HospitalInspections.org

Based on observation, staff interviews, medical record and document reviews, the hospital failed to demonstrate an effective governing body responsible for the conduct of institutional operations in order to ensure safe and effective care for all patients as evidenced by:

1)The failure to implement dietetic services in an effective and organized manner. (A-619, A-620)

2)The failure to develop a nutritional analysis that met the parameters of the physician ordered diets (A-630)

3)The failure to ensure safe and effective food storage/productions practices (A-749)

The cumulative effect of these systemic problems resulted in the inability of the hospital to ensure the provision of quality health care in a safe environment.

Based on record review and interview, the hospital failed to ensure that medications were administered in accordance with physicians' orders. Patient 221 was not administered heparin (a blood thinner) for stroke management in accordance with the physician ' s titration order.

Findings:

A review of Patient 221's electronic clinical record with Pharmacist 11 showed that the patient was admitted to the hospital on 6/21/12 for acute cerebrovascular accident (stroke) with presentation of severe headache and left sided weakness and numbness. Intravenous (into the vein) heparin (a blood thinner) was ordered at 3:55 a.m. on 6/21/12 as follow:

Intravenous Heparin:

Start at 840 units per hour. Titration instructions below:

PTT <35 seconds: Increase by 200 units per hour
PTT 35 to 75 seconds: Increase by 100 units per hour. Give bolus dose 2000 units
PTT 76 to 115 seconds: No change
PTT 131 to 150 seconds: Hold infusion for 1 hour, then reduce rate by 200 units per hour
PTT above 150 seconds: Stop heparin infusion. Resume saline lock. Call MD for orders

Partial Thromboplastin Time (PTT) is a laboratory test used to monitor the effect of heparin. Heparin is a drug that is given intravenously (IV) or by injection to prevent and to treat thromboemboli (blood clots). When heparin is administered for therapeutic purposes, it must be closely monitored to minimize any adverse outcomes as a result of over or under anticoagulation (thinning of blood).

A review of Patient 221 ' s laboratory records showed a reported PTT of 67.8 seconds at 7:00 p.m. on 6/21/12. According to the physician order, Patient 221's therapeutic or goal PTT should be 76 to 115 seconds. A PTT result of 67.8 should warrant a bolus dose of heparin 2000 units and an increase in heparin infusion rate by 100 units per hour.

A review of Patient 221's electronic medication administration record (eMAR) showed that no bolus heparin dose was administered to the patient after the reported PTT of 67.8 seconds at 7:00p.m. on 6/21/12. A subsequent PTT result reported at 12:10 a.m. on 6/22/12 showed continued under-anticoagulation with a PTT result of 57.2 seconds. There was no documented clinical rationale for the withholding of the heparin bolus dose. The failure of the hospital to administer heparin to Patient 221 in accordance with the physician's order had resulted in prolonged under-anticoagulation which had the potential
to cause worsening stroke symptoms and poor stroke prognosis.

Based on observation, interview and record review, the hospital failed to deliver pharmaceutical services to meet the needs of patients when medications were not controlled and distributed in accordance with standards of practice, federal and state laws as evidenced by:

1. Failure to ensure the distribution of medications was in accordance with standards of practice. Fentanyl transdermal patches and concentrated oral morphine sulfate solution were stocked in non-profiled automated dispensing cabinets in the emergency department.

2. Failure to ensure appropriate review of medication orders by pharmacists. Duplicated orders for hydromorphone (a potent narcotic pain medication) was not identified by the reviewing pharmacist.

3. Adverse drug reactions was reviewed and evaluated in accordance with hospital policy and procedure.

Findings:

1. A review of the Pyxis (automated dispensing cabinet, ADC) inventory list for the emergency department showed that 3 fentanyl transdermal patch 25mcg/hr (micrograms per hour) were stocked in Pyxis in the emergency department. In addition, concentrated morphine sulfate 20mg/ml oral solution was available in one of the Pyxis stations in the emergency room.

During an interview at approximately 1:23 p.m. on 6/27/11, Pharmacy Supervisor 1 stated that the Pyxis stations in the emergency department were not profiled with individual patient information which allowed medications to be removed by nursing staff before the medication orders were reviewed and approved by the pharmacists. Pharmacy Supervisor 1 added that she did not see the need for fentanyl patch and concentrated morphine sulfate solution to be stocked in the emergency room Pyxis as the hospital pharmacy was open 24 hours a day and that it was the policy of the hospital that all fentanyl patch orders be reviewed by a pharmacist to ensure appropriate prescribing before dispensing.

Fentanyl transdermal patch and concentrated morphine sulfate oral solution are both potent opioid pain medications for management of moderate to severe pain in opioid-tolerant patient. Patients should be evaluated for opioid tolerance status prior to receiving these medications. Inadvertent administration of these medications to non opioid-tolerant patients may result in opioid overdose which may lead to respiration depression, over-sedation and in serious cases, death. ISMP (Institute for Safe Medication Practices) has identified this class of medication as one of the high alert medications. High alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Special safeguards should be implemented to reduce the risk of errors.

The High Alert Medication Guidelines on Fentanyl Transdermal Patch by the California Hospital Association Medication Safety Committee indicates that fentanyl patches should only be stocked in ADC that are profiled and releases medication only after the pharmacist order verification has occurred. In non profiled ADCs, fentanyl patches should be sent from the pharmacy once pharmacist order validation has occurred. In addition, the guidelines suggested hospitals to consider eliminating storage of fentanyl patches in emergency rooms, PACU, operating rooms, short day surgery, which are considered problem-prone areas for fentanyl patch use.

2. A review of Patient 225 ' s clinical record showed that the patient was admitted to the hospital on 6/12/12. Patient 225 ' s electronic medication administration record (eMAR) showed that the patient had 2 hydromorphone (a potent opioid pain medication) orders for moderate pain as follow:

Order 1: Hydromorphone 0.5 mg intravenously (into the vein) every 3 hours as needed for pain scale 4 to 6.

Order 2: Hydromorphone 0.5mg intravenously every 30 minutes as needed for pain scale 4 to 6.

Both Order 1 and Order 2 were written at 1:21 a.m. on 6/13/12 and were reviewed and approved by Pharmacist 12 prior to administration. There was no documentation indicating that the prescribing physician was contacted to clarify the duplicated orders. Patient 225 ' s eMAR showed that Registered Nurse 31 (RN 31) executed Order 1 and administered 0.5 mg of hydromorphone to the patient at 2:45 p.m. on 6/14/12. At 3:29 p.m. on 6/14/12, 44 minutes after the previous dose of hydromorphone, RN 31 administered another 0.5mg of hydromorphone to Patient following Order 2. At 4:45 p.m. on 6/14/12, RN 31 administered a dose of Naloxone (a reversing agent for opioid overdose) 0.4mg to Patient 225.

During a telephone interview at approximately 2:20 p.m. on 6/28/12, RN 31 stated that she remembered that Patient 225 became hard to arouse and not very responsive consistent with signs and symptoms of opioid overdose after the second dose of hydromorphone on 6/14/12 and RN 31 decided to call the physician for an order of Naloxone to reverse the effect of the hydromorphone. RN 31 added that Patient 225 became more alert and responsive after the administration of Naloxone.

A review of the hospital policy and procedure on Medication Order and Profile Review indicated that pharmacist medication profile review should include screening of any therapeutic duplication and assessing the appropriateness of such duplication. In addition, the policy also stated that it was the responsibility of the pharmacist to verify the order with the prescriber in the event that an order was unclear or questionable.

3. A review of Patient 225 ' s electronic clinical record with Pharmacist 11 on 6/28/12 showed that the patient received Naloxone 0.4mg intravenously on 6/14/12. Pharmacist 11 stated that the hospital had a policy to review the use of triggered drugs for identification of adverse drug reactions. Naloxone was included in the list of triggered drugs to screen for possible adverse drug reaction from opioid use.

Naloxone is a reversal agent (antidote) for opioid overdose. A review of naloxone usage in hospital facilitates the identification of opioid use irregularities, adverse drug reaction or medication errors and hence allow hospitals to improve medication safety.

During an interview at approximately 11:00 a.m. on 6/28/12, Pharmacist 13 stated that possibly due to a different report generating time on that day, Patient 225 ' s naloxone us was not captured on the report and hence the incident was not reviewed by the pharmacy department as required by the pharmacy policy.

Based on observation, interview, and document review, the hospital failed to ensure that dietary services met the needs of all patients as evidenced by failure to:
1. Ensure the implementation of dietetic services in an effective and organized manner. (Cross Reference A 619, A620).
2. Ensure the development of a nutritional analysis that met the parameters of the physician ordered diets (Cross Reference A630).
3. Ensure safe and effective food storage/production practices (Cross Reference A749)
The cumulative effect of these systemic problems resulted in the inability of the hospitals' food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients' were met in accordance with practitioners' orders and acceptable standards of practice.






21155

Based on food services observations, dietary staff interview and dietary document review the hospital failed to ensure effective organizational processes as evidenced by the lack of implementation of food service systems relative to the scope and nature of the departments' activities. Failure to ensure implementation of effective food handling procedures may result in unsafe food handling practices putting patients at risk for food borne illness, further compromising medical status.

Findings:

During review of food production practices on 6/26/12 beginning at 1:45 pm, it was noted there were unsafe food handling practices as evidenced by lack of time/temperature control monitoring of potentially hazardous foods (PHF) (Cross Reference A749) . Potentially hazardous foods are foods that are capable of supporting bacterial growth associated with foodborne illness. The standard of practice for all PHF's, which are prepared and held for later use, rather than for immediate consumption, would be to monitor for time/temperature control for food safety (Food Code, 2009). It was also noted there was lack of an effective system to ensure physician ordered diets were followed (Cross Reference A630).

In an interview on 6/27/12 beginning at 3:10 pm, with FSM 1 (Food Service Manager), he was asked to describe the system for ensuring safe food handling practices. He stated that he relied on the Executive Chef for day to day oversight of departmental operations. He further stated that if the Executive Chef was not working day to day supervision was the responsibility of the kitchen supervisors. He also stated that on occasion he did spot checks that consisted of a general walk through procedure. He also stated that if she happened to notice something that did not meet safe food handling standards he would instruct staff at that time. Hospital position description dated 6/2012 titled "Food Services Director" revealed that it was the responsibility of this position to develop policies, procedures and methods for all aspects of the Food Services Department to ensure adherence to specifications, regulatory requirements and food handling principles.






21155

Based on observation, staff interview and document review, the hospital failed to have the Food Services Director responsible for the daily management of the department who: 1) ensured food service staff were knowledgeable in food serving practices including portion control and 2) storage of food per manufacturers ' guidance. Failure to evaluate the comprehensive scope of operational processes may result in patient exposure to food production systems that may not meet the nutritional needs of patients compromising medical status.

Findings:

1. On 6/26/12 starting at 5:30 p.m., FSW 6, a cook serving food for patient dinner room service was observed serving mashed potatoes with a grey handled scoop. The FSM 1 stated concurrently that this was a #10 scoop (3 ounce) after looking at the scoop identification. Review of the patient menu showed the portion specified was 4 ounces mashed potato. A second cook was overheard stating that he thought all the grey handle scoops were the same since they looked alike.


2. On 6/26/12 at 5:30 p.m., FSW 6, a cook was asked the portion of the tri-tip beef being served onto a patient tray. He stated the portion was to be 3 ounces. He stated that they used to have a digital scale. The FSM 1 stated concurrently that one was on order but they had a scale with increments that went to 5 pounds. The cook proceeded to weight a portion of the tri-tip beef on the scale to verify the portion. The cook used a regular plate and verified three ounces. He acknowledged that since the scale was to measure in the pounds that it was difficult to accurately measure the small 3 ounces portion on this scale.

Patient menus especially for the therapeutic calorie control, carbohydrate control, and renal diets require the food served be measured accurately and as specified on the menu to ensure accurate carbohydrate and protein requirements.
FSM 1 acknowledged that the staff was not serving accurately and the scale was not appropriate for the 3 ounce portions to be measured accurately.

3. During food production observations on 6/27/12 beginning at 11:30 am, a cook was observed preparing a grilled cheese sandwich as a lunch entree. It was noted that the cook placed 2 slices of cheese on the sandwich. In a concurrent interview with the CNM she stated that the noon entree should equal 2 ounces of protein. Concurrent review of the cheese package revealed that there were 160 slices in 5 pounds of cheese, therefore each slice equaled ? ounce, totaling 1 ounce of protein per sandwich.

Review of recipe dated 11/2/09 titled "Grilled Cheese Sandwich" noted that the sandwich had 2 slices of cheese; however failed to ensure that each of slices equaled 1 ounce of protein.

*4. During initial tour on 6/26/12 beginning at 1:45 pm, it was noted that in refrigerator #6 there were 4 cases of biscuits as well as 2 cases of brownies. The manufacturers' instructions printed on both of the boxes noted to "keep frozen at 0?F or below." In a concurrent interview with the CNM she stated that it was the usual practice within the department to store baked products in the refrigerator. It would be the standard of practice to store foods per manufacturers' guidance to ensure flavor and palatability.




21155

Based on food production observations, dietary staff interview and dietary document review the hospital failed to ensure patient nutritional needs and physician ordered diets were met as evidenced by 1) the development of an inaccurate nutritional analysis for patients with sodium restricted diets. Failure to develop accurate nutritional analysis may result in compromising nutritional status of patients on specialized diets.

Findings:

1. In an interview on 6/26/12 at 2:15 pm, with FSM (Food Service Manager) 1, he stated that recently the hospital began purchasing pre-cooked salmon and chicken breast in addition to the macaroni and cheese.

During trayline observations on 6/26/12 beginning at 4:45 pm, it was noted that a random patient (Patient 4) had a physician ordered 800 milligram gram sodium restriction for the noon meal. It was also noted that the patients' tray card read that he was to receive a low sodium/low fat macaroni and cheese. Patient 4 also selected a low sodium broth. In an interview on 6/26/12 beginning at 5:10 pm, with FSW 3 he stated that the macaroni and cheese was a commercially prepared product. He also stated that the hospital stocked one product for all diets.

Review of the recipe analysis and convenience product nutritional label, in the presence of the FSM 1 and the CNM, revealed that for 8 ounces of entree the sodium content was 820 milligrams of sodium. Review of the hospitals' nutritional analysis revealed that the calculated food vales were based on recipes that were prepared from scratch ingredients rather than utilizing the nutritional analysis of the convenience products. Similarly, the nutritional analysis for the salmon (no caper sauce) entree that was intended for sodium restricted diets was calculated as containing 38 grams of sodium; in contrast the sodium content of the purchased convenience product contained 220 grams of sodium. The FSM 1 and the CNM acknowledged based on use of convenience products the nutritional analysis for sodium restricted diets was not accurate and as such the department was unable to ensure that the physician ordered diet parameters were followed.




21155

Based on observation, staff interview, and record review, the hospital failed to have an effective system for infection control prevention when:

1.The staff did not wear appropriate attire in the central processing department and surgical perioperative areas in accordance with nationally acceptable infection control guidelines and facility policy.

2.The hospital failed to ensure food production activities were completed safely and in accordance to standards of practice as evidenced by comprehensive time/temperature control monitoring of potentially hazardous foods, reuse of utensils used in the production of ready to eat potentially hazardous foods, and clean cups were placed in close proximity to the handwashing sink. The cups could potentially get overspray of dirty handwashing water when a staff needed to wash their hands during the food service period.

Failure to ensure food production practices that support safe food handling standards may put patients at risk for food borne illness. Food borne illness may lead to nausea, vomiting, decline in medical condition and in severe instances may result in death.

Findings:

1. On 6/26/12 at 2:50 p.m. OR Technician 5 was observed cleaning in operating room 10 on Campus 1 with his mustache uncovered. In a concurrent interview with Staff H, she acknowledged OR Technician 5's mustache was uncovered and indicated facility staff persons were required to wear a full face mask when inside the operating rooms and in the clean core of the perioperative area.

During a tour of the Campus 1 central processing department on 6/26/12 at 3:35 p.m., Staff O was observed in the sterile supply storage area with his mustache uncovered. During a concurrent interview, Staff O acknowledged the central processing department was considered a semirestricted area, but stated staff person needed to cover their beards and mustache only when they were in the decontamination and instrument assembly areas.

On 6/28/12 at 11:30 a.m. Staff B was observed in the surgical instrument assembly area and sterile storage areas in the central processing department of Campus 2. The Staff B's head cap only partially covered his hair. The hair on the sides of his head and at the nape of his neck was exposed.

On 6/28/12 at 11:35 a.m. the Central Processing Technician 6 was observed packaging sterile instruments in the Central processing Department of Campus 2. The Central Processing Technician 6 's head cap only partially covered the hair on his head. The hair on the sides of his head and at the nape of his neck was exposed.

On 6/28/21 at 11:45 a.m. the Central Processing Technician 5 was observed in the surgical instrument assembly area in the central processing department of Campus 2. The Central Processing Technician 5 ' s head cap only partially covered his hair. The hair on the sides of his head and at the nape of his neck was exposed. In a concurrent interview with Infection Control Staff 2, she acknowledged Staff B and Technicians 5 and 6 did not have all hair covered. Infection Control Staff 2 indicated the staff members should have had all hair covered.

Review of the facilities policy titled "Surgical Attire and Infection Control in the Surgical and Invasive Suites ", dated revised 6/12, and presented as current stipulated: "All possible head and facial hair should be covered completely by a surgical hat or hood in the semirestricted and restricted areas. " The facility referenced AORN standards, recommended practices, and guidelines 2012 Edition as the source for its policy.

Review of the 2012 perioperative standards and recommended practices published by the Association of periOperative Registered Nurses (AORN) Perioperative Traffic Pattern guidelines was conducted. The guidelines indicated semi-restricted areas included the areas for storage and processing instruments, corridors leading to restricted areas of the surgical suite. The guidelines indicated restricted areas included operating rooms, procedure rooms, and the clean core area. The guidelines indicated all personnel, including visitors entering the semirestricted and restricted areas even for a brief period of time should wear surgical attire and head covering.

Review of the 2012 perioperative standards and recommended practices published by the Association of periOperative Registered Nurses (AORN) Perioperative Surgical Attire guidelines was conducted. The guidelines indicated "All personnel should cover head and facial hair, including sideburns and the nape of neck, when in the semirestricted and restricted areas. Human hair can be a site of pathogenic bacteria such as MRSA. Routine shampooing of hair with natural detergents does not remove MRSA or have a bactericidal effect."






17065

2a. On 6/26/12 starting at 5:30 p.m., the room service patient meal assemble was observed. It was noted that dietary staff would remove an individual chicken breast from the refrigerator adjacent to the grill and place it in a countertop oven after which the item was given to trayline staff for patient meals. There was no observation of temperature monitoring prior to placing the item on patient trays.

In an interview on 6/27/12 starting at 9:00 a.m., the FSM 1 stated the plan of correction from findings of deficient practices on the validation survey 3/12/2012, they changed to a fully cooked meat like chicken breast and the cook would document the temperature of four items (beef tri-tip, grilled chicken, crusted chicken, and salmon) before each meal.

Review of the logs dated for 6/3/12 to 6/9/12 showed the temperature range was to be greater than 140 degrees Fahrenheit (F). Review of the temperatures on the logs showed some of the items recorded at 151 degrees F and 160 degrees F. The FSM 1 stated the form had been developed by the FSM 3 the Food Manager. He confirmed that the reheating temperature should have been to 165 degrees F, a standard in the FDA Food Code 2009. He stated that he had not reviewed the forms for to ensure the correct reheating temperature. He confirmed the closing supervisor signed off on the forms and had approved the below appropriate cook temperatures.

*2b. Potentially hazardous foods (PHF's) are defined as those capable of supporting bacterial growth associated with foodborne illness. PHF's require time/temperature control at all times to ensure food safety. Protein based foods such as meats are PHF's. The standard of practice when thawing meats would ensure that it was completely submerged under running water:
(1) At a water temperature of 70?F or below,
(2) With sufficient water velocity to agitate and float off loose particles in an overflow, and
(4) For a period of time that does not allow thawed portions of a raw animal food requiring cooking to be above 41?F for more than 4 hours including:
(a) The time the food is exposed to the running water and the time needed for preparation for cooking, or
(b) The time it takes under refrigeration to lower the food temperature to 41?F (Food Code, 2009).

During initial tour on 6/26/12 beginning at 1:45 pm, it was noted that there were two trays of thawed chicken pieces with a use by date 6/28/12. In a concurrent interview with FSW 1 he stated that he thawed the chicken earlier in the day under running water which would be used over the next several days. He further stated that after thawing the chicken he marinated it and placed it in the walk-in refrigerator. In a follow up interview with FSW 1 he stated that there was no monitoring of time and/or temperature during the described thawing process. In an interview on 6/26/12 at 2 pm, with FSM 1 he stated that the department did not have a policy/procedure for this practice. FSM 1 also acknowledged that the current process for thawing foods did not meet the standard of practice to ensure food safety.

2c. During initial tour on 6/25/12 beginning at 1:45 pm, it was noted that there was a product called Dal (cooked lentil based product) as well as a cooked garbanzo bean dish, both of which are considered to be potentially hazardous foods (PHF's). PHF's that are cooked and held for later use must be comprehensively monitored for time/temperature control for food safety. Cooked PHF's must reach 70?F within 2 hours and 41?F within an additional 4 hours, a total of 6 hours (Food Code, 2009). Concurrent review of hospital document titled "HACCP Cooling and Reheating Chart" beginning 6/15/12 noted that while there was documentation of cooldown monitoring there was no monitoring of the lentils or garbanzos. FSM 1 confirmed that the items were not logged on the cooldown chart and that it would be the expectation that all items were documented.

In a concurrent interview with FSW 2, he stated that once he prepared the items he covered, labeled, dated and placed the cooked items in the refrigerator. He also stated that he did not take temperatures of the items once they were refrigerated. He also stated this item was prepared several times/week.

In an interview on 6/26/12 with FSM 1 he was asked to describe how he ensured food safety principles were being followed. He stated that the supervisors reviewed the cooldown logs and passed them on to him for review. He also acknowledged that while he reviewed the logs to ensure that the documented items met the specified temperature parameters he did not evaluate whether the monitoring system included all cooked PHF foods that were held for later use were monitored.

Hospital policy titled "HACCP Cooling and Reheating" dated 6/11 guided staff that all hazardous foods would undergo temperature/time control monitoring for food safety and recorded on the HACCP cooling and reheating chart.

*2d. During food production observations on 6/27/12 beginning at 11:30 am, in the presence of the CNM, it was noted that dietary staff were preparing sandwiches using ready to eat potentially hazardous foods (PHF's). It was also noted that staff would pull a knife from the knife holder, cut the sandwich and replace it into an adjacent holder. It was also noted that in one instance the staff member rinsed the knife under running water and replaced it in the knife holder. In a concurrent interview with the CNM she stated that dietary staff was guided to obtain a clean knife when handling PHF's.

2e. On 6/27/12 starting at 12:00 p.m. the Mills Campus food service kitchen was observed. The staff set up two trays of cups (approximately 40 cups) on the counter and within 6 inches of the handwashing sink. FSM 2 and FSW 2 and FSM1 were present and observed the cups in close proximity to the handwashing sink and potential for overspray of dirty handwashing water when a staff needed to wash their hands during the food service period. The cups were moved after the surveyor questioned the infection control of the cup setup. FSM2 stated that when the cups were on the counter and ready to be filled with coffee the food service staff would not wash their hands.

Handwashing sinks cannot be obstructed from use at all times and all clean utensils must be kept clear of overspray from handwashing sinks. Reference standard of practice is FDA Food Code 2009.




28798