HospitalInspections.org

Based on staff interview, document review, and policy and procedure review, the hospital failed to ensure that an effective governing body (GB) is responsible for overseeing the conduct of the hospital in the provision of patient care as evidenced by failure:

1. To provide and maintain and effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI). (Cross Reference A263, A264, A266, A285)

2. To ensure that an effective nursing staff delivered quality patient care, by assessing and reporting patient's abnormal lab values to the attending physician. (Cross Reference A395).

3. To ensure that an effective nursing staff delivered quality patient care by assessing, developing, implementing, and evaluating patient care plan to meet the needs of the patient. (Cross Reference A396).

4. To ensure that medications were administered in accordance with the physician order. (Cross Reference A404).

5. To provide pharmaceutical services that meet the needs of the patients. (Cross Reference A490, A500, A502)

6. To ensure that the food and nutrition department had an organized dietary service that was directed by qualified staff to meet the needs of the patients, to ensure safe and effective food production practices were implemented and maintained and to meet the dietary needs of patients and staff during an emergency disaster situation. (Cross Reference A057,A618, A620, A621, A622, A631, A701).

7. To ensure the development, implementation, and maintenance of an effective, ongoing hospital wide data driven infection control program to provide a sanitary environment. (Cross Reference A713, A747, A749).

The cumulative effect of these systemic failures resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Governing Body.

Based on interview, the governing body failed to appoint a chief executive officer who was responsible for managing the entire hospital when the food and dietetic services had no quality program for food service and clinical nutrition, failed to ensure qualified management of the food and nutrition department, and hospital was not in compliance with safe food handling practices. This failure placed the patients at risk for poor nutrional care.

Findings:

On 4/22/10 at 9 a.m., the President, and CEO were interviewed. Findings of deficient practices and Imediate Jeporady in the dietary department were reviewed with the President, including; the food and dietetic services had no quality program for food service and clinical nutrition, failed to ensure qualified management of the food and nutrition department, and hospital was not in compliance with safe food handling practices that led to an Imediate Jeopardy being called.

The President agreed there were serious and substantial issues regarding the food and dietetic services. The CEO stated that he was the individual in administration who was responsible for the food and dietetic department.

Based on staff interview and document review, the hospital failed to develop a QAPI program for Food and Dietetic Service and failed to maintain an effective quality assessment and performance improvement program for the existing QAPI program. The failure to ensure an effective quality improvement program could impact patient care and services as evidenced as by:

1. Failure to ensure QAPI program was in place for the Food and Dietetic Service. (Cross Reference 264)




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2. The hospital 's quality assurance program did not identify medication errors (Refer to 0266)
3. The facility failed to take actions aimed at performance improvement. (Refer to 0285)
4. Medications were not administered in a safe manner or consistent with the order of the prescriber (Refer to A-0404)
5. Pharmaceutical services were not delivered in a safe and effective manner.(Refer to A-0490, 0500 and 0502)

The cumulative effects of these systemic problems resulted in the hospital's inability to meet statutorily mandated compliance with the condition of participation: Quality Assurance Performance Improvement.

Based on staff interview and document review, the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services. Failure to have an ongoing quality appraisal and performance improvement program could potentially affect safe food handling practices.

Findings:

The quality appraisal and performance improvement (QAPI) activities for the Food and Dietetic Services were reviewed 4/21/10 at 9 a.m., with Staff M. She stated that the kitchen staff recorded refrigerator temperatures. She stated that there was no QAPI program for the clinical nutrition.

There was no program provided to ensure the QAPI program was developed for the scope of the hospital food and clinical nutrition areas. There was no QAPI program monitoring the application of safe food handling practices.

Based on staff interview and document review, the hospital's quality assurance program failed to identify and reduce medical errors. This had the potential to place patients at risk for severe adverse reactions as evidenced by:
1. The hospital had no system for identifying and tracking near misses, medication errors that did not reach patients.
2. Errors, or potential for errors, were not recognized and/or prevented by hospital staff as errors were occurring for multiple days and were not identified until the day of the survey:
a. Patient 402 was at risk of receiving Tylenol, for which he was allergic, for five days without evidence or intervention.
b. Patient 401 did not receive her antibiotic medication (Augmentin) for tonsillitis until the second day from the time it was ordered, a 21-hour delay with no clinical justification.
c. Patient 401 was administered 15 tablets of the wrong dose of Augmentin from 4/17/10 until 4/19/10.


Findings:
1. On 4/21/10 at 10:30 a.m., Staff T was interviewed about quality measures for pharmaceutical services. When asked for tracking medication errors he presented a medication variance form and explained that this is what the staff used to report errors. Staff T was asked about tracking any filling or processing medication errors that are corrected before they reached patients; he said that they did not. There was no documented evidence of any errors identified and corrected during processing orders, re-packaging medications, or filling new orders during the weekly cart fill. Staff T was asked if they performed any random audits of what was removed from the night locker, he said that they did; however, there was no documented evidence of that.
2. Multiple errors with potential for causing patients' harm lasted days. Multiple facility staff had many opportunities to evaluate the information and intervene to stop these errors, but there error continued with no evidence of staff interventions.
a. On 4/20/10 at 8:30 a.m., five days after admission, Patient 402, stated during medication pass observation that he had allergy to Tylenol and that he told multiple staff about it numerous times. Review of the medical record for Patient 402 revealed that Tylenol was ordered on admission, 4/15/10, and that allergy to Tylenol was documented in the hospital computer system, shortly after admission, on 4/16/10 at midnight.
On 4/20/10, around 10 a.m., review of the (medication administration record) MAR revealed that on the MAR for 4/19/10, a Tylenol order had a red-line across it and the word " allergy " also written in red. The front cover of the record had a red sticker listing allergies to "Aspirin, Dilaudid, Tylenol, and medication ending with zine." The same information regarding allergies was printed on the top of the MAR.
During medication pass observation on 4/20/10, Patient 402 did not have a RED ID band. Although the information about allergy was available since admission and was documented on the chart (red sticker), in the MAR, and in the hospital computer system, Tylenol order remained active with no follow up, clarification, or physician contact.
On 4/20/10, review of the facility policy for "Allergy Screening" revised on 1/07, indicated that if allergies were identified and verified to "place RED ID band on patient's arm."
The hospital policy for allergy screening was not fully implemented. Furthermore, the information about allergies was not used to make the appropriate medication decisions and protect the patient from receiving medications for which he stated to be allergic.
b. On 4/22/10 at 8:15 a.m., review of the record for Patient 401 revealed a physician order for Augmentin 875 milligrams to be given two times every day for five days. Augmentin is an antibiotic medication that is used to treat infections. The order was written on admission, 4/16/10 at 9 p.m., for Patient 401 for tonsillitis (inflammation of the tonsils because of infection).
On the following day, on 4/17/10 at 4:30 p.m., the order was changed to 750 mg to be given in the morning and to "give am (morning) dose now" and 1000 mg at hour of sleep.
Review of the MAR for Patient 401 revealed that the patient did not receive the evening dose on 4/16/10, or the morning dose on 4/17/10. The first dose that Patient 401 received as documented on the MAR was on 4/17/10 at 5:40 p.m. That was a delay of 21 hours from the time of ordering the medication. There was no documented clinical justification for not administering the medication.
c. A concurrent review of Patient 401's record revealed an order change for Augmentin on 4/17/10 at 4:30 p.m. to administer 750 mg in the morning and to give the morning dose now and 1000 mg at hour of sleep. Staff T stated that the pharmacy closed at 3:30 p.m.; therefore, medications had to be obtained from the night locker. Review of the night locker log revealed that seven tablets of Augmentin were removed on 4/17/10 at 10:40 a.m., and eight more on 4/18/10 at 1:30 p.m., for Patient 401. The strength of the Augmentin removed from the night locker was not documented in the log. However, clarification with the Staff Tconfirmed that the only Augmentin available in the night locker was 250 mg.
According to the manufacturer's labeling for Augmentin, listed under warning and precautions, "Due to differing content of clavulanic acid, not all formulations are interchangeable." Augmentin is a combination medication that contains varying strengths of amoxicillin and 125 mg clavulanate potassium. Augmentin 875, therefore, contains 875 mg of Amoxicillin and 125 mg clavulanate potassium. Clavulanate or clavulanic acid help prevent break down of amoxicillin resulting in expanded spectrum of activity of amoxicillin. Augmentin that was stored in the night locker and accessed by the nurse supervisor was Augmentin 250, which meant that it contained 250 milligrams for amoxicillin and 125 mg of clavulanate potassium.
Review of the MAR revealed that Patient 401 received a 750 milligrams dose at 5:40 p.m. on 4/17/10, as evidence by a staff initial on the MAR. Patient 401 was administered three tablets of Augmenting 250 to make up the 750 mg dose. That meant Patient 401 was 375 mg of clavulanate potassium, three times the amount of clavulanate potassium ordered by the physician.
Between 4/17/10 and 4/19/10, Patient 401 received fifteen tablets of the wrong strength (dose) of Augmentin 250 milligrams.

Based on document review and staff interview, the facility failed to take actions aimed at performance improvement as evidence by the following:

1. Number of reported events was very low, and there was no evidence of any attempts to increase reporting.
2. Information related to allergy was not used to protect Patient 402 from receiving Tylenol for which he stated to have allergy.
3. High-risk medications, such as opiates, were not given in a safe manner as there was no oversight to ensure compliance with pain management policy.
4. There was no system in place to evaluate near misses in attempt to identify any weakness or system vulnerability for performance improvement.
5. Accuracy of records for controlled substance sheets were not evaluated for at least 11 months. These incomplete records were used to sign out medication and administer to patients.

These failures posed a potential for unsafe care for patients in the facility.

Findings:

1. On 4/21/10 at 10:30 a.m., Staff T was interviewed regarding quality assurance and performance improvement for pharmaceutical service. Staff Tpresented samples of the medication variances, adverse drug reactions, and falls reports. He stated that these reports are forwarded to risk management, so he did not have specific details on who reported or about the number of reported events.



On 4/23/10 at 11: 30 a.m., Staff Q presented Medication Variance and Falls report for January and February. The reports had 26 medication variance events reported for January and 21 for February. When asked about the number, hospital staff stated that they evaluated the consistency of reporting but did not evaluate the numbers for being high or low. According to the (Institute of Medicine) IOM report 2006, it is estimated that one medication error occurs per patient per day in hospital care. The numbers of events reported in the facility were low, and there was no evidence of any systems or surveillance to identify medication errors or adverse drug events that occurred but not reported. Additionally, the data was not trended by reporters (pharmacy, physicians, or nurses) so that efforts to increase reporting would be focused on the group that reported the least. There was no documented evidence that the hospital took any actions to increase reporting.

On 4/22/10 at approximately 10 a.m., Staff Q was asked about projects aimed at performance improvements resulting from incident reporting data. Staff Q stated that Staff H tracked the data for nursing performance. To facilitate increase reporting there needed to be a culture change, that is blame free and that evaluate error as system errors.

The facility policy titled "Medication Variances, Adverse Drug Events" revised on 1/07 indicated: "Data related to medication variances and adverse drug events are reviewed at the Medication Safety Committee and the Pharmacy and Therapeutic Committee for the purpose of making recommendations to the current process." There was no evidence of recommendations by the Pharmacy and Therapeutic Committee.

2. On 4/20/10 at 8:30 a.m., five days after admission, Patient 402, stated during medication pass observation that he had allergy to Tylenol and that he told that to multiple staff numerous times.

Review of the medical record revealed that Tylenol was ordered on admission, on 4/15/10, and allergy to Tylenol was documented in the hospital computer system shortly after admission, on 4/16/10, at midnight.


On 4/20/10, around 10 a.m., review of the MAR revealed that on 4/19/10, a Tylenol order had a red-line across it and the word "allergy" was also written in red across the order. The front cover of the record had a red sticker listing allergies to "Aspirin, Dilaudid, Tylenol, and medication ending with zine." The same information regarding allergies was printed on the top of the MAR.


During medication pass observation on 4/20/10, Patient 402 did not have a RED ID band. Even though the information was on the chart (red sticker), in the MAR, and in the hospital computer system, Tylenol order remained active, 5 days after it was identified, with no evidence of follow up, clarification, or physician contact.


On 4/20/10, review of the facility policy for "Allergy Screening" revised on 1/07, revealed that if allergies are identified and verified to " place RED ID band on patient's arm." Although the hospital had policy in place, it was not fully implemented.
The information about allergies was available for five days in the computer, on the MAR, and on top of the chart (red sticker), Patient 402 was very clear about it, and multiple staff had numerous opportunities to intervene and correct, but the information was not used to protect the patient. In addition, there was no quality measures to ensure that medication was used in a safe manner.


3. On 4/21/10, at 1 p.m., review of the medical record for Patient 200 revealed that the patient had a history of multiple surgeries for chronic back pain for which she received multiple medications prior to admission. Patient 200 was placed on the same regimen of opiate (strong pain medication like morphine) that she was on before her admission; however, there was no system for monitoring to guide therapy and prevent toxicity considering the age of the patient and the medications she was taking.

These medications, opiates and narcotics, have severe adverse events and are considered high alert medications by standards or professional practice such as the Institute for Safe Medication Practices (ISMP) and The Joint Commission. High alert medications are those most likely to cause harm to patients. Methadone, has a boxed warning which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems that can lead to serious injury or death.
Methadone has a boxed warning related to respiratory depression. It alerts users and prescribers to use extreme caution during treatment initiation, dose titration, and conversion from other opioid agonists to methadone. "Peak respiratory depressant effects occur later and persist longer than peak analgesic effects possibly contributing to cases of iatrogenic overdose. "In addition, the boxed warnings address the potential for QT prolongation ( a specific heart abnormality) and increasing the risk of a fatal arrhythmia ( abnormal heart rhythm or heart beat pattern), torsade de pointes (A specific variety of heart abnormality shown on an electrocardiogram which is a graphic recording of the cardia cycle).


Patient 200 was also receiving morphine, which had side effects, similar to methadone, such as respiratory depression and decreased blood pressure. These risks are increased in elderly patients, and Patient 200 was seventy-five years old.


On 4/21/10 around 3 p.m., Staff S was interviewed about monitoring patients. He stated that if the pain medication was ordered routinely, he would not ask the patient about their pain, so that he does not harass them. He said that he would ask about the pain if medications were ordered on as needed basis.

Patient 200 was given high doses of morphine and methadone, but there was no evidence of monitoring to guide therapy and prevent toxicity. There was no evidence of monitoring for the side effects of these medications such as respiratory rate, blood pressure, or monitoring for sedation. In addition, there was no evidence that the effectiveness of the medication was evaluated to ensure that the pain is controlled, and that the patient was receiving the optimal dose.


Review of the facility's policy titled "Pain Management" revised on 6/08, revealed the following: under "ONGOING PAIN ASSESSMENT," the policy's direct nurses to "assess pain as the fifth vital sign using the Pain Severity Scale with ordered or designated routine vital signs." And under "CONTROL OF PAIN," the policy also instructed nurses to "assess patient for side effects to medications such as sedation, nausea and vomiting ....If side effects occur discuss with physician, take appropriate action and document in patient care plan." The policy was not implemented and there were no systems in place to ensure that it was.

4. On 4/21/10 at 10:30 a.m., Staff T was interviewed about quality measures or project for performance improvement related to pharmaceutical services. When asked if near misses were identified and tracked, he said that they were not. The facility did not have a process for tracking filling or processing medication errors that do not reach patients. There was no documented evidence of any errors identified and corrected within the pharmacy during processing orders, re-packaging, or filling new orders or during cart fill. Staff T was asked if they were performing any random audits of what was removed from the night locker, he said that they did when they process these orders; however, there was no documented evidence of that.
Tracking near misses and trending them is essential to look for system weakness or vulnerability and identify opportunities for improvement.
5. On 5/22/10, at 2 p.m., during review of medical record for Patient 200, the CSAR (control substance audit records) numbered 10182, 10183, and 10184 from May 2009 were reviewed. They did not have the strength or the formulation of what morphine the pharmacy staff dispensed to the nursing unit. Morphine comes in many different oral formulations and different strengths. In addition, the CSAR did not have the strength of all the other medications that were added (hand written) on the printed CSAR sheets, Methadone, Adderall, Adderall XR, or Ritalin.


On 4/23/10 at approximately 10 a.m., review of the facility's policy titled "Controlled Substance" revised on 12/09, revealed instruction as follow: "Licensed employees must use caution when signing for controlled substances because their signature will be taken as absolute proof that they received the controlled substance that they signed for." Pharmacy staff delivered these medications to the nursing unit, nursing staff signed for receiving them, and nursing staff signed these medications out to administer them to various patients without identifying the missing information. Clearly, the missing information (the strength) was not evaluated; otherwise, it would have been corrected. Almost a year from that date, and confirmed by Staff T and Staff Q, current CSAR on unit 1, on 4/22/10 at 3:15 p.m., did not have the strengths of the drugs added.

Based on staff interview and document review, the facility failed to evaluate the nursing care for 1 of 20 sampled patients (Patient 200) who had a low blood sugar reading of 46 mg/dl and did not assess or monitor her for signs and symptoms of hypoglycemia (low blood sugar) and failed to notify her physician of the laboratory results with the potential for neurological damage, coma and death.

Findings:

Patient 200 was admitted to the facility on 5/05/09. Clinical record review, on 4/20/10 at 11 a.m., revealed that she was not diabetic and that had a blood draw which was collected on 5/12/09 at 6:35 a.m. The results indicated a low blood glucose reading of 46 mg/dl. Review of the laboratory chemistry document revealed that normal blood glucose levels ranged between 70 to 125 mg/dl.

Review of Patient 200's clinical record, on 4/21/10, revealed that there was no reference to her low blood glucose results, any assessment or monitoring that related to fluctuations in blood glucose levels until 5/13/09 at 10 a.m., when Staff E (a physician) noted that her low blood sugar reading was probably due to her low meal intake.

Staff J (the regional laboratory director) stated during an interview, on 4/20/10 at 6 p.m., that the laboratory results for Patient 200 were electronically available to the facility on 5/12/09 at 12:25 p.m.

Staff G stated during an interview, on 4/20/10 at 10:30 a.m., that she worked the day shift on 5/12/09, but was not aware of Patient 200's low blood glucose values and was not instructed to check for laboratory results during her shift. She said she would not know if a patient had abnormal laboratory results unless the lab called to report critical results or if she had been made aware of it some other way.

Staff H (the director of nurses) stated during an interview, on 4/20/10 at 12 noon, that nursing duties included physician notification of out of range laboratory results and implementation of nursing measures if a patient was experiencing abnormal lab values including monitoring for adverse signs and symptoms and a decline in their health status.

Staff E (a physician) stated during an interview, on 4/21/10 at 10:30 a.m., that the laboratory results should have been communicated to a physician. He said that Patient 200's low blood glucose values required re-checking and appropriate treatment as soon as the results were available.

Based on interview and clinical record review, the facility failed to keep the nursing care plan current for 1 of 20 sampled patients (Patient 200), who experienced a possible episode of hypoglycemia (low blood sugar) and the facility did not develop a care plan to monitor and intervene appropriately to prevent potentially serious consequences i.e. neurological damage, coma and death.

Findings:

Patient 200 was admitted to the facility on 5/05/09. Clinical record review, on 4/20/10 at 11 a.m., revealed that she was not diabetic and that had a blood draw which was collected on 5/12/09 at 6:35 a.m. The results indicated a low blood glucose reading of 46 mg/dl. Review of the laboratory chemistry document revealed that normal blood glucose levels ranged between 70 to 125 mg/dl.

Review of Patient 200's clinical record, on 4/21/10, revealed that there was no reference to her low blood glucose results, any assessment or monitoring that related to fluctuations in blood glucose levels until 5/13/09 at 10 a.m., when Staff E (a physician) noted that her low blood sugar reading was probably due to her low meal intake.

Review of Patient 200's care plan, on 4/21/10, revealed that there was no reference to her low blood glucose results or any monitoring that related to fluctuations in blood glucose levels.

Staff H (the director of nurses) stated during an interview, on 4/20/10 at 12 noon, that all licensed nurses were instructed to check laboratory results throughout their shifts and as part of their assessment charting for each shift. She said that shift charting would be done by the day shift at approximately 1 p.m. The nurses would then use the information to take appropriate measures for each patient including the development of their care plan.

On 4/21/10, review of the facility policy titled "Care Planning"and revised on 7/09, revealed that each patient would have a care plan that provided "planned, individualized, and appropriate interventions (based on problems identified) in settings responsive to specific individual needs."

Based on staff interview and document review, the facility failed to ensure that medications were administered in accordance with the physician order for Patients 401 and 402. Patient 402 was offered Tylenol for pain, although he was allergic to it. Patient 401 did not receive the antibiotics (Augmentin) for 21 hours from the time it was ordered with no clinical justification for the delay. When Augmentin was finally started, Patient 401 received the wrong dose of Augmentin for two days. Delaying medication administration, giving the wrong dose, or administering medications to someone with contraindications or allergies to the medication may compromise patients conditions or lead to potentially harmful situation: not achieving therapeutic goals.

Findings:

1. On 4/20/10 at 8:35 a.m., during observation of medication administration, Patient 402 was observed receiving his morning medications. The patient asked for pain medication; the nurse checked the medication administration record (MAR) and told the patient that there was a current order for Tylenol (pain medication). Patient 402 stated that he would not take Tylenol because he was allergic to it and that he had informed multiple staff about his allergy. Patient 402 asked for ibuprofen (another pain medication), but the nurse told him that she needed to contact the doctor and obtain an order first. Patient 402 told the nurse to "never mind" because he was being discharged that day, and that he would take ibuprofen at home.

On 4/20/10, around 10 a.m., review of the MAR revealed that on 4/19/10, the Tylenol order was red-lined and the word "allergy" was written in red across it. Further review of the record revealed no documented evidence of any follow up, clarifications, or informing the physician of the allergy situation.

Tylenol, preprinted on the admission order set, was ordered on admission, 4/15/10, but the allergy was not filled in. However, review of the pharmacy computer system revealed that Staff QQQ entered Tylenol allergies, on 4/16/10 at midnight. A pharmacy staff, Staff RRR, processed the Tylenol order on 4/16/10 at 7:36 a.m. and Staff T verified it shortly after.

On 4/20/10 at approximately 10 a.m., review of Patient 402's record with Staff RR revealed a red sticker on the front cover of the record indicating allergies to "Aspirin, Dilaudid, Tylenol, and medication ending with zine." The same information regarding allergies was printed on the top of the MAR.

During medication pass observation on 4/20/10, Patient 402 did not have a RED ID band. Even though the information about Tylenol allergy was on the chart (red sticker), in the MAR, and in the hospital computer system for five days, the Tylenol order remained active to be administered to the patient.
2. On 4/22/10 at 8:15 a.m., the record for Patient 401 was randomly selected for review from the night locker log, where medications accessed after pharmacy hours were documented. Review of the record for Patient 401 revealed a physician order written on admission, 4/16/10 at 9 p.m., for Augmentin (an antibiotic to treat infection) 875 milligrams to be given two times every day for five days for tonsillitis. On the next day, 4/17/10 at 4:30 p.m., the order was changed. The new order was to administer Augmentin 750 mg in the morning and to "give am (morning) dose now" and 1000 mg at hour of sleep.


Review of the (medication administration record) MAR for Patient 401 revealed that the patient did not receive the evening dose on 4/16/10 or the morning dose on 4/17/10. The first dose that Patient 401 received as documented in the record was on 4/17/10 at 5:40 p.m. That was a delay of 21 hours from the time of ordering the medication. There was no documented clinical justification for delaying the medication.


3. Review of Patient 401's record revealed an order change for Augmentin on 4/17/10 at 4:30 p.m. to administer 750 mg in the morning and to "give am (morning) dose now" and 1000 mg at hour of sleep. On 4/19/10 at approximately 9:55 a.m., Staff T stated that the pharmacy closed at 3:30 p.m.; therefore, medications had to be obtained from the night locker.

Review of the night locker log revealed that seven tablets of Augmentin were removed on 4/17/10 at 10:40 a.m. and eight more on 4/18/10 at 1:30 p.m. for Patient 401. The strength of the Augmentin removed from the night locker was not documented. But clarification with Staff T confirmed that the only strength available in the night locker was Augmentin 250 mg. It was also confirmed that the pharmacy was closed on 4/18/10.


According to the manufacturer's labeling for Augmentin listed under warning and precautions, "Due to differing content of clavulanic acid, not all formulations are interchangeable." Augmentin is a combination medication that contains varying strengths of amoxicillin and 125 mg clavulanate potassium. Augmentin 875, therefore, contains 875 mg of Amoxicillin and 125 mg clavulanate potassium. Clavulanate or clavulanic acid help prevent break down of amoxicillin resulting in expanded spectrum of activity of amoxicillin. Augmentin 250 was stored in the night locker and accessed by nurse supervisor. That preparation contained 250 milligrams for amoxicillin and 125 mg of clavulanate potassium.


Review of the MAR revealed that Patient 401 received a 750 milligrams dose at 5:40 p.m. on 4/17/10 as evidence by a staff initial on the MAR. Patient 401 was administered three tablets of Augmentin 250 to make up the 750 mg dose. That meant Patient 401 was given 750 milligrams of amoxicillin and 375 mg of clavulanate potassium, which is three times the amount of clavulanate potassium ordered by the physician.

Between 4/17/10 and 4/19/10, Patient 401 received fifteen tablets of the wrong strength (dose) of Augmentin 250 milligrams.

Based on staff interview and document review, the hospital failed to ensure Registered Dietitian's Nutritional Assessments were available in the patient medical record in a timely manner for the physician to acknowledge and or implement recommendations necessary for the patients' conditions. This failure put Patient 301 and Patient 302 at nutritional risk.

Findings:

1. Patient 302 was admitted 4/13/10, with diagnoses of depression NOS (not otherwise specified). The medical record was reviewed on 4/20/10 at 10 a.m. The patient's weight was 103 pounds and height was 5 feet 3 inches. There was no Nutrition Screening and Assessment available in the medical record.

During an interview on 4/20/10 at 10 a.m., Staff M stated that when the patient's paper chart is not available, when she completed the nutritional assessment, she would keep the report until she can locate the medical record. Staff M provided the nutrition assessment form which she located in her office on 4/21/10. The nutrition assessment dated 4/16/10, showed elevated LDL (low density lipoprotein)cholesterol of 132 and total protein elevated of 8.5. The assessment was to recommend a low cholesterol diet.

The nutritional assessment was not available for the physician for 5 days.

2. Patient 301 was admitted 3/8/10. Medical record was reviewed 4/20/10 at 10 a.m. The physician order, dated 4/5/10, was for "nutrition consult-to develop meal plan; wants egg salad sandwiches."

There was no consult in the paper medical record nor was one provided after requesting from Staff M on 4/20/10 at 10 a.m.

Based on observation, medical records and policies review, and staff interview, the facility failed to ensure that pharmaceutical services met the needs of the patients. Policies and procedures to provide safe and effective use of drugs were not developed or implemented as evidence by the following:

1. Medications were not administered in accordance with standards of professional practice or consistent with the order of the practitioner. (Refer to A 0404).
2. Medications were not controlled, distributed, and administered to provide patient safety. (Refer to A 0500)
3. Drugs and biological were not locked when appropriate to prevent unauthorized access. (Refer to A 0502)

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure the provision of quality pharmaceutical services safely and effectively.

Based on observation, medical record, document and staff interview, the facility failed to develop and implement policies and procedure to ensure safe and effective use of medications, for patients 402, 200, 404 and 401, as evidence by the facility failure to do the following:

1. Evaluate allergies and ensure follow up and communications so that patients with allergies to specific medications do not receive them.
2. Assess and monitor patients receiving high alert medications (opiates) to ensure efficacy and prevent toxicity of these medications.
3. Complete the Clinical Pharmacy Monitoring Form for Clozaril according to policy.
4. Develop a comprehensive quality assurance and performance improvement system to ensure quality of service provided and track errors for performance improvement.
5. Develop polices and procedure for accountability of medication use and distribution.
6. Ensure accurate distribution and use of controlled substance accountability by accurate documentation on control substance audit record
7. Authenticate verbal/telephone orders within 48 hours consistent with policy.
8. Clarify unclear orders consistent with policy.

Because of the facility's failure to have a system in place to protect patients from receiving medications to which they have allergy, an immediate jeopardy (IJ) was called on 4/21/10 at 5:22 pm.

Those attending the IJ announcement were:
Corporate Staff A
Staff Q
Staff H
Corporate Consultant 1
Corporate Consultant 2

On 4/21/10 at 6:20 p.m., the hospital management staff presented a plan of corrective action that included the following:
1. 100 % of all patients in-house will be checked for allergies
? Documented on PDP [prescription drug plan]
? Allergy band placed ( red) on patient
? Allergies are written on the physician admission order sheet
? Stickers placed on the front of the chart
? Allergies written on the MAR [medication administration record]
2. Prepare written communication to every staff member, in-service on process.
3. For new admissions
? Assess for allergies for all new admission
? Follow steps outlined above
4. For night locker
? Patient chart will be taken to the night locker when the medication is retrieved by the nursing supervisor.
? A second nurse accompanies the supervisor to the night locker to verify medications and allergy status.
? The allergies are written on the night locker log
5. The nurse who gives the medication, compares the patient's allergy band to the MAR before giving the medication assuring that the patient does not receive medication to which she/he is allergic.

On 4/23/10 at 11:05 a.m., the surveyors met with the administrator and management staff and informed them the Immediate Jeopardy was abated.

The following staff were present for the abatement:
Corporate Staff A
Staff Q
Staff H
Corporate Consultant 1
Corporate Consultant 2

Findings:
1. On 4/21/10 at 8:35 a.m., Patient 402 was observed receiving his morning medications. The patient asked for pain medication; the nurse checked the medication administration record (MAR) and told him that there was a current order for Tylenol (pain medication). Patient 402 stated that he would not take Tylenol because he is allergic to it and that he had informed multiple staff about it. He asked for ibuprofen (another pain medication), but the nurse told him that she needed to contact the doctor and obtain an order first. Patient 402 told the nurse "never mind" because he was being discharged that day, and that he would take ibuprofen at home.


On 4/20/10, around 10 a.m., review of the MAR revealed that on 4/19/10, a Tylenol order was red-lined and the word "allergy" was also written in red across it. Additional review revealed that Tylenol was ordered for Patient 402 on admission, 4/15/10, but the allergy section was not filled in on the order. Staff QQQ entered Tylenol allergies, in the computer system on 4/16/10 at midnight. Pharmacy staff, Staff RRR, processed the Tylenol order on 4/16/10 at 7:36 a.m. and Staff T verified it shortly after.


On 4/20/10 at approximately 10 a.m., review of Patient 402's record with Staff RR revealed a red sticker on the front cover of the record indicating allergies to "Aspirin, Dilaudid, Tylenol, and medication ending with zine." The same information regarding allergies was printed on the top of the MAR. Staff T was interviewed on the same date; he stated that he discussed the allergies with Staff S who informed him, "Tylenol caused nausea." The communication between Staff T and Staff S about the allergies took place on 4/19/10, five days from admission. Staff T stated that he did not interview the patient directly.


Patient 402 did not have a RED ID band when he was observed during medication pass on 4/20/10. Even though the information was on top of the chart (red sticker), in the MAR, and in the hospital computer system, Tylenol order remained active for 5 days after the allergy to Tylenol was initially identified.


On 4/20/10, review of the facility policy for "Allergy Screening" revised on 1/07, revealed that if allergies are identified and verified to "place RED ID band on patient's arm."


According to (American Society of Health-System Pharmacists) ASHP Guidelines on a Standardized Method for Pharmaceutical Care, 1996: "Information should be collected and used as a patient-specific database to prevent, detect, and resolve the patient's medication-related problems and to make appropriate medication-therapy recommendations. The database should include the following sections, each containing specific types of information to the extent that it is relevant to medication therapy ..."
The list included multiple categories and data to be collected; allergies and intolerances were listed twice. The first was listed under medical information and the other was under medication therapy. The guidelines states: "The patient ' s database should be assessed for any of the following medication-therapy problems: ...Prescribing of medications to which the patient is allergic ... "


Although there was a system failure, Patient 402 did not receive any doses of Tylenol because he was alert and spoke up and was his own advocate. If Patient 402 was not able to speak for himself, was not alert, or was not aware of what was going on, hospital staff would have administered Tylenol, the medication he is allergic to. Patients that could not speak for themselves for any reasons or were not alert enough to stop nurses from giving them medications to which they were allergic, would be placed at higher risk for harm. Although facility staff implemented some components of the policy and the information was available for multiple staff, the information was not used to protect or promote patient health and safety. For five days, multiple health care providers had multiple chances to intervene and stop a potentially harmful situation, but nothing was done as evidence by the presence of the active order and lack of documentation for any clarification.



2. On 4/21/10, at 1 p.m., review of the medical record for Patient 200 revealed that the patient had a history of multiple surgeries for chronic back pain for which she received multiple medications prior to admission. Although, Patient 200 was placed on the same regimen of opiate (strong pain medication like morphine) that she was receiving before admission, there was no system for monitoring to guide therapy and prevent toxicity considering the age of the patient and the medications she was taking.

These medications, opiates and narcotics, have severe adverse events and are considered high alert medications by standards or professional practice such as the Institute for Safe Medication Practices (ISMP) and The Joint Commission. High alert medications are those most likely to cause harm to patients. Methadone, has a boxed warning which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems that can lead to serious injury or death.

Methadone has a boxed warning related to respiratory depression. It alerts users and prescribers to use extreme caution during treatment initiation, dose titration, and conversion from other opioid agonists to methadone. "Peak respiratory depressant effects occur later and persist longer than peak analgesic effects possibly contributing to cases of iatrogenic overdose." In addition, the boxed warnings address the potential for QT prolongation and increasing the risk of a fatal arrhythmia, torsade de pointes.


On 4/21/10 around 3 p.m., Staff S was interviewed about pain management and patient monitoring. He stated, that if the pain medication were ordered routinely, he would not ask the patient about their pain, so that he does not harass them, but he will ask them about the pain if the pain medication is ordered on as needed basis. Patient 200 was given high doses of morphine and methadone, but there was no evidence of monitoring to guide therapy and prevent toxicity. There was no evidence of evaluating side effects of these medications such as respiratory rate, blood pressure, or the presence or absence of sedation. In addition, there was evidence of evaluating the effectiveness of the pain medication to ensure that the pain was controlled, and that the patient received the optimal dose.


Patient 200, in addition to morphine and methadone, received other medications which had similar side effects such as respiratory depression, decrease blood pressure and sedation. These risks are increased in elderly patients, and Patient 200 was seventy five years old.


Review of the facility's policy titled "Pain Management" revised on 6/08, revealed the followings: under "ONGOING PAIN ASSESSMENT," the policy direct nurses to "assess pain as the fifth vital sign using the Pain Severity Scale with ordered or designated routine vital signs." And under "CONTROL OF PAIN," the policy also instructed nurses to "assess patient for side effects to medications such as sedation, nausea and vomiting ....If side effects occur discuss with physician, take appropriate action and document in patient care plan."
In the absence of monitoring, it is impossible to know if the patient developed adverse effects. Additionally, review of the medical record with Staff H revealed no care plan for pain management. When asked about monitoring for side effects, Staff H, stated that nurses are supposed to monitor for side effects.
According to "Pain Management Policy" by the Board of Registered Nursing:
"The Nursing Practice Act, Section 2725(b) (1), states that the registered nurse provides "direct and indirect patient care services that insure the ...comfort ...of patients.
Proper management of patient's pain is a nursing function incorporated within the registered nurses role as a patient advocate [Standards of Competent Performance, Section 1443.5(6) of the Nursing Practice Act].

The nursing function of appropriated pain management includes, but is not limited to:
? assessing pain and evaluating response to pain management interventions using a standard pain management scale based on patient self-report.
? using knowledge of equianalgesic dosages to maintain both patient safety and pain relief ...
? documenting pain assessment, ... in a clear and concise manner.
? intervening to minimize drug side effects.
? implementing quality assurance/improvement standards to monitor the pain management.

On 4/23/10, at approximately 11 a.m., review of the facility's policies titled "Look - Alike / Soundalike (sic) and High Risk Drugs" revised on 3/10 and "Drug Warning" revised on 3/06, revealed that methadone was not included in the list of high risk drugs. Therefore, there were no policies, procedures, or specific instruction for screening patients before starting any patients on Methadone or for monitoring parameters related to its use.

3. On 4/23/10 at 11 a.m., review of the medical record for Patient 404, revealed that the patient received Clozaril, an antipsychotic medication, that is associated with agranulocytosis (low white blood cells) which is a potentially life-threatening side effect. Because of the severity of the side effect, anyone receiving Clozaril should have weekly monitoring of blood count.

Patient 404 was admitted to the hospital on 4/1/10, and weekly blood count was performed for him. However review of the facility policy titled "Clozapine Dispensing and Reporting" revised on 3/10, revealed specific instructions that a "Clinical Pharmacy Monitoring Form" will be maintained. The policy had specific instructions that "The pharmacy will monitor the patient WBC/ANC (white blood cells/absolute neutrophil count) using a Clinical Pharmacy Monitoring Form." But inconsistent with facility's policy there was no clinical pharmacy monitoring form for Patient 404.


4. On 4/21/10 at 10:30 a.m., when interviewed about adverse event and medication error reporting, Staff T did not know how the reports were trended, what the number is and who reports and who does not or if pharmacy staff, for example, were underreporting.
Staff T indicated that they were not tracking any filling or processing medication errors that do not reach patients. There was no documented evidence of any errors identified and corrected during processing orders, re-packaging medications, or filling new orders or weekly cart fill. Staff T was asked if they were performing, any random audits of what was removed form the night locker; Staff T said that they did, however, there was no documented evidence of that.


5. On 4/19/10 at approximately 4 p.m., during inspection of the night locker located in an exam room, with Staff QQ and SS, it was observed that one of the cabinets containing medications for access after pharmacy hours was unlocked with the door visibly ajar. Inside it, there were two unlocked bins containing oral medications and three small cardboard boxes containing injectables. The first bin had twenty tablets of Lasix (diuretic) 20 milligrams, and the other had 32 amitriptyline (antidepressant) 25-milligram tablets. In addition, the three small cardboard-boxed had injectable antipsychotic medications: nine vials of haloperidol 50 milligram per milliliter; six vials of haloperidol 100 milligrams per milliliters and fluphenazine 25 milligrams per milliliter.


On 4/20/10, about 11 a.m., pharmacy staff was asked about accountability of what was removed from the night locker. When asked if there was a specific number of tablets or vials placed in each bin, facility Staff TT stated that the par level fluctuated based on needs. When clarified further, Staff TT stated that there was no actual par level and there was no tracking of what was filled to determine what was removed. In the absence of such a system, it would be impossible to know if staff accessing the night locker removed one or ten units of any given medications.


6. On 4/22/10, at 2 p.m., during review of medical record for Patient 200, the (control substance audit records) CSARs were reviewed. The CSARs numbered 10182, 10183, and 10184 from May 2009, did not have the strength or the formulation of what morphine the pharmacy staff dispensed to the nursing unit. Morphine comes in many different oral formulations and different strengths. The CSAR did not have the strength of all the other medications that were added (hand written) on the printed CSAR sheets. Methadone ( opioid analgesic) comes in 5,10 and 40 milligrams oral formulations; Adderall (psychostimulant drug used for attention deficit disorder, comes in 5, 7.5, 10, 12.5, 15, 20, and 30; Adderall XR, comes in 5, 10, 15, 20, 25 and 30 milligrams formulation; or Ritalin (central nervous system stimulant) comes in 5, 10, 20, 30 , 40, 50 and 60 milligrams and in different formulations as 18, 27, 37, 54 milligrams.


On 4/23/10 at approximately 10 a.m., review of the facility's policy titled "Controlled Substance" revised on 12/09, revealed instruction as follow: "Licensed employees must use caution when they sign for controlled substances because their signature will be taken as absolute proof that they received the controlled substance that they signed for." Pharmacy staff delivered these medications to the nursing unit; nursing staff signed for receiving them, and in turn signed them out for administration to patients. Clearly, the missing information was not evaluated; otherwise, it would have been corrected. Almost one year from that date, on 4/22/10 at 3:15 p.m., and confirmed by Staff T and Staff Q, current CSAR, on unit 1, did not have the strengths of the drugs added to CSAR.


7. Review of medical records on 4/21/10, revealed that telephone/ verbal orders were not signed within 48 hours consistent with the facility policy.


a. On 4/21/10 at approximately 4 p.m., review of the clinical record, for Patient 200, revealed that the admission orders were written as a telephone order on 5/5/09. The prescriber authenticated the telephone order on 5/18/09 at 7 a.m., thirteen days from the time written.


b. On 4/21/10 at 8:15 a.m., review of Patient 401's record revealed that the admission orders were written as a telephone order on 4/16/10. The orders were authenticated on 4/19/10, three days from the time written.


On 4/23/10 at 9 a.m., review of the facility's policy titled: "Verbal and Telephone Orders" revised on 1/07, revealed, "Verbal and telephone medication orders shall be signed, dated, and timed by the prescribing practitioner within 48 hours."


8. On 4/19/10 at approximately 10 a.m., review of the medical record for patient 403, after the morning medication pass observation, revealed a physician order dated 4/17/10, to "continue all orders as written on admission ..." Review of the medical record with Staff H and Staff RR revealed no evidence that the order was clarified.


On 4/23/10 at approximately 10 a.m., review of the facility policy titled "Medication Orders" revised on 1/07, revealed that hospital nursing and pharmacy staff " will clarify any unclear orders at the time they are received ..."

Based on observation, record review and staff interview the facility failed to ensure that medications were locked to prevent access by unauthorized personnel as the night locker was found unlocked with medications that were not securely stored.


Findings:


On 4/19/10 at approximately 4 p.m., during inspection with Staff QQ and SS, it was pointed out that the night locker, where medications for pharmacy after hour access, were stored in a patient exam room. One of the cabinets was found unlocked with the door visibly ajar. Inside it, there were two unlocked bins containing Lasix (water pill) and amitriptyline (antidepressant). In addition, inside the cabinet on the top shelf, three small cardboard-boxed containing injectable antipsychotic medications were observed. The boxes contained haloperidol different strengths: 50 milligrams per milliliter and 100 milligram per milliliter and fluphenazine. These medications were accessible to anyone that entered the room.


On 4/20/10 at about 11 a.m., Staff T stated on interview that multiple facility staff had access to the room where the night locker is located. Staff T said that leaving the door unlocked was a "mistake." Facility Staff TT, confirmed that the night locker medications were restocked on Monday indicating that the bins should have been locked with the tamper proof locks.

This condition is not met as evidenced by:
Based on observation, interview, and document review, the hospital failed to ensure that dietary services met the needs of all patients as evidenced by failure to:

1. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of Dietary Department. (Cross Reference A620)
2. Ensure the availability of organized dietary services that are directed and staffed by adequate qualified personnel. (Cross reference A622)
3. Ensure comprehensive disaster planning. (Cross Reference A701)
4. Develop performance improvement activities that reflected the scope and nature of services. (Cross Reference A264)
5. Ensure safe and effective food production practices (Cross Reference A749)
6. Ensure qualified dietitian develop comprehensive nutritional criteria for all age patients identified with altered nutrition status as necessary to ensure ongoing nutritional needs of patients were met and provided 9 patients with therapeutic 2 gram sodium diet. (Cross Reference A621)
7. Ensure a current therapeutic diet manual approved by the dietitian and medical staff was available for the adolescent and pediatric population served. (Cross reference A631).

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

Based on food service observations, dietary staff interview, and document review the hospital failed to ensure safe food handling practices as evidenced by 1) Lack of an effective system to ensure the monitoring of cool down of all potentially hazardous foods: The lack of an effective system to ensure the monitoring of a cool down system resulted in immediate jeopardy; 2) Lack of fulltime employee who served as director of food service department; 3) Lack of disaster menu and water. 4) Lack of system to prevent cross-contamination from metal shavings from a table mounted can opener. 5) Lack of a system to ensure milk and Juice from frozen was used per manufacturers directions and expiration dates: 6) Potential of cross contamination from contaminated measuring scoop stored in direct contact with the powdered protein product: 7) Staff not wearing hair coverings to protect food from contamination; 8) Maintaining hot food on tray line for excessive time with the potential of loss/compromise of nutrient content. and 9) Lack of quality appraisal and performance improvement for the food and dietetic services

Findings:

1. On Tuesday, 4/20/10 at 11:30 a.m., there was one pan containing approximately 4 large pieces of roast beef in a deep pan on the stove. Staff N identified this as the roast beef she had cooked this morning and would serve for lunch Wednesday (4/21/10).

On 4/21/10 at 10 a.m., the roast beef was sliced and on the steam table for lunch service. The staff N identified the roast beef as the beef she had prepared on 4/20/10. She stated the p.m. cook was responsible for the roast beef after she left at 2 p.m. yesterday. She stated that she left the roast beef (approximately 30 to 40 pounds) covered in one pan on the stove.

Staff M, a dietary administrative staff, was questioned on 4/20/10 at 10 a.m., about the practice of cool down for the roast beef prepared and held overnight. Staff M was unable to answer the question but asked a diet aide in the diet office if there was a log or documentation for the roast beef cool down. The diet aide was unable to provide Staff M with documentation for the cool down process. Staff M was asked if the roast beef now ready for service to 60 patients was safe to serve. She stated that they would provide a meal substitute and acknowledged there was no way to ensure the product was safe.

At 11:00 a.m., Staff Q who was responsible for the roast beef on 4/20/10 in the evening was interviewed. She stated that she " cooled down " the roast beef before she put it in the refrigerator. She confirmed the roast beef was in one large pan and was very heavy. She stated " I take temperature at 2:00 p.m. and it was 134 degrees Fahrenheit (F): at 4:00 p.m., 100 degrees F: and at 5:00 p.m., 84 degrees f: and at 6:00 p.m., 64 degrees F. " Staff Q confirmed that all temperatures were taken before the large pan of roast beef was placed in the refrigerator. She stated that the roast beef was put in the refrigerator at 6:00 p.m. at 65 degrees F. She stated that the pan should have been placed in an ice bath but the pan was too heavy so she left it on the counter and just measured the temperatures.

Staff M confirmed the roast beef was cooked one time a month on the four week cycle menu.

Review of the policy titled " Leftover food items, " on 4/21/10 at 11:00 a.m., stated leftover foods are cooled over a 6 hour period to 41 degrees F, then covered, labeled and dated. The policy stated that " All leftover food that is to be retained is to be placed in the blast chiller upon removal from the steam table. " There were additional directions for placing food in a 200 pan in the refrigerator until 70 degrees F and continue cooling until temperature reached 41 degrees F within an additional 4 hours.

Staff M confirmed on 4/21/10 at 11:00 a.m., that there was no blast chiller for the rapid cooling of a leftover and acknowledged the policy did not address the safe cooling of the regularly prepared roast beef that was not a leftover but prepared the day ahead for service to patients.

In addition, the policy stated that the Nutrition Service Supervisor (NSS)/designee will check the items that have cooled. Staff M confirmed the NSS was on medical leave for the last month and that she did not oversee the management of the kitchen.

Review on 4/21/10 at 11:00 a.m., of the time/temperature discussion with Staff M, acknowledged the roast beef (a potentially hazardous food), had been held in the danger zone of 135 to 40 degrees for four or more hours and had not been cooled according to the facility policy or Food Code 2009 directions.


Review of the dietary staff in-services from 4/09 to 3/10 did not show any review of the cooling, refrigeration or safe food handling for food items cooked a day ahead and served the next day.

Potentially hazardous food (PHF ' s) must be maintained under time/temperature control to minimize the risk of growth of bacteria associated with food borne illness (Food Code 2009).

Because of the facility ' s failure to have a system in place to ensure the monitoring of cool down for potentially hazardous food and adequate qualified staff to direct the food service department an Immediate Jeopardy was called on 4/21/10 at 4:40 p.m. Those present during the Immediate Jeopardy announcement were:
Administrator
Regional Vice President Patient Care Services
Director of Nursing
Int. Quality Manager
An action plant dated 4/22/10, was presented and reviewed at 8 a.m. The plan specified:

1. Prepare Policy and Procedure to address the cooling of food according to the FDA (food and drug administration) Food Code 2009.
2. Assure education and training of Nutrition Services Department staff.
3. Implement an audit process.
4. Assure that there was an appropriate leadership for Nutrition Services department at all times.

The Immediate Jeopardy was lifted on 4/22/10 at 3:40 p.m. Those present during the announcement were:
Administrator
Regional Vice President Patient Care Services Director of Nursing
Int. Quality Manager

2. Review on 4/20/10 at 8:00 a.m., showed the nutrition services organization chart with the clinical dietitian directly responsible for the Nutrition Service Supervisor (NSS). The job description for the Clinical Dietitian also stated " 9. Provides over sight for the Nutritional Services Supervisor. " Staff M stated on 4/21/10 at 11:30 p.m., that she had been employed at the hospital from 3/09 with responsibilities for the patient clinical nutrition. She stated that she had no direct oversight of the kitchen. Staff M confirmed that the NSS had been on medical leave for the past month and was not expected to return for another month.

Later in discussion with Corporate Staff 1 on 4/21/10 at 08:00 a.m., (a corporate representative) confirmed that there had been no direct oversight of the kitchen by the RD or had the RD been assigned to cover the kitchen management in the absence of the NSS.


3. Disaster food and water were reviewed on 4/19/10 at approximately 3:00 p.m.: Staff identified the plan was for 100 patients and staff.
a. Disaster food was stored in a closet in the Plant Services department. There were approximately 9 large cases of disposable service ware in the middle of the room and obstructing access to the cases of disaster food. To access the disaster food the large cases would have to be removed from the storage room. Corporate Staff 2 acknowledged the room needed to be organized to ensure staff could efficiently find and access the stored disaster food.
b. Review of the policy " Food and water, emergency/disaster " showed a plan for 4 day staple food. There was part of a disaster food inventory form on the storeroom door, but the staff could not verify the quantity of disaster foods present in the storeroom to meet requirement for the four days specified in the plan.
c. The Disaster Plan provided for a guide for foods to serve and a note that the Nutrition Service Manual contained regular and vegetarian menus for emergency/disaster situation. The staff was asked to provide the disaster menus but acknowledged that there were no disaster menus.
d. The water for disaster was store in the employee lounge closet. The staff verified that there were 200 gallons in 5 gallon bottles. The policy " food and water, emergency/disaster " stated that there was a " 4-day emergency supply of bottled water on the basis of one gallon per person per 24 hours. "
Based on the plan for 100 staff and patients, the hospital required 400 gallons disaster water.

There was not adequate stored bottled water per the disaster plan.

e. the policy " food and water, emergency/disaster also specified a " minimum for 2-day supply of disposable wares. " There was no plan to ensure adequate disposable serving wares for the plan for 4 day emergency food supply.

4. On 4/19/10 at 4:00 p.m., the table mounted can opener was observed with buildup of black food residue and worn blade with metal shaving on the ledge. Staff M stated she did not know when the blade was changed but acknowledged the blade was visually worn. Staff M stated the can opener was to be cleaned each day but acknowledged the black residue was old dirt and not clean a required.

Review of the Cooking Equipment Quarterly Inspection report dated 1/7/10 showed the can opener needs new blade, but there is no documentation that the blade was changed.

5. On 4/20/10 at 12:00 p.m., there were 6 pint cartons of milk in the unit 2 patient nourishment refrigerator located in the day room. There was no expiration date visible on the cartons. Staff M stated dietary staff stocked the refrigerator each day and acknowledged that there were no expiration dates on the 6 cartons.

On 4/19/10 at 12:00 p.m., there were 3 pint size 100 percent fruit juice containers in the unit 1 day room patient nourishment refrigerator. There were labels dated 5/3, 4/29, 4/24 on the juice containers. The juice containers were held thawed and delivered frozen. Staff M stated the dietary staff labels the juice pints with the date on the case they come in. Staff M stated that she was not aware of how long the juice could be stored when thawed.

Review on 4/22/10 at 8:30 a.m., the RD provided the manufacturer ' s directions for frozen juice stated the " Under optimal conditions (chilled at a constant 38 degrees F or below), the product will retain a 10 day shelf life after being thawed. "

The hospital did not follow manufacturer ' s directions and date thawed fruit juice to be held for 10 days.

Dietary staff stocked pint milk cartons with no expiation dates with the potential of serving expired and contaminated milk to patient.

6. On 4/20/10 at 11:30 p.m., there was a scoop in the can of powder protein supplement in the diet office. Staff M acknowledged the scoop was not to be left in the powder and was a potential for cross contamination. Manufacturer ' s directions stated to store the scoop separately.

7. On 4/20/10 at 11:40 p.m., in the patient cafeteria, Staff O was serving lunch and observed with bangs not covered by the hairnet. Staff M acknowledged the hair was to be completely covered to protect food from contamination. At 11:55 p.m., Staff N was observed serving food in the kitchen with bangs not covered. Staff M acknowledged the food service staff was not wearing the hairnet to cover all of their hair.
Review of policy ' Food contamination, avoiding: stated " Hairnets or approved head covering to restrain hair are worn by employees during food production/serving activities. "

8. On 4/21/10 at approximately 12:00 p.m., the lunch tray line was observed. Staff N had prepared the roast beef and placed it on the tray line before 10:00 a.m., for service from 12:00 p.m. to 1:00 p.m. Staff N acknowledged that the practice was to get the hot food on the trayline early to ensure she had time to get all of the food prepared. Staff M acknowledged that holding hot food on the trayline for two to three hours would compromise the nutrition content especially the heat labile vitamins.

9. The quality appraisal and performance improvement (QAPI) activities for the Food and Dietetic Services were reviewed 4/21/10 at 9:00 a.m., with Staff M. She stated that the kitchen recorded refrigerator temperatures. She stated that there was no QAPI program for the clinical nutrition.

There was no program provided to ensure the QAPI program was developed for the scope of the hospital food and clinical nutrition areas.

Based on staff interview and document review, the hospital failed to ensure the qualified dietitian supervised the nutritional aspects for all patient care and approved patient menus with the potential of 60 of 60 patients not receiving therapeutic diets and compromised nutrition care.

Findings:

1. On 4/21/10 at approximately 9 a.m., Staff M was interviewed regarding the therapeutic menus and low sodium (2 gram sodium diets). Staff M stated that the patients receive a selective menu and the diet clerk modified the patient's selections to be in line with the physician orders and restrictions. Staff M explained the menu for lunch 4/20/10 for the 2 gram sodium diet, would receive the low sodium soup, meatball sandwich, tossed salad with low fat salad dressing, and dessert, and milk. Review on 4/21/10 of the product detail for three meatballs provided approximately 1260 milligrams (mg) sodium, one roll provided 529 mg sodium, fat free salad dressing 410 mg sodium, meat sauce 1 ounce- approximately 480 mg sodium, and 1 tbsp shredded cheese, approximately 90 mg sodium. The menu for breakfast included grits and the recipe nutritional summary provided 530 mg sodium. The menu for breakfast and lunch provided approximately 3300 mg (3.3 grams) sodium for the 9 patients on physician ordered 2 gram sodium diets. Staff M acknowledged there was not RD oversight of the 2 gram sodium diet.

2. Patient 302 was admitted 4/13/10, with diagnoses of depression NOS (not otherwise specified).
Medical record was reviewed on 4/ 20/10 at 10 a.m. The patient weight was 103 pounds and height was 5 feet 3 inches. The nutrition assessment dated 4/16/10, showed elevated LDL (low density lipoprotein) cholesterol of 132 and total protein elevated of 8.5. The assessment recommended a low cholesterol diet and to monitor nutritional parameters.

Staff M stated that when the nutrition assessment stated "to monitor parameters," she meant that there would be a follow up only when the physician ordered a consult. She stated there was no scheduled follow-up policy based on patient nutrition acuity.

On 4/21/10 at approximately 9:15 a.m., the RD was asked to explain the nutrition care of the pediatric and adolescent population of the hospital. Staff M stated that 20 beds were pediatric and adolescent patient with admissions starting at age 5. Review of the policy " Screening Nutrition Risk," last revised on 12/09, showed that patients receive nutritional assessment and reassessment. The Policy Screening Nutrition Risk did not include any patient screening, nutrition assessment or reassessments criteria for pediatric and adolescent patients. Staff M acknowledged that there were no specific guidelines on follow up or identifying patient risk levels for the adult or adolescent and pediatric patients.

There was no system for the assessment; reassessment of the patient population to ensure all patients received appropriate nutrition care

Based on observation, staff interview, and document review the hospital failed to ensure competent staff as evidenced by a lack of system to monitor food service staff practices to ensure safe food handling practices.

Findings:

During a review of dietetic services operations on 4/21/10 at 8:00 a.m. it was noted that there were issues with safe cooling of potentially hazardous food, cross contamination during patient meal delivery, staff hand washing and hair-net practices.

Examples include:
1. On 4/20/10 at 11:40 p.m., in the patient cafeteria, Staff O was serving lunch and observed with bangs not covered by the hairnet. Staff M acknowledged the hair was to be completely covered to protect food from contamination. At 11:55 p.m., Staff N was observed serving food in the kitchen with bangs not covered. Staff M acknowledged the food service staff was not wearing the hairnet to cover all of their hair.
Review of policy ' Food contamination, avoiding: stated " Hairnets or approved head covering to restrain hair are worn by employees during food production/serving activities. "

2. On 4/ 20/10 at 11:45 a.m., Staff O was observed to serve food, enter information into a keyboard and then run her hands under water and return to serving food. Staff was asked to demonstrate handwashing procedures. Staff O put soap on hands and immediately rinsed. On the fourth observation of Staff O hand washing the wash with soap was approximately 4 seconds before rinsing the hands with water.
Staff M acknowledged that this was not the standard of practice for hand washing.

Review of policy " Hand Hygiene Practice " last revised on 1/10, stated when washing hands with soap and water, wet hands with water, apply an amount of product recommended by the manufacturer to hands, and rub hands together vigorously for at least 15 seconds, covering all surfaces for the hands and fingers. Rinse hands with water ad dry thoroughly with a disposable towel. Use towel to turn off the faucet.

In addition, there was a documented handwashing and glove use in service dated 2/9/10. Sign in document confirmed that O was present.

3. On 4/20/10 at 12:00 Staff N was serving lunch in the kitchen. Staff N was observed to put on disposable gloves, opened refrigerator, and changed gloves with no handwashing. New gloves were in contact with serving cart, cook grilled cheese sandwiches, serve soup and wipe counter with a wiping towel and continue to serve bun with contaminated gloves.

Review of the inservice dated 2/9/10 for handwashing and glove use in food service showed to wash hands before putting on gloves, and touching anything that may contaminate hands. Sign in document for the inservice showed Staff N was present at this training.

Corporate Staff 2 who observed the Staff N practice confirmed the standard of practice is to wash hands when gloves are changed and to maintain clean gloves when serving the bun (ready to eat food) (RTE) is not in contact with the bare hands.

Food Code 2009 specifies that bare hands are not to be used when serving RTE foods for highly susceptible population (examples are congregate living and hospitals).

4. On 4/20/10 at 12:45 p.m., two patients were observed to place their dirty used tray onto the clean cart that still contained 5 un-served patient food trays. The unit nursing staff did take these two dirty trays to the empty cart, but the staff including Staff M did not ensure the 5 trays (now potentially contaminated) were not served and replacements meals were not requested.

5. On Tuesday, 4/20/10 at 11:30 a.m., there was one pan containing approximately 4 large pieces of roast beef in deep pan on the stove. Staff N identified this as the roast beef she had cooked this morning and would serve for lunch Wednesday (4/21/10).

On 4/21/10 at 10:00 a.m., the roast beef was sliced and on the steam table for lunch service. The Staff N identified the roast beef as the beef she had prepared on 4/20/10. She stated that the p.m. cook was responsible for roast beef after she left at 2 p.m. yesterday. She stated that she left the roast beef (approximately 30 to 40 pounds) covered in one pan on the stove.

Staff M, a dietary administrative staff, was questioned on 4/20/10 at 10:00 a.m., about the practice of cooldown for the roast beef prepared and held overnight. Staff M was unable to answer the question but asked a diet aide in the diet office if there was a log or documentation for the roast beef cooldown. The diet aide was unable to provide Staff M with documentation. The Staff M was asked if the roast beef now ready for service to 60 patients was safe to serve. She stated that they would provide a meal substitute and acknowledged there was no way to ensure the product was safe.

At 11:00 a.m., Staff Q who was responsible for the roast beef on 4/20/10 in the evening was interviewed. She stated that she " cooled down " the roast beef before she put it into the refrigerator. She confirmed the roast beef was in one large pan and was very heavy. She stated that " I take temperature at 2:00 p.m. and it was 134 degrees Fahrenheit (F); at 4:00 p.m., 100 degrees F; and at 5:00 p.m., 84 degrees F; and at 6:00 p.m., 64 degrees F. " Staff Q confirmed that all temperatures were taken before the large pan of roast beef was placed in the refrigerator. She stated that the roast beef was put in the refrigerator at 6:00 p.m., at 65 degrees F. She stated that the pan should have been placed in an ice bath but the pan was too heavy so she left it on the counter and just measured the temperatures.

Staff M confirmed the roast beef was cooked one time a month on the four week cycle menu.

Review of the policy titled " Leftover food items, " on 4/21/10 at 11:00 a.m., stated leftover foods are cooled over a 6-hour period to 41 degrees F, then covered, labeled, and dated. The policy states that " All leftover food that is to be retained is to be placed in the blast chiller upon removal from the steam table. " There were additional directions for placing food in a 200 pan in the refrigerator until 70 degrees F and continue cooling until temperature reaches 41 degrees F within an additional 4 hours.

Staff M confirmed on 4/21/10 at 11:00 a.m., that there was no blast chiller for the rapid cooling of a leftover and acknowledged the policy did not address the safe cooling of the regularly prepared roast beef that was not a leftover but prepared the day ahead for service to patients.

In addition, the policy stated that the Nutrition Service Supervisor (NSS)/designee will check the items that have cooled. Staff M confirmed the NSS was on medical leave for the last month and that she did not oversee the management of the kitchen.

Review on 4/21/10 at 11:00 a.m., of the time/temperature discussion with Staff M, acknowledged the roast beef (a potentially hazardous food), had been held in the danger zone of 135 to 40 degrees for four or more hours and had not been cooled according to the facility policy or Food Code 2009 directions.


Review of the dietary staff in-services from 4/09 to 3/10 did not show any review of the cooling, refrigeration or safe food handling for food items cooked a day ahead and served the next day.

Potentially hazardous food (PHF ' s) must be maintained under time/temperature control to minimize the risk of growth of bacteria associated with food borne illness (Food Code 2009).

On 4/21/10 at 8:00 a.m., Corporate Staff 1 discussed the food service operation and the findings during the survey. She stated that there was no system to evaluate the food service staff competencies associated with safe food handling practices.

Based on staff interview, the hospital failed to ensure there was a current therapeutic diet manual, approved by the dietitian that addressed the nutritional care of the pediatric and adolescent age patient population with the potential of staff including physicians would not have therapeutic diet references for pediatric and adolescent patients that could compromise patient care.

Findings:

On 4/22/10 at 10:30 a.m., Staff M stated that the hospital used the American Dietetic Association's Manual for Clinical Dietetics. She confirmed this was adult based. The hospital admissions included both pediatric and adolescent patients. She confirmed there was no pediatric or adolescent diet manual for reference.

Based on observation, staff interview, and document review, the hospital failed to develop and maintain adequate disaster food, disaster menus, and water for the licensed bed count, staff and any visitors. The facility was not prepared to provide the appropriate nutrition for patients, staff and any visitors during an emergency situation.

Findings:

Disaster food and water were reviewed on 4/19/10 at approximately 3 p.m., Staff M identified that the plan was for 100 patients and staff.

a. Disaster food was stored in a closet in the Plant Services department. There were approximately 9 large cases of disposable service ware in the middle of the room and obstructing access to the cases of food specified for use during a disaster. To access the food, the large cases would have to be removed from the storage room. Corporate Staff 2 acknowledged the room needed to be organized to ensure staff could efficiently find and access the stored food for disaster.
b. Review of the policy "Food and water, emergency/disaster" showed a plan for 4 day staple food. There was part of a disaster food inventory form on the storeroom door, but the staff could not verify the quantity of disaster foods present in the storeroom to meet requirement for the four days specified in the plan.
c. The Disaster Plan provided for a guide for foods to serve and a note that the Nutrition Service Manual contained regular and vegetarian menus for emergency/disaster situation. The staff was asked to provide the disaster menus but acknowledged that there were no disaster menus.
d. The water for disaster was store in the employee lounge closet. Staff M verified that there were 200 gallons in 5 gallon bottles. The policy "food and water, emergency/disaster " stated that there was a "4-day emergency supply of bottled water on the basis of one gallon per person per 24 hours. "
Based on the plan for 100 staff, patients, and visitors, the hospital required 400 gallons of water for an emergency situation. There was not adequate stored bottled water per the disaster plan.
e. The policy "food and water, emergency/disaster" last revised on 12/09, also specified a " minimum for 2-day supply of disposable wares." There was no plan to ensure adequate disposable serving wares for the plan for 4 day emergency food supply.

Based on observation and staff interview, the hospital failed to ensure the trash bins were tightly closed and secured from insect and vermin with a potential for insect and vermin infestation.

Findings:

On 4/19/10, during initial kitchen tour starting at 2 p.m., two outside trash bins had lids that did not close securely. In a concurrent interview, Corporate Staff 2 acknowledged that the lids were not closing to prevent access from insects and vermin and should be changed.

Based on observation, staff interview, and document review, the hospital failed to ensure a comprehensive infection control oversight of the food service department and patient food service met the needs of all patients as evidenced by failure to:

1. Ensure safe and effective food production practices to prevent potential for food borne illness when hospital prepared and served food that had been held in the danger zone (135 degrees Fahrenheit (F) to 41 degrees F) and failed to follow time/temperature requirements for safe food handling. (Cross Reference A749)

2. To maintain a clean and sanitary environment to avoid sources and transmission of infection and communicable diseases [Cross Reference A749]

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

Based on observation, staff interview, and document review, the hospital failed to ensure the safe handling of potentially hazardous food as evidenced by; 1) lack of monitoring the cool down process for potentially hazardous food; 2) sanitized food thermometers when testing foods; 3) two of two ice machines used in food and drink were sanitized per manufacturer's directions; 4) food service staff observing standard of practice for hand washing in the food act of serving food; 5) food service staff observing standard of practice for use of gloves when serving food; 6) no system to ensure patient trays were safe from cross contamination; and 7) no comprehensive infection control oversight of the food service department and patient food service. The above deficient practices in handling potentially hazardous food have the potential of food borne illness for 60 of 60 patients.

Findings:

1. On Tuesday, 4/20/10 at 11:30 a.m., there was one pan containing approximately 4 large pieces of roast beef in a deep pan on the stove. Staff N identified this as the roast beef she had cooked this morning and would serve for lunch on Wednesday (4/21/10).

On 4/21/10 at 10 a.m., the roast beef was sliced and was on the steam table for lunch service. Staff N identified the roast beef as the beef she had prepared on 4/20/10. She stated that the p.m. cook was responsible for the roast beef she left at 2 p.m. yesterday. She stated that she left the roast beef (approximately 30 to 40 pounds) covered in one pan on the stove.

Staff M, a dietary administrative staff, was questioned on 4/20/10 at 10 a.m., about the practice of the cool down process for the roast beef prepared and held overnight. Staff M was unable to answer the question but asked a diet aide, in the dietary office, if there was a log or documentation for the temperatures of the roast beef during the cool down process. The diet aide was unable to provide Staff M with documentation. Staff M was asked if the roast beef, now ready for service to 60 patients, was safe to serve. She stated they would provide a meal substitute and acknowledged there was no way to ensure the product was safe.

At 11 a.m., Staff Q, who was responsible for the roast beef on 4/20/10 in the evening, was interviewed. She stated she "cooled down " the roast beef before she put it into the refrigerator. She confirmed the roast beef was in one large pan and was very heavy. She stated "I take temperature at 2:00 p.m. and it is 134 degrees Fahrenheit (F); at 4:00 p.m., 100 degrees F; at 5:00 p.m., 84 degrees F; and at 6:00 p.m., 64 degrees F. " Staff Q confirmed that all temperatures were taken before the large pan of roast beef was placed in the refrigerator. She stated that the roast beef was put in the refrigerator at 6:00 p.m., at 65 degrees F. She stated that the pan should have been placed in an ice bath but the pan was too heavy so she left it on the counter to cool down.

Staff M confirmed the roast beef was cooked one time a month on the four week cycle menu.

On 4//21/10 at 11 a.m., review of the policy titled " Leftover food items, " revised 5/06, indicated that leftover foods are cooled over a 6-hour period to 41 degrees F, then covered, labeled, and dated. The policy indicated "All leftover food that is to be retained is to be placed in the blast chiller upon removal from the steam table." There were additional directions for placing food in a 200 pan in the refrigerator until 70 degrees F and continue cooling until temperature reaches 41 degrees F within an additional 4 hours.

Staff M confirmed on 4/21/10 at 11 a.m., that there was no blast chiller for the rapid cooling of a leftover and acknowledged the policy did not address the safe cooling of the regularly prepared roast beef that was not a leftover but prepared the day ahead for service to patients.

In addition, the policy stated that the Nutrition Service Supervisor (NSS)/designee will check the items that have cooled. Staff M confirmed the NSS was on medical leave for the last month and that she did not oversee the management of the kitchen.

Discussion on 4/21/10 at 11 a.m., of the time/temperature with Staff M, acknowledged the roast beef (a potentially hazardous food), had been held in the danger zone of 135 to 40 degrees for four or more hours and had not been cooled according to the facility policy or Food Code 2009 directions.

Review of the dietary staff in-services from 4/09 to 3/10 did not show any review of the cooling, refrigeration or safe food handling for food items cooked a day ahead and served the next day.

Potentially hazardous food (PHF 's) must be maintained under time/temperature control to minimize the risk of growth of bacteria associated with food borne illness (Food Code 2009).

2. On 4/20/10 at 11:45 a.m., Staff O tested the hot lunch food with a thermometer that she wiped with a clean paper towel. There were no alcohol swabs or other system to sanitize the thermometers prior to testing food temperatures. Staff M acknowledged there were no alcohol swabs available even though she was to use an alcohol swab to ensure the thermomeret was sanitized before using it to take the food temperatures.

Review of the policy manual showed no policy for directing staff procedures for sanitizing thermometers.

3. On 4/20/10 at 11 a.m., Staff NN stated that the hospital had two ice machines.
a. The cafeteria ice machine was maintained by a maintenance company every 6 months. Review of the invoice dated 1/11/10, for cafeteria ice machine showed the service for water filter and nickel free ice machine cleaner.

Review of the manufacture's use and care manual showed " use only [manufacturer's name] approved ice machine cleaner and sanitizer. " The invoice did not confirm that the nickel free ice machine cleaner was the product specified by the manufacturer. In addition, there was no documentation of a sanitizer process as specified in the manufacturer's use and care manual.

b. Staff NN stated that he cleaned the bin of the kitchen crushed ice machine every 2 months. Review of the inspection report dated 3/6/10 verified the inspection.

Review of the manufacturer's instruction manual showed a recommendation for cleaning solution (scale away) and a sanitizing solution of 2.5 fluid ounces IMS-II sanitizer or 5.25 percent sodium hypochlorite solution. Both the cleaning and sanitizing direction specify application to the interior of the ice making reservoir.

Staff NN acknowledged that he did not follow the cleaning and sanitizing directions as outlined in the manufacturer's instructions.

4. On 4/ 20/10 at 11:45 a.m., Staff O was observed to serve food, enter information into a keyboard and then run her hands under water and return to serving food. Staff O was asked to demonstrate handwashing procedures. Staff O put soap on hands and immediately rinsed. On the fourth observation of Staff O washing her hands she had soap on her hands for approximately 4 seconds before rinsing the soap, on her hands, with water. Staff M acknowledged that this was not the standard of practice for hand washing.

Review of policy " Hand Hygiene Practice " revised 1/10, stated when washing hands with soap and water, wet hands with water, apply an amount of product recommended by the manufacturer to hands, and rub hands together vigorously for at least 15 seconds, covering all surfaces for the hands and fingers. Rinse hands with water and dry thoroughly with a disposable towel. Use towel to turn off the faucet. "

In addition, there was a documented handwashing and glove use in service dated 2/9/10. Sign in document confirmed that Staff O was present.

5. On 4/20/10 at 12:00, Staff N was serving lunch in the kitchen. Staff N was observed to put on disposable gloves, opened refrigerator, and changed gloves with no handwashing. New gloves were in contact with the serving cart, cook grilled cheese sandwiches, served soup and wiped the counter with a wiping towel and continued to serve buns with contaminated gloves.

Review of the inservice dated 2/9/10, for handwashing and glove use in food service, revealed that staff should wash hands before putting on gloves, and before they touched anything that may contaminate their hands. Sign in document for the inservice showed Staff N was present at this training.

Corporate Staff 2, who observed Staff N practice, confirmed that the standard of practice is to wash hands when gloves are changed and to maintain clean gloves when serving the buns (ready to eat food) (RTE) and not in contact with the bare hands.

Food Code 2009 specifies that bare hands are not to be used when serving RTE foods for highly susceptible population (examples are congregate living and hospitals).

6. On 4/20/10 at 12:45 p.m., two patients were observed to place their dirty used tray onto the clean cart that still contained 5 un-served patient food trays. The unit nursing staff did take these two dirty trays to the empty cart, but the staff, including Staff M, did not ensure the 5 trays (now potentially contaminated) were not served and replacement meals were not requested.

7. On 4/21/10 at 11:45 a.m., the infection control staff was interviewed. Staff Q and corporate infection control consultant were present. Staff Q stated the program covered the patient areas and a dietary walk through. Staff Q stated that she did observe food service staff when she was in the cafeteria but there was no comprehensive infection control.