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Based on record review and interview, the facility failed to ensure the informed consent was signed by the patient and/or patient's legal representative to ensure the patient made an informed decision regarding the procedure for 2 of 23 sampled patients (18 and 20).

This deficient practice had the potential to result in the patients not being able to have an opportunity to refuse or consent to the treatment or procedure.

Findings:

1. A review of the Facesheet indicated Patient 18 was admitted to the facility on September 15, 2014, with admitting diagnosis of choledocholithiasis (presence of gall stone in the bile duct). On September 22, 2014, the patient was discharged to home.

During a review of electronic medical record of Patient 18 with Registered Nurse (RN) 1 on March 24, 2015, at 2:50 p.m., the Authorization For and Consent to Surgery or Special Diagnostic or Therapeutic Procedures or Blood Transfusions Form for endoscopic retrogradecholangio-pancreatography (ERCP- a procedure that includes the use of endoscope, a flexible, lighted scope, and x-rays to diagnose problems in the liver, bile ducts and pancreas) was not signed by the patient and/or the patient's representative. The ERCP was performed on September 16, 2014.

2. A review of the Facesheet indicated Patient 20 was admitted to the facility on September 21, 2014, with admitting diagnosis with obstructive jaundice (obstruction of the bile ducts (long tube-like that carries bile necessary for food digestion). The patient expired on October 6, 2014.

During a review of electronic medical record of Patient 20 with RN 1, on March 24, 2015, at 3:30 p.m., the Consent for HIV [Human Immunodeficiency Virus- which is the causative agent of Acquired Immune Deficiency Syndrome (AIDS)] Blood Test dated October 1, 2014, was signed by the patient's significant other. The HIV test result was done on the same the day the consent was signed.

During an interview with RN 1 while reviewing patient's electronic record, the California Advance Health Care Directive signed by the Patient 20 on May 6, 2012, authorized and designated his three (3) family members to make health care decisions for him. The patient's significant other was not indicated on the advanced directive document for Patient 20.
According to the facility's policy and procudure on "Consent: Informed Policy Clinical/Administrative,"effective date October 2, 2014, the Authorization Form and Consent to Surgery or Special Diagnostic or Therapeutic Procedures does not represent an informed consent, but rather represents documentation, for the Medical Center, physician, and patient that a discussion between the physician and the patient occurred and that the patient or the patient's surrogate decision maker agree to proceed with the specified care or treatment as verified by their signature on the Consent Form.

Based on record review and interview, the facility failed to ensure advance directive information was completed during the patient's admitting process, as indicated in the facility policy, to determine whether or not the patient has an Advance Directive for 8 of 23 sampled patients (1, 2, 3, 5, 7, 15, 17, and 23).

This deficient practice had the potential for not having the right to formulate advance directives and not having the hospital staff comply with the patient's advance directive.


Findings:


1. A review of the Facesheet indicated Patient 23 was admitted to the facility on November 11, 2014, with admitting diagnosis of bile duct stricture. On admission the patient had an endoscopic retrogradecholangio-pancreatography (ERCP- a procedure that includes the use of endoscope, a flexible, lighted scope, and x-rays to diagnose problems in the liver, bile ducts and pancreas)ERCP with cholangioscopy (examination of the bile ducts by using a non invasive endocospe), biliary ductal dilation, brushing, and biopsy.

During an interview with Registered Nurse (RN) 1 and a review patient's electronic medical record, there was no documentation to indicate advance directive was discussed with the patient and/or patient's representative during the patient's admitting process.

According to the facility's policy and procedure on "Advance Directives Policy: Ethics," effective date of September 16, 2014, indicated the Admission staff nurse, or other hospital personnel completing the admitting process for a patient being admitted to the hospital or presenting to the ED would ask the patient or the patient's Legal Representative or Surrogate if a patient lacks Decision-Making Capacity, whether the patient has an Advance Directive. The answer would be documented on the Admissions Intake, in the inpatient unit Admission Navigator under "Directives" or other designated information documentation templates in the patient's medical record and would be communicated to the next nurse receiving the patient on transfer in the SBAR hand-off report.



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2. A review of the Patient Demographic Profile, indicated Patient 15 was admitted to the facility on October 11, 2014 and was discharged on October 16, 2014.

During an electronic record review for Patient 15 with Licensed Vocational Nurse (LVN) 1 on March 25, 2015, at 11:55 a.m., she stated according to the informed consent, Patient 15 had undergone an endoscopic retrogradecholangio pancreatography (ERCP is a diagnostic procedure designed to examine diseases of the liver, bile ducts and pancreas. The ERCP is performed under intravenous sedation, usually without general anesthesia) with possible biopsy).

A reviewed the Flow Sheet Data dated October 11, 2014, under Advance Directives for Healthcare section, indicated "Yes," the patient had an advance directive for healthcare, copy in chart - "No," and a copy was requested from the family. LVN 1 further reviewed the social worker notes and she stated there was no documentated evidence regarding Patient A's advance directive information in the social worker's notes. There was no further follow-up of Patient A's advance directive.

3. A review of the Patient Demographic Profile indicated Patient 17 was admitted to the facility on October 11, 2014, with diagnoses that included pancreatico jejunostomy (surgical formation of an artificial passage connecting the pancreas to the jejunum).

A review of the Flow sheet Data dated October 11, 2014, indicated Patient 17 did not have an advance directive for Healthcare Treatment. LVN 1 further stated there was documented evidence of an advance directive and no information provided to the patient.



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4. On March 25, 2015 at 2:00 p.m, an analysis and interview of ten (10) closed medical records and one (1) open patient record was conducted with Staff 2, 3, and 4. It was revealed that while Patients 4, 8, 9 and 10 had been admitted to the hospital with an advance directive, Patients 1, 2, 3, 5 and 7 had no documentation that advance directive information was provided. Patients 1, 2, 3, 5, and 7, or their delegated representatives, had failed to be provided such information by the hospital staff.

Based on observation, interview, and record review, the hospital failed to implement and maintain an effective Quality Assurance Performance Improvement (QAPI) program to meet the needs of its patients receiving surgical care and to focus on indicators to reduce or eliminate contamination of medical instruments and equipment used in the hospital. The facility failed to meet the Condition of Participation in QAPI as evidenced by the facility's failure to:

1. Identify or enact a program or to collect data, to monitor the effectiveness, or safety of services, to track the quality of care in accordance with facility policy and nationally recognized infection control standards, for evaluation and tracking of infection control in the hospital (Refer to A 273).

2. Identify, implement or maintain a program to focus on high risk, high volume, problem prone activities in the hospital to improve patient safety (Refer to A 283).

3. Ensure the implementation and maintenance of a program to address priorities for quality of care, patient safety and evaluation of activities to ensure reduction in contamination of surgical instruments (Refer to 309).

4. Identify or implement a program for safe storage of endoscopes used for gastrointestinal procedures on hospital patients and provide infection control quality rounding through the facility (Refer to A 748, A 749).

5. Identify temperature and humidity for areas in the gastrointestinal suite to ensure infection reduction for processed and stored gastrointestinal endoscopes used for procedures on hospital patients (Refer to A 749).

6. Inspect, evaluate and implement a program for safe procedures to ensure disinfection of endoscopes being processed following patient use (Refer to A 749).

7. Ensure evaluation and implementation of a program for safe washing and processing of surgical instruments in the hospital (Refer to A 749)

8. Ensure a safe and sanitary environment in the gastrointestinal surgery rooms (Refer to A 749).

9. Provide effective monitoring of sterile supplies and sterile surgical instrument storage throughout the facility in specialty operating rooms and GI Procedure rooms (Refer to A 749).

10. Provide effective monitoring to ensure the staff was trained and competent to effectively decontaminate and sterilize hinged surgical instruments (Refer to A 749).

11. Provide for and monitoring and infection control cleaning of operating room equipment and the operating room environment, (i.e. patient gurney, floors, counters) to ensure operating rooms were maintained in a clean condition that would permit the equipment and environment to be disinfected (Refer to A 749).

12. Provide effective monitoring to ensure sterile supplies were maintained in accordance with facility policy regarding event-related sterility standard (Refer to A 749).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide program for Quality Assurance Performance Improvement program designed to provide for patient care in a safe and effective manner.

Based on observation, staff interview, and record review, the hospital failed to identify or enact a program or to collect data, to monitor the effectiveness, or safety of services, to track the quality of care in accordance with the nationally recognized infection control standards, for evaluation and tracking of infection control in the hospital. This deficient practice resulted in the facility's inability to integrate active system wide infection prevention and control program into the facility Quality Assurance Performance Improvement (QAPI) program.

Findings:

1. A tour observation of the outpatient endoscopic gastrointestinal area was conducted on 3/23/2015 at approximately 10:14 A.M., in the presence of MD 1 and Gastro Intestinal Laboratory Manager. During the tour, a cabinet was found in the hallway, in an alcove, adjacent to a door that led to an exterior hallway, in which Gastrointestinal Endoscopes (GI Scopes) were hanging, awaiting clearance for patient use.

During a concurrent interview, at 10:14 A.M., the Gastro Intestinal Laboratory Manager stated this hallway was not in a restricted area of the GI Suite and easily accessible by visitors. A striped line was painted on the floor of entry way to the restricted area of the laboratory, and she stated the cabinet containing the GI scopes was in the public area of the GI laboratory rooms, and not maintained according to the national standards, that the facility followed, the AORN (Association of Perioperative of Registered Nurses) guidelines. She stated there was no mechanism to determine the temperature and humidity of the area as is required by AORN standards, a nationally recognized authority.

During a meeting conducted with the Quality Assurance, Performance Improvement Committee (QAPI), on 3/26/2015, at approximately 11 a.m., representatives of the committee stated they were aware of Carbapenem Resistant Klebsiella, an organism found to cause serious bacterial infections in hospital patients consequent to Upper Gastrointestinal Endoscopy. There was no documentation to indicate the QAPI committee had assessed and monitored for the environmental factors in the GI suites area that could contribute to patient morbidity or mortality. There was no documentation provided by QAPI committee to indicate any review or knowledge that these restricted areas were monitored for temperature or humidity.

Based on observation, interview, and record review, the hospital failed to identify, implement or maintain a program to focus on high risk, high volume, problem prone activities in the hospital to improve patient safety. This deficient practice resulted in the facility's inability to integrate active system wide infection prevention and control program into the facility Quality Assurance Performance Improvement (QAPI) program.

Findings:

1. A tour observation of the endoscope processing room was performed on 3/23/2015 at approximately 11:15 A.M., Scope Technician 2 removed a cleaned endoscope (an instrument which consist of a flexible tube with a light attached and used to look inside a person's body organ) from the sink in the processing room and placed the endoscope in a Steris machine. After draining the water from the sink, Scope Technician 2 filled the sink with tap water to the "fill line" labeled on the sink with fresh tap water and then added enzymatic detergent to the water. There was no evidence that Scope Technician 2 cleaned or disinfected the sink between uses. Scope Technician 2 placed a used (dirty) endoscope in the water for cleaning.

2. During the same on observation on 3/23/2015 at 11:15 a.m., the area around the sink being used for endoscope washing and disinfecting contained splash contamination. Visible dried and wet droplets were on the back splash, on the walls above the sink, on the floor, and some splash droplets were even noted on the ceiling above the sink. Directly next to the sink area were 4 Steris machines, used to clean the endoscopes after washing to continue the process of high level disinfection. Splash contamination from the sink was on the sides and front of the Steris machines. There was no physical barrier between the sinks and the Steris machines, allowing for possible gross contamination of the machines. Two of the Steris machines, not in use were found with the plastic tops open, for possible splash contamination from droplets. When visited, the procedure room contained no monitoring to assess or record temperature or humidity, as required by AORN Standards, the policy being used by the Nursing department of the hospital.

3. On 3/23/2015 at 11:30 A.M., during an observation, the room directly adjacent to the endoscope room, connected by an open doorway had no physical barrier to separate the two rooms. An alcove was just beyond the doorway, where Scope Technician 1 used high pressure air to dry the GI endoscopes, following removal from the Steris machine. Scope Technician 1 wore no eye shield, a personal protective equipment (PPE). The high pressure air device delivered blasts of air (similar in appearance to that used to inflate automobile tires) to the endoscopes with droplets noted to disperse about the room. In this room were cabinets containing vertically hung GI endoscopes. Dried droplet particles were noted about the alcove and on the cabinet closest to the alcove.

During a concurrent interview, Scope Technician 1 and Scope Technician 2 stated the possible contamination of the disinfected endoscopes could be possible as a result of the blasts of high pressure air. When interviewed in the presence of the Director of Licensing and Accreditation, Scope Technician 1 and Scope Technician 2 stated they were unable to demonstrate temperature or humidity monitoring for the room being used to store the endoscopes. The Director of Licensing and Accreditation stated that out of range temperature or humidity was a factor for bacterial growth in this area.

4. On 3/24/2015 at approximately 2 P.M., an endoscopic procedure was observed in Room 2 of the endoscopy suite. Following the procedure, the radiology table on which the procedure was performed, had dried debris and dirt caked material in the seam of the radiology fluoroscopy table.

During a concurrent interview, Registered Nurse (RN) 2, who was present in the room, stated the debris had been present for a considerable period of time. RN 2 stated that disinfecting liquids were poured into the seam of the table, in an effort to disinfect the seam which extended the entire length of the table. She stated it would be impossible to ensure adequate disinfection unless the debris was cleaned and removed from the table, to ensure patient safety and appropriate infection control. Endoscopy room 4 was then inspected. The radiology table in this room contained a seam extending the length of the radiology fluoroscopy table. This radiology table also was noted to contain an amount of caked, hardened debris, which had not been removed to ensure patient safety from contamination on the table.

5. During a meeting conducted with the Quality Assurance, Performance Improvement Committee (QAPI), on 3/26/2015, at approximately 11 A.M., the representatives of the QAPI committee were interviewed and stated they were aware of Carbapenem Resistant Klebsiella, an organism found to cause serious bacterial infections in hospital patients consequent to Upper Gastrointestinal Endoscopy. There was no documentation or any evidence to indicate the representatives of the QAPI committee had visited inside the procedure room to assess and monitor the cleaning and disinfection procedures in the endoscope processing room.

Based on observation, interview, and a record review, the hospital failed to ensure the implementation and maintenance of a program to address priorities for quality of care, patient safety and evaluation of activities to ensure reduction in contamination of surgical instruments. This deficient practice resulted in the facility's inability to integrate active system wide infection prevention and control program into the facility Quality Assurance Performance Improvement (QAPI) program.

Findings:

A tour observation of the central sterile procedures area was conducted on 3/24/2015 at approximately 11:30 A.M. During the tour observation, a vaginal speculum (an instrument used for examination of a woman's pelvic organs) containing residual, dried material on the blade, was lying on a cart containing Plastic Surgery trays, filled with surgical instruments. These carts were directly adjacent to the large instrument washers.

During a concurrent interview, the Central Processing Unit (CPU) Director and the CPU Supervisor stated all instruments were hand washed and brushed prior to being placed in instrument trays, prior to being placed in the large instrument washers. When requested, the manufacturer's booklets for Maintenance and Cleaning of the instrument washers were reviewed. The manufacturer's directions for the machine washers gave instructions for daily, weekly and monthly hand cleaning and maintenance procedures by hospital staff, in addition to maintenance by contracted service providers. When a log to document daily, weekly and monthly cleaning by department staff was requested, plastic indicators used to verify surgical instrument washing were produced. The CPU Director and CPU Supervisor stated when the plastic indicators are clouded over, the instrument washers were cleaned and the instruments re-washed. There was no written documentation provided by the Sterile Department to verify, by means of a daily, weekly, or monthly log, routine cleaning of the instrument washers. There was no documentation to indicate the filters or other elements in the machine washers were removed, inspected or cleaned, as required by the manufacturer ' s recommendations.

During a meeting conducted with the Quality Assurance, Performance Improvement Committee (QAPI), on 3/26/2015, at approximately 11 A.M., representatives of the QAPI committee and the Chief Medical Officer were interviewed and stated the staff were aware of evidence of bio-burden being observed on instruments ready for terminal sterilization.

Based on observation, interview, and document review, the hospital failed to meet the Condition of Participation in Infection Control by failing 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 surgical care in the hospital as evidenced by the facility's failure to:

1. Ensure an active surveillance to identify policies and procedures which were not implemented correctly in an active infection control program (Refer to A 749).

2. Ensure a sanitary condition of the Operating Room Suites and GI Procedure Room environment:

a. by providing effective monitoring to ensure the staff was trained and competent to effectively sterilize hinged surgical instruments (Refer to A 749).

b. by providing for and monitoring patient care equipment. GI Procedure Room equipment, (i.e. patient gurney; maintain in a condition which would permit the equipment to be disinfected (Refer to A 749).

3. Ensure the sterility of surgical instruments and sterile supplies:

a. by providing an effective monitoring of sterile supplies and sterile surgical Instrument storage throughout the facility in specialty operating rooms and GI Procedure room (Refer to A 749)

b. by ensuring sterile supplies were maintained in accordance with facility policy regarding event-related sterility standard (Refer to A 749).

4. Identify and implement a program for safe storage, cleaning, and disinfecting of endoscopes used for gastro intestinal procedures (Refer to A 749).

5. Integrate active hospital-wide infection prevention and control program into the facility ' s QAPI program by providing infection control quality rounds through the facility (Refer to A 748).


The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide infection control program and to provide care in a safe and effective manner in accordance with the Condition of Participation for Infection Control Services.


Findings:

Immediate Jeopardy

1. On 3/25/15 at 1:00 P.M., an immediate Jeopardy (IJ) was identified regarding the widespread pattern of potential ineffective sterilization and storage of surgical instruments and pattern of potential ineffective sterilization of endoscopes((an instrument which consist of a flexible tube with a light attached and used to look inside a person's body organ).

2. On 3/25/15 at 1:55 P.M., the CDPH survey team declared an Immediate Jeopardy and informed the facility's Administrative Team of an Immediate Jeopardy identified in the sterile processing of surgical instruments, the storage of sterile instruments and supplies, and for the cleaning and disinfecting of endoscopes. The Vice President of Nursing identified herself as the spokesman and/or contact for the Administration Team. The team included the Regional Chief Executive Officer (RCEO), the Chief Financial Officer (CFO), and the Chief Nursing Officer (CNO),

3. On 3/25/2015 at 11:40 P.M., following a meeting to discuss potential problems with the implemented corrective actions taken to ensure effective sterilization processes, the hospital modified and submitted their final corrective action plan, which was accepted.

4. On 03/26/2015 at 2:40 P.M., in the presence of CPU Supervisor and Quality Doc. Specialist, the Immediate Jeopardy was removed after compliant practices in cleaning and disinfecting of endoscopes, storage and processing of Sterile Surgical instrument were observed, verified, and reported to the survey team by the team of Infection Control Nurse Consultants.

Based on observation, interview, and document review, the facility and governing body in governance, of the infection control officer and in accordance with the nationally recognized infection control standards, failed to ensure an effective, active system wide infection surveillance control program for prevention, control, and investigation of infections and communicable diseases, as evidenced by the hospital's failure to:

1. Identify and implement a program for safe storage of endoscopes used for gastrointestinal procedures on hospital patients and provide infection control quality rounds through the facility. This deficient practice resulted in the hospital's inability to ensure an effective system-wide infection control program which failed to provide a safe environment, free of transmission sources of infections and communicable disease.

Findings:

1. On 3/23/2015 at 10:14 A.M., a tour observation of the Gastro Intestinal (GI) procedure unit was conducted. In the unrestricted area of the GI procedure unit, there was an endoscope cabinet containing 8 scopes. During a concurrent interview, the Gastro Intestinal Laboratory Manager stated the facility follows the Association of Perioperative Registered Nurses (AORN) standards in processing and storing scopes. The endoscope cabinet was not maintained in accordance with nationally recognized standards and facility policies when:

a. The endoscope storage cabinet was placed in an uncontrolled traffic area;

b. The endoscope storage cabinet was placed in an area of uncontrolled temperature and humidity;

c. Eight (8) of eight (8) endoscopes were vertically hung and stored with a green "sponge" on the distal end of the scope.

During a concurrent interview at 10:14 A.M., the Gastro Intestinal Laboratory Manager acknowledged the cabinet was not maintained according to national standards and she did not know if a facility policy existed. She stated, "we do not have much space but the cabinet will be moved to a space to allow the cabinet to be maintained in accordance with national recognized standards." Continuing with the interview, the Infection Control Preventionist (ICP) verified the decision to locate the cabinet in the hallway was a department decision and she did not believe the infection control committee or that any formal process was followed when placing the scopes were located in the hallway.


On 3/24/2015 at approximately 2:00 P.M., during an interview, the ICP admitted that she did not have any original tools filled out from rounds. She said that she informally does rounds. She stated she was the ICP responsible for the Sterile Processing, She was not familiar with the policy and procedures for the unit. The ICP acknowledged she was not sure if she understood the event related sterility.

In a subsequent interview with the CPU Director, she acknowledged a lack of coordination and oversight by infection control staff of the Sterile Processing Center.

Based on observation, interview, and document review, the hospital failed to provide a functional and sanitary environment for the provision of surgical services, in order that the types of surgery conducted may be performed in a manner which protects lives and assures the physical safety of all individuals. The facility failed to ensure staff are competent and trained for job/duty specific, current and nationally recognized standards and facility policies regarding sterile processing of surgical instruments, the storage of sterile supplies and area specific, facility adopted, nationally recognized infection control standards. Consequently, the facility failed to ensure:


1. Hinged and ratcheted surgical instruments were sterilized in the open position.

a. Staff were competent in the knowledge for current standards of sterile processing hinged instruments.

i. Hinged instruments un-ratcheted placed with tips open.

ii. Hinged instruments placed in appropriate size peel packs.

iii. Hinged instruments appropriately packed in double peel packs according to the facility policy and nationally accepted standards.

2. Rigid trays selected and loaded to ensure all instruments have maximum exposure to the sterilizing agent to ensure sterility.

a. Staff competent on current standards of selecting and loading technique of appropriate size rigid tray to accommodate contents and instruments to be sterilized.

i. Hinged instruments loaded on the appropriate size stringer to allow tips to be open and available to sterilization.

ii. Surgical instruments to have all surfaces available to sterilizing agent.

iii. Staff member was trained and competent to effectively disinfect the perioperative environment.

b. Restricted areas and traffic patterns in procedure areas were identified and maintained in accordance with nationally accepted standards of practice.

i. Traffic through the pass of decontamination

ii. The cleanliness of the area in semi restrictive area

3. Staff members were trained and competent to ensure the sub- sterile environment is effectively disinfected.

4. The facility staff members wear appropriate surgical attire in the sterile central processing area in accordance with nationally accepted standards of practice.

5. The facility staff members were trained and competent to ensure the GI (gastro intestinal) procedure room were effectively disinfected.

a. Surgical mattress pads free from debris;

6. High level disinfection processes were staffed to allow workflow configurations function effectively to prevent cross contamination.

a. Appropriate workflow of decontamination process to prevent the exposure of sterile and high-level disinfected supplies and instruments to the process.

i. Avoid close proximity to decontamination processes with potential for cross contamination of GI instruments.

ii. Avoid cross contamination of High level disinfected endoscopes when staff stored processed and stored the endoscopes in close proximity to decontamination processes.


7. A program for safe storage of endoscopes used in gastro intestinal (GI) procedures and for safe procedures to ensure cleaning and disinfection of endoscopes being processed following patient use.


8. Sterile supply and reprocessed surgical instruments were stored in accordance with nationally recognized standards, and the clean utility room had no dust on the telephone, the telephone cord was not touching the sponges in the bins, and there were no splash marks on the cabinet, bins and the back splash areas.

9. The medication vial septum was disinfected with alcohol before drawing up the medication as indicated in the facility policy.


These deficient practices resulted in the hospital's inability to ensure an effective system-wide infection control program which failed to provide a safe environment free of transmission sources of infections and communicable disease.

Findings:

1. During an observation on 3/23/2015 at 10:14 A.M., a tour of the GI procedure unit was conducted. In the unrestricted area of the GI procedure unit, there was an endoscope cabinet containing 8 scopes. During a concurrent interview, the Gastro Intestinal Laboratory Manager stated the facility follows the Association of Perioperative Registered Nurses (AORN) standards in processing and storing scopes. The endoscope cabinet was not maintained in accordance with nationally recognized standards and facility policies when:

a. The endoscope storage cabinet was placed in an uncontrolled traffic area.

b. The endoscope storage cabinet was placed in an area of uncontrolled temperature and humidity.

c. Eight (8) of eight (8) endoscopes were vertically hung and stored with a green "sponge" on the distal end of the scope.


During a concurrent interview at 10:14 A.M., the Gastro Intestinal Laboratory Manager and the Infection Control Preventionist (ICP), acknowledged the cabinet was not maintained according to national standards and she did not know if a facility policy existed. She stated, " We do not have much space but the cabinet will be moved to a space to allow the cabinet to be maintained in accordance with nationally recognized standards."

2. An observation on 3/23/2015 at 10:30 A.M., was conducted of the sterile storage room located next to and connected to the GI scope decontamination room. The two rooms are connected by an open doorway approximately 2.5 ft. wide, thereby, providing an open space without a barrier to prevent contamination of the sterile instruments and supplies during the decontamination of the endoscopes.


During a concurrent interview, the Gastro Intestinal Laboratory Manager stated the expectation of the staff in the two rooms is to go out the main doors of the rooms and re-enter the other room. The Gastro Intestinal Laboratory Manager stated the staff are not to use the pass through. They are not to enter the sterile room without proper hand hygiene and PPE (Personal Protected Equipment).


During an observation at 11:00 A.M. on 3/23/2015, the following was noted:

a. Two (2) out of four (4) GI staff members entering the sterile storage room were observed to pass through the decontamination room and back when retrieving scopes to deliver to a procedure room.

b. Two GI procedure staff out of 6 staff observed passing through the decontamination room to the sterile room and back during decontamination of an endoscope.


3. During an observation tour on 3/23/2015 at 11:00 A.M., of the GI Procedural Room (PR), in the unrestricted hallway a locked endoscope cabinet was observed to contain 8 scopes. On the north side of the cabinet, an 11 x 12 inches, white sign was hung with "Scopes on hold" written in red words.

a. Eight (8) of eight (8) scopes were observed to be vertical hung with a green sponge on the distal end of the scope.

b. The three staff members were observed passing by the cabinet without PPE and on their way to connecting rooms.


4. An observation on 3/23/2015 at 11:20 A.M., the Gastro Intestinal Laboratory Manager and the ICP stated the two (2) endoscope cabinets approximately 6 ft. by 8 feet high contained endoscopes.


a. Cabinet #1 contained adult sized scopes. Six (6) out of six (6) endoscopes were observed to vertically hung in the GI cabinet with a green "sponge" attached to the end of the scope.

b. Cabinet #2 contained pediatric sized scopes. Five (5) out of seven (7) endoscopes were observed to be vertically hung in the cabinet with a red "sponge" attached to the distal end (tip) of the scope.

c. During this observation, the GI staff was observed retrieving scopes for transportation to the procedure room. The staff entered the sterile storage room without performing hand hygiene. The scopes were touched with ungloved, non-sanitized hands.

A subsequent interview with the Gastro Intestinal Laboratory Manager confirmed the facility policy is to "gel" in and gel" out of each patient room or sterile storage area.

A review of records on 3/24/2015 at 3:30 P.M., revealed the facility practice for storing the endoscopes is inconsistent with the AORN standards, the nationally recognized standards 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 removing all accessories
facilitates drying. The scope protector may create an environment
favorable for microbial growth if the flexible endoscope is not dry
and cannot hang straight.


5. On 3/24/2015 at 1:45 P.M., during an interview and observation with the Central Processing Unit (CPU) Director, the staff observed surgical trays packed inconsistent with AORN standards. The CPU Director stated they follow AORN standards.


Open and inspected:
A laminectomy or spine tray (instruments used for surgery on the back) also known as a Major Tray ready for transport to the operating room.

Assembled in the tray:
A stringer (typically, approximately a foot long 3 rod type device to assist with the positioning of instruments for sterilizing On the stringer Twenty-three (23) hinged instruments observed packed in a tight group. Sixteen (16) out of Twenty (20) hinged instruments blades closed and tips touching.

A large handle instrument (approximately 12 inches with each handle approx. ½ inch wide) stacked on top of surgical instruments layered on the bottom of the tray. Ten (10) instruments observed wrapped in a packet and stacked on top of each other. Six (6) out of the ten (10) instruments had spots of colored substance on the instruments.

6. In a subsequent observation and interview with the CPU Director on 3/24/2015 at 10:00 AM., two smaller trays labeled "Plastics" and identified as a minor tray open in sterile processing room revealed instruments in similar condition to the previous open package with hinged instruments closed and blades touching.


Assembled in tray:
One Large long blade scoop type instrument was packed touch the side of the rigid tray with other six (6) other instruments stacked on top. Stacked on top of those instruments were 10 smaller instruments with 6 of 10 closed with blades observed touching. Thus, four out of four trays were pack inconsistent with facility policy following the nationally recognized standards to ensure the sterility of instruments.


In an interview, the CPU Director of the supply chain management and the Infection Control Preventionist (ICP) agreed this is a typical condition of the instruments. The CPU Director acknowledged the staff members were not following the facility policy and procedure for packing the surgical Instruments for sterilization. The policy and procedures for Sterile Processing of Instruments dated 2010.


(AORN) Recommendation IV:

"Instruments should be kept free of gross soil during surgical procedures.


Blood and body fluids can cause pitting of instruments and, if left to dry, can be difficult to remove. If blood and body fluids are not removed, they can prevent adequate sterilization, which could be an avenue for transmission of other potentially infectious materials.

IV.a. Instruments should be wiped as needed with sterile surgical sponges moistened with sterile water during the procedure to remove gross soil.

Blood and body fluids, as well as saline, are highly corrosive. Corrosion, rusting, and pitting occur when saline, blood, and debris are allowed to dry in or on surgical instruments. Dried blood and debris can be difficult, if not impossible, to remove from all surfaces during the decontamination process; therefore, subsequent disinfection or sterilization may not be achieved.


AORN, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, 2013: Instruments should be inspected for ...corrosion, pitting, burrs, nicks, and cracks ...wear and chipping of ...plated surfaces damage[d] protective surfaces of instruments, contribute to corrosion, impede sterilization surface corrosion damage ...can inhibit sterilization."


Spotting, Staining, and Corrosion of Surgical Instruments:

Surgical instrument Herbert J. Kaiser, PhD; Patrick Schwab, MBA; Jason F. Tirey, MA. (October 1, 2000). Spotting, Staining, and Corrosion of Surgical Instruments. Infection Control Today.

Retrieved from: spotting, staining, and corrosion are serious problems in many healthcare facilities ... Spotting, staining, and corrosion of surgical instruments can impair their function ... Spotting, staining, and corrosion also interfere with sterilization. Spores can be protected from destruction by the layers of iron oxide (rust). Corrosion can result in a shortened instrument life, which results in increased cost.


Stainless Steel:
It is important to remember that stainless steel means stainless steel, not stain-proof steel. All types of stainless steel will eventually become corroded and stained. Also, while a surface of an instrument may look bright and shiny to the naked eye, under microscopic examination the surface is actually very rough. The rough surface allows for entrapment of impurities from soils and water ....Spotting lies loosely on the surface. Staining is integral with the surface. Corrosion penetrates the surface... Stainless steel is indeed reactive, meaning that it will corrode and become stained under certain conditions.


(AORN) Recommendation IV (2009)
Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. ...Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible.


IV.c. Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces.3 [3: Limited Evidence]. Sterilant contact is necessary for sterilization to be achieved.


IV.e. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer's written and validated IFU specifies that disassembly is not required.3 [3: Limited Evidence]
Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant.3


IV.f. Items to be sterilized that have concave or convex surfaces that create potential for water retention should be positioned within packages in a manner that prevents those surfaces from retaining water.3,4 [1: Strong Evidence]Preventing water retention can help avoid the occurrence of wet packs and sterilization failure.


IV.g. Towels placed within instrument sets should be lint-free, freshly laundered, and thoroughly rinsed by a health care-accredited laundry facility. [3: Limited Evidence]


Adequate rinsing reduces the risk of leaving chemical residues that could be transferred from the towels to instruments.28 Lint left on sterile instruments may be transferred to the surgical wound and may cause a foreign-body reaction.


IV.h. Items to be sterilized should be placed in the package or tray in an open or unlocked position. [3: Limited Evidence]


7. On 3/24/2015 at 11:30 A.M., in the Central Sterile room, a 6 Vaginal Speculums were observed. One (1) of the six ( 6) speculums had visible debris with approximately 4 areas covered by 2 centimeters of bio-burden and one (1) area with approximately 3 to 4 centimeters strip of visible bio-burden dried on the speculum.


During a concurrent interview with the CPU Director, she all acknowledged the condition of the speculum as unacceptable and should not have left the decontamination room in the condition they were in.


(AORN) Recommendation IV:
"Instruments should be kept free of gross soil during surgical procedures."

Blood and body fluids can cause pitting of instruments and, if left to dry, can be difficult to remove. If blood and body fluids are not removed, they can prevent adequate sterilization, which could be an avenue for transmission of other potentially infectious materials.


V.a. Instruments should be wiped as needed with sterile surgical sponges moistened with sterile water during the procedure to remove gross soil.

Blood and body fluids, as well as saline, are highly corrosive. Corrosion,
rusting, and pitting occur when saline, blood, and debris are allowed to dry in or on surgical instruments. Dried blood and debris can be difficult, if not
impossible, to remove from all surfaces during the decontamination process; therefore, subsequent disinfection or sterilization may not be achieved.

8. On 3/23/2015 at 1:00 P.M., in an interview with the CPU Director and six (6) staff members, 5 of the staff members could not verbalize the facility policy for Event-Related Sterility. All stated they were not sure what quality assurance policy the facility followed to ensure sterility of instruments.

9. On 3/24/2015 at 1:00 P.M., an observation of bins containing stored processed sterile instruments revealed the instruments were not maintained in a manner consistent with the facilities policy titled, "Storage of Sterile supplies and Sterile Instruments" was conducted.


In a concurrent interview, the CPU Director acknowledged the maintained
condition of the supplies were not consistent with hospital policy. The ICP stated she is not aware of the term, "Event Related Sterility." However, in review of the facility policy and procedure dated 2010 acknowledge the facility followed, "Event Related Sterility" when processing and storing of sterile surgical instruments. The CPU Director acknowledged the Sterile Surgical Instruments and the Sterile Supplies were not maintained consistent with the facility policy.


Observed:
Sample storage bin, measuring approx. 2 feet (ft.) by 1 ft. with twenty-four (24) packages were viewed pushed into the bin space placing pressure on the packages. The CPU Director acknowledged peel packs viewed were
creased and crumpled. The packages were stored in mostly horizontal state allowing compression on the packages. The CPU Director agreed sterility could not be ensured and the Surgical Instruments would be removed from circulation.

10. On 3/25/2015 at 2:45 P.M., in GI procedure Room #1, a gurney/bed observed to have brown colored substance build-up in a crevice running down the length of the procedure bed/ gurney.

During a concurrent interview, the Gastro Intestinal Manager
acknowledged the substance and said it should be cleaned. In a subsequent
interview, at 3:30 P.M., she stated, "that should have been cleaned." The Gastro Intestinal Laboratory Manager acknowledged the gurney/bed could not be disinfected as it was not clean. The ICP confirmed that terminal cleaning was completed the night before on Procedure Room #1 and the environmental staff believed the GI Procedure Room to be ready for
patient procedures. The Gastro Intestinal Laboratory Manager acknowledged the substance should not be left on the gurney.


11. On 3/24/2015 at 3:41 p.m., at the sterile supply room (SSR) of the 5th
Floor operating room, eight single packed hinged instruments with 3 out of 8 hinged instruments in peel packs with tips touching and handles ratcheted
(locked). The packs were arranged vertically but some are hanging on top of the edge of the containers causing them to be compressed, folded and torn on the edges; these had the potential for a breach in an event-related sterility.


During an observation of the SSR in the 6th floor operating room at 4:07 p.m., the cabinet containing three (3) compressed peel-packs with torn edges. The peel packs were each curled on the upper corner and edges in the direction the traffic is headed. Five packages were hanging diagonally on the edge of the container and not vertically; Two contained two (2) hinged-instruments each and
were in a closed position. CPT 3 could not verbalize the critical steps in the facility's policy for Event-Related Sterility. The CPU Director was asked if there is a need to visit operating rooms in the 8th and 9th floors; The CPU Director stated there was no need, for the findings will be the same.


12. An observation was conducted on 3/25/15 at 12:24 p.m., and randomly selected basic spine tray assembled by CPT 4 showed stringed instruments were maintained in open positions by a white towel placed in between the handles; however, there were 3 Kerrison rongeurs on top of each other under the stringed-instrument in closed position; The CPU Director and CPU Supervisor concurred with the findings.


A review of the documents provided by the facility entitled, Decontamination:
CSMC, Standard Work Instruction (REV25/03/2015) .... #17. " Ensure all
instruments are open and/or disassembled.

a. Organize for safe removal on the assembly side.

Instruments are not to be restrung.

b. Any instrument the same size or longer than a sponge forceps should be
taken off of the stringer and laid in an open position in the basket. "



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13. A tour observation of the endoscope processing room was performed on 3/23/2015 at approximately 11:15 A.M., Scope Technician 2 removed a cleaned endoscope (an instrument which consist of a flexible tube with a light attached and used to look inside a person's body organ) from the sink in the processing room and placed the endoscope in a Steris machine. After draining the water from the sink, Scope Technician 2 filled the sink with tap water to the "fill line" labeled on the sink with fresh tap water and then added enzymatic detergent to the water. There was no evidence that Scope Technician 2 cleaned or disinfected the sink between uses. Scope Technician 2 placed a used (dirty) endoscope in the water for cleaning.

During the same on observation on 3/23/2015 at 11:15 a.m., the area around the sink being used for endoscope washing and disinfecting contained splash contamination. Visible dried and wet droplets were on the back splash, on the walls above the sink, on the floor, and some splash droplets were even noted on the ceiling above the sink. Directly next to the sink area were 4 Steris machines, used to clean the endoscopes after washing to continue the process of high level disinfection. Splash contamination from the sink was on the sides and front of the Steris machines. There was no physical barrier between the sinks and the Steris machines, allowing for possible gross contamination of the machines. Two of the Steris machines, not in use were found with the plastic tops open, for possible splash contamination from droplets. When visited, the procedure room contained no monitoring to assess or record temperature or humidity, as required by AORN Standards, the policy being used by the Nursing department of the hospital.

On 3/23/2015 at 11:30 A.M., during an observation, the room directly adjacent to the endoscope room, connected by an open doorway had no physical barrier to separate the two rooms. An alcove was just beyond the doorway, where Scope Technician 1 used high pressure air to dry the GI endoscopes, following removal from the Steris machine. Scope Technician 1 wore no eye shield, a personal protective equipment (PPE). The high pressure air device delivered blasts of air (similar in appearance to that used to inflate automobile tires) to the endoscopes with droplets noted to disperse about the room. In this room were cabinets containing vertically hung GI endoscopes. Dried droplet particles were noted about the alcove and on the cabinet closest to the alcove.

During a concurrent interview, Scope Technician 1 and Scope Technician 2 stated the possible contamination of the disinfected endoscopes could be possible as a result of the blasts of high pressure air. When interviewed in the presence of the Director of Licensing and Accreditation, Scope Technician 1 and Scope Technician 2 stated they were unable to demonstrate temperature or humidity monitoring for the room being used to store the endoscopes. The Director of Licensing and Accreditation stated that out of range temperature or humidity was a factor for bacterial growth in this area.

On 3/24/2015 at approximately 2 P.M., an endoscopic procedure was observed in Room 2 of the endoscopy suite. Following the procedure, the radiology table on which the procedure was performed, had dried debris and dirt caked material in the seam of the radiology fluoroscopy table.

During a concurrent interview, Registered Nurse (RN) 2, who was present in the room, stated the debris had been present for a considerable period of time. RN 2 stated that disinfecting liquids were poured into the seam of the table, in an effort to disinfect the seam which extended the entire length of the table. She stated it would be impossible to ensure adequate disinfection unless the debris was and removed from the table, to ensure patient safety and appropriate infection control. Endoscopy room 4 was then inspected. The radiology table in this room contained a seam extending the length of the radiology fluoroscopy table. This radiology table also was noted to contain an amount of caked, hardened debris, which had not been removed to ensure patient safety from contamination on the table.

On 3/25/15 at 1:55 P.M., the CDPH survey team declared the Immediate Jeopardy and informed the facility's Administrative Team of an Immediate Jeopardy identified in the sterile processing of surgical instruments, the storage of sterile instruments and supplies, and for the cleaning and disinfecting of endoscopes. The Vice President of Nursing identified herself as the spokesman and/or contact for the Administration Team. The team included the Regional Chief Executive Officer (RCEO), the Chief Financial Officer (CFO), and the Chief Nursing Officer (CNO),

On 3/25/2015 at 11:40 P.M., following a meeting to discuss potential problems with the implemented corrective actions taken to ensure effective sterilization processes, the hospital modified and submitted their final corrective action plan, which was accepted.

On 03/26/2015 at 2:40 P.M., in the presence of CPU Supervisor and the Quality Doc. Specialist, the Immediate Jeopardy was removed after compliant practices in cleaning and disinfecting of endoscopes, storage and processing of Sterile Surgical instrument were observed, verified, and reported to the survey team by the team of Infection Control Nurse Consultants.




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14. On March 24, 2015, at 9 a.m., in the Gastrointestinal Procedure Room 2, Patient 13 was observed for a procedure, double balloon oral enteroscopy under a monitored anesthesia care. The Anesthesiologist was observed, on several occasions, not cleaning the septum of the medication vials prior to drawing medications from the vials of Fentanyl Citrate (narcotic analgesic drug used for surgery), Midazolam (muscle relaxing, sedative drug) and Propofol (strong anesthetic drug used for a procedure or surgery). The Anesthesiologist also failed to wipe the port of the intravenous tubing that leads to the patient to receive the medications.

A review of the facility's policy number MM.06.01.01 with effective date of October 23, 2014, titled, "Medication: Administration and Documentation Procedure: Medication Management," indicated to disinfect the medication vial septum with Isopropyl alcohol and allow it to dry before drawing up medication. This is performed when the vial cap is removed and each time the vial septum is to be pierced.

The facility policy on Intravenous Therapy: Initiation and Management of Peripheral Intravenous Lines Policy: Clinical Manual/General Clinical with effective date of October 3, 2014, indicated areas where the alcohol-impregnated catheter hub covers are not the standard are to be disinfect all ports by performing the 15 second "scrub-th-hub" techniques with an alcohol swab before port entry.

During an interview with the Anesthesiologist on the same day, at 11:30 a.m., he stated the septum of the medication vial should be cleaned the first time you open the vial of medication.




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15. On March 25, 2015, at 11:30 a.m., during the observation of the gastrointestinal laboratory, the following was noted:

a. In the Clean Utility Room where endoscopes channels were purged/flushed with air until drying occurs, there was dust on a telephone hanging on the wall above the counter. There were two blue bins which contained 20 green sponges for the one bin and eight (8) pink sponges for the other bin. The telephone cord was hanging and touching the green sponges inside the bin. There were splash marks on the drying cabinet, the two blue bins with the green and pink sponges, and the back splash areas.

b. Underneath the drying area cabinet, there were processed instruments in peel packs which were "jammed" in the cabinet. When the surveyor pulled out a sterile peel pack to inspect the integrity of the processed peel packs, one processed peel pack, which contained a sterile water bottle, had a brownish color ring stain and the pack was crumpled or wrinkled. Another peel pack was crumpled.

c. At 11:45 a.m., on March 25, 2015, the GI Endoscope Technician entered the clean utility room, took an endoscope from Cabinet #1, placed a green sponge on the endoscope tip, the endoscope rubbed against the green scrubs of the GI Endoscope Technician, as he placed the scope in a plastic bag. He left the clean utility room and went to the procedure room directly across from the clean utility room.

During an interview at 11:35 a.m., the Gastro Intestinal Laboratory Manager stated that the green sponges were for the adult scopes and the pink sponges were for the pediatrics scopes. She further stated the sponges were to be placed on the tip of the endoscope after the flushing of all the air channels to protect the tips of the scopes once placed in the cabinet.

When asked how often the cleaning for the drying (purging/flushing) area was conducted, the Gastro Intestinal Laboratory Manager stated the reprocessing staff cleaned the cabinets daily. The staff checked the integrity of the processed peel packs prior to use. The surveyor asked about the "wrinkled" (creases) processed peel packs. The Gastro Intestinal Laboratory Manager stated the wrinkled (creases) processed peel packs were not compromised. "I know they check them for event related." She further stated the green sponges were placed on the tips to prevent damage to the tips. Scope Technician 2 stated he cleans the area in "the a.m. with Sani- wipes." He further stated that area needed to be cleaned.

According to Association of PeriOperative Registered Nurses (AORN) Guidelines for PeriOperative Practice, 2015 Edition, Recommendations XV -
"XV.b. 4. Sterile storage areas, including racks, shelves, bins, and containers, should be kept clean and dry."