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Based on administrative staff interview, the hospital failed to ensure that the governing body was responsible for the services provided under contract that met all applicable conditions of participation and standards which included assessment of contracted food services identify quality and performance problems, implement appropriate corrective actions and improvement activities.

Findings:

In an interview, the survey findings were discussed with the hospital administration represented by the chief operating officer (COO) and VP of General Services on 7/18/12 at 1:10 p.m. The COO acknowledged that she held administrative responsibility for the hospital.

The COO acknowledged the food service operation was a contracted service. The COO acknowledged the performance indicators for the contracted food service had addressed the patient satisfaction of the newly implemented room service (patient ordering and meal service) and had not monitored the food safety procedures and supervision of safe food practices in a developed quality appraisal and performance improvement plan relative to the scope of the department. The COO acknowledged the organization of the contracted food service operation did not ensure safe food practices when implemented by the staff responsible for the day to day operation of the food service.

It was also noted that the COO and VP of General Services had not identified the lack of a comprehensive performance improvement program that reflected the depth and breadth of the contracted food service.

Based on administrative and dietary staff interview and dietary department document review, the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of the food serviced which resulted in failure to identify issues in safe food handling practices, food storage and sanitation all of which could result in food-borne illness. In addition, during pharmacy staff interview and document review, the hospital failed to use available data of controlled substance (CS) discrepancies from the automatic dispensing cabinet (Pyxis) to identify opportunities for improvement or changes that will lead to improvement. There were 523 pages (each page averaged 12 to 14 transactions of discrepancies) in a six-month period and there were 11 Pyxis Units with unresolved discrepancies at the time of Pyxis CS medication discrepancy review. Discrepancies could be related to medication errors such as when the amount taken to administer to patients differed from the amount prescribed.

Findings:

1. During the survey from 7/16 to 7/19/2012, deficient practices related to 1) safe and sanitary food services operation (cross-reference A620, A749), 2) ensuring patient nutritional needs were met (cross-reference A621, and A630) were identified.

In an interview on 7/18/12 beginning at 2:20 p.m., with the director of hospitality, food service general manager (both contract food service employees) and hospital chief clinical dietitian, food service and clinical nutrition quality programs were reviewed.

The food service general manager stated the food service quality program was based on patient satisfaction which included food temperatures and patient tray assessments with the implementation of the room service program. She acknowledged there was no food service quality program regarding the safe food practices as addressed during the survey which included the accurate documentation of food cool down, raw food stored with ready to eat, managing thawing meat, managing safe food storage of potentially hazardous foods (food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation), ensuring safe cooking temperatures of high risk products like ground beef used for patient meals, and cleaning and maintaining kitchen food prep surfaces and equipment.

The chief clinical dietitian stated the clinical performance improvement emphasizes the identification of high risk nutritional patients. She acknowledged there was no system to identify patients who did not meet the high risk nutritional nursing screen on admission but would require nutritional interventions.



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2. An automated dispensing cabinet (ADC) is a computerized medication dispensing machine. The ADC is similar to a vending machine in that the user enters what they want and the machine dispenses the product. CS medication discrepancies are when the count of the medication is different from what is expected. This occurs from misuse of the ADC when medications are not correctly taken or entered into the computer.

On 7/16/12, a review of the ADC generated discrepancy report, which listed discrepancies over the period from 01/15/12 to 07/15/12, indicated there were 523 pages of CS medication discrepancies (about 3 inches thick). In the process of reconciliation, the user had to document the reason(s) for the discrepancy. Many of the documented reasons for the reconciled transactions included "miscounted" and "previous shift took 2 but accounted for 1" or similar reasons.

At 4:20 p.m. on 7/16/12, during an interview with the pharmacy manager of business operations (PMGR), she said CS discrepancies were to be reconciled at the end of each shift or as soon as possible. She said she was responsible for reviewing the Pyxis discrepancy report to ensure discrepancies were reconciled appropriately and timely. She said due to the high volume, she could only "spot check" a few discrepancy transactions each month; questionable reconciliations were forwarded to the pharmacy director (who was not available for interview).

PMGR also provided the outstanding discrepancy report. There were 11 Pyxis Units with unresolved CS discrepancies; two discrepancies had not been resolved since 6/20/12. The 4/12 "Medication Administration Requirements" policy indicated the following under CS Discrepancies: "The Resource Nurse or manager's designee runs a discrepancy report at the end of each shift, and follows up on any discrepancies. Unresolved discrepancies are to be reported immediately to the Patient Care Manager or her/his designee."

On 7/19/12 at 11:50 a.m., during an interview, the associate director of pharmacy (Pharm 1) was asked to comment on the volume of CS discrepancies. He said the hospital had nothing to compare against. He said there had been no trending analysis or studies to find out the root causes for the large volume of CS discrepancies.

The medication safety/adverse drug events committee (MSC) is a multidisciplinary committee responsible for medication safety in the hospital. A review of the MSC minutes from the past six months revealed the hospital did not identify the large volume of CS medication discrepancies as an opportunity for improvement; there were no documented evidence the hospital studied why many CS discrepancies occurred, and as a result, failed to institute improvement efforts (such as nursing education if Pyxis misuse was the reason) to reduce the discrepancy incidents.

Based on observation, staff interviews, and record reviews, the hospital failed to set priorities for its performance improvement activities that focused on high risk, high volume areas that might affect health outcomes, patient safety, and quality of care. The hospital failed to ensure the pharmacy department had quality data to show it employed proactive mechanisms to measure, analyze, and track medication errors related to intravenous (IV) compounding and medication dispensing and distribution. There was no internal tracking mechanism to identify actual and/or potential medication-related errors so weaknesses and deficiencies could be identified and actions implemented to improve performance. The pharmacy performed about 17,000 compounded IV products each month; the pharmacists verified and dispensed about 255,000 prescription orders per month.

Findings:

On 7/16/12 at 10:30 a.m., a tour of the central pharmacy was conducted. The IV room, where most of the intravenous medication compounding occurred, was observed in the presence of the pharmacy manager of clinical effectiveness (Pharm 2) and the IV supervisor. The IV supervisor was asked if the pharmacy had quality data that tracked medication errors related to IV compounding, he said he had just begun collecting IV compound related error data this month but had nothing to present. He said the pharmacy leadership had talked about tracking and trending IV compound related errors but never got around to it. The central pharmacy IV room made about 17,000 compounded products per month.

The June 2, 2011 Issue of the Institute for Safe Medication Practices (ISMP) Alert indicated the following:

"Errors during pharmacy preparation of parenteral products and admixtures may happen more often than you think. A five-hospital observational study on the accuracy of preparing small- and large-volume injectables, chemotherapy solutions, and parenteral nutrition showed a mean error rate of 9%, meaning almost 1 in 10 products was prepared incorrectly and then dispensed. Error rates for complex solutions such as parenteral nutrition were especially high - 37% for manual preparation and 22% for preparations that were partly automated. More recently, a 2009 State of Pharmacy Compounding Survey showed that 30% of hospitals have experienced a patient event involving a compounding error in the past 5 years."

An interview with the associate director of pharmacy (Pharm 1) and Pharm 2 was conducted on 7/19/12 at 1 p.m. They both indicated the pharmacy relied on the SAFE (Stanford Alert for Event) reporting to extract medication error data, from which analysis and trending was conducted. The SAFE is the hospital's event reporting system, which is voluntary. In other words, the data is dependent upon staff voluntary reporting and is retrospective. When asked if the pharmacy had an internal tracking to proactively identify actual or potential errors for analysis and trending, to identify weaknesses, system failures, etc., both pharmacists said no. A review of the SAFE reported data indicated the hospital reported about 70 to 90 medication errors hospital-wide per month. Pharm 1 said the pharmacy department verified and dispensed 8,500 prescription orders per day (or 255,000 per month).

Based on interview and record review, the hospital failed to ensure that a physician's order to obtain daily weights for Patient 20 was implemented daily.

Findings:

On 7/17/12 at 1:51 P.M., Patient 20's medical record was reviewed.

On 7/13/12 a physician wrote an order for Patient 20 to be weighed daily.

On 7/15/12 a physician ordered a tube feeding of Glucerna 1.2 at 85 cc/hour (a method to receive nutrition via a tube).

On 7/17/12 at 2:00 p.m., registered nurse 10 (RN 10) reviewed Patient 20's electronic medical record and stated the patient's weight was taken on 7/13/12, and 7/17/12. There was no weight listed in the medical record for 7/14/12, 7/15/12, or 7/16/12. RN 10 reviewed the EMR and was unable to state why Patient 20's weight had not been taken for those three days in accordance with the physician's order.

According to the hospital's Enteral Tube Feeding Guidelines, under the category of recommendations and monitoring, "Body weight and intake and output should be monitored daily or per unit weighing standard."

Based on interview and record review the hospital failed to care plan patient nursing care needs and nursing interventions in response to those patient care needs for four of 21 sampled patients (2, 6, 18, and 24).

Findings:

1. Patient 2 was admitted to the hospital on 7/13/12 for right knee surgery. On 7/16/12 at 11:30 a.m. Patient 2's medical record was reviewed. The medical record indicated Patient 2 was receiving insulin as part of his medical treatment. Further review of Patient 2's medical record had no indication a care plan was initiated for Patient 2's insulin treatment.

On the above same day and time during an interview with Patient 2's primary nurse, she confirmed an insulin care plan was not initiated for Patient 2.

2. Patient 6 was admitted to the hospital on 7/9/12 for complications of a bone marrow transplant. On 7/16/12 at 1:45 p.m. Patient 6's medical record was reviewed. The medical record indicated Patient 6 had a history of diabetes and high blood pressure. Patient 6 was being treated for his diabetes and high blood pressure with medication at the hospital. Further review of Patient 6's medical record had no indication a care plan addressing Patient 6's diabetes and high blood pressure was initiated.

During an interview on the above date and time with registered nurse 1 (RN 1), she confirmed Patient 6 did not have a care plan addressing his diabetes and high blood pressure. RN 1 further stated if she were his nurse, she would have initiated care plans for Patient 6 addressing his diabetes and high blood pressure.

3. Patient 18 was admitted to the hospital on 6/25/12 for a stomach bleed. On 7/17/12 at 2:15 p.m. Patient 18's medical record was reviewed. The record indicated that on 7/15/12 Patient 18 was started on antibiotics for an infection. Further review of Patient 18's medical record had no indication nursing had initiated a care plan addressing Patient 18's change of condition requiring Patient 18's need of antibiotic therapy.

On the above same day and time during an interview with Patient 18's primary nurse, she confirmed nursing had not initiated a care plan addressing Patient 18's antibiotic therapy.

Review of the hospital's "Plan of Care" policy and procedures dated 11/09 indicated "as patient needs change, each discipline can add or discontinue problems, goals and interventions."

4. Patient 24 was admitted 5/12/2012 with diagnoses of depression. Patient identified 5/12/12 with decreased oral intake and a physician order for swallowing screen was ordered. Diet order was regular diet mechanical soft.

The medical nutrition therapy progress note dated 5/15/12 identified Patient 24 with diagnoses of depression, hypothyroid and uterine cancer with an admission weight of 48.1 kilograms (105.82 pounds). The nutrition monitoring and evaluation listed energy intake, fluid and beverage intake and food intake and protein profile for albumin. Patient was at high nutritional risk.

The primary team note dated 5/16/12 stated the patient on mechanical soft diet and "does not care for the food that is offered to her. She states the food is hard and she cannot eat it. Patient refuses food that is offered."

Review of the care plans on 7/17/12 starting at 2:10 p.m. showed there was no care plan developed for Patient 24 addressing decreased intake, and medical nutrition therapy monitoring criteria.

Interview with the nurse manager psych unit G 2 acknowledged there was no plan of care developed for Patient 24 to address the nutrition and feeding issues that were identified at admission.

Review of the policy titles interdisciplinary plan of care stated, "to develop a plan of care for treatment and services is individualized and takes into consideration the patient's needs, strengths, limitations and goals. The following disciplines collaborate in developing the plan of care as appropriate for each patient: nursing, rehab services, nutrition services. The RN identifies the appropriate problems, goals and interventions for each patient within 24 hours of admission."

Based on staff interview and medical record review, the hospital failed to ensure medications were prepared and administered as ordered by the physician or in accordance with the hospital's established protocol or policy and procedures when:

1. Staff failed to carry out an order for morphine as prescribed for one (Patient 57) of six emergency department (ED) medical records reviewed; and,

2. Staff failed to recheck fingerstick blood sugar within 30 minutes following the administration of D50W (50% dextrose in water, a sugar solution) for a hypoglycemic (low blood sugar) event, as per hospital protocol, for three of three D50W administrations in two patients (Patients 66 and 68). The failure demonstrated the lack of assessment and monitoring for the patient's condition and medication effectiveness after the event; and,

3. Staff failed to administer insulin (a hormone used to reduce blood sugar) as in accordance with the prescribed insulin infusion protocol, which resulted in administration error, for one of three patients (Patient 68) who were receiving insulin infusion administration; and,

4. Staff failed to carry out an insulin order in a timely manner for one of three patients (Patient 68) who were receiving insulin when patient 68 had a blood glucose (BG) reading of 843 milligrams per deciliter (mg/dL) (target BG range 110-150 mg/dL) while in the Emergency Department (ED). The failure to carry out an order timely resulted in prolonged high blood sugar (hyperglycemia) for Patient 68.

Findings:

1. On 7/17/12 at 1 p.m., a review of Patient 57's ED record with Pharm (pharmacist) 1 and Pharm 2 revealed the patient came in on 7/11/12 for abdominal pain. He had a physician order for morphine 6 mg "once" at 2:44 p.m. The record showed 4 mg was withdrawn from the Pyxis (automated dispensing cabinet) and administered at 3:21 p.m. The Pyxis record indicated the nurse "pulled 4 mg/iv instead of 8 mg/iv per pt (patient) request." However, there was no documented evidence the order to give 4 mg was clarified with the physician. Pharm 2 agreed the medication was not given as ordered.

2. The hospital's "Hypoglycemia Protocol" defined "hypoglycemic" as when BG was less than 70 mg/dL (milligram/deciLiter). The protocol indicated to give one dose (amount varied depending on BS reading) of D50W intravenously and "check BG every 30 minutes until BG is above 80, then every hour until glucose is 110 or greater."

A review of Patient 66's medical record at the North Intensive Care Unit (NICU) with Pharm 1 and Pharm 2 was conducted on 7/18/12 at 10:45 a.m. The record revealed that, on 7/15/12 at 11:55 a.m., the patient required a dose of D50W when her BG was at 65. The record showed a dose was administered but there was no BG recheck within 30 minutes of the D50W administration. The next BG check was at 1:24 p.m., 1 hour and 29 minutes later. The ICU flowsheet and nursing narratives did not document the post 30 minute BG recheck. Pharm 2 verified that staff did not follow the hospital hypoglycemia protocol.

Patient 68 came into the hospital on 7/16/12 at around midnight with severe respiratory distress and coughing out blood. He was Type I diabetic.

On 7/18/12 at 1 p.m., a review of Patient 68's medical record at the E2 (ICU) Unit with the E2 nurse manager, the clinical nurse specialist (CNS), and Pharm 2 showed the patient had a BG of 62 at 11:02 a.m. (on 7/16/12), a dose of D50W was given. However, the next BG check happened at 12:13 p.m., 1 hour at 11 minutes later. Similarly, at 9:03 p.m. (same day), the patient's BG went down to 53, which required another dose of D50W. The next BG happened 50 minutes later. All three staff confirmed the staff did not follow the hospital hypoglycemia protocol.

3. The review of Patient 68's medical record (as above) also revealed an administration error that led to the patient's hypoglycemia at 9:03 p.m. on 7/16/12. The record showed the patient was on continuous insulin infusion on 7/16/12. At 7:37 p.m., the BG was at 91 (low; target is 110-150). The protocol indicated to turn off the infusion, but the record showed the staff continued to run the insulin at the rate of 1 unit/hour and did not turn it off until 9 p.m., at which time the BG was 53 (hypoglycemia). As a result, a dose of D50W was needed to manage the hypoglycemia. All three staff confirmed that staff did not follow the protocol, resulting in an administration error.

4. The review of Patient 68's medical record also revealed when the patient arrived at the ED on 7/16/12 at 00:06 a.m., his BG was 843 (extremely high). The ED physician ordered 10 units of intravenous insulin to be given once at 3:33 a.m., however, it was not given until the patient arrived at the E2 Unit at 5:25 a.m. (BG was 748). Thus, insulin was not given until almost 2 hours after it was prescribed. The patient sustained a very high BG for over 5 hours before given the insulin for treatment. Although efforts (such as intubation) were made to manage the patient's condition at the time in the ED, the E2 Manager and the CNS could not provide explanations why there was such a delay.

The hospital policy and procedures on "Medication Administration Requirements", dated 4/12, stipulated: "Medications should be prepared and given as close to the specified time as possible (no more than 60 minutes before or after designated time)...."

Based on interview and record review, the hospital failed to administered blood and blood products as per the hospital's policy and procedures for two of 18 sampled patients (3, 12).

Findings:

1. Patient 3 was admitted to the hospital on 7/9/12 for acute myelogenous leukemia (cancer of the blood and bone marrow).

On 7/16/12 at 12:40 p.m. review of Patient 3's medical record indicated the patient received blood on 7/11/12 at 12:25 p.m. and on 7/11/12 at 6:10 p.m., although the record indicated the blood was verified by the primary nurse and "by another nurse" the record did not indicate the name of the second nurse. The hospital failed to document the name and signature of the verifying nurse (second nurse) and therefore the department was not able to determine if two licensed provider verified the blood products prior to administration.

During an interview with the department manager of the oncology unit (F ground), she confirmed the above findings and acknowledged the department was not able to determine if two licensed providers verified the blood products prior to administration.

2. Patient 12 was admitted to the hospital on 6/29/12 for hepatic encephalopathy (brain dysfunction directly due to liver dysfunction).

On 7/17/12 at 11 a.m. a review of Patient 12's blood transfusion record was conducted. The record indicated Patient 12 had received 6 units of red blood cells and 4 units of plasma (liquid part of blood). The blood transfusion records for the above blood products did not contain the required two licensed providers' signatures verifying the correct blood was administered to the correct patient. The blood transfusion records was not filled out completely and did not indicate the date and time of administration.

Both hospital escorts confirmed the above findings with the department.

Review of the hospital's "Blood and Blood Component Administration" policy and procedures dated 3/12, indicated "two licensed providers must verify the blood products with the order to transfuse just before the transfusion is initiated"...and must document the nurse's signature.

Based on observation, staff interview, and record review, the hospital failed to ensure drugs were controlled and distributed according to hospital policy and procedures and standards of practice, when: 1) The hospital failed to ensure the development and implementation of a policy and procedures for fentanyl patches (Duragesic, a potent opioid applied to the skin for pain control). Four medical records were reviewed for patients who had received a fentanyl patch. The hospital did not establish that one (Patient 72) met the black box warning (BBW) criteria for a fentanyl patch. This failure had the potential for the patient to be exposed to respiratory (breathing) depression; and,
2) There lacked a close monitoring for the automated dispensing cabinet (Pyxis) override process to ensure overrides were performed according to the hospital policy and procedures. Override takes place when an authorized user obtains medication(s) before the pharmacist has a chance to review the physician order for appropriateness, i.e., dose, duration, allergies, drug-interactions, etc. Eight of 140 Pyxis Units did not have the correct Pyxis setting, allowing users to override without documenting valid reasons for doing so.

These failures had potential to result in unsafe medication use practices.

Findings:

1. The U.S. Food and Drug Administration (FDA) issued a boxed warning (the strongest label warning, aka BBW) on fentanyl regarding the "...potentially life-threatening [risk] of hypoventilation (too shallow or too slow breathing), respiratory depression [a condition of having a breathing rate that becomes too low to ventilate the lung], and/or death... Duragesic?... should only be prescribed for opioid-tolerant patients ...Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg (milligrams) of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic (same level of pain control) dose of another opioid."
On 7/19/12 at 9:55 a.m., review of Patient 72's medical record with Pharm 1 and Pharm 2 revealed the patient was admitted to the hospital for advanced metastatic melanoma (a serious form of skin cancer). Six days after admission on 7/17/12, she had a physician order for fentanyl 12 micrograms per hour (mcg/hr) (a low dose) patch to be applied every 3 days "for long-acting pain control". The medication use history revealed the patient had only received as-needed doses of Vicodin (hydrocodone with Tylenol) and occasional as-needed doses of hydromorphone (Dilaudid) six days prior to the administration of fentanyl. The amount of usage did not qualify the patient as opioid-tolerant (usage of at least 7 days or longer of 60 mg morphine, 8 mg of Dilaudid, 30 mg oxycodone, or a dose comparable to fentanyl patch).

The record showed the patient was transitioned to comfort care on 7/17/12; all therapy monitoring was turned off, including the monitoring for respiratory status. On 7/19/12 at 10 a.m., Pharm 2 agreed that Patient 72 did not meet the opioid-tolerance requirement per the FDA BBW to warrant the use of fentanyl patch, however, she reasoned that a low dose of fentanyl patch was justified since the patient was on comfort care. The hospital did not have evidence-based literatures to support the use outside of the BBW and did not have a policy and procedures delineating such use.

2. The hospital medication administration policy and procedures on "Automated Dispensing Cabinets", 5/12, indicated Pyxis overrides were allowed "in situations where a delay in pharmacist verification of physician order entry has potential to harm a patient" such as in cases of nausea/vomiting, pain, or change in patient status that required immediate attention. The "Medication Administration Requirements" policy, dated 4/12, indicated, "The reason for the override must be appropriate for the drug removed, and documented in Pyxis." The policy also indicated the override report was "reviewed monthly for trending and assignments as necessary."

On 7/16/12, the pharmacy manager of business operations (PMGR) provided a 30-day report of Pyxis override transactions, from 6/14/12 to 7/14/12 (108 pages). The report revealed there were 39 of 108 pages of override transactions that did not include reasons for the overrides.

On 7/18/12 at 4 p.m., Pharm 1 indicated eight of 140 Pyxis units did not have the right setting under the clinical data, therefore, did not require the users to document the reason for the overrides. The pharmacist monthly review of the override report did not identify this as a Pyxis setting problem.

Based on observations and staff interview, the hospital failed to ensure expired and otherwise unusable medications were removed from the patient care area and not available for patient use. The failure had the potential for unusable medications to be given in error or for patients given expired medications.

Findings:

On 7/16/12 at 1:15 p.m., a visit to the D2 satellite pharmacy with the Pharm (pharmacist) 2 and Pharm 3 found four bags of intravenous (IV, directly administered into the vein) Azactam (antibiotic to treat infections) in the medication refrigerator with expiration date of 7/14/12. There was also one IV Vancomycin (antibiotic) which expired 7/15/12. Both pharmacists confirmed they were not usable.

On 7/12/12 at 2:50 p.m., during a visit to the B2 Satellite Pharmacy, the inspection of the pharmacy code bag (the bag of emergency medications the pharmacist uses when attending codes) with Pharm 2 and Pharm 4 found two expired medications: One flumazenil (to reverse effect of benzodiazepine overdose) vial which expired 5/2012 and one vial of Amidate (a general anesthetic) which expired 7/1/12. Pharm 4 said a pharmacist was responsible to inspect the code bag monthly for complete contents and no expired medications.

A visit to the emergency department (ED) was conducted with Pharm 1 and Pharm 2 on 7/17/12 at 10:15 a.m. An inspection of the Pyxis Room 7 medication refrigerator found the entire supply (3 vials) of succinylcholine (to induce anesthesia or when inserting a tube in the windpipe) all expired on 1/1/12. The monthly pharmacist unit inspection did not identify the expired succinylcholine vials since 1/12.

On 7/16/12 a visit was made to the hospital nuclear medicine department. While in the hot lab (location where radioactive material is stored) a refrigerator was observed near a work counter. The evaluator opened the refrigerator which revealed a 3 cubic centimeter (cc) syringe filled with approximately 1 cc of an unknown substance. The syringe was not labeled and staff (director of the department) did not know the contents of the syringe when asked. According to the director, the syringe should have a label identifying the contents and date.

Based on observation, documentation and interview, the hospital failed to provide radiological services in a manner that was safe for staff.

Findings:

In an interview with the patient care manager for radiology (Staff A) on 7/16/12 stated he coordinated the radiation badge program for the radiology department. The radiation badge program consisted of a monitoring device (badge) that measured the amount of radiation exposure for staff/visitors during procedures that use radiation. According to Staff A, each staff member was responsible for their own radiation badge thus location of the badge was not monitored.

On 7/16/12 the hospital policy and procedure titled, "Radiation Therapy: Health and Safety guidelines for Patient Care" was reviewed. Under Section E. Radiation Monitoring, 1. Radiation Badges, Section b. indicated, "badges should be worn only when caring for radiation patients and should never be worn home, as this can result in an inaccurate reading."

By not monitoring the location of radiation badges, there is no assurance the badges are not taken home (per policy) or stored in areas that would effect the radiation reading, e.g., exposure to sun.

Based on observation, interview, and document review, the hospital failed to ensure that food services met the needs of all patients as evidence by failure to:

1. Provide organized food services as evidenced by findings of unsafe food handling practices and supervision of the food service department (cross-reference A620, A749).

2. Ensure the nutritional needs of patients were met as evidenced by the lack of a comprehensive nutritional analysis of regular and therapeutic menus and ensure a system to identify all patients at high nutritional risk (cross-reference A630).

3. Develop performance improvement activities that reflected the scope and nature of the services and that identified opportunities for improvement (cross-reference A276, finding 1).

The cumulative effect of these systemic problems resulted in the inability of the hospital's food and nutrition services to direct staff in such a manner to ensure that the nutritional needs of the patients were met in accordance with practitioners' orders and acceptable standards of practice.

Based on food storage, production and service observations, dietary staff interview and document review, the hospital failed to ensure that the specific food and dietetic services organization requirements were met. The lack of organization and oversight of food services department resulted in deficient practices in multiple areas related to food safety, service, sanitation, and storage.

Findings:

During several interviews with the contract food service director of hospitality and the contract food service general manager from 7/16/12 to 7/19/12, observations were made that reflected the lack of oversight of the food service operations. During the interviews conducted with the general manager she indicated that while she bore the ultimate responsibility of food service operations, she managed the day-to-day operations through the executive chef and operation managers.

As a result of this management organization, the general manager was not fully aware of the issues that affected safe food handling practices. For example, although there was cool down procedure for food cooked ahead of service, there was no consistent monitoring and documentation of the process by the executive chef and staff that ensured food was prepared and maintained in a safe manner. Review of the position profile for Executive Chef 3 indicated he would "supervise all aspects of food production including menu planning and food preparation". During the course of the survey there were areas in menu serving, safe food handling and infection control issues that the executive chef did not respond with the knowledge base to ensure he demonstrated supervisory knowledge.

There were findings where the designated supervisors were not knowledgeable or did not demonstrate supervision over the food service staff to correct deficient practices observed during the survey process.

Based on food storage and food production observations, dietary staff interview and dietary document review, the hospital failed to ensure the food and dietetic service manager developed and monitored written procedures, according to standards of practice for operational processes. The food and nutrition director failed to ensure the daily management of the dietary services to ensure safe food handling and sanitation as evidenced by: 1) potentially hazardous food (food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation) not cooled down safely and accurate documentation maintained (cross-reference A749); 2) failure to ensure frozen meat was dated to ensure it was used within the manufacturer's recommended shelf life; 3) failure to ensure that expired oral nutritional supplements were unavailable for patient use; 4) five food service staff wore hairnets per policy to cover all of the hair; 5) fresh ready to eat produce was washed in sanitary condition; 6) reach in freezer was maintained at zero degrees Fahrenheit (F) or below; 7) open shelf refrigeration units maintained potentially hazardous food at 41 degrees F or below; 8) maintain kitchen refrigerator, and food preparation surfaces, refrigerator gaskets, shelving, floors and microwaves, clean and sanitary; 9) ensure ground beef product cooked to safe and designate temperature; 10) open products not dated when opened. There was no ongoing quality appraisal and performance improvement program that addressed the complexity and scope of the food service which resulted in failure to identify issues in safe food handling practices, food storage and sanitation all of which could result in food borne illness (cross-reference A276).

Failure to develop and implement for safe food handling and supervision of food service staff practices and procedures may result in patient being exposed to food borne illness and cross-contamination which may further compromise medical status.

Findings:

During several interviews with the contract food service director of hospitality and the contract food service general manager from 7/16/12 through 7/19/12 there were observations made that reflected the lack of oversight of the food service operations. During the interviews conducted with the general manager she indicated that while she bore the ultimate responsibility of food service operations, she managed the day to day operations through the executive chef and operation managers.

As a result of this management organization, the general manager was not fully aware of the issues that affected safe food handling practices. For example, although there was cool down procedure for food cooked ahead of service, there was no consistent monitoring and documentation of the process by the executive chef and staff that ensured food was prepared and maintained in a safe manner. Review of the position profile for Executive Chef 3 stated he "supervise all aspects of food production including menu planning and food preparation...." Requirements include an education or equivalent experience and no certification required." During the course of the survey there were areas in menu serving, safe food handling and infection control issues that the executive chef did not respond with the knowledge base to ensure he demonstrated supervisory knowledge or demonstrated supervision over food service staff.

There were findings listed below where the designated supervisors were not knowledgeable or demonstrated supervision over the food service staff to correct deficient practices observed during the survey process.

The following are specific examples of food safety deficient practices identified during the survey:

1. Potentially hazardous food was not cooled down safely and accurate documentation maintained (cross-reference A749).

2. On 7/16/12 at 11:30 a.m., inside the walk-in refrigerator, on the lower shelf, thawing, were several pans of a variety of raw meat located in individual pans. The executive chef acknowledged the thawing meat was not dated as to when the thaw process began. There was also a rolling rack that contained several pans of thawed ground beef that had blood covering the pan, and undated as to when thawed. The executive chef stated it was the food and nutrition department's policy to have a three-day thaw date, and then the food needed to be cooked. The executive chef acknowledged that, without a date as to when the thawing process started, there was no assurance the thawed meat would be used by day three.

The hospital's policy and procedure, "Food Products Label, Dating and Shelf Life," indicated "Frozen products moved into the refrigerator to thaw will be labeled and dated with the date place to thaw and the date intended for service."

3. On 7/16/12 at 10:49 a.m., in the walk-in refrigerator were several individually-sized cartons of resource dairy thick that had the manufacturer's expiration date printed on them that indicated May 18, 2012. Food service supervisor A checked the manufacturer's dates on all of the resource dairy thick cartons and stated that there were 42 expired cartons on the shelf, with varied expiration dates. Food service supervisor A verified the expired dairy thick cartons should have been discarded. The hospital policy and procedure, "Food Products Label, Dating and Shelf Life," indicated "Items with a printed expiration date will follow that date."

During the same observation, there was an unopened quart-sized container of half and half undated as to when opened. The contract director of hospitality verified there was no date as to when opened, and acknowledged the hospital's policy of keeping for only 3 days once opened could not be ensured without an opened date.

On 7/17/12 at 11:41 a.m., located in the nourishment room identified as C2 were six enteral nutrition formula packages (dietary food for special medical purposes) designed for tube feedings (a method for a patient to receive nutrients via a tube) that had printed manufacturer's guidelines that indicated "Best By July 1 2012." There was another bag of enteral nutrition formula, at the same location, that indicated "Best by 6/13/12." Licensed nurse 5 (LN 5) observed the dates on the formula, and stated, "Those shouldn't be there." LN 5 stated that it was dietary staffs' responsibility to ensure expired formula was not available in the nourishment rooms. The contract director of hospitality verified that "best by" dates should be treated as expiration dates, and should be discarded.

On 7/17/12 at 11:47 a.m., the general manager verified that dietary staff was responsible to ensure expired formula products were discarded.

4. On 7/16/12 starting at 10:10 a.m., in the kitchen area, food service (FS) supervisor A was observed with his hairnet covering the top of his head and FS tray carrier A was observed with her bangs not covered by the hairnet. FS workers A and B serving in the cafeteria were also observed with hairnets not completely covering hair.

The director of hospitality acknowledged concurrently that the hairnet was to completely cover the hair of the staff to prevent cross-contamination and department policy was not followed.

On 7/17/12 at 10:00 a.m., a staff in the salad preparation area preparing sandwiches had the hairnet not covering the back of her hair which was in a ponytail. The general manager acknowledged the hairnet was not covering all of the exposed hair, and the supervisors were not monitoring the staff to ensure the hairnets were completely covering hair.

There is a potential of hair cross-contaminating the food if not contained in hairnets.

5. On 7/16/12 at approximately 11:00 a.m., a food service worker was washing tomatoes he identified for slicing in a food preparation sink which had dirty dishes. The general manager acknowledged and directed staff to remove the dirty dishes before washing tomatoes.

The use of a food preparation sink used to store dirty dishes was a risk of cross-contamination of ready to eat food.

6. On 7/16/12 at 10:30 a.m., the ice cream freezer A external thermometer read 10 degrees F. The general manager identified this as defrost cycle. The July 2012 log for July 1 to 16 was reviewed. The log showed temperatures for ambient air temperature (inside thermometer) recorded opening and closing temperature. The temperatures ranged from zero degrees to 6 degrees F. The directions on the log (adapted from a refrigerator log) did not indicate the required freezer temperature.

Review of the policy, "Refrigerator/Freezer Temperature Log," indicated "Freezer temperature must be 0 degrees or below, variance plus of minus 2 degrees F. Discrepancies are reported to the manager who calls Facilities for repair."

Standard of practice for freezers is 0 degrees or below and does not have a variance of plus or minus 2 degrees F.

7. On 7/16/12 at 11:00 a.m., in the cafeteria, one of two open shelf refrigeration units had orange juice at 46 degrees F when temperature was taken by the executive chef. The general manager acknowledged concurrently the case had been stocked at 6:45 a.m., and the products required refrigeration and used all day. The thermometer was in the back upper shelf and did not reflect the temperature of the products at the front edge of the shelving unit. All foods should be maintained at 41 degrees F or below to prevent growth of micro-organisms and potential of food-borne illness.

8. Starting on 7/16/12 starting at 10:10 a.m., the following were observed:

a. The walk-in refrigerator four shelf rack had buildup of food debris on the shelving and the front grill. The general manager acknowledged the rack and shelves were not clean.

b. The rack also had areas where the finish was gone and the areas were not cleanable. The general manager acknowledged the rack should be replaced.

c. In the food prep area, the under counter three door refrigerator had gaskets black with food debris. The executive chef acknowledged the gaskets needed cleaning and he was the responsible person to ensure the staff cleaned the area.

d. The basement milk refrigerator was observed at 12:00 p.m., and had dried milk on the floor under milk crates. Dietary Employee 3 (DE 3) stated the floor was cleaned one time per week and the staff assigned to clean it was on vacation. There was no staff assigned to ensure the floor was cleaned when staff was on vacation.

e. Throughout the kitchen food preparation areas were nylon food preparation counters and tan food prep boards that had cut marks and visible black debris in the cut marks. The general manager and the executive chef acknowledged the surfaces with the cuts were not cleanable.

Standard of practice for the Food Code 2009 stated all food preparation surfaced are to be a cleanable smooth surface.

On 7/16/12 at 11:40 a.m., inside the walk-in freezer, located directly under the fans inside the freezer was a stainless steel pan with a build-up of thick ice covering the outside and the top edge of the pan. Executive Chef 1 pulled down the pan that had a sticker label indicating "Use First," was undated, and inside the pan was uncovered cooked frozen beef top round with ice build-up directly on the meat.

The hospital's policy, "Food Products Label, Dating and Shelf Life," indicated "All purchased and prepared food products will be labeled, dated and stored in a manner that assures the quality and safety of the product."

9. On 7/17/12, starting at 11:00 a.m., the Cook A prepared ground beef patties. He placed one on a patient's plate and stated he knew it was done by experience.

Food Code 2009 states, cook to 155 degrees F for 15 seconds to heat all parts of the food.

There was no system to ensure the ground beef product, a potentially hazardous food and a potential for food-borne illness, was cooked to the correct temperature.

10. On 7/16/12 at 10:42 a.m., in the dry storage room was a 25 pound container of sunflower seeds that had a handwritten date of "7/11." DE 3 stated the "7/11" date was an opened date, and the sunflower seeds had a shelf life of 6 to 12 months.

During the same observation of the dry storage room was a 25 pound bag of toasted crumbs which was opened and undated. There was a sealed container of jasmine rice, and cornmeal that was undated.

DE 3 and the contract director of hospitality verified there was no thermometer located in the dry storage room to monitor the temperature to ensure the hospital's policy of no more than 70 degrees F was maintained.

The hospital's policy and procedure, "Food Products Label, Dating and Shelf Life," indicated "All purchased and prepared food products will be labeled, dated and stored in a manner that assures the quality and safety of the product...Any item opened and re-labeled for storage will be dated with the USE BY date, also following the Quick Reference Shelf Life List."

DE 3 acknowledged the hospital's quick reference shelf life list system could not be implemented if food items were not dated as to when opened, and if the shelf life guidelines were not implemented.

The hospital's policy and procedure, "Receiving, Storage, Security," indicated "Dry storage areas are well lighted and ventilated with temperature maintained below 70 degrees F."

Based on observation, dietary document review and staff interview, the hospital failed to, 1) ensure standard menus 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; 2) That nutritional needs of patient were met in accordance with recognized dietary practices and in accordance with orders of the practitioner or practitioners responsible for the care of the patients by failing to ensure that portion sizes were utilized by trayline staff during meal service, and that there was a complete nutritional analysis for all diets served; 3) a system in place which would have identified Patient 19 as a patient who was at nutritional risk to the nutritional services department in order to appear on the clinical registered dietitian's list for a nutritional assessment in order to recommend nutrition intervention. There was no mechanism in place in which the registered dietitian with the expertise in food and nutrition would evaluate whether the therapeutic diet prescribed for Patient 19 was appropriate, in order to recommend nutrition intervention appropriate to the patient. This failure has the potential to compromise patients' nutritional and medical status.

Findings:

1. The DRI/RDA consists of nutrient based references whose purpose is to plan diets for individuals, focusing on optimizing health status, disease prevention and ensuring consumption of nutrients in adequate amounts. The provisions of the Dietary Reference Intakes, which include the Recommended Dietary Allowances (RDAs) Adequate Intake, and Acceptable Macro and Micronutrient distribution ranges, developed by the Food and Nutrition Board under the auspices of the Institute of Medicine used to evaluate the nutritional adequacy of patient menus.

On 7/17/12 starting at 8:45 a.m., the hospital nutrient analysis for hospital diets was reviewed. The diets provided were low microbial, renal, and low cholesterol diets. The nutrient analysis was limited to calories, protein, carbohydrate, fat, cholesterol, sodium, potassium, phosphorous, dietary fiber. A second round of nutrition analysis was provided that included some vitamins and calcium. There was no analysis that included daily nutrients for fiber, vitamins and minerals that are specified in the RDA and DRI. There was no analysis of the hospital diets comparison to the RDA and DRIs.

The policy, "Nutrient Analysis," reviewed 9/11, stated the "nutrient analysis is an evaluation of food intake and/or an estimation of specific nutrients ingested by a patient for a specific period of time. As a standard a nutrition analysis includes an estimation of calorie and protein intake."

The general manager stated on 7/17/12 at 8:45 a.m., that it would not be possible based on the limited nutrition analysis to ensure the hospital developed menus met patient nutritional needs. She confirmed that the hospital policy as written ensured comprehensive evaluation of the nutritional adequacy of patient menus. The menus were not evaluated to assess whether the menus met the required nutrients or where deficient in nutrients.

2. On 7/16/12 starting at 10:30 a.m., Cook 1 was observed serving one ramekin of preplated mac and cheese and spinach with tongs for mechanical soft diet. The executive chef stated the mac and cheese portion was 4 to 5 ounces, and the spinach was to be 3 ounces. Cook A stated the portion of the mac and cheese was 4 ounces and he had been doing this for a long time so he knew the spinach was 3 ounces when not measured.

Cook A poured an unmeasured amount of liquid egg product into a pan. He stated this was a three egg omelet. The meal ticket identified a 2 gram sodium diet.

One low micro lactose restricted diet (a diet restricted in dairy and food-borne organisms) received #12 scoop with a green handle. Cook A looked at the green scoop but was unable to identify the serving size provided. The executive chef identified the scoop #12 scoop portion as 2 and one-half ounces. One carbohydrate diet received a pasta dish that was not measured when served.

The general manager acknowledged the cooks should be using a measured portion for the diets and acknowledged there was no system to ensure the cooks were serving the specified and correct portions for the diets.

On 7/18/12 at 8:30 a.m., general manager provided a list of portions and scoop sizes they had just developed. The portion size for the mac and cheese was 6 ounces, coleslaw was 3 ounces and was served with a #10 scoop. The penne pasta was to be 4 ounces and scrambled eggs were specified as 2 ounces.

3. On 7/18/12 at 10:52 A.M., Patient 19's medical record was reviewed with RD 9. According to Patient 19's history and physical, dated 7/16/12, Patient 19 had diagnoses that included end stage renal disease on hemodialysis (process for removing waste and excess water from the blood), liver cirrhosis (a chronic liver disease), and diabetes mellitus type II. Patient 19 was prescribed a therapeutic diet of renal, 2 gm [gram] sodium, 2 gm potassium, low phosphorous, and 100 gm protein.

On 7/16/12, a nursing admission assessment was completed by a registered nurse for Patient 19. According to the nursing admission assessment, Patient 19 was identified as "Nutritional Risk Factor-Patient Not at Risk."

On 7/18/12 at 11:18 a.m., RD 9 stated that within her expertise as a registered dietitian (RD), "I would consider this patient to be at nutritional high risk." RD 9 stated that the hospital's system to identify nutritional high risk triggers which would then involve the clinical RD's to assess the patient was based on the nursing admission nutrition trigger questions, whether an MD or nurse requested a nutrition consult or if the patient was NPO greater than 5 days, or via daily multidisciplinary rounds, otherwise we would see the patient by day 14 of admission.

RD 9 acknowledged that the hospital's method of identifying patients that may be nutritional high risk had not identified Patient 19, which RD 9 considered to be a patient at nutritional high risk.

According to the hospital's policy and procedure, "Nutrition Screening, Assessment, Reassessment and Documentation," "Purpose: The purpose of nutrition screening is to identify patients who are at nutritional risk upon admission in order to provide early nutrition intervention..., Nutrition screening at [name of hospital] is completed by nursing. Nursing screens all inpatients for nutritional risk within 24 hours of admission using the Admission Assessment in the Clinical Information System (CIS). Patients identified at risk appear on the Dietitian's system lists within CIS. Patients not identified at risk on admission will be reviewed by the Dietitian by Day 14."

During an interview with the chief clinical dietitian on 7/18/12 at 2:20 P.M., she stated, "The average length of a patient's stay is 5 days." The chief clinical dietitian verified that the clinical RD's relied on nursing to do the primary identification of patients who may be at high risk nutritionally. The chief clinical dietitian verified that the primary mechanism by which a clinical RD would conduct a patient nutrition assessment was when contacted by another discipline, that had not had the expertise in food and nutrition, either being via the nursing admission assessment, physician or nursing nutrition consult request, or from information that may or may not be discussed during daily roundings of patients. There was not an independent system in which the discipline that had the expertise in food and nutrition, RD's, would utilize their expertise to identify nutritionally high risk patients, or to assess whether a therapeutic diet prescribed for a patient was appropriate or not. Patient 19's therapeutic diet order had not been assessed by an RD to determine if the therapeutic diet was appropriate for the patient's individualized needs, and whether the patient was consuming the quantity specified by the therapeutic diet, or needed a nutritional intervention. RD 9 confirmed that an RD was not monitoring dietary intake or nutritional status of Patient 19.

According to the hospital's policy and procedure, "Nutrition Screening, Assessment, Reassessment and Documentation," "nursing screens all inpatients for nutritional risk within 24 hours of admission using the admission assessment. The nursing admission assessment for nutrition related questions in which would identify a patient at nutritional high risk for a RD to complete a nutrition assessment was limited to the following; decreased food intakes for more than 5 days, multiple episodes of diarrhea for more than 5 days, pressure ulcers, unintentional significant weight loss greater than 10 pounds in 6 months, appears cachetic (loss of weight and muscle wasting), malnourished, dysphagia, pregnant/lactating, tube feeding or TPN (total parenteral feeding) dependent, cystic fibrosis (an inherited chronic disease that affects the lungs and digestive system), transplant, transplant diabetes, bone marrow transplant."

Based on interview and record review, the hospital did not ensure the hospital approved diet manual contained physician approved parameters for a physician ordered low phosphorous diet to ensure the therapeutic diet was provided to the patient in accordance with physician orders. In addition, the hospital failed to ensure that a physician's order to obtain daily weights for Patient 20 was implemented.

Findings:

1. On 7/18/12 at 10:52 a.m., Patient 19's medical record was reviewed at the nursing unit labeled as B1. On 7/16/12, the physician ordered a therapeutic diet that indicated renal diet 2 gm [grams] sodium, 2 gm potassium, low phosphorous, 100 gram protein.

On 7/18/12 at 11:15 a.m., LN 8 reviewed the therapeutic diet order for Patient 19, and stated, "I don't know what low phosphorous is and I do not know how to access the diet manual."

On 7/18/12 at 11:20 a.m., registered dietitian 9 (RD 9) reviewed the therapeutic diet order for Patient 19 while located at nursing unit B1. RD 9 stated that she thought a low phosphorous diet meant no more than 2 gm of phosphorous per day. RD 9 was asked to utilize the hospital's approved diet manual to confirm how the physician's practicing at that hospital defined a low phosphorous diet. RD 9 accessed the on-line diet manual while at nursing station B1, but stated, "I'm not familiar with how to find information on the electronic diet manual."

On 7/18/12 at 11:37 a.m., the chief clinical dietitian reviewed the hospital's approved diet manual and confirmed that there was no specific parameters for a low phosphorous diet specific to that hospital, and thus could not be used as guidance to hospital staff on how to prepare a low phosphorous diet for patients when ordered. A non-customized diet manual which did not reflect how the hospital prepared and implemented physician's diet orders had the potential for miscommunication from multidisciplinary team members to the patient and had the potential for misinterpretations by staff of a physician's diet order.

During the same interview, the chief clinical dietitian stated that the HealthTouch program that was specific to the food and nutrition department had variety of ways to define low phosphorous diet, but that the dietary staff would select the low phosphorous 1,000 mg parameter for the diet order of low phosphorous. When the chief clinical dietitian was asked who determined the 1,000 mg parameter for low phosphorous diet, she stated, "I did and my staff." Diet orders are prescribed by the practitioner responsible for the care of the patient, and the hospital needed to provide the therapeutic diet order as intended by the physician, or the practitioner responsible for care of the patient. That information needed to be physician driven and incorporated into the hospital's approved diet manual.

According to the hospital's policy and procedure, "Order Policy," "This policy provides guidelines for the use of medical orders given to direct patient care."

The hospital's policy, "General Policies (Policy No. 1-001.0)," indicated "A current diet manual approved by the Director of Clinical Nutrition, in cooperation with the medical staff, and other appropriate nutrition staff, is used as the basis for diet orders and for planning modified diets. Copies of the diet manual are available online for patient care unit and in the Departments of Clinical Nutrition and Food Services..., The diet manual serves as a guide for ordering diets and the served menus are consistent with the requirements of the diet manual. The diet manual is reviewed annually, revised as necessary, and approved by the medical staff."

2. On 7/17/12 at 1:51 p.m., Patient 20's medical record was reviewed.

On 7/13/12, a physician wrote an order for Patient 20 to be weighed daily.

On 7/15/12, a physician ordered a tube feeding of Glucerna (nutritional product) 1.2 at 85 cc/hour (a method to receive nutrition via a tube).

On 7/17/12 at 2:00 P.M., RN 10 reviewed Patient 20's electronic medical record and stated the patient's weight was taken on 7/13/12 and 7/17/12. There was not a weight in the medical record for 7/14/12, 7/15/12, or 7/16/12. RN 10 reviewed the EMR and was unable to state why Patient 20's weight had not been taken for those three days in accordance with the physician's order.

According to the hospital's Enteral Tube Feeding Guidelines, under the category of recommendations and monitoring, "Body weight and intake and output should be monitored daily or per unit weighing standard."

Nursing had not ensured that a physician's order for daily weights was implemented in accordance with the physician's order.

Based on observation and interview, the facility failed to maintain the hospital environment in a manner that ensured the safety of staff, visitors and patients.

Findings:

On 7/18/12, a tour of the emergency department (ED) was conducted. During the visit, it was noted in a back hall (area for pediatric patients) two portable air conditioning units were in operation to cool down the area. Both units were venting hot air into a duct that penetrated the ceiling. The manager of the ED, who was interviewed the same day, stated the units are only used during the summer to cool the back hall and treatment rooms. In addition, she did not know where the units were venting.

On 7/18/12 at 2:05 p.m., the hospital engineer was interviewed. According to the engineer, there were no construction permits for the venting system of either air conditioning units. Upon further inspection, the engineer stated the units were not venting into the exhaust ducts of the hospital but rather into the plenum (empty space between floors). The hospital engineer was not certain if the hospital exhaust could handle the additional flow thus had the units removed.

Failing to obtain proper permits for constuction purposes does not ensure that the hospital is maintained in a safe manner.

Based on observation, interview and record review, the hospital failed to ensure that the walk-in freezer located in the kitchen was maintained properly to ensure food quality and safety as evidenced by thick, extensive ice-build up.

Findings:

On 7/16/12 at 11:40 a.m., the walk-in freezer's ceiling had extensive thick ice build-up, which was also located directly on the shelves that stored food. The freezer contained boxes of frozen food stored directly on top of each other 5 to 6 boxes high which did not allow for air circulation. The freezer was very full and was one of two walk-in freezers that stored food for the licensed bed capacity, as well as an average of 3,000 meals per day via the retail cafeteria according to the contract general manager, food.

During the same observation, inside the walk-in freezer, located directly under the fans, was a stainless steel pan with a build-up of thick ice covering the outside and top edge of the pan. Executive Chef 1 pulled down the pan that had a sticker label that indicated "Use First," was undated, and inside the pan was uncovered cooked frozen beef top round with ice build-up directly on the meat. The walk-in freezer was observed in a condition that prevented necessary maintenance and easy cleaning.

On 7/17/12 at 10:09 a.m., the assistant chief engineer observed the extensive ice buildup in the freezer and acknowledged the extensive ice buildup along the ceiling, and on shelves was not expected under normal operating conditions. The assistant chief engineer stated, "We need a shut-down of the freezer."

According to the hospital's document entitled Receiving and Storing that was used in the food and nutrition department as part of dietary staff training, "Are there signs of thawing and refreezing - large ice crystals on product, fluid or frozen liquid at bottom of case, or water stains on packaging?"

The hospital's policy and procedure, "Preventative Maintenance," indicated "Preventative Maintenance is the responsibility of the Department of Engineering and Maintenance."

Based on observation, interview, and document review, the hospital's infection prevention staff failed to develop an effective system for identifying unsafe food handling practices that involve, 1) cool down of potentially hazardous food (food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation); 2) cooking of ground beef products; 3) prevention of cross-contamination from raw chicken and vegetables; 4) lack of the preventative maintenance system for the ice machine's following manufacturer's directions; 5) a system to ensure the engineering staff used the products as specified by the ice machine manufacturers; 6) contamination of food storage area that was not reported or adequately identified to infection control; 7) infection control review and involvement with the food service department.

Failure to clean and sanitize ice machines could potentially place patient at risk of infection. Failure to cook and cool food could place patients at risk of food borne illness. Failure of the infection control committee to plan and review the high risk and high volume food service department had the potential to cause food borne illness and compromised patient care.

Findings:

1. On 7/16/12 at 10:55 a.m., inside the walk-in refrigerator was a pan of meatloaf dated "7/14," a pan of roast beef dated "7/14," and two large pans of alfredo sauce dated "7/14." Executive Chef 1 stated the meatloaf, roast beef and alfredo sauce were cooked at the facility on 7/14/12. There was a pan of custard dated 7/16/12.

Executive Chef 1 was not able to locate the roast beef on the "HACCP (Hazard Analysis and Critical Control Point Program) COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS," and stated, "It should've been documented on the log."

The cool down log did contain the alfredo sauce that was prepared on 7/14/12, with the following information; the cool down started at 10:00 a.m., at 167 degrees Fahrenheit (F) and in the "Temp after 2 Hours" column the temperature was 76 degrees F.

According to the directions located on the cooling log, "Food is cooled quickly and safely from 140 degrees F to 70 degrees F within 2 hours and then to 40 degrees F or below within an additional 4 hours (total cooling time 6 hours)."

On 7/16/12 at 11:22 a.m., Cook 2 stated he had cooked the custard that morning which was cooling down in the walk-in refrigerator. Cook 2 stated he placed the custard in the walk-in refrigerator at 10:30 a.m. Cook 2 stated he would check the temperature of the custard in 3 to 4 hours to ensure the temperature got down to 41 degrees F. Cook 2 then reviewed the cool down log which lacked documentation of the beginning of the cool down of the custard. When the directions on the cool down log were pointed out to Cook 2 about the 70 degrees F at 2 hours, he stated, "If the temperature was still above 70 degrees F at two hours I would continue to cool it down."

A review of the "HACCP COOLING AND REHEATING CHART TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS" from April 2012 to present indicated that 22 out of 74 logged cool down entries (30% of the time) exceeded 70 degrees F after two hours.

Executive Chef 1 verified that potentially hazardous food which had not reached 70 degrees F during the cool down process by two hours should have been reheated to 165 degrees F, and the cool down process started again.

Improper cool down of potentially hazardous foods had occurred at least 30% of the time in the last four months.

Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to food-borne illness. The initial two-hour cool is a critical element of this cooling process (FDA Food Code 2009).

2. On 7/17/12, starting at 11:00 a.m., the cook prepared ground beef patties. He placed one on a patient's plate and stated he knew it was cooked to the correct temperature by experience.

Food Code 2009 states "cook to 155 degrees F for 15 seconds to heat all parts of the food."

There was no system to ensure the ground beef product, a potentially hazardous food and a potential for food-borne illness, was cooked to the correct temperature.

3. On 7/16/12 at 10:30 a.m., one sheet pan of raw chicken was observed on the same counter with raw asparagus. A passing cook stated he had had the chicken on a cart but another staff had placed the raw chicken on the counter and taken the cart.

The FDA Food Code 2009 states that food shall be protected from cross-contamination by separating raw animal food during storage, preparation, and holding.

4. Starting on 7/16/12 10:10 a.m., the three ice machines in the kitchen were observed. The general manager stated the ice machines and bins had just been cleaned and the engineering department was responsible for the cleaning of the mechanical ice making parts.

a. One white plastic material door to a bin was observed to have a black stained and dirty area on all of the front edge where hands contacted the surface to open the bin. The general manager acknowledged the interior door area had not been cleaned to remove the black grime.

b. The general manager concurrently stated the interior of the bin ice machines were sanitized with a quaternary ammonia product. Review of the bin ice machine manufacturer's direction shows the sanitizing solution was to be a 5.25% sodium hypochlorite solution (chlorine bleach). The general manager acknowledged the staff had not been directed to follow the manufacturer's directions.

5. On 7/17/12, starting at 11:20 a.m., the engineering department staff represented by the assistant chief of engineering and Engineer A brought the manufacturer's instruction manuals for the three food service ice machines, and the approximately 50 ice and water dispensing units used through the hospital patient care areas.

Engineer A was introduced on 7/17/12 at 11:50 a.m. as the engineer who was responsible for the cleaning and maintenance of the hospital ice machines.

On 7/17/12, starting at 11:50 a.m., the preventative maintenance task form dated 7/17/12 was reviewed. One item specified "Clean water system." In a concurrent interview, the assistant director of engineering stated that engineers knew what to do the clean the ice machines.

Review of the manufacturer's directions for the ice and water patient care area dispensers showed a weekly cleaning of the drain pan and grill with a solution A specified a 200 parts-per-million (ppm) of available chlorine content to prevent algae growth in the drain lines. The semi-annual cleaning of the dispenser hopper (internal ice making mechanism) was to wipe lid and baffle with solution A (200 ppm chlorine) and sanitize items with a solution B (50 ppm solution chlorine). The manufacturer directions did not specify the chlorine bleach concentration to be used.

During an interview on 7/17/12 at 12:05 p.m. Engineer A stated that he wiped the areas exposed to air with sani-wipe cloths. Engineer A stated he used a chlorine product and brought a gallon bottle of "Cidex." He stated this is what he used as a chlorine bleach and that this smelled like chlorine.

During the interview with Engineer A there was no verification if the weekly drain pan and grill were cleaned as specified by the manufacturer. It was not clear how the manufacturer's directions were followed or if the hospital had verified the concentration of Chlorine bleach to be used with the manufacturer.

The manufacturer's directions for the three ice machines in the kitchen manufacturer's were reviewed and specified a cleaning step with a "scale away" product used to remove hard water deposits and a sanitizing procedure with a 5.25 percent sodium hydrochlorite solution. The manufacturer's recommendations were for an annual cleaning and sanitizing.

On 7/17/12, starting at 12:20 p.m., the meeting included infection control (IC) nurses A and B to discuss the infection control oversight of the ice machine cleaning and sanitizing and the use of "Cidex" product. The IC nurses stated that the Cidex was not a product for cleaning ice machines and did not know how Engineer A was able to obtain the Cidex. The IC nurses A and B stated the infection control committee had a policy for ice machine cleaning and a copy was reviewed during the interview. The ice machine policy from the Infection Control Manual reviewed on 3/10 stated the ice machine was to clean the ice bin with water and detergent, and sanitize with 50 to 100 ppm solution sodium hydrochlorite. There was no concentration specified for the chlorine product and the direction did not follow the manufacturer's directions for either type of ice machine identified at the hospital.

In addition, the assistant chief of engineering stated he did not have any policy for the ice machine cleaning or sanitizing when interviewed earlier. IC nurses A and B stated this policy was online and available to the hospital departments. The assistant engineer confirmed he was not aware of the infection control policy.

Review of manufacturer's information determined Cidex is classified for use of processing heat sensitive medical devices and was not specified as food grade (used in contact with food or food processing equipment).

6. On 7/16/12 at 12:04 p.m., located in the basement in the dry food storage room, the ceiling tiles had an area of approximately 4 inches by 6 inches of yellow discoloration near a pipe. Located more in the center of the dry storage room, two large ceiling panels were discolored and appeared to have possible moisture. Dietary Employee (DE) 3 stated that he had not reported the discoloration of the two large ceiling panels.

On 7/17/12 at 9:52 a.m., the assistant chief engineer observed the two large discolored ceiling panels and stated the food and nutrition department had just reported a work order for that issue yesterday. The assistant chief engineer could not confirm if the tiles were moist, or what the source of the discoloration was "until I inspect."

The assistant chief engineer observed the yellow discoloration of the ceiling tiles located next to a pipe, and stated, "That is from a sewage pipe leak repair about four months ago." The assistant chief engineer observed the discolored ceiling tiles, observed that food storage remained located directly underneath a sewage pipe, and stated, "Food can be stored here. If the sewage pipe ever leaks again then we would just remove the food."

The contract general manager, food who was present during the above observation and interview was unable to explain why the ceiling tiles were still in disrepair and why food remained stored underneath a known sewage pipe.

According to standards of practice in the food service industry food storage should not be under sewer lines that are not shielded. Pathogens can contaminate and/or grow in food that is not stored properly. Drips of condensate and drafts of unfiltered air can be source of microbial contamination for stored food. Moist conditions in storage areas promote microbial growth (FDA Food Code 2009 and FDA Food Code Annexes 2009).

7. On 7/17/12 at 11:45 a.m., in the nourishment room labeled as C2, the vented area located in the back on the inside of the microwave was covered with a yellow discoloration. On 7/17/12 at 11:49 a.m., housekeeper 6 stated that she was responsible for cleaning the microwaves. Housekeeper 6 proceeded to demonstrate how she cleaned the microwave. She used a clean cloth that was located in a bucket filled with a product called A-456 II Disinfectant Cleaner. Housekeeper 6 proceeded to clean the inside of the microwave, which was limited to wiping down the microwave turntable with the cloth and then allowed to air dry. Housekeeper 6 observed the yellow substance that covered the vent area and used her cloth on that area which did remove the yellow substance. Housekeeper 6 verified that it was not her usual practice to clean that area of the microwave.

On 7/17/12 at 12:28 p.m., infection control registered nurse (RN) A, and infection control RN B were requested to e-mail the manufacturer of the cleaning product to verify if it was acceptable for cleaning food service equipment such as a microwave.

On 7/18/12 at 10:41 a.m., in the nourishment room labeled as B1, the ceiling inside the microwave was covered with dried food debris. Licensed nurse (LN) 7 used a paper towel and confirmed that the soiled area was not just a stain. The same microwave's turntable was free of food debris.

On 7/18/12 at 2:00 p.m., hospital staff provided a document, "Product Specification Document A-456 II Disinfectant Cleaner," that indicated "Rinse all surfaces that come in contact with food such as countertops, appliances, tables and stovetops with potable water before reuse. Do not use on utensils, glassware and dishes." Hospital staff had not provided an e-mail from the manufacturer specifically asking the question if the disinfectant was appropriate to be used as a cleaner inside the microwave, and allowed to air dry.

On 7/24/12 at 2:25 p.m., surveyor placed a call to the manufacturer of the product A-456 II Disinfectant Cleaner and was informed by the manufacturer that the disinfectant was not appropriate to be used as a cleaner inside of a microwave which was allowed to be air dried.

During an interview on 7/19/12 at 8:45 a.m. with the infection control committee members, including IC nurses A, B, C and D, it was stated there was an annual infection control inspection of the kitchen and they followed the basics in food and sanitation including cool down, cross-contamination, and handwashing.

The infection control nurses were asked if their committee had been notified regarding the waste water spill that occurred approximately four months ago in the basement food storage area, as there were still stained ceiling tiles in the area. They acknowledged they had not known about the spill, or the steps to clean the area or to protect the food storage area.

Based on medical record review and document review, the hospital failed to enforce its rules and regulations addressing the requirement that a complete medical history and physical be completed and documented within 30 days prior to admission for elective surgery. This failure had the potential to result in inappropriate admission for surgery.

Findings:

On 7/17, 7/18, and 7/19/12, review of the medical records of 12 patients admitted for surgery demonstrated that the records of Patients 36, 40, 41, 42, 43, 44, 45, and 46 were absent documentation of complete medical histories and physical assessments (H&P) performed within 30 days prior to admission. Patient 36's H&P was absent documentation of presence or absence of allergies to medications and contained a long list of current medications without explanation of the reasons for the medications. Patient 40's H&P contained a present illness that did not fully explain the reason for the procedure. There was no mention of drug abuse, yes or no. The questions on the short form H&P regarding past or family history of anesthetic problems and history of bleeding disorders were not answered. Vital signs and patient weight were absent. There was no lung examination documented. The record of Patient 41 was absent documentation of allergies to medications and absent mention of drug abuse, yes or no. The record of Patient 42 was absent past surgical history, social history, family history, vital signs, and weight. The record of Patient 43 was absent past surgical history, social history, family history, vital signs, and weight. The record of Patient 44 was absent past surgical history, social history, family history, vital signs, and weight. The record of Patient 45 was absent any physical evaluation except for the left knee examination. The record of Patient 46 was absent family history.

On 7/19/12, review of the hospital's rules and regulations (R&R), last reviewed 8/11, demonstrated the following "required components of history and physical exams" under "Complete H&P":

History includes chief complaint/reason for visit, symptoms, current medications, drug allergies, significant past medical and surgical history, review of systems, family history, psychosocial status, indications for surgery, ASA classification.

Physical examination includes vital signs, cardiovascular system, respiratory systems, neurological system, gastrointestinal system, eye, ear, nose, and throat, genitourinary system, musculoskeletal, skin, psychiatric, and hematologic/lymphatic/immunologic.

Also included under complete H&P are assessment and treatment plans.

In addition, the R&R describe a "Focused H&P" as a brief account of the patient's condition that must provide sufficient detail to allow the formulation of a reasonable picture of the patient's clinical status to include: chief complaint and present illness, current medications, allergies, relevant past medical and surgical history, family history, review of systems, indications and proposed procedures for any surgery or invasive procedure, physical examination as indicated, assessment, and treatment plan.

In interview on 7/18/12 at 3 p.m., Admin B acknowledged that the Focused H&P defined in the R&R did not meet all aspects of the definition of a complete H&P. The intent of the federal regulation, however, is to ensure that a complete H&P is documented within 30 days prior to admission for any surgery to ensure that the patient is a proper candidate for the procedure.