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

RONALD REAGAN UCLA MEDICAL CENTER 757 WESTWOOD PLAZA LOS ANGELES, CA 90095 March 5, 2015
VIOLATION: PATIENT RIGHTS: ADVANCED DIRECTIVES Tag No: A0132
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the facility failed to ensure Patient 19 had not had the right to formulate advance directives.


Findings:

A review of the discharge summary indicated Patient 19 was admitted to the facility on on [DATE] and was discharged on [DATE].

A review of the procedure report with Employee 4 (Informatic Nurse) on March 5, 2015 indicated Patient 19 had undergone a surgical procedure -tracheostomy on September 30, 2013. The tracheostomy Informed consent was reviewed and indicated the patient's sister had signed the consent as the patient's representative. However, there was no documentation that the patient had been asked to sign the UCLA Healthcare Temporary Advance Directive designating their decision maker and/or healthcare instructions."

During the interview with Employee 4 on March 5, 2015 at 9:47 a.m., she stated the patient had not been asked to sign the UCLA Healthcare Temporary Advance Directive designating their decision maker and/or healthcare instructions."

According to the facility's policy and procedure dated October 31, 2012, titled "ADVANCE DIRECTIVES":

"POLICY

II Written Information regarding Advance Directives to be Provided to Patients

B. Provision of written Information (Inpatient)

4. If a patient has not designated an agent on a PAHC (power attorney for healthcare), the patient will be asked to sign the UCLA Healthcare Temporary Advance Directive designating their decision maker and/or healthcare instructions."
VIOLATION: QAPI Tag No: A0263
Based on observations, interview and record review, the facility failed to implement and maintain an effective, ongoing, hospital wide, quality assessment and performance improvement program (QAPI) as evidenced by:

1. Failure to identify a specific mechanism to observe, evaluate certain high risk, problem prone activities within the hospital (Refer to A283).

2. Failure to identify a specific person in charge to perform onsite inspection and evaluation for post-procedure cleaning of the environment in the Medical Procedure Unit (MPU) or in the surgical areas of the hospital (Refer to A283).

3. Failure to identify or designate a specific person or persons in the committee who would observe and evaluate disinfection activities within the hospital or specifically for the post-procedure cleaning of endoscopes (Refer to A283).

4. Failure to monitor and oversight of the temperature and humidity control for the MPU, procedure areas for prevention of hospital acquired infections (Refer to A283).

The cumulative effects of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on interviews, observations, a tour of the hospital and a review of selected policies and procedures from the hospital, the hospital failed to ensure development and implementation of a program to focus on certain high risk, high volume, problem prone activities within the hospital.

Findings:

Interviews with the entire (QAPI) Quality Assessment, Performance Improvement committee on 3/5/2015, at 11:15 a.m., the committee seemed unable to identify a specific mechanism to observe, evaluate certain high risk, problem prone activities within the hospital. The committee was unable to identify a specific person in charge to perform onsite inspection and evaluation for post-procedure cleaning of the environment in the MPU or in the surgical areas of the hospital. The committee was unable to identify or designate a specific person or persons in the committee who would observe and evaluate disinfection activities within the hospital or specifically for the post-procedure cleaning of endoscopes. When asked if the infection control committee had performed environmental cultures, to detect, microbes, following an outbreak of Carbapenem Resistant Enterbacteriaciae(CRE), the infection control committee stated this had not been performed. The QAPI committee was unaware of the requirement for the monitoring and oversight of temperature and humidity control for the MPU procedure areas for the prevention of hospital acquired infections. The QAPI committee and the infection control nurse stated that processing of endoscopes had not been witnessed by a member of the committee. The QAPI committee seemed unaware of the contamination of the enzymatic tubing and reservoir, as well as the procedure sink, during disinfection activities in the sub-sterile room of the MPU. (Refer to A747, A748, A749)
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, interview, and document review, the facility failed to ensure an effective, active system wide infection surveillance control program for prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving care in the hospital as evidenced by the facility failure to:

1. Ensure the sterility of surgical instruments and sterile supplies (refer to A749)
a. Failed to provide effective monitoring of sterile supplies and sterile surgical Instrument storage room. (refer to A749)
b. Failed to ensure sterile supplies were maintained in accordance with facility policy regarding event-related sterility standard (refer to A749 )
c. Failed to ensure endoscopes were stored in accordance with manufactures recommendations, facility policy and procedures and National recognized standards adopted by the facility (refer to A749).

2. Ensure sanitary condition of the Operating Room Suites procedure room environment. (refer to A749)
a. Failed to provide effective monitoring to ensure staff was trained and competent to effectively sterilize hinged surgical instruments, (refer to A749,)
b. Failed to provide for and monitor cleaning of operating room beds and material covering operating room equipment (i.e. patient gurney, arm board) which failed to be maintained in a condition that would permit the equipment to be disinfected. (refer to A749)
d. Failed to ensure sterile supplies were maintained in accordance with facility policy regarding event-related sterility standard (refer to A749 )
e. Failed to ensure endoscopes were stored in accordance with manufactures recommendations, facility policy and procedures and National recognized standards adopted by the facility(refer to A749).

On 03/04/2015, at 2 p.m., an Immediate Jeopardy was declared with the Chief Medical Officer. The facility failed to have a system in place to ensure patient's safety as it relates to the use of contaminated water, contaminated enzymatic cleaner dispensing reservoir, and dispensing tube during the reprocessing of the endoscope.

The facility developed an immediate action plan in response to the Immediate Jeopardy. After verifying that the immediate action plan was implemented on 3/04/15, at 5:30 p.m., the survey team abated the Immediate Jeopardy in the presence of the Chief Medical Officer (see A0749).

The cumulative effects of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
2. During review of personnel files of the medical procedure unit staff members with Administrative Nurse (AN) 2 on March 4, 2015
indicated the following:

a. Registered nurse (RN) G was hired as a clinical nurse on November 10, 1998.

b. Gastointestinal Endoscopy Techinician (GI Tech) 5 was hired as a Gastointestinal Endoscopy Techinician on Decemnber 11, 2000.

c. GI Tech 6 was hired as a Gastointestinal Endoscopy Technician on June 7, 2002.

d. GI Tech 7 was hired a Gastrointestinal Endoscopy Technician on June 7, 2004.

A copy of the On Track Reprocessing In-Service/Competency for Endoscopes (i.e., TJF-160VF, TJF-Q180V, etc) dated February 9 -12, 2015 and March 3-4, 2015 conducted by an endoscopy support specialist from the manufacturer of the endoscope in use at the facility was reviewed. The form did not indicate the facility verified the competency.

During an interview with AN 2 at the time of record review, AN 2 stated there was no independent competency evaluation performed on the clinical staff on how to clean and disinfect of the endoscopes by the clinical staff members. She added she was present at the time the representative from the manufacturer of the endoscopes conducted the inservice/competency. There was no documentation to indicate it was verified by the facility staff.




3. A review of the facility's personnel files for seven (7) direct patient care employees with the Manager, Human Resources (Employee 5) on March 4, 2015, indicated the following:

a. Registered nurse (RN) 1 was hired as a GI (Gastroenterology) nurse on April 6, 1998. There was no documentation that RN 1's clinical skills in the use, care, and processing of flexible endoscopes and related equipment was periodically validated by a qualified preceptor or supervisor.

b. RN 2 was hired as a GI nurse on July 18, 2011. There was no documentation that RN 2's clinical skills in the use, care, and processing of flexible endoscopes and related equipment was periodically validated by a qualified preceptor or supervisor.

c. RN 3 was hired as a GI nurse on February 1, 2015. There was no documentation that RN 3's clinical skills in the use, care, and processing of flexible endoscopes and related equipment was periodically validated by a qualified preceptor or supervisor.

d. Gastrointestinal Endoscopy Technician (GI Tech) 1 was hired as a GI technician on January 28, 1991. There was no documentation that GIT1's clinical skills in the use, care, and processing of flexible endoscopes and related equipment was periodically validated by a qualified preceptor or supervisor. There was no documentation that GI Tech 1 had an annual performance evaluation since December 13, 2013.

e. GI Tech 2 was hired as a GI technician on January 14, 2008. There was no documentation that GI Tech 2's clinical skills in the use, care, and processing of flexible endoscopes and related equipment was periodically validated by a qualified preceptor or supervisor. There was no documentation that GI Tech 2 had an annual performance evaluation since June 14, 2013.

f. GI Tech 3 was hired as a GI technician on December 8, 2008. There was no documentation that GI Tech 3's clinical skills in the use, care, and processing of flexible endoscopes and related equipment was periodically validated by a qualified preceptor or supervisor. There was no documentation that GI Tech 3 had an annual performance evaluation since May 17, 2013.

g. GI Tech 4 was hired as a GI technician on January 12, 2015. There was no documentation that GI Tech 4's clinical skills in the use, care, and processing of flexible endoscopes and related equipment was periodically validated by a qualified preceptor or supervisor.

During a concurrent interview, Employee 5 stated the Competency Assessment should be be determined to be satisfactory and signed by the employee and preceptor or supervisor. According to Employee 5, the supervisor should complete a performance evaluation for an employee prior to the end pf the twelve (12) month employment period.
During the interview with Employee 1 on March 4, 2015 at 3:30 p.m., she stated the Competency Assessment for clinical skills in the use, care, and processing of flexible endoscopes and related equipment for the aforementioned staffs, were provided by the vendors, instead of preceptor or supervisor .
According to the facility's policies and procedures dated August 30, 2013, tilted "Employee Performance Evaluation and Competency Assessment":
POLICY
III. A supervisor may complete a performance evaluation for an employee prior to the end of the twelve (12) month employment period.
VII. Competency Assessment
B. An initial Competency Assessment will be performed for all staff at the point of hire or transfer to a new position. This Competency Assessment must be determined to be satisfactory and signed by the employee and preceptor or supervisor no later than 6 months from the date of hire or transfer.
G. Management staff who have direct patient care are required to complete an Annual Competency every twelve (12) months."
According to Perioperative Standards and Recommended Practices for 2013 of the AORN, "Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories:"
"Recommendation XIII
Personnel should demonstrate competency in the use, care, and processing of flexible endoscopes and related equipment periodically and before new endoscopic equipment and/or accessories are introduced into the practice setting.

Recommendation XIII.c

Designated administrative personnel should validate the competencies of personnel participating in decontamination of flexible endoscopes and accessories. The validation of competencies should include all types of flexible endoscopes and accessories the individual is authorized to reprocess."






Based on observations, interviews, and a review of selected manufacturer's recommendations, the hospital failed to ensure oversight for the cleaning and disinfection of non-porous surfaces. The facility also failed to perform staff competency in the use, care, and processing of the flexible endoscopes and related equipment for 11 direct patient care employees.



Findings:

1. A tour of the medical procedure unit (MPU) was conducted on 3/04/2015 at 11:30 a.m., the surveyor observed a registered nurse (RN G) and the administrative nurse (AN 2) cleaning procedure room 2, following a colonoscope procedure. The Director of Nursing Out-Patient Services was also interviewed at the time. No temperature or humidity displays were present either in Procedure Room 1 or Procedure Room 2. The Director of Nursing Out-Patient Services stated temperature and humidity were monitored centrally, in the facilities management area. She stated temperature and humidity monitoring were not required.

Both RN G and AN 2 were observed wiping non-porous surfaces following the procedure. When interviewed regarding the manufacturer's recommendations for keeping the surfaces wet, neither was aware of the dwell time for the product. (The dwell time is the time required for surfaces to remain wet with the disinfecting agent, according to manufacturer's recommendations to ensure killing of all bacteria, viruses and other contaminants.)

Neither RN G or AN 2 were aware of the duration the surfaces remained wet to ensure adequate disinfecting for all surfaces. When the labels on the dispensers for the hand wipes was shown, they both agreed that three minutes dwell time, was required, but had never been verified by timing the duration the surfaces remained wet.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
16. During an observation of a colonoscopy procedure for Patient 6, on March 3, 2015, at 11 a.m., in the Procedure Room #2, the following were noted:

a. Registered nurse (RN) A was wearing a yellow gown with the belt not tied around the waist. The belt was hanging and was dragging on the floor.

Gastrointestinal Endoscopy Technician (GI Tech) 7 and RN A were not observed performing hand hygiene when they changed gloves. Both employees failed to change gloves when they touched the patient and they moved to touching the equipments during procedures.

b. The trash bin by the door had a broken pedal to open the bin without touching it.

c. When the procedure was done GI Tech 7, started cleaning the scopes in a basin of water and soap while the patient was lying at procedure table.

17. During a tour of the Main Sterile Processing Unit in the basement area on March 4, 2015, at 10 a.m., with the Director of Out-patient Services [Administrative Nurse (AN)] 1 and Infection Control Officer (AN 3), the following were noted:

a. The sterilized paper-plastic pouches of surgical instrument were found with discolorations and creases and folds. To name a few MOR FCPS Locked Lame Lg ORT-00 dated December 28, 2002; Retractor Taylor dated December 1, 2008, Forceps with cord dated September 25, 2012.

b. Central Supply Techician (CST) 1 was observed preparing a Plastic Tray for sterilization. The tray consisted of Parts 1 and 2 where they stack the instrument on each other. The forceps were placed on a paper bag, with tips touching and blades closed. The paper bag that contained forceps was placed on top of the scissors and other hinged instruments with blades closed and tips touching.

During an interview with CST 1 at the time of observation, he stated the surgical instruments like scissors and clamps should be opened meaning tips are not touching and blades are not closed.

c. CST 2 was requested to open a Plastic Tray which was ready for use. There was 18 hooks and forceps in a paper bag. There was no indicator to indicate it was sterilized. The blades are closed and tips were touching in the scissors and clamps.

d. There was a hairnet and a stir-up not in a package mixed with sterile supplies in a cart.

18. During a tour of the Pre-Operative Area with Infection Control Officer on March 5, 2015, at 10 a.m., it was noted the operative staff members were noted crossing the red line ( signifies sterile areas -coming out of operating rooms and going back to operating rooms) wearing their hair covers and their facial mask hanging by their necks.

During an interview with MD 4 at the time of observation, he stated when staff members were coming out of the operating rooms all personnel protective equipments (Mask, gloves, hair covers) should be removed and discarded.

19. During the tour of the 2nd Floor Staging Area with Infection Control Officer on March 4, 2015, at 10:30 a.m., the following was noted:

a. A peel pack of Dilator dated December 6, 1999 with creases and pen marks.

b. A peel pack of Nathan Liver Re-charger with a label that sits on the sterilized instrument that "bleeds on".

20. During the tour of the Operating Room Cores A, B, and C with Infection Control Officer on March 4, 2015, at 10:45 a.m., the following was noted:

a. A facility staff member with a facial mask hanging by his neck.

b. A package of Mayfieled Disposable Skull Pin with expiration date of February 2015 mixed with current supplies in use.

c. A peel pack of Maestro Drill dated September 27, 2012 contained brown spots.

d. A peel pack that contained 4 clamps, placed on top of each other and blades closed and tips touching.






15. During the tour with Director of Out-patient Services (AN 1) and Administrative Analyzer (Employee 2) in the MPU (Medical Procedure Unit) on March 3, 2015 between 9:50 a.m. and 11 a.m., the following were observed:

There was no temperature and humidity display in the Procedure Rooms and the Endoscope Storage Room. During the concurrent interview with Employee 1 at that time, she stated the temperature and humidity were monitored by the Building Manager.

In the Endoscope Storage Room, there were seven (7) ERCP endoscopes in a shelf, and multiple endoscopes stored and hung in a vertical position, in three (3) closed cabinets. During the concurrent interview at that time, Employee 2 stated the ERCP endoscopes in the shelf were sterilized by the contracted services, and were transported to and stored in the MPU.

During an interview with MEP Manager (Employee 3) on March 4, 2015 at 9:50 a.m., he stated he and his staff had not been monitoring the temperature and humidity in the MPU.

According to Perioperative Standards and Recommended Practices for "Sterilization, 2013:"
"III.c. Room temperature, humidity, and ventilation should be controlled in accordance with local, state, and federal policies and regulations.
Table 2. parameters for Controlled Environments during Sterilization
Clean/Sterile Storage: Temperature <75 F, Humidity <=70%
Bacteria and fungi thrive at warm temperatures whereas cooler temperature may impede bacterial and fungal growth in the decontamination area. Regulated environmental controls in work areas are essential for the comfort of personnel wearing appropriate attire and PPE."
III.d. Monitoring results should be readily retrievable."

According to AAMI (Association for Advanced Medical Instrument) (2014) Chapter 3: Design Considerations
3.3.6.5 Temperature
General work areas should have a temperature controlled between 20C and 23C (68F and 73F). The decontamination area should have a temperature controlled between 16C and 18C (60F and 65F). The temperature in sterilization equipment access rooms should be controlled between 24C and 29C (75F and 85F) or as recommended by the equipment manufacturer. The temperature in sterile storage and personnel support areas (e.g., toilets, showers, locker rooms) may be as high as 24C (75F). Independent monitors should be located in each of the areas where temperature should be controlled; temperature should be recorded daily.

Processing personnel in each work area are responsible for monitoring and recording the temperature to ensure that the correct temperature is being achieved.

Rationale: Work areas should be comfortable for properly attired personnel. Comfort is a particular consideration in the decontamination area, where PPE is worn for long periods of time and where temperatures suitable for general work areas might be uncomfortably hot. Also, bacteria thrive at high temperatures; cool temperatures in the decontamination area might help minimize bioburden. Although AIA (2006) allows the temperature in clean work areas to be as high as 24C (75F), the consensus of the AAMI committee was to recommend consistent temperature ranges for all general work areas. Controlling the temperature in sterilization equipment access rooms promotes higher efficiency of the equipment contained within the enclosures. For additional information on temperature control, see AIA (2006).
3.3.6.6 Relative humidity
Relative humidity should be controlled between 30% and 60% in all work areas except the sterile storage area, where the relative humidity should not exceed 70%. An independent humidity monitor should be located in each area that requires controlled relative humidity. Relative humidity should be recorded daily. Processing personnel in each work area are responsible for monitoring and recording the relative humidity to ensure that the correct relative humidity is being achieved.

NOTE-Ideal relative humidity in the preparation and packaging area is 50% and should not be less than 35% for best results in achieving sterilization. In the decontamination area, the recommended range of relative humidity should be maintained to the extent possible, but temporary elevations might occur because of the type and quantity of cleaning and decontamination equipment.
Humidifiers may be installed to maintain the recommended humidity level seasonally (e.g., during the winter months, when the heating system is functioning). If duct humidifiers are located upstream of the final filters, they should be placed at least 15 feet (4.57 meters) upstream of the final filters. For ductwork with duct-mounted humidifiers, there should be a means of water removal. An adjustable high-limit humidistat should be locateddownstream of the humidifier to reduce the potential for condensation inside the duct. All duct takeoffs should be sufficiently downstream of the humidifier to ensure complete moisture absorption. Steam humidifiers should be used. Reservoir-type water spray or evaporative pan humidifiers should not be used.

Rationale: Relative humidities higher than those recommended can promote microbial growth and thus increase bioburden. Relative humidity lower than 30% will permit absorbent materials to become excessively dry, which can adversely affect certain sterilization parameters (such as steam penetration) and the performance of some products (such as BIs and CIs). Thus, for best results, the committee recommends an ideal relative humidity level of 50% and a minimum level of 35%. The recommended range for relative humidity was largely based on AIA (2006).






Based on observations, interviews, record review, the hospital failed to:
1. Ensure an effective, ongoing, collaborative, hospital wide program for infection control.

2. Provide a functional and sanitary environment for the provision of surgical services. The facility failed to provide sterile supplies maintained in accordance with facility policy regarding, event-related sterility standards and ensure re-processed surgical instruments were sterilized and stored in accordance with nationally recognized standards adopted by the facility.

3. Ensure the temperature and humidity were monitored in the MPU (Medical Procedure Unit) in accordance with recommendation from AAMI (Association for Advanced Medical Instrument), the Association of Peri-Operative Registered Nurse (AORN) Recommended Practices . AORN is the National Recognized Standards (NRS) the hospital identified as the standard they followed. This deficient practice had the potential to promote microbial growth and can result in contamination of sterile items


4. Ensure personal protective equipment (disposable gown) was properly secured, in order to prevent contamination.
5. Ensure staff sanitized/washed hands according per acceptable professional guidelines.
6. Ensure biological specimens were handled per standard of practice in order to prevent contamination and alteration of the biopsy samples.
7. Ensure the initial cleaning of the soiled colonoscope followed national guidelines: use of face shield, waiting until after everyone else had left procedure room.
8. Prevent potential contamination of the enzymatic dispenser system with same water used in cleaning the colonoscope.
9. Follow manufacturer guidelines regarding amount of cleaner to add to water.


Findings:

1. On 3/04/2014 at 9 a.m., a tour of the MPU (Medical Procedures Unit) was performed. I was accompanied by Gastrointesinal Endoscopy Technician (GI Tech) 7, Director of Licensing and Accreditation, MPU Unit Director and GI Tech 3.
Following a colonoscopy procedure, I accompanied GI Tech 7, accompanied by Director of Licensing and Accreditation and MPU Unit director into the substerile room to observe cleaning and processing of the colonoscope used in the procedure. The cleaning sink was still wet from the previous cleaning of a colonoscope performed by GI Tech 3. GI Tech 7 proceeded to fill the sink to the indicated water line, measured at 5 gallons of tap water. I noted a wall mounted Enzymatic dispenser, mounted to the wall and connected by a long clear plastic tube to the sink, coiled in the bottom of the sink, under the five gallons of water.
GI Tech 7 added three pumps of Enzymatic Cleaner (Ecolab) as directed by manufacturers recommendations. Following each pump, I observed water and air bubbles from the sink refluxing up the clear plastic tube. The water from the sink refluxed approximately 50% up the length of the tube, however air bubbles were noted extending to the length of the tube into the enzymatic reservoir.
GI Tech 7 and GI Tech 3 stated they had not noted this on prior occasions but admitted contaminated water had entered the dispensing reservoir and tube.
GI Tech 7 and GI Tech 3 stated the sink was not routinely decontaminated or disinfected following processing of colonoscopes or other endoscopes after each use. Both agreed the water and enzymatic cleaner was contaminated, as a result of the current procedure and use.
GI Tech 7 and GI Tech 3 and the Medical Consultant Surveyor, observed an air leak for the colonoscope being processed after a procedure. GI Tech 7 stated this colonoscope would be removed from use, to be returned to the manufacturer for repair.
As a result of the use of contaminated water, contaminated enzymatic cleaner dispensing reservoir, and dispensing tube, an Immediate Jeopardy (IJ) was declared at 2 p.m., on 3/04/2015.
A written plan of correction was presented at 5 p.m., on 3/04/2015. A tour of MPU was conducted. Present during the tour were, Chief Medical Officer, Director of Nursing for Out-patient Services, Nursing Infectious Disease Preventionist and Unit Director RN, and the survey team. A tour of the sub sterile room revealed the tubing extending from the wall mounted dispenser had been removed. The Chief Medical Officer stated the enzymatic detergent would be hand measured and added to the 5 gallons of water in the sink, to process the various endoscopes. When the issue of disinfecting the sink being used for cleaning of the endoscopes was discussed, the Chief Medical Officer stated he refused to include this step in disinfecting, unless this was mandated by a nationally recognized authority such as the AORN (Association of Operating Room Nurses, an organization that has published standards for surgical suite safety and standards of care.) The Immediate Jeopardy status was abated at 5:30 p.m., on 3/4/2015.

2. A tour of the MPU was conducted at 11a.m., on 3/3/2015. A colonoscopy procedure was observed at that time. At approximately 10:30 a.m., on 3/3/2015, Patient 6 was interviewed. Verbal and written permission to witness the colonoscopy procedure was obtained. I was accompanied by the Infection Control Consultant (Survey team). At approximately 11:07 a.m., MD 1, the anesthesiologist was observed to don disposable gloves and assist in positioning Patient 6, placing his left hand on the flank, buttock area of the patient. MD 1 did not change gloves. At 11:09 a.m., MD 1 adjusted the infusion pump and place IV tubing prior to anesthesia. At 11:10 a.m., MD 1 retrieved monitoring lines from the floor, and placed the lines on the patient gurney. MD 1 was then observed reaching into his scrub trouser pocket for an item. At approximately 11:12 a.m., MD 1 connected the Propofol syringe and tubing to the port leading to the patient without wiping the Alcohol to clean the port. ( Propofol is an easily recognized milky white medication utilized to induce general anesthesia). During this procedure MD 1 failed to practice any hand hygiene, as required by the policy and procedure of the hospital, dated June, 2014, Policy HS IC 001 hand hygiene. This policy requires washing of the hands with alcohol based hand rub or soap and water prior to and following direct contact with the patient.

3. During the tour of the MPU conducted at approximately 1000 hours on 3/3/2015, the Director of Nursing for Out Patient Services (AN 1) and the Unit Director, were interviewed. Temperature and humidity indicators were not present in the procedure rooms being used for endoscopic procedures. The Nursing Director stated these gauges had never been used because the temperature and humidity was monitored in the Facility Maintenance areas of the hospital.

4. On 3/4/2015 an Upper Endoscopy Procedure was observed in the MPU at 11:30 a.m. The endoscopic retrograde cholangiopancreatography procedure was performed by MD 2. Patient 7 underwent the procedure to replace a stent (tube), providing flow of bile from the liver into the intestine. Certified Registered Nurse Anesthetist (CRNA) 1 was supervised by MD 3. CRNA 1 was noted to don disposable gloves at approximately 11:20 a.m. to assist in positioning Patient 7. Following positioning the patient, CRNA placed intravenous tubing connections to the patient's indwelling lines. There was no observed hand hygiene by CRNA during the procedure, including placing the endotracheal tube to maintain airway that occurred at 11:36 a.m. This is in violation of the policy and procedure of the hospital (HSIC 001 Hand Hygiene). This policy requires washing of the hands with alcohol based hand rub or soap and water prior to and following direct contact with the patient.
Following a colonoscopy procedure, I accompanied GI Tech 7, accompanied by Director of Licensing and Accreditation and MPU Unit director into the substerile room to observe cleaning and processing of the colonoscope used in the procedure. The cleaning sink was still wet from the previous cleaning of a colonoscope performed by GI Tech 3. GI Tech 7 proceeded to fill the sink to the indicated water line, measured at 5 gallons of tap water. I noted a wall mounted Enzymatic dispenser, mounted to the wall and connected by a long clear plastic tube to the sink, coiled in the bottom of the sink, under the five gallons of water.
GI Tech 7 added three pumps of Enzymatic Cleaner (Ecolab) as directed by manufacturers recommendations. Following each pump, I observed water and air bubbles from the sink refluxing up the clear plastic tube. The water from the sink refluxed approximately 50% up the length of the tube, however air bubbles were noted extending to the length of the tube into the enzymatic reservoir.





21. On March 5, 2015 at 1:50 p.m., an observation of a colonoscopy (a procedure that enables a gastroenterologist- a physician who specializes in the digestive system- to evaluate the inside of the colon with a specialized scope) was conducted on Patient 22. The patient was brought into the procedure room and positioned on the guerney. There were a total of six people in the room, which included the patient, physician, GI Tech 2, RN 5, the surveyor, and nursing administrative staff person. After RN 5 administered sedation medication through the patient's intravenous (IV) line, the gastroenterologist began the procedure. RN 5 was wearing a sweatshirt over her scrub uniform top, and wore a disposable gown over the sweatshirt. The top of the gown was not fastened, which resulted in part of the sweatshirt being exposed.

RN 5 had donned a pair of disposable gloves, assisted in positioning Patient 22 on the guerney, drew up sedation medication into a syringe, and administered the medication through the patient's IV port. Then, wearing the same gloves, RN 5 opened a storage cabinet in order to obtain another syringe, drew up more medication, and administered more medication through the patient's IV port. She then went to the biopsy cart, placed a towel on top of the cart, obtained a specimen cup and specimen cassettes from the cart, placed these items on the towel, then removed her gloves and sanitized her hands.

GIT2 obtained a biopsy sample (a small piece of tissue from the colon for microscopic evaluation) with the biopsy forceps (device used to obtain small pieces of biological samples) through a port in the colonoscope, then removed the forceps. RN 5 grabbed the end of the forceps, and positioned it over a cassette (a small container used for collecting specimens). GI Tech 2 then released the biopsy sample into the cassette. RN 5 placed the cassette in a specimen cup which contained formalin (a solution used for securing and preserving biologic specimens for microscopic examination). After obtaining several biological samples using this method, GI Tech 2 obtained another biopsy sample, then removed the sample from the forceps with his gloved finger. RN 5 held out her hand, and GI Tech 2 placed the biological sample on top of RN 5's gloved hand. RN5 then removed the sample with her other hand, and placed the sample in a cassette. This process was repeated two more times.
After the procedure was completed, the gastroenterologist removed the colonoscope, then handed the scope to the GI technician, who was standing next to Patient 22's guerney. While the facility staff, physician, and surveyor were still in the procedure room, the GI Tech 2 immediately began cleaning the colonoscope. The technician, who was wearing a disposable gown and gloves, but was not wearing a face shield, added water to a basin which contained a sponge with a cleansing agent. Holding onto one end of the endoscope with the same washcloth the physician had used in order to grasp the colonoscope during the procedure, GI Tech 2 began cleaning the scope by running his other hand over the scope, from one end to the other, with the soapy solution. GI Tech 2 was standing directly next to the patient, who was lying on the guerney, while cleaning the scope. GI Tech 2 then wrapped the endoscope in the disposable endoscopy tray, and carried the tray to the Endoscope Room.
GI Tech 2 handed the endoscopy tray to GI Tech 6, who filled the cleaning sink to the water line inside the sink, then placed the colonoscope in the water. A dispenser containing enzymatic cleaner was attached to the wall above the sink, and a rubber dispensing tubing, which was attached to the dispenser, ran down from the wall, into the sink. An estimated three inches of the dispensing tubing was submerged in the water with the colonoscope. After testing the colonoscope for air leaks, GI Tech 6 added a total of five pumps of enzymatic cleaner to the sink, attached an Endoscope Flushing Pump unit to the colonoscope ports, then turned the unit on, in order to flush the ports. Following this, GI Tech 6 drained the sink, rinsed the scope under running water, patted the scope dry with towels, and placed the scope in the window area between the Cleaning Room and Reprocessing Room. GI Tech 6 then entered the Reprocessing Room, and placed the colonoscope in the reprocessing unit (a machine which provides high level disinfection of items which cannot be sterilized, such as endoscopes and surgical instruments).
On March 5, 2015 at 10:35 a.m., during an interview with RN 5, when informed she opened the supply cupboard without removing her gloves and sanitizing her hands, she replied the staff always cleaned the procedure room and equipment surfaces with Clorox wipes following each procedure. RN 5 then stated she should have sanitized her hands before and after touching the patient, following preparing and administering of medication, and prior to obtaining another syringe, in order to prevent contamination. When questioned regarding the method used to obtain the biopsy samples, RN 5 replied there were two methods: one of the methods included the nurse grabbing hold of the biopsy forceps, and the GI technician releasing the sample onto the nurse's hand. The nurse would then remove the specimen from her other hand, and place the speciment in a cassette. The second method involved the GI technician obtaining a biological sample, then placing the sample onto his hand. The nurse would then remove the sample from his hand and place it into a cassette.
Immediately following, during an interview with GI Tech 2, he indicated the colonoscope was supposed to be cleaned immediately following the procedure. When asked regarding the wearing a face shield during the cleaning process, GI Tech 2 stated he should have worn one, in order to protect himself from splashing and possible contamination. He also verified he used the same washcloth with which to hold the endoscope while cleaning, that was used by the physician during the procedure. GI Tech 2 further stated he should wait until everyone leaves the room, prior to cleaning the colonoscope, in order to prevent contamination risk.
According to the facility's policy, titled, "Standard and Transmission Based Precautions", revised June 30, 2014:
"Wear protective equipment (PPE) when there is risk of exposure to blood or other potentially infectious material (OPIM)e.g. wear a fluid-resistant barrier gown when clothes are likely to be contaminated with blood or OPIM. Wear mask and eye protection during procedures that are likely to generate splashes or sprays of blood or OPIM."






5. On 03/03/2015 at 10:15 AM. An observation of the medical procedure area (referred to as the endoscopy area) was conducted. The medical procedure area or endoscopy area contained a recovery area, procedure room, sterile and clean storage and an area where equipment was cleaned and disinfected. When entering the GI area there was no signs that indicated authorized personnel only, attire required, or indicated the permitted movement of staff and patients.

A subsequent interview on 03/03/2015 at 11 AM was conducted with Director of Unit (DMPU). When asked about the traffic patterns in the endoscopy area, DMPU indicated the area was not considered a surgical area therefore there are no restrictions or requirements related to alerting personnel that traffic is restricted in specific areas and the type of attire required in the Medical Procedure area. DMPU indicated the types of procedures performed in the MPU area included colonoscopy (the visualization of the colon [portion of the large intestine] with a long, flexible instrument consists of a tube and a light), EGD (Esophagogastroduodenoscopy or upper endoscopy - a procedure that enables the examiner to examine the swallowing tube, stomach, and the first portion of small bowel using a thin flexible tube that can be looked through on a monitor), and biopsy (the removal of a small piece of living tissue from an organ or other part of the body for microscopic examination), peg reinsertion (the placement of a tube in the abdomen through which nutrition can be given). In addition, minor procedures that required light or Deep sedation.

On 03/03/2015 at 11:45AM DMPU confirmed endoscopy procedures performed in the MPU were billed as surgical procedures. The Nursing Infection Control Preventionist (ICP) indicated the hospital followed AORN standards for all surgical procedures.

A review of the definition of surgery developed by the American College of Surgeons dated 4/2007 and adopted by the Centers for Medicare and Medicaid (CMS) in regulations was conducted. The definition of surgery indicated "Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or diseases processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles......All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel".

Review of The Perioperative Standards and Recommended Practices published by the AORN (Association of perioperative Registered Nurses), 2014 edition indicated "Traffic patterns should be designed to facilitate movement of patients and personnel into, though, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. The semi-restricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and patients. The restricted area includes operating rooms, procedure rooms, and the clean core area. "

6. An interview was conducted with on 03/03/2015 at 11:45 AM. When asked about the use of surgical attire in the medical procedure area, DMPU indicated the medical procedure room area was not considered a surgical area. The staff was not required to cover their hair or wear a mask in the medical procedure room.

On 03/03/2015 at 10:15 a.m. the ICP confirmed endoscopy procedures performed in the outpatient GI center were billed as surgical procedures. The ICN indicated the hospital followed AORN standards for all surgical procedures.

Review of the hospital's policy titled, "Attire, Surgical", dated implemented 2013, stipulated "All individuals who entering the restricted and semi-restricted areas of the surgical suite will wear commercially laundered surgical attire provided by the hospital and proper hair covering, shoes and or shoe coverings /booties ... " Disposable caps are to be worn to confine hair and scalp skin and all possible head and facial hair, including bangs, sideburns, and neckline" "All individuals entering the operating room should wear a surgical mask when open supplies and equipment are present and /or during any procedure must wear a mask."

Review of the 2014 AORN Preoperative Standards and Recommended Practices, under Recommended Practices for Surgical Attire, documented, "Clean surgical attire, including shoes, head covering, and all individuals who enter the semi- restricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite. Persons entering the semi- restricted or restricted areas of the surgical suite for a brief time for a specific purpose should cover all head and facial hair and should don either freshly laundered surgical attire; single-use attire, or a single-use jumpsuit designed to completely cover outside apparel. All individuals who enter the semi- restricted or restricted areas should wear freshly laundered attire that is laundered at a health care-accredited laundry facility or disposable surgical attire provided by the facility and intended for use within the perioperative setting. All individuals entering the restricted areas should wear a mask when open sterile supplies and equipment are present."

7. An observation on 03/03/2015 at 11:25 a.m. with GI Tech 4 revealed 4 out of 4 endoscopes were observed to vertical hung in the GI cabinet. 2 of 3 with tips touching the back of the cabinet. The GI Tech demonstrated the hanging of the scopes, touched the scope with ungloved, non-sanitized hands which sent the scope into a swinging motion hitting the back of the cabinet. The GI Tech indicated, it is ok to handle the scopes without PPE as the scopes were disinfected.

A review of records on 03/03/2015 at 2:20 PM, revealed the facilitiy's practice for storing the endoscopes is inconsistent with the AORN standards, the National Recognize Standard identified and adopted by the facility.

A review of AORN Standard IX 2012:
Titled, " Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes microbial contamination " .
IX.a. Flexible endoscopes should be stored:
in a closed cabinet with:
venting that allows air circulation around the flexible endoscopes,
internal surfaces composed of cleanable materials,
adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet, and
sufficient space for storage of multiple endoscopes without touching;
When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential development of an environment conducive to microbial growth in the endoscope. Proper storage facilitates drying and decreases potential for contamination. Opening all valves and removin