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Based on document review and staff interview, the hospital failed to ensure that the GMMS who had the delegated authority by the governing body to be the food service director was full-time and qualified in accordance to State law.

Findings:


The hospital failed to ensure the GMMS met qualifications according to the Health and Safety Code 1265.4. The hospital failed to meet State law as specified in 70275 (b) in regard to the person responsible for the operation of the food service did not meet the written requirements for qualifications as specified in State and Health and Safety Code 1265.4 law.

On April 26, 2011, at 11:45 a.m., based on interview and record review, the GMMS was unable to provide documentation he was qualified for his position in accordance with the Health and Safety Code 1265.4. The GMMS reviewed the Health & Safety Code 1265.4 and stated he did not meet any of the listed pathways to be qualified to be responsible for the operation of the food service in accordance with the law.

According to the law, Health and Safety Code 1265.4(b) "...A health facility that employs a registered dietitian less than full time, shall also employ a full-time dietetic services supervisor who meets the requirements of subdivision (b) to supervise dietetic service operations. The dietetic services supervisor shall receive frequently scheduled consultation from a qualified dietitian.
(b) The dietetic services supervisor shall have completed at least one of the following educational requirements:
(1) A baccalaureate degree with major studies in food and
nutrition, dietetics, or food management and has one year of
experience in the dietetic service of a licensed health facility.
(2) A graduate of a dietetic technician training program approved
by the American Dietetic Association, accredited by the Commission on
Accreditation for Dietetics Education, or currently registered by
the Commission on Dietetic Registration.
(3) A graduate of a dietetic assistant training program approved
by the American Dietetic Association.
(4) Is a graduate of a dietetic services training program approved
by the Dietary Managers Association and is a certified dietary
manager credentialed by the Certifying Board of the Dietary Managers
Association, maintains this certification, and has received at least
six hours of in-service training on the specific California dietary
service requirements contained in Title 22 of the California Code of
Regulations prior to assuming full-time duties as a dietetic services
supervisor at the health facility.
(5) Is a graduate of a college degree program with major studies
in food and nutrition, dietetics, food management, culinary arts, or
hotel and restaurant management and is a certified dietary manager
credentialed by the Certifying Board of the Dietary Managers
Association, maintains this certification, and has received at least
six hours of in-service training on the specific California dietary
service requirements contained in Title 22 of the California Code of
Regulations prior to assuming full-time duties as a dietetic services
supervisor at the health facility.
(6) A graduate of a state approved program that provides 90 or
more hours of classroom instruction in dietetic service supervision,
or 90 hours or more of combined classroom instruction and instructor
led interactive Web-based instruction in dietetic service
supervision.
(7) Received training experience in food service supervision and
management in the military equivalent in content to paragraph (2),
(3), or (6).

On April 26, 2011, at 11:45 a.m., the GMMS stated he was the general manager of multiple services. The GMMS stated that he spent 20 -30% of his time to provide consultation to the environmental services department. The GMMS stated that he had the authority and responsibility for the operation of the food and dietetic services department.

On April 26, 2011, at 1:45 p.m., the COO acknowledged that the GMMS was the person who had the authority and responsibility for the food and nutrition department, and he stated, "He's the food service director."

On April 27, 2011, at 10:15 a.m., in the hospital's dietary policies and procedures manual was an organization chart entitled Nutritional and Environmental Services Organization Chart. The GMMS had oversight over the food and nutrition department, and also had oversight over the EVS Director. The organizational structure and functions diminished the GMMS to less than full-time over the food and nutrition department.

During the same interview the GMMS stated that the dietary department did have a qualified DSS in accordance with the Health and Safety Code 1265.4 However, the GMMS acknowledged that the DSS was not the responsible person for the food service operation.

On April 26, 2011, at 1:20 p.m., the dietary staff member who the GMMS referred to as meeting DSS qualifications stated she was the "Retail Manager." The Retail Manager stated she was in charge of the cafeteria and retail sales, and was in an equivalent managerial position as the Executive Chef, Patient Service Manager and the person in charge of catering, coffee shop and projects. The Retail Manager stated the GMMS was responsible for the foodservice operation.

Based on observation, interview, and record review, the governing body did not have full oversight of all activities of the hospital. The hospital condition of participation for governing body was not met as evidence by the hospital failing to:

Findings:

1. ensure the General Manager of Multiple Services who had the delegated authority by the governing body to be the food service director was full-time and qualified in accordance to State law (refer to A023, A618);

2. ensure patients were protected while investigating an allegation of abuse at the hospital (refer to A118, A115);

3. implement a process for prompt resolution of patient grievances (refer to A145, A115);

4. ensure orders for the use of restraints were not written on an as needed basis (refer to A169, A115);

5. ensure the hospital condition of participation for quality assessment and performance improvement program was met (refer to A263);

6. measure, analyze, and track quality indicators that affected processes of care in regard to the hospital's food and nutrition services (refer to A267);

7. ensure data for temperature and humidity was obtained in areas where invasive procedures were being performed. The facility had no policy to monitor temperature and humidity levels in three Gastrointestinal laboratory procedures rooms and three cardiac catheterization lab procedure rooms, as surgical and invasive procedure settings (refer to A275, A951, A940);

8. ensure review of the flash sterilization log identified the need for additional surgical instruments to ensure the facility had enough instruments so all instruments could undergo the required steam sterilization process. Two specialty trays were flashed sterilized on a routine basis as instruments were not available in sufficient quantities to make up additional trays (refer to A276, A940, A951);

9. ensure three of three Registered Nurses (RN 50, RN 207, and RN 208) demonstrated competence in (1) providing sedation and (2) monitoring patients who received sedation, prior to being assigned to do so (refer to A397);

10. ensure all orders were properly authenticated with the time and date of the physician's signature(refer to A454, A457);

11. ensure all medical records included a time and date to determine which events or entries in other sections of the chart were before or after the untimed entries( refer to A450);

12. ensure supervision of non-employee dialysis nurses who provided services to the patients in the hospital (refer to A398);

13. ensure the hospital condition of participation for pharmacy was met (refer to A490);

14. Ensure patient safety by failing to control and distribute medications to prevent potentially serious medication related errors due to accidental overdose by storing injectable vials of heparin (100 units per ml and 10 units per ml) next to each other in the Neonatal Intensive Care Unit (refer to A500, A490);

15. ensure intravenous medication compounding areas met the requirement to be compliant according to the United States Pharmacopeia 797 standards as stated in the facility's policy and procedures (refer to A500, A490);

16. ensure scheduled II-V drugs were logged and accounted according to the facility's policy and procedures (refer to A500, A490);

17. ensure medications brought in by the patients were inspected and verified by the pharmacist or the physician before use by the patients in the facility according to the state law (refer to A500, A490);

18. ensure contents in Pediatric Crash Carts matched the committee approved list of medications to be included in the Cart (A500, A490);

19. ensure medications were administered in accordance with the manufacturer's recommendation (refer to A500, A490);

20. ensure stored expired scheduled II-V drugs were locked in a secure area to prevent access by unauthorized personnel in the Pharmacy (refer to A503, A490);

21. ensure expired and unusable medications were removed from the patient care area and not available for patient use (refer to A505, A490);

22. ensure the hospital condition of participation for food and dietetic services was met (refer to A618);

23. ensure the daily management of dietary services to provide patients with safe high quality food due to a lack of monitoring of cool down of potentially hazardous foods. (refer to A620, A749, A622, A267, A618);

24. ensure equipment in the kitchen was maintained in good condition to ensure a safe and sanitary environment. (refer to A620, A724, A749, A618);

25. develop a system that integrated the food and dietetic services into the hospital-wide QAPI (quality assurance program improvement) and Infection Control programs. (refer to A267, A749, A620, A622, A724, A629, A630, A618);

26. ensure the hospital's condition of participation for infection control was met (refer to A747);

27. ensure that the hospital's infection control officer had a system to identify deficient infection control practices relating to;

a. instrument sterilization in one of nine operating rooms. Facility staff were using a quick sterilization method (flash) for instruments used by two physicians, resulting in the potential for use of improperly sterilized instruments and the spread of infectious diseases during surgical procedures (refer to A747, A749, A940, A951);

b. temperature and humidity monitoring in the gastrointestinal and Cardiac Catheterization settings (refer to A747, A749, A940, A951);

c. the policy and procedure for Operating Room attire, as facility staff were observed entering restrictive area of the operating room wearing personal/home laundered clothing and hair covers (refer to A747, A749, A940, A951);

d. cleaning of reusable patient equipment. One Sterile Processing Technician was observed not following manufacturer's instructions for contact time (refer to A747, A749, A940, A951);

e. handling and processing of sterile equipment as the Policy and Procedure was unavailable for sterile instrument presoak and washing and one Sterile Processing Technician was unaware of the correct concentration of wash or the type of wash used for prewashing sterile instruments (refer to A747, A749, A940, A951);

28. ensure proper storage of expired invasive equipment in the cardiac catheterization laboratory. Three guide wires were found stored in the cardiac catheterization storage cabinet and available for use, resulting in the potential to spread infections during cardiac catheterizations (refer to A747, A749, A940, A951);

29. ensure on going integration of an infection control program involving food service and sanitation to ensure food safety and sanitation of food service operations (refer to A747, A749, A618, A620, A630);

30. ensure the air vents were kept clean and free fom dust and debris, resulting in dust and debris particles falling on top of patients during a test of the fire alarm system in the emergency room (refer to A747, A749, A940, A951);

31. ensure the hospital's condition of participation for surgical services was met (refer to A747, A749, A940, A951);

32.ensure the facility provided safe surgical services in accordance with acceptable standards of practice as evidenced by:

a. failure to enforce policies and procedures for sterilization of surgical instruments. (Refer to A951, A940);

b. failure to monitor temperature and humidity in all areas used for surgical or invasive procedures. (Refer to A951, A940);

c. failure to implement their policy and procedure for surgical attire. (Refer to A951, A940).

The cumulative effects of these systemic problems and deficient practices resulted in failure to ensure hospital services were delivering care in the safest and most effective manner.

Based on observations, staff interview and document review, the hospital condition of participation for patient rights was not met as evidenced by:

1. the facility failed to ensure patients were protected while investigating an allegation of abuse at the hospital (refer to A118);

2. the facility failed to implement a process for prompt resolution of patient grievances (refer to A145); and,

3. the hospital failed to ensure orders for the use of restraints were not written on an as needed basis (refer to A169).

The cumulative effects of these systemic problems resulted in failure to ensure care was provided in a manner that protected the rights of each patient.

Based on interview and record review, the facility failed to implement a process for prompt resolution of patient grievances for three patients (Patient 100, 313, and 309).

Findings:

An interview was conducted with the DRM on April 20, 2011, starting at 9:15 a.m. The DRM stated a complaint was defined as any issue "in-house that could be resolved and addressed right away. If the complaint could not be resolved while the patient was in the hospital, then it would become a grievance." The grievance procedure would require additional steps and written response to the person who initiated the grievance. The DRM further stated any complaint made in writing, or that could not be addressed while the patient was in the hospital, would be classified as a grievance.

The facility's policy and procedure titled, "Patient Complaints Grievances," with February 2010 as approval date by the Board of Directors, was reviewed. The policy and procedure did not establish a clearly explained procedure for the submission of a patient's written or verbal grievance to the hospital. The definitions of grievance and complaint did not match CMS's definitions. The policy did not follow CMS guidelines for time frames for review and provision of a response for the grievance. The policy did not include that all verbal or written complaints regarding abuse, neglect, patient harm, or hospital compliance with CMS requirements are considered grievances.

In a concurrent interview with the DRM on April 21, 2011, at 10 a.m., the DRM acknowledge their current policy and procedure needed to be updated to include the missing elements and revised to include a more clearly explained procedure to be followed for the submission and investigation of a patient's written or verbal grievance to the hospital. The DRM was unable to voice how she incorporated the data collected regarding patient grievances, as well as other complaints that are not defined as grievances, into the hospital's QAPI Program. The DRM stated she only tracked grievances and did not keep a log of complaints.

Three cases were discussed with the DRM:

1. The first case involved a female patient (Patient 100) in the ED. The female patient reported inappropriate behavior by a staff member. The patient stated the staff member identified himself as a doctor and grabbed her buttocks while she was lying in bed. The staff member was later identified by the facility as a registry CNA.

The DRM stated she became aware of the complainant's allegation on February 23, 2011, and stated she was unable to speak to Patient 100 prior to the patient being discharged from the hospital

The DRM stated she decided she would classify Patient 100's allegation as a "complaint" that did not require any further follow up because she felt Patient 100 was satisfied with how things had been handled prior to the patient leaving the hospital. The DRM stated she came to her conclusion because when she spoke to Patient 100 over the phone, the patient did not tell her about the incident. The DRM stated Patient 100 told her, "She was very happy and rated their care as excellent." The DRM stated she did not directly ask Patient 100 about the incident where she had been grabbed by the male staff. When the DRM was asked why she did not ask Patient 100 about the incident, the DRM stated she was afraid she would mis-lead the patient into making the complaint. The DRM stated she should have asked the patient directly about the incident and been more clear and specific about the reason for her phone call to Patient 100.

The facility failed to ensure all steps were taken on behalf of the patient to thoroughly investigate the patient's concern. The facility failed to provide written notice of the hospital's resolution to the patient for the incident that took place on February 21, 2011.

2. The second case involved a male patient on the 6th floor, involving an allegation of staff to patient abuse. Patient 313 reported to the facility that a CNA was abusive and pushed his face into the bed rail.

The DRM stated she also considered this incident a complaint that did not require any further follow up. The DRM stated she considered the incident a complaint based on the history of the patient's agitated and confused condition, therefore she did not follow the hospital's grievance policy for this case. The DRM stated she did not feel that the allegation of abuse itself was sufficient to make this patient complaint a "grievance."




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3. The record for Patient 309 was reviewed on April 20, 2011. Patient 309, a 21 year old female, presented to the ED on April 2, 2011, at 3:45 a.m., after being involved in a motor vehicle accident. The patient was treated and released at 7:53 a.m.

Patient 309 returned to the ED on April 2, 2011, at 1:25 p.m., complaining of a headache and vomiting. During the second visit, Patient 309 told the treating PA she was sexually assaulted by a staff member during her first visit.

During an interview with the DRM on April 21, 2011, at 10 a.m., the DRM stated she was in frequent contact with Patient 309, as she was attempting to get the detective's name who was assigned to the case, and a police report. She stated even though she was still involved in investigating the incident, she considered this a complaint from the patient, not a grievance. The DRM stated she did not feel that the allegation of sexual assault itself was sufficient to make this patient complaint a "grievance."

Based on interview and record review, the facility failed to ensure patients were protected while investigating an allegation of abuse for one of two patients who reported abuse by facility staff (Patient 313). This failed practice resulted in the potential for patient harm or death.

Findings:

During an interview with the DRM on April 19, 2011, at 1:20 p.m., the DRM stated Patient 313 reported on Saturday, April 16, 2011, a CNA had pushed his face into the side rail of his bed. She stated the CNA was allowed to continue working the remainder of the shift, and his following scheduled shifts. She stated he was working on Monday, April 18, 2011, when she began her investigation.

The facility policy titled, "Abuse Assessment and Reporting," was reviewed on April 19, 2011. The policy included definitions of abuse and neglect, and directions for the staff to identify, investigate, and report abuse of patients who they suspected were abused prior to coming to the facility. The policy did not include information on patient allegations of abuse by staff at the facility. The policy did not include procedures to ensure patients were protected while investigating an allegation of staff to patient abuse.

Based on observation, interview and record review, the hospital failed to ensure orders for the use of restraints were not written on an as needed basis for one of five sampled patients (Patient 200) in restraints. This resulted in the potential for the patient to be restrained without clinical justification for use, the duration of use and the behavior based criteria for use.

Findings:

During facility tour on April 18, 2011, at 10:45 a.m., the unit director stated there was one patient with restraints earlier, but the restraints had been removed. The unit director stated the original order for Patient 200 was a "PRN order," and the restraints were removed.

On April 18, 2011, at 11 a.m., Patient 200 was observed lying in bed. Patient 200 responded quietly and appropriately to questions asked. Patient 200 was not restrained.

In an interview with RN 202, on April 18, 2011, at 11 a.m., RN 202 stated Patient 200 had been attempting to remove medical devices, but he was better now. RN 202 stated soft mitten restraints were placed on Patient 200, but he was no longer restrained. The restraint monitoring form posted on the wall was reviewed with RN 202. The form indicated Patient 202 was restrained between 9:15 and 10:15 a.m.

The record for Patient 200 was reviewed on April 18, 2011, with the director and manager of Unit D3. Patient 200 was admitted to the facility on April 14, 2011, with diagnoses that included right lower lobe pneumonia (inflamatory condition of the lungs) and acute kidney failure. On April 16, 2011, the following order was written: "Soft Restraints PRN." There was no documentation for type, duration, clinical manifestation or behavior criteria for release. On April 18, 2011, the following order was written: "Soft Restrains (sic)." There was no documentation for type, duration, clinical manifestation or behavior criteria for release.

In an interview with the unit director, on April 18, 2011, at 11:15 a.m., the director stated restraint orders cannot be written as a PRN order. The director stated she instructed her staff that as written, the restraint order was invalid and a telephone order was to be obtained.

During a review of the record with the director, on April 18, 2011, there was no evidence of a telephone order in the record.

The facility's policy and procedure titled "Restraint and Seclusion Guidance Policy," with a last revised date of January 2010, was reviewed on April 18, 2011. The policy indicated its purpose was to protect the dignity and safety of inpatients through the safe restraint process and to provide guidelines "to define the procedure to be followed when all alternatives have been exhausted and proven ineffective, and restraints are necessary to maintain patient safety." The policy further indicated in Section 5 "Order for Restraint," the restraint order must be obtained from an Licensed Independent Practitioner (LIP)/physician who is responsible for the care of the patient prior to the application of the restraint. According to the policy the order must specify clinical justification for the restraint, the date and time ordered, the duration of use, the type of restraint to be used and behavior-based criteria for release. In addition, the policy indicated "An order for restraint may not be written as a standing order, protocol or as a PRN or "as needed" order."

Based on observation, interview, and record review, the hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program as evidenced by:

1. the facility failed to measure, analyze, and track quality indicators that affected processes of care in regard to the hospital's food and nutrition services (refer to A267);

2. the facility failed to ensure data for temperature and humidity was obtained in areas where invasive procedures were being performed. The facility had no policy to monitor temperature and humidity levels in three GI laboratory procedure rooms and three cardiac catheterization lab procedure rooms, (AORN), as surgical and invasive procedure settings (refer to A275);

3. the facility failed to ensure review of the flash sterilization log identified the need for additional surgical instruments to ensure the facility had enough instruments so all instruments could undergo the required steam sterilization process. Two specialty trays were flashed sterilized (quicker sterilization process using a hotter temperature for a shorter period of time than regular sterilization) on a routine basis as instruments were not available in sufficient quantities to make up additional trays (refer to A276).

The cumulative effects of these systemic problems resulted in failure to ensure hospital services were delivering care in the safest and most effective manner.

Based on observation, interview and record review, the hospital failed to measure, analyze, and track quality indicators that affected processes of care in regard to the hospital's food and nutrition services.

Findings:

1. On April 25, 2011, the Executive Chef was unable to state correct cooling down procedures in accordance with the directions on the dietarys cooling log. Further, he stated four cooks had not documented roast beef on the cooling log for the period of April 13 - April 23, 2011 to ensure the food was safe to serve to patients.

A review of the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, from March 2, 2011 - April 6, 2011, indicated that roast beef was greater than 70 degrees F after the initial 2 hour cool down time for 14 of 17 (82%) logged entries.

According to the instructions that were located on the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, "Critical Control Points: Food is cooled quickly and safely from 140 degrees F to 70 degrees F within 2 hours and then to 40 degrees F or below within an additional 4 hours (total cooling time 6 hours)."

On April 26, 2011 at 2:30 p.m., the QI Director responsible for oversight of the QAPI within the hospital stated, "The focus of quality improvement activities have been on clinical aspects. There currently is zero criteria on food service operations." The QI Director stated the quality assurance department currently did not have any quality improvement indicators for the food service department. The QI Director acknowledged the food service operation utilizes a method of pre-day cooking that was high risk, high volume and potentially problem prone, and should have been a quality indicator that should have been involved in surveillance, monitoring, analyzing and evaluated for improvement to ensure food safety.

2. On April 27, 2011 at 11:45 a.m., LN 8 reviewed Patient 9's clinical record and verified a nurse provided tube feeding of Jevity 1.2 at 20 cc hr on April 8, 2011 while gradually increasing the rate to Jevity 1.2 at 75 cc/hr on April 9, 2011. LN 8 stated a RD left a yellow note to the physician communicating a recommendation to the physician to start a tube-feeding of Jevity 1.2 at 20 cc/hr to an eventual goal rate of 75 cc/hr. LN 8 stated the nurse infused the tube feeding as recommended by the RD, without obtaining a specific physician's order. LN 8 stated, "Some of my nurse's treat it [the RD's yellow communication note to the physician] as an order and they need some in-servicing on that."

On April 27, 2011 at 1:09 p.m., Patient 5's record was reviewed by the Clinical Nutrition Manager and LN 10. The Clinical Nutrition Manager and LN 10 verified there was not a physical MD order in the clinical medical record despite a nurse entering a diet order for 1800 calorie ADA diet on April 11, 2011 and diet order of mechanical soft chopped on April 12, 2011 into the electronic medical record. The QI Director and LN 10 verified the physicians do not write their orders directly into the electronic medical record, and there should have been a manually written physician's diet order in the clinical record to correspond with the diet orders entered by the nurse into the electronic medical record system.

On April 27, 2010 at 2:30 p.m., the Clinical Nutrition Manager stated it was her expectation for the clinical RDs to verify the physician's order from the paper clinical record to the order that the dietary was providing to patient at each time the RD was completing a nutrition assessment or follow-up visit for a patient. The Clinical Nutrition Manager stated the clinical RD's had been completing "Diet Order Audits" since May of 2010 due to the discrepancies between diet order's received by the dietary department via the electronic medical record versus what the physician ordered, or lack of a physician order, in the paper clinical record. The Clinical Nutrition Manager stated the "Diet Order Audits" were internal audits to the dietary department only. The Clinical Nutrition Manager stated that she had not analyzed the reports to ensure quality improvement.

According to the hospital's policy and procedure entitled NUTRITION CARE DOCUMENTATION IN THE MEDICAL RECORD, "DIET ORDER CONFIRMATION; The physician is responsible for providing a written diet order for all patients (includes NPO order.)"

The hospital lacked a comprehensive system for interdepartmental communication in order to measure, analyze, and track quality indicators that assess processes of care, hospital services and the food and nutrition services operations.

Based on observation, interview, and record review, the facility failed to ensure data for temperature and humidity was obtained in areas where invasive procedures were being performed. The facility had no policy to monitor temperature and humidity levels in three GI laboratory procedure rooms and three cardiac catheterization lab procedure rooms, (areas identified by AORN), as surgical and invasive procedure settings. This failed practice resulted in the potential for procedures being performed in an unsafe manner due to the increased risk for infections and fire.

Findings:

On April 19, 2011, at 1:45 p.m., a tour of the GI lab was conducted with the manager. The area consisted of three procedure rooms, a decontamination room, pre procedure and post procedure beds and a nursing station. The manager stated they performed about 20 procedures daily. During a tour of procedure room 1 there was a cabinet for storage of endoscopes (an instrument used to examine the interior of a hollow organ or cavity of the body, for example the colon or the esophagus). The cabinet was enclosed and vented to allow for drying of the endoscopes after processing. There was a thermostat on the wall that indicated the room temperature was 70? Fahrenheit.

In an interview with the manager, on April 19, 2011, at 2 p.m., the manager stated they were not monitoring humidity at this time, just temperatures.

On April 20, 2011, at 9:15 a.m., during an interview with the manager of the GI lab, the manager stated while there was a thermostat on the wall, unit personnel did not monitor room temperatures. The manager also stated there was no way of monitoring room humidity. The manager stated patients undergoing procedures were given oxygen during the procedure and a cautery device was occasionally used.

Record review for Patient 208 was conducted on April 19, 2011. Patient 208 underwent a colonoscopy (examination of the colon and part of the small bowel with a flexible tube passed through the rectum). Patient 208 underwent this procedure under moderate sedation (conscious sedation- administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardiorespiratory function).

In an interview with the VP of Quality on April 20, 2011, at 9:30 a.m., the VP stated she was unaware additional areas of the hospital required temperature and humidity monitoring.

On April 21, 2011, at 12:30 p.m., an interview was conducted in the cardiac catheterization lab with the Catherization Lab Coordinator and RN 209. RN 209 stated they were not monitoring temperature and humidity levels in the cath lab procedure rooms.
During an interview with the VP of Quality on April 21, 2011, at 12:45 p.m., the VP stated monitoring of temperatures and humidity was not being done in the cath lab.
On April 21, 2011, the temperature and humidity logs were reviewed. There was no documentation in the log books that indicated temperature and humidity of the GI procedure rooms and cardiac catheterization rooms was monitored.

The facility policy and procedure titled "Temperature and Humidity Control in Operating Suites," with a last revision date of July 2010, was reviewed on April 21, 2011. The policy and procedure indicated Operating suites were defined as operating room and labor and delivery areas. The policy did not specify any additional procedural areas as requiring daily monitoring. The document listed as a reference AORN (2009) Perioperative Standards and Recommended Practices including "Safe Environment of Care."

According to the AORN 2009 Perioperative Standards and Recommended Practices: The Mission was to promote safety and optimal outcomes for patients undergoing operative and other invasive procedures. In the section for "Recommended Practices for Safe Environment of Care," AORN indicated the practice guidelines were adaptable to various practice settings including traditional operating rooms, cardiac catheterization laboratories, endoscopy suites, and all other areas where surgery could be performed. Recommendation V indicated: "Relative humidity should be maintained between 30 % and 60 % within perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas Low humidity increases the risk for fire hazards, while high humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed." Recommendations indicated temperature and humidity should be monitored and recorded daily

Based on interview and record review, the facility failed to ensure review of the flash sterilization log identified the need for additional surgical instruments to ensure the facility had enough instruments so all instruments could undergo the required steam sterilization process. Two specialty trays were flashed sterilized (quicker sterilization process using a hotter temperature for a shorter period of time than regular sterilization) on a routine basis as instruments were not available in sufficient quantities to make up additional trays. This failure had the potential to increase risk of post operative infection in patients undergoing these procedures.

Findings:

On April 18, 2011, at 2 p.m., a tour of the Operating Room was conducted. The restrictive area of the department was identified with a red stripe on the floor. There were nine operating rooms and six flash sterilizers. According to the AORN 2009 Perioperative Standards and Recommended Practices: Use of flash sterilization should be kept to a minimum and flash sterilization should be used only in selected clinical situations and in a controlled manner). Each flash sterilizer had a log with documentation of run cycles nearby.

The flash sterilization log for sterilizer six was reviewed on April 18, 2011. There was documentation that a special spinal tray was flash sterilized due to "not enough trays/singles."

On April 20, 2011, at 2 p.m., OR RN 1 was interviewed. OR RN 1 stated two specialty trays used by two different surgeons were not sent to the Sterile Processing Department for sterilization. According to the RN, the trays contained instruments that were not available in sufficient quantities to make up more than one tray for each surgeon. OR RN 1 stated these trays were sent to SPD for decontamination and cleaning then flash sterilized in the OR prior to surgery. OR RN 1 stated she had been flash sterilizing these specialty trays for six years.

In an interview with the SPD Manager on April 20, 2011, at 2:15 p.m., the manager stated to ensure proper sterilization of instruments, the items in a tray should be undergoing soaking, cleaning and sterilization after each use. The SPD manager stated the two specialty trays were not being sent to SPD for sterilization.

The sterilization logs and flash control strips for sterilizer six were reviewed on April 20, 2011. Specialty trays identified as either "Dr. X tray," or "Dr. XX tray," were documented as being flash sterilized on the following dates:

February 7, 2011, at 5:46 a.m.;
February 8, 2011, at 5:24 a.m., and 10:48 a.m.;
February 9, 2011, at 5:05 a.m.;
February 10, 2011, at 5:43 a.m., 12:03 a.m., and 2:29 p.m.;
February 11, 2011, at 5:59 a.m.;
February 15, 2011, at 6:12 a.m., 10:48 a.m., and 11:58 a.m.;
February 17, 2011 at 5:27 a.m.;
February 18, 2011, at 5:54 a.m., and 7:42 a.m.;
February 22, 2011, at 5:13 a.m., and 10:42 a.m.;
February 24, 2011, at 5:30 a.m., and 9:52 a.m.;
March 1, 2011, at 6:02 a.m.;
March 3, 2011, at 5:37 a.m., 11:17 a.m., and 3:05 p.m.;
March 7, 2011, at 6:11 a.m.;
March 8, 2011, at 5:52 a.m., and 1:14 p.m.;
March 10, 2011, at 6:09 a.m., and 10:41 a.m.;
March 14, 2011, at 5:03 a.m.;
March 17, 2011, at 6:23 a.m.;
March 18, 2011, at 6:13 a.m., and 10:30 a.m.;
March 22, 2011, at 5:28 a.m.;
March 23, 2011, 8:24 a.m.;
March 24, 2011, at 5:31 a.m., 9:02 a.m., and 10:37 a.m.;
March 28, 2011, at 10:24 a.m.;
March 29, 2011, at 12:44 p.m., and;
March 30, 2011, at 5:46 a.m.

Each of these entries on the sterilizer log indicated "not enough trays/singles," as the reason for the flash sterilization.

In an interview with the SPD Manager on April 20, 2011, at 2:30 p.m., the manager stated she had identified the overuse of flash sterilization and notified the OR Director in 2010. The SPD manager stated she documented the number of times per day a flash sterilizer was used and the information was sent to the OR Director and Infection Control. The "Sterile Processing Biological Monitoring Report," form for February 2011, was reviewed with the SPD manager. The manager stated in addition to this report another report titled "OR FLASHING Total Processed Items and DME (Durable Medical Equipment) Statistics," was presented for review.

On April 20, 2011, at 4 p.m., the VP of Quality, Patient Safety and Risk Management was interviewed. The VP stated the specialty trays should be cleaned and sterilized in SPD and she was unaware it was not being done.

The Chief of the Medical Staff was interviewed by phone on April 20, 2011, at 4:15 p.m. He was unaware of the special spinal trays for the two spine physicians undergoing repeated flash sterilizations without full sterile processing.

The facility's policy and procedure titled "Sterilization-Steam Using Unwrapped Method (Flash Sterilization) with a last revised date of August 2009 was reviewed on April 20, 2011. The policy indicated flash sterilization would only be used when was insufficient time to process by the preferred wrapped or container method. According to the policy flash sterilization would not be used as a substitute for insufficient instrument inventory. The policy and procedure indicated references used included AORN (2009) Standards and Recommended Practices.

The facility's policy and procedure titled "Steam Sterilization," with a revision date of August 2009, was reviewed on April 20, 2011. The policy indicated the creation and maintenance of aseptic environments had a direct influence on patient outcomes. The policy indicated measures for preventing surgical wound infections included "Provision of instrumentation, supplies, and equipment free of contamination at the time of use. Sterilization provides the highest level of assurance that an object is free of viable microbes." According to the policy, steam sterilization was a process that utilized saturated steam under pressure, for a specific exposure time and at a specified temperature, as a sterilizing agent. Items to be sterilized are those that enter sterile tissue or the vascular system.

Minutes from the Treatment and Surveillance Committee were reviewed on April 20, 2011. There was no documentation/evidence in the report that indicated flash sterilization in the OR was being reviewed.

The "Sterile Processing Biological Monitoring Report," forms for January 2010 through March 2011 were reviewed on April 20, 2011. The form indicated the report would be sent to "Infection Control no later than the tenth of every month." The form contained areas to document "Total # of loads ran, # Biological ran, # of Positive Biologicals, and Days out of service." for the two steam sterilizers, and two plasma sterilizers. The form instructed that all steam and plasma autoclaves would have a biological test run once per day. For the six flash sterilizers, the form indicated instead of loads ran, "# of days ran," was to be documented. From January through June 2010 the following numbers were documented in the section to record "# of days ran" for sterilizer six:

January-67;
February-77;
March-86;
April -77;
May-81;
June-102;
(These numbers more closely resemble number of loads run as opposed to number of days ran.)

The reports for September 2010 through February 2011, indicated the number of loads ran were similar to the number of biologicals ran. According to the report, sterilizer six was run 31 days in January 2011 and 31 biological tests were completed. There was no indication of the number of flash sterilizations processed in sterilizer six for January 2011. In February 2011, there were 28 biological tests run in sterilizer six and the unit was run 28 days. There was no indication of the number of flash sterilizations processed in sterilizer six for February 2011.

The "Sterile Processing Biological Monitoring Report," form for February 2011 was reviewed on April 20, 2011. The form indicated 85 loads were processed in sterilizer six in February 2011, with 9 loads processed on February 10, 2011.

Based on interview and record review, the facility failed to ensure three of three Registered Nurses (RN 50, RN 207, and RN 208) demonstrated competence in 1. providing sedation and 2. monitoring patients who received sedation, prior to being assigned to do so. This failed practice resulted in the potential for harm or death in patients undergoing sedation.

Findings:

1. During an interview with RN 50 on April 19, 2011, at 9:20 a.m., the RN stated he was getting a patient ready for a cardiac procedure that required conscious sedation. He stated he usually used versed and/or fentanyl (sedative medications) to provide the sedation. He stated he administered the medications, and monitored the patients during and after the procedures.

The employee file for RN 50 was reviewed on April 20, 2011. The file indicated RN 50 answered questions to a written test regarding sedation on January 17, 2011. There was no evidence in the file RN 50 demonstrated competence in providing the sedation, or monitoring the patient who received sedation.

2. On April 20, 2011, at 9 a.m., a tour of the GI lab was conducted. RN 207 was assigned to Procedure Room 1 and was assisting with a colonsoscopy (examination of the colon and part of the small bowel with a flexible tube passed through the rectum). Patient 208 underwent this procedure under moderate sedation (conscious sedation- administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardiorespiratory function). Patient 208 received versed and/or fentanyl (sedative medications) during the procedure.
The employee file for RN 207 was reviewed on April 21, 2011. The file indicated RN 207 answered questions to a written test regarding sedation, but there was no evidence in the file RN 207 demonstrated competence in providing the sedation, or monitoring the patient who received sedation.
3. During an interview with RN 208, on April 20, 2011, at 9:30 a.m., RN 208 stated she was recovering patients following their endoscopic procedures. RN 208 stated if the patient met criteria, they were discharged home with a responsible adult. RN 208 stated the nurse in the procedure room was responsible for drawing up the ordered medications.

The employee file for RN 208 was reviewed on April 21, 2011. The file indicated RN 208 answered questions to a written test regarding sedation on March 25, 2010. There was no evidence in the file that RN 208 demonstrated competence in providing the sedation, or monitoring the patient who received sedation. RN 208's position requirements indicated the nurse was to have successful completion of conscious sedation self study guide and her "Sedation analgesia," expired on February 28, 2011.




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The facility policy titled, "Sedation Analgesia," was reviewed on April 20, 2011. The policy indicated the following:

a. Individuals who provided sedation should be trained and have demonstrated competence in standards and techniques to monitor patients carefully in order to maintain them at the desired level of sedation and to manage complications of sedation;

b. Individuals administering sedation would have the appropriate credentials to manage the patient at whatever level of sedation was achieved;

c. The nurse responsible for managing the patient should have completed appropriate education and training related to sedation;

d. The nurse responsible for managing the patient should be able to demonstrate a working knowledge of resuscitation equipment;

e. The nurse responsible for managing the patient should be able to demonstrate the function and use of monitoring equipment;

f. The nurse responsible for managing the patient should be able to interpret data obtained;

g. For a RN to administer sedation and monitor patients receiving sedation during a procedure, the nurse must demonstrate the acquired knowledge of pharmacology, cardiac dysrhythmia recognition, and complications related to sedation and medications;

h. For a RN to administer sedation and monitor patients receiving sedation during a procedure, the nurse must demonstrate skill in airway management and emergency resuscitation;

i. For a RN to administer sedation and monitor patients receiving sedation during a procedure, the nurse must possess the knowledge and skills to assess, diagnose, and intervene in the event of complications or undesired outcomes; and,

j. For a RN to administer sedation and monitor patients receiving sedation during a procedure, the nurse must successfully complete the established hospital course of instruction in sedation.

Based on observation, interview, and record review, the facility failed to ensure supervision of two of two non-employee dialysis nurses (Dialysis RN 1 and Dialysis RN 2) who provided services to the hospital patients. This failed practice resulted in the potential for an unlicensed nurse, a non nurse, or a nurse without training to provide dialysis treatments, and the potential for harm or death to patients.

Findings:

1. During a tour of the MICU on April 18, 2011, at 2:25 p.m., Dialysis RN 2 was observed pushing a dialysis machine out of a patient room. The RN stated she received her assignments from the agency she worked for the previous night, and when she arrived at the hospital she went to the third floor to get her equipment, then she went straight to the patient's room to do the dialysis treatment. She stated she did not have to check in anywhere in the facility like she did at other places.

During an interview with the staffing coordinator on April 19, 2011, the coordinator stated the facility required registry (non employed) nurses were not required to check in before every shift they worked. She stated the staffing office would verify licensure, orientation, evaluation, BLS, and ACLS. She stated they did not require the dialysis nurses to check in when they arrived to do treatments.

2. On April 20, 2011, at 10:15 a.m., during a tour of the fourth floor medical unit, the VP of Quality was asked if a dialysis nurse was available for an interview. The VP made two calls and was unable to obtain the information from staffing personnel. While standing near the nursing station on the fourth floor, a dialysis nurse walked by and was recognized by the VP of Quality.

Dialysis RN 1 was interviewed on April 20, 2011, at 10:30 a.m. Dialysis RN 1 was wearing a hospital issued badge that indicated she worked for a contracted agency. Dialysis RN 1 stated she received her assignments for the day, the night before she was scheduled to work at the facility. Dialysis RN 1 stated she had access to a computer on the third floor, and after her arrival at the facility she checked the location of her assigned patients, obtained her equipment, and started her procedures. Dialysis RN 1 stated she did not have to check in with staff prior to starting her day. Dialysis RN 1 stated she was working with a trainee that day.

On April 20, 2011, at 10:40 a.m., the VP of Quality stated she did not know what dialysis nurses were there that day. The VP stated she was unaware a trainee was there, and was uncertain if a file was available for the trainee. The VP stated the contracted agency provided a list of nurses who provided dialysis services at the facility. The VP of Quality stated the dialysis nurses did not check in with facility staff when they arrived to do treatments.

Based on record review and interview the hospital failed to ensure that all medical records included a time and date. Two closed surgical records were reviewed (Patients 414 and 415). Each had many examples of untimed progress notes, untimed orders, and verbal orders lacking the time of the physician's authenticating signature. This resulted in an inability for the record to be reviewed accurately for quality purposes. There is no way to determine which events or entries in other sections of the chart were before or after the untimed entries.

Findings:

Two closed surgical records were reviewed on April 20, 2011, at 11:30 a.m. The record for Patient 414 contained many orders that were not properly authenticated. Examples include Orthopedic post-op orders that were not signed (on either of 2 pages) by the physician, a page of physician orders dated December 1, 2010 that was part pre-printed, part hand-written, that was signed and dated but not timed by the physician and orders for medications on December 1, 2010 that were not dated. The verbal medication order set titled "Intraoperative Verbal Orders" did not contain the time of the physician's authenticating signature. The record for Patient 515 also had many orders not properly authenticated including a verbal order for insulin dated January 10, 2011, that was not timed when it was authenticated and a verbal order on January 10, 2011, for a bedtime medication that did not have the time of authentication. There was a written order for Home Health dated January, 2011, that was not timed by the physician as well as a written order for several instructions and medications on December 31, 2010, that had no time.

Many progress notes in the record for Patient 415 also lacked the time including an entry on December 26, 2010, that seems to say "1 Med #230896," an immediate post operative progress record from December 27, 2010, and two progress notes from December 28, 2010. The progress records for December 29, 2010, had a single vertical mark for a time. It is not clear if this was used to mean 1:00. A progress note from December 30, 2010, was also not timed.

The two records were reviewed with the Director of Medical Staff on April 20, 2011, at 12:30 p.m., and the Director of Medical Records, and the VP of Quality and Risk, on April 20, 2011, at 2 p.m.. All agreed with the findings and deficient practice.

Based on record review and interview the hospital failed to ensure that all orders were properly authenticated with a date of the physician's signature. Two closed surgical records were reviewed (Patients 414 and 415). Each had many examples of untimed orders, and verbal orders lacking the time of the physician's authenticating signature. This resulted in an inability for the record to be able to be reviewed accurately for quality purposes. There is no way to determine which events or entries in other sections of the chart were before or after the untimed orders.

Findings.

Two closed surgical records were reviewed on April 20, 2011, at 11:30 a.m.

The record for Patient 414 contained many orders that were not properly authenticated. Examples include Orthopedic post-op orders that were not signed (on either of 2 pages) by the physician, a page of physician orders dated December 1, 2010, that was part pre-printed, part hand-written, that was signed and dated but not timed by the physician and orders for medications on December 1, 2010, that were not dated. The verbal medication order set entitled "Intraoperative Verbal Orders" did not contain the time of the physician's authenticating signature.

The record for Patient 415 also had many orders not properly authenticated including a verbal order for insulin dated January 10, 2011, that was not timed when it was authenticated and a verbal order on January 10, 2011, for a bedtime medication that did not have the time of authentication. There was a written order for Home Health dated Janurry 3, 2011, that was not timed by the physician as well as a written order for several instructions and medications on December 31, 2010, that had no time.

The two records were reviewed with the Director of Medical Staff on April 20, 2011, at 12:30 p.m., and the Director of Medical Records, and the VP of Quality and Risk, on April 20, 2011, at 2 p.m.. All agreed with the findings and deficient practice.

The Rules and Regulations of the Medical Staff were reviewed on April 20, 2011, at 3 p.m. Section 4 indicates: "All orders for treatment or discharge shall be documented in the medical record. They must be legible, dated, timed and signed."

Based on record review and interview the hospital failed to ensure that all verbal orders were fully authenticated including the time of the physician's signature. Two closed surgical records were reviewed (Patients 414 and 415). Each had many examples of verbal orders lacking the time of the physician's authenticating signature. This resulted in an inability for the record to be able to be reviewed accurately for quality purposes. There is no way to determine which events or entries in other sections of the chart were before or after the untimed authentications of verbal orders.

Findings:

Two closed surgical records were reviewed on April 20, 2011, at 11:30 a.m. In the record for Patient 414 the verbal medication order set entitled "Intraoperative Verbal Orders" did not contain the time of the physician's authenticating signature.

The record for Patient 415 also had several verbal orders not properly authenticated including a verbal order for insulin dated January 10, 2011, that was not timed when it was authenticated and a verbal order on January 10, 2011, for a bedtime medication that did not have the time of authentication.

The two records were reviewed with the Director of Medical Staff on April 20, 2011, at 12:30 p.m., and the Director of Medical Records, and the VP of Quality and Risk, on April 20, 2011, at 2 p.m.. All agreed with the findings and deficient practice.

Based on observation, staff interview, and record review, the facility condition of participation for pharmaceutical services was not met as evidenced by the facility's failure to:

1. Ensure patient safety by failing to control and distribute medications to prevent potentially serious medication related errors due to accidental overdose (A500);

a.There were two 30-ml injectable vials of 10 units per ml heparin and one 30-ml injectable vial of 100 units per ml that looked identical except the written strength which was highlighted in pink (10 units per ml) and blue (100 units per ml) to distinguish one strength from the other, observed stored next to each other, in the NICU;

2. ensure IV medication compounding areas met the requirement to be compliant according to the USP (United States Pharmacopeia) 797 standards as stated in the facility's policy and procedure (A500);

3. log and account for expired scheduled II-V drugs according to the facility's policy and procedure (A500);

4. ensure medications brought in by the patients were inspected and verified by the pharmacist or the physician before use by the patients in the facility according to the state law (A500);

5. maintain contents in Pediatric Crash Carts that matched the committee approved list of medications to be included in the Cart (A500);

6. administer medication in accordance with the manufacturer's recommendation (A500);

7. store expired scheduled II-V drugs locked in a secure area to prevent access by unauthorized personnel in the Pharmacy (A503);

8. ensure expired and unusable medications were removed from the patient care area and not available for patient use (A505);

9. Ensure enough adenosine (medication used to treat SVT - a dangerously fast heart rate) was available in the adult crash carts to provide a full regimen to a patient suffering from SVT, resulting in the potential for harm or death in these patients (A500); and,

10. Ensure physician orders for medication doses were specific and did not include ranges, resulting in the potential for under or over medicating patients for pain and sedation (A500).


The cumulative effect of the systemic problems resulted in the hospital's failure to ensure the provision of pharmaceutical services in a safe environment that met the needs of the patients.

7. During a tour of the ED on April 18, 2011, at 10:45 a.m., the contents of the adult crash cart was observed. The medication tray included three vials of adenosine, 6 mg in 2 ml.

According to Lexi-Comp's Drug Information Handbook for Nursing, adenosine is indicated for SVT as follows:

a. Administer 6 mg rapid IV push (over 1 - 2 seconds);

b. If ineffective, repeat in 1 - 2 minutes with 12 mg rapid IV push;

c. If ineffective, repeat in 1 - 2 minutes with an additional 12 mg rapid IV push.

The facility policy titled, "Emergency Carts (Crash Carts)", was reviewed on April 20, 2011. The policy included a list of the medications stored in the adult crash cart. The list included three vials of adenosine, 6 mg in 2 ml.

To administer 6mg, followed by 12 mg, followed by 12 mg as indicated in the Drug Information Handbook, five vials of adenosine would be needed. The crash cart did not include enough adenosine to provide a complete regimen to a patient suffering from SVT.

8. The record for Patient 302 was reviewed on April 18 and 19, 2011. Patient 302, a 61 year old female, was admitted to the facility on April 9, 2011, with diagnoses that included substance abuse and respiratory failure.

A physician's order dated April 9, 2011, at 11:25 a.m., indicated the patient was to receive a continuous IV infusion of propofol (used for sedation), with instructions to titrate (increase and decrease) to achieve a MRSS of 2-3. The order did not specify how to titrate the medication, or whether the physician wanted Patient 302 to remain at a MRSS of 2 or of 3.

(An MRRS is a scale used to determine the patient's level of sedation to ensure adequate sedation, but not over sedation. The scale ranges from one [anxious and agitated] to six [no response at all]).

A physician's order dated April 9, 2011, at 2:45 p.m., indicated the patient was to receive fentanyl (a pain medication) 25-50 mcg IV every hour as needed for pain. The order did not specify whether the physician wanted Patient 302 to receive 25 mcg or 50 mcg.

A physician's order dated April 18, 2011, at 3:10 p.m., indicated the patient was to receive a fentanyl continuous IV infusion, with instructions to titrate to a MRSS of 2-3, increasing by increments of 50 mcg/hr. The order did not specify what dose of fentanyl to start with, or whether the physician wanted Patient 302 to remain at a MRSS of 2 or of 3.

A physician's order dated April 18, 2011, at 5:32 p.m., indicated the patient was to receive a fentanyl continuous IV infusion of 100 mcg/hr, and increase by increments of 50 mcg/hr, titrating to a MRSS of 2-3. The order did not specify whether the physician wanted Patient 302 to remain at a MRSS of 2 or of 3.

The facility ICU sedation pre-printed orders were reviewed on April 19, 2011. Each pre-printed order had a box next to it for the physician to check, and the order would be implemented. The orders included the following:

a. Fentanyl infusion 1-2 mcg/kg/hr IV (titrate 1 mcg/kg/hr prn according to pain/MRSS). The order did not specify what dose of fentanyl to start with, what the maximum allowable dose was, or what MRSS value the physician wanted the patient to remain at;

b. Fentanyl bolus 1-2 mcg/kg IV (given at start of infusion and every 30 minutes prn for pain). The order did not specify what dose of fentanyl to give, or what the maximum allowable dose was;

c. Morphine infusion (given for pain) 1-5 mg/hr IV (titrate 1 mg/hr prn according to the MRSS). The order did not specify what dose of morphine to start with, or what MRSS value the physician wanted the patient to remain at;

d. Morphine bolus 2-5 mg IV (given at start of infusion and prn for pain. The order did not specify what dose of morphine to give;

e. Versed 1-2 mg bolus IV. Start drip at 2 mg/hr and increase by 1 mg/hr until adequate sedation is achieved. May rebolus with 1-2 mg every 30 minutes for agitation. The order did not specify what bolus dose or rebolus dose(s) to give, or what level of sedation the physician wanted the patient to remain at;

f. Propofol infusion, start at 5 mcg/kg/min IV. Increase in 5-10 mcg/kg/min increments every 5-10 minutes until adequate sedation is achieved. The order did not specify what infusion rate to start with, what dose(s) the incremental increases should be, or what level of sedation the physician wanted the patient to remain at;

g. Ativan (for sedation) 1-4 mg bolus IV followed by a drip of 1-4 mg/hr. May rebolus prn and increase drip in 1 mg increments every hour until adequate sedation is achieved. The order did not specify what bolus dose or rebolus dose(s) to give, what infusion rate to start with, what the maximum allowable dose was, or what level of sedation the physician wanted the patient to remain at;

h. Norcuron (to induce paralysis) bolus: 0.08-0.1 mg/kg IV. The order did not specify what dose of norcuron to give;

i. Pavulon (to induce paralysis) initially 0.04 to 0.1 mg/kg IV, then 0.01 mg/kg every 30 to 60 minutes. The order did not specify what initial dose of pavulon to give, or how often to repeat the medication;

j. Haldol (for agitation) 2-10 mg IV every hour as needed. The order did not specify what dose of haldol to give; and,

k. Haldol (for agitation) infusion 5-10 mg/hr. Increase rate by 1 mg/hr every 20 minutes until patient calm. The order did not specify what initial dose of haldol to give, or what the maximum allowable dose was.



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Based on observation, interview, and document review, the facility failed to:

1. Ensure patient safety by failing to control and distribute medications to prevent potentially serious medication related errors due to accidental overdose;

2. Ensure IV medication compounding areas met the requirement to be compliant according to the USP (United States Pharmacopeia) 797 standards as stated in the facility's policy and procedure;

3. Log and account for expired scheduled II-V drugs according to the facility's policy and procedure;

4. Ensure medications brought in by the patients were inspected and verified by the pharmacist or the physician before use by the patients in the facility according to the state law;

5. Maintain contents in Pediatric Crash Carts that matched the committee approved list of medications to be included in the Cart;

6. Administer medication in accordance with the manufacturer's recommendation;

7. Ensure enough adenosine (medication used to treat SVT - a dangerously fast heart rate) was available in the adult crash carts to provide a full regimen to a patient suffering from SVT, resulting in the potential for harm or death in these patients; and,

8. Ensure physician orders for medication doses were specific and did not include ranges, resulting in the potential for under or over medicating patients for pain and sedation.


Findings:


1a. Inspection of the facility's NICU was conducted with the DOP on April 21, 2011, at 1:30 p.m. It was noted, in the upper cabinet in the medication storage area, there were two 30-ml injectable vials of 10 units per ml heparin and one 30-ml injectable vial of 100 units per ml that looked identical except the written strength which was highlighted in pink (10 units per ml) and blue (100 units per ml) to distinguish one strength from the other. They were located in separate bins in plastic bags next to each other on the same shelf.

During concurrent interview, the DOP stated the heparin vials were prepared by the Pharmacy and acknowledged the potential danger of picking the wrong strength for use on neonatal patients.

A nationally recognized organization dedicated to medication error prevention called Institute for Safe Medication Practices (ISMP) had in 2006 recognized the importance of paying special attention to the different strengths of similar looking heparins that contributed to the overdose and death of three infants had this to say about the incident in its publication ISMP Medication Safety Alert Acute Care Edition:

"Infant Heparin Flush Overdose

The news media recently reported that three premature infants died at a Midwestern hospital after receiving an overdose of heparin last weekend. Two, possibly three, other babies also were affected but are not in danger. Apparently, 1 mL heparin vials that contained 10,000 units/mL were placed incorrectly into a unit-based automated dispensing cabinet where 1 mL, 10 units/mL vials were normally kept. The vials looked very similar...Several nurses requested 10 units/mL vials to prepare an umbilical line flush and were directed to that drawer, but did not notice that the vials contained the wrong concentration. No doubt there's a lot more to the story but, for now, we have to say that similar medication errors could probably happen in most hospitals.

Automated dispensing cabinet filling errors are quite common. Please take a close look at your own restocking processes. Having a double-check of items before they leave the pharmacy is an important way to prevent mistakes, but even that is not fool-proof. Wherever possible, hospitals should avoid stocking items on nursing units that require further preparation by nurses before administration. As you examine your own practices, pay special attention to cabinets that are used for neonates and pediatric patients, since these are especially high-risk patients. For example, assess the medications and strengths that are stocked in cabinets.

The hospital involved is lowering the 10,000 unit strength of heparin. Perhaps this is time for you, too, to consider what might be removed for safety sake. Although not a factor in this case, this is also a good time to examine which medications are being removed from the cabinet without a pharmacist's review.

Also, even with the perceived safety of automated dispensing cabinets, hospitals should take steps to minimize look-alike packages and labels. Finally, if you aren't already discussing bar coding at your location, it's time to do so. FDA began requiring bar codes on drug containers for a reason-to help all of us prevent medication errors. Bar coding is valuable for bedside scanning to confirm the accuracy of the patient, drug and dose. But even without bedside scanning, cabinet vendors also provide bar code systems for assuring proper medications are stocked. We don't profess to know the easy answers, but this tragic case brings to light a serious national problem about which all should be concerned."

According to ISMP, high-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients.

During an interview with the DOP on April 21, 2011, at 1:30 p.m., the DOP confirmed heparin was a high risk high alert medication.

US Food and Drug Administration (FDA) along with Baxter, manufacturer of the heparin 10 units per ml and 10000 units per ml vials that resulted in the death of 3 infants alerted the health care community about the dangerous error caused by the similarity of the two vials in its FDA MedWatch Alert in February 2007:

"Baxter and FDA notified healthcare professionals of the potential for life threatening medication errors involving two Heparin products, Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL. Baxter is aware of fatal medication errors that have occurred when two Heparin products with shades of blue labeling were mistaken for each other. Three infant deaths resulted when the higher dosage Heparin Sodium Injection 10,000 units/mL was inadvertently administered instead of the lower dosage of HEP-LOCK U/P 10 units/mL. The currently marketed 1 mL vials of both Heparin products use blue as the prominent background color on their labels."

1b. Inspection of the facility's Transplant Unit was conducted with the DOP on April 20, 2011 at 9 a.m. It was noted in the medication refrigerator there was a plastic bin containing two unit dose tablets of dronabinol (controlled substance used as an appetite stimulant) 2.5 mg and four unit dose tablets of 5 mg dronabinol that were mixed together.

It was observed the 2.5 mg and 5 mg dronabinol unit dose tablets were identical in appearance except the written strength. There were no other distinguishable markers.

During an interview with the DOP on April 21, 2011, at 1:30 p.m., the DOP stated the different strengths of dronabinol should have been stored separately to prevent picking the wrong strength.


2. The Pharmacy was inspected on April 18, 2011 starting at 10 a.m., with the DOP. It was observed that the IV compounding area was not structurally separated from the rest of the Pharmacy area by a physical wall. There existed a pathway from the front of the Pharmacy leading to the back area of the Pharmacy. On one side of the pathway was the Narcotic drug room and on the other side was the IV compounding area. There was a demarcation line by way of red tape separating the pathway and the IV compounding area.

There did not exist an ante-area, designated buffer zone, or area separating the rest of the Pharmacy and the IV compounding area. The IV compounding area had two horizontal laminar flow hoods for mixing TPNs, IV antibiotics, etc. and one vertical flow hood for compounding IV chemotherapeutic agents. It was observed that there was no physical structure that completely separated the area of horizontal flow hoods from the area of vertical flow hoods. Thus there existed interchange of room air between these two areas.

It was also observed that the pharmacist was crossing the red tape to get inside the IV compounding area to check and approve for dispensing the drugs compounded by the technicians. It was observed the pharmacist did not use gloves or gowns before crossing the red tape.

It was also observed that the pharmacy technician with gloves and gowns from inside the IV compounding area crossed the red tape walked across the pathway and placed compounded IV medications on the cart and walked back in the IV compounding area and was observed to not wash his hands.

It was also observed the pathway directly next to the IV compounding area was used frequently by the Pharmacy staff to get from the front of the Pharmacy to the back.

During an interview with the DOP on April 18, 2011, at 10:15 a.m., the DOP acknowledged that the IV compounding area was not yet compliant with the USP 797 standards and was in the process of meeting the standards.

The DOP also stated the authorized staff needed to wear gloves and gowns before crossing the red tape to enter the IV compounding area.

The facility's policy and procedure titled, Compounded Sterile Preparations (CSPs) - General Information, that was reviewed stated,

"II. Policy...
Sterile product compounding shall be performed in compliance with the current USP-NF Chapter 797 regulations, State Board of Pharmacy Laws and Regulations and recommendations from the Joint Commission on Accreditation of Health Care Organizations."

The facility's policy and procedure titled, IV Solution, that was reviewed stated,

"III. Procedure...
2. A clean work area with adequate lighting, isolated from heavy traffic will be provided...
5. Wash hands before beginning admixture, and after any interruption, which could contaminate hands."

According to American Society of Health-System Pharmacists (ASHP), a nationally recognized organization, publication titled, ASHP Guidelines on Handling Hazardous Drugs,

"Environment. Hazardous drugs should be compounded in a controlled area where access is limited to authorized personnel trained in handling requirements. Due to the hazardous nature of these preparations, a contained environment where air pressure is negative to the surrounding areas or that is protected by an airlock or anteroom is preferred. Positive pressure environments for hazardous drug compounding should be avoided or augmented with an appropriately designed antechamber because of the potential spread of airborne contamination from contaminated packaging, poor handling technique, and spills."

US Pharmacopeia on its website addressed the requirement to have a negative pressure room for preparation of hazardous drugs below in questions and answers format:

"73. Can CACI that meets the negative pressure requirement be used if it is placed in a regular room or does the negative pressure CACI need to be placed in a separate negative pressure room?

The CACI shall be placed in a separate negative pressure room. The ISO Class 5 (see Pharmacists' Pharmacopeia, Table 1, page 797) BSC or CACI shall be placed in an ISO Class 7 (see Table 1 above) area that is physically separated (i.e., a different area from other preparation areas) and optimally has not less than 0.01- inch water column negative pressure to adjacent positive pressure ISO Class 7 (see Table 1 above) or better ante-areas, thus providing inward airflow to contain any airborne drug. However, in facilities that prepare a low volume of hazardous drugs, the use of two tiers of containment (example: closed-system vial-transfer device within a BSC or CACI that is located in a non-negative pressure room) is acceptable.

76. Should the room be negative pressure if you have a room with a horizontal flow hood and a vertical flow hood for hazardous drugs?

As stated in chapter <797>, hazardous drugs shall be prepared in a negative pressure room. All hoods and procedures used in the room should be designed for proper operation in the negative pressure environment unless the situation allows for the low volume exception in the chapter. A second-tier of containment (e.g., CSTD) would be required when a BSC is located in a positive-pressure ISO Class 7 buffer area.

79. Can you explain what a "closed-system vial transfer device (CSTD)" is?

A Closed System Vial Transfer Device is a generic term used to describe a device that does not allow any substance to escape outside the vial or bag during the transfer process. This will include vapors, liquids, powders, etc. The system should be totally closed. An air vent is not considered a closed system even if the vent includes a 0.22 micron filter."

3. During inspection of the Pharmacy on April 18, 2011 starting at 10 a.m., it was noted there was a cabinet located within the controlled substance (CS) Drug Room.
There was another cabinet in black located just near the Pharmacy main entrance door. The room had the door removed. These cabinets contained expired controlled medications and they were observed to be unlocked.

The facility's expired controlled substance log book was examined and noted that the log was missing entries for the expired controlled medications received or checked in for the past 4 months which was the time the expired controlled medications were picked up by the contracted company for disposal.

During concurrent interview with Pharmacist 500 on April 18, 2011 starting at 10 a.m., he stated the technicians would check in expired controlled substances and place them in the cabinet and the expired controlled drugs were logged in the book at the time of pick up by the company for disposal.

The facility's policy and procedure titled, Expired Drugs, was reviewed and it stated,

"III. Procedure
A. The Pharmacy Staff shall check:
1. To see that outdated drugs are placed in appropriate bin for credit.
2. Outdated Schedule II Controlled Substances. These shall be separated and logged for returns processing.
3. Outdated Schedule III Controlled Substances. These shall be separated and logged for returns processing."

During concurrent interview with Pharmacist 500 on April 18, 2011, at 10:15 a.m., he acknowledged the outdated controlled substances in the box were not logged.


4. During inspection of the Medication Room located on sixth floor Medical/Surgical Unit on April 18, 2011 at 2 p.m., it was noted there were following prescription medications filled at outpatient pharmacies for two patients:

Synthroid 0.05 mg #30 filled at Walgreens Pharmacy for Patient 500; and,
Thiothixene 10 mg #21 in a blister pack filled at RxExpress Pharmacy for Patient 501.

It was also noted there was no indication these medications were verified by either a licensed pharmacist or a physician.

During concurrent interview, RN 500 stated both patients were discharged and no longer in the hospital.

During concurrent interview, the DOP stated the medications were not verified and acknowledged they should not have been used until sent to the Pharmacy for verification.

The DOP did not provide evidence the Pharmacy was aware of the medications filled from outside sources being used in the facility.

The facility's policy and procedure titled, Drugs Brought at Admission was reviewed and it stated,

"II. Policy
All drugs brought by the patient on admission to the hospital will be sent home with the patient's family, unless a physician writes an order for the drugs to be administered while in the hospital. If no family is available to take medications home, the medications will be delivered in person to Pharmacy for safe keeping, until the patient is discharged.

III. Procedure
E. If the physician writes an order for the patient to have their own medication from home, the nursing staff will hand-deliver medication to Pharmacy for identification prior to administration at Riverside Community Hospital."

5. During inspection of the facility's Pediatric Unit on April 18, 2011 at 3:30 p.m., it was observed in the Pediatric Crash Cart there were one 30-ml vial bottle of Cetacaine (local anesthetic) and one 30-ml tube of lidocaine (local anesthetic) 2 percent jelly inside the top drawer with adjacent sealed drug tray.

The approved list of medications in the Pediatric Crash Cart was reviewed and it did not include these two medications.

During concurrent interview, the DOP acknowledged that these extra medications should not have been included in the Pediatric Crash Cart.

6. During medication pass observation conducted on April 19, 2011 starting at 8:30 a.m., it was observed RN 500 administered via IV route 40 mg Protonix (drug for acid reflux) for Patient 502. The infusion of the medication lasted less than forty seconds.

During concurrent interview, the DOP acknowledged the infusion should have lasted at least 2 minutes.

According to the Package Insert that accompanied Protonix IV,

"Two Minute Infusion
Protonix I.V. for Injection should be reconstituted with 10 ml of 0.9 percent Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/ml. The reconstituted solution may be stored up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light. The total volume from both vials should be administered intravenously over a period of at least 2 minutes."

Based on observation, interview, and document review, the facility failed to store expired scheduled II-V drugs locked in a secure area to prevent access by unauthorized personnel in the Pharmacy.

Findings:

During inspection of the Pharmacy on April 18, 2011 starting at 10 a.m., it was noted there was a cabinet located within the controlled substance (CS) Drug Room. There was a second cabinet (black in color) located just near the Pharmacy main entrance door. The door to the room had been removed. Inside the controlled substance medication room was a medication refrigerator containing controlled substance that was also unlocked.

During an interview with Pharmacist 500 on April 18, 2011, at 10 a.m., the pharmacist stated the expired controlled substances were checked in and collected in box inside the cabinet located in the CS Drug Room and that the cabinet was supposed to be locked, with the key located within the Pyxis CII Safe MedStation (automated dispensing cabinet for controlled substances).

Inspection of the Pyxis CII Safe MedStation revealed that the key to the cabinet was not located in the CII Safe Medstation. Pharmacist 500 found the key in the black cabinet located outside the CS Drug room and it was observed to be open and also contained expired controlled substances.

Pharmacist 500 explained that both cabinets were in the CS Drug Room before Pyxis CII Safe was placed inside it and the black cabinet was placed outside because of space limitations.

Pharmacist 500 added that both cabinets and the medication refrigerator should have been locked at all times.

The facility's policy and procedure titled, Controlled Substances - Scheduled, was reviewed and it stated:

"III. Procedure...
E. Pharmacist shall...
8. Please keep narcotic vault door closed at all times..."

The facility failed to store expired scheduled II-V drugs locked in a secure area to prevent access by unauthorized personnel in the Pharmacy.

3. During a review of the medication cart used by RN 200, on April 18, 2011, at 11 a.m., two opened vials of insulin were observed. Each vial of insulin had a sticker applied to document the expiration date. A ten milliliter (ml) vial of Novolin 70/30 insulin had a written expiration date of April 15, 2011, three days ago. The second vial, a ten ml vial of Humalog, had a written expiration date of April 14, 2011, four days ago.

In an interview with the unit RN 200 and the unit director, on April 18, 2011, at 11 a.m., the director stated the written date should be 28 days from the day the vial was opened. The director stated in this case the date may have been the date the insulin vials were opened, but there was no way of knowing.

During a review of the medication cart used by RN 202, on April 18, 2011, at 11:10 a.m., opened vials of insulin were noted to have plastic zip type tags attached with hand written expiration dates. RN 202 stated the vials come up from the pharmacy with the tags and the vials expire on the date indicated on the tag.

The facility's policy and procedure for "Medication Administration," with a last revised date of February 2011, was reviewed on April 20, 2011. The policy and procedure indicated in the section titled "Procedures," indicated "Insulin must be dated with a 28 day expiration date when first opened and discarded after 28 days.





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Based on observation and interview, the facility failed for one of two medication carts on unit D3 and in the main pharmacy, to ensure medications available for patient use had not expired, resulting in the potential for administration of outdated, ineffective medications.

Findings:

1. During inspection of the Pharmacy on April 18, 2011 starting at 10 a.m., it was noted the following unusable medications were stored together with usable medications in the Pharmacy medication refrigerator:

One vial of Tubersol (Tuberculin Purified Protein Derivative injection used to test for tuberculosis) with an open date of December 22, 2010; Two single use vials of Cubicin 500 mg for injection that were reconstituted; and one Novolin insulin R multi-use vial without open date.

During concurrent interview with Pharmacist 500 and the DOP on April 19, 2011 at 3:30 p.m., the DOP acknowledged these vials should have been removed from the medication refrigerator and the insulin vial should have been dated.

2. During inspection of the medication storage rooms of the facility's Pediatrics Unit on April 19, 2011 at 3:30 p.m., it was noted there was an open packet containing three 2-ml budesonide (steroid inhalation solution for asthma or airway disease) 0.5 mg/2 ml inhalation unit-of-use solutions. The drug is packaged by the manufacturer in foil envelopes. When opened per package insert it should be used within two weeks.

The open foil envelope did not have the date opened.

During concurrent interview with the DOP on April 19, 2011 at 3:30 p.m., he acknowledged the open date was not present and the drug should have been removed.

The review of the facility's policy and procedure titled, Expired Drugs, indicated the following:

"II. Policy...Outdated or otherwise unusable drugs shall be removed from distribution to prevent administration to patients. "

Based on observations, staff interview and document review, the hospital condition of participation for food and dietetic services was not met as evidenced by:

1. The hospital failed to employ a director of food and dietetic services that was full-time in that capacity. The Food Service Director failed to ensure organized dietary services (Cross refer A-620, A-630);

2. The Food Service Director failed to ensure the daily management of dietary services to provide patients with safe high quality food due to a lack of monitoring of cool down of potentially hazardous foods (Cross refer A-620, A-749, A-622, A-267);

3. The hospital failed to ensure that equipment in the kitchen was maintained in good condition to ensure a safe and sanitary environment. (Cross refer A-620, A-724, A-749), and

4. The hospital failed to develop a system that integrated the food and dietetic service into the hospital-wide QAPI (quality assurance program improvement) and Infection Control programs (Cross refer A-267, A-749, A-620, A-622, A-724, A-0629, A-0630).

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure safe food handling to prevent the potential of food borne illness and to ensure quality and coordinated nutrition care was provided to patients. The cumulative effects of systemic problems resulted in the hospital's inability to ensure the provision of dietetic services for the health and safety needs of patients in compliance with the Condition of Participation for Food and Dietetic Services.

Based on food service observation, interview, and record review, the hospital failed to employ a director of food and dietetic services that was full-time in that capacity. The hospital failed to ensure safe food handling practices as evidenced by:
1. potentially hazardous foods were not consistently cooled down,
2. a gas and sewage smell in the kitchen was not completely addressed by hospital staff,
3. the ice-machines in the kitchen were not sanitized, and
4. staff were unclear on how to utilize the planned Disaster menu which could impact the nutritional needs of patients in the event of a disaster.

Findings:

On April 26, 2011, at 11:45 a.m., the GMMS stated he was the general manager of multiple services. The GMMS stated he spent 20 -30% of his time to provide consultation to the environmental services (EVS) department. The GMMS stated he had the authority and responsibility for the operation of the food and dietetic services department.

On April 26, 2011, at 1:45 p.m., the COO acknowledged the GMMS was the person who had the authority and responsibility for the food and nutrition department, and he stated, "He's the food service director."

On April 27, 2011, at 10:15 a.m., in the hospital's dietary policies and procedures manual was an organization chart entitled Nutritional and Environmental Services Organization Chart. The GMMS had oversight over the food and nutrition department, and also had oversight over the EVS Director. The organizational structure and functions diminished the GMMS to less than full-time over the food and nutrition department.

1. On April 25, 2011, at 11:10 a.m., in the walk-in refrigerator was a large pan that was approximately 6 inches deep that contained roast beef, with a sticker label on the pan that indicated "4/23/11 and use by 4/26/11."

On April 25, 2011, at 11:30 a.m., the Executive Chef stated the large pan of roast beef in the refrigerator was approximately 35 pounds. The Executive Chef stated the "HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS" lacked documentation that the roast beef was cooled down safely.

During the same interview, the Executive Chef stated he was responsible for ensuring that foods were cooled down safely and that they were documented on the cool down log. The Executive Chef held the HACCP COOLING log and stated, "If roast beef has not reached 70 degrees F after 2 hours then it needs further cooling."

According to the instructions that were located on the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, "Critical Control Points: Food is cooled quickly and safely from 140 degrees F to 70 degrees F within 2 hours and then to 40 degrees F or below within an additional 4 hours (total cooling time 6 hours)."

A review of the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, from March 2, 2011 - April 6, 2011, indicated that roast beef was greater than 70 degrees F after the initial 2 hour cool down time for 14 of 17 (82%) logged entries. Directions on the log indicated, "SEE REVERSE SIDE OF THIS FORM FOR: --Corrective action steps if time/temperature requirement for cooling and reheating have not been met." The reverse side of the log that had the above entries was blank. There was no Xeroxed copy on the reverse side, it was one-sided only.

According to standards of practice in the food service industry if the initial cooling to 70?F took 3 hours, for example, the food safety hazards may not be adequately controlled (FDA Food Code 2009)

A review of the April 2011 HACCP ROAST MEAT CHART indicated that roast beef in quantities between 40 - 50 lbs were cooked a total of seven times from 4/13/11 - 4/23/11. The Executive Chef stated that the roast beefs on the April 2011 HACCP ROAST MEAT CHART should have been cooled down, and documented on the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS. The Executive Chef reviewed the cooling logs and stated that four cooks were not documenting cool-down on the logs. The Executive Chef acknowledged that there was no documentation on the cool down logs to indicate that the roast beefs that were cooked from April 13, 2011- April 23, 2011 were cooled down safely.

A potentially hazardous food that is allowed to remain in the temperature danger zone enough for the bacteria to produce toxins will become unsafe to eat. Most toxins are not destroyed by high temperatures which could cause a food borne illness. Excessive time for cooling of potentially hazardous foods has been consistently identified as one of the leading contributing factors to foodborne illness. (FDA Food Code 2009)

2. On April 25, 2011, at 2:45 p.m., there was an odor in the kitchen that seemed to smell like gas and/or sewage as verified by the GMMS, and the QI Director. The odor would come strong and then fade over the following 45 minutes. The GMMS stated he thought it was due to a pilot light.

On April 25, 2011, at 3:10 p.m., the Executive Chef stated the gas valve needed a repair on the previous Saturday which was done by an outside company that was arranged by the hospital's engineering staff. The Executive Chef acknowledged he had smelled gas in the kitchen even after the repair. The Executive Chef and the GMMS both stated the gas odor had not been reported to hospital staff since the Saturday repair. The invoice from the outside service that did the repair on the gas valve was requested. The invoice was not provided to the surveyor prior to exit on April 27, 2011.

On April 25, 2011, at 4:10 p.m., the Director of Engineering indicated he was not aware there was a problem in the kitchen of a gas odor, and stated he was not aware there was a repair on a gas valve in the kitchen on the previous Saturday.

On April 25, 2011, at 4:17 p.m., in the kitchen, was a large metal panel on the floor, and above that location was a food preparation table. An odor was coming from the area that smelled like sewage as acknowledged by the QI Director, and Engineering Staff 1. Engineering Staff 1 stated that underneath the panel was sewage pipes. To the left of the panel on the floor was a floor drain in which three small black insects flew out of.

On April 25, 2011, at 4:21 p.m., the Director of Engineering was in the kitchen and stated, "We do not routinely flush plumbing. We wait until it plugs up."

According to review of work orders placed by the dietary department to the engineering department, there were seven work orders placed in 2010 that referred to clogged and smelly drains in the kitchen. One of the work orders, dated May 27, 2010, indicated "1. There is a possible gas leak on an oven in the kitchen. 2. There is a chemical smell of some kind coming from a floor drain in the kitchen...Smell coming from tunnel hatch." Although the work orders had a completion date listed, the hospital was unable to demonstrate that there was a preventative maintenance system in place.

On April 25, 2011, at 4:25 p.m., Engineering Staff 1 used a "Flammable Gas Detector" and stated the device did indicate that there was a gas leak in the kitchen. Engineering Staff 1 identified the piece of equipment in which he determined the gas leak was coming from. He further stated the device was not signaling that there was a gas leak by another oven in which the repair was completed on the previous Saturday. The hospital then contacted an outside service to assess the odors in the kitchen.

On April 25, 2011, at 4:53 p.m., Dietary Staff 2 was asked how long she had smelled the unusual odor in the kitchen and she stated, "It's been about a month."

On April 26, 2011 the hospital provided a copy of the invoice for the outside company that was chosen to assess the odor. The invoice was from a plumbing company and indicated, "4/25/11; Upon arrival smell of gas in kitchen unable to use gas sniffer due to draft from access panel uses gas bubbles to find leak on gas line at ball valve on 1 ? gave...removed ball valve and put cap on line."

Improper maintenance of plumbing may result in potential health hazards or creation of other unsanitary conditions that may attract insects and other vermin.

3. On April 25, 2011 at 2:56 p.m., in the presence of the Manager of Engineering, Engineering Staff 1 stated he used a cleaner on both ice-machines in the kitchen to de-scale on a quarterly basis. Engineering Staff 1 was asked to bring all products used on the ice-machine, in which he brought the de-scale cleaner. The Manager of Engineering stated he was a manager and that he trained the engineering staff on how to clean the ice-machines in the kitchen. The Manager of Engineering stated he did not have any additional steps to add to Engineering Staff 1's comments about the maintenance of the ice-machine. He also verified no other products were used on the ice-machine.

Engineering Staff 1 was asked to remove the panel from the ice-making apparatus to expose the internal components. There were furry brown substances on the inside. The Manager of Engineering stated, "It is due to be cleaned."

On the inside of one of the ice-machines were posted manufacturer's guidelines that indicated the ice-machine should have been sanitized using a hypochlorite solution (household bleach). Engineering Staff 1 and the Manager of Engineering acknowledged the ice-machines in the kitchen were not being sanitized.

Engineering staff provided the manufacturer's guidelines for each ice-machine in the kitchen, that were made by two different manufacturers. Both manufacturers' guidelines indicated the ice-machines had a sanitizing step, and a hypochlorite solution would be appropriate for each machine.

Two of two ice-machines located in the kitchen were not sanitized in accordance with manufacturer's guidelines.

4. On April 25, 2011, at 1:20 p.m., the GMMS stated in the event of a disaster the hospital's Disaster Menu was planned to feed 1500 people per day for 5 days. The GMMS provided a policy and procedure (P&P) entitled CODE TRIAGE - EMERGENCY MASS FEEDING PLAN (NUMBER: FNS342, last approved April 22, 2009). The GMMS, in the presence of the Clinical Nutrition Manager and QI Director, was asked to provide the disaster menu that hospital staff would use to meet the nutritional needs of patients in the event of a disaster. The GMMS provided P&P 342, pages 4-8, that indicated "Table 4. Sample Disaster Menu". The GMMS verified the "Sample Disaster Menu" was the disaster menu that was to be implemented by hospital staff during the event of a disaster.

The Sample Disaster Menu was not detailed on how the nutritional needs of patients on a therapeutic diet or texture modification would be met in the event of a disaster. The menu for lunch on Day 1 indicated, "2 oz. protein; cheese, sliced meat, tuna or other protein foods not requiring cooking, bread product (2 oz) - bread, bagel, English muffin, dinner roll, crackers, vegetable (1/2 cup) - green salad or other raw vegetables as appropriate to pt diet. Use refrigerated dressing, individual packets or oil and vinegar, 8 oz. milk (EXCEPT RENAL GIVE JUICE) ENLIVE - CLEAR LIQUIDS ONLY, Fruit (1/2 cup) ENSURE PUDDING-PUREE/FULL LIQUIDS." The disaster menu for Day 1 for dinner for a full liquid diet order indicated "Fruit (1/2 cup) APPLESAUCE -PUREE/FULL LIQUIDS."

The CNM acknowledged there was not a detailed written plan on what hospital staff should serve to those patients on a full liquid diet order, other than a pudding for lunch, and apple sauce for dinner. The disaster menu also indicated to give juice to those patients on a renal diet instead of milk. There was no written direction for hospital staff on what juice to include, or omit, for those on a renal diet in which there was potential for dialysis to be interrupted during the event of a disaster. The GMMS and the CNM stated they were aware the disaster menu was not clear.

On April 25, 2011, at 3:30 p.m., the CNM provided another set of Disaster Menus. The CNM acknowledged they were isolated to her computer and hospital staff had not been trained on how to implement the newly developed menu, nor had the disaster inventory supply been evaluated and compared to the newly developed disaster menu. In addition, the CNM was not able to clearly state the kitchen equipment that would remain in working condition via generator, or for duration of usage, in order to support the menu as developed, which included use of frozen entrees and defrosted meat to cook on day 3 and day 4 of a disaster.

On April 26, 2011, at 1:20 p.m., the GMMS stated the freezers in the kitchen would be on emergency generators in the event of a disaster.

According to the hospital's DISASTER PLAN; NUTRITIONAL SERVICES, page 21 ELECTRICAL FAILURE WITH EMERGENCY GENERATOR BACK UP, "A. Kitchen - areas with emergency generator back up 1. Ceiling lighting, 2. All walk in refrigerators, 3. All upright refrigerators, 4. Ice Machine, 5. Food warmer near cafeteria, 6. Dish Machine, no conveyor, and 7. Receptacles located on either end of the cooks prep tables."

According to the hospital's DISASTER PLAN; NUTRITIONAL SERVICES, "RESPONSIBILITY A. Planning, preparing and serving patient and staff meal appropriate to their needs while ensuring food safety and sanitation. B. Ensure that all patients receive meals appropriate to their diet orders. To provide nutritional assessment and support to patients at nutrition risk."

Based on observation, interview and record review, the GMMS failed to ensure the Executive Chef was competent in safe cool-down of potentially hazardous foods before delegating the Executive Chef to be in charge of cooks.

Findings:

On April 25, 2011, at 11:30 a.m., the Executive Chef stated a large pan of roast beef, observed in the refrigerator, was approximately 35 pounds and was cooked previously at the facility to be served on another day. The Executive Chef stated the facility "HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS" lacked documentation that the roast beef was cooled down safely.

During the same interview, the Executive Chef stated he was responsible for ensuring foods were cooled down safely and that they were documented on the cool down log. He further added he was responsible to train the cooks on proper cool down procedures. The Executive Chef held the HACCP COOLING log and stated, "If roast beef has not reached 70 degrees F after 2 hours then it needs further cooling."

According to the instructions that were located on the HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, "Critical Control Points: Food is cooled quickly and safely from 140 degrees F to 70 degrees F within 2 hours and then to 40 degrees F or below within an additional 4 hours (total cooling time 6 hours)."

According to standards of practice in the food service industry if the initial cooling to 70?F took 3 hours, for example, the food safety hazards may not be adequately controlled (FDA Food Code 2009).

On April 25, 2011, at 2:46 p.m., the Executive Chef reviewed the cooling logs and stated the four cooks were not documenting cool-down on the logs. The Executive Chef acknowledged there was no documentation on the cool down logs to indicate the roast beefs that were cooked from April 13, 2011 - April 23, 2011 were cooled down safely.

According to the Executive Chef's 2010 performance evaluation, the GMMS documented that the Executive Chef was below expectations under the category of Ensuring Safe and Quality Operations, and indicated, "Weekly kitchen inspections turn up violations of Department of Health Services (DHS) laws such as undated product, outdated product and temperature charts are not filled out." Under the category of Value Behaviors on the Executive Chef's performance evaluation the GMMS indicated, "Below expectations...should take more personnel accountability within his kitchen an actively take corrective action when needed."

According to a "Management Skill Competencies" list completed in 2010 for the Executive Chef, a score of 1 was given for "Demonstrates/articulates the handling and storage standards for all perishable food products, the danger zone, 3 primary causes of FBI [foodborne illness] and 3 primary preventins." A score of 1 was also rated for the Executive Chef under the category of "Articulates the process and systems that assure food quality and critical control points." The possible scoring available on the Management Skill Competencies check list was 0, 1, or 2 with 2 being the highest.

The GMMS did not have a system in place to increase oversight over the high risk, and potentially problem prone pre-day cooking method of potentially hazardous foods despite being aware that the Excecutive Chef was displaying performance that was "below expectations".

Based on interview and record review, the hospital failed to ensure that a tube-feeding, and a therapeutic diet order were ordered by a physician prior to providing to patients. (Patient 7 and 5)

Findings:

On April 27, 2011, at 11:45 a.m., Patient 7's paper medical record and electronic medical record was reviewed. On April 7, 2011 there was a physician's order that indicated, "T.feed [tube feed] per Dietitian eval [evaluation]". LN 8 reviewed Patient 7's clinical record and verified that a nurse provided tube feeding of Jevity 1.2 at 20 cc hr on April 8, 2011, while gradually increasing the rate to Jevity 1.2 at 75 cc/hr on April 9, 2011. LN 8 stated that a RD left a yellow note to the physician communicating a recommendation to the physician to start a tube-feeding of Jevity 1.2 at 20 cc/hr to an eventual goal rate of 75 cc/hr. LN 8 stated that the nurse infused the tube feeding as recommended by the RD, without obtaining a specific physician's order. LN 8 stated, "Some of my nurses treat it [the RD's yellow communication note to the physician] as an order and they need some in-servicing on that."

On April 27, 2011, at 1:09 p.m., Patient 5's record was reviewed by the Clinical Nutrition Manager and LN 10. The CNM and LN 10 verified there was not a physical MD order in the clinical medical record despite a nurse entering a diet order for 1800 calorie ADA diet on April 11, 2011 and diet order of 1800 calorie ADA mechanical soft chopped on April 12, 2011 into the electronic medical record. The QI Director and LN 10 verified the physicians do not write their orders directly into the electronic medical record, and there should have been a manually written physician's diet order in the clinical record to correspond with the diet orders entered by the nurse into the electronic medical record system. The QI Director stated the patient had an NPO diet order at one point, and then a nurse probably resumed a diet order after speaking to an MD, but no physician's diet order was obtained.

According to the hospital's policy and procedure entitled NUTRITION CARE DOCUMENTATION IN THE MEDICAL RECORD, "DIET ORDER CONFIRMATION; The physician is responsible for providing a written diet order for all patients (includes NPO order)."

Based on interview and record review, the hospital failed to serve three diabetic and one renal therapeutic diet order as written by the physician for four patients (Patient 3, 4, 5 and 6).

Findings:

On April 25, 2011 at 5 p.m., Dietary Staff 7 stated the dietary department provided Patient 3 with 1,521 calories on April 25, 2011 based on the dietary office electronic nutrient data system. Dietary Staff 7 stated the 1,521 calories accounted for the breakfast, lunch and dinner, and there were no snacks provided, nor was there a PM snack planned, for April 25, 2011. Dietary Staff 7 stated the physician's diet order for Patient 3 was 2,000 calories ADA diet. The dietary department provided 479 calories less than the physician's prescribed therapeutic diet order on April 25, 2011. The CNM was present during the joint record review of the electronic nutrient data system.

During an interview on April 25, 2011, at 5 p.m., Dietary Staff 7 stated the dietary department provided Patient 4 with 1,392 calories based on the dietary office electronic nutrient data system. Dietary Staff 7 stated the 1,392 calories accounted for the breakfast, lunch and dinner, and there were no snacks provided, nor was there a PM snack planned, for April 25, 2011. Dietary Staff 7 stated the physician's diet order for Patient 4 was 1,800 calories ADA diet. The dietary department provided 408 calories less than the physician's prescribed therapeutic diet order.

Dietary Staff 7 stated the dietary department provided Patient 5 with 1,200 calories on April 25, 2011 based on the dietary office electronic nutrient data system. Dietary Staff 7 stated the 1,200 calories accounted for the breakfast, lunch and dinner, and there were no snacks provided, nor was there a PM snack planned, for April 25, 2011. Dietary Staff 7 stated the physician's diet order for Patient 5 was 1800 calories ADA diet, renal. Record review for % PO intake from April 21, 2011 - April 25, 2011 indicated Patient 5 was eating 90 -100% of her meals the majority of the time. The dietary department provided 600 calories less than the physician's prescribed therapeutic diet order.

Dietary Staff 7 stated the dietary department provided Patient 6 with 51 grams of protein on April 25, 2011 based on the dietary office electronic nutrient data system. Dietary Staff 7 stated the 51 grams of protein accounted for the breakfast, lunch and dinner, and there were no snacks provided, nor was there a PM snack planned, for April 25, 2011. Dietary Staff 7 stated the physician's diet order for Patient 6 was 60 grams of protein, 2 grams of sodium, 2 grams of potassium.

On April 27, 2011 at 2 p.m., the CNM stated the dietary staff should have been ensuring that the dietary office provided the specified amount of calories and/or protein in accordance with the physician's therapeutic diet order. The CNM stated she was aware that there was one operator [ie dietary staff] on multiple occasions who failed to ensure that the dietary "Diet Menu Guidelines" policy was followed.

The CNM provided the dietary "Diet Menu Guidelines" which provided instruction to dietary staff as follows, "...Diabetic; Patients need to meet within .5 of their carb [carbohydrate] allowance at each meal. Calorie level can be met with adding protein and fat items such as additional meat portions, salad dressings, margarine, sour cream, peanut butter, etc. Patients must be within 50 calories of their caloric level by the end of the day... Renal; ...If patients are on a specific protein allowance, that protein allowance must be met by the end of the day, NO exceptions."

Based on interview and record review, the hospital failed to customize their on-line diet manual to be hospital specific.

Findings:

On April 27, 2011 at 2:15 p.m., the CNM stated the hospital's on-line ADA Nutrition Care Manual had not been customized to reflect how therapeutic diet orders were defined and approved by the medical executive team and governing body. The on-line ADA Nutrition Care Manual had not been customized to reflect the therapeutic diets routinely ordered at the hospital and was too broad to be used as guidance for preparing patient diets at [hospital name].

The CNM acknowledged there were carbohydrate patterns that the diet office used in order to implement various calorie level of diabetic diets that were routinely ordered at the hospital. A doctor, nursing or food service personnel would not be able to use the on-line ADA diet manual to obtain information on how a diabetic diet would be implemented for a patient on a diabetic diet at the hospital.

The hospital's on-line ADA Nutrition Care Manual, that was the hospital's reviewed and approved diet manual, according to the CNM, was not customized to include the actual practice that the hospital used to carry out a variety of diet orders. The CNM stated, "It's a work in progress."

The hospital's policy and procedure entitled DIET MANUAL (last approved by the Medical Executive Committee on 12/08) indicated, "Nutritional Services provides accurate diet modifications, as prescribed by the physician, and in accordance with the approved Manual of Clinical Dietetics. The manual will serve as a guide to ordering diets, and the menus served will be consistent with the requirements of the manual."

Based on observation, interview and record review, the hospital failed to:
1. maintain sufficient emergency water supply in the event of a disaster and
2. maintain a walk-in freezer located in the kitchen in good condition.

Findings:

1. On April 25, 2011, at 1:25 p.m., the GMMS stated the hospital's emergency water supply was planned for 1500 people for 5 days at a quantity of one quart per person per day. The GMMS stated the American Red Cross was the hospital's community standard of reference for recommendations on emergency water supply.

The hospital's policy and procedure entitled CODE TRIAGE -EMERGENCY MASS FEEDING PLAN for the Nutritional Services department indicated, "Policy: Refer to Engineering policy regarding emergency water supply...,Procedure: To provide for basic nutrition and hydration needs to inpatients, employees and emergency personnel in the event of a disaster, including but not limited to , major earthquake, fire, flood or terrorist attack." The department of Engineering P&P entitled FAILURE OF WATER DISTRIBUTION SYSTEM indicated, "In the event of a total failure, backup water supply is available through: a. on-site bottled water and b. contractual supply from outside vendor."

The hospital's DISASTER PLAN; NUTRITIONAL SERVICES (last reviewed 4/10), page 8, indicated, "The hospital's source of potable water is obtained from Engineering..., Dishwashing will be limited to cooking pots, utensils, and the sanitizing of trays.

According to the hospital's DISASTER PLAN; NUTRITIONAL SERVICES, page 13, indicated, "An emergency may interrupt the supply of safe drinking water. It is advisable to have adequate quantities of canned water in storage. One quart of water per person per day is essential. Two quarts of water per person per day allows some water for cooking." In review of the hospital's disaster menu, there were items incorporated that would require water for preparation. The hospital's DISASTER PLAN; NUTRITIONAL SERVICES, page 22, indicated "To obtain emergency water, nutritional services will maintain contact with the Engineering Department to supply an adequate amount of bottle water."

The hospital failed to ensure an acceptable level of emergency water supply to meet its patients' needs in the event of a disaster. The hospital's planned water supply for one quart of water per person per day was not consistent with community standards of practice. In addition, the hospital's disaster policies and procedures addressed some drinking, menu planning and pot and pan needs for emergency water supply. The hospital's disaster water plan did not indicate that the hospital identified the supply of water it would need to meet the hygiene needs, fluid needs of the highly susceptible fragile population with accompanying medical needs not limited to tube feeding and medication flushes, wound care needs, and incontinence.

2. On April 25, 2011, at 11:05 a.m., inside the walk-in freezer in the kitchen was thick condensation build-up that covered the ceiling of the freezer, and on the floor of the freezer. There were boxes of frozen food stacked high in close proximity to the ceiling of the freezer. The external thermometer of the freezer indicated, "25 - 30 degrees F." There was a delivery of food that was being put away at that time. There was no internal thermometer inside the freezer, verified by the Executive Chef.

The GMMS observed the excessive condensation and stated the ice-build up should have been removed.

On April 25, 2011, at 2:31 p.m., the external thermometer for the freezer indicated "10 degrees F."

On April 25, 2011, at 3:30 p.m., Engineering Staff 1 observed the thick condensation build-up inside the walk-in freezer. Engineering Staff 1 acknowledged that if the freezer was working correctly, under normal conditions, then the build-up of condensation that was currently present would not have been expected.

A record review of work orders that were placed by the dietary department, in regard to the walk-in freezer not working properly, indicated that the issue was reported eight times to the engineering department in 2010.

The dietary department had placed five work orders in 2011 to the engineering department due to the freezer had elevated temperatures. The dietary department was aware that the freezer was prone to excessive temperatures, and yet had not ensured that an internal thermometer was located inside the freezer, and had not increased temperature monitoring to ensure food safety.

On April 26, 2011, at 9:30 a.m., the Manager of Engineering stated there had been no preventative maintenance completed on the walk-in freezer located in the kitchen from January 2010 until current. The Manager of Engineering acknowledged that if preventative maintenance had been incorporated into a routine schedule for the walk-in freezer that problems identified would have been caught sooner. The Manager of Engineering was unable to explain why the walk-in freezer had excessive build up of thick ice with temperatures exceeding 0 degrees F.

The hospital failed to ensure that the walk-in freezer was operating in good condition throughout the day to ensure food quality, and food safety.

Based on observation, interview and record review, the facility condition of participation for infection control was not met as evidenced by the facility's failure to ensure:

1. the hospital's infection control officer had a system to identify deficient infection control practices relating to:

a. instrument sterilization in one of nine operating rooms. Facility staff were using a quick sterilization method (flash) for instruments used by two physicians, resulting in the potential for use of improperly sterilized instruments and the spread of infectious diseases during surgical procedures (refer to A749, A276);

b. temperature and humidity monitoring in the GI and Cardiac Catheterization settings (refer to A749, A275, A951, A940);

c. the policy and procedure for OR attire, as facility staff were observed entering restrictive aread of the operating room wearing personal/home laundered clothing and hair covers (refer to A749, A951, A940);

d. cleaning of reusable patient equipment. One SPD Technician was observed not following manufacturer's instructions for contact time (refer to A749, A951, A940); and

e. handling and processing of sterile equipment. Policy and Procedures were unavailable for sterile instrument presoak and washing and one SPD Tech was unaware of the correct concentration of wash or the type of wash used for prewashing sterile instruments (refer to A749, A951, A940);

f. the correct mixing of solution for cleaning of instruments by RT staff, the correct contact time of cleaning solution used in the OR after a surgical case, and the correct mixing of solution and contact time for cleaning of equipment, such as an IV pump, in the SPD area (A 749);

2. expired invasive equipment was not stored in the cardiac catheterization laboratory. Three guide wires were found stored in the cardiac catheterization storage cabinet and available for use, resulting in the potential to spread infections during cardiac catheterizations (refer to A749, A951, A940);

3, on going integration of an infection control program involving food service and sanitation to ensure food safety and sanitation of food service operations (refer to A749, A951, A940); and

4. the air vents were kept clean and free fom dust and debris, resulting in dust and debri particles falling on top of patients during a test of the fire alarm system in the emergency room (refer to A749).

The cumulative effects of this systemic problem resulted in the hospital's inability to ensure the provision of an infection control program in a safe and effective manner, placing the patients at risk for hospital aquired infections.

Based on observation, interview and record review, the hospital's infection control officer failed to have a system to identify deficient infection control practices relating to:

1. instrument sterilization in one of nine operating rooms. Facility staff were using a quick sterilization method (flash) for instruments used by two physicians. This resulted in the potential for use of improperly sterilized instruments and the spread of infectious diseases during surgical procedures;

2. temperature and humidity monitoring in the GI and Cardiac Catheterization settings (areas identified by AORN, as surgical and invasive procedure settings). This resulted in the potential for patients being at risk for infections;

3. the policy and procedure for OR attire. Facility staff were observed entering restrictive areas of the OR wearing personal/home laundered clothing and hair covers. This failure resulted in the facility placing patients at risk for health care-associated infection;

4. cleaning of reusable patient equipment. One SPD Technician was observed not following manufacturer's instructions for contact time. This resulted in the potential to spread infections;

5. handling and processing of sterile equipment. Policy and Procedures were unavailable for sterile instrument presoak and washing and one SPD Tech was unaware of the correct concentration of wash or the type of wash used for prewashing sterile instruments;

6. storage of expired invasive equipment in the cardiac catheterization laboratory. Three guide wires were found stored in the cardiac catheterization storage cabinet and available for use. This resulted in the potential to spread infections during cardiac catheterizations;

7. the correct mixing of solution for cleaning of instruments by RT staff;

8. the correct contact time of cleaning solution used in the OR after a surgical case;

9. the correct mixing of solution and contact time for cleaning of equipment, such as an IV pump, in the SPD area;

10. on going integration of an infection control program involving food service and sanitation to ensure food safety and sanitation of food service operations; and

11 maintaining the air vents clean and free from dust and debris. This resulted in dust and debris particles falling on top of patients during a test of the fire alarm system in the emergency room.

Findings:

1. On April 18, 2011, at 2 p.m., a tour of the OR was conducted. The restrictive area of the department was identified with a red stripe on the floor. There were nine operating rooms and six flash sterilizers. According to the AORN 2009 Perioperative Standards and Recommended Practices: Use of flash sterilization should be kept to a minimum and flash sterilization should be used only in selected clinical situations and in a controlled manner). Each flash sterilizer had a log with documentation of run cycles nearby.

The flash sterilization log for sterilizer six was reviewed on April 18, 2011. There was documentation that a special spinal tray was flash sterilized due to "not enough trays/singles."

On April 20, 2011, at 2 p.m., OR RN 1 was interviewed. OR RN 1 stated two specialty trays used by two different surgeons were not sent to the SPD for sterilization. According to the RN, the trays contained instruments that were not available in sufficient quantities to make up more than one tray for each surgeon. OR RN 1 stated these trays were sent to SPD for decontamination and cleaning then flash sterilized in the OR prior to surgery. OR RN 1 stated she had been flash sterilizing these specialty trays for six years.

In an interview with the SPD Manager on April 20, 2011, at 2:15 p.m., the manager stated to ensure sterility of instruments the items in a tray should be undergoing sterilization after each use. The SPD manager stated the two specialty trays were not being sent to SPD for sterilization.

The sterilization logs and flash control strips for sterilizer six were reviewed on April 20, 2011. Specialty trays identified as either "Dr. A tray," or "Dr. B tray," were documented as being flash sterilized on the following dates:

February 7, 2011, at 5:46 a.m.;
February 8, 2011, at 5:24 a.m., and 10:48 a.m.;
February 9, 2011, at 5:05 a.m.;
February 10, 2011, at 5:43 a.m., 12:03 a.m., and 2:29 p.m.;
February 11, 2011, at 5:59 a.m.;
February 15, 2011, at 6:12 a.m., 10:48 a.m., and 11:58 a.m.;
February 17, 2011 at 5:27 a.m.;
February 18, 2011, at 5:54 a.m., and 7:42 a.m.;
February 22, 2011, at 5:13 a.m., and 10:42 a.m.;
February 24, 2011, at 5:30 a.m., and 9:52 a.m.;
March 1, 2011, at 6:02 a.m.;
March 3, 2011, at 5:37 a.m., 11:17 a.m., and 3:05 p.m.;
March 7, 2011, at 6:11 a.m.;
March 8, 2011, at 5:52 a.m., and 1:14 p.m.;
March 10, 2011, at 6:09 a.m., and 10:41 a.m.;
March 14, 2011, at 5:03 a.m.;
March 17, 2011, at 6:23 a.m.;
March 18, 2011, at 6:13 a.m., and 10:30 a.m.;
March 22, 2011, at 5:28 a.m.;
March 23, 2011, 8:24 a.m.;
March 24, 2011, at 5:31 a.m., 9:02 a.m., and 10:37 a.m.;
March 28, 2011, at 10:24 a.m.;
March 29, 2011, at 12:44 p.m., and;
March 30, 2011, at 5:46 a.m.

Each of these entries on the sterilizer log indicated "not enough trays/singles," as the reason for the flash sterilization.

In an interview with the SPD Manager on April 20, 2011, at 2:30 p.m., the manager stated she had identified the overuse of flash sterilization and notified the OR Director in 2010. The manager stated she was attempting to obtain additional instruments but some were on back order and she did not have all the items required to make complete trays.

On April 20, 2011, at 4 p.m., the VP of Quality, Patient Safety and Risk Management was interviewed. The VP stated the specialty trays should be cleaned and sterilized in SPD and she was unaware it was not being done as directed by policy.

The Chief of the Medical Staff was interviewed by phone on April 20, 2011, at 4:15 p.m. He was unaware of the special spinal trays for the two spine physicians undergoing repeated flash sterilizations without full sterile processing.

The facility's policy and procedure titled "Sterilization-Steam Using Unwrapped Method (Flash Sterilization) with a last revised date of August 2009 was reviewed on April 20, 2011. The policy indicated flash sterilization would only be used when there was insufficient time to process by the preferred wrapped or container method. According to the policy flash sterilization would not be used as a substitute for insufficient instrument inventory. The policy and procedure indicated references used included AORN (2009) Standards and Recommended Practices.

The facility's policy and procedure titled "Steam Sterilization," with a revision date of August 2009, was reviewed on April 20, 2011. The policy indicated the creation and maintenance of aseptic environments had a direct influence on patient outcomes. The policy indicated measures for preventing surgical wound infections included "Provision of instrumentation, supplies, and equipment free of contamination at the time of use. Sterilization provides the highest level of assurance that an object is free of viable microbes." According to the policy, steam sterilization was a process that utilized saturated steam under pressure, for a specific exposure time and at a specified temperature, as a sterilizing agent. Items to be sterilized are those that enter sterile tissue or the vascular system.

In an interview with the Director of Surgical Services and the COO, on April 21, 2011, at 9:15 a.m., they stated they were unaware these specialty trays were not being sent to SPD for processing. Both agreed the items should go through the presoaking, cleaning and steam sterilization process before use. The Surgical Director stated the decision to flash the equipment in the operating room was made by the ortho resource nurse.

During an interview with the Manager of Infection Control, on April 21, 2011, at 10:30 a.m., the manager agreed that instruments should be sent to SPD for clearing and sterilization.

The Infection Control meeting minutes (Treatment and Surveillance Committee) from August 2011, through February 2011 were reviewed.

2. On April 19, 2011, at 1:45 p.m., a tour of the Gastrointestinal (GI) lab was conducted with the manager. The area consisted of three procedure rooms, a decontamination room, pre procedure and post procedure beds and a nursing station. The manager stated they performed about 20 procedures daily. During a tour of procedure room 1 there was a cabinet for storage of endoscopes (an instrument used to examine the interior of a hollow organ or cavity of the body, for example the colon or the esophagus). The cabinet was enclosed and vented to allow for drying of the endoscopes after processing. There was a thermostat on the wall that indicated the room temperature was 70? Fahrenheit.

In an interview with the manager, on April 19, 2011, at 2 p.m., the manager stated they were not monitoring humidity at this time, just temperatures.

On April 20, 2011, at 9:15 a.m., during an interview with the manager of the GI lab, the manager stated while there was a thermostat on the wall, unit personnel did not monitor room temperatures. The manager also stated there was no way of monitoring room humidity.

Record review for Patient 208 was conducted on April 19, 2011. Patient 208 underwent a colonoscopy (examination of the colon and part of the small bowel with a flexible tube passed through the rectum). Patient 208 underwent this procedure under moderate sedation (conscious sedation- administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardiorespiratory function).

In an interview with the VP of Quality on April 20, 2011, at 9:30 a.m., the VP stated she was unaware additional areas of the hospital required temperature and humidity monitoring.

On April 21, 2011, at 12:30 p.m., an interview was conducted in the cardiac catheterization lab with the Cath Lab Coordinator and RN 209. RN 209 stated they were not monitoring temperature and humidity levels in the cath lab procedure rooms.
During an interview with the VP of Quality on April 21, 2011, at 12:45 p.m., the VP stated she had identified that monitoring of temperatures and humidity was not being done in the cath lab.
On April 21, 2011, the temperature and humidity logs were reviewed. There was no documentation in the log books that indicated temperature and humidity of the GI procedure rooms and cardiac catheterization rooms was monitored.

The facility policy and procedure titled "Temperature and Humidity Control in Operating Suites," with a last revision date of July 2010, was reviewed on April 21, 2011. The policy and procedure indicated Operating suites were defined as operating room and labor and delivery areas. The policy did not specify any additional procedural areas as requiring daily monitoring. The document listed as a reference AORN (2009) Perioperative Standards and Recommended Practices including "Safe Environment of Care."

According to the AORN 2009 Perioperative Standards and Recommended Practices: The Mission was to promote safety and optimal outcomes for patients undergoing operative and other invasive procedures. In the section for "Recommended Practices for Safe Environment of Care," AORN indicated the practice guidelines were adaptable to various practice settings including traditional operating rooms, cardiac catheterization laboratories, endoscopy suites, and all other areas where surgery could be performed. Recommendation V indicated: "Relative humidity should be maintained between 30 % and 60 % within perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed." Recommendations indicated temperature and humidity should be monitored and recorded daily.

3. On April 19, 2011, at 2:30 p.m., two facility staff were observed in the restrictive area of the operating rooms wearing personal hats.

On April 20, 2011, at 3:30 p.m., the SPD Manager was observed in the SPD department wearing a personal scrub hat. (SPD was not in the restrictive area at the time).

In a concurrent interview, the SPD manager stated there was no policy about wearing personal scrub attire, but she washed the hat daily.

On April 21, 2011, at 9:15 a.m., the Director of Surgical Services was interviewed in a facility conference room. The director stated the corporation's consultant was reviewing recent information about home laundered/personal scrub attire, but the AORN standards were unclear and there was no definitive answer.

The facility policy and procedure titled "ATTIRE IN THE OPERATING ROOM," with a last revision date of July 2006, was reviewed on April 21, 2011. The policy indicated it applied to all persons authorized to enter the restrictive areas of the operating room. The policy indicated "Persons entering the restrictive areas of the Operating Room will wear approved, hospital supplies, clean Operating Room apparel." The policy indicated "AORN Standards, Recommended Practices and Guidelines for Surgical Attire (2006)" was a reference.

According to the AORN 2009 Perioperative Standards and Recommended Practices: "All individuals who enter the semirestricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite." The recommended practices indicated AORN did not support the practice of home laundering of surgical attire. Reususable scrub attire, including cover jackets and cloth hats, should be laundered by a designated facility approved and monitored commercial laundry after daily use.

During an interview with the Manager of Infection Control, on April 21, 2011, at 10:30 a.m., the manager stated personal scrub attire was an issue.

4. On April 20, 2011, at 10 a.m., SPD Tech 2 was observed cleaning reusable patient equipment in the D3 dirty utility room. SPD Tech 2 poured solution from a bottle of MicrocleansePlus onto several cloth washcloths and used one wash cloth to wipe down a pump for infusing intravenous fluids. The wash cloth was not saturated with solution and the equipment appeared dry on contact. After cleaning the equipment, a green sticker indicating the piece was "Clean," was placed on it and it was transferred into the clean storage room.

The facility's policy and procedure for "Cleaning Patient Equipment," with an origination date of March 2011, was reviewed on April 21, 2011. The policy was "Under Review, Pending Approval." The policy indicated it applied to all staff that handle reusable patient equipment, such as IV pumps and sequential compressive devices. According to the policy: " Cleaning will be done with hospital approved germicidal according to manufactures guideline."

In an interview with the Infection Control Manager and VP of Quality on April 20, 2011, at 1 p.m., the Infection Control Manager stated the cleanser used to clean equipment had a five minute contact time.

The manufacturer's information for MircorcelansePlus was reviewed on April 21, 2011. Instructions indicated: "To achieve maximum affect allow surface to remain wet for 5 minutes..."




20914

5. Central processing was toured on April 19, 2010, at 10 a.m. Certified SPD Technician A was seen in the pre-wash area and was interviewed. She explained that for the soaking and hand wash of surgical instruments prior to sterilization, she would add water to the sink to a level that covered the tray and instruments well. She did not use a measured amount of water. In order to reach that mixture, she stated she used, "about a medicine cup," (which holds one ounce) of solution, and just made sure there was enough water to cover the instruments, but did not measure the water.

The label of the product she was using was examined on April 19, 2010. The product was Steris Prolystica Ultra Concentrate. The instructions were for use only in mechanical washing systems. There was no mention of use in instrument hand washing. The amount to be used was less than a milliliter per gallon. The manufacturer recommendations indicated it was meant to be automatically dispensed using an automatic mixing process, not mixed by the SPD technician. The manufacturer recommended a mixture of 1/40-1/10 of an ounce for every gallon of water (10-40 times less concentrated than the technician was mixing).


During a concurrent interview, Certified SPD Technician A, stated she could not explain how she came to be using this product in this way. Most products used to clean surgical instruments are enzymatic cleaners (contain enzymes that break down the protein in biological material). This label did not mention any enzymatic ingredients of activity. There were no signs posted at the station with the pre-wash procedure and she could not cite any policy that she was following.

The Director of the SPD was interviewed on on April 19, 2010, at 10 a.m. The Director seemed unaware of the fact that the technician was using a product not recommended for instrument soaking and prewash by the manufacturer. She also did not seem aware that the concentration being used was not known and no policy was being followed.

A policy on instrument soaking and hand washing was requested several times but not produced by the hospital.

The Manager of Infection Control (IC), the Infection Control nurse and the Director of Quality, Safety and Risk were jointly interviewed on April 20, 2011, at 1p.m. They were unaware of these issues. It was discussed that this issue should have been identified by the IC staff. The three staff members all agreed.

6. The Interventional Radiology Suite was toured on April 19, 2011, at 11:05 a.m. The room was lined with cabinets containing catheters, wires and other instruments used in the procedures. The cabinets were inspected and three expired wires were found. The first, a Cook VAD 2 had expired February 2011, more than six weeks before the survey. The other two, Cook JB 2, had expired in January 2011.

The Director of Radiology was interviewed on April 19, 2011, at 11:05 a.m. and stated all of the techs checked for expired products each time they accessed the cabinets but there was no individual responsible for checking the entire inventory at any set frequency. She stated there was no policy for the checking of outdated products and instruments.

The Manager of Infection Control (IC), the Infection Control nurse and the Director of Quality, Safety and Risk were jointly interviewed on April 20, 2011, at 1 p.m. They were unaware of the issue. It was discussed that this issue should have been identified by the IC staff. The three staff members all agreed.


21898

11. On April 20, 2011, at 10:42 a.m., while the fire alarm system in the Emergency Department was being tested, it was observed that dust and debris discharged from the vent in the ceiling in Exam Room C186. Four patients came out of the Exam Room wiping dust and debris from their clothes. The vent was observed to be covered in dust and debris as well as the floor, chair and exam bed.

When interviewed on April 20, 2011 at 10:42 a.m., the patients stated that dust and debris had fallen on them while sitting in the Exam Room.

In an interview with a nursing staff, on April 20, 2011, at 11:15 a.m., the nurse stated housekeeping was responsible for cleaning the vents.

In an interview with the housekeeper, on April 20, 2011, at 11:20 a.m., the housekeeper stated her department did not clean the air vents.

A tour of the ED indicated there were several other vents that were coated with dust.



22764

7. During an interview with the RT equipment technician, the technician stated he cleaned instruments with an enzymatic solution called Prolystica. He stated when he mixed the solution for cleaning the instruments, he would, "visualize," the water level, and, "eyeball," the amount of enzymatic solution he added.

According to the Prolystica manufacturer recommendations, the solution should be mixed using 1/2 ounce of solution in one gallon of water.

8. During a tour of the OR on April 19, 2011, at 3 p.m., the OR EVS employee explained how she cleaned a room after a surgical case. She stated she used a solution in a spray bottle called Phenolic Disinfectant Cleaner. She stated she would sometimes spray and wipe the solution off, and other times she would wet a towel and use that. The EVS employee stated the contact time (amount of time she allowed the surfaces to remain wet) depended on the type of surgical procedure that had been done, if it was a, "normal," case, she would spray the surfaces and wipe them off right away, but if it was an, "infected," case, she would allow a contact time of 15 minutes.

According to the manufacturer recommendations, the Phenolic Spray solution should remain of the surfaces for a minimum of 10 minutes for effective disinfection.

9. During a tour of the SPD area on April 20, 2011, SPD Technician 2 was observed cleaning an IV pump. He stated he cleaned the equipment with a solution called Microcleanse. He stated he mixed it himself using four quarts of water and, "a little bit of microcleanse." He stated he used 1/2 of a medicine cup (equal to 1/2 ounce) of the solution, which he defined as one ounce. The technician stated he cleaned the equipment and wiped the solution off right away. He stated he did not know if there was a required contact time (amount of time he allowed the surfaces to remain wet).

According to the manufacturer recommendations for Microcleanse, 6 1/2 ounces of water should be added to each gallon of water (13 times more than the technician was using). The manufacturer also recommended, to achieve maximum effect, the surface should remain wet for five minutes.



27157

10. During the course of the survey, unsafe and unsanitary issues were identified in the kitchen which involved potentially hazardous foods were not consistently cooled down, a lingering sewage smell was not comprehensively addressed by hospital staff, and the ice machines were not being sanitized. Failure to provide a safe and sanitary environment may result in food borne illness, and may further compromise patients' medical status. (Cross Reference A-0620)

On April 26, 2011 at 2:25 p.m., the ICN stated she was not aware of the above identified concerns that had the potential to result in a foodborne illness. The ICN acknowledged the food and nutrition services should have reported the odor that smelled like sewage to the ICN.

The ICN stated she had been employed in the specific role of the designated infection control nurse for the hospital for one year. The ICN stated the only role that she had been involved in with the food and nutrition services department was a hand washing in-service that was provided to the dietary staff that delivers meal trays to patients. The former ICN was present during the interview and stated the last environment round that was done involving the ICN and the food and nutrition department was three years ago. The ICN acknowledged the hospital did not have an active mechanism in place in which surveillance, reporting, monitoring and prevention aspects would be integrated with the food and nutrition department.

The improper cooling down practices of potentially hazardous foods by dietary staff was identified at [name of hospital] five years earlier, and was still being done incorrectly. Excessive time for cooling of potentially hazardous foods has been consistently identified as one of the leading contributing factors to foodborne illness. (FDA Food Code 2009)

During the same interview, the ICN stated there was not a process in place for the Infection Prevention and Control Program to be involved in monitoring or approving chemicals used for the ice-machines. The ICN was unaware that the ice-machines were not being sanitized.

The hospital's PROCEDURES/GUIDELINES entitled INFECTION CONTROL PLAN (Last revised 1/10) indicated, "The Infection Prevention & Control Program is a multidisciplinary, systemic approach to quality patient care that emphasizes risk reduction of disease transmission in a health care environment by using sound epidemiological principles..., to analyze practices that have the potential to affect rates of health care associated infections.... The Infection Prevention & Control Program is divided into functional groups of routine activities that address the integrated faucets of surveillance (observation, monitoring, and evaluation)..."

Based on observation, interview and record review, the facility to provide safe surgical services in accordance with acceptable standards of practice as evidenced by:

1. The failure of the facility to maintain and enforce policies and procedures for sterilization of surgical instruments. Two specialty spinal trays (that included multiple instruments) were flash sterilized daily and did not undergo steam sterilization prior to scheduled spinal surgeries. This failure resulted in the potential use of improperly sterilized instruments and the spread of infectious diseases during surgical procedures. (Refer to A951, item 1);

2. The failure of the facility to monitor temperature and humidity in all areas used for surgical or invasive procedures. The facility failed to monitor temperature and humidity in three of GI lab procedure rooms and three of three cardiac catheterization rooms. This failure placed patients at risk for infections and injury due to flash fires. (Refer to A951, item 2);

3. The failure of the facility to implement their policy and procedure for surgical attire. Three staff working in restrictive areas were observed wearing personal, non facility furnished attire (scrub hats). This failure resulted in the facility placing patients at risk for health care-associated infection. (Refer to A951, item 3)

The cumulative effects of this systemic problem resulted in the hospital's inability to ensure the provision of surgical services in a safe and effective manner.

Based on observation, interview, and document review, the facility failed to:

1. ensure policy and procedures for instrument sterilization was followed in one of ten operating rooms by using a quick sterilization method (flash) for instruments used by two physicians. This resulted in the potential for use of improperly sterilized instruments and the spread of infectious diseases during surgical procedures;

2. ensure temperature and humidity was monitored, and corrective actions taken in the GI and Cardiac Catheterization settings (areas identified by AORN, as surgical and invasive procedure settings), resulting in the potential for patients at risk for infections and injuries due to fires; and

3. ensure the policy and procedure for OR attire was followed by allowing three staff to wear personal/home laundered clothing and hair covers in the restrictive areas of the Operating Room. This failure resulted in the facility placing patients at risk for health care-associated infection.

Findings:

1. On April 18, 2011, at 2 p.m., a tour of the OR was conducted. The restrictive area of the department was identified with a red stripe on the floor. There were nine operating rooms and six flash sterilizers. According to the AORN 2009 Perioperative Standards and Recommended Practices: Use of flash sterilization should be kept to a minimum and flash sterilization should be used only in selected clinical situations and in a controlled manner). Each flash sterilizer had a log with documentation of run cycles nearby.

The flash sterilization log for sterilizer six was reviewed on April 18, 2011. There was documentation that a special spinal tray was flash sterilized due to "not enough trays/singles."

On April 20, 2011, at 2 p.m., OR RN 1 was interviewed. OR RN 1 stated two specialty trays used by two different surgeons were not sent to the SPD for sterilization. According to the RN, the trays contained instruments that were not available in sufficient quantities to make up more than one tray for each surgeon. OR RN 1 stated these trays were sent to SPD for decontamination and cleaning then flash sterilized in the OR prior to surgery. OR RN 1 stated she had been flash sterilizing these specialty trays for six years.

In an interview with the SPD Manager on April 20, 2011, at 2:15 p.m., the manager stated to ensure sterility of instruments the items in a tray should be undergoing sterilization after each use. The SPD manager stated the two specialty trays were not being sent to SPD for sterilization.

The sterilization logs and flash control strips for sterilizer six were reviewed on April 20, 2011. Specialty trays identified as either "Dr. A tray," or "Dr. B tray," were documented as being flash sterilized on the following dates:

February 7, 2011, at 5:46 a.m.;
February 8, 2011, at 5:24 a.m., and 10:48 a.m.;
February 9, 2011, at 5:05 a.m.;
February 10, 2011, at 5:43 a.m., 12:03 a.m., and 2:29 p.m.;
February 11, 2011, at 5:59 a.m.;
February 15, 2011, at 6:12 a.m., 10:48 a.m., and 11:58 a.m.;
February 17, 2011 at 5:27 a.m.;
February 18, 2011, at 5:54 a.m., and 7:42 a.m.;
February 22, 2011, at 5:13 a.m., and 10:42 a.m.;
February 24, 2011, at 5:30 a.m., and 9:52 a.m.;
March 1, 2011, at 6:02 a.m.;
March 3, 2011, at 5:37 a.m., 11:17 a.m., and 3:05 p.m.;
March 7, 2011, at 6:11 a.m.;
March 8, 2011, at 5:52 a.m., and 1:14 p.m.;
March 10, 2011, at 6:09 a.m., and 10:41 a.m.;
March 14, 2011, at 5:03 a.m.;
March 17, 2011, at 6:23 a.m.;
March 18, 2011, at 6:13 a.m., and 10:30 a.m.;
March 22, 2011, at 5:28 a.m.;
March 23, 2011, 8:24 a.m.;
March 24, 2011, at 5:31 a.m., 9:02 a.m., and 10:37 a.m.;
March 28, 2011, at 10:24 a.m.;
March 29, 2011, at 12:44 p.m., and;
March 30, 2011, at 5:46 a.m.

Each of these entries on the sterilizer log indicated "not enough trays/singles," as the reason for the flash sterilization.

In an interview with the SPD Manager on April 20, 2011, at 2:30 p.m., the manager stated she had identified the overuse of flash sterilization and notified the OR Director in 2010. The manager stated she was attempting to obtain additional instruments but some were on back order and she did not have all the items required to make complete trays.

On April 20, 2011, at 4 p.m., the VP of Quality, Patient Safety and Risk Management was interviewed. The VP stated the specialty trays should be cleaned and sterilized in SPD and she was unaware it was not being done.

The Chief of the Medical Staff was interviewed by phone on April 20, 2011, at 4:15 p.m. He was unaware of the special spinal trays for the two spine physicians undergoing repeated flash sterilizations without full sterile processing.

The facility's policy and procedure titled "Sterilization-Steam Using Unwrapped Method (Flash Sterilization) with a last revised date of August 2009 was reviewed on April 20, 2011. The policy indicated flash sterilization would only be used when there was insufficient time to process by the preferred wrapped or container method. According to the policy flash sterilization would not be used as a substitute for insufficient instrument inventory. The policy and procedure indicated references used included AORN (2009) Standards and Recommended Practices.

The facility's policy and procedure titled "Steam Sterilization," with a revision date of August 2009, was reviewed on April 20, 2011. The policy indicated the creation and maintenance of aseptic environments had a direct influence on patient outcomes. The policy indicated measures for preventing surgical wound infections included "Provision of instrumentation, supplies, and equipment free of contamination at the time of use. Sterilization provides the highest level of assurance that an object is free of viable microbes." According to the policy, steam sterilization was a process that utilized saturated steam under pressure, for a specific exposure time and at a specified temperature, as a sterilizing agent. Items to be sterilized are those that enter sterile tissue or the vascular system.

In an interview with the Director of Surgical Services and the COO, on April 21, 2011, at 9:15 a.m., they stated they were unaware these specialty trays were not being sent to SPD for processing. Both agreed the items should go through the presoaking, cleaning and steam sterilization process before use. The Surgical Director stated the decision to flash the equipment in the operating room was made by the ortho resource nurse.

2. On April 19, 2011, at 1:45 p.m., a tour of the GI lab was conducted with the manager. The area consisted of three procedure rooms, a decontamination room, pre procedure and post procedure beds and a nursing station. The manager stated they performed about 20 procedures daily. During a tour of procedure room 1 there was a cabinet for storage of endoscopes (an instrument used to examine the interior of a hollow organ or cavity of the body, for example the colon or the esophagus). The cabinet was enclosed and vented to allow for drying of the endoscopes after processing. There was a thermostat on the wall that indicated the room temperature was 70? Fahrenheit.

In an interview with the manager, on April 19, 2011, at 2 p.m., the manager stated they were not monitoring humidity at this time, just temperatures.

On April 20, 2011, at 9:15 a.m., during an interview with the manager of the GI lab, the manager stated while there was a thermostat on the wall, unit personnel did not monitor room temperatures. The manager also stated there was no way of monitoring room humidity. The manager stated patients undergoing procedures were given oxygen during the procedure and a cautery device was occasionally used.

Record review for Patient 208 was conducted on April 19, 2011. Patient 208 underwent a colonoscopy (examination of the colon and part of the small bowel with a flexible tube passed through the rectum). Patient 208 underwent this procedure under moderate sedation (conscious sedation- administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardiorespiratory function).

In an interview with the VP of Quality on April 20, 2011, at 9:30 a.m., the VP stated she was unaware additional areas of the hospital required temperature and humidity monitoring.

On April 21, 2011, at 12:30 p.m., an interview was conducted in the cardiac catheterization lab with the Cath Lab Coordinator and RN 209. RN 209 stated they were not monitoring temperature and humidity levels in the cath lab procedure rooms.
During an interview with the VP of Quality on April 21, 2011, at 12:45 p.m., the VP stated monitoring of temperatures and humidity was not being done in the cath lab.
On April 21, 2011, the temperature and humidity logs were reviewed. There was no documentation in the log books that indicated temperature and humidity of the GI procedure rooms and cardiac catheterization rooms was monitored.

The facility policy and procedure titled "Temperature and Humidity Control in Operating Suites," with a last revision date of July 2010, was reviewed on April 21, 2011. The policy and procedure indicated Operating suites were defined as operating room and labor and delivery areas. The policy did not specify any additional procedural areas as requiring daily monitoring. The document listed as a reference AORN (2009) Perioperative Standards and Recommended Practices including "Safe Environment of Care."

According to the AORN 2009 Perioperative Standards and Recommended Practices: The Mission was to promote safety and optimal outcomes for patients undergoing operative and other invasive procedures. In the section for "Recommended Practices for Safe Environment of Care," AORN indicated the practice guidelines were adaptable to various practice settings including traditional operating rooms, cardiac catheterization laboratories, endoscopy suites, and all other areas w.ere surgery could be performed. Recommendation V indicated: "Relative humidity should be maintained between 30 % and 60 % within perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas. Low humidity increases the risk for fire hazards, while high humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed." Recommendations indicated temperature and humidity should be monitored and recorded daily.

3. During a tour of the OR on April 19, 2011, at 2:20 p.m., accompanied by the Trauma Coordinator Nurse, the nurse attempted to obtain a, "bunny suit," to cover her uniform worn from home prior to entering the OR. The PACU Manager told the nurse she could enter the OR without covering up.
The nurse was observed entering the OR in her uniform worn from home.

On April 19, 2011, at 2:30 p.m., two facility staff were observed in the restrictive area of the operating rooms wearing personal hats.

On April 20, 2011, at 3:30 p.m., the SPD Manager was observed in the SPD department wearing a personal scrub hat. (SPD was not in the restrictive area at the time).

In a concurrent interview, the SPD manager stated there was no policy about wearing personal scrub attire, but she washed the hat daily.

On April 21, 2011, at 9:15 a.m., the Director of Surgical Services was interviewed in a facility conference room. The director stated the corporation's consultant was reviewing recent information about home laundered/personal scrub attire, but the AORN standards were unclear and there was no definitive answer.

The facility policy and procedure titled "ATTIRE IN THE OPERATING ROOM," with a last revision date of July 2006, was reviewed on April 21, 2011. The policy indicated it applied to all persons authorized to enter the restrictive areas of the operating room. The policy indicated "Persons entering the restrictive areas of the Operating Room will wear approved, hospital supplies, clean Operating Room apparel." The policy indicated "AORN Standards, Recommended Practices and Guidelines for Surgical Attire (2006)" was a reference.

According to the AORN 2009 Perioperative Standards and Recommended Practices: "All individuals who enter the semi-restricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite." The recommended practices indicated AORN did not support the practice of home laundering of surgical attire. Reusable scrub attire, including cover jackets and cloth hats, should be laundered by a designated facility approved and monitored commercial laundry after daily use.

During an interview with the Manager of Infection Control, on April 21, 2011, at 10:30 a.m., the manager stated personal scrub attire was an issue.