A-1104)

16. Vital signs were taken per policy and procedure for Patient 2. (Refer to A-1104)

17. Verbal orders for a medication was documented for Patient 2. (Refer to A-1104)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: Quality Assessment and Performance Improvement.

Based on observation, interview, and record review, the Quality Assurance Improvement Program (QAPI), failed to ensure:

1a. Eight (8) GI scopes were stored in accordance with infection control (IC) standards and in a manner to prevent cross contamination.

b. The GI scopes were stored in a compliant storing cabinet per manufacturer recommendations.

c. The GI scope accessories were stored with their perspective scopes.

2. Terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed in the GI lab procedure room.

3. GI procedures were not being performed in the same room where the scopes are reprocessed and are stored.

4. The Trophon (a high level disinfection system for vaginal ultrasound probes) was maintained per manufacturer recommendations.

5. Terminal cleaning was performed in the sterile processing department (the area in the facility where they clean and sterilize the surgical instruments).

6. One of two steam sterilizer machines (used to sterilize surgical instruments) did not have a brown stain located in the left lower part of the cylinder.

7. A sterile processing department technician (SPDT 1) was wearing gloves, when he prepared a small bone tray (where sterilized surgical instruments are placed in the tray).

8. The temperatures and humidity (amount of moisture in the air) were monitored in the sterile processing department and where sterile surgical instruments were stored.

9. The call light system was functioning in one of two restrooms located in the emergency department main lobby.

10. There was documented evidence of physician orders for Patient 3.


These deficient findings had the potential to affect the health and safety of patients in a universe of 64.

Findings:

1. During a tour of the Gastrointestinal (GI-referring collectively to the stomach and the small and large intestine) lab room, the following observations were made:

a. Eight (8) GI scopes hanging in a white cabinet touching each other.

b. A white scope storing cabinet with a fan located in the right lower side of the cabinet containing eight (8) scopes. The cabinet was not intended to be a scope storage cabinet, it did not have a HEPA filter and was not a drying cabinet.

c. All scope accessories were stored separate form their perspective scopes and stored in a urine specimen cup adjacent to the decontamination sink. The accessories also stored in a drawer in a rolling work station that is used to perform the pre-cleaning of the GI scopes and is used by the physician during the procedure.

During an interview with a GI LAB technician (GILT) on November 15, 2017, at 9:30 AM, he stated the GI scope cabinet stored eight (8) scopes and the cabinet was not a HEPA filter or an air drying cabinet. The GILT stated the GI scopes should not be touching each other and it was the hospital's practice to store the scope accessories separate from their perspective scopes. The GILT stated the scope accessories located adjacent to the decontamination sink were clean and were left overnight to dry.

During an interview with the Infection Control Preventionist (ICP) on November 15 , 2017, at 10:13 AM, she stated the GI scope cabinet was made by the facilities department and there was no instructions for use (IFU). The ICP stated the GI scopes are touching and they are not suppose to be touching and are potentially contaminated.

During an interview with the ICP on November 15, 2017 at 10:13 AM, she stated the hospital adopted and followed the Nationally Recognized Infection Control guidelines

During a concurrent interview with the ICP on November 15, 2017 at 10:13 AM, she stated that the hospital adopted and followed the Nationally Recognized Infection Control guidelines from:

a. APIC - Association for Professionals in Infection Control

b. AORN - Association of Perioperative Registered Nurses

c. CDC -Centers for Disease Control

d. SGNA - Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal
Endoscopes

According to the "AORN Journal, May 2016, Vol. 103, No. 5, Back to Basics Flexible Endoscope Processing" stipulates, "Endoscopes should be stored in a manner which prevents them from contamination and protects them from damage...If no drying cabinet is available, personnel should store the endoscopes in a closed cabinet with a High-Efficiency Particulate Arrestance (HEPA), filtered air that provides positive pressure and allows air circulation ...Flexible endoscopes should be stored with all valves opened and detached parts stored with the endoscope.

According to SGNA, "Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes":

"Key consideration in storage include: a. Use storage cabinets that are made of a material that can be disinfected ...Reusable buttons and valves should be reprocessed and stored together with the endoscope as a unique set for tracking purposes...SGNA supports a 7-day storage interval for reprocessed endoscopes-but only if they were reprocessed and stored according to professional guidelines and manufacturer instructions ..."

2. During an interview with the Infection Control Preventionist (ICP) on November 15, 2017 at 10:13 AM, she stated the hospital followed the Nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation-an organization for advancing and development, and safe and effective use of medical technology, CDC (Center for Disease Control), APIC (Association of Professionals in Infection Control and Epidemiology) and AORN (Association of perioperative practice and healthcare).

During a review of the "Terminal Cleaning Checklist," dated, July 26, 2017 completed by Environmental Services Staff (EVS 1), indicated, "...Using germicidal damp dust ceilings, AC return/vents ...clean all cabinets and check to ensure all surfaces are clean, dusted and spot free."

During an interview with EVS 1 on November 15, at 10:30 AM, she stated she was responsible for the terminal cleaning of the GI lab procedure room. EVS 1 stated she signed and completed the "Terminal Cleaning Checklist," dated July 26, 2017. EVS 1 stated she documented that she completed the tasks but did not dust the vents, cabinets or the ceiling because she could not reach. EVS 1 stated she should have thoroughly terminally cleaned the GI lab procedure room but did not.

During an interview with the Environmental Services Manager (EVSM) on November 15, 2017 at 9:05 AM, she reviewed the terminal cleaning log for the GI lab procedure room and was not able to find documented evidence of terminal cleaning for the months of August 2017, September 2017 and October 2017. The EVSM stated she was not aware of the issues identified in the GI lab procedure room.

The facility's policy and procedure titled, "Environmental Cleaning and Disinfecting of Procedural Practice Settings," dated March 2017, indicated, "...C. Terminal cleaning: Terminal cleaning is done in each procedure room ...once in each 24-hour period during the workweek."

AORN, one of the nationally recognized infection control guidelines the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of the day when the area is being used."

3. During a tour of the of the GI lab room on November 15, 2017 at 9:30 AM, an observation was made of a Medivators processor (a machine used for cleaning and disinfecting reusable patient equipment), and a white cabinet storing eight (8) scopes located within the room.

During a concurrent interview with the GI lab Technician (GILT), he stated GI (Gastrointestinal-referring collectively to the stomach and the small and large intestine) procedures were being performed in the same room where the Medivators processor is located, the reprocessing of scopes takes place, and the scopes are stored.

During an interview with the Director of Quality and Risk Management (DOQRM) on November 15, 2017 at 10:07 AM, she stated It was her understanding that it was okay to reprocessed scopes in the same room were procedures are performed and where the scopes are stored because it was licensed that way.

During an interview with the ICP on November 15, 2017 at 10:13 AM, she stated the hospital followed the Nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation-an organization for advancing and development, and safe and effective use of medical technology, CDC (Center for Disease Control), APIC (Association of Professionals in Infection Control and Epidemiology) and AORN (Association of perioperative practice and healthcare). The ICP stated the scopes are currently stored in a non-compliant storing cabinet in the same room that is used as a procedure room and a decontamination room where the scopes are reprocessed. The ICP stated the scopes are potentially contaminated. The ICP stated the issues that were identified in the GI lab procedure room included procedures being performed in the same room where the scopes are reprocessed and where the scopes are stored has been elevated to administration and awaiting a response.

AORN, one of the nationally recognized infection control guidelines the hospital followed indicated, "Cabinets used for storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscope processing room in a two-room design or in a separate clean area close to, but not within, the endoscope procedure room."

4. During a review of the "Trophon User Manual, indicated, "Section B6: Routine Care and Maintenance...B6.2 Service Once the service interval of 12 months..."

During an interview with the Director of Quality and Risk Management (DOQRM) on November 16, 2017 at 9:43 AM, she stated she was not able to find documented evidence of the preventative maintenance for the Trophon (a machine used for cleaning and disinfecting reusable vaginal ultrasound probes). The DOQRM stated the Trophon machine was purchased by the hospital in 2014. The DOQRM stated the Trophon was not in the hospital system therefore, a preventative maintenance schedule was not developed.

During an interview with the Director Imaging Services (DIS) on November 17, 2017, at 2:40 PM, he stated he could not find documented evidence of preventative maintenance for the Trophon. The DIS stated the manufacturer recommendations for annual preventative maintenance was not being followed.

5. During an interview with the Manager of Environmental Services (MOES) on November 16, 2017 at 9:05 AM, the MOES stated that they never had a separate terminal cleaning log to document that terminal cleaning was performed in the sterile processing department,

During an interview with the Director of Quality and Risk Management (DOQRM) on November 16, 2017 at 9:14 AM, the DOQRM stated that there was no documentation proof that terminal cleaning was performed in the sterile processing department from January 1, 2017 to November 14, 2017.

AORN, one of the nationally recognized infection control guidelines the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of each day when the area is being used." Both AORN and AAMI (Association for the Advancement of Medical Instrumentation) ST79 recommend that sterile processing be terminally cleaned the same as the operating, delivery, and invasive procedure rooms. AAMI ST79 (Section 3.4) states that the best practice is to provide separate housekeeping facilities for the decontamination and clean areas to avoid transferring contaminates from dirty to clean "areas."

The facility policy and procedure titled, "Environmental Cleaning and Disinfecting of Procedural Practice Setting", dated September 2017, indicated: "Terminally cleaning is done in each procedure room, scrub, and utility room once in each twenty-four period during the regular work week. Mechanical frictions, Environmental Protection Agency, and hospital approved cleaning agents shall be used for terminal cleaning following the same procedure used for between surgery procedures cleaning including, but not limited to the following: surgical lights, external tracks, fixed ceiling mounted equipment, all furniture, equipment including wheels, casters, step stools, foot pedals, telephones and light switches. Hallways, floors, handles of cabinets, push plates, ventilation faceplates, horizontal surfaces including tops of counters, sterilizers, fixed cabinetry, utility areas, and scrub sinks. Relocate furniture to one side of the room or into the hallway, mop the floor with hospital approved neutral floor cleaning solutions, one half of the floor at a time, move furniture to newly cleaned side of the room, and mop the remaining of the floor area..."

6. During a tour of the hospital sterile processing department area on November 15, 2017 at 3:09 PM, one of two sterilizer machines (used to sterilize surgical instruments) had a brown stain located in the left lower part of the cylinder.

During a concurrent interview with the Lead Sterile Processing Technician (LSPT 1), he confirmed there was a brown stain located in the left lower part of the cylinder.

The facility policy and procedure titled, "Operation, Maintenance, and Cleaning of Sterilizers" dated September 2017, indicated: "Cleaning and maintenance of sterilizers must be completed according to the manufacturer's recommendations..."

7. During a tour of the hospital sterile processing department area on November 15, 2017 at 3:15 PM, a Sterile Processing Department Technician (SPDT 1) was observed not wearing gloves while assembling surgical instruments (instruments used for surgical procedures).

During a concurrent interview with the Lead Sterile Processing Technician (LSPT 1), he confirmed the SPDT 1 should have been wearing gloves when assembling surgical instruments.

The facility policy and procedure titled, "Processing Contaminated Instruments and Equipment for Sterilization", dated February 2013, indicated: "Care and handling of surgical instruments and powered equipment should follow the manufacturers recommendations. Employees must wear personal protective equipment during the process. The personal protective equipment includes gown, gloves, eye, and face protection..."

8. During an interview with the Facilities Manager (FM 1) on November 16, 2017 at 10:17 AM, the FM 1 stated that the facility was not monitoring temperatures and humidity in the sterile processing department since two years ago.

During an interview with the Infectionist Perfectionist (IP) on November 16, 2017 at 10:34 AM, the IP stated that there was not a thermostat (regulates the room temperature) located in the clean room area where they stored sterilized surgical instruments. The IP also stated there was no monitoring of the temperatures and humidity since construction began in the sterile processing department.

During an interview with the Director of Quality and Risk Management (DOQRM) on November 17, 2017 at 8:10 AM, the DOQRM stated there was no monitoring of the temperatures and humidity since May 2, 2016 when construction began in the sterile processing department.

The facility policy and procedure titled,"Scope of Service Central Sterilization", dated May 2009, indicated: "Sterile packages should be stored under environmentally controlled conditions..."

9. During initial tour of the emergency department with the Facilities Manager (FM 1) on November 15, 2017 at 9:35 AM, it was observed the call light system in the restroom located in the emergency department was not working. When the call light was activated, there was no loud noise from the annunciator (a bell, light, or other devices that provides information on the state or condition of something by indication which of several electrical circuits has been activated) located in the emergency department nurses station.

During a concurrent interview with the FM 1, he confirmed there should have been a loud noise coming from the annunciator located in the nurses station when the call light from the restroom was activated.

During an interview with the Emergency Technician (ET 1) on November 15, 2017 at 9:36 AM, ET 1 stated the call light should have made a loud noise.

The facility policy and procedure titled, "Call Lights", dated March 2016, indicated: "Call systems are maintained at each bed station and in the bathrooms. Pressing the call button may activate the call system. Activation shall result in a flashing light over the entrance to the patient care area involved. A flashing light at the control sole indicating the specific room or station involved. An interrupted beep tone shall be heard throughout the Emergency Department. If the alarm has been activated, all available Emergency Department staff shall respond to the area where the alarm originated..."

10. During a review of Patient 3's face sheet (demographics) indicated, Patient 3 was admitted to the facility on November 2, 2017, with a diagnosis of constipation.

During a review of Patient 3's clincal record the, "Pre-Procedure Assessment Report," dated November 2, 2017, indicated Patient 3 was aministered Versed (a medication used to sedate a person who is having a minor surgery, dental work, or other medical procedures) 9 MG (milligrams), Fentanyl (a fast acting narcotic analgesic and sedative) 200 MCG (micrograms) and Benadryl (used as a sleep aid) 50 MG.

During an inteview with the Chief nursing Officer (CNO) on November 17, 2017 at 11:01 AM, she reviewed the clinical record and was unable to find documentation of physican orders for the medications that were administered.

The facility policy and procedure titled,"Procedural Sedation" dated May 2014, indicated: "Obtain and verify physician's order for procedural sedation medications to be administered..."



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11. During a review of Patient 19's face sheet (a form with health and medical information) indicated, Patient 19 was admitted to the facility on September 25, 2017, with diagnoses which included rectal bleeding (bleeding from the rectum often noted as a small amount of bright red blood) and abdominal pain (often related to pain coming from the digestive tract).

During a review of Patient 19's medical record review dated September 25, 2017, indicated the Registered Nurse (
RN 5) administered Versed (is used to sedated a person who is having a minor surgery, dental work, or other medical procedures) 6 milligrams and Fentanyl (a fast acting narcotic analgesic and sedative) 150 micrograms, and Benadryl 50 milligrams. Also, there was no documentation proof that the physician ordered Versed 6mg, Fentanyl 150 micrograms and Benadryl (used as a sleep aid) 50 mg.

During a concurrent interview with the Supervisor of Ambulatory Services (SA), he confirmed that there was no documentation proof that the physician wrote an order for the administration of Versed 6 milligrams, Fentanyl 150 micrograms, and Benadryl 50 milligrams that was given to Patient 19.

The facility policy and procedure titled,"Procedural Sedation" dated May 2014, indicated: "Obtain and verify physician's order for procedural sedation medications to be administered..."

12. During a review of Patient 1's clinical record, indicated Patient 1 presented to the Emergency Department on August 11, 2017 with a chief complaint (the patient's reported reason for seeking medical care) of suicidal ideations (thoughts of killing oneself).

During a review of the "Triage Report," dated August 11, 2017, indicated, "Pt (Patient) BIBA (brought in by ambulance) with SI (suicidal ideations). Pt was found in middle of highway waiting to get hit by car with intent to die. Pt (Patient) HX (history) SI, depression, bipolar (a mental illness that causes dramatic shifts in a person's mood, energy and ability to think clearly), Schizo (Schizophrenia- a severe mental disorder that affects how a person thinks, feels, and behaves), Meth (Methamphetamine an illegal drug that is abused for its euphoric high that provides increased energy).

During an interview with a Registered Nurse 1 (RN 1) on November 17, 2017 at 8:35 AM, RN 1 stated she was the assigned night shift nurse for Patient 1 on August 11, 2017. RN 1 stated Patient 1 verbalized she had suicidal ideations and attempted to kill herself in the past. RN 1 stated she attempted to conduct a contraband search on Patient 1, however Patient 1 refused and she did not document her attempt. RN 1 stated she visualized the metal belt on Patient 1 but did not attempt to conduct another contraband search.

A review of the "Daily Focus Assessment Report," completed by RN 1 dated August 11, 2017 at 11:34 PM, indicated the following:

History of suicide Attempts-Yes

Ideations-Suicidal thoughts now

Patient at Risk-Yes

A review of Patient 1's "Application for Assessment, Evaluation, and Crisis Intervention or Placement for Evaluation and Treatment," dated August 12, 2017 at 8:47 AM, indicated, "Based upon the above information, there is probable cause to believe that said person is, as a result of mental disorder: A danger to herself."

During an interview with Registered Nurse 2 (RN 2) on November 16, 2017 at 12:16 PM, she stated she was the assigned day shift nurse for Patient 1 on August 12, 2017 [the day of the incident]. RN 2 stated the nursing staff was responsible to conduct a contraband search for patients who present to the ED with suicidal ideations. RN 2 stated a contraband search was not conducted for Patient 1 and her personal belongings were not removed and the facility's policy and procedure was not followed. RN 2 stated Patient 1's clothes should have been removed and Patient 1 should have been placed in a hospital gown or paper scrubs but she did not why it was not done. RN 2 stated CCRT (Community Crisis Response Team-a crisis response program for those experiencing a psychiatric emergency utilizing specially trained mobile crisis response teams to provide crisis interventions, and assessments) evaluated Patient 1 and Patient 1 was deemed to be a danger to herself but the information was not communicated with her.

RN 2 stated on August 12, 2017 at 9:40 AM, Patient 1 requested to use the restroom, Patient 1 ambulated to the restroom by herself. RN 1 stated she was timing Patient 1 and after some time went by [approximately 10 minutes], she went to check on Patient 1. RN 1 stated she knocked on the restroom door and called out Patient 1's name but there was no answer. RN 1 attempted to open the restroom door but it was locked. RN 1 retrieved the restroom key and unlocked the door. RN 1 stated she opened the door and Patient 1 was found lying on the restroom floor tied to the side rail with her belt around her neck. RN 1 stated "she [Patient 1] was blue I thought she was dead." RN 1 stated she palpated for a pulse. RN 1 stated she released the belt around Patient 1's neck and Patient 1 gasped for air and Patient 1 was angry she was still alive. RN 1 stated Patient 1 was assisted on the gurney and was transported bed 3. RN 1 stated once Patient 1 was in bed 3 she was observed to have jerking movements, the physician was notified of the incident and Patient 1 was administered Ativan (a medication used to treat seizures).

A review of Patient 1's "Physician Emergency Department Record," indicated "I was called by the nursing staff because the patient [Patient 1] had hung herself in the bathroom and turned blue. Shortly after the patient was removed from the bathroom and placed in the room 3, she [Patient 1] began to have a seizure, she was administered Ativan 1 MG (milligrams). She will now have one-on-one supervision/monitoring ..."

During an interview with the Emergency Department Director (EDD) on November 16, 2017 at 10:27 AM, he stated a contraband check was not conducted on Patient 1, she was not given a hospital gown, and she remained in her street clothes. The EDD stated the process was not followed. The EDD stated Patient 1 was deemed a danger to herself and was not monitored by the ED staff. The EDD stated the expectation was for Patient 1 to have a safety attendant.

The facility's policy and procedure titled, "Emergency Department 5150 Procedures," dated November 2010, indicated, "...All psychiatric patients who are admitted to a nursing unit must submit to a contraband search by Public Safety and/or hospital staff.

The facility's policy and procedure titled, "Emergency Department Scope of Service," dated December 2015, indicated, "...H. Psychiatric patients ...including suicidal patients, shall receive careful considerations of both physical and psychosocial needs...1. A definite follow-up plan to ensure safety of the patient ...shall be arranged as needed."

13. During a review of Patient 1's clinical record, the facesheet (demographics) indicated Patient 1 presented to the Emergency Department on August 11, 2017 with a chief complaint (the patient's reported reason for seeking medical care) of suicidal ideations (thoughts of killing oneself).

During a review of the "Triage Report," dated August 11, 2017, indicated, "Pt (Patient) BIBA (brought in by ambulance) with SI (suicidal ideations). Pt was found in middle of highway waiting to get hit by car with intent to die. Pt (Patient) HX (history) SI, depression, bipolar (a mental illness that causes dramatic shifts in a person's mood, energy and ability to think clearly), Schizo (Schizophrenia- a severe mental disorder that affects how a person thinks, feels, and behaves), Meth (Methamphetamine an illegal drug that is abused for its euphoric high that provides increased energy). Suicide Risk: Screened-No Risk."

During an interview with Registered Nurse 3 (RN 3) on November 17, 2017 at 8:20 AM, she stated she completed the Triage Report for Patient 1. RN 3 stated Patient 1 was a suicide risk. RN 3 stated the "Suicide Risk," question was answered incorrectly, it was an error.

During an interview with the Emergency Department Director (EDD) on November 16, 2017 at 10:27 AM, he stated Patient 1's triage suicide screening question was incorrect. The EDD stated RN 3 documented incorrectly.

14. During a review of Patient 1's clinical record, the facesheet (demographics) indicated Patient 1 presented to the Emergency Department on August 11, 2017 with a chief complaint (the patient's reported reason for seeking medical care) of suicidal ideations (thoughts of killing oneself).

A review of the physician orders dated August 12, 2017, indicated "Consult Social Services."

During an interview with Social Services (SS) on November 17, 2017 at 9:23 AM, he reviewed the clinical record and was unable to find documented evidence of a social service consult. The SS stated he evaluated Patient 1 but did not have time to document his consult.

During an interview with the Interim Director Case Manager (IDCM) on November 17, 2017 at 9:25 AM, she stated her expectation was for her staff to document the Social Services assessment and plan.

The facility's policy and procedure titled, "It is the policy of (name of facility) to make social services available to patients, families and hospital personnel."

15. During a review of Patient 2's clinical record, indicated Patient 2 presented to the Emergency Department(ED) on August 27, 2017 with a chief complaint of shortness of breath.

A review of Patient 2's "Triage Report," dated August 27, 2017 at 6:19 PM, indicated, Vital Signs as follow:

BP (Blood Pressure) 205/130 (normal ranges are between 120/80 and 140/90)

Temperature 97.8

Pulse 111 (normal ranges are between 60-100)

Respirations 24

SpO2 84 % (amount of oxygen in the blood-normal ranges are between 95 to 100)

Acuity 3 (triage algorithm that categorizes emergency department patients by evaluating both patient acuity and resource needs- acuity 3=urgent)

During an interview with Registered Nurse 4 (RN 4) on November 15, 2017 at 4:17 PM, she stated she was the triage nurse who completed Patient 2's triage assessment. RN 4 stated Patient 2's vital signs were abnormal, Patient 2's BP was high 205/130, pulse of 111 was high, and his oxygen saturation level was low at 84%. RN 4 stated she did not listen to Patient 2's lung sounds, therefore Patient 2 did not receive a complete triage assessment and the process was not followed. RN 2 stated the acuity of 3 she assigned to Patient 2 was inappropriate. RN 2 stated Patient 2 should have been assigned a more appropriate acuity of 2 (Emergent-conditions that require immediate evaluation and treatment to prevent further complications or deterioration).

During an interview with the Emergency Department Director (EDD) on November 16, 2017 at 10:27 AM, he stated Patient 2's assigned triage acuity level of 3 was inappropriate. The EDD stated Patient 2's low oxygen level of 84% and high blood pressure of 205/130 should have been an indication to assign a higher acuity. The EDD stated an acuity level of 1 or 2 would have been appropriate.

The facility's policy and procedure titled, "Emergency Department Assessment," dated May 2009, indicated, "...Patients shall receive a physical assessment ..."

16. During a review of Patient 2's clinical record, indicated Patient 2 presented to the Emergency Department(ED) on August 27, 2017 with a chief complaint of shortness of breath.

A review of Patient 2's "Triage Report," dated August 27, 2017 at 6:19 PM, indicated, Vital Signs as follow:

BP (Blood Pressure) 205/130 (normal ranges are between 120/80 and 140/90)

Temperature 97.8

Pulse 111 (normal ranges are between 60-100)

Respirations 24

SpO2 84 % (amount of oxygen in the blood-normal ranges are between 95 to 100)

A review of Patient 2's "Vital Sign Report," dated August 27, 2017, indicated the following:

At 6:24 PM (Triage vital signs)

BP 205/130

02 sats 84%

Pulse 111

Resp (Respirations) 24

Temp (Temperature) 97.8

No documentation of vital signs between 6:24 PM and 8:28 PM.

At 8:28 PM

BP 123/83

02 sats 91%

Pulse 98

Resp 20

During an interview with Registered Nurse 6 (RN 6) on November 17, 2017 at 8:40 AM, she stated she was the assigned nurse for Patient 2 on August 27, 2017. RN 6 reviewed the clinical record and was unable to find documentation of Patient 2's vital signs from the time of triage at 8:24 PM to 8:28 PM (a total of 1.5 hours).

A review of Patient 2's "Order Report," dated August 27, 2017, indicated, "Labetalol (a medication to treat high blood pressure) 20 MG (milligrams) intravenous (in the vein)."

RN 6 stated Patient 2's BP and pulse maintained high at 220's/130's and pulse 110's but she did not document. RN 6 stated the physician was notified of Patient 2's high blood pressure and high pulse and new orders were received. RN 6 stated she administered Labetalol 20 MG IV (intravenous-in the vein) as ordered. RN 6 stated she obtained vital signs prior to administering Labetalol to Patient 2 but did not document.

During an interview with the Emergency Department Director (EDD) on November 16, 2017, at 10:27 AM, he stated Patient 2's vital signs should have been obtained more frequently. The EDD stated the expectation was for Patient 2 to have vital signs taken every 30 minutes since Patient 2's vital signs were abnormal in triage. The EDD stated the blood pressure was not taken prior to the administration of Labetalol and the expectation was for RN 6 to obtain vital signs prior to administering medications that treat blood pressure.

The facility's policy and procedure titled, "Emergency Department Assessment," dated May 2009, indicated, ...Patient's shall receive a physical assessment including vital signs...2. All patients shall have vital signs taken to include: blood pressure, heart rate, respiratory rate, temperature...4. Frequency of assessment shall be dictated by the patient's condition and shall be adequately monitored to assure patient safety. a. Minimum standard for reassessment is every 2 hours."

17. During a review of Patient 2's clinical record, indicated Patient 2 presented to the Emergency Department(ED) on August 27, 2017 with a chief complaint of shortness of breath.

A review of the "Daily Focus Assessment Report," dated August 27, 2017 at 7:30 PM, indicated "...Lasix administered."

During an interview with Registered Nurse 6 (RN 6) on November 17, 2017 at 8:40 AM, she stated she was the assigned nurse for Patient 2 and documented on August 27, 2017. RN 6 reviewed the clinical record and was unable to find documentation of a physician order for Lasix (a medication that treats fluid buildup). RN 6 stated she received a ver

The facility failed to ensure the Condition of Participation: CFR 482.82 Infection Control was met by failing to ensure:

1a. Eight (8) GI scopes were stored in accordance with infection control (IC) standards and in a manner to prevent cross contamination. (Refer to A-0747)

b. The GI scopes were stored in a compliant storing cabinet per manufacturer recommendations. (Refer to A-0747)

c. the GI scope accessories were stored with their perspective scopes. (Refer to A-0747)

2. Terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed in the GI lab procedure room. (Refer to A-0747)

3. GI procedures were not being performed in the same room where the scopes are reprocessed and are stored.

4. The Trophon (a high level disinfection system for vaginal ultrasound probes) was maintained per manufacturer recommendations. (Refer to A-0747)

5. Terminal cleaning was performed in the sterile processing department (the area in the facility where they clean and sterilize the surgical instruments). (Refer to A-0747)

6. One of two steam sterilizer machines (used to sterilize surgical instruments) did not have a brown stain located in the left lower part of the cylinder. (Refer to A-0747)

7. A sterile processing department technician (SPDT 1) was wearing gloves, when he prepared a small bone tray (where sterilized surgical instruments are placed in the tray). (Refer to A-0747)

8. The temperatures and humidity (amount of moisture in the air) were monitored in the sterile processing department and where sterile surgical instruments were stored. (Refer to A-0747)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: Infection Control. (Refer to A-0747)

Based on observation, interviews, and record reviews, the hospital failed to ensure they had a system in place for evaluating and implementing a hospital wide infection control prevention program, in addition, the hospital failed to ensure their hospital infection control program had a system in place for the surveillance, prevention, and control of infections in a universe of 64 patients.

These failures occurred when:

1a. Eight (8) GI scopes were stored in accordance with infection control (IC) standards and in a manner to prevent cross contamination.

b. The GI scopes were stored in a compliant storing cabinet per manufacturer recommendations.

c. The GI scope accessories were stored with their perspective scopes.

2. Terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed in the GI lab procedure room.

3. GI procedures were not being performed in the same room where the scopes are reprocessed and are stored.

4. The Trophon (a high level disinfection system for vaginal ultrasound probes) was maintained per manufacturer recommendations.

5. No documented evidence that terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed in the sterile processing department (the area in the facility where they clean and sterilize the surgical instruments)

6. In the hospital sterile processing department one of two steam sterilizer machines (used to sterilize surgical instruments) had a brown stain located in the left bottom lower part of the cylinder.

7. A sterile processing department technician (SPDT 1) was observed not wearing any gloves, when he prepared one small bone tray (where sterilized surgical instruments are placed in the tray)

8. No documented evidence that the temperatures and humidity (amount of moisture in the air) were monitored in the sterile processing department and where sterilized surgical instruments were stored.

Findings:

1. During a tour of the Gastrointestinal (GI-referring collectively to the stomach and the small and large intestine) lab room, the following observations were made:

a. Eight (8) GI scopes hanging in a white cabinet touching each other.

b. A white scope storing cabinet with a fan located in the right lower side of the cabinet containing eight (8) scopes. The cabinet was not intended to be a scope storage cabinet, it did not have a HEPA filter and was not a drying cabinet.

c. All scope accessories were stored separate form their perspective scopes and stored in a urine specimen cup adjacent to the decontamination sink. The accessories also stored in a drawer in a rolling work station that is used to perform the pre-cleaning of the GI scopes and is used by the physician during the procedure.

During an interview with a GI LAb technician (GILT) on November 15, 2017, at 9:30 AM, he stated the GI scope cabinet stored eight (8) scopes and the cabinet was not a HEPA filter or an air drying cabinet. The GILT stated the GI scopes should not be touching each other and it was the hospital's practice to store the scope accessories separate from their perspective scopes. The GILT stated the scope accessories located adjacent to the decontamination sink were clean and were left overnight to dry.

During an interview with the Infection Control Preventionist (ICP) on November 15 , 2017, at 10:13 AM, she stated the GI scope cabinet was made by the facilities department and there was no instructions for use (IFU). The ICP stated the GI scopes are touching and they are not suppose to be touching and are potentially contaminated.

During an interview with the ICP on November 15, 2017 at 10:13 AM, she stated the hospital adopted and followed the Nationally Recognized Infection Control guidelines.

During a concurrent interview with the ICP on November 15, 2017 at 10:13 AM, she stated that the hospital adopted and followed the Nationally Recognized Infection Control guidelines from:

a. APIC - Association for Professionals in Infection Control

b. AORN - Association of Perioperative Registered Nurses

c. CDC -Centers for Disease Control

d. SGNA - Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal
Endoscopes

According to the "AORN Journal, May 2016, Vol. 103, No. 5, Back to Basics Flexible Endoscope Processing" stipulates, "Endoscopes should be stored in a manner which prevents them from contamination and protects them from damage ...If no drying cabinet is available, personnel should store the endoscopes in a closed cabinet with a High-Efficiency Particulate Arrestance (HEPA), filtered air that provides positive pressure and allows air circulation ...Flexible endoscopes should be stored with all valves opened and detached parts stored with the endoscope.

According to SGNA, "Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes":

"Key consideration in storage include: a. Use storage cabinets that are made of a material that can be disinfected ...Reusable buttons and valves should be reprocessed and stored together with the endoscope as a unique set for tracking purposes ...SGNA supports a 7-day storage interval for reprocessed endoscopes-but only if they were reprocessed and stored according to professional guidelines and manufacturer instructions..."

2. During an interview with the Infection Control Preventionist (ICP) on November 15, 2017 at 10:13 AM, she stated the hospital followed the Nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation-an organization for advancing and development, and safe and effective use of medical technology, CDC (Center for Disease Control), APIC (Association of Professionals in Infection Control and Epidemiology) and AORN (Association of perioperative practice and healthcare).

During a review of the "Terminal Cleaning Checklist," dated, July 26, 2017 completed by Environmental Services Staff (EVS 1), indicated, "...Using germicidal damp dust ceilings, AC return/vents...clean all cabinets and check to ensure all surfaces are clean, dusted and spot free.""

During an interview with EVS 1 on November 15, at 10:30 AM, she stated she was responsible for the terminal cleaning of the GI lab procedure room. EVS 1 stated she signed and completed the "Terminal Cleaning Checklist," dated July 26, 2017. EVS 1 stated she documented that she completed the tasks but did not dust the vents, cabinets or the ceiling because she could not reach. EVS 1 stated she should have thoroughly terminally cleaned the GI lab procedure room but did not.

During an interview with the Environmental Services Manager (EVSM) on November 15, 2017 at 9:05 AM, she reviewed the terminal cleaning log for the GI lab procedure room and was not able to find documented evidence of terminal cleaning for the months of August 2017, September 2017 and October 2017. The EVSM stated she was not aware of the issues identified in the GI lab procedure room.

The facility's policy and procedure titled, "Environmental Cleaning and Disinfecting of Procedural Practice Settings," dated March 2017, indicated, " ...C. Terminal cleaning: Terminal cleaning is done in each procedure room ...once in each 24-hour period during the workweek."

AORN, one of the nationally recognized infection control guidelines the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of the day when the area is being used."

3. During a tour of the of the GI lab room on November 15, 2017 at 9:30 AM, an observation was made of a Medivators processor (a machine used for cleaning and disinfecting reusable patient equipment), and a white cabinet storing eight (8) scopes located within the room.

During a concurrent interview with the GI lab Technician (GILT), he stated GI (Gastrointestinal-referring collectively to the stomach and the small and large intestine) procedures were being performed in the same room where the Medivators processor is located, the reprocessing of scopes takes place, and the scopes are stored.

During an interview with the Director of Quality and Risk Management (QORM) on November 15, 2017 at 10:07 AM, she stated It was her understanding that it was okay to reprocessed scopes in the same room were procedures are performed and where the scopes are stored because it was licensed that way.

During an interview with the ICP on November 15, 2017 at 10:13 AM, she stated the hospital followed the Nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation-an organization for advancing and development, and safe and effective use of medical technology, CDC (Center for Disease Control), APIC (Association of Professionals in Infection Control and Epidemiology) and AORN (Association of perioperative practice and healthcare). The ICP stated the scopes are currently stored in a non-compliant storing cabinet in the same room that is used as a procedure room and a decontamination room where the scopes are reprocessed. The ICP stated the scopes are potentially contaminated. The ICP stated the issues that were identified in the GI lab procedure room included procedures being performed in the same room where the scopes are reprocessed and where the scopes are stored has been elevated to administration and awaiting a response.

AORN, one of the nationally recognized infection control guidelines the hospital followed indicated, "Cabinets used for storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area close to, but not within, the endoscopy procedure room."

4. During a review of the "Trophon User Manual, indicated, "Section B6: Routine Care and Maintenance ...B6.2 Service Once the service interval of 12 months ..."

During an interview with the Director of Quality and Risk Management (DOQRM) on November 16, 2017 at 9:43 AM, she stated she was not able to find documented evidence of the preventative maintenance for the Trophon (a machine used for cleaning and disinfecting reusable vaginal ultrasound probes). The DOQRM stated the Trophon machine was purchased by the hospital in 2014. The DOQRM stated the Trophon was not in the hospital system therefore, a preventative maintenance schedule was not developed.

During an interview with the Director Imaging Services (DIS) on November 17, 2017, at 2:40 PM, he stated he could not find documented evidence of preventative maintenance for the Trophon. The DIS stated the manufacturer recommendations for annual preventative maintenance was not being followed.


34959

5. During an interview with the Manager of Environmental Services (MOES) on November 16, 2017 at 9:05 AM, the MOES stated that they never had a separate terminal cleaning log to document that terminal cleaning was performed in the sterile processing department.

During an interview with the Director of Quality and Risk Management (DOQRM) on November 16, 2017 at 9:14 AM, the DOQRM stated that there was no documentation proof that terminal cleaning was performed in the sterile processing department from January 1, 2017 to November 14, 2017.

AORN, one of the nationally recognized infection control guidelines the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of each day when the area is being used." Both AORN and AAMI (Association for the Advancement of Medical Instrumentation) ST79 recommend that sterile processing be terminally cleaned the same as the operating, delivery, and invasive procedure rooms. AAMI ST79 (Section 3.4) states that the best practice is to provide separate housekeeping facilities for the decontamination and clean areas to avoid transferring contaminates from dirty to clean" areas."

The facility policy and procedure titled, "Environmental Cleaning and Disinfecting of Procedural Practice Setting", dated September 2017, indicated: "Terminally cleaning is done in each procedure room, scrub, and utility room once in each twenty-four period during the regular work week. Mechanical frictions, Environmental Protection Agency, and hospital approved cleaning agents shall be used for terminal cleaning following the same procedure used for between surgery procedures cleaning including, but not limited to the following: surgical lights, external tracks, fixed ceiling mounted equipment, all furniture, equipment including wheels, casters, step stools, foot pedals, telephones and light switches. Hallways, floors, handles of cabinets, push plates, ventilation faceplates, horizontal surfaces including tops of counters, sterilizers, fixed cabinetry, utility areas, and scrub sinks. Relocate furniture to one side of the room or into the hallway, mop the floor with hospital approved neutral floor cleaning solutions, one half of the floor at a time, move furniture to newly cleaned side of the room, and mop the remaining of the floor area..."

6. During a tour of the hospital sterile processing department area on November 15, 2017 at 3:09 PM, one of two sterilizer machines (used to sterilize surgical instruments) had a brown stain located in the left lower part of the cylinder.

During a concurrent interview with the Lead Sterile Processing Technician (LSPT 1), he confirmed there was a brown stain located in the left lower part of the cylinder.

The facility policy and procedure titled, "Operation, Maintenance, and Cleaning of Sterilizers", dated September 2017, indicated: "Cleaning and maintenance of sterilizers must be completed according to the manufacturer's recommendations..."

7. During a tour of the hospital sterile processing department area on November 15, at 3:15 PM, a Sterile Processing Department Technician (SPDT 1) was observed not wearing gloves while assembling surgical instruments (instruments used for surgical procedures).

During a concurrent interview with the Lead Sterile Processing Technician (LSPT 1), he confirmed the SPDT 1 should have been wearing gloves when assembling surgical instruments.

The facility policy and procedure titled, "Processing Contaminated Instruments and Equipment for Sterilization", dated February 2013, indicated: "Care and handling of surgical instruments and powered equipment should follow the manufacturers recommendations. Employees must wear personal protective equipment during the process. The personal protective equipment includes gown, gloves, eye, and face protection..."

8. During an interview with the Facilities Manager (FM 1) on November 16, 2017 at 10:17 AM, the FM 1 stated that the facility was not monitoring temperatures and humidity in the sterile processing department since two years ago.

During an interview with the Infectionist Perfectionist (IP) on November 16, 2017 at 10:34 AM, the IP stated that there was not a thermostat (regulates the room temperature) located in the clean room area where they stored sterilized surgical instruments. The IP also stated there was no monitoring of the temperatures and humidity since construction began in the sterile processing department.

During an interview with the Director of Quality and Risk Management (DOQRM) on November 17, 2017 at 8:10 AM, the DOQRM stated there was no monitoring of the temperatures and humidity since May 2, 2016 when construction began in the sterile processing department.

The facility policy and procedure titled,"Scope of Service Central Sterilization" dated May 2009, indicated: "Sterile packages should be stored under environmentally controlled conditions..."

The facility failed to ensure the Condition of Participation: CFR 482.51 Surgical Services was met by failing to ensure:

1a. Eight (8) GI scopes were stored in accordance with infection control (IC) standards and in a manner to prevent cross contamination. (Refer to A-0747)

b. The GI scopes were stored in a compliant storing cabinet per manufacturer recommendations. (Refer to A-0747)

c. The GI scope accessories were stored with their perspective scopes. (Refer to A-0747)

2. Terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed in the GI lab procedure room. (Refer to A-0747)

3. GI procedures were not being performed in the same room where the scopes are reprocessed and are stored.

4. The Trophon (a high level disinfection system for vaginal ultrasound probes) was maintained per manufacturer recommendations. (Refer to A-0747)

5. Terminal cleaning was performed in the sterile processing department (the area in the facility where they clean and sterilize the surgical instruments). (Refer to A-0747)

6. One of two steam sterilizer machines (used to sterilize surgical instruments) did not have a brown stain located in the left lower part of the cylinder. (Refer to A-0747)

7. A sterile processing department technician (SPDT 1) was wearing gloves, when he prepared a small bone tray (where sterilized surgical instruments are placed in the tray). (Refer to A-0747)

8. The temperatures and humidity (amount of moisture in the air) were monitored in the sterile processing department and where sterile surgical instruments were stored. (Refer to A-0747)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: Surgical Services. (Refer to A-0747)

Based on observations, interviews, and record reviews, the hospital failed to ensure surgical services were provided in accordance with infection control standards of practice and guidelines.

These failures occurred when:

1a. Eight (8) GI scopes were stored in accordance with infection control (IC) standards and in a manner to prevent cross contamination.

b. The GI scopes were stored in a compliant storing cabinet per manufacturer recommendations.

c. The GI scope accessories were stored with their perspective scopes.

2. Terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed in the GI lab procedure room.

3. GI procedures were not being performed in the same room where the scopes are reprocessed and stored.

4. The Trophon (a high level disinfection system for vaginal ultrasound probes) was maintained per manufacturer recommendations.

5. No documented evidence that terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed in the sterile processing department (the area in the facility where they clean and sterilize the surgical instruments).

6. In the hospital sterile processing department one of two steam sterilizer machines (used to sterilize surgical instruments) had a brown stain located in the left bottom lower part of the cylinder.

7. A sterile processing department technician (SPDT 1) was observed not wearing any gloves, when he prepared one small bone tray (where sterilized surgical instruments are placed in the tray).

8. No documented evidence that the temperatures and humidity (amount of moisture in the air) were monitored in the sterile processing department and where sterilized surgical instruments were stored.

These failures had the potential for the spread of infection in a universe of 64 patients.

Findings:

1. During a tour of the Gastrointestinal (GI-referring collectively to the stomach and the small and large intestine) lab room, the following observations were made:

a. Eight (8) GI scopes hanging in a white cabinet touching each other.

b. A white scope storing cabinet with a fan located in the right lower side of the cabinet containing eight (8) scopes. The cabinet was not intended to be a scope storage cabinet, it did not have a HEPA filter and was not a drying cabinet.

c. All scope accessories were stored separate form their perspective scopes and stored in a urine specimen cup adjacent to the decontamination sink. The accessories were also stored in a drawer in a rolling work station that is used to perform the pre-cleaning of the GI scopes and is used by the physician during the procedure.

During an interview with a GI LAb technician (GILT) on November 15, 2017, at 9:30 AM, he stated the GI scope cabinet stored eight (8) scopes and the cabinet was not a HEPA filter or an air drying cabinet. The GILT stated the GI scopes should not be touching each other and it was the hospital's practice to store the scope accessories separate from their perspective scopes. The GILT stated the scope accessories located adjacent to the decontamination sink were clean and were left overnight to dry.

During an interview with the Infection Control Preventionist (ICP) on November 15 , 2017, at 10:13 AM, she stated the GI scope cabinet was made by the facilities department and there was no instructions for use (IFU). the ICP stated the GI scopes are touching and they are not suppose to be touching and are potentially contaminated.

During an interview with the ICP on November 15, 2017 at 10:13 AM, she stated the hospital adopted and followed the Nationally Recognized Infection Control guidelines

During a concurrent interview with the ICP on November 15, 2017 at 10:13 AM, she stated that the hospital adopted and followed the Nationally Recognized Infection Control guidelines from:

a. APIC - Association for Professionals in Infection Control

b. AORN - Association of Perioperative Registered Nurses

c. CDC -Centers for Disease Control

d. SGNA - Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes

According to the "AORN Journal, May 2016, Vol. 103, No. 5, Back to Basics Flexible Endoscope Processing" stipulates, "Endoscopes should be stored in a manner which prevents them from contamination and protects them from damage ...If no drying cabinet is available, personnel should store the endoscopes in a closed cabinet with a High-Efficiency Particulate Arrestance (HEPA), filtered air that provides positive pressure and allows air circulation ...Flexible endoscopes should be stored with all valves opened and detached parts stored with the endoscope.

According to SGNA, "Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes":

"Key consideration in storage include: a. Use storage cabinets that are made of a material that can be disinfected ...Reusable buttons and valves should be reprocessed and stored together with the endoscope as a unique set for tracking purposes ...SGNA supports a 7-day storage interval for reprocessed endoscopes-but only if they were reprocessed and stored according to professional guidelines and manufacturer instructions ..."

2. During an interview with the Infection Control Preventionist (ICP) on November 15, 2017 at 10:13 AM, she stated the hospital followed the Nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation-an organization for advancing and development, and safe and effective use of medical technology, CDC (Center for Disease Control), APIC (Association of Professionals in Infection Control and Epidemiology) and AORN (Association of perioperative practice and healthcare).

During a review of the "Terminal Cleaning Checklist," dated, July 26, 2017 completed by Environmental Services Staff (EVS 1), indicated, " ...Using germicidal damp dust ceilings, AC return/vents ...clean all cabinets and check to ensure all surfaces are clean, dusted and spot free.""

During an interview with EVS 1 on November 15, at 10:30 AM, she stated she was responsible for the terminal cleaning of the GI lab procedure room. EVS 1 stated she signed and completed the "Terminal Cleaning Checklist," dated July 26, 2017. EVS 1 stated she documented that she completed the tasks but did not dust the vents, cabinets or the ceiling because she could not reach. EVS 1 stated she should have thoroughly terminally cleaned the GI lab procedure room but did not.

During an interview with the Environmental Services Manager (EVSM) on November 15, 2017 at 9:05 AM, she reviewed the terminal cleaning log for the GI lab procedure room and was not able to find documented evidence of terminal cleaning for the months of August 2017, September 2017 and October 2017. The EVSM stated she was not aware of the issues identified in the GI lab procedure room.

The facility's policy and procedure titled, "Environmental Cleaning and Disinfecting of Procedural Practice Settings," dated March 2017, indicated, " ...C. Terminal cleaning: Terminal cleaning is done in each procedure room ...once in each 24-hour period during the workweek."

AORN, one of the nationally recognized infection control guidelines the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of the day when the area is being used."

3. During a tour of the of the GI lab room on November 15, 2017 at 9:30 AM, an observation was made of a Medivators processor (a machine used for cleaning and disinfecting reusable patient equipment), and a white cabinet storing eight (8) scopes located within the room.

During a concurrent interview with the GI lab Technician (GILT), he stated GI (Gastrointestinal-referring collectively to the stomach and the small and large intestine) procedures were being performed in the same room where the Medivators processor is located, the reprocessing of scopes takes place, and the scopes are stored.

During an interview with the Director of Quality and Risk Management (DOQRM) on November 15, 2017 at 10:07 AM, she stated It was her understanding that it was okay to reprocessed scopes in the same room were procedures are performed and where the scopes are stored because it was licensed that way.

During an interview with the ICP on November 15, 2017 at 10:13 AM, she stated the hospital followed the Nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation-an organization for advancing and development, and safe and effective use of medical technology, CDC (Center for Disease Control), APIC (Association of Professionals in Infection Control and Epidemiology) and AORN (Association of perioperative practice and healthcare). The ICP stated the scopes are currently stored in a non-compliant storing cabinet in the same room that is used as a procedure room and a decontamination room where the scopes are reprocessed. The ICP stated the scopes are potentially contaminated. The ICP stated the issues that were identified in the GI lab procedure room included procedures being performed in the same room where the scopes are reprocessed and where the scopes are stored has been elevated to administration and awaiting a response.

AORN, one of the nationally recognized infection control guidelines the hospital followed indicated, "Cabinets used for storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area close to, but not within, the endoscopy procedure room."

4. During a review of the "Trophon User Manual, indicated, "Section B6: Routine Care and Maintenance ...B6.2 Service Once the service interval of 12 months ..."

During an interview with the Director of Quality and Risk Management (DOQRM) on November 16, 2017 at 9:43 AM, she stated she was not able to find documented evidence of the preventative maintenance for the Trophon (a machine used for cleaning and disinfecting reusable vaginal ultrasound probes). The DOQRM stated the Trophon machine was purchased by the hospital in 2014. The DOQRM stated the Trophon was not in the hospital system therefore, a preventative maintenance schedule was not developed.

During an interview with the Director Imaging Services (DIS) on November 17, 2017, at 2:40 PM, he stated he could not find documented evidence of preventative maintenance for the Trophon. The DIS stated the manufacturer recommendations for annual preventative maintenance was not being followed.

5. During an interview with the Manager of Environmental Services (MOES) on November 16, 2017 at 9:05 AM, the MOES stated that they never had a separate terminal cleaning log to document that terminal cleaning was performed in the sterile processing department,

During an interview with the Director of Quality and Risk Management (DOQRM) on November 16, 2017 at 9:14 AM, the DOQRM stated that there was no documentation proof that terminal cleaning was performed in the sterile processing department from January 1, 2017 to November 14, 2017.

AORN, one of the nationally recognized infection control guidelines the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of each day when the area is being used." Both AORN and AAMI (Association for the Advancement of Medical Instrumentation) ST79 recommend that sterile processing be terminally cleaned the same as the operating, delivery, and invasive procedure rooms. AAMI ST79 (Section 3.4) states that the best practice is to provide separate housekeeping facilities for the decontamination and clean areas to avoid transferring contaminates from dirty to clean" areas."

The facility policy and procedure titled, "Environmental Cleaning and Disinfecting of Procedural Practice Setting", dated September 2017, indicated: "Terminally cleaning is done in each procedure room, scrub, and utility room once in each twenty-four period during the regular work week. Mechanical frictions, Environmental Protection Agency, and hospital approved cleaning agents shall be used for terminal cleaning following the same procedure used for between surgery procedures cleaning including, but not limited to the following: surgical lights, external tracks, fixed ceiling mounted equipment, all furniture, equipment including wheels, casters, step stools, foot pedals, telephones and light switches. Hallways, floors, handles of cabinets, push plates, ventilation faceplates, horizontal surfaces including tops of counters, sterilizers, fixed cabinetry, utility areas, and scrub sinks. Relocate furniture to one side of the room or into the hallway, mop the floor with hospital approved neutral floor cleaning solutions, one half of the floor at a time, move furniture to newly cleaned side of the room, and mop the remaining of the floor area..."

6. During a tour of the hospital sterile processing department area on November 15, 2017 at 3:09 PM, one of two sterilizer machines (used to sterilize surgical instruments) had a brown stain located in the left lower part of the cylinder.

During a concurrent interview with the Lead Sterile Processing Technician (LSPT 1), he confirmed there was a brown stain located in the left lower part of the cylinder.

The facility policy and procedure titled, "Operation, Maintenance, and Cleaning of Sterilizers" dated September 2017, indicated: "Cleaning and maintenance of sterilizers must be completed according to the manufacturer's recommendations..."

7. During a tour of the hospital sterile processing department area on November 15, 2017 at 3:15 PM, a Sterile Processing Department Technician (SPDT 1) was observed not wearing gloves while assembling surgical instruments (instruments used for surgical procedures).

During a concurrent interview with the Lead Sterile Processing Technician (LSPT 1), he confirmed the SPDT 1 should have been wearing gloves when assembling surgical instruments.

The facility policy and procedure titled, "Processing Contaminated Instruments and Equipment for Sterilization" dated February 2013, indicated: "Care and handling of surgical instruments and powered equipment should follow the manufacturers recommendations. Employees must wear personal protective equipment during the process. The personal protective equipment includes gown, gloves, eye, and face protection..."

8. During an interview with the Facilities Manager (FM 1) on November 16, 2017 at 10:17 AM, the FM 1 stated that the facility was not monitoring temperatures and humidity in the sterile processing department since two years ago.

During an interview with the Infection Control Preventionist (ICP) on November 16, 2017 at 10:34 AM, the ICP stated that there was not a thermostat (regulates the room temperature) located in the clean room area where they stored sterilized surgical instruments. The ICP also stated there was no monitoring of the temperatures and humidity since construction began in the sterile processing department.

During an interview with the Director of Quality and Risk Management (DOQRM) on November 17, 2017 at 8:10 AM, the DOQRM stated there was no monitoring of the temperatures and humidity since May 2, 2016 when construction began in the sterile processing department.

The facility policy and procedure titled,"Scope of Service Central Sterilization" dated May 2009, indicated: "Sterile packages should be stored under environmentally controlled conditions..."

The facility failed to ensure the Condition of Participation 482.55: Emergency Services was met by failing to ensure:

1. The hospital staff appropriately monitored Patient 1, conducted a contraband search of Patient 1's personal belongings when Patient 1 presented to the Emergency Department (ED) with suicidal ideations (thoughts of killing oneself). (Refer to A-1104)

2. The Registered Nurse (RN 3) triage suicide risk screening for Patient 1 was accurate. (Refer 10 A-1104)

3. There was documented evidence Patient 1 received a Social Services consult as ordered by the physician. (Refer to A-1004)

4. The Registered Nurse (RN 4) conducted a complete triage assessment for Patient 2. (Refer to A-1104)

5. Vital signs were obtained per policy and procedure for Patient 2. (Refer to A-1104)

6. Verbal orders for a medication was documented for Patient 2. (Refer to A-1104)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation 482.55: Emergency Services.

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

1. The hospital staff appropriately monitored Patient 1, conducted a contraband search of Patient 1's personal belongings when Patient 1 presented to the Emergency Department (ED) with suicidal ideations (thoughts of killing oneself). This failure resulted in Patient 1 attempting suicide with her personal belt.

2. Registered Nurse's (RN 3) triage suicide risk screening for Patient 1 was accurate. This failure resulted in Patient 1's triage suicide risk assessment inaccurate.

3. There was documented evidence Patient 1 received a Social Services consult as ordered by the physician. This failure resulted in no documented evidence Patient 1 received a Social Services consult.

4. The Registered Nurse (RN 4) conducted a complete triage assessment for Patient 2. This failure resulted in Patient 2 not being accurately assessed.

5. Vital signs were obtained per policy and procedure for Patient 2. This failure resulted in Patient 2's vital signs not being obtained per policy and procedure.

6. Verbal orders for a medication order was documented for Patient 2. This failure resulted in no documented evidence of a physician medication order.

Findings:

1. During a review of Patient 1's clinical record, indicated Patient 1 presented to the Emergency Department on August 11, 2017 with a chief complaint (the patient's reported reason for seeking medical care) of suicidal ideations (thoughts of killing oneself).

During a review of the "Triage Report," dated August 11, 2017, indicated, "Pt (Patient) BIBA (brought in by ambulance) with SI (suicidal ideations). Pt was found in middle of highway waiting to get hit by car with intent to die. Pt (Patient) HX (history) SI, depression, bipolar (a mental illness that causes dramatic shifts in a person's mood, energy and ability to think clearly), Schizo (Schizophrenia- a severe mental disorder that affects how a person thinks, feels, and behaves), Meth (Methamphetamine an illegal drug that is abused for its euphoric high that provides increased energy).

During an interview with a Registered Nurse 1 (RN 1) on November 17, 2017 at 8:35 AM, RN 1 stated she was the assigned night shift nurse for Patient 1 on August 11, 2017. RN 1 stated Patient 1 verbalized she had suicidal ideations and attempted to kill herself in the past. RN 1 stated she attempted to conduct a contraband search on Patient 1, however Patient 1 refused and she did not document her attempt. RN 1 stated she visualized the metal belt on Patient 1 but did not attempt to conduct another contraband search.

A review of the "Daily Focus Assessment Report," completed by RN 1 dated August 11, 2017 at 11:34 PM, indicated the following:

History of suicide Attempts-Yes

Ideations-Suicidal thoughts now

Patient at Risk-Yes

A review of Patient 1's "Application for Assessment, Evaluation, and Crisis Intervention or Placement for Evaluation and Treatment," dated August 12, 2017 at 8:47 AM, indicated, "Based upon the above information, there is probable cause to believe that said person is, as a result of mental disorder: A danger to herself."

During an interview with Registered Nurse 2 (RN 2) on November 16, 2017 at 12:16 PM, she stated she was the assigned day shift nurse for Patient 1 on August 12, 2017 [the day of the incident]. RN 2 stated the nursing staff was responsible to conduct a contraband search for patients who present to the ED with suicidal ideations. RN 2 stated a contraband search was not conducted for Patient 1 and her personal belongings were not removed and the facility's policy and procedure was not followed. RN 2 stated Patient 1's clothes should have been removed and Patient 1 should have been placed in a hospital gown or paper scrubs but she did not why it was not done. RN 2 stated CCRT (Community Crisis Response Team-a crisis response program for those experiencing a psychiatric emergency utilizing specially trained mobile crisis response teams to provide crisis interventions, and assessments) evaluated Patient 1 and Patient 1 was deemed to be a danger to herself but the information was not communicated with her.

RN 2 stated on August 12, 2017 at 9:40 AM, Patient 1 requested to use the restroom, Patient 1 ambulated to the restroom by herself. RN 1 stated she was timing Patient 1 and after some time went by [approximately 10 minutes], she went to check on Patient 1. RN 1 stated she knocked on the restroom door and called out Patient 1's name but there was no answer. RN 1 attempted to open the restroom door but it was locked. RN 1 retrieved the restroom key and unlocked the door. RN 1 stated she opened the door and Patient 1 was found lying on the restroom floor tied to the side rail with her belt around her neck. RN 1 stated "she [Patient 1] was blue I thought she was dead." RN 1 stated she palpated for a pulse. RN 1 stated she released the belt around Patient 1's neck and Patient 1 gasped for air and Patient 1 was angry she was still alive. RN 1 stated Patient 1 was assisted on the gurney and was transported bed 3. RN 1 stated once Patient 1 was in bed 3 she was observed to have jerking movements, the physician was notified of the incident and Patient 1 was administered Ativan (a medication used to treat seizures).

A review of Patient 1's "Physician Emergency Department Record," indicated "I was called by the nursing staff because the patient [Patient 1] had hung herself in the bathroom and turned blue. Shortly after the patient was removed from the bathroom and placed in the room 3, she [Patient 1] began to have a seizure, she was administered Ativan 1 MG (milligrams). She will now have one-on-one supervision/monitoring ..."

During an interview with the Emergency Department Director (EDD) on November 16, 2017 at 10:27 AM, he stated a contraband check was not conducted on Patient 1, she was not given a hospital gown, and she remained in her street clothes. The EDD stated the process was not followed. The EDD stated Patient 1 was deemed a danger to herself and was not monitored by the ED staff. The EDD stated the expectation was for Patient 1 to have a safety attendant.

The facility's policy and procedure titled, "Emergency Department 5150 Procedures," dated November 2010, indicated, "...All psychiatric patients who are admitted to a nursing unit must submit to a contraband search by Public Safety and/or hospital staff.

The facility's policy and procedure titled, "Emergency Department Scope of Service," dated December 2015, indicated, "...H. Psychiatric patients ...including suicidal patients, shall receive careful considerations of both physical and psychosocial needs...1. A definite follow-up plan to ensure safety of the patient ...shall be arranged as needed."

3. During a review of Patient 1's clinical record, the facesheet (demographics) indicated Patient 1 presented to the Emergency Department on August 11, 2017 with a chief complaint (the patient's reported reason for seeking medical care) of suicidal ideations (thoughts of killing oneself).

During a review of the "Triage Report," dated August 11, 2017, indicated, "Pt (Patient) BIBA (brought in by ambulance) with SI (suicidal ideations). Pt was found in middle of highway waiting to get hit by car with intent to die. Pt (Patient) HX (history) SI, depression, bipolar (a mental illness that causes dramatic shifts in a person's mood, energy and ability to think clearly), Schizo (Schizophrenia- a severe mental disorder that affects how a person thinks, feels, and behaves), Meth (Methamphetamine an illegal drug that is abused for its euphoric high that provides increased energy). Suicide Risk: Screened-No Risk."

During an interview with Registered Nurse 3 (RN 3) on November 17, 2017 at 8:20 AM, she stated she completed the Triage Report for Patient 1. RN 3 stated Patient 1 was a suicide risk. RN 3 stated the "Suicide Risk," question was answered incorrectly, it was an error.

During an interview with the Emergency Department Director (EDD) on November 16, 2017 at 10:27 AM, he stated Patient 1's triage suicide screening question was incorrect. The EDD stated RN 3 documented incorrectly.

4. During a review of Patient 1's clinical record, the facesheet (demographics) indicated Patient 1 presented to the Emergency Department on August 11, 2017 with a chief complaint (the patient's reported reason for seeking medical care) of suicidal ideations (thoughts of killing oneself).

A review of the physician orders dated August 12, 2017, indicated "Consult Social Services."

During an interview with Social Services (SS) on November 17, 2017 at 9:23 AM, he reviewed the clinical record and was unable to find documented evidence of a social service consult. The SS stated he evaluated Patient 1 but did not have time to document his consult.

During an interview with the Interim Director Case Manager (IDCM) on November 17, 2017 at 9:25 AM, she stated her expectation was for her staff to document the Social Services assessment and plan.

The facility's policy and procedure titled, "It is the policy of (name of facility) to make social services available to patients, families and hospital personnel."

5. During a review of Patient 2's clinical record, indicated Patient 2 presented to the Emergency Department(ED) on August 27, 2017 with a chief complaint of shortness of breath.

A review of Patient 2's "Triage Report," dated August 27, 2017 at 6:19 PM, indicated, Vital Signs as follow:

BP (Blood Pressure) 205/130 (normal ranges are between 120/80 and 140/90)

Temperature 97.8

Pulse 111 (normal ranges are between 60-100)

Respirations 24

SpO2 84 % (amount of oxygen in the blood-normal ranges are between 95 to 100)

Acuity 3 (triage algorithm that categorizes emergency department patients by evaluating both patient acuity and resource needs- acuity 3=urgent)

During an interview with Registered Nurse 4 (RN 4) on November 15, 2017 at 4:17 PM, she stated she was the triage nurse who completed Patient 2's triage assessment. RN 4 stated Patient 2's vital signs were abnormal, Patient 2's BP was high 205/130, pulse of 111 was high, and his oxygen saturation level was low at 84%. RN 4 stated she did not listen to Patient 2's lung sounds, therefore Patient 2 did not receive a complete triage assessment and the process was not followed. RN 2 stated the acuity of 3 she assigned to Patient 2 was inappropriate. RN 2 stated Patient 2 should have been assigned a more appropriate acuity of 2 (Emergent-conditions that require immediate evaluation and treatment to prevent further complications or deterioration).

During an interview with the Emergency Department Director (EDD) on November 16, 2017 at 10:27 AM, he stated Patient 2's assigned triage acuity level of 3 was inappropriate. The EDD stated Patient 2's low oxygen level of 84% and high blood pressure of 205/130 should have been an indication to assign a higher acuity. The EDD stated an acuity level of 1 or 2 would have been appropriate.

The facility's policy and procedure titled, "Emergency Department Assessment," dated May 2009, indicated, "...Patients shall receive a physical assessment ..."

6. During a review of Patient 2's clinical record, indicated Patient 2 presented to the Emergency Department(ED) on August 27, 2017 with a chief complaint of shortness of breath.

A review of Patient 2's "Triage Report," dated August 27, 2017 at 6:19 PM, indicated, Vital Signs as follow:

BP (Blood Pressure) 205/130 (normal ranges are between 120/80 and 140/90)

Temperature 97.8

Pulse 111 (normal ranges are between 60-100)

Respirations 24

SpO2 84 % (amount of oxygen in the blood-normal ranges are between 95 to 100)

A review of Patient 2's "Vital Sign Report," dated August 27, 2017, indicated the following:

At 6:24 PM (Triage vital signs)

BP 205/130

02 sats 84%

Pulse 111

Resp (Respirations) 24

Temp (Temperature) 97.8

No documentation of vital signs between 6:24 PM and 8:28 PM.

At 8:28 PM

BP 123/83

02 sats 91%

Pulse 98

Resp 20

During an interview with Registered Nurse 6 (RN 6) on November 17, 2017 at 8:40 AM, she stated she was the assigned nurse for Patient 2 on August 27, 2017. RN 6 reviewed the clinical record and was unable to find documentation of Patient 2's vital signs from the time of triage at 8:24 PM to 8:28 PM (for a total of 1.5 hours).

A review of Patient 2's "Order Report," dated August 27, 2017, indicated, "Labetalol (a medication to treat high blood pressure) 20 MG (milligrams) intravenous (in the vein)."

RN 6 stated Patient 2's BP and pulse maintained high at 220's/130's and pulse 110's but she did not document. RN 6 stated the physician was notified of Patient 2's high blood pressure and high pulse and new orders were received. RN 6 stated she administered Labetalol 20 MG IV (intravenous-in the vein) as ordered. RN 6 stated she obtained vital signs prior to administering Labetalol to Patient 2 but did not document.

During an interview with the Emergency Department Director (EDD) on November 16, 2017, at 10:27 AM, he stated Patient 2's vital signs should have been obtained more frequently. The EDD stated the expectation was for Patient 2 to have vital signs taken every 30 minutes since Patient 2's vital signs were abnormal in triage. The EDD stated the blood pressure was not taken prior to the administration of Labetalol and the expectation was for RN 6 to obtain vital signs prior to administering medications that treat blood pressure.

The facility's policy and procedure titled, "Emergency Department Assessment," dated May 2009, indicated, "...Patient's shall receive a physical assessment including vital signs...2. All patients shall have vital signs taken to include: blood pressure, heart rate, respiratory rate, temperature...4. Frequency of assessment shall be dictated by the patient's condition and shall be adequately monitored to assure patient safety. a. Minimum standard for reassessment is every 2 hours."

7. During a review of Patient 2's clinical record, indicated Patient 2 presented to the Emergency Department(ED) on August 27, 2017 with a chief complaint of shortness of breath.

A review of the "Daily Focus Assessment Report," dated August 27, 2017 at 7:30 PM, indicated "...Lasix administered."

During an interview with Registered Nurse 6 (RN 6) on November 17, 2017 at 8:40 AM, she stated she was the assigned nurse for Patient 2 and documented on August 27, 2017. RN 6 reviewed the clinical record and was unable to find documentation of a physician order for Lasix (a medication that treats fluid buildup). RN 6 stated she received a verbal order for Lasix 100 MG (milligrams) IV (Intravenous) and administered the medication as ordered. RN 6 stated she did not document the verbal medication order or entered it into the system. RN 6 stated since she did not enter the order into the system therefore she was not able to document the medication administration on the Medication Administration Record (MAR).

During an interview with the Director of Pharmacy (DOP) on November 16, 2017 at 11:15 AM, she reviewed the clinical record for Patient 2 but was not able to find documentation of the physician order for Lasix 100 MG. The DOP stated RN 6 documented Lasix was administered but there was no order in the system. The DOP stated the medication order should have been documented in the system or written as a verbal order.

The facility's policy and procedure titled, "Verbal and Telephone Orders, Validating Accuracy," dated November 2016, indicated,"...4. Computerized physician order entry (CPOE) shall be used for all orders by providers ...5. Verbal and telephone orders guidelines: ...record the order directly on to the physician order sheet in patient's medical record ..."

The facility's policy and procedure titled, "Medication Administration," dated April, 2017, indicated, "...c. The nurse administering medications must document on the eMAR."