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Based on observation, staff interviews, medical record and document reviews, the hospital failed to ensure an effective governing body that was legally responsible for the conduct of the hospital as evidenced by:

A. The governing body failed to accurately assess the depth and breadth of food handling practices associated with cafeteria food services as evidenced by lack of effective review of the hospitals' contract for cafeteria services at the Modesto and Manteca campus. The governing body failed to ensure that all services performed under contract were provided in a safe and effective manner. The governing body failed to maintain a current and accurate list of all contracted services. (Cross reference A-83, A-85)

B. The governing body failed to ensure that identified problems associated with contracted cafeteria food services at the Modesto and Manteca campuses were effectively analyzed and corrective actions implemented. (Cross reference A-267)

C. The governing body failed to ensure that the pharmaceutical services met the needs of the patients and that polices were developed that would minimize adverse outcomes and medication errors. (Cross reference A-490)

D. The hospital failed to 1) ensure the availability of organized dietetic services that are directed and staffed by adequately qualified personnel, 2) provide organized dietetic services as evidenced by findings of unsafe food handling practices and lack of effective monitoring of potentially hazardous foods by contracted vendors, 3) provide effective sanitation of food production equipment, and 4) ensure effective care planning for patients identified at nutritional risk. (Cross reference A-618)

E. The governing body failed to ensure competency of hospital and contract staff responsible for delivering food services at the Modesto and Manteca campus. (Cross reference A-620)

F. The governing body failed to ensure hospitals adequately planned to ensure available food for all patients and staff at both campuses during a disaster that would require the hospital to be self sufficient for seven days. This is evidenced by lack of planned menu and food for staff for seven days, lack of portion sizes for serving bulk food (not already pre-portioned in individual containers), to ensure food lasts the time planned for, lack of directions for food to serve patients on therapeutic diets, an inadequate amount of frozen entrees and ready-to-eat meals, and lack of knowledge of dietary management staff in how to implement the disaster menu. (Cross reference A-701)

G. The governing body failed to ensure that the hospital provide an active surveillance program that would ensure a clean and sanitary environment and implement infection control policies for all areas of the hospital. (Cross reference A-747)

H. The hospitals failed to develop an orthopedic splinting policy and procedure (P&P) that would encompass a standardized process for ordering, applying and physician reassessment of splints that were applied by non-licensed ED staff. Both the Modesto and Manteca hospitals allowed licensed and non-licensed emergency department personnel to apply orthopedic splints on ED patients prior to receiving specialized training. (Cross reference A-1104, A-1112)

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Governing Body.

Based on dietetic services observations, dietary and contract staff interview and dietary and administrative document review the hospital failed to ensure the governing body effectively monitored the outside contracted cafeteria services. Observations of food handling practices by the contracted vendor had the potential to place patients, who obtained food from the cafeteria, at risk for food borne illness.

Findings:

The Dietetic services review was conducted from 5/3 to 5/6/10. During that timeframe numerous issues were identified surrounding lack of effective systems to minimize risk of food borne illness (Cross Reference 749). Specifically the identified issues included:
1) Lack of a consistent system for labeling or dating of stored food items in the cafeteria.
2) Lack of cool down temperature monitoring of cafeteria prepared PHF's (Potentially Hazardous Foods) held and intended to be used at a later time.
3) Failure by the cafeteria vendor to develop standardized operating policies and procedures related to safe food handling practices (Cross Reference 619).
4) Lack of effective monitoring of food production, holding or distribution by the hospital or the contracted cafeteria vendor (Cross Reference 749).
5) Lack of effective and accurate evaluation and/or performance improvement activities of contracted services (Cross Reference 083).

In an interview on 5/3/10 at 11:00 a.m. with DMS H, he stated that patients would have access to cafeteria prepared foods provided the physician approved it.

In an interview on 5/4/10 at 11:00 a.m. with DMS A, the surveyor asked if she provided any oversight into cafeteria food production, to which she replied that she did not. She stated she relied on DMS B to provide guidance and oversight to the cafeteria functions.

Review on 5/4/10 of hospital document titled, "Kaiser Permanente Contract No. NU1644" dated 7/31/08 noted the following contractual obligations: "1) Contractor shall comply with applicable standards of operations of ...Department of Health Services (DHS) related to sanitary practices and precautions ...The Food Code, ...will be used as a model for meeting these requirements ...; 2) Contractor shall comply with ...all federal, state and local laws and regulations governing sanitation ...and the preparation, handling and serving of foods; 3) Contractor shall ...train ...staff ...capable of conducting the operation ...Contractor will provide regular training to employees regarding safe food handling ... 4) No employee ...shall begin work until they have undergone medical screening ... 5) Contractor will provide an annual training schedule with content and completion status to Kaiser Permanente." There was no documentation that any of the contractual obligations were implemented.

Review on 5/4/10 of hospital document titled "Quality and Performance Improvement Committee" dated 2/27/09 identified issues with cafeteria services with an action plan for the daily check lists to be "completed twice daily by AM and PM supervisors." There was no evidence this plan was implemented. Similarly the performance improvement meeting held on 8/19/09 identified similar issues with compliance for the contracted vendor; however the actions remained the same as 6 months earlier. There was no evidence that the department attempted to analyze the reason for non-compliance and prepare a performance improvement plan that addressed the identified issues. The 9/16/09 and 10/21/09 performance improvement meeting noted that the cafeteria met the expected threshold. The 11/18/09 performance improvement meeting noted that overall, the contractor did not meet expectations. The minutes also noted that the contractor would identify specific problems such as revising labeling/dating procedures and to reinforce "procedures", job expectations and the importance of following work standards. There was no evidence that any of these identified issues were addressed or implemented. It was also noted that the dietetic department committed to conduct unannounced bi-monthly inspections and daily oversight. There was no documentation that any of the hospital's action plans were fully implemented.

In an interview on 5/5/10 beginning at 2:00 p.m., the surveyor asked the Hospital Administrator (A 1, a governing body member) if he was aware of any of the problems associated with the cafeteria contract. A 1 replied that until 5/3/10 he was unaware of any current problems. The surveyor also asked how he ensured that hospital contracts were implemented according to agreements. He replied that in the instance of the cafeteria contract he would delegate the oversight to the nutrition management team and would review the effectiveness of the contract via submitted reports.

Based on staff interview and record review, the facility failed to maintain a current and accurate list of all contracted services (more than 55).

Findings:

On 5/3/10, during the entrance conference, the Department requested a list of all contracted services. On 5/4/10, the facility provided a list that identified 23 services with contractual agreements. The list was incomplete as it did not identify 3 pharmaceutical companies (Pharmedium, Cardinal Health, American Source Berger), a medical record coding company(Code works) or 4 laboratories (Quest, Genzyme Genetics, Mayo Medical Labs, Promethesus), all of which were mentioned during interviews with staff on 5/3/10 and 5/4/10.

On 5/4/10, the Department requested a second list following a tour of the facility's laboratory and surgical departments which identified several contracted vendors for each department. The second list identified approximately 55 services and was still incomplete as it did not contain Life Net, Bio Tissue Inc., Allosource or the above mentioned except Quest Laboratory.

On 5/5/10, an interview was conducted with the A1 regarding the contracted services and those not identified on the list. The A1 informed the Department that the facility was comprising a more thorough list and would provide the list when completed. On 5/10/10, when the survey process was completed, the Department did not receive a current accurate list of all contracted services including the scope and nature of the services provided.

Based on patient observation, nursing staff interview, medical record review and nursing document review the hospital failed to ensure that 1 of 46 patients (Patient 9) was free from unnecessary restraints. Patients who are unnecessarily restrained may injure themselves attempting to remove the restraints, further compromising their medical status. In severe instances restraints may be a contributing cause of death.

Findings:

A review of Patient 9's medical record was conducted on 5/4 and 5/5/10. Patient 9 was admitted with diagnoses that included asthma which required intubation to maintain Patient 9's airway and a naso-gastric tube for feeding. Further review showed a physician's order (dated 4/29/10) for left and right soft tie wrist restraints and they could be discontinued when there was an, "absence of activity that required restraint."

On 5/4/10 at 10:15 a.m., Patient 9 was observed lying in bed. Patient 9's airway was maintained by a mechanical ventilator and a naso-gastric feeding tube was in place. A visitor was observed by the patient's bedside speaking with her and stroking her hair. During this observation, Patient 9 was not restrained and appeared to be resting comfortably.

On 5/4/10 at 10:30 a.m., Patient 9's nurse (RN 20) was asked why Patient 9 was restrained and she stated that restraints are usually used for intubated patients. RN 20 stated that the restraints prevented patients from pulling on any of the their tubes. RN 20 was asked if Patient 9 had attempted to pull at her tubes and she stated that she was unsure.

Further review of the medical record showed part of the care plan was for, "1:1 patient care as a less restrictive alternative," to the restraints. Documentation showed that the restraints were re-ordered every 24 hours through 5/4/10. There was no documentation that showed that any least restrictive interventions were implemented or that Patient 9 attempted to pull the tubes. Restraint documentation beginning on 4/29/10 at 11:22 p.m. noted the clinical justification as "pulling lines" but there were no nursing entries stating that the patient had attempted to pull at her tubes or that any attempts at less restrictive interventions had been unsuccessful. It was noted that from 4/29/10 to 5/5/10 (6 days) there were 3 entries that the patient was agitated and restless; however the remainder of the time the patient was noted to be asleep or subdued.

Hospital policy titled "Restraints" dated 3/3/10 guided nursing staff that "Restraint ...may only be used when less restrictive interventions have been determined to be ineffective." There was no documentation that hospital staff attempted to implement less restrictive methods prior to implementing bi-lateral soft wrist restraints.

Based on food handling observations, administrative document review and administrative staff interview the hospital failed to ensure that identified problems associated with cafeteria food services at Modesto and Manteca campuses were effectively analyzed and corrective actions implemented. The hospital failed to ensure the completion of performance improvement activities related to clinical nutrition care at the Manteca campus. Failure to effectively analyze and/or accuratly identify opportunities for performance improvement related to vendor performance may result in patients, who consumed cafeteria foods, being exposed to a food borne illness, further compromising medical status and in severe instances may result in death. Failure to identify areas of improvement for clinical nutritional care may result in lack of nutritional intervention for patients at nutritional risk, further compromising medical status.

Findings:

Review of the performance improvement activities on 5/4/10 and 5/5/10 indicated that the hospital had submitted two performance improvement reports dated 5/09 and 2/24/10. The 2/24/10 report documented that the dietary department would be completing daily rounds by the assistant manager and the morning cook. The report also noted that both the Modesto and Manteca cafeteria sites "struggle with the area of labeling leftovers and expired items," however there was no documentation that the hospitals attempted to analyze reasons for the continuing deficient practices within the cafeteria or provided consistent, measurable interventions to ensure the problems did not persist. Though the dietary department had submitted information to the QAPI committee, the dietary department failed to implement significant corrective actions and failed to accurately reflect the depth and breadth of the unsafe food handling practices with in the cafeteria services (Cross Reference A-749).

In an interview on 5/5/10 beginning at 2:00 p.m. with the A1 and two performance improvement administrative staff, they were asked if they were aware of any of the problems associated with the cafeteria contract. the A1 replied that until 5/3/10 he was unaware of any current problems. The surveyor asked how he ensured that the quality of hospital contracts were maintained. He replied that in the instance of the cafeteria contract he would delegate the oversight to the nutrition management team and he would review the effectiveness of the contract via submitted reports.

Additionally, the hospital failed to provide any performance improvement activities related to hospital food service or clinical nutrition care, despite requests by surveyor on during the survey.

Based on medical record review, clinical nutrition staff interview and dietary document review the hospital failed to ensure comprehensive nutrition care planning for 2 of 46 patients (Patients 9 and 41) who were identified at nutritional risk. Failure to ensure consistent and comprehensive nutritional care planning activities may result in delayed nutritional interventions, further compromising patients nutritional and medical status.

Findings:

Manteca Campus

1. Patient 9 was admitted with diagnoses including asthma. Medical record review was conducted on 5/4 and 5/5/10. A physician's order dated 4/28/10 noted that the patient was intubated (a tube place in the patients airway to help with breathing). The physician also ordered a naso-gastric tube (tube placed through the nose into the stomach) for feeding.

A physician's order dated 4/29/10 noted the initiation of tube feeding with at a rate of 10 cc's/hour with a final rate of 40 cc's/hour.

A comprehensive nutrition assessment dated 4/29/10 and completed by the RD noted that while the tube feeding met the patient's nutritional needs, the RD also noted inadequate hydration as demonstrated by low urine output. The RD recommended an increase in free water flushes as well as the implementation of a multi vitamin/mineral supplement.

A follow up nutrition consultation dated 4/30/10 and completed by the RD noted the patient had inadequate protein/energy intake related to poor feeding tolerance. The documentation also noted that the patient was at high nutritional risk. The assessment also noted interventions to continuing advancing the formula with a 2nd request for a multi vitamin/mineral supplement as well as aggressive bowel care. An additional nutrition assessment dated 5/3/10 included recommendations for the progression to a full liquid diet once the tube feeding was discontinued and a 3rd recommendation for a multi vitamin/mineral supplement.

Review of Patient 9's care plan revealed there were no documented nutrition care plans despite the Patient 9's documented nutritional risk.

In an interview on 5/5/10 at 9:30 a.m., with RD K the surveyor asked her to describe the nutritional care planning process. RD K stated that care plans would not be developed for all patients with nutritional needs; however that a care plan would be developed for patients on tube feedings. She also stated that the hospital implemented an electronic medical record and the RD's did not receive training on care plan entry into the system. The surveyor asked how long the electronic system was in place, to which RD K replied, 18-24 months.

Review of hospital policy titled "Nutrition Assessment and Care Planning" dated 12/31/08 revealed that it would be the responsibility of the RD to develop a nutrition care plan. The policy also guided staff that a nutritional care plan would include measurable goals, quantifiable measures to determine progress, strategies for achieving goals/time frames and the roles of the interdisciplinary team.

2. Patient 41 was admitted with diagnoses including a urinary tract infection. The admission history and physical dated 4/30/10 noted poor dietary intake for the previous 2-3 days. The admission nursing assessment dated 4/30/10 failed to note the poor dietary intake. Admission diet order dated 4/30/10 was a low sodium diet. A physician order dated 5/1/10 requested an albumin lab test (a measure of protein stores). A comprehensive nutrition assessment dated 5/1/10 documented an inadequate oral intake and noted the patient's nutritional risk as moderate, due to the decreased intake. The assessment also noted the patient's poor dietary intake prior to admission.

There was no documentation of a nutritional care plan for Patient 41 who was identified as being at moderate nutritional risk and had a history of poor dietary intake. Laboratory results dated 5/2/10 revealed an albumin value of 2.0 gm/dl (normal 3.4-4.8 gm/dl), indicating moderate protein depletion (Nutrition Consultants Pocket Guide, 2002).

In an interview on 5/5/10 at 9:30 a.m., she acknowledged that while the patient was seen for nutritional assessment there was no nutritional care plan.

Based on observation of six nurses passing medications to ten patients on two Med Surg Units (one on the Modesto Campus and one on the Manteca Campus) the hospital failed to ensure that:
1. Staff followed the hospital procedures and manufacturer guidelines for the administration of famotidine (gastric acid reducer).
2. The staff failed to ensure that an order for administration of a medication was discontinued as ordered by the physician and as provided for in hospital procedures.

Findings:

1. On May 4, 2010 at 8:43 a.m. Staff B1 administered 2 ml (20mg) of famotidine (reduces stomach acid to Patient 21 on the Modesto Campus 3rd Floor Med Surg Unit. Staff B1 drew up 2 ml of famotidine into a syringe and injected it over 10 seconds. On May 4, 2010 at 9:23 a.m. a review of Patient 21's clinical record indicated that there was an order to administer 20 mg of famotidine to Patient 21 at the time it was given but the administration instructions stipulated that the famotidine was to be diluted in 10 ml of NS and administered over 2 minutes. During an interview of Staff B2 at this time he stated that these instructions would appear on the MAR and that the nurse would be expected to follow those instructions. A review of the MAR at this time indicated that it directed the nurse to "Dilute (famotidine) with normal saline to a total volume of 10 ml and give IV push over 2 minutes." Finally the manufacturer's product labeling for famotidine documents that famotidine is to be diluted in 5 to 10 ml of NS prior to injection and that it is to be injected over a period of time that is not less than 2 minutes.

2. On May 4, 2010 at 9:45 a.m. a review of Patient 22' s clinical record on the Modesto Campus the 3rd Floor Med Surg Unit showed a physician's order (dated May 3), for labetalol (used to lower blood pressure) 5 mg IV every 10 minutes as needed for a systolic blood pressure (the top blood pressure number). It was written while the patient was in the PACU and the last part of the order directed the nursing staff to discontinue the order when the patient was transferred out of the PACU to a regular medical floor (such as the 3rd Floor Med Surg Unit). During an interview of Staff B5 at this time she stated this order was a current order and appeared on the current MAR which was an error as the medication order should have been discontinued when the patient left the PACU. A review of the MAR at that time indicated that staff had not administered IV labetalol to Patient 22 after the patient left the PACU.

During an interview of Staff B14 at this time, he stated that nurses went over the MARs at handoff when a patient transferred from the PACU to a Medical Surgical floor and at change of shift. He stated that an order such as the one for Patient 22 should have been caught by the PACU nurse transferring Patient 22 and the Med Surg nurse accepting Patient 22 at the time he left the PACU. He said both nurses missed this order and in doing so failed to carry out a "work-flow" procedure of the hospital.

Based on closed record review and staff interview, the facility failed to ensure that the conditions of admission forms contained documentation of the advance directive information for patients who do not have advance directives upon admission in 2 of 7 records reviewed (Patients 16 & 17)

Findings:

On May 5, 2010, closed record review beginning at 9:30 a.m. revealed that 2 records (Patients 16 & 17) contained "Conditions of Admissions Outpatient/Inpatient Services" forms that lacked the following information: "Does this patient have an advance directive: ____yes_______no. (box is to be checked). If no, advance directive brochure provided by_________(name of admitting staff member)." The name of the admitting staff member was left blank. The yes or no areas were blank. Staff H2 verified the above in a subsequent interview.

Based on document and medical record review and staff interview, the facility failed to ensure that all records documented a discharge summary in accordance with hospital policy in 2 of 5 records reviewed (Patients 17 & 33).

Findings:

Patient 17's and patient 33's records were reviewed on 5/5/10. In the discharge summary, the final diagnoses were recorded using abbreviations. The Bylaws, Rules and Regulation of the Professional Staff were reviewed on 5/5/10. Section II-A, item 1.C. states that all final diagnoses and complications are recorded without the use of symbols or abbreviations. This finding was confirmed by Staff H1 on 5/6/10.

Based on observations and inspections in the Surgical Departments, Emergency Departments and Medical Surgical Floors of the Modesto and Manteca Campuses, staff interview, review of polices and procedures and of patient clinical records, the hospital failed to ensure that the pharmaceutical services met the needs of the patients and that polices were developed that would minimize adverse outcomes and medication errors as evidenced by:

A. The failure of the hospital to ensure the safe use of fentanyl patches in the hospital which could potentially result in a clinically significant drop in the breathing rate and the potential for death of a patient (Cross reference A-500).

B. The failure of the hospital to ensure that a process was developed so that staff could always pick the correct dosing reference for emergency medications and the failure to ensure a process was developed to notify nursing staff of changes in the emergency supplies so that they could select the correct medications in a medical emergency. These findings could potentially result in the administration of the wrong dose of an emergency drug or the delay of treatment of a medical emergency (Cross reference A-500).

C. The hospital failed to ensure that 1) staff followed the hospital procedures and manufacturer guidelines for the administration of famotidine (gastric acid reducer) and 2) staff failed to ensure that an order for administration of a medication was discontinued as ordered by the physician as provided for in hospital procedures. (Cross reference A-405)

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Pharmaceutical Services.

Based on observations and inspections in the Surgical Departments, Emergency Departments and Medical Surgical Floors of the Modesto and Manteca Campuses, staff interview, review of polices and procedures and review of patient medical records, the hospital failed to ensure that medications were controlled according to standards of practice and state regulations as evidenced by:

1. The failure of the hospital to ensure fentanyl patches were used for 2 of 38 patients (23, 24) in a manner consistent with the boxed warning in the product labeling and by failing to ensure an evidence based and committee approved process was developed to ensure the safe use of this medication if used for an "off-label" purpose which potentially could have resulted in a significant drop in a patient's breathing rate or possibly a patient's death (see #1 and #2).

2. The failure of the hospital to ensure a process was developed that would allow staff to immediately select the correct reference source for dosing medications in a pediatric code blue. Two out two nurses who were interviewed on the Modesto Campus Med Surg Unit initially picked the incorrect dose for lidocaine (intended for the emergency treatment of irregular heart rate) which was 50% larger than the PALS guidelines used by the hospital because they used the incorrect reference sheet in the reference binder kept on the Broselow Cart (see #3).

3. The failure of the hospital to ensure that the Modesto Campus ED nursing staff had been notified that a different than usual dosage unit of injectable lidocaine had been placed in the Broselow Cart. As a result two out of three nursing staff interviewed could not locate this product in the cart, which in an actual code blue situation could have delayed emergency treatment of an irregular heart rate (see #4).

4. The failure of the hospital to ensure nursing staff disinfected the tops of vials of injectable medications prior to entering the vial with a hypodermic needle and syringe as stipulated by hospital policy and recommended by standards of practice. This failure could potentially result in contamination of the contents of the vial (see #6).

5. The failure of the hospital to ensure that polices regarding emergency medication supplies were current with respect to the intent of the hospital for the use of those supplies, the failure to ensure policies established the contents of these supplies as stipulated by state regulations, and the failure to ensure that the contents of these supplies and the date of the first drug to expire within the supply were posted on the outside cover of the supply as stipulated by state regulation (see #7 through #10).

6. The failure of the hospital to ensure that temperatures in one out of six warmers in the Modesto Campus Surgery Department were logged daily as required by hospital policy which could potentially result in solutions being stored outside a normal temperature range without staff knowledge (see #11).

Findings:

1. The fentanyl transdermal system also called a fentanyl patch contains fentanyl, a potent synthetic opiate medication used to treat pain. This medication has a boxed warning (also called a "black box" warning) which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling (package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the fentanyl patch documents that it has an associated risk of fatal overdose due to respiratory depression (decrease rate and depth of breathing). It documents that the fentanyl patch is indicated for the management of persistent moderate to severe chronic pain that requires continuous around-the-clock opioid (narcotic pain relievers derived from or having the pain relieving action of opium) administration for an extended period of time and that cannot be managed by other pain medications such as non-steroidal antiinflammatory medications which include ibuprofen (Motrin), combinations of acetaminophen and opiates such as Vicodin and Percocet, or pure opiates such as morphine. It documents that use of this patch to treat patients who are not opioid-tolerant is contraindicated because serious or life-threatening respiratory depression can occur. It documents that it should only be used in patients who are opioid-tolerant which is defined in the boxed warning as those patients who have taken at least 60 mg of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone (opiate medications used to treat pain) daily for a week or longer or an equal analgesic dose of another opiate medication. The product labeling documents that the mean time to maximal concentration of fentanyl in a patient after placement of a 12 mcg/hr path is 28.8 hours.

On 5/5/10 at 11:57 a.m. a review of Policy 10.25 entitled Medication Administration and Utilization-Black Boxed Warnings (reviewed 8/09) indicated that the policy of the hospital was to "...identify and appropriately prescribe and administer medications that carry a black box warning." It documented the purpose was: "To promote medication safety involving drugs that possess serious or life threatening side effects."

On 5/5/10 at 12:01 p.m. a review of Policy 10.27 entitled Medication and Utilization-Fentanyl Transdermal Patch (reviewed 8/09) indicated that pharmacy staff were to determine if the patch was contraindicated for a given patient, that the patient was opiate tolerant per product guidelines documented in the policy and that if contraindicated: "...the pharmacist will call the prescriber." It did not provide any guidelines for the pharmacist if there was a disagreement between the prescriber and the pharmacist regarding the use of this patch if the pharmacist had determined per the policy criteria that the use of the patch was contraindicated.

On 5/5/10 at 11:39 a.m. a review of Patient 23's clinical record indicated that on 4/2/10 Patient 23 was admitted to the hospital at 6:28 p.m. from the ED. On 4/3/10 at 12:45 p.m. a physician ordered that a 12 mcg/hr fentanyl patch be placed on Patent 23 and a review of the MAR indicated the patch was placed on Patent 23 at 1:12 p.m. A review of the pharmacist "Intervention" for this order entry in the patient's computerized profile documented that the pharmacist had called the physician and notified him that the patient did not meet the criteria for the use of the fentanyl patch. The note documented that the physician told the pharmacist that the patient was demented and unable to relay or express pain and that the patient was terminal. The note documented that the physician had ordered a 25 mcg/hr patch but agreed to reduce the dose to a 12 mcg/hr patch.

On 5/7/10 at 10:44 a.m. a review of the Discharge Summary in Patient 23's clinical record indicated that the patient was recently diagnosed with probable lung cancer. It documented that the patient was discharged on 4/5/10 in stable condition. A review of the Discharge Instructions indicated that the fentanyl patch was not prescribed on discharge. A review of the History and Physical filed on 4/2/10 at 4:54 p.m. documented the medications that Patient 23 took at home. Patient 23 did not take any narcotic medications at home. The clinical record documented that no narcotics were administered to Patient 23 before the fentanyl patch was placed on Patient 23 on 4/3/10. A review of the nursing care plans indicated the care plans contained nothing regarding the fentanyl patch.

On 5/7/10 at 1:24 p.m. during an interview of Physician B3 and Physician B4, Physician B3 stated that Patient 23's family had elected comfort care. He stated that Patient 23 was NPO (nothing by mouth) and no feeding tube would be placed so the oral route for medications was ruled out. He stated the patient had rectal bleeding due to gastrointestinal bleeding and that suppositories were not indicated. It was felt that the fentanyl patch was the only alternative. Physician B4 presented data from Patient 23's clinical record. The data showed that in the ED the nursing staff rated the patient's pain as a 5 (on a scale of 0 to 10 with 0 as no pain and 10 as the worst pain ) at 2:26 p.m. and at 3:57 p.m. the ED staff rated Patient 23's pain at a level of 6. Physician B3 stated this was moderate pain. The next time pain was documented in Patient 23's clinical record was on 4/3/10 at 8 p.m. at a level of zero, 7 hours after the fentanyl patch was placed and on average 21 hours before maximal levels would be reached. There was no indication that Patient 23 was in pain between the last ED pain assessment on 4/2/10 at 3:57 p.m. and the first hospital pain assessment at 8 p.m. on 4/3/10. In fact, all times when staff went to assess the pain between these two times, the patient was documented as sleeping. Finally, a review of the 4/3/10 Physician Progress Note written at 7:40 p.m. documented that Patient 23 was wearing mittens to prevent her from pulling out an IV line so narcotics could have been given by the IV route in the hospital.

On 5/5/10 at 1:48 p.m. during an interview of Staff B2, he stated that the hospital did not have any special protocols for the use of fentanyl patches when used contrary to the boxed warning.

Patient 23 had no evidence that she had taken any narcotics prior to placement of the patch and therefore could not be considered to be opiate tolerant. There was no evidence Patient 23 was in pain when the patch was placed. Patient 23 had an IV in the hospital through which narcotics could have been administered intravenously. The ED staff was able to assess Patient 23's level of pain even though she was demented and non-verbal. No special evidenced based protocols had been developed by the hospital to ensure the safe use of the fentanyl patch in an "off-label" manner.

2. On 5/1010 at 8:09 a.m. a review of Patient 24's clinical record indicated that Patient 24 was admitted to the hospital on 4/12/10 from another hospital with a painful condition involving one of his arms. On 4/17/10 at 12:45 p.m. a physician ordered that a 12 mcg/hr fentanyl patch be placed on Patient 24. A review of the MARs from the previous hospital indicated that Patient 24 had taken a total of 30 mg and 10 mg of hydrocodone (an oral narcotic medication used to treat pain) on 4/11/10 and 4/12/10 respectively. A review of the MARs from this hospital indicated that Patient 24 had taken 5 mg of hydrocodone on 4/12/10, 5 mg of hydrocodone on 4/13/10, 20 mg of hydrocodone on 4/14/10, 20 mg of hydrocodone and 4 mg of IV morphine on 4/15/10, 20 mg of hydrocodone and 6 mg of IV morphine on 4/16/10, and 10 mg of hydrocodone and 4 mg of IV morphine on 4/17/10 prior to the placement of a fentanyl patch on 4/17. The manufacturer of the fentanyl patch does not include a conversion of hydrocodone to an oral morphine equivalent dose but the American Pain Society has provided an opinion that 30 mg of hydrocodone is equivalent to 30 mg of oral morphine. Table D in the product labeling provides a conversion of 10 mg of IM morphine at being equivalent to 60 mg of oral morphine in the treatment of acute pain. A footnote to Table D in the product labeling documents that in clinical practice it is customary to consider IM and IV doses of opioid narcotics to be equivalent. Based on these conversion factors, Patient 24 received the following amounts of oral morphine equivalents on the following days: 30 mg on 4/11, 15 mg on 4/12, 5 mg on 4/13, 20 mg on 4/14, 44 mg on 4/15, 56 mg on 4/16, and 34 mg on 4/17/10h prior to placement of the fentanyl patch. Patient 24 would have had to receive 60 mg of oral morphine or an equivalent dose of other narcotics on these days to have been considered opiate tolerant.

A review of the pharmacist "Intervention" for this order entry in the patient' s computerized profile documented that the pharmacist had called the physician and notified him boxed warning in regard to the fentanyl patch. The note documented that the physician told the pharmacist he would reduce the dose to a 12 mcg/hr patch from the 25 mcg/hr patch that he had originally had ordered.

On 5/10/10 at 1:48 p.m. during an interview of Staff B2, he stated that the hospital did not have any special protocols for the use of fentanyl patches when used contrary to the boxed warning.

Patient 24 could not be considered to be opiate tolerant when the patch was placed and no special evidenced based protocols had been developed by the hospital to ensure the safe use of the fentanyl patch in an "off-label" manner.

3. On 5/4/10 at 1:41 p.m. during an interview of Staff B5 on the 3rd Floor Med Surg Unit on the Modesto Campus, she stated that during a pediatric code blue a physician would give the dose of the emergency medication in mass units per unit patient weight such as mg per kg and the final total dose in mass units, such as mg, and the nurse would do an independent check. The nurse would use dosing charts based on PALS and Broselow guidelines that were kept in a three ring binder on the Med Surg Unit Broselow Cart. Dosing guidelines were provided for each weight class on the Broselow Cart and were separated by tabs.

On 5/4/10 at 1:58 p.m. during an interview of Staff B6 she was asked to calculate the volume of a 3 mg dose of lidocaine for a 3 kg child based on the Broselow dosing guidelines. She opened the three ringed binder and stated that the dose should be 4.5 mg (50 % more than the Broselow Guidelines) after inspecting the dosing sheets there. Staff B5 then looked at the binder and told Staff B6 she was using the Rapid Sequence Intubation chart which was the wrong sheet. Inspection of the binder revealed this sheet was close to the PALS/Broselow dosing guidelines for heart emergencies in the three ring binder. After Staff B5 pointed out the correct sheet to use, Staff B6 was able to give the correct volume of lidocaine to deliver the posted dose of 3 mg. Staff B5 stated she was going quickly and that was the reason why she picked the Rapid Sequence Intubation sheet in error.

On 5/4/10 at 2:08 p.m. during an interview of Staff B7 she was asked to calculate the volume of a 3 mg dose of lidocaine for a 3 kg child based on the Broselow dosing guidelines. She opened the three ringed binder and stated that the dose should be 4.5 mg (50 % more than the Broselow Guidelines) after inspecting the dosing sheets there. When the surveyor repeated the dose Staff B7 realized she was looking at the Rapid Sequence Intubation sheet. She found the correct PALS/Broselow dosing guidelines and gave the correct volume and dose.

4. On 5/4/10 at 3:34 p.m. in the ED on the Modesto Campus, Staff B8 was asked to calculate the volume to deliver a 3 mg dose of lidocaine and to locate the lidocaine dosage unit he would use in the ED Broselow Cart. He could not find the lidocaine. At one point he picked it up and read the label out-loud which was "Xylocaine" (brand name of lidocaine) and put the dosage unit back down and proceeded to search through the medication tray. After about two minutes the surveyor pointed out the dosage unit. Staff B8 noted that the medication tray did not have a label for the lidocaine compartment like the other medication compartments did. During an interview of Staff B2 at this time he stated it was pharmacy procedure to label the medication compartments in the medication tray for the Broselow Cart. Inspection of the lidocaine in this cart at this time indicated that it did not come in a standard vial with a rubber stopper normally used for injectable drugs. It was a 10 ml plastic container with a large flat twist-off top. It looked like a large unit-dose dosage unit for medication that would be put in a nebulizer for inhalation. Inspection of the label indicated that it was labeled "Xylocaine" with "lidocaine" printed in smaller letters beneath the brand name. The label documented this medication was for injection and that it was not for inhalation. It also did not match the content list kept on the outside of the cart per state regulation. This content list documented that this should have been a 5ml vial of 2% lidocaine for injection.

On 5/4/10 at 3:44 p.m. in the ED on the Modesto Campus, Staff B9 was asked to calculate a 3 mg dose of Lidocaine and to locate the lidocaine dosage unit she would use in the ED Broselow Cart. She could not find the lidocaine after 1 minute and 50 seconds. When the surveyor pointed out the 10 ml lidocaine container with the twist-off top, she said she thought it was for topical use to numb the patient.

On 5/5/10 at 8:29 a.m. during an interview of Staff B2 he stated the 10 ml dosage units with the twist-off tops were used due to a shortage from the manufacturer of the 5 ml vials of lidocaine. He stated that there had been no orientation of the nursing staff regarding this change in the dosage unit.

6. On 5/6/10 at 9:17 a.m. Staff B12 prepared a 2 ml dose of famotidine 20 mg/2ml and a 1 ml dose of heparin 5000 units/ml for Patient 25. Staff B12 removed the plastic flip top cover off of the vial and withdrew the contents and subsequently injected the dose into Patient 25. She did not swab the top of the vial with alcohol.

On 5/6/10 at 9:50 a.m. Staff B13 prepared a 60 mg dose of methylprednisolone (prednisone, a medication used to treat inflammation). She flipped the plastic top off of the vial and injected it with sterile water to dissolve the powdered drug and then withdrew the required dose. She did not swab the top of the vial with alcohol.

On 5/6/10 at 2:12 p.m. a review of Policy 2.27 entitled Injectable Single and Multiple Dose Containers (reviewed 8/09) indicated that Policy III a. iii stipulated that vials were to be swabbed with an alcohol pad before puncturing them with a needle.

The Association of Professionals for Infection Control and Epidemiology has published a positions paper in the American Journal of Infection Control entitled APIC position paper: Safe injection, infusion, and medication vial practices in health care (2010; Vol 38: pages 167-72). That paper documents that the access diaphragm (rubber stopper) of a vial should be rubbed with an alcohol swab or other suitable antiseptic product and allowed to dry before it is penetrated by a needle (page 170).

7. On 5/5/10 at 3:33 p.m. in the Modesto Campus Surgery Department a review of the Policy PC.OR.060 entitled Treatment of Malignant Hyperthermia (Approved 9/27/06, revised 6/08 and found on top the MH Cart) indicated on page 2 that medications used to treat this condition included mannitol (used to increase urine flow in acute kidney failure) and procainamide (an antiarrhythmic). During an inspection of the MH cart at this time no mannitol nor procainamide was found in the cart. During an interview of Staff B11 at this time, she stated that was the current policy in effect in the hospital.

MHAUS has documented that it no longer recommends that procainamide or mannitol be stored in an emergency supply to treat MH as procainamide is a second line antiarrhythmic and each vial of dantrolene contains 3 gm of mannitol. While there is no prohibition to storing mannitol and procainamide in the supply if deemed necessary by the P&T Committee, a review of the policy indicated that there was no mention of the mannitol in this policy while it did refer to the use of both of these medications.

On 5/10/10 at 2:39 p.m. during an interview of Staff B2, he stated that the MH Policy found in the Modesto Campus Surgery Department on 5/5/10 was obsolete as it was not the intent of the hospital that procainamide and mannitol were to be stored on the cart.

8. On 5/5/10 at 3:33 p.m. in the Modesto Campus Surgery Department a review of the Policy PC.OR.060 entitled Treatment of Malignant Hyperthermia (Approved 9/27/06, revised 6/08 and found on top the MH Cart) indicated that it did not establish or list the contents of this emergency medication supply. California Code of Regulations, Title 22, Section 70263(f)(1) stipulates that written policies and procedures will be developed that establish the contents of emergency medication supplies stored in nursing care areas.

9. On 5/4/10 at 11:10 a.m. during an inspection of the adult crash cart on the Modesto Campus 3rd Floor Med Surg Unit indicated it contained a plastic sealed tray containing IV solutions in the second drawer. These solutions are medications and their placement in the cart means they are intended to be used in the context of a medical emergency. The contents of this tray were not posted outside of the cart. California Code of Regulations, Title 22, Section 70263(f)(2) stipulates that the contents of an emergency medication supply shall be posted on the outside cover of the container for this emergency supply.

10. On 5/4/10 at 1:05 p.m. an inspection of the Modesto Campus 3rd Floor Med Surg Unit Broselow Cart indicated that there was a label on the outside of the cart listing the expiration date of June 2010 as the earliest date for medications to expire within the cart. During an interview of Staff B2 at this time, he stated that this date indicated that the first medications to expire within the cart would do so on the last day of June 2010. Inspection of the cart revealed that it contained two 4 ml vials of furosemide 10 mg/ml both of which were labeled by the manufacturer to expire June 1, 2010, three 50 ml vials of mannitol 25% (used to increase urine flow in acute kidney failure) labeled by the manufacturer to expire June 1, 2010, and four ampules of epinephrine 1:1000 (used to treat allergic reactions) labeled by the manufacturer to expire June 1, 2010. These dates were 29 days earlier than the posted expiration date. It is a standard of practice to post accurate expiration dates as required by Title 22, Section 70263(f)(2) which stipulates that the earliest expiration date of a medication within the cart shall be posted outside of the cart.

11. On 5/5/10 at 3:58 p.m. during an inspection of the warmer log for the OR #1 Warmer (used to warm blankets, IV solutions, and irrigation solutions used in surgery) in the Modesto Campus Surgery Department indicated that staff manually wrote temperatures on the log. During April 2010, temperatures were not recorded on the log for the fluid compartment (contained IVs and plastic pour bottles of irrigation solutions) on April 3rd, 6th, 10th, 11th, 21st, and 25th and during May 2010 temperatures were not recorded on the log for the fluid compartment on May 1st. During April 2010, temperatures were not recorded on the log for the blanket compartment for April 1st. 2nd, 3rd, 6th, 10th, 11th, 17th, 21st, 25th and during May 2010 temperature were not recorded on the log for the blanket compartment on 1st. During an interview of Staff B11 at this time she stated the temperatures were not logged when the department was closed. She stated there was no method to ensure that the solutions were stored at the proper temperatures at the times when the department was closed such as weekends.

On May 7, 2010 at 9:33 a.m. a review of Policy Number 2.22 entitled Inpatient Pharmacy Services-Drug Storage And Preparation (Original date: 2/07 and last reviewed 11/09) indicated at Policy II. D. a. that: logging of temperatures using a manual logging system was to be done daily.

Based on inspection one out of six warmers in the Modesto Campus Surgery Department and inspection of seven out of seven scrub sinks in the Modesto Campus Surgery Department, record review and interview the hospital failed to ensure that IVs and irrigation solutions were stored according to the manufacturer's specifications in the one warmer and that expired scrub brushes were not available for use by surgeons and other surgical personnel at one out of the seven scrub sinks.

Findings:

1. On May 5, 2010 at 3:40 p.m. an inspection of the OR #1 Warmer in the Modesto Campus Surgery Department indicated that the bottom compartment contained blankets and 3000 ml flexible bags of irrigation solutions manufactured by the Baxter Corporation. Three of these bags were NS for irrigation and two were sterile water for irrigation. The top compartment contained four 1000 ml IV bags of lactated ringers , eight 1000 ml plastic pour bottles of sterile water for irrigation and eight 1000 ml plastic pour bottles of NS for irrigation and they were all dated. During an interview of Staff B11 at this time, she stated that these were expiration dates and the solutions were dated to expire two weeks from the time they were put into the warmer.

Baxter has documented the following:

a. Irrigation solutions in plastic pour bottles can be warmed to 104 degrees Fahrenheit for 30 days and to 150 degrees Fahrenheit for 72 hours.

b. Large volume IV solutions can be warmed to 104 degrees Fahrenheit for 14 days.

c. Arthromatic and Uromatic irrigation solutions can be warmed to 113 degrees Fahrenheit for 14 days and 150 degrees Fahrenheit for 72 hours.

A review of the April 2010 temperature log May 5, 2010 at 3:58 p.m. indicated that the bottom compartment was above 113 degrees Fahrenheit on the April 5th, 7th, 12th, 13th, 14th, 16th, 18th, 19th, 20th, 22nd, 24th, 26th, 27th, 28th, 29th, and 30th. The temperatures ranged from 114.1 to 121.9 degrees Fahrenheit on these days. A review of the May 2010 temperature log at that time indicated that on May 3rd through 5th the temperature of the bottom compartment ranged from 113.8 to 120 degrees Fahrenheit on those dates.

A review of the April 2010 temperature log at this time indicated that the top compartment containing the plastic pour bottles and IV solution was above 104 degrees Fahrenheit on April 2nd, 7th, 8th, and 26th with temperatures ranging from 110 to 111.1 degrees Fahrenheit. A review of the May 2010 temperature log at that time indicated that the temperature of the top compartment was 115 degrees Fahrenheit on May 2nd.

Using a 14 day expiration date tied to a temperature of 113 degrees Fahrenheit the hospital was storing the 3000 ml irrigation solutions outside of the manufacturer specifications for 16 days out of 30 in April 2010 and three days out of five in May 2010. Using a 14 day expiration date tied to 104 degrees Fahrenheit the hospital was storing the IVs outside of the manufacturer's specifications for 4 days out of 30 in April and one day out of five during May 2010.

2. On May 5, 2010 at 3:09 p.m. inspection of the sink by the Inpatient Procedure Room in the Modesto Campus Surgery Department indicated that the box of povidone iodine scrub brushes (used by surgeons to "scrub" for surgery) stored at the sink for use by the surgeons and surgical personnel had expired March 2010.

Based on food service observations, dietary and administrative staff interview and dietary and administrative document review the hospital failed to:

A. Ensure the availability of organized dietetic services that are directed and staffed by adequately qualified personnel (Cross reference A-619, A-620, A-622, A-749).

B. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and lack of effective monitoring of potentially hazardous foods by contracted vendors. (Cross reference A620, A749)

C. Provide effective sanitation of food production equipment. (Cross Reference A-749)

D. Ensure effective care planning for patients identified at nutritional risk. (Cross Reference A-396)

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Food and Dietetic Services.

Based on contracted food service observations, contracted vendor and administrative staff interviews and contracted and administrative document review the hospital failed to 1) ensure the contracted cafeteria vendor provided an organizational structure that supported safe food handling practices and 2) hospital staff ensured safe food storage temperatures. Failure to provide safe food handling procedures may result in practices associated with food borne illness. Food borne illness may cause nausea, vomiting, compromise of patients' clinical conditions and in severe instances may result in death.

Findings:

Manteca Campus
1. During food storage observations in the cafeteria on 5/3/10 at 12 p.m., it was noted that in the walk-in refrigerator there were numerous previously cooked potentially hazardous foods (PHF's) that were unlabeled and/or undated (Cross Reference 749). PHF's are those foods that are capable of supporting bacterial growth associated with food borne illness if handled improperly (Food Code, 2009).

In a concurrent interview with CS L the surveyor asked him to describe the process for labeling foods. He stated that he would date the items with the date that they were to be thrown away. The surveyor also asked him to describe the hold time for previously cooked foods. CS L stated that items would be held between 7 and 10 days. The surveyor asked CS L to describe which items would be held for 7 days and which would be held for 10 days. CS L was unable to answer the question. CS L was also asked to determine the preparation date for the reviewed items. While CS L provided dates, he appeared to arbitrarily pick days of the week rather than being able to demonstrate the actual preparation date of the PHF's.

The surveyor also asked CS L the purpose of the leftover foods. He replied that these items were previously used as cafeteria entrees. He further stated the leftover foods would be used for cafeteria entrees at a later date. CS L was also asked to describe how he ensured that the PHF's were safe to be used at a later date. He replied that he would evaluate the appearance and smell of the food. If it looked like it was still good he would use it.

In a follow up interview on 5/3/10 at 2:40 p.m., the surveyor asked CS L to describe his process for handling leftover foods. He stated that once the item was taken off the steam table he would place the leftovers on the counter for about 1.5 hours after which they would be refrigerated. He also stated that there was no monitoring of temperatures for the items. The standard of practice would be to effectively monitor the cool down of PHF's. The guidelines for handling cooked PHF's would be to ensure the food temperature drops from 135-70°F within 2 hours and from 70-41°F or below within an additional 4 hours, for a total of 6 hours (USDA Food Code, 2009).

In an interview on 5/4/10 at 8:50 a.m., the surveyor asked CS D, who had responsibility for oversight of the cafeteria , if the contracted vendor had any policies and procedures (P&P) for staff to follow. He stated that there was a manual; however the Manteca location did not have one because "there was no space." CS D was also asked to describe the contents of the manual. He stated that included guidance on appearance, customer satisfaction and food handling, which included a food storage chart.

Review on 5/5/10 of undated contracted cafeteria P&P's revealed there was no guidance related to food storage practices.

2. During review of cafeteria food holding practices on 5/3/10 beginning at 2:35 p.m., food temperatures of PHF's were taken and noted as follows: egg salad and tuna salad 47°F; roast beef 48°F; ham 44°F; sliced tomatoes 46°F and cut melon 46°F. In a concurrent interview the surveyor asked CS L at what time the salad bar was set up. He replied that it set up at 11 a.m.. Review of contracted food service documents titled "Cold and Hot Exhibition" for the months of March, April and May revealed that there was only one daily temperature recorded for items such as meat, vegetables and dressing. Additionally it was noted there was no recording of hot food temperatures.

The standard of practice would be to monitor PHF's for time/temperature control ensuring that cold foods are consistently held below 41°F or below and that hot foods were held at 135°F or above (USDA Food Code, 2009). An effective monitoring system would also ensure that foods were not held in the food danger zone between 41-135°F for greater than 4 hours (USDA Food Code 2009). There was no documentation that the contracted food service had any policies/procedures related to monitoring holding temperatures of hot or cold potentially hazardous foods.

Review on 5/5/10 of undated contracted cafeteria P&P's revealed there was no guidance related to food handling practices.

Based on food production observations, dietary staff interview and dietary document review the hospital failed to ensure the director of the food and dietetic services effectively managed the daily operations of the department as evidenced by lack of safe food handling/storage practices in the cafeteria and patient food services. Lack of safe food handling practices may result in food borne illness causing further compromise of clinical status and in severe instances may result in death.

Findings:

Manteca Campus Kitchen

1. During patient food storage observations in the cafeteria kitchen on 5/3/10 at 12 p.m., it was noted that in the walk-in refrigerator there were multiple issues surrounding the safe handling and/or storage of potential hazardous foods (PHF's). PHF's are those foods that are capable of supporting bacterial growth associated with food borne illness if handled improperly (USDA Food Code, 2009). (Cross Reference-749).

Specifically the identified issues included 1) lack of a consistent system for labeling or dating of stored food items in the cafeteria; 2) lack of cool down temperature monitoring of cafeteria prepared PHF's intended to be used at a later time; 3) failure by the cafeteria vendor to develop standardized operating policies and procedures related to food production; 4) lack of effective monitoring of food production, holding or distribution by the hospital or the contracted cafeteria vendor; 5) lack of effective and accurate evaluation of contracted services.

In an interview on 5/3/10 at 11 a.m., with DMS H he stated that patients would have access to cafeteria prepared foods provided the physician approved it.

In an interview on 5/4/10 at 11 a.m., with DMS A, who was a Registered Dietitian, the surveyor asked if she provided any oversight into cafeteria food production, to which she replied that she did not. She stated she relied on DMS H to provide guidance and oversight to the cafeteria functions.

Review of hospital position description titled "Manager Nutrition Services" dated 3/31/08 revealed that this position, held by the RD, was "Responsible for on-site management of patient and/or staff food services, cafeteria ..."

Review on 5/5/10 of continuing education activities for DMS A it was noted that while she maintained a current registration with the American Dietetic Association, there was no evidence that she had participated in any continuing education or held any specialized training related to food services operations; rather the documented continuing education related solely to clinical nutrition care.

2. During review on 5/3/10 at 12 p.m., of patient food storage practices it was noted that the internal thermometer of the stand up refrigerator read 28°F. The internal probed temperature of a 4-ounce cup of macaroni salad was taken in the presence of DMS H and was noted to be 45°F. It was also noted that the item was placed in the refrigerator 15 hours earlier.

In a follow up observation on 5/3/10 at 3:05 p.m., an additional temperature of an omelet was taken and noted to be 47°F. The surveyor asked DMS H to describe the steps that would be taken to ensure food safety if elevated temperatures were noted. He stated that he would pull out the food and put it in the walk-in refrigerator. The surveyor also asked him how long hazardous food could remain at elevated temperatures, to which he replied that they would be "ok for up to 8 hours" after which he would throw them away. The standard of practice would be to ensure foods whose temperature was greater than 41°F were held no longer than 4 hours (USDA Food Code, 2009).

In an follow up interview on 5/3/10 at 3:10 p.m., the surveyor asked DMS H to describe how he ensured foods stored in the refrigerator were kept at safe food temperatures. DMS H replied that he would check the refrigerator logs. The surveyor asked if there were any temperatures that would concern him. He replied that low thermometer temperatures , such as 28-30°F, may signify a problem with the thermometer.

Concurrent review of the undated hospital document for the months of April and May 2010, titled "Temperature Monitoring" revealed that during April the refrigerator was below 35°F for 11 of 30 days. Similarly for May the refrigerator was below 30°F for 2 of 3 days. DMS H also stated that in April 2010 he thought he replaced the thermometer, but acknowledged he did not do any follow up food temperatures to ensure the unit was working properly. DMS H was unable to explain why the observed thermometer was not accurate, despite being replaced.

In an interview on 5/4/10 at 11 am the surveyor asked RD 1 if she provided any oversight to patient food services, she replied that she relied on DMS H to oversee the day to day operations. On 5/4/10 at 8 am, policies related to food storage were requested. As of 5/7/10 the hospital failed to provide any policies.

3. During review of cafeteria food holding practices on 5/3/10 beginning at 2:35 p.m., food temperatures of PHF's were taken and noted as follows: egg salad and tuna salad-47°F; roast beef-48°F; ham-44°F; sliced tomatoes-46°F and cut melon-46°F. In a concurrent interview with CS L the surveyor asked what time the salad bar was set up. He replied that it was set up at 11 am. He also stated that the items would remain in the salad bar area until 6 p.m.. The surveyor asked if there was any temperature monitoring throughout the day, to which he replied there was not. He did however state that the temperature of items was taken at 11:00 a.m..

Review of contracted food service documents titled "Cold and Hot Exhibition" for the months of March, April and May 2010 revealed that there was only one daily temperature recorded for items such as meat, vegetables and dressing. Additionally it was noted there was no recording of hot food temperatures.

The standard of practice would be to monitor PHF's for time/temperature control, ensuring that cold foods were consistently held below 41°F or below and that hot foods were held at 135°F or above (Food Code, 2009). An effective monitoring system would also ensure that foods were not held in the food danger zone between 41-135°F for greater than 4 hours (Food Code, 2009).

4. On 5/3/10 at 3:30 p.m., in an interview with Engineering Staff M the procedures for ice machine maintenance were reviewed. The surveyor asked him to describe the cleaning process. He stated that on a monthly basis he utilized an ice machine cleaner after which he utilized a sanitizing solution. He stated that both of these chemicals were flushed through the system as well as the ice holding bin.

Review on 5/4/10 at 12 p.m., of the chemical revealed that it was a quaternary ammonia solution. It was also noted that the manufacturers' guidance for the ice machine recommended utilizing a sanitizing solution of 5.25% sodium hyper chloride, rather than quaternary ammonia. There was no documentation that the RD ensured that the process to clean the ice machine met manufacturers' guidelines.

5. During review of sanitation procedures on 5/4/10 beginning at 11:00 a.m., the surveyor asked CS L to describe the cleaning of the meat slicer. He stated that after using the slicer he would remove the food particles and wash it with hot water and use a sanitizer after which he would rinse off the sanitizer.

Review of the manufacturers' guidance revealed that once the sanitizer was placed on the equipment it should be air dried rather than wiped off. There was no documentation that the RD ensured the procedures utilized by contract cafeteria staff met standards of practice, manufacturers' guidance for chemical use or that the contracted vendor developed standardized procedures.

6. During general kitchen observations on 5/3/10 beginning at 10:30 am, it was noted that:

a) on the shelf above the stove there were several unlabeled/undated items. The surveyor asked CS L to identify the items. He identified them as sugar, salt and parmesan cheese. It was also noted that there was a red colored paste in a small plastic container that was unlabeled. CS L stated that it was a combination of garlic, paprika and butter.

b) Additional items that were opened, undated and/or unlabeled included oil, cooking wine and beef base. It was also noted that there was a bottle of teriyaki sauce that had two dates, 8/15 and 9/25. The surveyor asked CS L to explain the significance of the different dates, he replied he was unsure.

c) In the walk-in refrigerator dietary staff was storing a box of sausage patties that were opened and thawed. It was noted that the manufacturers' instructions for the product were to "keep frozen."

7. In the cafeteria preparation area there were multiple spices such as baking soda, poppy seeds, lemon pepper, sage, turmeric, ginger and mustard, many of which were dated 3/09 (14 months earlier). In a concurrent interview with DMS H staff he was asked how likely it was that all the spices were opened in 3/09. He replied that they may have all been purchased at that time. He was also asked to describe the expiration for these products, to which he replied he believed it was 2 years.

Review on 5/4/10 of an undated and unreferenced document, provided by the contracted vendor responsible for cafeteria food production activities, titled "Food Storage Chart" revealed that once spices were opened they expired after 6 months.

8. During initial tour on 5/3/10 beginning at 11:30 am, it was noted that contract cafeteria staff was storing scoops in a can of protein powder as well as in the flour and oatmeal bins. In a concurrent interview with DMS H he stated that this was the normal storage practices for scoops.

Review of contracted cafeteria P&P's revealed none directly related to food storage practices.

Based on observation, staff interview and document review, the hospital failed to ensure dietary staff were competent in their assigned duties to prepare, store, and serve food in the cafeteria in a manner to ensure food safety. This was evidenced by the lack of training of staff and failure to ensure competencies in critical safe food handling and placed staff, patients and visitors at risk for food borne illness. (cross reference A 749)

Findings:
Modesto Campus
1. On 5/3/10 between 2:50 p.m. and 4:30 p.m., food service observations were made in the cafeteria. CMS C introduced CS D as the "p.m. cook." During observations of the Hot Food Temperature Log, CS D stated he was responsible for cooking food as needed for the dinner meal. When the surveyor asked what temperature to cook chicken to (chicken was on the menu), CS D stated "about 140 ° F. According to the Federal Food Code chicken must be cooked to 165 ° F to ensure safety.

On 5/7/10 at 3:00 p.m. during a review of CS D's personnel file, it was revealed he had been hired as a dishwasher on 4/24/09. Documented training was a Certificate of Completion for Departmental Equipment Training presented on July 28, 2009. During a concurrent interview, CMS C stated CS D had been promoted to a cook and his entire cook training consisted of working with another cook for one week, and then proceed as a fully trained cook. Further review of the employee file revealed a "Kaiser Permanente Initial or Annual Competency Assessment/Evaluation of CS D completed on 3/22/10 by CMS C and that indicated the following infection control competencies: maintains temperature logs of refrigeration, complies with hand washing policy and complies with policy regarding dating and labeling items for sale and leftovers. Knowledge of and competency in safe food handling and preparation was not determined, time/temperature control to prevent food borne illness, quality of food left for five hours on a hot steam table, were not on the listed competencies.

2. On 5/3/10 between 3:30 p.m. - 4:30 p.m. during observations in the food preparation area of the cafeteria, CMS C was unable to provide accurate information regarding food labeling and dating, length of food storage, time/temperature monitoring of food held on the steam table, or training provided to the food service staff working there (This is cross referenced to A 749).

On 5/7/10 at 3:15 p.m. review of personnel file of CMS C revealed hire date 10/1/08 as the Assistant General Manager. The job description signed on 4/3/10 revealed CMS C duties included supervising all food preparation, hiring and training new employees in the department, and maintains records of personnel performance. On 3/19/10 DMS A completed the same KP Initial or Annual Competency Assessment for CMS C with same noted infection control elements. Knowledge and competency in safe food handling and preparation food quality, and was not determined. Additionally, CMS C was a staff from a contracted food service catering company. Elements of compliance with the vendor contract failed to be included in the annual assessment. This is cross-referenced to Tag 084, and 749.


17065

Manteca Campus Kitchen

3. During food storage observations in the cafeteria kitchen on 5/3/10 at 12 p.m., it was noted that in the walk-in refrigerator there were numerous previously cooked potentially hazardous foods (PHF's) that were unlabeled and/or undated. PHF's are those foods that are capable of supporting bacterial growth associated with food borne illness if handled improperly (Food Code, 2009). It was also noted that while some of unlabeled/undated PHF items such as rice, pasta and mashed potatoes were easily identifiable, other items were not. The unlabeled PHF's were identified by CS L as: 1) a combination of cooked beef and beans labeled with dates of 4/27 and 5/7; 2) baked beans that were undated; 3) cooked shredded beef dated 5/20, 4) roast beef with an expiration of 4/12; and 5) pinto beans dated 4/26 and 5/25.

In a concurrent interview with CS L the surveyor asked him to describe the process for labeling foods. The surveyor also asked him to describe the production date of the identified foods, the hold time for previously cooked foods and the safe cool down of PHF's (Cross Reference 749). CS L was unable to effectively answer any of the questions.

Review on 5/4/10 at 8 am, of the hospital document completed by DMS H and titled "Manteca Kaiser Permanente Cafeteria Quality Inspection and Report" dated 1/29/10, 2/26/10 and 4/15/10 revealed that in each of the 3 reports DMS H noted that the contracted food vendor properly followed cooling procedures.

In an interview on 5/4/10 at 9 a.m., with DMS H he was asked to describe how he determined that the contracted vendor was in compliance with proper cool down without the presence of trained staff and a monitoring system. He stated that he asked one of the cooks and believed he provided the correct answer. He acknowledged he did not correctly evaluate the process.

Review of personnel files on 5/5/10 for CS L revealed that the hospital nor the contracted vendor provided any orientation or competency evaluation. It was also noted that while the hospital had a competency evaluation form it was limited to general items such as proper handling of knives, cooking procedures, and stock rotation. The form did not allow for the opportunity to comprehensively evaluate competency for safe food handling procedures. Review on 5/5/10 of training for CS L revealed that while he participated in an orientation, the topics were not relevant to food handling.

4. During review on 5/3/10 at 12 p.m., of food storage practices it was noted that the internal thermometer of the stand up refrigerator read 28°F. The internal temperature of a 4-ounce cup of macaroni salad was taken in the presence of DMS and was noted to be 45°. In a concurrent interview with DMS the surveyor asked how long the item had been in the unit, to which he replied that it was delivered approximatloy 15 hours earlier.

In a follow up observation on 5/3/10 at 3:05 p.m., the temperature of an omelet was taken and noted to be 47°F. DMS H staff concurrently confirmed that this item was also received 15 hours prior. The surveyor also asked DMS H to describe the steps that would be taken to ensure food safety if elevated food temperatures were noted. He stated that he would pull out the food and put it in the larger walk-in refrigerator. The surveyor also asked him how long hazardous food could remain at elevated temperatures, to which he replied that they would be ok for up to 8 hours, after which he would throw them away. The standard of practice would be to ensure foods whose temperature was greater than 41°F we held no longer than 4 hours (Food Code, 2009).

On 5/4/10 at 8 am, policies related to food storage were requested. As of 5/7/10 the hospital failed to provide any policies.

In an follow up interview on 5/3/10 at 3:10 p.m., the surveyor asked DMS H to describe how he ensured foods stored in the refrigerator were kept at safe food temperatures. DMS H replied that he would check the refrigerator logs. The surveyor asked if there were any temperatures that would concern him. He replied that low thermometer temperatures , such as 28-30°F, may signify a problem with the thermometer.

Concurrent review of the undated hospital document for the months of April and May 2010, titled "Temperature Monitoring" revealed that during April the refrigerator was below 35°F for 11 of 30 days. Similarly for May the refrigerator was below 30°F for 2 of 3 days. DMS H also stated that in April 2010 he thought he replaced the thermometer, but acknowledged he did not do any follow up food temperatures to ensure the unit was working properly. DMS H was unable to explain why the observed thermometer was not accurate, despite being replaced.

Review on 5/5/10 of the competency evaluation for DMS H it was noted that with respect to "Job-specific Knowledge and skills" the rating was listed as "partially successful." It was also noted that while the hospital identified deficiencies in the skill set for DMS H, there was no documentation that additional training was provided.

Based on observation, interview, and document and food inventory review, the hospital failed to adequately plan to ensure available food for all patients and staff at both campuses (Modesto and Manteca) during a disaster that would require the hospital to be self sufficient for seven days. This is evidenced by lack of planned menu and food for staff for seven days, lack of portion sizes for serving bulk food (not already pre-portioned in individual containers) to ensure food lasts the time planned for, lack of directions for food to serve patients on therapeutic diets, an inadequate amount of frozen entrees and ready-to-eat meals, and lack of knowledge of DMS in how to implement the disaster menu. This put 188 patients at risk of not receiving foods to meet their nutritional needs should there be a disaster requiring the hospital to be self sufficient for seven days, which could further compromise their acute or chronic illness.

Findings:

Modesto campus Findings:

1. On 5/4/10 between 12:35 p.m.-1:00 p.m., the disaster menu plan was reviewed with DMS A, and observations were made of the supporting inventory of foods and supplies that would be needed to implement the planned menu.
The undated "Disaster menu" was a seven day plan, and revealed the planned food for 100 patients although there are 128 licensed beds. Additionally, patient food was planned for seven days while the 270 staff was to be provided food for four days. During a concurrent interview, DMS A stated that the cafeteria was to provide food for staff for three of the seven day plan, but there was no planned menu or inventory to indicate a food plan that could be implemented for an additional four days. DMS A stated "they are supposed to have enough food" and acknowledged there was no menu to determine adequate foods available.

Further review of the menu revealed many of the food items were individual servings, but that bulk items (large cans) were included, with no serving size indicated that would ensure accurate portions for therapeutic diets or that the food would last the amount of time planned. Directions for renal diets included " use low potassium fruits and vegetables " but did not list foods in the planned inventory that should be used. Additionally, renal directions were "Use Mocha Mix instead of milk." The inventory supporting the disaster menu did not include milk or Mocha Mix. During a concurrent interview, DMS A stated the cafeteria was to provide food for staff for three of the seven day plan, but there was no planned menu or inventory to indicate a food plan that could be implemented for an additional four days. DMS A stated "they are supposed to have enough food."


17065

Manteca Campus

2. During review of disaster preparedness on 5/3/10 beginning at 12:30 p.m., it was noted that while the hospital had a specified disaster supply, the supply did not fully meet the nutritional needs of the licensed bed count and staff required to care for the licensed bed count. It was noted that the hospital had an outside contract for patient meal service. As such, the hospital did not prepare any meals during the normal course of business. It was also noted that the disaster plan included multiple actions to be taken in the event the contracted vendor failed to bring daily entrée items (an internal emergency) as well as wide-spread external disaster such as an earthquake. Additionally, there were no specific instructions for dietary staff to implement the disaster menu. It guided staff to provide baby food to patients with pureed diets for both lunch and dinner; however did not specify any quantity. Similarly it guided staff to provide a sandwich or entrée to residents on regular diets; however did not guide staff on what type of sandwich to prepare or how to prepare it.

It was also noted that while the hospital planned to feed patients frozen entrees during the first 3 days of a disaster, the employees would receive meals ready to eat (MRE's) throughout the 4 day timeframe for the anticipated 197 employees (the number of staff which would be required to care for the full licensed bed count). Review of the number of MRE's on-site revealed 300 meals; however this plan would require 800 MRE's for a 4-day period. Similarly the hospital planned on feeding patients frozen entrees or sandwiches for both lunch and dinner for the first 3 days requiring 366 frozen meals; however the planned hospital supply noted only 240 entrees.

In an interview on 5/5/10 at 9 am, with DMS H he was asked to describe how much of the baby food he would offer patients in the event the disaster meal plan would be implemented. He stated that he would mimic a regular menu and give patients' one jar each of a starch, meat and fruit. DMS H was also asked to describe the source of staffing during a disaster. He replied that he would utilize existing dietary staff with the use of designated cafeteria equipment as necessary.

Review of the nutritional content of one jar of each of the baby food revealed that they would have between 40 and 90 calories each, totaling 250-300 calories per meal which would be significantly less than the nutritional needs of the average adult in the general acute care hospital.

Review of the cafeteria vendor contract number NU1644, dated 7/31/08 revealed that the in the event of a disaster or emergency situation the "Contractor shall continue ...to provide services hereunder ..." The contract also noted that the "contractor shall provide food services ...through the use of supervisory or other personnel." There was no documentation that dietary staff of contracted cafeteria personnel received any training in implementing dietetic services in the event of a disaster.

Based on observations, staff interviews and policy review the hospital failed to provide an active surveillance program that would ensure a clean and sanitary environment and implement infection control policies for all areas of the hospital. 1) The cafeteria, utilized by staff, patients and visitors did not reflect safe techniques in food handling and storage, temperature controls or compliance with the facility's policies and procedures and, 2) Nursing staff did not implement standards for infection control during the preparation and administration of medications for single and multiple dose injectable vials, as evidenced by:

A. The hospital failed to ensure infection control practices when the water temperature in the handwashing sink was 75 degrees and not maintained according to the facility's policy for 105-120 degrees; and the ice machine was not sanitized according to the manufacturer's recommendations. (Cross reference A-749)

B. The hospital failed to store and prepare foods under sanitary conditions and prevent potential food borne illnesses when various food items were not labeled, dated or stored, or prepared according to the safe food handling guidelines. (Cross reference A-749)

C. The hospital failed to ensure dietary and contracted food service staff in the cafeteria were competent in their assigned duties, develop policy and procedures to ensure safe food handling, food cool-down and time/temperature controls, and implement state and federal standards for food safety. (Cross reference A-622)

D. The hospital failed to ensure nursing staff disinfected the tops of vials for injectable medications prior to administration, and properly label a multi-dose vial of insulin, to prevent cross contamination and the potential risk for infection. ( Cross reference A-500).

The cumulative effects of these systemic problems resulted in infection control practices not in compliance with the statutorily-mandated Condition of Participation for Infection Control.

Based on observation, staff interview and policy review the Facility failed to implement infection control practices when:
a) The water temperature in the handwashing sink in the cafeteria was 75 degrees and not maintained according to the facility's policy for 105-110 degrees.
b) The ice machine was dirty and not sanitized according to the manufacturer's recommendations.
c) Multiple food items were not labeled, dated or stored, prepared or served under safe and sanitary conditions to prevent potential food borne illnesses.
d) There were no written policies and procedures to be used to train staff on safe food handling.
e) Dietary staff completing cafeteria inspection reports were not knowledgeable of the process of science based safe food handling and did not have the knowledge to provide competent oversight of the food handling observed.

Findings:


20245

Modesto Campus
1. On 5/3/10 at 10:45 a.m., while the surveyor was washing hands prior to kitchen observations, it was noted the water remained cool, and did not warm up during the wash period. DMS A obtained a digital thermometer and tested the water temperature and reported it was 75 degrees F. DMS A notified facility Engineer B (Eng B) who arrived at 11:00 a.m. and after temperature testing, Eng B concurred that the temperature of the handwashing water was 75 degrees. Eng B reported handwash sinks should have water maintained at 105-110 degrees and commenced to adjust the water mixing valves located underneath the sink. During a concurrent interview, Eng B stated his department was responsible for testing water temperatures on a regular basis but the valves on some of the sinks didn't stay where they should and temperature was not always correct.

On 5/5/10 at 10:00 a.m., the facility provided Policy EC.EN.024 titled Maintenance & Inspection-Water, Domestic Hot and Cold that revealed Hot water temperatures are maintained between 105-120 degrees Fahrenheit.

2. On 5/3/10 at 2:50 p.m., an individual wearing a standard hospital gown was observed sitting in the hospital cafeteria. An interview conducted with CMS C revealed patients come to the cafeteria to purchase food, should they desire. During observations with CMS C in the cafeteria food preparation and service area between 2:50 p.m.-4:40 p.m., the following was observed:
a. In the walk-in refrigerator:
1. A one gallon container of a semi-solid that was hand-labeled "Queso" (brand name of the cheese) and dated " Prep 4/24, use by 4/28. " When the surveyor asked about specific policies and procedures regarding labeling and dating foods, CMS C stated "we don't have any." At 4:30 p.m. CMS C provided an undated, multi-page chart labeled, "Food Storage Chart-Shelf Life of Food-How to Store Foods." The Food Storage Chart did not provide guidance on safe storage of "Queso".

2. A box labeled fresh basil, dated 4/14/10, exp 6/10. CMS C stated the dates indicated fresh basil was received 4/14/10 and was good until 6/10, when it expired. The box was opened and the contents were observed to be a grey-green cloud of filamentous material, entirely encasing the contents which could not be identified. The cafeteria Food Storage Chart provided guidelines that fresh greens had a refrigerated life of 3-5 days.

3. One unopened 10 pound case of thawed, raw pork patties dated 4/26 and one and one-half trays of raw, undated fresh pork patties. CMS C stated the patties were received 4/26 and the cafeteria Food Storage Chart revealed the safe refrigerated life was 1-2 days. When the surveyor asked how long the patties had been in the refrigerator, CMS C replied "I don't know." During a concurrent interview, CS D the pm cook, stated he would use the patties for the cafeteria.

4. A 12" by 24" pan of sliced ham, and one equal size pan of sliced roast beef, both dated, "Use by 5/1." During a concurrent interview CS D, stated he had used the meats from the pans in the sandwich bar for customers to purchase that day.

5. An undated, opened box of thawed turkey burgers labeled "Keep Frozen." CMS C stated the product was "ok". On 5/7/10 CMS E provided a document from the food distributor that revealed "Product (turkey burger) should be kept frozen and cooked from the frozen state."

6. An opened box of thawed hamburger patties labeled "Keep Frozen" and dated 4/29 Exp. 5/20. CMS C stated, "the product was received on 4/29 and would be safe until 5/20". When the surveyor asked how long the patties had been in the refrigerator, CMS C replied "I don't know." On 5/7/10, CMS E provided a document from the food distributor that revealed, "Product (beef hamburger patties) has a 5-day shelf life when thawed.

7. Pineapple chunks dated 4/22/10, and 4/27/10. CMS C stated the fruit was opened on 4/22 and was good until 4/27. The cafeteria Food Storage Chart revealed opened canned fruits were safe for 2-3 days.

b. In the under the counter refrigerator:
There was an approximately 12" by 18" item wrapped with plastic wrap and dated 4/30; 5/5. The item had visible bubbles. CMS C stated the item was raw pizza dough that was made in a larger amount on 4/30, and then would be used up in five days. The Food Storage Chart revealed refrigerated unbaked dough was safe for 1-2 days.

3. On 5/3/10 at 4:30 p.m., the cafeteria hot food serving line was observed to have eight different foods available in pans. Chicken (dated 5/3, 5/8), beef strips (dated 5/3, 5/8) and rice (5/3, 5/8). CMS C stated, "The dates indicated the foods were prepared on 5/3 and leftovers would be refrigerated and could be used until 5/8". The Hot Food Temperature Log was reviewed with CS D and listed Entrée 1, Entrée 2, and Entrée 3. The log revealed the temperature of all three entrees had been taken at 11:00 a.m. and determined to be 157°F, 150°F and 157°F respectively. During a concurrent interview, CS D stated he was the afternoon cook and all the foods then on the serving line had been there since he arrived at 2:00 p.m. and he had not replaced any of them. When surveyor inquired whether he had taken any temperatures, CS D stated he had not. When asked if he knew which of the foods was Entrée 1, Entrée 2 or Entrée 3, he stated he did not. According to the Federal Food Code 2009, hot foods must be held at temperatures greater than 135 degrees F to ensure safety, and that food held between 70 degrees and 135 degrees F must be discarded for safety reasons after four hours. CMS C acknowledged there was no way to know the temperatures of the foods following the time it had originally been taken at 11:00 a.m. which was five and one half hours earlier.

During a concurrent interview, CMS C stated, "There were no written policies or procedures to train staff or provide information about how or when to take and record food temperatures" that would ensure food safety. CMS C stated, "The process she followed was to go through the cafeteria in the morning when she arrived and fix things, or tell staff what to do if needed". When the surveyor asked whether there were written, in-service trainings provided to staff, CMS C stated, "She provided one, approximately 18 months ago on the topic "Equipment usage".

4. Review on 5/4/10 of hospital document titled "Modesto Cafeteria Quality Inspection and Report" dated 10/27/09, 11/30/09, 12/15/09, 1/27/10, 2/26/10, 3/29/10, and 4/27/10 documented observation only of "All products with expiration dates are current" but failed to have a component to determine available comprehensive food storage labeling and dating policies and procedures of all foods to ensure safe food storage guidelines are implemented. During a concurrent interview, DMS H, who reported her job was to complete the inspection report, she replied she followed the list on the report, but the list did not include questions regarding correct storage for potentially hazardous foods without expiration dates on the packaging. DMS H reported it was "hard to get them to do anything; it's better than it was." When asked about the temperature for Entree 1, Entree 2, and Entree 3, DMS H stated "Maybe the temperature is for all three. I take my own temperatures of each food when I complete the inspection. I just check to see there are temperatures on the logs. It doesn't make sense to not name the food the temperature is for."

5. At 4:20 p.m. the Manitowoc ice machine in the cafeteria was inspected for cleanliness. The bin was observed to have a reddish substance on the edge. During a concurrent interview, DMS A stated the hospital engineering department was responsible for cleaning the ice machine. At 4:30 p.m. Eng B stated the ice machine was cleaned quarterly following the "standard." Eng B removed the front panel of the ice machine to expose the evaporator where ice was actually made, and the edges were observed to have a spotted brownish residue that could be wiped off with a clean paper towel. Eng B provided the product "IMS Sanitizing Solution" as the cleaning product and stated "no other solution is used." During the concurrent review of the ice machine cleaning/sanitizing directions printed directly on the front panel of the ice machine, it was revealed the manufacturer required Manitowoc ice machine cleaner (a de-scaling agent used to remove hard water residue) was to be flushed through the machine, and then the machine was to be sanitized with Manitowoc ice machine sanitizer flushed through the machine. The manufacturer's directions revealed bin was to be cleaned and sanitized with Manitowoc cleaning and sanitizing product.




17065

Manteca Campus

6. During food storage observations on 5/3/10 at 12:00 p.m., it was noted that in the walk-in refrigerator there were numerous previously cooked potentially hazardous foods (PHF's) that were unlabeled and/or undated. PHF's are those foods that are capable of supporting bacterial growth associated with food borne illness if handled improperly (USDA Food Code, 2009). It was also noted that while some of unlabeled/undated PHF items such as rice, pasta and mashed potatoes were easily identifiable, other items were not. The unlabeled PHF's were identified by CS L as: 1) a combination of cooked beef and beans labeled with dates of 4/27 and 5/7; 2) baked beans that were undated; 3) cooked shredded beef dated 5/20, 4) roast beef with an expiration of 4/12; and 5) pinto beans dated 4/26 and 5/25.

In a concurrent interview with DMS H he stated that hospital inpatients would have access to foods prepared by the contracted cafeteria vendor, provided that patient's physician allowed it. In a concurrent interview the surveyor asked CS L to describe the process for labeling foods. He stated that he would date the items with the date that they were to be thrown away. The surveyor also asked him to describe the hold time for previously cooked foods. CS L stated that items would be held between 7 and 10 days. The surveyor asked CS L to describe which items would be held for 7 days and which would be held for 10 days. CS L was unable to answer the question. The surveyor also asked CS L to determine the preparation date for the reviewed items. While CS L provided dates, he appeared to arbitrarily pick days of the week rather than being able to demonstrate the actual preparation date of the PHF's.

The surveyor also asked CS L the purpose of the leftover foods. He replied that these items were previously used as cafeteria entrees and he would use leftover foods for the cafeteria at a later date. CS L was also asked to describe how he ensured that the PHF's were safe to be used later. He replied that he would evaluate the appearance and smell of the food. If it looked like it was still good he would use it.

In a follow up interview on 5/3/10 at 2:40 p.m., the surveyor asked CS L to describe his process for handling leftover foods. He stated that once the item was taken off the steam table he would place the leftovers on the counter for about 1.5 hours after which he would refrigerate the item. He also stated that there was no temperature monitoring of the items. The surveyor asked CS L to describe a safe food temperature. CS L stated that he would want food temperatures to be between 65-75°F. The standard of practice would be to effectively monitor the cool down of PHF's. The guidelines for handling cooked PHF's would be ensure the food temperature drops from 135-70°F within 2 hours and from 70-41°F or below within an additional 4 hours, for a total of 6 hours (Food Code, 2009).

In an interview on 5/3/10 at 2:50 p.m., with DMS H he was asked how the hospital ensured safe food handling practices. DMS H staff stated that he completed a monthly food safety and sanitation check.

In an interview on 5/3/10 at 3:10 p.m. with Infection Control Preventionist N (ICP), the surveyor asked how the infection control department ensured safe food handling practices. The ICP N replied that he would rely on the expertise of the nutrition services staff to identify problems. The surveyor also asked if the IC department completed monitoring rounds in the dietary department. He stated he was unsure as he was from another campus; however he would request any IC rounds that were completed.

In an interview on 5/4/10 at 8:50 a.m., the surveyor asked CS D, who had responsibility for oversight of the cafeteria, to describe how he ensured safe food handling practices. He stated that he would evaluate the appearance of the employee, customer interaction and food handling. The surveyor also asked how he would evaluate the food handling; however he was unable to answer. The surveyor also asked CS D to describe how he evaluated the competency of employees. He stated that an evaluation was performed every 6 months by the hospital by asking employees questions. The surveyor also asked CS 2 if the contracted vendor had any policies and procedures for staff to follow. He stated that there was a manual; however the Manteca location did not have one because "there was no space." The surveyor also asked CS D to describe the contents of the manual. He stated that included guidance on appearance, customer satisfaction and food handling, which included a food storage chart.

Concurrent review of the undated and unreferenced document titled "Food Storage Chart ..." presented by CS D, revealed that there was no guidance for refrigerated bean based products such as chili and that cooked meat leftovers would be held no longer than 4 days.

Review on 5/4/10 at 8 am, of the hospital document completed by DMS H and titled "Manteca Kaiser Permanente Cafeteria Quality Inspection and Report" dated 1/29/10, 2/26/10 and 4/15/10 revealed that in each of the 3 reports DMS H noted that the contracted food vendor properly followed cooling procedures.

In an interview on 5/4/10 at 9:00 a.m., with DMS H he was asked to describe how he determined that the contracted vendor was in compliance with proper cool down without the presence of trained staff or a monitoring system. He stated that he asked one of the cooks and believed he provided the correct answer. He acknowledged he did not correctly evaluate the process.

In an interview on 5/4/10 at 11:00 a.m., the surveyor asked DMS A if she provided any oversight into cafeteria food production, to which she replied that she did not.

Review on 5/4/10 of hospital document titled "Infection Prevention and Control Committee" dated 3/16/09, 6/15/09, 7/20/09, 8/17/09, 9/21/09 failed to document any systems issues surrounding safe food handling practices at the Manteca campus cafeteria. Additionally it was noted that on 2/26/10 the committee reported that the Manteca campus reached a target of 90%. There was no documentation that the Registered Dietitian, Food Service Manager, Infection Control Committee, or the contracted vendor identified any unsafe food handling practices, rather all documentation noted that the food handling practices were in compliance with hospital developed bench marks per the cafeteria quality inspection reports.

7. On 5/3/10 at 12:00 p.m., during review of cafeteria food storage practices it was noted that the internal thermometer of the stand up refrigerator read 28°F. The internal probed temperature of a 4-ounce cup of macaroni salad was taken in the presence of DMS H and was noted to be 45°F. In a concurrent interview with DMS H the surveyor asked how long the item was in the unit. DMS H replied that it was delivered during the previous night.

In a follow up observation on 5/3/10 at 3:05 p.m., an internal temperature of an omelet was taken and noted to be 47°F. DMS H staff concurrently confirmed that this item was received during the night (15 hours prior). The surveyor also asked DMS H to describe the steps that would be taken to ensure food safety if elevated temperatures were noted. He stated that he would pull out the food and put it in the walk-in refrigerator. The surveyor also asked him how long hazardous food could remain at elevated temperatures, to which he replied that they would be ok for up to 8 hours after which he would throw them away. The standard of practice would be to ensure foods whose temperature was greater than 41°F we held no longer than 4 hours (Food Code, 2009).

On 5/4/10 at 8 a.m., policies related to food storage was requested. As of 5/7/10 the hospital failed to provide any policies.

In an interview on 5/3/10 at 3:10 p.m., the surveyor asked DMS H how he ensured foods stored in the refrigerator were kept at safe food temperatures. DMS H replied that he would check the refrigerator logs. The surveyor asked if there were any temperatures that would be a red flag for him, to which he replied that temperatures that appeared to be low such as 28-30°F "because the food would be frozen" and may signify a problem with the thermometer.

Concurrent review of the undated hospital document for the months of April and May 2010, per DSM H staff, titled "Temperature Monitoring" revealed that during April the refrigerator was below 35°F for 11 of 30 days. Similarly for May the refrigerator was below 30°F for 2 of 3 days. DMS H also stated that in April 2010 he replaced the thermometer, but acknowledged he did not do any follow up food temperatures to ensure the unit was working properly.

8. During review of cafeteria food holding practices on 5/3/10 beginning at 2:35 p.m., food temperatures of PHF's were taken and noted as follows: egg salad and tuna salad 47°F; roast beef 48°F; ham 44°F; sliced tomatoes 46°F and cut melon 46°F. In a concurrent interview the surveyor asked CS L what time the salad bar was set up. He replied that it was set up at 11:00 a.m. He also stated that the items would remain in the salad bar area until 6:00 p.m.. The surveyor asked if there was any temperature monitoring throughout the day, to which he replied there was not. He did however state that the temperature of items was taken at 11:00 a.m.

Review of contracted food service documents titled "Cold and Hot Exhibition" for the months of March, April and May 2010 revealed that there were temperatures recorded for items such as meat, vegetables and dressing. It was also noted that the temperatures for each of the items were consistently recorded between 36 and 40°F. It was also noted that all of the temperatures were remarkably similar. Additionally it was noted there was no recording of hot food temperatures.

In an interview on 5/4/10 at 8:50 a.m., the surveyor asked CS D if he had reviewed the temperature monitoring process for foods held in the cafeteria. He stated that he had. He was also asked if he had noted any deficiencies regarding the method of temperature monitoring. He replied that he had not. The surveyor stated that it appeared that there was no comprehensive hot or cold food monitoring of potentially hazardous foods. He stated "I guess I missed that."

The standard of practice would be to monitor potentially hazardous foods for time/temperature control ensuring that cold foods are consistently held below 41°F or below and that hot foods were held at 135°F or above (USDA Food Code, 2009). An effective monitoring system would also ensure that foods were not held in the food danger zone between 41-135°F for greater than 4 hours (USDA Food Code, 2009).

9. On 5/3/10 at 3:30 p.m., in an interview with ES M the procedures for ice machine maintenance were reviewed. The surveyor asked that he describe the cleaning process. He stated that on a monthly basis he utilized an ice machine cleaner after which he utilized a sanitizing solution. He stated that both of these chemicals were flushed through the system as well as the ice holding bin.

Review on 5/4/10 at 12:00 p.m., of the chemical revealed that it was a quaternary ammonia solution. It was also noted that the manufacturers' guidance for the ice machine recommended utilizing a sanitizing solution of 5.25% sodium hyperchloride, rather than quaternary ammonia.

10. During review of sanitation procedures on 5/4/10 beginning at 11:00 a.m., the surveyor asked CS L to describe the cleaning of the meat slicer. He stated that after using the slicer he would remove the food particles and wash it with hot water and use a sanitizer after which he would rinse off the sanitizer.

Review of manufacturers guidance revealed that once the product was placed on the equipment it should be air dried. The contracted food vendor had no policies/procedures for cleaning high risk equipment such as the meat slicer.

Based on interviews and review of facility documents, the emergency departments (ED) at both the Modesto and Manteca hospitals failed to develop an orthopedic splinting policy and procedure (P&P) that would encompass a standardized process for ordering, applying and physician reassessment of splints that were applied by non-licensed ED staff.

Findings:

On 5/3/10 at 10:20 a.m., during a review of facility job descriptions with a human resource staff member (HR), it was discovered that the ED technicians (ED techs) at both the Manteca and Modesto hospital campuses, were allowed to apply orthopedic splints on patients in the ED. The following information for both hospitals was requested for review, the splinting P&P, the lesson plan, the sign-in sheets and the educational files for all ED techs in both hospitals.

On 5/4/10 at 9:25 a.m., one of the day shift, Assistant Department Managers (ADM) was interviewed about the splinting P&P in the ED. The ADM stated that there was no splinting P&P. The ADM was asked how the ED staffs at both hospitals knew what the splinting process was without a P&P. The ADM stated that, "the practice" for both hospital EDs was that the physician would write the order, the ED tech would apply the splint and the physician would then reassess the splint post application to ensure that the splint was applied correctly and that the neurovascular status was assessed. The ADM stated that the ED techs did not document in the chart, however, the physician was expected to document a reassessment in the chart. The ADM was asked if the ED physician group had taken part in the development of the training program and she stated that she was unsure if the physician's participated in the development process and that it was a nursing educator who had trained the ED techs at both hospitals.

On 5/4/10 the Physician Quality Director (PQD) was asked on interview if the ED physicians were involved in the development of the splint program as it pertained to the medical care provided in the ED and he stated that he was not sure. The facility could not produce a splinting P&P and the hospital liaisons were asked for a copy of the ED meeting minutes which discussed the development of the splinting process. The facility was unable to produce any documents that showed that the ED physicians had discussed or were involved in the development of the splinting procedure.

On 5/5/10 at approximately 2:55 p.m., an interview was conducted with one of the on-duty ED physicians (EDMD) at hospital B. The EDMD was asked if the ED physicians had discussed the program and had participated in its' development and he stated that he could not be sure. The EDMD stated that some of the physicians document a reassessment and some of them don't, "It is not 100% of the time." The EDMD was asked why the physician would reassess the splint post application and he stated; "We go in to see if the splint is correct, the patient is pain free and the injured area shows that it has good neurovascular involvement (Circulation Sensation Motion)." The EDMD was asked how you would know that a physician had reassessed the patient's splint if not documented and he stated, "You wouldn't."

A random review of ED charts (2007-2009) showed 7 charts that did not contain physician documentation related to the Circulation Sensation Motion reassessment of a splint application by ED staff.

Based on interviews and review of facility documents, both Modesto and Manteca hospitals (hospitals A&B) allowed licensed (4 of 4 files reviewed) and non-licensed emergency department (ED) personnel (15 of 15 files reviewed) to apply orthopedic splints on ED patients prior to receiving specialized training.


Findings:

On 5/3/10 at 10:20 a.m., during a review of facility job descriptions with a human resource staff member (HR), it was discovered that the ED technicians (ED techs) were allowed to apply orthopedic splints on patients in both EDs (A&B). The following information for both hospitals was requested for review, the splinting P&P, the original lesson plan, any sign-in sheets, follow-up competencies and the educational files for all ED techs in both hospitals. The facility produced a power point presentation as the lesson plan, however, they did not have a splinting P&P and they were unable to locate any sign-in sheets. Per HR, all education and competencies were located in the employee files. HR was asked to produce all ED tech files for hospital A&B.

On 5/4/10 at 9:25 a.m., during an interview with a day shift Assistant Department Managers (ADM) it was discovered that per the ADM, the lesson plan submitted was recently developed in 2009 and the ED techs in hospital A had been retrained on it, but not hospital B's ED techs. The ADM stated that the techs were to be re-evaluated on splint application every two years. The ADM was asked how long the ED techs had been splinting and she was not sure. During a follow-up inquiry to the facility's liaisons, it was discovered that the facility had utilized both ED nurses and techs to apply splints in the ED since at least 2006. The facility could not produce any previous educational plans, staff sign-in sheets or competency reviews to show that the ED staff received specialized training in putting on orthopedic splints.

Four ED RN's (2 from each hospital) and hospital A&B ED tech files were reviewed on 5/4/10 and 5/5/10 and showed the following:

1. The ED nurses' files did not contain any documented initial training, assessment or follow-up competencies related to splint application.
2. Hospital A's 10 ED techs showed no initial splint training. In 2008 there was documentation of skills related to the application of ready made splints such as Hare, sager and immobilizers. There was no documented splint application competencies until 2009.
3. Hospital B's 5 ED techs showed no initial splint training, however, the files contained a form that indicated the staff had completed a skills day in 2007 with numerous topics that included orthopedic splinting review. The files did not contain any documentation before or after 2007 to indicate how the techs were trained and evaluated on splint application.

On 5/5/10 at 9:40 a.m., the ED Nursing Director (EDD) was interviewed about the splinting process in both EDs. The EDD stated that she was hired in 2006 and that the staff was already applying splints in the ED, although nursing was supposedly in-serviced in 2008 by one of the facility ortho techs. The EDD was asked if there was a lesson plan in place prior to the 2009 module and she thought so, but the educator had left and they could not find the lesson plan. The EDD was asked how new employees were trained in splint application and she stated that 2 of the techs are used as trainers for both nurses and techs. The EDD was asked if these trainers had some type of, "train the trainer" class and she stated, "No."The EDD was asked if there was a quality system in place to monitor that the splints were being applied correctly and she stated, "No." The EDD was shown the documentation related to ready made splints and asked if that was the competency for the splint application and she stated, "No, there should be a form that indicated the training and types of splints that the techs were trained on." The EDD concurred that the files did not show evidence of splint training prior to allowing the staff to perform the task.

On 5/5/10 at 10:55 a.m., an ED tech (EDT 1) from hospital B was interviewed. EDT 1 stated that she was one of the splinting trainers. EDT 1 stated that she did not receive a special class, but she had made a copy of a splinting binder that was supplied by the orthopedic supply representative and had been splinting since before 2007. EDT 1 stated that she had not received any formal training, but she learned a lot from watching the doctors. The EDT 1 was asked if anyone had evaluated her performance to ensure that she was applying the splints correctly and she stated, "No." EDT 1 stated that there was to be a class in December, 2009 but the educator was ill and there had been no discussion about a follow-up class.

On 5/5/10 at 11:40 a.m., EDT 2 from hospital B was interviewed. EDT 2 stated that she had splinted prior to 2006 when the facility was owned by another entity. EDT 2 stated that she had not gone to a special class for splinting after 2006. EDT 2 stated that they had developed a competency class, but she was unable to attend the class when it was scheduled in December, 2009. EDT 2 stated that there was no discussion of a make-up class or how they were going to attend a competency class.