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1101 VAN NESS AVENUE

SAN FRANCISCO, CA 94109

GOVERNING BODY

Tag No.: A0043

Based on observation, interview, and record review, the hospital's governing body, the legally responsible entity for the conduct of the hospital as an institution failed to provide oversight in the areas of infection control, nursing, and dietary/food service which resulted in the identification of systemic deficiencies in these fields.
Findings:

1. The facility failed to ensure that insulin was administered in accordance with physicians' orders and established hospital policies. In addition, the hospital nursing staff failed to administer intravenous fluids as ordered by the physician, to patients in the post anesthesia care unit. (A 385, A 404).

2. The hospital failed to ensure that the director of dietetic services had been responsible for the daily operations of the department, in order to provide sufficient, safe and healthful food to its patients. (A 618, A 620).

3. The hospital failed to ensure that physicians' diet orders had been implemented for Patients 4 and 6, resulting in the advancement of a tube feeding without a physician's order, and the failure to ensure an effective system of registered dietitian review of complex diets. (A 618, A 629).

4. The hospital failed to ensure that there were adequate food and water supplies located on each campus to implement the planned menu during a disaster, which requires that the hospital be self sufficient for seven days. (A 618, A 701).

5. The hospital failed to ensure that there were infection control measures to prevent the development of foodborne illness in the kitchen, failed to have a thorough infection control surveillance system to monitor conditions and practices (Time-Temperature) of dietetic service staff and failed to identify breaches in infection control practices. The hospital also failed to ensure an effective system for 1) monitoring the expiration of protein supplements and 2) failed to maintain the integrity of countertops in a cafeteria area. (A-749).

The cumulative effect of these system failures resulted in the hospital's inability to provide safe and effective care for its patients.






























23107

PATIENT RIGHTS: INFORMED DECISION

Tag No.: A0132

17031

Based on interview and record review, the hospital failed to ensure that two of three patients whose records were examined had evidence that the hospital promoted and protected their rights to formulate an advanced directive. Patients 15 and 16.

Findings:

1. On 6/29/10 at 3:42 p.m. on 6 South, during a review of Patient 15's clinical record, it was noted that the advanced directive sticker in the progress notes was not signed or dated by the patient's physician. The patient had been admitted at 2 p.m. on 6/28/10. had The physician signature and date was the method the hospital used to indicate that a discussion about the patient's right to formulate an advanced directive had taken place between patient and physician.

2. On the same date at 4:05 p.m. on 6 North, during a review of Patient 16's clinical record, it was also noted that the advanced directive sticker in the progress notes was not signed or dated by the patient's physician. The physician signature and date was the method the hospital used to indicate that a discussion about the patient's right to formulate an advanced directive had taken place between patient and physician. Patient 16 had seven physician progress notes written since admission, without the advanced directive discussion between physician and patient having had taken place.

During an interview on the same date at 3:50 p.m. the interim Nurse Manager acknowledged that the required information was missing. She told surveyors that the Unit Coordinators will check the stickers, and if they are not signed and dated, they will call the physician. "It should have been followed up by the Unit Coordinator and the Nurse Manager", she said, the Unit clerk should have looked at it."

NURSING SERVICES

Tag No.: A0385

Based on observation, interview and record review, the facility failed to provide nursing services according to established policies and acceptable standards of practice when Patient 7's tube feeding was stopped but nursing staff did not contact the physician for orders for an alternate source of glucose even though the patient was on long acting insulin, when Patient 8 continued to receive Lantus insulin subcutaneously after an intravenous insulin infusion was started and when no alternate source of glucose was ordered or adjustment of insulin infusion rate was made when Patient 8's total parental nutrition was reduced by 50%. This resulted in Patient 7 developing hypoglycemia (low blood sugar) on 6/27/10 and 6/29/10 and Patient 8 developing hypoglycemia on 6/25/10 and 6/27/10 which required the administration of dextrose 50% intravenously to correct the patients low blood glucose level. Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death. The facility staff also failed to administer intravenous fluids as ordered by the physician for Patient 9, 10, 11, 12, 13 and 14 in the post anesthesia care unit. The infusion rates were run up to 5 times faster when compared to physicians' orders.

Findings:

1. The facility failed to ensure that insulin was administered in accordance with physicians' orders and established hospital policies. (A-0404).

2. The facility staff failed to administer intravenous fluids as ordered by the physician for patients in the post anesthesia care unit. (A-0404).

The cumulative effects of these systemic problems resulted in the failure of the hospital to provide safe and effective nursing care to its patients.

No Description Available

Tag No.: A0404

Based on interview and record review, the hospital failed to ensure that insulin was administered in accordance with physicians' orders and established hospital nursing protocols as evidenced by:

1. Nursing order to notify physicians was not followed when Patient 7's glucose need was not addressed while on long-acting insulin and tube feeding was held, which resulted in Patient 7 developing hypoglycemia (low blood sugar) and required the administration of dextrose 50% on 6/27/10 and 6/29/10.

2. The TICU (Transitional Intensive Care Unit) insulin infusion protocol was not followed when Patient 8 continued to receive Lantus insulin subcutaneously after insulin infusion was started. Patient 8 developed hypoglycemia and required the administration of dextrose 50% to correct blood glucose level to prevent adverse effects from hypoglycemia on 6/25/10. In addition, the TICU insulin infusion protocol was not followed when no alternate source of glucose was ordered and no adjustment was made to Patient 8's insulin infusion rate when the patient's total parenteral nutrition (TPN) infusion rate was reduced by 50% on 6/27/10, which resulted in Patient 8 developing hypoglycemia and required the administration of dextrose 50% to correct the patient's blood glucose level.

3. The hospital also failed to administer intravenous fluids as ordered by the physician for patients in the post anesthesia care unit. The infusion rates were run up to 5 times faster when compared to physicians' orders. This affected Patients 9, 10, 11, 12, 13, and 14.


Findings:

1. A review of Patient 7's clinical record showed that the patient was admitted to the hospital on 6/11/10. Lantus insulin (a long acting insulin) was ordered on 6/19/10. Patient 7 was on NPO diet (nothing by mouth) and was on enteral tube feeding since 6/18/10. The following were ordered by the physician on 6/18/18:

" Call physician for instructions for covering hypoglycemic (low blood sugar) effects from insulin and other drugs already given to patient regarding diet-NPO. "

" Please consult physicians regarding patient's order for hypoglycemic drugs whenever the tube feeding rate has been adjusted."
Lantus insulin is a long-acting insulin with a duration of action of 24 hours or longer for blood sugar control . Insulin works by facilitating the uptake of glucose (sugar) by muscles and fat cells to reduce glucose level in circulation. The most common adverse effect of insulin is hypoglycemia (low blood sugar). Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death.
Patient 7's clinical record showed that the patient received 35 units of Lantus insulin at 8:00 a.m. on 6/27/10. At 9:21 a.m., Patient 7's tube feeding was ordered by the physician to be held for CT (computed tomography) scan of the abdomen on that day. Patient 7's critical care 24-hour flow sheet showed that the patient's tube feeding was turned off at 12:00 noon for 3 hours. There was no documentation indicating that the nursing staff consulted the physician regarding the patient's need for alternate glucose source while on long-acting insulin and tube feeding was being held. Patient 7 developed hypoglycemia (low blood sugar) at approximately 4:00 p.m. with a reported blood sugar level of 63mg/dL. Dextrose 50%, a high concentration glucose solution for the treatment of insulin induced low blood sugar, was administered intravenously to correct Patient 7's blood glucose level to prevent adverse effects from low blood sugar.

On 6/28/10, Patient 7 received 40 units of Lantus insulin at 4:00 p.m. Patient 7's tube feeding was ordered by the physician to be held for CT (computed tomography) scan of the abdomen at 12:00 midnight on 6/29/10. Patient 7's critical care 24-hour flow sheet showed that the patient's tube feeding was turned off at 12:00 midnight on 6/29/10 for 12 hours. There was no documentation indicating that the nursing staff consulted the physician regarding Patient 7's need for alternate source of glucose. Patient 7 developed hypoglycemia with a reported blood sugar level of 53mg/dL at approximately 3:00 a.m. Blood glucose level was repeated by the laboratory and was reported to be 42mg/dL. Patient 7 required the administration of 25ml of dextrose 50% intravenously to correct the blood sugar level.

During an interview at approximately 3:05 p.m. on 6/29/10, Staff 21 stated that Patient 7's low blood glucose levels on 6/27/10 and 6/29/10 were caused by the fact that the patient's tube feeding was stopped but no alternate source of glucose was ordered while the patient still had long acting insulin in his system. Staff 21 further stated that based on the physician's orders, nursing staff should have communicated with the physician about starting the patient on a 10% dextrose infusion when the patient's tube feeding was ordered to be held to prevent the patient from developing low blood sugar. Staff 21 added that she noticed that Patient 7's blood sugar continued to drop soon after the administration of dextrose 50% and found out that the patient was not receiving glucose from any source. Staff 21 then contacted Patient 7's physician to start a dextrose 5% ? normal saline infusion to prevent Patient 7 from developing hypoglycemia while tube feeding was on hold.
2. A review of patient 8's clinical record showed that the patient was admitted to the hospital on 6/21/10. Patient 8 was on total parenteral nutrition (TPN). TPN is intravenous infusion of nutrients for patients who cannot receive adequate nutrients by other means. Lantus insulin 4 units subcutaneously (under the skin) daily was ordered on 6/21/10 for blood sugar control. At 11:00 p.m. on 6/23/10, continuous insulin infusion was ordered by the physician. Patient 8's critical care flow sheet showed that the patient received Lantus insulin injection at 5:00 p.m. on 6/24/10 while receiving insulin by continuous intravenous infusion. At 4:00 a.m. on 6/25/10, Patient 8 developed hypoglycemia with a blood glucose level of 70 mg/dL. The blood glucose level was repeated by the laboratory and was reported to be 45 mg/dL. Dextrose 50% was administered to Patient 8 to correct the patient's low blood glucose level. Patient 8's Lantus insulin ordered was not discontinued until 6/25/10 at 1:46 p.m.
On 6/27/10 at 7:47 a.m., Patient 8's physician ordered for the patient's TPN to be discontinued. Patient 8's critical care flow sheet on 6/27/10 showed that the TPN rate was adjusted from 63ml/hour to 30 ml/hour at approximately 9:00 a.m. There was no record indicating that alternate source of glucose was ordered and no adjustment was made to the patient's insulin infusion. Patient 8 developed hypoglycemia at approximately 10:15 a.m. with a blood glucose level of 33 mg/dL. Dextrose 50% was administered intravenously to correct Patient 8's low blood glucose to prevent serious adverse effects from hypoglycemia.
A review of the hospital nursing protocol on insulin management on 6/30/10 indicated that hypoglycemia is blood glucose level of 70 mg/dL or below and required immediate attention to correct blood glucose level.
A review of the hospital nursing protocol titled " Insulin Infusion Protocol, Transitional Intensive Care Units TICU) " on 6/30/10 indicated that all previous insulin orders should be discontinued upon initiation of insulin infusion. In addition, the nursing protocol indicated that a continuous glucose source should be ordered for all patients on insulin infusion with at least 5 grams of carbohydrates per hour. The protocol also stated that it was important to adjust the insulin dose when changes in rates of TPN or tube feeding were made.
During an interview at approximately 11:55 a.m. on 6/30/10, Staff 22 stated that according to hospital insulin infusion protocol, nursing staff should communicate with physicians regarding insulin infusion rate and alternate glucose source when tube feeding or TPN was ordered to be on hold to prevent hypoglycemia.


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3. An observation on 06/30/10 at 12:10 pm in the post anesthesia care unit (PACU) revealed Patient 9 and Patient 10 were on intravenous (IV) fluids. The IV fluids were run gravity not run through an IV pump. In order to determine an accurate rate of infusion the nurses would have to count the drops over time.

During an interview on 06/30/10 at 12:10 pm Nurse 1 stated that she was not sure of the rate of the infusion. She could give an approximate rate but she did not know the actual rate of infusion for the IV fluids. She was not sure of the actual rate of the infusion because she did not count IV fluids drops over time to determine the rate of infusion.

In an interview on 06/30/10 at 12:15 pm Nurse 2 stated that he was not sure of the rate of the infusion. He could give an approximate rate but he did not know the actual rate of infusion for the IV fluids. He was not sure of the actual rate of the infusion because he did not count IV fluids drops over time to determine the rate of infusion.

A review of clinical record for Patient 9 and 10 indicated physicians' orders for IV fluids at a rate of 1ml/kg/hr. Patient 9 was 83.8 kg and Patient 10 was 66.2 kg. According to the physicians' orders the rate of Patient 9 would be 84 ml/hr and Patient 10 would be 66 ml/hr.

A review of the PACU Record indicated rates based on IV fluid bag levels. The measured IV fluid bag level could then be calculated to determine the rate of infusion. This would be the documented fluid amount the patient actually received. The actual rates for Patient 9 and Patient 10 at 12:00 pm on 06/30/10 were 428 ml/hr and 340 ml/hr respectively. The physicians' orders for Patient 9 and 10 were 84 ml/hr and 66 ml/hr respectively. What were actually administered were IV fluid rates 5 times faster than what were ordered by the physicians.

A 24 hour random audit on 06/29/10 of four patients' clinical record physicians' orders for IV fluids indicated the following:
Patient 11 at 82 ml/hr
Patient 12 at78 ml/hr
Patient 13 at70 ml/hr
Patient 14 at70 ml/hr

A 24 hour random audit on 06/29/10 of four patients' PACU record for IV fluids rates actually received indicated the following:
Patient 11 at 116 ml/hr
Patient 12 at 282.8 ml/hr
Patient 13 at 363 ml/hr
Patient 14 at 164 ml/hr

The audits indicated that the IV fluids were not administered as ordered by the physicians. In some cases the rates were up to five times faster.

During an interview on 07/01/10 at 12:30 pm Administrator 1 stated that the nurses were not counting drops and did not administer the IV fluids as ordered by the physicians. He acknowledged that the wrong rates of infusion were all medication errors.

FOOD AND DIETETIC SERVICES

Tag No.: A0618

Based on observation, staff interview, and document review, the Condition of Food and Dietetic Services is not met due to:

1. The hospital failed to ensure that the director of dietetic services had been responsible for the daily operations of the department so as to have provided sufficient, safe, healthful food. By not having ensured food safety there was the potential for food borne illness and risk of unmet nutritional needs in a hospital with a licensed bed capacity of 576 patients.(A 620)


2. The hospital failed to ensure physicians' diet orders were implemented for two patients, 4 and 6, as evidenced by: 1) advancement of tube feeding without a physician's order, and 2) failure to ensure an effective system of registered dietitian review of complex diets. Failure to follow physicians' orders for diets had the potential to further compromise patient medical status.(A 629)


3. The hospital failed to ensure adequate food and water supplies located on each campus to implement the planned menu during a disaster that required the hospital to be self sufficient for seven days. This had the potential to further the compromise the medical status of 576 hospitalized patients. (A701)

The cumulative effect of these system problems resulted in the failure of the hospital to provide safe and effective care to its patients.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

17065


Based on observation, staff interview and document review, the hospital failed to ensure that the director of dietetic services,granted the authority and delegated responsibility by the governing body and the medical staff for the operation of the dietary service assured that established policies and procedures were maintained so as to have provided sufficient, safe, healthful food. By not having ensured food safety there was the potential for food borne illness and risk of unmet nutritional needs in a hospital with a licensed bed capacity of 576 patients.

Findings:


On 7/1/10 at 12:00 p.m. while in the administrative conference room, a summary of concerns identified between 6/29/10 and 7/1/10 that were observed by surveyors was presented to both Dietary Management Staff 5, RD 14, and Hospital Management Staff 4. The concerns included the failure to have maintained a safe food service at both hospital campuses, the failure to have identified effective systems to ensure food is maintained at safe temperatures, and the observed under utilization of registered dietitians in guiding the food service staff with respect to food safety and meal delivery. (This is cross referenced to A 629, A701, A749).

THERAPEUTIC DIETS

Tag No.: A0629

05041








20245

Based on nursing and clinical nutrition staff interview, medical record review, nursing and dietary document review, the hospital failed to ensure physicians' diet orders were implemented for two patients, 4 and 6, as evidenced by: 1) advancement of tube feeding without a physician's order, and 2) failure to ensure an effective system of registered dietitian review of complex diets. Failure to follow physicians' orders for diets had the potential to further compromise patient medical status.

Findings:

1. Patient 6 was admitted with diagnoses including severe abdominal pain. The admission diet order dated 6/16/10 was noted to be NPO (nothing by mouth). The nursing admission assessment dated 6/16/10 noted that Patient 6 was at nutritional risk due to poor dietary intake, nausea and vomiting. A physician's order dated 6/21/10 noted the implantation of total parenteral nutrition ( TPN, feeding through a vein in the arm) at a rate of 63 cc's/hour.

Medical record review was conducted on 6/30/10 beginning at 10:30 am. On 6/28/10 at 10:57 am, the physician also implemented an order for tube feeding (in addition to the TPN) "Protocol A", formula to start at 25 cc/hour with the RD to determine the appropriate feeding and goal rate. On 6/28/10 at 4:53 pm, the RD completed a comprehensive nutrition assessment and recommended tube feeding using Isosource 1.5 with a maximum rate of 40 cc's /hour. It was also noted that the RD (Registered Dietitian) entered this recommendation into the electronic medical record. It was additionally noted that the physician ordered the recommended feeding on 6/29/10 at 7:35 am, guiding nursing staff to utilize the Isosource 1.5 at a maximum rate of 40 cc's/hour.

Hospital document titled "Medical Surgical Flow Sheet" dated 6/18/10 noted that nursing started the tube feeding on 6/18/10 at 1 pm, at a rate of 25 cc's/hour. It was also noted that nursing staff advanced the feeding on 6/29/10 at 3 am, to 40 cc's/hour; however there was no physician's order to advance the feeding.

In a concurrent interview, RD 14 acknowledged that the hospital has recently been cited for advancing enteral feeding without a physician's order. She also stated that the information technology department revised the computer entry system for physician orders, and noted that while the RD would enter recommendations in the PCIS system (Patient Care Information System) the recommendation would flash only on the physician orders screen. Nursing staff would not be able to see the RD recommendation. The surveyor asked how nursing staff was trained in the process. She stated that to her knowledge nursing staff was trained through in-services.

In an interview on 7/30/10 at 2 pm, Administrative Nursing Staff 15 stated that the nursing staff was educated by posting flyers in the nursing units as well as being in the nursing communication binder. She also stated it was the responsibility of charge nurses to ensure that all nursing staff, including traveling nurses, were aware of the policy. She also stated that those nurses who were not following the policy would receive individual counseling.

The undated Hospital document titled "New Enteral Care Plan for Tube Feeding" guided staff to "not increase tube feeing [feeding] beyond 25 ml/hour until there is a physician order."

2. During tray line observation on 6/29/10 at 12:30 it was noted that there was a patient tray whose physician ordered diet was a low phosphorus/ 3-4 gram sodium diet. In an interview on 6/30/10 beginning at 10:40 am, with DS 12, the surveyor asked her to describe how she would implement such a diet order. She pulled out the tray ticket for Patient 4 to use as a demonstration. She stated that once patients filled out their tray cards she would review them and make adjustments as necessary. She further stated that Patient 4 was a recent admission and in that situation the diet office would fill out the items to be served for the first day of admission. It was also noted that Patient 4's breakfast was already served she likely would have given him a serving of eggs and hot cereal. DS 12 (Dietary Staff) additionally stated that all specialized diet tray tickets were reviewed by a Registered Dietitian (RD) prior to tray line. During a concurrent review of the meal ticket for Patient 4 it was noted that for the lunch and dinner meal he was being offered a total of 35 grams of protein. The nutritional content of 2 eggs and 1 cup cream of wheat would have added an additional 17 grams of protein, for a total of 52 grams of protein (ADA Exchange List 2009), significantly less that the physician ordered 80 grams. Ensuring adequate protein intake with patients on dialysis is crucial to effective nutritional management (Wolfson, 1999, Journal of the American Society of Nephrology).

Medical record review was conducted on 6/30/10 beginning at 10:30 am. Patient 4 was admitted with diagnoses including renal failure and dehydration. Admission diet order dated 6/29/10 noted a physician order for low phosphorus/3 gram potassium/80 grams of protein/carbohydrate consistent diet. There was also a physician order dated 6/29/10 for dialysis (removal of toxins from the blood by use of an external membrane and machine pump) with no removal of fluid. Admission weight and post dialysis weight was noted to be 159 pounds.

In an interview on 6/30/10 at 11 am, with RN 11, who was Patient 4's nurse, the surveyor asked her to describe the patient's breakfast. She stated that he received cream of wheat and eggs. She further stated he complained about receiving no milk or sugar and that he complained of being hungry.

In an interview on 6/30/10 at 11:45 am, RD 13, who approved Patient 4's meal selections, was asked how the RD's provided guidance to diet office staff. She stated that patients filled out their own meal selections and that if there was a specialized diet the office staff would make corrections after which the RD would review for approval. RD 13 was asked to confirm if she approved the menu selection, to which she replied that she had. She also stated that she felt the selections would be acceptable since the protein content did not exceed the physician ordered 80 grams.
In an interview on 6/30/10 at 2:30 pm, DMS (Dietary Management Staff) 5 and RD 14 stated that the intent of the physician ordered diet was not to exceed 80 grams of protein and that the hospital's physician approved diet manual allowed for less than the physician ordered diet to be served. The surveyor requested copies of the physician approved diet pattern. On 6/30/10 at 3:15 pm, the hospital submitted patient education material from the American Dietetic Association (ADA) Nutrition Care Manual. There was no evidence that any level of protein would be acceptable to a physician ordered 80 gram protein diet. The ADA describes the Nutrition Care Manual as an online resource for nutrition management such as disease-specific nutrition assessment, diagnosis, intervention, monitoring and evaluation recommendations, printable client handouts and formulary data base. The ADA does not describe this publication as a diet manual (eatright.org, 2010).

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

20245

Based on observation, interview and document review, the hospital failed to ensure adequate food and water supplies located on each campus to implement the planned menu during a disaster that required the hospital to be self sufficient for seven days. This had the potential to further the compromise the medical status of 576 hospitalized patients.

Findings:

Pacific Campus

1. On 6/29/10 beginning at 1:25 pm, review of disaster preparedness for meal service was accomplished in the presence of DS 1. In a concurrent interview the surveyor asked DS 1(Dietary Staff 1) to describe the plans for meal preparation during a disaster. She stated that they had a 3-day menu that relied partially on designated disaster foods as well as foods that were stored in the refrigerator and freezer. DS 1 also stated that they had increased the amount of water that would be utilized in an event of a disaster; however they had not increased the food supplies to ensure adequate food supplies both patients and staff.

The surveyor also asked DS 1 to describe the number of people that would be fed. She stated that the hospital planned on feeding 227 patients. She further stated that while they planned on feeding staff ready to eat meals during the disaster, the hospital currently did not have the required supplies to accomplish this. The surveyor asked what number of staff would likely be present during a disaster. DS 1 stated that they would anticipate 1,100 hospital staff.

Concurrent review of the disaster menu revealed that the plan consisted of items such as roast beef, cheese, turkey and egg sandwiches as well as cold deli-type meat plates. DS 1 stated that the refrigeration units would be supported with electricity during a disaster and that that the majority of the items would require some degree of preparation, such as slicing or mixing in addition to individual portioning of the items. The surveyor asked if that in the event of a disaster the hospital would readily be able to implement a menu that required the described level of food production activities, to which she replied that she felt confident that they would be able to implement the menu. The surveyor also asked if the dietary department had provided any training to dietary and/or hospital staff on the implementation of the disaster plan, to which they replied they had not.

California Campus

On 6/13/10 at 10:30 a.m. during review of the hospital disaster menu and observation of the corresponding inventory with DMS 5 and DMS 1, it was revealed the hospital did not have the available inventory to feed staff during a disaster. DMS 5 acknowledged the food was on order but would not be received until a later date.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

Based on observation, interview, and record review, the hospital failed to ensure there were infection control measures to prevent the development of foodborne illness in the kitchen, failed to have a thorough infection control surveillance system to monitor conditions and practices (Time-Temperature) of dietetic service staff and failed to identify breaches in infection control practices. The hospital also failed to ensure an effective system for 1) monitoring the expiration of protein supplements and 2) failed to maintain the integrity of countertops in a cafeteria area. This exposed patients to an unsafe environment that could be a source of food borne illness when staff did not follow time temperature control when holding potentially hazardous foods in refrigerators prior to cooking, ensure the integrity of foods and food preparation areas. (A749)
The cumulative effects of these systemic problems resulted in the facility's inability to provide a safe and sanitary environment for its patients.



















20245




23107

INFECTION CONTROL PROGRAM

Tag No.: A0749

20245

Based on observation, interview, and document review, the facility failed to identify breaches in the cold food storage processes and failed to develop an effective system to ensure potentially hazardous foods were maintained at a safe temperature at or below 41 degrees F. This put patients at risk of food-borne illness that had the potential to cause nausea, vomiting, and diarrhea, and in severe cases death.

Findings:

California Campus:

1. On 6/29/10 at 1:30 p.m. during food storage observations, the external thermometer on the cook's refrigerator #11 was observed to be 42.3 degrees F while the internal thermometer indicated a temperature of 38 degrees F. Based on the Federal Food Code 2009, the safe cold-holding temperature of potentially hazardous foods is 41?F or less. Dietary Management Staff 1 (DMS 1) took temperatures of foods in the refrigerator at the request of the surveyor and the following temperatures were revealed:
a. Raw salmon: 43? F.
b. Better-n-Eggs a liquid egg substitute product: 45?
c. Prepared liquid pancake batter 53? F
d. 10 Raw Chicken breasts in a 12x5 pan: 43.9 degrees?
Following the taking of the temperature of the foods in Cooks refrigerator 11, DMS 1(Dietary Management Staff 1) verified the accuracy of the temperatures by using the same thermometer to check the temperature an 8-ounce carton of milk taken from the dairy walk-in refrigerator which was observed to have a temperature of 32 ? F based on internal and external thermometers. The observed temperature of the milk was 33? F.
At 1:40 p.m. during an interview, Cook 2 stated the chicken and the salmon had been in there when he arrived at 5:30 a.m that morning. and he had put the liquid egg product and the pancake batter in there at "six or seven a.m. today." Cook 2 stated the foods were being cooked and served to patients as they called and requested lunch from the "room service" menu starting at 11:30 a.m. and continuing until 1:45 p.m. or 2:00 p.m. He stated any unused foods would remain in the refrigerator to be used the next meal in the evening, or the next day. During a concurrent interview, DMS 1 clarified the "room service" menu process to involve the cook preparing meals one at a time over a period of 2-3 hours at each meal. The refrigerator #11 was the main refrigerator to contain the protein-based potentially hazardous foods (PHF) used by the cook for "room service" meals.
At 1:45 p.m. the facility provided "Refrigerator Temperature Log" that revealed the temperature of the refrigerator had been 39 degrees at 5:30 a.m. Temperatures of food inside the refrigerator had not been taken at that time.
When questioned by the surveyor, DMS 1 acknowledged there was no way to determine the amount of time the PHF foods had been at the observed unsafe temperatures.
On 6/30/10 at 11:50 a.m., the facility Engineer 3 stated he regularly walked through the kitchen and "looked at" the refrigerator thermometers, but did not know what those temperatures should be, and depended on the dietary staff to let him know if there was a problem with food temperature maintenance in any specific refrigerator.

On 6/30/10 at 9:00 a.m. Hospital Management Staff 4 provided Administration Policy 1.82, Revised 1/13/10, that required refrigerators used to store patient food to be maintained between 34-41?. According to the policy, "Monitoring of Temperatures", the procedure was to for the Department Manager to assign the task of recording temperatures on a daily basis.

On 7/1/10 at 8:45 a.m., Dietary Management Staff 5 (DMS 5) acknowledged the refrigeration and preparation processes used to prepare the foods for the "room service" menu had not been evaluated to determine that the foods within the cooks refrigerator #11 would maintain safe temperatures over the time they were there. DM 5 stated there needed to be "critical thinking" to ensure food safety.

Pacific Campus:

1. During review of food storage practices on 6/29/10 beginning at 12:55 pm the following was noted:

a. The tray line refrigerator contained several turkey sandwiches that had a use by date of 6/29/10. Turkey is considered to be a potentially hazardous food (PHF), capable of supporting bacterial growth associated with food borne illness. The standard of practice would be to ensure the temperature of PHF's are maintained at 41?F or below. In a concurrent interview, DS 1 stated that the sandwich would have been prepared the previous day and placed in the refrigerator for use as a patient meal substitute. The internal temperature of 2 sandwiches was noted to be 46?F and 47?F. It was also noted that the refrigerator thermometer was 42?F.

In a concurrent interview, DS 1 was asked to describe the system for ensuring PHF's are held at safe food temperatures. She stated that refrigerator temperatures are checked twice daily, at 5 am and 8 pm. She further stated that if the temperatures were elevated, a work order for plant operations would be generated. The surveyor asked DS 1 if food temperatures were ever taken. DS 1 replied they were not. DS 1 also acknowledged that the refrigerator temperatures were taken first thing in the morning, after being closed all night, as well as at the end of the day, at which time the units would likely have been closed for several hours. Concurrent review of the monthly refrigerator log, dated June 2010, noted that both the 5 am and 8 pm refrigerator temperatures were documented as 38?F. There was no documentation that the effectiveness of the refrigeration units was obtained while they were in use.

In an interview on 6/29/10 at 1:20 pm with Infection Control Practitioner 5, the surveyor asked how the department ensured safe food handling practices. He stated that quarterly rounds were done in the department that reviewed cleanliness, sanitation, refrigerator food temperature logs and expiration dates. He acknowledged that these rounds did not include food holding temperatures.

b. In the dry storage area there were 2 cases of protein supplements that were stored in individual bottles. In a concurrent interview, DS 1 stated that the items were utilized for patients who had abdominal surgery. It was also noted that while the items were labeled with a lot number, the bottle had no manufacturing or expiration date. DS 1 acknowledged that she had not noticed that there was no expiration date. She also stated that there was no dietary policy with respect to the item.

In a follow up interview on 6/29/10 at 3:30 pm, Hospital Management Staff 4 stated that the hospital contacted the manufacturer of the product. He stated that the manufacturer was able to determine the production date by the lot number. He further stated that the product was stable for up to 18 months after production. He also stated that the hospital did not have a system to monitor the production date of these supplements.

c. During environmental review of the lobby cafe area it was noted that several sections of the countertop had worn and broken surfaces, exposing the wood underneath. In a concurrent interview, DS 2 stated that the cafe currently did not have any pending work orders for repairs. He also acknowledged that he had not noticed the compromised area.

The standard of practice would be to ensure that surfaces in a food establishment be smooth, durable and easily cleanable (Food Code, 2009).







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