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Based on observation, interview, and medical record reviews the hospital failed to have effective systems in place to provide an environment to avoid sources and transmission of infections and communicable disease consistent with hospital policy and nationally accepted infection control guidelines when:

A. The hospital failed to provide a functional and sanitary environment for the provision of healthcare services;

B. The hospital failed to ensure appropriate identification of traffic patterns;

C. The hospital failed to ensure that personnel wore appropriate surgical attire laundered by the hospital were required;

D. The hospital failed to ensure maintenance of a daily log for temperature, humidity, and ventilation in perioperative areas;

E. The hospital failed to ensure that proper isolation precautions were followed;

F. The hospital failed to ensure that all healthcare workers were screened for vaccine preventible diseases;

G. The hospital failed to ensure that safe injection practices were followed;

H. The hospital failed to ensure sterilization was performed in accordance with acceptable standards;

Refer to A-0749

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services and care in a safe and effective manner in accordance with the statutorily-mandated Condition for Coverage for Infection Control.

Based on observations, staff interviews and document review, the hospital failed to maintain a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel, as evidenced by:

1. The hospital did not have effective system to identify patients who tested positive for MRSA (Methicillin-Resistant Staphylococcus Aureus - a type of bacteria which is resistant to common antibiotics). As a result 2 patients (Patients 5 and 6) who tested positive for MRSA upon discharge were not identified in a timely manner;

2. Neonatal Intensive Care Unit (NICU) patients were not placed in isolation per Centers for Disease Control and Prevention (CDC) guidelines. VRE (Vancomycin Resistant Enterococci, a type of bacteria which is resistant to common antibiotics) case was cohorted with MRSA positive cases;

3. The hospital did not require staff members to wear gowns upon entering the isolation room (Room E) where contact precautions were used for preventing transmission of MRSA among the colonized neonates (newborn babies who had the pathogen present on the body, but is not causing any signs or symptoms of an infection);

4. The hospital did not ensure the discharged patient(s) with positive results of the MRSA screen were notified by the physician(s) in accordance with the hospital's policy and procedure.

5. The hospital failed to have a system to ensure that airway devices (laryngeal mask airways, LMA - an alternative airway device used for anesthesia and airway support) were maintained in a manner to protect patients from the devices failing.

6. The hospital failed to perform monitoring of temperature and humidity in the endoscopic procedure room and the endoscope reprocessing room (Hospital 2).

7. The hospital failed to maintain a sanitary physical environment when air ventilation was not monitored in the decontamination room (Hospital 1).

8. Traffic patterns and appropriate attire were not established and followed per standards in the Central Services/Material Management area (Hospital 1).

9. The surgery staff responsible for cleaning and disinfecting between cases, were not knowledgeable about the manufacturer's recommendation for the disinfecting product used.

10. The facility's policies lacked description and/or requirement for the implementation of enhanced contact precautions "Special Contact Precautions" used for Clostridium difficile (a pathogen that is a major cause of healthcare-associated diarrhea and has been responsible for many large outbreaks in healthcare settings) infections.

11. Anesthetic medication, Propofol, labeled for a single-patient use, was found open and unlabeled in a surgery suite;

12. Hinged instruments were sterilized in the closed position;

13. The hospital failed to provide a functional and sanitary environment for the provision of cardiac catheterization surgical services when:

13. a. Appropriate identification of restricted areas and traffic patterns;

13. b. Personnel did not wear surgical attire laundered by the hospital;

13. c. A daily log for temperature and humidity in the procedure rooms was not maintained;

13. d. The cardiac catheterization surgical procedure rooms were not maintained with positive pressure;

14. Environmental Services Staff (EVS) and nursing staff in NICU used vinyl gloves for environmental cleaning, which was not according to the manufacturer's instructions for the product used;

15. Staff were not trained and competent to to effectively disinfect the neonatal intensive care unit environment;

16. Overflowing trash cans containing contaminated waste presented opportunities for cross contamination;

17. Cribs, with infants on MRSA isolation precautions, were located in close proximity to each other, not in accordance with the CDC guidelines;

18. The hospital did not ensure that a clean sink area outside Patient 25's contact isolation room was kept clear of a soiled washbasin and soiled washcloths;

19. The hospital did not ensure that 2 of 3 physicians (MD 1, MD 2) adhered to CDC recommendations related to annual screening for tuberculosis (TB) nor have a policy addressing TB screening for physicians;

20. The facility failed to ensure that 4 of 5 Environmental Services employees (EVS) were trained to properly use cleaning solutions for infectious bacteria such as MRSA (Methicillin Resistant Staph. Aureus) and C-diff (Clostridium difficile). This failure occurred at both Hospital 1(H1) on the 4th floor telemetry unit and Hospital 2 (H2) on the Orthopedic unit and the Bone Marrow Transplant unit. This failure could result in spread of infectious bacteria to a fragile population (other hospital patients);

21. The facility failed to ensure that Patient 9 and visitors participated appropriately in the contact isolation precautions for MRSA. Patient 9 and a in-home services caregiver (not a hospital employee) were observed walking in the unit hall upon returning from being off the unit. Neither Patient 9 or his caregiver were wearing any personal protective equipment (PPE), such as a gown, gloves or masks. This failure had the potential to spread the MRSA organisms within a fragile population at the hospital;

These failures had the potential for placing patient(s) at risk for possible transmission of communicable diseases.

Findings:

1. On 8/20/12, the facility reported to the Department an outbreak of infants colonized with MRSA in the NICU. According to the hospital report, all NICU patients were screened for MRSA upon admission and again at discharge for infants with a hospital stay over 7 days. The hospital became aware on 8/10/12 that 3 infants discharged that week tested positive for MRSA. Upon further investigation and looking back (laboratory results review) the hospital identified 2 infants who tested positive for MRSA upon discharge in July 2012,. The hospital proceeded to test all infants in the NICU. On 8/14/12 four (4) additional cases were identified. The hospital tested all infants present in the NICU by 8/17/12 and identified additional 12 cases on 8/19/12 per the report.

Review of the hospital policy titled "Structure Standards Infection Control Program" (undated, presented as current on 8/28/12) indicated that "...The Infection Control Team (ICT) develops policies and makes recommendations for infection control practices... Most of the activities of the program are administered by the ICCC (Infection Control Clinical Coordinators) as a designee of the ICT..." The policy indicated that ICN 1 and ICN 2 were the ICCCs for the hospital. The policy further indicated that "...the ICCC is responsible for: a. establishing and maintaining a hospital-wide infection control program that is in compliance with regulatory agencies; b. collection and analysis of infection control data; ...d. identifying and directing activities designed to interrupt the transmission of disease, including outbreak management..."

The policy titled, "Methicillin-Resistant Staphylococcus Aureus (MRSA) Active Surveillance Protocol" (dated 1/2011) indicated that MRSA surveillance screening was to be done within 24 hours of admission. Patients screened for MRSA included NICU infants. Per the policy, NICU infants were re-tested at the time of transfer/discharge, if their length of stay was equal to or more than 7 days, and if they tested negative on admission.

The Protocol "For the Management of Resistant Organisms" (undated) indicated that for MRSA and VRE "more than 2 cases occurring with a temporal relationship with one another" defined an outbreak. (a temporal relationship in epidemiology means, the timing of a relationship between a factor and an outcome).

An on-site visit was conducted on 8/28/12 starting at 1 p.m. and on a follow-up visit on 8/31/12 starting at 10 a.m. Interviews and document reviews were conducted with the hospital ICCCs (ICN 1 and 2) and administrative staff (AS 1, AS 2, AS 3 and AS 4) to evaluate the hospital's process for identifying and responding to outbreaks in the hospital, specifically for MRSA in the NICU unit. They stated that a total of 28 MRSA cases were identified for this outbreak. The ICCCs stated that the hospital followed Centers for Disease Control and Prevention (CDC) guidelines for MRSA prevention and outbreak control. Once outbreak was identified and additional environmental and other controls were implemented, no new cases were identified. ICN 1 stated that as a hospital rule, two or more patients testing positive for MRSA would trigger investigation to determine if there was an outbreak. Both ICCCs confirmed that their responsibilities included collection and analysis of infection control data and identifying and directing activities designed to interrupt the transmission of disease, including outbreak management, as per the policy.

ICN 1 explained the process for MRSA surveillance in NICU as follows: All MRSA positive test results for tested NICU infants were received by a Infection Control Data Technician and were input into the electronic database (Excell worksheets). ICCNs were responsible for reviewing the data and identifying trends and problems on ongoing basis. ICCNs usually reviewed the worksheets daily for any new infections. ICN 1 stated that on 7/31/12 she learned that 2 discharged NICU patients (Patient 2 and 3) tested positive for MRSA at discharge (tests 7/29 and 7/28/12 respectively). ICN 1 was alerted by an e-mail on 8/8/12 about a 3 rd positive MRSA result for Patient 1 (tested upon discharge on 8/7/12). The ICN stated that interventions and investigation were initiated on 8/9/12 that included current case reviews and look-back (contacting the microbiology laboratory department and reviewing past tests results for any positive cases). ICN 1 stated that during the look-back, two additional MRSA cases were identified by the discharge screening tests. Patient 5 and Patient 6 tested positive for MRSA upon discharge on 7/3/12 and on 7/20/12 respectively.

The policy titled "Methicillin-Resistant Staphylococcus Aureus (MRSA) Active Surveillance Protocol" indicated that "...1. The results of the MRSA screen will be recorded in the electronic laboratory system and in the patient chart. 2. Upon receipt of a positive result, microbiology staff will call the nursing unit according to policy "Phoned Reporting of Critical Values..." The administrative staff presented policy titled "Critical Value Reporting" as the policy named for reporting. The "Critical Value Reporting" policy indicated that critical values (including MRSA results) should be reported to the nursing units for the inpatients and to the ordering licensed practitioner within 30 minutes of finalizing the result for the outpatients. The policy required to document that critical values were phoned-in and who received the results.

Review of the MRSA test results for Patients 5 and 6 showed that Patient 5 was tested upon discharge for MRSA on 7/3/12 with final result on 7/4/12 identifying MRSA infection. The report documented that result was called to the unit on 7/4/12. No other interventions were documented. The record showed that Patient 6 was tested upon discharge for MRSA on 7/20/12 with final result on 7/21/12 indicating that MRSA was identified. The report documented that patient was discharged. There was no documentation that the results were called-in to the unit or to the physician ordering the test. No other interventions were documented.

Both ICCCs and the administrative staff (in the above interview) agreed on 8/31/12 that the collection and analysis of infection control data were not performed per policies and some policies may need revisions. ICCCs confirmed that Patients 5 and 6's positive MRSA results were not identified in a timely manner, delaying interventions to prevent and interrupt the transmission of the MRSA infection.

2. During an on-site visit on 8/28/12 starting at 2 p.m. a tour of the NICU was conducted with the hospital Infection Control Nurse (ICN 1) and administrative staff (AS 1, AS 2 AS 3 and AS 4). Observations, confirmed with concurrent interviews, showed the following: Currently 14 patients colonized with MRSA were cohorted in 2 NICU rooms B and E, with 5 MRSA colonized infants in room B and 9 MRSA colonized infants in room E. In addition to the 5 MRSA infants in room B, an infant infected with VRE but not MRSA was cohorted (physically separated, but grouped together) with the MRSA colonized infants.

The Protocol "For the Management of Resistant Organisms" (undated) indicated that patients colonized or infected with MRSA or VRE should be placed in a private room. Room sharing by cohorting of patients infected or colonized with the same organism is a second choice.

ICN 1 stated on 8/28/12 that the VRE infected infant was in the same room and bassinet before the MRSA infants were placed there and remained there due to space issues. The ICN agreed that the infant was not colonized or infected with MRSA therefore should have been separated from the MRSA colonized infants to minimize the risk for infection.

3. During an interview in the isolation room E with the NICU (Neonatal Intensive Care Unit) registered nurse (RN 4) on 8/29/12 at 1:45 p.m., the RN 4 stated staff members were required to put on gowns and gloves when working at the bedside in the isolation room where contact precautions were used.

During an observation and a concurrent interview with the Environmental Services Staff (EVS 1) on 8/29/12 at 2 p.m., the EVS 1 did not put on gown for protection when emptying the trash in the isolation room E and the EVS 1's clothing was observed touching the barrel of trash. The Director for NICU (AS 3) acknowledged that the EVS 1 should have worn a gown to protect the clothing.

During an interview with the infection control nurse (ICN 1) on 8/29/12 at 4 p.m., the ICN 1 confirmed that the hospital had no requirement of wearing gowns and gloves upon entering the isolation room(s) where contact precautions were implemented. The ICN 1 stated staff members were required to put on gowns and gloves when working at the bedside in the isolation room(s). The ICN 1 acknowledged that staff members' clothing had the potential be contaminated by the soiled environment in the isolation room(s).

On 8/29/12 at 4:30 p.m., a review of an undated document titled "Structure Standards Infection Control Program" indicated "...Isolation...transmission based precautions, as put forth by the Centers for Disease Control and Prevention, shall be used..."

On 8/29/12 at 4:45 p.m., a review of the document titled "Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006", published by the Centers for Disease Control and Prevention (CDC), indicated "Infection Control Precautions...Contact Precautions...Donning gown and gloves upon room entry and discarding before exiting the patient room is done to contain pathogens..."

4. On 8/31/12 at 12:05 p.m., a review of the hospital's policy and procedure titled "Methicillin Resistant Staphylococcus Aureus (MRSA) Active Surveillance Protocol" dated 1/2011 indicated "Results Reporting and Notification...Patient notification...If the patient has been discharged, the physician should make a good faith effort to notify the patient."

During an interview with ICN 2 and the Administrative Staff (AS 1) on 8/31/12 at 11:50 a.m., ICN 2 stated that based on the MRSA positive list, the regional staff usually sent letter(s) to the discharged patient(s) for notification of positive MRSA result(s) every 2 weeks. The ICN 2 stated that the test ordering physician or the physician who's name was on the letter, would not review the MRSA positive patients' record and notify the patient(s) prior to the regional staff's delivery of notification letters. AS 1 confirmed that the hospital did not comply with the hospital's policy and procedure for patient notification of MRSA positive results.

The above findings (1-4) were confirmed in interviews conducted with the hospital ICCCs (ICN 1 and 2) and administrative staff (AS 1, AS 2 and AS 4) during survey from 10/9/12 to 10/11/12.

5. Review of sterilization record on 10/11/12 at 2:30 p.m. for Autoclave 4 located in the clean core of the surgery department showed that Laryngeal Mask Airways (LMAs) x 9 were reprocessed on 10/1/12. Multiple reprocessed LMAs were observed wrapped in sterile processing packs in the perioperative area ready for use.

In concurrent interview with the Anesthesia Technician, (Tech 1), Tech 1 stated that he routinely reprocessed LMAs for the surgery department. Tech 1 indicated that he did not track the number of times an LMA was sterilized or reused or a date when an LMA was purchased. LMAs were disposed of when they appeared worn-out. Tech 1 stated that all LMAs used in the surgery department were purchased from LMA North America manufacturer.

Review of a document titled "The 40 Use Program," dated 4/04 from LMA North America (copy presented by the facility), indicated that the LMA manufacturer (The Laryngeal Mask Company) warrants reusable LMA products for 40 uses or a period of one year from date of invoice, whichever comes first. Pre-use performance checks were recommended by the manufacturer. If the LMA fails the performance check prior to 40 uses, it should also be discarded. With repeated use, the LMA materials break down and the device may fail to function to permit a patient to breathe, or may injure a patient.

The hospital presented no policy, procedure or written system to ensure LMAs were checked before use and tracked and processed in accordance with the manufacturer's directions as described by the LMA North America reference above.

6. During observations on 10/11/12 at 2:30 p.m. of the endoscopic procedure room and the endoscopy reprocessing room in Hospital 2, no temperature or humidity gauges were observed in neither procedure or reprocessing room. In an interview with the endoscopy Registered Nurse (RN) 5 present during the tour, RN 5 stated that he was not aware of any temperature or humidity logs maintained in the endoscopy area.

The Director of Surgical Services (AS 5) confirmed in concurrent interview that monitoring of temperatures and humidity was not performed in the endoscopy area (procedure room and the adjacent room for reprocessing of endoscopes).

Review of the AORN (Perioperative Standards and Recommended Practices 2012 edition), "Recommended Practices for a Safe Environment of Care" in part indicated, "Recommendation V.b. Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and be maintained below 70% in sterile storage areas... Section V.b.2. indicated "Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system. Section V.c. indicated "Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system.V.c.1. Temperature should be maintained between 68 F to 73 F (20 C to 23 C) within the operating room suite and general work areas in sterile processing."

7. Observations on 10/10/12 starting at 8:30 a.m. of the Central Services/Material Management area (Hospital 1) showed that in the basement a large room/area was used for storage of clean and sterile supplies as well as for cleaning, inspecting, packaging and sterilization of surgical instruments and patient care equipment. Central Services Technician (CS) 1 stated that cleaning and decontamination of surgical instruments and patient care equipment was performed in the decontamination room before instruments and patient care equipment were sent to the clean area for reprocessing, sterilization and/or storage. CS 1 stated that the cleaner and disinfectant used in the decontamination area was Asepticcare TB+II. The room had very strong vapors in the air. The temperature gauge read 25.1 degrees Celsius.

Review of the Material Safety Data Sheet for the Asepticcare TB+II cleaner and disinfectant used in the decontamination area indicated: "Harmful if inhaled or absorbed through skin. Causes eye irritation. Flammable liquid and vapor. Vapor may cause flash fire. Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist. Keep away from heat, sparks and flame. Keep container closed. Use only with adequate ventilation. Wash thoroughly after handling." (http://216.178.82.98/leonardpaper/pub/msds/41500/AK-61121521.PDF)

In a collaborative interview on 10/10/12 starting at 10 a.m. with the hospital administrative and engineering staff, the staff stated that the engineering department monitored air exchanges throughout the hospital but none of the results were a part of environmental monitoring by the infection control staff or quality reviews. No monitoring of temperature or humidity was presented for the decontamination area. The hospital staff presented policy titled "Policy for reducing Organization-acquired illness" as a policy for monitoring of air exchanges in the hospital.

Review of the policy titled "Policy for reducing Organization-acquired illness" (rev 1/2010) in part indicated, "To reduce the potential for organization-acquired illness due to hospital utility system, the following areas are identified as having specific and direct potential to cause harm due to the spread of pathogenic agents and/or contaminants. These areas include certain areas of the hospital designed to control airborne contaminants (such as biological agents, gases, fumes and dust). These include operating rooms, special procedure rooms, delivery rooms, rooms for patients diagnosed or suspected of having airborne communicable diseases..., laboratories and sterile supply rooms. These areas are protected by means of installing and maintaining appropriate pressure relationships, air exchange rates and filtration efficiencies for ventilation systems." The policy did not identify decontamination areas as part of the monitoring. The policy further indicated that air exchange rates were to be monitored annually per California Mechanical Code and AIA (American Institute of Architects) specifications.

Review of the AIA "Ventilation Requirements for Areas Affecting Patient Care in Hospitals and Outpatient Facilities" indicated that soiled or decontamination room should have air negative flow with the minimum air exchanges of 6 per hour (retrieved at http://www.filterair.info/pdf/AIA%20DHHS%20Ventilation%20Requirements%20for%20Areas%20Affecting%20Patient%20Care%20in%20Hospitals.pdf).

During survey the facility measured the air exchanges in the decontamination room. The report showed that the air exchange rate in the decontamination room on 10/11/12 was 3.8 and not 6 air exchanges per hour as per AIA specifications.

The 2012 Perioperative Standards and Recommended Practices published by the Association of periOperative Registered Nurses (AORN), Recommendation V of the "Recommended Practices for Safe Environment" indicated, that "Potential hazards associated with HVAC systems in the practice setting should be identified, and safe practices should be established... V.c.2. The decontamination area temperature should be maintained between 60? F to 65? F (16? C to 18? C)... "

8. The following observations were made on 10/10/12 starting at 8:30 a.m. of the Central Services/Material Management area (Hospital 1) while touring with the Director of Quality Services (AS 4), other Administrative Staff and the Distribution Supervisor:

The Central Services/Material Management was a warehouse-like room that contained storage of clean and sterile supplies as well as areas for reprocessing and sterilization of surgical instruments (inspecting and wrapping of surgical instruments and sterilization). Upon entrance to the area, street clothing was allowed with only head and shoes coverings required; there was no clear designation/separation between clean (restricted and/or semirestricted) and dirty (unrestricted) areas. Clean equipment and supplies were stored in the unresticted area where shoe and head coverings were located. No hand sanitizer or sink were located near the entry. In the clean area were sterile supplies were stored, two side by side supply elevators were located labeled as "clean" and "dirty," without designated traffic pattern for separation of the clean and dirty supplies movement.

Toward the back of the Central Services/Material Management room staff was observed preparing clean surgical instruments for sterilization while wearing only head and shoe covers and street clothing. Staff confirmed in a concurrent interview that their clothing was laundered at home and worn while traveling to work. In the same room in a corner an autoclave was located, which per staff, was used to sterilize surgical instruments for the hospital's Labor and Delivery and other departments.

The 2012 Perioperative Standards and Recommended Practices published by the Association of periOperative Registered Nurses (AORN), Recommendation III of the "Recommended Practices for Sterilization" indicated, "Items to be sterilized should be cleaned, decontaminated, inspected, packaged, sterilized, and stored in a controlled environment... A controlled environment is intended to facilitate effective decontamination, assembly, sterilization, and storage and to minimize environmental contamination and maintain sterility of sterilized items... III.b.3. Traffic patterns should be established to protect personnel, equipment, supplies, and instrumentation from sources of potential contamination. Traffic patterns should define access restrictions, movement of personnel, and appropriate attire according to AORN recommended practices.

The Association of perioperative Registered Nurses (AORN) 2012 Edition recommended the following in the "Recommended Practices for Traffic Patterns in the Perioperative Practice Setting," Recommendation I: "Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environment controls and surgical attire required." Traffic pattern areas were defined in item 1 as: (1) "unrestricted," a central control point established to monitor the entrance of patients, personnel, and materials; (2) "semirestricted," the peripheral support areas of the surgical suite with storage for clean and sterile supplies, work areas for storage and processing of instruments, scrub sinks, and corridors leading to the restricted areas of the surgical suite; surgical attire and hair coverings required; (3) "restricted," includes operating rooms, procedure rooms, and the clean core area; surgical attire and hair coverings required, masks required when sterile supplies open. Item 2 documented, "Movement of personnel from unrestricted areas to either semirestricted or restricted areas should be through a transition zone. A transition zone exists where one can enter the area in street clothing and exit into the semirestricted or restricted zone in surgical attire..."

9. During a tour of Hospital 1's Surgery Department on 10/9/12 at 12 p.m. with the Director of Quality Services (AS 4) and the Director of Surgical Services (AS 5), the Lead Surgery Attendant and random staff were interviewed about cleaning and disinfecting of the surgery suites between surgical cases. The surgery staff who confirmed that they were responsible for cleaning and disinfecting between cases in surgery suites, were not knowledgeable about the manufacturer's recommendation for the disinfecting product used. The staff was not aware that the disinfectant HB Quat 25 used for disinfecting of the surgery suites needed to remain wet for 10 minutes on a surface, for the disinfectant to be effective, per manufacturer's label.

10. During observations on 10/9/12 at 1:30 p.m. of the Cardiac Interventional Unit, a sign next to one of the patient room's entry indicated "Special Contact Precautions." A Registered Nurse assigned to Patient 7 in that room stated that the patient was on "Special Contact Precautions" because of infection with Clostridium difficile (a pathogen that is a major cause of healthcare-associated diarrhea and has been responsible for many large outbreaks in healthcare settings). The RN stated that "Special Contact Precautions," although similar to "Contact precautions," required staff to practice enhanced precautions: for patients on special precautions handwashing with soap and water was required, unlike "contact precautions" for which alcohol hand rubs (gel or foam) was allowed. Also, the disinfecting of inanimate objects required bleach preparations for "Special Contact Precautions" rooms.

Review of Patient 7's medical record with the nursing staff following the tour confirmed that Patient 7 tested positive for Clostridium difficile. However, the record showed that only "contact precautions" were implemented for Patient 7 and not "Special Contact Precautions."

Review of the facility's policies and procedures showed no description and/or requirement for the implementation of "Special Contact Precautions." The "Contact precautions" did not require handwashing with soap and water and the use of bleach agents for disinfecting.

11. During a tour of the surgery suites in Hospital 1 on 10/9/12 at 11:45 a.m. with the administrative and surgery staff (AS 4 and AS 5), a vial of anesthetic medication, Propofol (Diprivan) was found open and not labeled (with an "open" date) on an unattended anesthesia cart in surgery suite #6. The Anesthesia Assistant (AA 2) present in OR #6 stated that anesthesiologists used the Propofol for multiple patients during the surgery day and discarded used vials at the end of the day if not used. AA 2 stated that Propofol vials were good for 6 hours after opening.

Review of manufacturer labeling for Propofol indicated, the medication was not intended for multiple patient use: "...Strict aseptic technique must always be maintained during handling. Diprivan Injectable Emulsion is a single-use parenteral product which contains 0.005% disodium edetate to inhibit the rate of growth of microorganisms, up to 12 hours, in the event of accidental extrinsic contamination. However, Diprivan Injectable Emulsion can still support the growth of microorganisms as it is not an antimicrobially preserved product under USP standards. Accordingly, strict aseptic technique must still be adhered to..."

FDA site had the following recommendation posted for Propofol: " Information for Healthcare Professionals: Propofol (marketed as Diprivan and as generic products) FDA ALERT [6/2007]: Recommendations and Considerations: "Propofol is an intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. Although propofol vials and prefilled syringes contain an ingredient that retards the growth of microorganisms, propofol products can still support the growth of microorganisms. To minimize the potential for bacterial contamination when using propofol for general anesthesia or procedural sedation: both the vial and prefilled syringe formulations must be used on only one patient; administration must commence immediately after the vial or syringe has been opened; and administration from a single vial or syringe must be completed within six hours of opening. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm125817.htm



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12. During an initial tour of the hospital's labor and delivery, on 10/9/12 at 3:15 p.m., perioperative area staff memebers were asked to unwrap several packages of sterile hinged surgical instruments located on a supply cart available for use. When unwrapped, the instruments were observed to have their blades in the unlocked but closed position. In a concurrent interview the OB technician (OB tech) indicated the folding process when wrapping the instruments (to prepare them for sterilization) caused the instrument blades to close. The OB tech confirmed the folding process resulted in the hinged surgical instruments being sterilized with their blades in the closed position. The OB tech indicated it was likely all hinged instruments wrapped in this manner for sterilization would be sterilized with the blades in the closed position.

Review of the hospital's policy titled "Instrument Tray Assembly and Wrapping,"dated approved 5/10 and presented as current, stipulated, "Cleaned instruments are package