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2823 FRESNO STREET

FRESNO, CA 93721

CONTRACTED SERVICES

Tag No.: A0084

Based on observation, staff interview and administrative document review, the governing body failed to ensure the contracted service for the Food and Dietetics Services of the hospital were provided in a safe and effective manner when:
1. Substandard infection control practices were not identified and monitored for improvement (Cross reference A749);
2. The food service department practiced unsafe food preparation and storage (Cross reference A620, A631);
3. The day-to-day operation of food preparation and service was not overseen by a qualified registered dietician (cross reference A620).
4. The hospital QAPI program did not implement an effective quality improvement program for Food and Dietetics (cross reference A273).

These failures resulted in the potential risk of not meeting the nutritional needs of all patients and possibly increasing the risk for food-borne illnesses to visitors, staff and patients.

Findings:

In an interview with the hospital administration represented by the CEO (Chief Executive Officer) and COO (Chief Operating Officer) on 10/10/12 at 3:30 p.m., stated that he had responsibility for all operations at the hospital including the contracted food service operation. He stated he expected all conditions of participation to be met with medical staff, quality patient care and all regulations to provide nourishing meals.

He agreed there were serious and substantial issues regarding the Food and Dietetic Services after discussion of relevant findings.

The following findings represent specific examples of the lack of oversight on the day-to-day operation of the Food and Dietetic Service at the hospital.

During the kitchen tour with the Assistant Director of Nutrition Services (ADNS) and Executive Chef (EC) on 10/8/12 starting at 9:30 a.m., the ADNS was unable to state the standard of practice for food service staff on the cooling of hot food to be held or the maintenance of the kitchen in a clean and effective operating condition. The ADNS referred all questions to the EC.

The milk walk-in refrigerator had 8 condenser covers (approximately 18 to 20 inches in diameter) covered with dust and debris buildup. The ADNS stated she thought the food service staff was to clean the covers. The ADNS could not state when the vents had been cleaned or if there was a cleaning schedule.

Chill Tank 1 (processes food to ensure safe cooling and prevention of cross contamination) had 2 to 3 inch white and brown layer of scaly debris around the upper inner edges. There was also tape residue on the lids that was not cleaned. The EC and ADNS stated the operation of the Chill Tank 1 processes daily 40 or more large bags of food (soups and gravies) that are held and served for patients. The ADNS was not able to state when the tank had been cleaned or if there was a cleaning schedule to maintain the equipment in a sanitary operational condition. The EC explained that the tank had a self-cleaning feature but did not clean the sides above the water line and needed to be hand scrubbed and acknowledged that the tank was dirty. The EC and ADNS stated this presented a risk of cross contamination to the food processed in it.

One of two blast chiller's (super refrigeration units that quickly cool potentially hazardous food - capable of growing pathogenic microorganisms) interior surfaces and three approximately 20 inch fan covers had visible food debris. The ADNS acknowledged the interior was to be cleaned each day and agreed this equipment was not clean. She could not state when the blast chiller unit had been cleaned or if there was a cleaning schedule.

One "Craftsman" tool chest had a visible layer of rust and food debris on the top cover and both sides. The Executive Chef explained the tool chest held tools for the cook's chill equipment. The EC acknowledged the tool chest could not be maintained clean and should not be in the kitchen area.

A room service food preparation cutting board approximately 4 feet long, had yellow stains and black cut marks on the surface and food service staff used this cutting board to prepare patient food. The ADNS acknowledged the cutting board was not clean. The ADNS did not know the monitoring schedule to replace cutting boards unable to be cleaned.

Two cutting boards with yellow stained surface and black cut marks were observed in the dish room after being washed. Cutting boards were processed and ready for use by food service staff until the Patient Services Manager was asked to evaluate the cleanliness and sanitary condition of the boards. The Patient Services Manager (PSM) acknowledged that the cutting boards should be replaced when they could not be cleaned and sanitized due to the cuts in the surface. The ADNS and the PSM stated there was no routine monitoring in place to make sure that unsuitable cutting boards were taken out of service.

The janitor closet in the Dish Room contained a bucket of water that was visibly dirty. The floor and walls of the janitor closet were visibly dirty. There was trash on the floor. The ADNS was not able to state the cleaning schedule to maintain the area clean.

One (two door) reach-in refrigerator in patient tray assembly area had door gaskets with black substance and were loose and hanging away from the door when opened. ADNS stated the gaskets needed to be cleaned and replaced. She did not know if there was a work order placed to repair and was unsure of the process to place in a work order to repair.

Two Cafeteria supervisor (Cafe Sup 1 and Cafe Sup 2) staff were observed in the main kitchen area with bangs of hair exposed. The ADNS was present but did not correct staff practice until she was asked about the hair that was not held in the hairnet. She then requested staff to correct this behavior. Review of the hospital policy titled Infection Control dated 6/13/12, indicated that staff was to wear hair coverings with no hair exposed.

On 10/8/12 starting at 10:30 a.m. the temperature of one pan of (approximately 40 servings) of penne pasta noodles dated 10/8/12 and expired 10/10/12 was 89 degrees F (Fahrenheit - a measurement of temperature). The temperature was taken with facility digital thermometer by the Patient Services Manager. At 10:45 a.m. the cook stated that he had cooked the noodles and put in the full deep pan into the blast chiller at approximately 8:30 a.m. and they were 32 degrees F when he put them in the walk in refrigerator. There was no cooling log to verify the cool down period. The cook could not explain how the noodles went from 32 degrees F to 89 degrees F in 2 hours. The ADNS could not explain the standard for cool down period.

At 11:30 a.m. the Patient Services Manager was asked if the penne pasta noodles found at 89 degrees F and exceeding the 2 hours temperature of cooling to 70 degrees F was now safe to serve as prepared. She acknowledged that the product should be discarded and phoned the kitchen to request it to be discarded.

On 10/8/12 starting at 3:00 p.m., during an observation and concurrent interview of the cafeteria kitchen with the Assistant Director of Catering and and Dining (ADCD) the following was found:

The four-door deli box (kit 901) had corroded and black debris on the shelves. The ADCD was not able to state when the shelves had been cleaned. The ADCD acknowledged the shelves were not maintained in a sanitary condition.

The vegetable walk-in refrigerator and the catering walk-in refrigerator (approximately 8 feet by 6 feet) had black substance along the entire length of the ceiling braces. The ADCD acknowledged the refrigerator ceilings needed to be cleaned.

The following product was observed in the large walk-in refrigerator: two large packages of turkey dated 6/29/07 preparation and 7/15/07 expiration. The ADNS was not able to explain when this product had been produced or how the staff knew the date of preparation and expiration. On 10/8/12 at approximately 3:00 p.m., the EC demonstrated the product labeling computer which required the dates to be changed to the current dates. He stated the cook who did the preparation did not label the product correctly.
The ADNS and EC acknowledged there was no system to ensure the product labeling was being operated correctly. The ADNS and EC acknowledged that by leaving date mislabeled products in the walk-in and ready for patient service placed patients at risk of food borne illness because the product could be used without accurate knowledge of the length of holding.

On 10/10/12 at 12:00 p.m., during an interview, the ADNS stated there were no logs to monitor the temperature for the cold food items after they were made such as egg salad, tuna salad, and potato salad. The ADNS was unaware of the following hospital policy titled Cafeteria Food Temperatures dated 2/2/11 which indicated all cold prep items would be maintained at a temperature of 41 degrees or less. All temperatures logs will be dated, timed, and initialed. Any cold food item found to be above the range will be removed and discarded. The interview was in reference to several cold food items found to be in the reach-in refrigerator of the cafeteria and all above 41 degrees F.

Review of the organizational chart of the Nutrition and Dining Department indicated the ADNS was equal to the Director of Nutrition and Dining Services and they both reported to the Assistant Administrator and the contract services Regional Director of Operations. The organizational chart indicated the ADNS was over the clinical dietitians, patient services manager and executive chef.

Review of the position job description of the Assistant Director of Nutrition Services showed the following: "responsible to direct the operations of patient food services such as the planning and supervision of patient food assembly and service, scheduling, hiring, training, evaluating, and discipline of patient food service personnel and the functions of clinical nutrition services such as nutrition assessment, performance improvement and management of clinical team to ensure high quality nutritional care is provided to patients, ensures patient satisfaction, quality care, regulatory compliance." In addition this organizational chart had the Executive chef and cooks reporting to the ADNS. This reporting tree was not reflected in the job description. The job description indicated the ADNS position reported to the Director of Food and Nutrition Services. On 10/9/12 at 8:30 a.m., the ADNS stated she does not meet or report to the Administrative Assistant just to the Director of Nutrition and Dining Services.

Review of the position job description for the Director of Food and Nutrition Services indicated this position directed the operation of Food and Nutrition Services. The supervisory responsibilities were for the food service staff. The Director reported to the Regional Director of Operations. The job description does not specify a dual reporting tree to the Assistant Administrator as indicated on the organizational chart.

Review of the position job description of the Patient Services Manager indicated this position directed the operations of patient food services, including the planning and supervision of patient food assembly and service, scheduling, hiring, and training of food service personnel. The job description stated the position ensured quality care, regulatory agency compliance, assisted with management of the department in the absence of the director and/or other managers. The job description/initial competency review was signed by the ADNS and the Regional Director of Operations indicating they did the evaluation.

Review of the position job description of the clinical dietitian indicated they reported to the Clinical Nutrition Manager or Director Food and Nutrition Services. This was not consistent with the organizational chart.

Review of the position job description of the Executive Chef (EC) indicated the EC was responsible for the purchasing and food production operations of Food and Nutrition Services, under the supervision of the Director, ensured HACCP (Hazard Analysis and Critical Control Points - a management system in which food safety is addressed) controls were in place and regularly enforced and ensured the kitchen was inspection ready at all times and responsible for strict cleanliness and food sanitation controls and ensured preventative maintenance program was adhered to. The job description/initial competency review was signed by the Director of Food and Nutrition Services indicating they did the evaluation. This was not consistent with the organizational chart.

Review of the position job description of the cooks indicated they reported to the team leader. No team leader appeared on organizational chart and there was no job description for team leader.

As a result of this management organizational structure, the ADNS was not fully aware of the issues that affected safe food handling practices, meal service and patient nutrition care. There was no consistent monitoring of the process to ensure food was prepared and maintained in a safe manner. There was no therapeutic diet manual that accurately reflected physician ordered diets and current standards of practice.

The organization chart showed a direct report plan to the hospital administration but when this was not practiced the ADNS was not able to directly bring patient and food service issues directly to the administration. (Cross Reference A749, A620, A630, A631).

PATIENT RIGHTS: NOTICE OF RIGHTS

Tag No.: A0117

Based on observation, patient and staff interview and administrative document review, the hospital failed to inform each patient or the patient's representative, in a language or manner that can be understood, of the patient's rights when four of four patients (Patients 1, 2, 3 and 4) did not receive patient rights information. This failure resulted in not protecting the patient's right to be informed in advance of providing care.

Findings:

On 10/8/12 at 8:45 a.m., during observation and concurrent interview, Patient 1 was in the Star unit (before surgery/procedure area) of the second floor for a same day procedure. Patient 1 stated no patient rights information had been given to him or verbally explained.

On 10/8/12 at 8:50 a.m., during an interview, the Admissions Clerk (AC)(second floor short stay/procedure registration) stated she had not given Patient 1 patient rights information. The AC explained she had never given patient rights information to patients admitted for outpatient procedures. The AC stated she had never been instructed to give patient rights information to patients being admitted for outpatient procedures.

On 10/8/12 at 1:45 p.m., during a concurrent observation and interview on the 2 east unit, Patient 2 (Spanish speaking) in room 205-A was observed with family at bedside. Patient 2 stated she was never given a patient guide brochure or told of what her patients rights were.

On 10/8/12 at 1:50 p.m., during a concurrent observation and interview, Patient 3 room 206-A was sitting in bed waiting to be discharged. Patient 3 stated she had not received a patient guide/rights brochure and had not been informed of what her rights were.

On 10/8/12 at 2:05 p.m., during a concurrent observation and interview, Patient 4 in room 243-A was observed in bed. Patient 4 stated she was going to be discharged the following day. Patient 4 stated she had not been given any information about patient rights.

On 10/8/12 at 2:15 p.m., during a concurrent interview and clinical record review, Registered Nurse Manager 1 for 2 East and 2 Central, confirmed Patients 2, 3 and 4 did not receive patient rights information and should have received them.

On 10/11/12 at 2:30 p.m., during a concurrent interview and clinical record review, Patient Safety Manager 1 (staff member of the Quality Management Team) confirmed Patients 1 through 4 did not receive patient rights information and should have received them.

On 10/11/12 at 3:30 p.m., during a concurrent interview and clinical record review, Admitting Supervisor (AS) of inpatient, outpatient, short stay, and all admitting areas stated, only inpatients routinely received patient guide/ patient rights information brochures. AS stated that patient face sheets had an area to indicate when patients received information during the time of stay. AS stated her department was the only department that was responsible for giving out this information.

The hospital's "Your Patient Guide" undated, indicated on page 1, "PATIENT'S RIGHT TO MAKE DECISIONS ABOUT MEDICAL TREATMENT...As a patient you have have the right to make health care decisions and plan what should be done if you are not able to speak for yourself. Federal law requires us to give you this information." page 3, "4. Receive information about your health status, course of treatment and prospects of recovery in terms you can understand."

PATIENT RIGHTS: PERSONAL PRIVACY

Tag No.: A0143

Based on observation, staff interview, and administrative document review, the hospital failed to protect patients right to personal privacy when patients were placed on a gurney in hallways of the Emergency Department (ED) for medical treatment. This failure resulted in patients receiving medical care in areas without the benefit of the right to personal privacy.

Findings:

On 10/8/12 at 10 a.m., during observation of the ED there were patients in gurneys (specialized hospital bed on wheels) placed in all hallways and patient treatment areas. There were letters posted on the wall above each gurney that indicated the hallway spaces were used as patient treatment areas.

On 10/9/12 at 12:27 p.m., during an observation, Patient 5 was lying on a gurney in the hallway of the Green Zone (a wing of the ED). Patient 5's blood was being drawn in full view in the hallway. No privacy curtain or device was placed around Patient 5 to provide privacy.

On 10/9/12 at 1 p.m., during an interview, Patient 5 stated he was admitted on 10/8/12 at 11:15 a.m. and placed in the hallway on the gurney. Patient 5 stated, "They drew my blood right here. They later inserted an IV (intravenous) line and have been doing a lot of blood work and x-rays."

On 10/9/12 at 1:05 p.m., during an observation, Patient 6 was lying on a gurney in the hallway of the Yellow Zone (an area of the ED). Patient 6's temperature and blood pressure were being checked in the open hallway with no regard to privacy.

On 10/9/12 at 1:19 p.m., during concurrent observation and interview, RN 1 was checking Patient 6's vital signs in the hallway without a screen for privacy. RN 1 stated, "There is no privacy around here, I should have used a screen or something for privacy."

On 10/9/12 at 1:45 p.m., during an interview, ED Manager stated, "We put patients in the hallway because we do not have enough rooms. Anybody that comes to the ED must be treated, when there are no beds on the floor we place them in the hallway until we have a bed..."

Review of the hospital's policy and procedure titled, "Patient's Rights and Responsibilities" dated 11/19/2010, indicated "IV. Patient Rights: 9. To receive full consideration of privacy concerning their medical care. Case discussion, consultation, examination and treatment are confidential and should be conducted discreetly. 10. To receive confidential treatment of all communications and clinical records pertaining to the care and stay in the hospital..."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0164

Based on staff interview, clinical record, and administrative document review, the hospital failed to ensure restraints were used only when less restrictive interventions had been determined to be ineffective when Patient 7 was placed in restraints without documented evidence of alternative methods being considered or attempted. This failure resulted in not protecting Patient 7's right to be free from restraints or being treated with the least restrictive method of restraints. .

Findings:

On 10/9/12 at 3:10 a.m., during a concurrent interview and clinical record review, RN 2 (and hospital educator), verified Patient 7 as admitted to the hospital on 10/5/12 at 8:46 p.m. with a diagnosis of hepatic encephalopathy (altered level of consciousness due to liver failure). RN 2 verified Patient 7 had an order for "bilateral(both) soft wrist restraints, 4 siderails up (a restraint). Restraint Reason: attempting to remove invasive lines/or tubes, attempting to crawl out of bed." The order "start date/time 10/8/12 12:25 AM." Under restraints for 10/8/12 at 12:25 a.m., "less restrictive restraint, PC (patient care), AL (alarm), under Rationale for use L (attempt to remove invasive lines, tubes) B (Attempting to climb out of bed). There was no documentation that alternatives were considered and determined to be ineffective before restraints were applied. RN 2 stated the expectation was to document alternative methods of restraints prior to applying restraints. RN 2 agreed that alternative, less restrictive methods of restraints were not attempted or considered for Patient 7.

On 10/11/12 the hospital policy and procedure titled, "Restraint and Seclusion, effective date 8/22/11, indicated, " 1. Purpose A. To provide a consistent standardized, corporate-wide policy and procedure for the assessment, application and evaluation of the use of restraint and seclusion... III. Policy... C. Alternatives to the Use of Restraint and Seclusion... 3. The use of restraint or seclusion occurs only after alternatives to such use have been considered and/or attempted as appropriate..."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0166

Based on observation, staff interview, clinical record and administrative document review, the hospital failed to provide a written modification to the Plan of Care for Patient 8 when restraints were initiated. This failure resulted in the risk of not ensuring a continuum of care for Patient 8.

Findings:

On 10/8/12 at 2 p.m., during a concurrent observation and interview, the Clinical Nurse Specialist (CNS) confirmed Patient 8 was confined by wrist restraints (fabric strips attached to both wrists and tied to the bed frame).

On 10/8/12 at 2 p.m., during an interview, the CNS stated Patient 8 was restrained due to attempting to pull out her peripheral IV (internal vein access) and attempting to climb out of bed.

On 10/9/12 at 2:55 p.m., during a concurrent observation and interview, RN 3 confirmed Patient 8 had been restrained because she attempted to climb out of bed.

On 10/11/12 at 9:20 a.m., during an interview, CNS confirmed there was not a modified nursing care plan (a plan to direct and evaluate nursing care) for Patient 8 when restraints were placed on 10/6/12. The CNS stated there should be a modification of the care plan when restraints were placed on Patient 8. The CNS stated the expectation was to modify the written care plan for each patient with restraints.

On 10/11/12 at 9:20 a.m., during a concurrent interview and review of Patient 8's clinical record the CNS stated there was no documentation to indicate how many attempts Patient 8 had made to remove invasive lines or tubes or to climb out of bed. The CNS stated the attempts for both of these behaviors should have been documented to evaluate the need for restraints and should have been included in the plan of care.

"V. DOCUMENTATION A. Document the following information in the medical record for each restraint or seclusion episode: ...8. Plan of care revisions." "NOTE : The use of restraint / seclusion ... must be documented in the plan of care or treatment plan within 24 hours of initiation."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

Based on observation, staff interview, clinical record and administrative document review, the hospital failed to obtain a valid medical doctor's (MD) order, for Patient 8's restraints when the MD failed to do a face to face assessment and sign the order within 24 hours of restraints being placed as per hospital protocol. This failure resulted in the potential of not protecting Patient 8's right to be free from restraints.

Findings:

On 10/8/12 at 2 p.m., during a concurrent observation and interview at the doorway of Patient Room 775, the Clinical Nurse Supervisor (CNS) confirmed Patient 8 was restrained by restraints attached to both wrists and had been tied to a wire attachment on the bed frame.

On 10/8/12 at 2 p.m., during an interview, the CNS stated Patient 8 was restrained due to attempting to pull out her peripheral IV (intravenous - a device used to administer medications directly into the bloodstream) and attempting to climb out of bed.

On 10/9/12 at 2:55 p.m., during a concurrent observation and interview, at the doorway of Patient Room 775, Registered Nurse 3 (RN) confirmed Patient 8 had restraints attached to both wrists and had been tied to a wire attachment on the bed frame. RN 3 stated Patient 8 had been restrained because she attempted to climb out of bed.

On 10/9/12 at 3 p.m., during an interview, the 7th floor Nurse Manager (NM) stated to place a patient in restraints an MD's order was needed. The NM stated MD orders for restraints were written per "episode." The Nurse Manager could not provide a clear definition of an "episode." The NM stated MD orders did not include an end date or time so restraints could be kept on patients as long as required. The NM stated the MD who ordered the restraints must complete a face to face assessment of the patient within 24 hours of the restraints being placed. The NM stated the order must be signed within 24 hours of being given, if the order was given verbally or telephonically.

On 10/9/12 at 3 p.m., during a concurrent interview and review of Patient 8's clinical record the NM validated an MD telephone order (an MD order given over the telephone) for Patient 8 dated 10/6/12 at 8:29 p.m.

The MD order was for "bilateral wrist restraints [restraints attached to both wrists] and bedside rails times 4 [4 bedside rails raised]." These orders were written for "Attempting to Remove Invasive Lines/or Tubes" and "and attempting (to) crawl out (of) bed" respectively.

The "Process Instructions" section of the Electronic Health Record (EHR) indicated, ... "The MD must conduct a face to face assessment within 1 calendar day of initiation when restraint order is verbal."

The "Verbal Order Info" section indicated, "Action " "Ordering", "Order Mode" "Telephone with readback"... "Signed By" [No Signature], "Signed On" [No Date].

Asked if the MD had conducted a face to face assessment with Patient 8 within 24 hours of issuing this restraint order and if the restraint order for Patient 8 had been signed within 24 hours of being issued? The NM stated there was no indication that a face to face assessment was done by the MD within 24 hours and as of 10/9/12 the restraint order had not been signed by the MD.

On 10/11/12 at 9:20 a.m., during a concurrent interview and review of Patient 8's clinical record, the CNS confirmed the MD order for restraints, for Patient 8 issued on 10/6/12 at 8:30 p.m., were not signed until 10/9/12 at 4:04 p.m.. The CNS stated the MD orders in question should have been signed within 24 hours of being issued because the orders were given by telephone.

The facility policy and procedure titled, "Restraint and Seclusion" dated 8/22/11 indicated: "I. PURPOSE" "A. To provide a consistent standardized, corporate-wide policy and procedure for the assessment, application and evaluation of the use of restraint and seclusion."...

"III. POLICY A. At a minimum, licensed independent practitioners (LIP) authorized to order restraint or seclusion must have a working knowledge of this policy regarding the use of restraint and seclusion. This training may include, but not necessarily be limited to, the following: 1. A patient's rights regarding the use of restraint or seclusion. 2. Prohibitions on such use. 3. Ordering requirements. 4. Requirements and time frames for patient assessment."

"V. DOCUMENTATION A. Document the following information in the medical record for each restraint or seclusion episode: ... 12. Physician order with proper authentication."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0174

Based on observation, staff interview, clinical record, and administrative document review the facility failed to ensure restraints were discontinued at the earliest possible time when Patient 8 was placed on restraints without a plan to discontinue at the earliest possible time. This failure resulted in the potential for not protecting Patient 8's right to be free from restraints.

Findings:

On 10/8/12 at 2 p.m., during an observation and concurrent interview, Patient 8's wrists were restrained by cloth ties attached to the frame of her bed. The CNS (Clinical Nurse Specialist) stated Patient 8 was restrained due to attempting to pull out her peripheral IV (a device used to administer medications directly into the bloodstream) and attempting to climb out of bed.

On 10/9/12 at 2:55 p.m., during a concurrent observation and interview, Registered Nurse 3 (RN) confirmed Patient 8 was restrained for attempting to climb out of bed.

On 10/9/12 at 3 p.m., the 7th floor Nurse Manager (NM) stated MD orders for restraints were written per "episode." The NM could not provide a definition of an "episode." The NM stated MD orders did not include an end date or time and that restraints could be kept on patients as long as required.

On 10/9/12 at 3 p.m., during a clinical record review (electronic health record - EHR), the physician's verbal order was documented for bilateral restraints dated 10/6/12 at 8:29 p.m. The "Order Information" section indicated, "Release Date/Time" "None", "Start Date/Time" "10/6/2012 8:30 PM", "End Date/Time" "Until Specified."

The "Order Details" section indicated, "Frequency" "CONTINUOUS", "Duration" "Until Specified", "Priority" "Routine."

The order "Process Instructions" section indicated, "Restraints must be removed when an alternative is available and effective and/or patient no longer meets criteria."

On 10/11/12 at 9:20 a.m., during a concurrent interview and clinical record review, the CNS stated the order for Patient 8 did not indicate a time limit for the restraints and this would be considered a "Continuous order." CNS stated there was no documentation to indicate how many attempts Patient 8 had made to remove invasive lines or tubes or to climb out of bed. CNS stated the attempts for both of these behaviors should have been documented to evaluate the discontinuation of restraints.

The facility policy and procedure titled, "Restraint and Seclusion" dated 8/22/11 indicated: "... B. Patients Rights 1. ...Restraint or seclusion may only be imposed to ensure the...and must be discontinued at the earliest possible time."

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on administrative and dietary staff interview and dietary department document review, the hospital failed to have an ongoing quality assessment and performance improvement program that addressed the complexity and scope of the Food and Dietetic Service. The hospital failed to identify issues in safe food handling practices and food storage. The hospital Food and Dietetic staff failed to recognize inadequacies in clinical nutrition care services provided to patients. These failures resulted in the potential to not meet the on-going nutritional needs of patients in the hospital.

Findings:

Specific issues related to food service, food preparation and storage and concerns related to clinical nutrition care were identified during the survey. For example, the hospital organizational structure of the Food and Dietetic Service did not match the day-to-day operational structure. This mismatch of managerial hierarchy led to lack of oversight by supervisor staff. The lack of oversight led to inadequate food handling and not adhering to food storage and food temperature requirements (cross-reference to A619 and A620). An example of inadequate clinical nutrition care was the hospital diets not adhering to standards as set forth by Recommended Dietary Allowances and Dietary Reference Intakes (cross-reference A630). The hospital diet manual was not current and did not adhere to professional standards (cross-reference A631).

On 10/10/12 at 11:20 a.m., during an interview, the Assistant Director Nutrition Services (ADNS) discussed quality improvement projects and performance indicators. The ADNS stated the department reached the expected goals and thresholds for all identified performance indicators. The ADNS, an employee of the contracted food service, stated that she reviewed the information on a monthly basis and would provide the information to the Quality Patient Safety Committee on a quarterly basis. The ADNS acknowledged they were reporting items that the department was doing well not on items that needed to be improved. The ADNS stated the Quality Patient Safety Committee did not request items needing improvement.

When asked to comment on quality indicators for the examples of findings listed above during the survey, the ADNS stated they (Food and Dietetic Service) needed to enhance what they were looking at in the cafeteria after what was observed this week. The ADNS stated that no quality indicators were being measured to identify areas of improvement for the findings listed above.

On 10/10/12, at 11:45 a.m., the Manager of Infection Control stated she was involved in annual safety rounds in the food service operation, provided handwashing training, and looked at refrigerator temperatures. She stated that her rounds did not involve the application of food safety standards that are outlined in the FDA (Food and Drug Administration) Food Code 2009. She stated that she was not familiar with the requirement for cooling potentially hazardous food. Review of the form used for environmental rounds showed it was a general form and not specific to food safe practices.

She stated that the quality committee reviewed the quality indicator measures that were presented by the Food and Nutrition department each quarter but did not question the consistent 90 to 100 percent reports that monitored the refrigerator temperatures. She stated that the committee did not require other measures of infection control monitoring for to reflect the high volume and high risk operation of the food service department.

The hospital document titled, "Performance Improvement Plan 2012" was reviewed. The document indicated the following: " Continuous Improvement ...based on the following principles: Quality at (the hospital)will be defined, designed, measured, and improved according to the following well-established dimensions of performance: safety, efficacy, timeliness, efficiency, equity, and patient centered." The document indicated an emphasis on prevention rather than detection, performance measures and quality improvement expectations that were consistent with the goals of the organization, and the development and adherence to the best practices for performing the tasks involved in the governance, managerial, clinical, and support processes that affect patient outcomes. Additionally, there was no indication that the hospital or the department identified that the information submitted by Food and Nutrition Services did not systematically identify opportunities for improvement, rather reflected monitoring of elements that demonstrated a satisfactory levels of performance.

The following findings represent specific examples of the lack of oversight on the day-to-day operation of the Food and Dietetic Service at the hospital.

During the kitchen tour with the ADNS and EC on 10/8/12 starting at 9:30 a.m., the ADNS was unable to state the standard of practice for food service staff on the cooling of hot food to be held or the maintenance of the kitchen in a clean and effective operating condition. The ADNS referred all questions to the EC.

The milk walk-in refrigerator had 8 condenser covers (approximately 18 to 20 inches in diameter) covered with dust and debris buildup. The ADNS stated she thought the food service staff was to clean the covers. The ADNS could not state when the vents had been cleaned or if there was a cleaning schedule.

Chill Tank 1 (processes food to ensure safe cooling and prevention of cross contamination) had 2 to 3 inch white and brown layer of scaly debris around the upper inner edges. There was also tape residue on the lids that was not cleaned. The EC and ADNS stated the operation of the Chill Tank 1 processes daily 40 or more large bags of food (soups and gravies) that are held and served for patients. The ADNS was not able to state when the tank had been cleaned or if there was a cleaning schedule to maintain the equipment in a sanitary operational condition. The EC explained that the tank had a self-cleaning feature but did not clean the sides above the water line and needed to be hand scrubbed and acknowledged that the tank was dirty. The EC and ADNS stated this presented a risk of cross contamination to the food processed in it.

One of two blast chiller's (super refrigeration units that quickly cool potentially hazardous food - capable of growing pathogenic microorganisms) interior surfaces and three approximately 20 inch fan covers had visible food debris. The ADNS acknowledged the interior was to be cleaned each day and agreed this equipment was not clean. She could not state when the blast chiller unit had been cleaned or if there was a cleaning schedule.

One "Craftsman" tool chest had a visible layer of rust and food debris on the top cover and both sides. The Executive Chef explained the tool chest held tools for the cook's chill equipment. The EC acknowledged the tool chest could not be maintained clean and should not be in the kitchen area.

A room service food preparation cutting board approximately 4 feet long, had yellow stains and black cut marks on the surface and food service staff used this cutting board to prepare patient food. The ADNS acknowledged the cutting board was not clean. The ADNS did not know the monitoring schedule to replace cutting boards unable to be cleaned.

Two cutting boards with yellow stained surface and black cut marks were observed in the dish room after being washed. Cutting boards were processed and ready for use by food service staff until the Patient Services Manager was asked to evaluate the cleanliness and sanitary condition of the boards. The Patient Services Manager (PSM) acknowledged that the cutting boards should be replaced when they could not be cleaned and sanitized due to the cuts in the surface. The ADNS and the PSM stated there was no routine monitoring in place to make sure that unsuitable cutting boards were taken out of service.

The janitor closet in the Dish Room contained a bucket of water that was visibly dirty. The floor and walls of the janitor closet were visibly dirty. There was trash on the floor. The ADNS was not able to state the cleaning schedule to maintain the area clean.

One (two door) reach-in refrigerator in patient tray assembly area had door gaskets with black substance and were loose and hanging away from the door when opened. ADNS stated the gaskets needed to be cleaned and replaced. She did not know if there was a work order placed to repair and was unsure of the process to place in a work order to repair.

Two Cafeteria supervisor (Cafe Sup 1 and Cafe Sup 2) staff were observed in the main kitchen area with bangs of hair exposed. The ADNS was present but did not correct staff practice until she was asked about the hair that was not held in the hairnet. She then requested staff to correct this behavior. Review of the hospital policy titled Infection Control dated 6/13/12, indicated that staff was to wear hair coverings with no hair exposed.

On 10/8/12 starting at 10:30 a.m. the temperature of one pan of (approximately 40 servings) of penne pasta noodles dated 10/8/12 and expired 10/10/12 was 89 degrees F (Fahrenheit - a measurement of temperature). The temperature was taken with facility digital thermometer by the Patient Services Manager. At 10:45 a.m. the cook stated that he had cooked the noodles and put in the full deep pan into the blast chiller at approximately 8:30 a.m. and they were 32 degrees F when he put them in the walk in refrigerator. There was no cooling log to verify the cool down period. The cook could not explain how the noodles went from 32 degrees F to 89 degrees F in 2 hours. The ADNS could not explain the standard for cool down period.

At 11:30 a.m. the Patient Services Manager was asked if the penne pasta noodles found at 89 degrees F and exceeding the 2 hours temperature of cooling to 70 degrees F was now safe to serve as prepared. She acknowledged that the product should be discarded and phoned the kitchen to request it to be discarded.

On 10/8/12 starting at 3:00 p.m., during an observation and concurrent interview of the cafeteria kitchen with the Assistant Director of Catering and and Dining (ADCD) the following was found:

The four-door deli box (kit 901) had corroded and black debris on the shelves. The ADCD was not able to state when the shelves had been cleaned. The ADCD acknowledged the shelves were not maintained in a sanitary condition.

The vegetable walk-in refrigerator and the catering walk-in refrigerator (approximately 8 feet by 6 feet) had black substance along the entire length of the ceiling braces. The ADCD acknowledged the refrigerator ceilings needed to be cleaned.

The following product was observed in the large walk-in refrigerator: two large packages of turkey dated 6/29/07 preparation and 7/15/07 expiration. The ADNS was not able to explain when this product had been produced or how the staff knew the date of preparation and expiration. On 10/8/12 at approximately 3:00 p.m., the EC demonstrated the product labeling computer which required the dates to be changed to the current dates. He stated the cook who did the preparation did not label the product correctly.
The ADNS and EC acknowledged there was no system to ensure the product labeling was being operated correctly. The ADNS and EC acknowledged that by leaving date mislabeled products in the walk-in and ready for patient service placed patients at risk of food borne illness because the product could be used without accurate knowledge of the length of holding.

On 10/10/12 at 12:00 p.m., during an interview, the ADNS stated there were no logs to monitor the temperature for the cold food items after they were made such as egg salad, tuna salad, and potato salad. The ADNS was unaware of the following hospital policy titled Cafeteria Food Temperatures dated 2/2/11 which indicated all cold prep items would be maintained at a temperature of 41 degrees or less. All temperatures logs will be dated, timed, and initialed. Any cold food item found to be above the range will be removed and discarded. The interview was in reference to several cold food items found to be in the reach-in refrigerator of the cafeteria and all above 41 degrees F.

MEDICAL RECORD SERVICES

Tag No.: A0450

Based on staff interview, administrative document and medical record review, the hospital failed to ensure that all entries were complete (with abbreviations defined), dated, and timed in 8 of 12 records. This failure resulted in the potential to not provide quality continuum of care to all patients.

Findings:

On 10/10/12 and 10/11/12, during closed record review and concurrent interview, abbreviations were found to have been used in entries for Patient Records 10, 12, 15, 16 and 18. In Patient Records 13 and 17, the Conditions of Admission consents were not timed when signed on the line indicated for entering the "date/time". Patient Record 19 contained a "Consent to Observe During Surgery: Vendor or Visitor ". This form was not dated in the space provided. Health Information staff confirmed these findings concurrently.

On 10/9/12, the 2011 Medical Staff Rules and Regulations were reviewed. Section G. 6. states: "Only the Medical Staff approved symbols and abbreviations may be used in the medical record ....Refer to the (hospital)policy, Abbreviations and Symbols." The Health Information Manager explained that this policy referenced was no longer in effect and the one replacing it was hospital policy #11915, " Use of Abbreviations," effective 7/17/12. This new policy was reviewed and statee that in order to promote optimal communication with clear intent, the use of abbreviations was highly discouraged. This policy's purpose was to define abbreviations that were prohibited from being used; however, there was no facility-specific list of approved abbreviations or a resource book. The Health Information Manager confirmed these finding concurrently.

CONTENT OF RECORD: INFORMED CONSENT

Tag No.: A0466

Based on staff interview, clinical record and administrative document review, the hospital failed to properly execute informed consents when the informed consents for surgery for two of two patients (Patient 21 and Patient 22) were to properly filled out per hospital policy. This failure resulted in the potential of not protecting the right of the patient to be informed prior to the decision for care.

Findings:

On 10/11/12 at 11:30 a.m., during a concurrent interview and clinical record review of Patient 21 the Manager of Surgical Services (MSS) two of Patient 21's consent for surgery forms dated 6/29/12 at 10:25 p.m. for a vaginal delivery, and Patient 21's consent form dated 6/29/12 at 11:13 p.m. for a labor epidural did not contain the name of the admitting physician, or surgeon performing the operation at the time the signature was obtained. The MSS stated the surgical forms should have been completed with the name of the surgeon and the admitting physician.

On 10/11/12 at 11:40 a.m., during a concurrent interview and clinical record review of Patient 22 with the MSS, Patient 22's consent for surgery forms dated 6/25/12 at 1 a.m. for a repeat c-section (cesarean incision through an abdominal opening) and bilateral tubal ligation (method of sterilization) did not contain names of admitting physician, or surgeon performing the operation at the time the patient signature was obtained. The MSS stated that all consent for surgery must include who the admitting physician was and who will be performing the surgical procedure. The MSS stated the surgical forms should have been completed with the names of the surgeon and the admitting physician.

The facility policy and procedure titled, "Consents" dated 3/11/12, indicated...Obtaining Consent...surgical procedures require consent...all procedures performed in the operation room...activities without consent would impinge on the patients rights..."

CONTENT OF RECORD: FINAL DIAGNOSIS

Tag No.: A0469

Based on staff interview and administrative document review, the hospital failed to ensure that records were completed within the time period required by the medical staff regulations. This failure resulted in the potential to not provide quality continuum of care to all patients.

Findings:

On the afternoon of 10/9/11, The Health Information Manager presented two reports listing the count of "Total Deficient Charts by Days Outstanding" and "Document/Dictate Aging Days Breakdown" (of delinquent reports). These reports indicated there were a total of 2055 delinquent charts with deficiencies. The breakdown of the 117 delinquent reports was as follows: 89 history and physicals; 18 operative/procedure reports; and 10 discharge summaries. Forty-two (42) of the reports still incomplete were for patients who had been discharged more than 91 days earlier.

On 10/9/12, the 2011 Rules and Regulations of the Medical Staff were reviewed. Section G. 5 states: ... " Medical record entries must be completed promptly, timed, dated and authenticated by the author within fourteen (14) days following the patient ' s discharge .... Medical records that are incomplete for any reason 14 days after discharge are considered to be delinquent .... "

FOOD AND DIETETIC SERVICES

Tag No.: A0618

Based on observation, staff interview and administrative document review, the hospital failed to ensure that the Food and Dietetic Service met the needs of all patients when:

1. No full-time qualified employee was responsible for the daily management of the Food and Dietetic Service. No qualified employee directed and monitored standards of practice for food handling and sanitation. The hospital failed to have a full-time qualified employee monitor and maintain equipment in the Food and Dietetic Service. (refer to A620)

2. The Food and Dietetics Service was not organized and effective. (refer to A84, A620 and A273).

3. The nutritional needs of patients were not met in accordance with recognized dietary practices. The menus were not analyzed to ensure they met the Recommended Daily Dietary (RDA) allowance or the Dietary Reference Intake (DRI) adopted by the Food and Nutrition Board of the National Research Council of the National Academy of Sciences. (Cross Reference A630, A631).

4. A therapeutic diet manual did not accurately reflect physician ordered diets and current standards of practice. (Refer to A631).

6. Equipment was not maintained to in acceptable level of safety and quality as evidenced by refrigeration monitoring system was not fully evaluated by the food service operation to ensure food was maintained in safe ranges of 40 degrees Fahrenheit (F) or below. (Refer to A724).

7. The Infection Prevention program was ineffective for identifying unsafe food handling practices that involved cool down of potentially hazardous food and integrated into the hospital wide infection control program. (refer to A749).

8. An ongoing quality appraisal and performance improvement program did not address the complexity and scope of Food and Dietetic Services. (refer to A273).

The cumulative effect of these systemic problems resulted in the inability of the hospital to meet the statutory requirements for Food and Dietetics Service.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observations of food storage, food production and food service, staff interviews and administrative document review, the hospital failed to have a full-time qualified employee responsible for the daily management of the Food and Dietetic Service. The hospital failed to have a qualified employee direct and monitor standards of practice for food handling and sanitation. The hospital failed to have a full-time qualified employee monitor and maintain equipment in the Food and Dietetic Service. These failures resulted in the potential risk of the nutritional needs of all patients to go unmet and possibly increase the risk to food-borne illness to visitors, staff and patients.

Findings:

On 10/8/12 at 9 a.m., during an interview, the Assistant Director of Nutritional Services (ADNS) discussed the day-to-day running of the Food and Dietetics Service and the organizational structure. The ADNS stated she bore the responsibility of Patients Services part of the food service operation. She stated she was responsible for the patient trayline staff and the clinical dietitians and supervisors that oversee the trayline patient meal service staff. She stated the management of the day-to-day food preparation and food service operations were directed through the Executive Chef (EC) and he reported to the Director of Nutrition and Dining Services (DNDS). The ADNS stated she reported directly to the DNDS. The ADNS stated the Food and Dietetic Service was a contracted service of the hospital.

As a result of this management organizational structure, the Assistant Director was not fully aware of the issues affecting safe food handling practice, which included the preparation of patient food. For example, although there was a cool down procedure (safe practice to ensure minimal growth of pathogenic (causing illness) microorganism in food prepared ahead of service or to be reserved after heating) there was no consistent monitoring of the process to ensure food was prepared and maintained in a safe manner. There was no organizational oversight of the work order process to ensure management was aware of equipment maintenance and cleanliness of the food service operations.

The following findings represent specific examples of the lack of oversight on the day-to-day operation of the Food and Dietetic Service at the hospital.

During the kitchen tour with the ADNS and EC on 10/8/12 starting at 9:30 a.m., the ADNS was unable to state the standard of practice for food service staff on the cooling of hot food to be held or the maintenance of the kitchen in a clean and effective operating condition. The ADNS referred all questions to the EC.

The milk walk-in refrigerator had 8 condenser covers (approximately 18 to 20 inches in diameter) covered with dust and debris buildup. The ADNS stated she thought the food service staff was to clean the covers. The ADNS could not state when the vents had been cleaned or if there was a cleaning schedule.

Chill Tank 1 (processes food to ensure safe cooling and prevention of cross contamination) had 2 to 3 inch white and brown layer of scaly debris around the upper inner edges. There was also tape residue on the lids that was not cleaned. The EC and ADNS stated the operation of the Chill Tank 1 processes daily 40 or more large bags of food (soups and gravies) that are held and served for patients. The ADNS was not able to state when the tank had been cleaned or if there was a cleaning schedule to maintain the equipment in a sanitary operational condition. The EC explained that the tank had a self-cleaning feature but did not clean the sides above the water line and needed to be hand scrubbed and acknowledged that the tank was dirty. The EC and ADNS stated this presented a risk of cross contamination to the food processed in it.

One of two blast chiller's (super refrigeration units that quickly cool potentially hazardous food - capable of growing pathogenic microorganisms) interior surfaces and three approximately 20 inch fan covers had visible food debris. The ADNS acknowledged the interior was to be cleaned each day and agreed this equipment was not clean. She could not state when the blast chiller unit had been cleaned or if there was a cleaning schedule.

One "Craftsman" tool chest had a visible layer of rust and food debris on the top cover and both sides. The Executive Chef explained the tool chest held tools for the cook's chill equipment. The EC acknowledged the tool chest could not be maintained clean and should not be in the kitchen area.

A room service food preparation cutting board approximately 4 feet long, had yellow stains and black cut marks on the surface and food service staff used this cutting board to prepare patient food. The ADNS acknowledged the cutting board was not clean. The ADNS did not know the monitoring schedule to replace cutting boards unable to be cleaned.

Two cutting boards with yellow stained surface and black cut marks were observed in the dish room after being washed. Cutting boards were processed and ready for use by food service staff until the Patient Services Manager was asked to evaluate the cleanliness and sanitary condition of the boards. The Patient Services Manager (PSM) acknowledged that the cutting boards should be replaced when they could not be cleaned and sanitized due to the cuts in the surface. The ADNS and the PSM stated there was no routine monitoring in place to make sure that unsuitable cutting boards were taken out of service.

The janitor closet in the Dish Room contained a bucket of water that was visibly dirty. The floor and walls of the janitor closet were visibly dirty. There was trash on the floor. The ADNS was not able to state the cleaning schedule to maintain the area clean.

One (two door) reach-in refrigerator in patient tray assembly area had door gaskets with black substance and were loose and hanging away from the door when opened. ADNS stated the gaskets needed to be cleaned and replaced. She did not know if there was a work order placed to repair and was unsure of the process to place in a work order to repair.

Two Cafeteria supervisor (Cafe Sup 1 and Cafe Sup 2) staff were observed in the main kitchen area with bangs of hair exposed. The ADNS was present but did not correct staff practice until she was asked about the hair that was not held in the hairnet. She then requested staff to correct this behavior. Review of the hospital policy titled Infection Control dated 6/13/12, indicated that staff was to wear hair coverings with no hair exposed.

On 10/8/12 starting at 10:30 a.m. the temperature of one pan of (approximately 40 servings) of penne pasta noodles dated 10/8/12 and expired 10/10/12 was 89 degrees F (Fahrenheit - a measurement of temperature). The temperature was taken with facility digital thermometer by the Patient Services Manager. At 10:45 a.m. the cook stated that he had cooked the noodles and put in the full deep pan into the blast chiller at approximately 8:30 a.m. and they were 32 degrees F when he put them in the walk in refrigerator. There was no cooling log to verify the cool down period. The cook could not explain how the noodles went from 32 degrees F to 89 degrees F in 2 hours. The ADNS could not explain the standard for cool down period.

At 11:30 a.m. the Patient Services Manager was asked if the penne pasta noodles found at 89 degrees F and exceeding the 2 hours temperature of cooling to 70 degrees F was now safe to serve as prepared. She acknowledged that the product should be discarded and phoned the kitchen to request it to be discarded.

On 10/8/12 starting at 3:00 p.m., during an observation and concurrent interview of the cafeteria kitchen with the Assistant Director of Catering and and Dining (ADCD) the following was found:

The four-door deli box (kit 901) had corroded and black debris on the shelves. The ADCD was not able to state when the shelves had been cleaned. The ADCD acknowledged the shelves were not maintained in a sanitary condition.

The vegetable walk-in refrigerator and the catering walk-in refrigerator (approximately 8 feet by 6 feet) had black substance along the entire length of the ceiling braces. The ADCD acknowledged the refrigerator ceilings needed to be cleaned.

The following product was observed in the large walk-in refrigerator: two large packages of turkey dated 6/29/07 preparation and 7/15/07 expiration. The ADNS was not able to explain when this product had been produced or how the staff knew the date of preparation and expiration. On 10/8/12 at approximately 3:00 p.m., the EC demonstrated the product labeling computer which required the dates to be changed to the current dates. He stated the cook who did the preparation did not label the product correctly.
The ADNS and EC acknowledged there was no system to ensure the product labeling was being operated correctly. The ADNS and EC acknowledged that by leaving date mislabeled products in the walk-in and ready for patient service placed patients at risk of food borne illness because the product could be used without accurate knowledge of the length of holding.

On 10/10/12 at 12:00 p.m., during an interview, the ADNS stated there were no logs to monitor the temperature for the cold food items after they were made such as egg salad, tuna salad, and potato salad. The ADNS was unaware of the following hospital policy titled Cafeteria Food Temperatures dated 2/2/11 which indicated all cold prep items would be maintained at a temperature of 41 degrees or less. All temperatures logs will be dated, timed, and initialed. Any cold food item found to be above the range will be removed and discarded. The interview was in reference to several cold food items found to be in the reach-in refrigerator of the cafeteria and all above 41 degrees F.

Review of the organizational chart of the Nutrition and Dining Department indicated the ADNS was equal to the Director of Nutrition and Dining Services and they both reported to the Assistant Administrator and the contract services Regional Director of Operations. The organizational chart indicated the ADNS was over the clinical dietitians, patient services manager and executive chef.

Review of the position job description of the Assistant Director of Nutrition Services showed the following: "responsible to direct the operations of patient food services such as the planning and supervision of patient food assembly and service, scheduling, hiring, training, evaluating, and discipline of patient food service personnel and the functions of clinical nutrition services such as nutrition assessment, performance improvement and management of clinical team to ensure high quality nutritional care is provided to patients, ensures patient satisfaction, quality care, regulatory compliance." In addition this organizational chart had the Executive chef and cooks reporting to the ADNS. This reporting tree was not reflected in the job description. The job description indicated the ADNS position reported to the Director of Food and Nutrition Services. On 10/9/12 at 8:30 a.m., the ADNS stated she does not meet or report to the Administrative Assistant just to the Director of Nutrition and Dining Services.

Review of the position job description for the Director of Food and Nutrition Services indicated this position directed the operation of Food and Nutrition Services. The supervisory responsibilities were for the food service staff. The Director reported to the Regional Director of Operations. The job description does not specify a dual reporting tree to the Assistant Administrator as indicated on the organizational chart.

Review of the position job description of the Patient Services Manager indicated this position directed the operations of patient food services, including the planning and supervision of patient food assembly and service, scheduling, hiring, and training of food service personnel. The job description stated the position ensured quality care, regulatory agency compliance, assisted with management of the department in the absence of the director and/or other managers. The job description/initial competency review was signed by the ADNS and the Regional Director of Operations indicating they did the evaluation.

Review of the position job description of the clinical dietitian indicated they reported to the Clinical Nutrition Manager or Director Food and Nutrition Services. This was not consistent with the organizational chart.

Review of the position job description of the Executive Chef (EC) indicated the EC was responsible for the purchasing and food production operations of Food and Nutrition Services, under the supervision of the Director, ensured HACCP (Hazard Analysis and Critical Control Points - a management system in which food safety is addressed) controls were in place and regularly enforced and ensured the kitchen was inspection ready at all times and responsible for strict cleanliness and food sanitation controls and ensured preventative maintenance program was adhered to. The job description/initial competency review was signed by the Director of Food and Nutrition Services indicating they did the evaluation. This was not consistent with the organizational chart.

Review of the position job description of the cooks indicated they reported to the team leader. No team leader appeared on organizational chart and there was no job description for team leader.

As a result of this management organizational structure, the ADNS was not fully aware of the issues that affected safe food handling practices, meal service and patient nutrition care. There was no consistent monitoring of the process to ensure food was prepared and maintained in a safe manner. There was no therapeutic diet manual that accurately reflected physician ordered diets and current standards of practice.

The organization chart showed a direct report plan to the hospital administration but when this was not practiced the ADNS was not able to directly bring patient and food service issues directly to the administration. (Cross Reference A749, A620, A630, A631).

DIETS

Tag No.: A0630

Based on observation, staff interviews, and reviews of patient clinical nutrition care records and administrative documents, the hospital failed to:

1. Meet the nutritional needs in accordance with recognized dietary standards for 1 of 5 patients (Patient 23). Patient 23's nutritional assessment and reassessments did not follow hospital protocol for content and timeliness.

2. Ensure nutrition menus offered patients were analyzed for the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and the DRI (Dietary Reference Intake) of the Food and Nutrition Board of the National Research Council.

These failures resulted in the potential to not meet the nutritional needs of all patients and possibly negatively affect the overall quality of health care of patients.

Findings:

The clinical record for Patient 23 was reviewed. Patient 23 was admitted on 9/5/12 with the following diagnoses: non-ST elevated myocardial infarction (heart attack), peptic ulcer disease (upper intestinal disease) and coronary artery disease (blocked arteries to the heart). The initial nursing assessment on 9/6/12 indicated a nutrition consult was needed for the following reasons: Patient 23 had a one week history of eating poorly, poor appetite for more than a week and unintended weight loss.

The initial comprehensive assessment by RD (registered dietitian) occurred on 9/11/12 - five days after the consult was requested. According to policy, the nutrition assessment should have occurred within 24 hours. According to hospital policy, the RD comprehensive assessment should have assigned a risk to Patient 23: low, moderate or high. Patient 23 was assigned no risk. This assigned risk would have determined the timing for subsequent reassessments by the RD. The comprehensive initial nutrition assessment indicated the following: nutritional diagnosis was inadequate energy-protein intake, the plan was recommend to advance to heart healthy diet and the monitoring plan included need for nutrition support and the RD to follow-up per protocol.

A nutritional reassessment dated 9/13/12 documented the following plan: "... 1) if able to extubate (take out the breathing tube), recommend a heart healthy diet with texture modification according to speech therapy; 2) if tube feeding (medical device used to provide nutrition to patients who cannot obtain nutrition by swallowing), recommend Jevity 1.2 at goal of 70 milliliters (ml) per hour to provide 2016 calories, 93 g of protein; 3) RD to follow within two to four days and as needed..." On this date (9/13/12) Patient 23 was in the intensive care unit and intubated and on the ventilator (artificial breathing machine).

A nutritional reassessment dated 9/16/12 documented the following plan: "... Once patient safe for oral diet, recommend heart healthy diet and to modify texture as needed. RD to follow up within two to four days or as needed..."

A nutritional reassessment dated 9/26/12 (10 days from the previous assessment) recommended re-starting Tube Feeding (feeding tube placed through the nose into the stomach for nutrition) and to "... monitor progress with speech therapy and ability to start oral diet and for the RD (registered dietitian) to follow up in two to four days, as needed..." The date of this reassessment was not timely and there was a delayed reassessment to monitor if the past intervention was effective and to determine if the nutritional needs of the patient were being met.

A nutritional reassessment dated 10/2/12 indicated the physician requested total parental nutrition (TPN - feeding a person intravenously, bypassing the usual process of eating and digestion) and the RD recommended the parameters required to meet the nutritional needs of the Patient 23 and "... and the RD will follow up in two to four days and as needed..." The reassessment was six days after the previous reassessment instead of the two to four days as per note and policy. There was delayed reassessment to monitor the past intervention and to determine if the nutritional needs of the patient were being met.

A nutritional reassessment dated 10/9/12 was seven days after the previous reassessment rather than the two to four days as per the RD note.

On 10/9/12 at 3:33 p.m. an interview was conducted with the Registered Dietitian (RD 3). RD 3 stated the expectation was to see critical care patients within two days and the patients on noncritical floors within four days. RD 3 stated the expectation was to reassess high risk in two to four days and see consults within 24 hours. The RD 3 stated that once the nurse screens the patients nutritionally and if the nursing note documented nutritional risk, then the nurse would enter the request for an RD consult.

On 10/11/12 at 8:05 a.m. an interview was conducted with the Assistant Director Nutrition Services (ADNS). The ADNS stated she was aware the area of reassessment timeliness needed work. On 10/11/12 at 8:20 a.m. an interview was conducted with RD 3. RD 3 stated the RDs do not get a TPN list therefore they are unsure when patients start on TPN. The ADNS was not aware of this. The RD 3 stated when the patient moves to a different floor the RD covering that floor may have a higher risk floor then those patients would be seen before them because they would be a higher priority. The ADNS stated it was not acceptable to see the high nutrition risk patients as late as they were being seen. RD 3 stated she felt they were short at least one full time person and she could not get to see all the patients she needed to see each day. The ADNS stated she did not know on a daily basis how many patients all the different RDs could not see.

2. On 10/9/12 at approximately 9:20 a.m., the hospital's nutrient analysis for the regular and therapeutic diet menus were reviewed.

Review of the Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes for Vitamins, Elements, and Macronutrients indicated recommended daily intake ranges. All RDA's/DRI's are age and gender specific. It was noted that the fiber content of the menus ranged from 8.9-21.7 grams (g) of fiber depending on the menu.

Review of the DRI for Macronutrients, dated 2002/2005, indicated total fiber for children one through three years is 19 g; four through eight years is 25 g; males nine through 13 years of age is 31 g; 14 through 50 years of age is 38 g; and 50 years through greater than 70 years of age is 30 g; females nine through 18 years of age is 26 g; 19 through 50 years of age is 25 g; 50 through greater than 70 years of age is 21 g. The hospital menus were inadequate in Fiber depending on the age and gender.

There was no menu for the high protein and high calorie diet that was ordered for patients on the burn unit. It is unclear what the diet provides or what standard they are using to meet this population.

Review of the pediatric menu indicated the referenced values for vitamins, elements and macronutrients were the same for the non-pediatric menus.

On 10/9/12 at approximately 9:20 a.m. an interview was conducted with the Assistant Director of Nutrition Services (ADNS).The ADNS stated she was unsure of the primary population of the hospital in order to make sure the nutrient analysis could meet that age and gender group.

On 10/9/12 at 12:10 p.m. an interview was conducted with the Patient Services Manager. The Patient Services Manager stated there are preset parameters in their nutrient analysis program and she had recently gotten access to the program. The Patient Services Manager stated the menus are not where they should be yet and she has been trying to tweak the menu to make more nutritionally adequate. The Patient Services Manager stated she has not been able to go through all diets and all of the nutrients at this time. The Patient Services Manager stated there was no nutrient analysis for the high protein, high calorie diet at this time.

THERAPEUTIC DIET MANUAL

Tag No.: A0631

Based on dietary staff interview, and dietary document review, the hospital failed to: 1) have a therapeutic diet manual that accurately reflected physician ordered diets and current standards of practice; and 2) ensure the diet manual was consistently utilized to develop the hospitals' diets. Lack of a current and comprehensive diet manual that reflected hospital developed diets may result in inaccurate guidance to dietary and hospital staff when following physician ordered diets and meeting the nutritional needs of patients, further compromising medical status.

Findings:

Review of the Diet Manual and Enteral Nutrition Formulary was conducted on 10/9/12 at approximately 9:15 a.m. with the Assistant Director of Nutrition Services (ADNS). Review of the description for the diabetic diet indicated there would be a "HS snack" provided by physician order which consisted of 1 carbohydrate exchange (15 grams) and 1 protein exchange (1 ounce of meat which equals 7 grams) and that the diet would provide 1500-1700 calories per day.

Review of the nutrient analysis for the consistent carbohydrate diet indicated a daily snack. The snack would provide approximately 200 calories, 20 grams (g) of protein and 25 g of carbohydrate. Review of the nutrient analysis for the consistent carbohydrate diet indicated the daily average of 1667 calories, 210 g carbohydrate, and 110 g protein. If no snack was ordered the diet would provide less than 1500 calories. It is unclear if this calorie level would be sufficient for the average patient population to meet their nutritional needs would be met.

Review of the "GI Bland/Low Fiber" diet description indicated it restricts most common digestive disturbance factors including high fiber foods. It was unclear how many grams of fiber the diet provided. Review of the nutrient analysis for the GI diet indicated the diet provided between 11.1 through 16.8 grams of fiber with a weekly average of 13.9 g. Review of the nutrient analysis for the regular diet indicated it provided 9.4 through 26 g per day with a weekly average of 16.5 g. This was only a difference of a weekly average 2.6 g of fiber.

Review of the renal diet for hemodialysis diet indicated a description that the diet had no protein restriction. Review of the nutrient analysis for the renal diet indicated the diet provided a weekly average of approximately 60 g of protein. This was approximately 30 g of protein less than the regular diet.

Review of the lists of the diets that could be ordered in the electronic medical record included high protein, high calorie diet. There was no mention of this diet in the diet manual. There was no nutrient analysis of this diet.

The standard of practice is that the diet manual included a sample meal plan, foods to avoid and foods they can have. These components were not in the diet manual for any of the diets listed.

On 10/9/12 at 9:15 a.m. an interview was conducted with the ADNS. The ADNS stated they needed to have a corporate diet manual for both this hospital and another therefore it was not specific to what they had there. The ADNS stated there was no sample meal plan. The ADNS was not aware the nutrient analysis did not match what was in the diet manual for some of the diets.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation, staff interview and administrative document review, the hospital failed to maintain equipment according to acceptable levels of safety and quality when:
1. The computerized monitoring system for refrigerators storing food was not consistently evaluated by the food service staff to ensure food was maintained in the safe range of 40 degrees Fahrenheit (F) or below.
2. The walk-in freezer in the cafeteria kitchen was not monitored for ice build-up.

These failures resulted in the potential to increase the risk to patients of food-borne illnesses.

Findings:

On 10/8/12 at 2:00 p.m. and continuing during the survey, Temptrak system (computerized temperature monitoring system) records were reviewed with the Assistant Director Nutrition Services (ADNS) and the Maintenance Coordinator (MC). The Temptrak system was used to monitor approximately 40 refrigerators and freeze temperatures in the food service operations. According to the ADNS and MC the monitoring system alerted food service and maintenance staff if refrigerators or freezers were out of safe temperature range. The ADNS stated food service staff were alerted when a refrigerator temperature was out of range- above 45 degrees Fahrenheit and 10 degrees F for the freezers. The ADNS stated food service staff monitor the day to day temperatures and respond to alerts but do not see a history of temperatures.

The ADNS provided a print out of weekly logs from the system for 9/22/12 to 10/13/12. Review of the weekly/monthly graphs for 9/22/12 to 10/13/12 showed: the #1 unit (110-90/E) temperature showed it was above 40 degrees F from mid-day 9/30/12 until approximately mid-day 10/1/12. (The temperatures that were above 40 degrees F for 4 or more hours put food in the danger zone of pathogenic microorganism growth and potential for food borne illness.) The graph showed the temperatures were above 40 degrees F for approximately 24 hours. The ADNS was not able to show documentation of the implementation of food safety practices when the temperature was above 40 degrees for extended time period. She stated this refrigerator was used for patient tray service and then food was restocked for the next meal. There was no verification that the food used for patient service was maintained in safe and acceptable temperatures.

A daily graph for the reach-in refrigerator #1 (149-205/E) was above 40 degrees F before 12:00 p.m., 10/6/12 to approximately 11:00 p.m., 10/6/12 - approximately a 12 hour period. There was no system to monitor and document the responses to temperatures when they were above the food safe temperatures. The ADNS stated that food service staff usually called for repairs when the system alerted them but they do not know how the food was maintained safe or when the engineering department repairs were done on the equipment.

The policy "Food Preparation dated 10/25/2011, stated "Holding Potentially hazardous Foods (PHF) "All cold PHF will be maintained at a product temperature of 40 degrees F or below at the warmest part of the mass (generally near the top of the product.)

Policy titled temperatures of refrigerators Freezers dated 4/19/12 stated Temptrak system was monitored a minimum of once in 24 hours by Supervisors, Managers or Assistant Director. The procedures were to: Document action taken and date problem was resolved. Actions should be taken as outlined: 1. Check reason for deviant reading and determine if problem can be easily corrected 2. Take temperatures of potentially hazardous food to determine if food has exceeded 41 degrees F. 3. If there is a reason to suspect that potentially hazardous food has exceeded 41 degrees F for more than 2 hours, discard the food.

Assistant Director Nutrition Services was not able to provide documentation of actions taken when Temptrak recorded the recorded temperatures exceeded 41 degrees F.

2. On 10/18/12 at 3:35 p.m. the condenser in the walk-in freezer in the cafeteria kitchen had approximately 6 inches of ice build-up. Ice on the air curtain and on the floor of the walk-in freezer was observed. A concurrent interview was conducted with the Sous (assistant) Chef. The Sous Chef stated about a week and a half ago the maintenance staff were out to fix the unit for ice build-up. The Sous Chef stated ice buildup in the freezer occurred frequently and maintenance would have to come out and fix.

On 10/11/12 at 8:40 a.m. an interview was conducted with the Plant Operations Manager. The Plant Operations Manager stated if they notice they have a repetitive work order for a type of equipment that may put this on a schedule. The Plant Operations Manager stated they probably need to take a more in-depth look at the walk-in freezer in the cafeteria kitchen. The Plant Operations Manager stated it was a problem with the ice build-up.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation, staff interview, and administrative document review, the hospital failed to have an active, hospital-wide infection control program reflecting the infection control practitioner's responsibilities for measures to identify, investigate, report, prevent and control infections and communicable diseases when:

1. Unsafe food handling practices that involved cool down of potentially hazardous foods were not identified.

2. The Pot Washer did not sanitize his hands between changing gloves from the dirty dishwashing area to handling clean sanitary dishware.

3. The refrigerator in the cafeteria area was not monitored for highly perishable food items such as fruit juice.

4. Multiple cold food items (for example - tuna salad, potato salad and raw fish) were stored above 41 degrees F (Fahrenheit - a measure of temperature) in violation of hospital policy and FDA (Food and Drug Administration) standards.

5. Staff members did not wear personal protective equipment (PPE) or incorrectly wore personal protective equipment in violation of hospital policy and procedure and/or did not clean personal stethoscope before and after use on a patient.

6. Hand-washing was not observed by a staff member prior to opening sterile items onto the sterile field in interventional radiology suite.

7. The hospital used flash-sterilization (fast cleaning technique of surgical instruments) as a substitute for sufficient instrument inventory.

These failures had the potential for obstructing the infection control and prevention process, which put the patient(s) and hospital personnel at risk for possible exposure to food-borne and blood-borne pathogen(s) (pathogens are organisms causing diseases) and/or transmission of communicable diseases.

Findings:

1. a. On 10/8/12 at 10:30 a.m. the temperature of one pan of (approximately 40 servings) penne pasta noodles dated 10/8/12 and expired 10/10/12 was 89 degrees F (Fahrenheit -measure of temperature). The temperature was taken with the facility digital thermometer by the Patient Services Manager.

At 10:45 a.m. the Cook stated that he had prepared the noodles and placed the pan into the blast chiller at 8:30 a.m. The Cook stated the noodles were 32 degrees F at this time and were then placed in the walk in refrigerator.

Review of the Cooling Log dated 10/8/12 "Penne pasta" was blank for all sections of the form: "remove from cooler", "record cooking temperature" and "cooling". No temperatures were recorded on the cooling log. The cook stated the cooling temperature log form was knew and he did not know how to record the food temperatures. The cook could not explain how the noodles reached 89 degrees F two hours after being taken out of the blast chiller.

On 10/8/12 at 11:30 a.m. the Patient Services Manager was asked if the penne pasta noodles found at 89 degrees F and exceeding the 2 hours temperature of cooling to 70 degrees F was now safe to serve as prepared. She acknowledged that the product should be discarded and phoned the kitchen to discard the penne pasta.

The Policy "Food Preparation dated 10/25/2011, stated the purpose: "Attention to detail in every procedure is essential to assuring high standards of quality. Errors made can cause food borne illness." The procedure indicated: "While all foods can transmit foodborne illness, some are more likely to do so because they support the rapid and continuous growth of bacteria that cause infections or that produce harmful toxins, or support the slower growth of bacteria that can cause botulism [deadly toxin). Such foods are called "Potentially hazardous food (PHF) and include food of animal origin. The procedure states the "hot PHF that are to be cooled must be rapidly cooled ..." The cooling standard was to cool after 2 hours to 70 degrees or below and 41 degrees F or below in 4 additional hours.

b. On 10/8/12 at 3:40 p.m. in the walk-in meat refrigerator in the cafeteria kitchen cooked rice was observed in a pan. The temperature of the cooked rice was measured at 125.2 degrees F. The cooked rice was labeled with a preparation time of 6 p.m. on 10/8/12.

An interview was conducted at 3:55 p.m. on 10/8/12 with the Cafeteria Cook. The Cafeteria Cook stated he put the cooked rice into the walk-in at 2:00 p.m. and he did not record on a cool down log the temperature of the food. (The cook stated the label for 6 p.m. was in error) He stated the food item must be cooled down to 41 degrees or below within 2 hours. A concurrent interview was conducted with the Sous (assistant) Chef. The Sous Chef stated the food must be cooled down to 41 degrees within 4 hours.

On 10/8/12 at 4:00 p.m. an interview was conducted with the Executive Chef (EC). The EC stated cool down was to 70 degrees F within 2 hours then to 41 degrees F in 4 hours after that. He stated if the recorded temperature did not meet those time frames then the food was to be discarded. The EC acknowledged this was a problem with the cooked rice and they would discard the rice.

Review of the HACCP (Hazard Analysis and Critical Control Points) Plan Form: HFS #001 Prepared Hot for Hot Service dated 6/10/98 and revised 1/24/02, indicated to chill unused portions. Food held at a temperature of 140 degrees F or higher for less than 2 hours must be chilled from 140 degrees F to 70 degrees F within 2 hours or less and from 70 degrees F to 41 degrees F in an additional 4 hours or less. The Plan indicated to monitor cooler temperature according to policy.

According to the Center for Disease Control and Prevention (CDC) report for 1993 - 1997, "Surveillance for Food-borne Disease Outbreaks - United States" identified the most significant factors to food borne illness. Improper cooking and improper holding temperatures were two of several categories identified as contributing factors directly related to food safety concerns.

The US Food and Drug Administration (FDA) referred to improper cooling and holding temperature activities as directly related to food safety concerns and as food-borne illness risk factors. The FDA gave these guidelines: to effectively reduce the occurrence of food-borne risk factors, food service operators should develop and implement food safety management systems to prevent, eliminate or reduce the occurrence of food-borne illness risk factors. The FDA Food Code identified a preventative rather than a reactive approach to food safety through a continuous system of monitoring and verification. Control measures essential to food safety, such as proper cooking, cooling, and refrigeration, includes time/temperature control for foods. For example, within two hours of cooking, the internal food temperature shall reach 70 degrees Fahrenheit (F) or less and 41 degrees F or less after an additional four hours.

2. On 10/8/12 starting at 4:00 p.m. the pot washer was observed to go from the dirty wash area and handle clean sanitized pots with only the changing of his gloves. He stated that he did not wash or sanitize his hands between changing gloves.

The Assistant Director of Nutrition Services stated that staff was to wash hands when changing gloves.

Review of the hospital policy titled Infection Control dated 6/13/12, indicated employees must thoroughly and frequently perform hand washing between handling of dirty dishes or equipment and handling clean food or utensils.

3. On 10/8/12 starting at 3:00 p.m. a reach-in refrigerator in the cafeteria area was observed to contain fresh fruit juice with the manufacturer's directions "Extremely perishable keep refrigerated". There was no manual internal thermometer or temptrak (computerized) internal temperature monitoring system for this refrigerator. The Assistant Director Dining and Catering confirmed there was no temperature monitoring for this refrigerator even though it contained a highly perishable product.

The hospital policy titled Temperatures of refrigerators Freezers dated 4/19/12 indicated: "If not on Temptrak system, refrigerator/freezer monitored minimum of twice daily and recorded by (cafeteria/dining area)dining associate or Retail associate."

There was no temperature documents provided for review for the refrigerator storing the fruit juice.

4. On 10/8/12 at 3:15 p.m. in two separate reach-in refrigerators the following items were observed: tuna salad cup that was 45.5 degrees F, egg salad cup that was 46.9 degrees F, sunshine roll (containing raw salmon) was 48.3 degrees F, chocolate milk that was 50.1 degrees F. A concurrent interview was conducted with the Assistant Director of Dining and Catering.

On 10/8/12 at 3:30 p.m., during an interview, the Retail Manager stated the food items were brought in at 7:00 a.m. each day and temperatures were taken at that time. The food service staff replenished the reach-in refrigerators as needed. The food service staff were supposed to record the temperatures twice daily. The Retail Manager stated the sushi (raw fish food product) came in at 10:30 a.m. daily.

On 10/8/12 at 3:40 p.m., during an observation, the walk-in meat refrigerator in the cafeteria kitchen contained the following items: sliced ham was 42.6 degrees F in an approximately a pan that was 12 inch by 6 inch by 4 inches deep pan, sliced turkey was 43.7 degrees F and 43.8 degrees F in two separate 12 inch by 6 inch by 4 inch pans, and gnocchi (various thick, soft dumplings) were 48 degrees F.

Review of the hospital policy titled Cafeteria Food Temperatures dated 2/2/11, indicated all cold prep items should be maintained at a temperature of 41 degrees or less. All temperatures logs should be dated, timed, and initialed. Any cold food item found to be above the range would be removed and discarded.

On 10/10/12 at 12:00 p.m., during an interview, the Assistant Director Nutrition Services stated that the Food Service did not have any logs to monitor the temperature for the cold items after they were made, such as egg salad, tuna salad, and potato salad.

Review of the refrigerator temperature log dated October 2012, indicated on 10/8/12 the sushi reach-in refrigerator was 36 degrees F in the "AM" column and the sandwich reach-in refrigerator was 39 degrees F in the "AM" column. The Assistant Director Nutrition Services and other food service staff could not clarify if the temperatures reflected refrigerator or food temperatures. It was unclear what time in the evening staff recorded the temperature or if the staff took temperatures of the food when they came out to replenish the food items. The replenishing of the food items at different times made it unclear to know how long the food items were placed out in the reach-in refrigerator.

On 10/10/12, at 11:45 a.m., the Manager of Infection Control stated she was involved in annual safety rounds in the food service operation, provided handwashing training, and looked at refrigerator temperatures. She stated that her rounds did not involve the application of food safety standards that are outlined in the FDA (Food and Drug Administration) Food Code 2009. She stated that she was not familiar with the requirement for cooling potentially hazardous food. Review of the form used for environmental rounds showed it was a general form and not specific to food safe practices.

She stated that the quality committee reviewed the quality measures that were presented by the Food and Nutrition department each quarter but did not question the consistent 90 to 100 percent reports that monitored the refrigerator temperatures. She stated that the committee did not require other measures of infection control monitoring or to reflect the high volume and high risk operation of the food service department.

5. a. On 10/8/12 at 11 a.m., during an observation on the 10th floor, step down unit 2, Housekeeper (HK) was observed cleaning Patient Room 1024. The room was designated with a sign outside the room as a "Contact Isolation Room" (a room where special precautions are taken to prevent the spread of infections). HK entered the room, removed her protective gown and gloves, and placed them in a waste receptacle. HK proceeded to clean the isolation room without PPE (Personal Protective Equipment) and came in contact with room surfaces.

On 10/8/12 at 11:05 a.m. during an interview, HK stated she did enter the contact isolation room without the proper PPE.

On 10/8/12 at 11:05 am., during an interview, the Manager of the step down unit on the 10th Floor confirmed HK did not wear proper PPE when entering the isolation room 1024.

b. On 10/9/12 at 9 a.m., during an observation and concurrent interview, on the Fourth Floor East Cardiac Pulmonary Care Unit, Admitting Clerk (AC) exited Contact Isolation Room 451 wearing a yellow protective gown. AC-4th Floor proceeded through the hallway approximately 10 feet and stopped at an Isolation Cart (a cart that holds personal protective equipment) and removed the protective gown. The AC-4th Floor acknowledged that she should not have exited and walked the hallway with the yellow protective gown.

On 10/9/12 at 9:05 a.m., during an interview, the Manager of the 4th floor unit confirmed the AC-4th Floor did not follow hospital policy and did not follow infection control standards by walking out of an isolation room with protective gown.

c. On 10/9/12 at 10:19 a.m., during an observation on the Fourth Floor East, Cardiac Pulmonary Care Unit (CPCU). Medical Doctor (MD) 1 was seen entering Patient Room 444. The room was designated as an "Isolation Precaution Room". MD 1 was not wearing a protective gown. MD 1 assessed the Patient in bed A using his personal stethoscope. MD 1 exited room 444 and entered room 450 and assessed the patient in bed A without cleaning the stethoscope or washing hands.

On 10/9/12 at 10:25 a.m., during an interview, MD 1 stated he did not clean his stethoscope after he assessed the patient in Room 444. MD 1 stated he should have cleaned his stethoscope between patient assessments, washed his hands and worn protective gown prior to entering the isolation room.


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6. On 10/9/12 at 9 a.m., during an observation and a concurrent interview, Interventional Radiology Tech 1 (IRT) was observed in a restricted area, opening sterile items onto a sterile field after removing contaminated gloves and with out washing his hands. IRT acknowledged that he did not perform hand hygiene after removing gloves. IRT stated he should have washed his hands after removing his soiled gloves and before opening sterile packages.

On 10/9/12 at 3:15 p.m., during an interview, Interventional Radiology department Manager (IRM) stated, the staff member should have washed his hands after taking off his gloves and before opening sterile items. The IRM stated the Interventional Radiology department follows AORN (Association of Peri-Operative Room Nurses), and the CDC (Centers of Disease Control) guidelines for infection control and sterile technique.

The facility policy and procedure titled, "Hand Hygiene" dated 7/30/12, indicated... Hand washing is the single most important means of preventing the spread of infection and is to be observed in any interaction where transmission of pathogenic organisms is possible...specific indications for hand washing...after contact with a patient...after contact with inanimate objects...after removing gloves."

On 10/11/12 at 9 a.m., during an interview, (ICP) stated, the CDC and AORN regulatory guidelines are the protocols that the Interventional Radiology department follows.

7. On 10/8/12 at 11:05 a.m., the document provided by the hospital titled "(Autoclave Log Detail Report): Instruments Flash Sterilized" dated from 7/1/12 to 7/31/12 was reviewed. The document indicated flash sterilization was performed 71 times, due to "sterile (item) not available, needed for next case." or " Needed for current case and sterile (item) not available."

Review of the "Autoclave Log Detail Report: Instruments Flash Sterilized" dated from 8/1/12 to 8/31/12 indicated, flash sterilization was performed 67 times due to "sterile not available, need for next case." or "Needed for current case and sterile not available."

Review of the "(Autoclave Log Detail Report): Instruments Flash Sterilized" dated from 9/1/12 to 9/30/12 indicated flash sterilization was performed 52 times due to "sterile not available need for next case." or "Needed for current case and sterile not available."

On 10/11/12 at 11:04 a.m., during an interview the Infection Control Manager (ICM) stated flash sterilization was not acceptable to perform because of a shortage of instruments. ICM stated flash sterilization should be used rarely and under strict guidelines. The ICM stated she was not aware of the Autoclave log report and how often flash sterilization was being done.

On 10/11/12 at 10 a.m., the 2012 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. The section titled "Recommended Practices for Sterilization in the Perioperative Practice Setting" indicated "Recommendation IV.a. Flash sterilization should not be used as a substitute for sufficient instrument inventory."