HospitalInspections.org

Based on staff interview, and clinical record and policy review, the hospital failed to ensure that the provision of Pharmaceutical Services met regulatory requirements as evidenced by the following:

The facility failed to ensure that the Hospital Performance Committee (HPC: served as the Pharmacy and Therapeutics Committee at this hospital) developed polices and procedures that would ensure the safe use of the fentanyl transdermal system. The procedures that were presently in use at the hospital would allow the 'off-label' use of the fentanyl transdermal system without special precautions being put into place to protect patients from potentially serious respiratory depression. 'Off-label' use of drugs is using drugs for conditions not listed on the manufacturer's product information insert.

The fentanyl transdermal system (also called the fentanyl patch) contains fentanyl, a potent pain relieving opioid (related to opium) drug. The fentanyl patch has a 'black box warning,' which is the most serious warning the Food and Drug Administration (FDA) requires a manufacturer to include in the drug's product information. The FDA is the federal government agency that provides regulatory oversight of medications in the United States. The 'black box warning' documents the potential for potentially fatal respiratory depression if the patch is used 'off-label.' The facility's failure to ensure that the HPC developed policies and procdures that would ensure the safe use of the fentanyl transdermal system could result in the potential for fatal respiratory events from fentanyl. Additionally, this deficient practice had been noted during the December 2010 validation survey (See C276).



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Additionally, the CAH failed to ensure that the Nutrition Services Department provided safe and effective implementation of food services and clinical nutriiton care as evidenced by the following issues:

a. Foodservice: Lack of a comprehensive diet manual that reflected the current standard of pratice and accuratly reflected the diets being served; lack of effective cooldown monitoring of potentially hazardous foods; observation of cross contamination during patient meal delivery services; retention of expired nutritional supplements; and lack of cleaning/sanitizing of the ice machine per manufacturers' guidance.
b. Clinical Nutrition Care: lack of physician orders for nutrition interventions; lack of physcian follow up for Registerd Dieitian recommendations; lack of accurate nutrition assessment with respect to estimated nutritional needs and nutritional intake; and lack of timely nutirtional follow up for a patient classified at high nutritional risk (See C279).

Based on staff interview, clinical record and document review, the hospital failed to ensure that the drug storage area was administered according to accepted professional principles as evidenced by the failure to ensure that the Hospital Performance Committee (HPC: served as the Pharmacy and Therapeutics Committee at this hospital) developed polices and procedures that would ensure the safe use of the fentanyl transdermal system (also called the fentanyl patch). The fentanyl patch has a black box warning, which is the most serious warning the Food and Drug Administration (FDA: provides regulatory oversight of medications in the United States), requires a manufacturer to place in the drug product labeling. The boxed warning documents the potential for fatal respiratory depression if the patch is used off-label (use contrary to the product labeling is considered off-label use).

The procedures that were presently in use at the hospital would allow the off-label use of the fentanyl patch without special precautions being put into place to protect patients from potentially serious respiratory depression. Two of three sampled patients (Patient 31 and 32), each of whom had fentanyl patches ordered and applied on them, had the patch placed on them when they did not meet the definition of opioid tolerance (tolerance to the respiratory depressant effects of pain relievers, such as morphine, that are related or derived from opium), as documented in the FDA approved black box warning in the fentanyl patch product labeling and one patient (Patient 32) subsequently expired from respiratory failure (see finding #1) This deficient practice had been noted during a previous survey conducted at this hospital during December 2010).

Findings:

1. The fentanyl transdermal system also called a fentanyl patch contains fentanyl, a potent synthetic opioid medication used to treat pain. This medication has a boxed warning (also called a"black box"warning) which is the most serious warning the Food and Drug Administration requires be placed in the product labeling 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. 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 pain relieving medication 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 opioids such as Vicodin and Percocet, or pure opioids such as morphine.

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 (opioid medications used to treat pain) daily for a week or longer or an equianalgesic dose of another opioid medication. 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. The product labeling documents that the fentanyl concentration in the body gradually rises after the patch is applied and then levels off between 12 and 24 hours. It documents that peak levels of fentanyl are achieved between 20 to 72 hours. It documents that after the first dosage increase in the patch, based on supplemental immediate release narcotic use to treat breakthrough pain while wearing the patch, that all subsequent dosages should be worn for a total of 144 hours (two 3 day cycles) before another dose increase in made.

On 7/15/2005 the FDA published a warning letter entitled SAFETY WARNINGS REGARDING USE OF FENTANYL TRANSDERMAL (SKIN) PATCHES. The FDA documented that: "The directions for using the fentanyl skin patch must be followed exactly to prevent death or other serious side effects from overdosing with fentanyl. These directions are provided in the product label and patient package insert."

During a survey conducted at the hospital during December 2010, the surveyor found that a physician had ordered and a nurse had placed a fentanyl patch on Patient 31 when this patient did not meet the criteria of opioid-tolerance as defined in the boxed warning for the fentanyl patch. The investigation resulted in the finding of a deficient practice at that time for failure to provide pharmaceutical services in a safe manner. The hospital submitted a plan of correction that documented the HPC approved a Fentanyl Patch Order Set that provided for the safe use of the fentanyl patch in patients admitted to the hospital and that the hospital revised Appendix A of Policy and Procedure MM 50-710-1 entitled HIGH RISK HIGH ALERT MEDICATIONS to reflect these changes.

On 8/23/11 a review of Policy and Procedure MM 50-710-1 entitled HIGH RISK/HIGH ALERT MEDICATIONS (HR/HA) (Effective 9/2004, current revision 6/2008, revised 1/2010) indicated that the hospital policy was to "...employ specific precautions to minimize adverse drug events associated with high risk/high alert medications ...Appropriate mechanisms shall be in place througout the facility to support the safe ...prescribing, administering, and monitoring of all medications considered high alert or high risk." There was an Appendix A appended to this policy entitled APPENDIX A: HIGH-RISK/HIGH-ALERT MEDICAITONS INCLUDING BBWs. BBWs means black box warnings. Review of this appendix indicated it documented "This procedure describes the steps to reduce or eliminate the risks associated with the medications indentified in the procedure." The fentanyl patch appeared on this appendix and the "Risk" was documented as "This dose form may result in respiratroy depression in opiate naive patients." The verbiage "opiate naive" does not appear and is not defined in the product labeling for fentanyl patches.

Under "Action" staff was directed to do the following:

"1. Determine if patient has history of opiate tolerance."

"2. If no history of opiate tolerance, contact MD for alternative dose form or medication if dose ordered exceeds 12 mcg/hr patch:
? Opiate naive patients
? Comfort Care Patients
? Immediate post-op pain"

"3. Use chain of command if MD refuses to change."

"4. See Fentanyl Patch Order Set for Pharmacist responsibility."

On 8/23/11 a review of the FENTANYL PATCH ORDER SET indicated:

? It provided for use of a 12 mcg/hr patch on "Non-comfort care patients" who had received less than 45 mg (milligrams)/day of oral morphine and/or who had received opioids for less than 7 days.

? It provided for use of a 12 mcg/hr patch on "terminal patients on comfort care who do not meet the 'opiate tolerant' FDA criteria ..."

? It documented that: "A 12 mcg/hr fentanyl patch is conservatively equivalent to the usual starting dose of oral morphine for opiate naive patients (30 - 60 mg per 24 hours)."

? It provided for the use of the patch in a patient who had been taking another opioid at a dose "approximately equivalent" to the prescribed fentanyl patch (based on conversion tables available in the product labeling).

? It provided for the adjustment of the fentanyl patch dose after "...2 days if patient requires q (every) 48 h (hours) dosing."

? It provided monitoring parameters for non-comfort care patients.

? It stipulated that "No additional monitoring indicated unless ordered separately by physician" for comfort care (end of life or terminal) patients.

? Under"Dosage Considerations" it documented that pain relief may not occur for 10 to16 hours and that full effects from the patch may not be seen for 24 to 72 hours after the application of the patch.

? Under"Dosage Considerations" it documented that the dosage should not be increased more frequently than every three days (see fifth bullet above which provides for dose adjustment after 2 days).

Under the "Dosage and Administration" section of the product labeling, the following is documented: "There has been no systematic evaluation of (the fentanyl patch) as an initial opioid analgesic in the management of chronic pain, since most patients in the clinical trials were convereted to (the fentanyl patch) from other narcotics. The efficacy of ... 12 mcg/hr (patch) as an initiating dose has not been determined ...(the fentanyl patch) should be used only in patients who are opioid-tolerant." The use of fentanyl patch in non-opioid tolerant patients is off-label and could expose the patient to the risk of respiratory depresssion.

The boxed warning documents that the use of the fentanyl patch to treat post-operative pain is contraindicated.

There is no provision to exempt terminal, hospice, or end-of-life patients from the requirements documented in the fentanyl patch product labeling.

There is no provision in the product labeling for use in patients who are "approximately" opioid-tolerant: one meets the guidelines of opioid-tolerance or one does not.

There is no provision in the product labeling for changing the dose of the patch after two days. The product labeling documents that the dose may be increased after 3 days of wearing the initial dose based on supplemental use of immediate release narcotics for breakthrough pain during this period. The product labeling recommends that all subsequent dosage increases should not take place more frequently than every six days.

On 8/23/11 at 1:10 p.m. during an interview of Pharmacist H in the pharmacy, she stated she followed the Fentanyl Patch Order Set when dispensing the 12 mcg/hr fentanyl patch. She stated that the 12 mcg/hr patch was one-half the strength of the 25 mcg/hr patch so she would consider use of 30 mg of oral morphine daily for 7 days as establishing opioid-tolerance (this criteria was documented on the order sheet that she referred to during the interview). She stated she used the order set as her guide. She stated that she did not know what a physician would mean if he checked the order set that contained the words "approximately equivalent" and that her interpretation of this may not match that of the physician.

On 8/23/11 at 2:14 p.m. during an interview of Pharmacist I in the pharmacy, she stated that if a patient had taken 30 mg of oral morphine for 7 days and then a physician prescribed a 12 mcg/hr patch, she would consider the patient to be opioid-tolerant for a 12 mcg/hr patch. She stated she used the the Fentanyl Patch Order Set as her guideline.

On 8/23/11 at 3:26 p.m. and on 8/24/11 at 9:48 a.m. during an interview of the Director of Pharmacy, he stated that the Fentanyl Patch Order Set was part of the Policy and Procedure MM 50-710-1 (entitled HIGH RISK/HIGH ALERT MEDICATIONS (HR/HA)). He verified this after viewing both the policy and Appendix A on his compter. He stated that Appendix A was part of this policy and procedure and he pointed out that Appendix A documented: "See Fentanyl Patch Order Set for Pharmacist responsibility" to support his assertion that the Fentanyl Patch Order Set was part of the policy and procedure. He stated that the conversion of 30 to 60 mg of oral morphine in 24 hours applied to both non-comfort care patients and to terminal patients on comfort care. He stated that 30 mg of oral morphine for one day could justify the placement of a 12 mcg patch per the order set. When asked, he stated that "approximately equivalent" meant "reasonably close" to the guidelines (for determining opioid-tolerance) published in a table format on the second page of the order set (a review of which indicated they matched the product labeling guidelines). He could not define what "reasonably close" meant. He stated that he could provide a reference that supported a dosage increase after 2 days (as of the end of the survey, no such reference was provided). With regard to the patient monitoring parameters for non-comfort care patients documented on the form, he stated this was done for all patients whether they were opioid-tolerant or not opioid-tolerant. With regard to comfort care patients, he stated that one physician had told him that comfort care patients would not get the monitoring given to non-comfort care patients because that woud be a higher level of care. He stated that this issue regaring comfort care patient monitoring was not discussed at the HPC meeting: "No one brought that up at all." When the surveyor pointed out the contradiction on the order set between increasing the dose after 2 days versus 3 days as documented on the second page of the order set and when the surveyor pointed out that as written, the dose could be increased every three days even after the first dose increase in the fentanyl patch, the Director of Pharmacy looked up a copy of the product labeling on his computer. He verified that it documened that after the first increase in dose of a fentanyl patch, all subsequent dose changes should only take place after 6 days of wearing the same dosage. He stated he did not have any evidence that supported changing the dose more frequently than every 6 days. He stated that if his staff did not call the physician regarding the placement of a 12 mcg patch that "maybe" they would be carrying out the policy but he stated that his staff would call on all patients.

On 8/24/11 a review of Patient 32's clinical record indicated that she was 85 years old and admitted on 3/30/11 with a diagnosis of pleural effusion (fluid in the space between the the lungs and the body cavity). On 4/2/11 she was placed on comfort care.

A review of the "Reconciliation Home Medication List" contained in her clinical record indicated that Patient 32 had taken 1 to 2 tablets of Norco 5-325 mg orally every 4 hours as needed for pain prior to admission. Norco contains 5 mg of hydrocodone, an opioid pain reliever, and 325 mg of acetaminophen, the active ingredient of Tylenol.

A review of the medication administration records (MARs: used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) contained in Patient 32's clinical record indicated that Patient 32 had taken two tablets of hydrocodone/acetaminophen 5 mg - 500 mg (generic Vicodin) on 3/30/11, two tablets of hydrocodone/acetaminophen 5 mg - 500 mg and 1 mg of intravenous (IV) hydromorphone (generic Dilaudid, an opioid pain reliever) on 3/31/11, two tablets of hydrocodone/acetaminophen 5 mg - 500 mg and 1 mg of IV hydromorphone on 4/1/11, one tablet of hydrocodone/acetaminophen 5 mg - 500 mg and 3 mg of IV hydromorphone on 4/2/11, one tablet of hydrocodone/acetaminophen 5 mg - 500 mg, 4 mg of IV hydromorphone, and 20 mg of oral morphine sulfate on 4/3/11, and one tabet of hydrocodone/acetaminophen 5 mg - 500 mg, 2 mg of IV hydromorphone, and 20 mg of oral morphine sulfate on 4/4/11 before a 12 mcg/hr fentanyl patch was placed on Patient 32 at 12:51 p.m. on 4/4/11. Convering these doses to hydromorphone equivalents, Patient 32 received the following oral hydromorphone doses on the following days:

3/30/11 1.3 mg
3/31/11 6.3 mg
4/1/11 6.3 mg
4/2/11 15.7mg
4/3/11 23.3 mg
4/4/11 13.3 mg

Therefore, Patient 32 had not received enough oral hydromorphone equivalents (8 mg daily for seven days) to be considered opioid-tolerant as documented in the boxed warning.

On 8/24/11 a review of Patient 33's clinical record indicated she was 86 years old and admitted via the Emergency Department (ED) from a local skilled nursing facility with a diagnosis of Cerebral Vascular Accident (a stroke). Her Discharge Summary dictated 5/5/11 documented she had an acute stroke and had severe osteoporosis (loss of bone structure which weakens the bones and can result in painful fractures) with severe chronic pain.

A review of the "Reconciliation Home Medication List" contained in her clinical record indicated that Patient 33 had not taken opioid pain relievers prior to her admission to the hospital.

A review of the MARs contained in Patient 33' s clinical record indicated that Patient 33 had taken no opioid pain relievers on 5/3/11, that Patient 33 had been administered 4 mg of IV hydromorphone on 5/4/11, had been administered 3 mg of IV hydromorphone on 5/5/11, and had been administered 2 mg of IV hydromorphone on 5/6/11 before a 12 mcg/hr fentanyl patch was placed on Patient 33 at 10:51 p.m. She continued to receive 3 mg of IV hydromorphone on after the patch was placed for a total of 5 mg IV hydromorphone administered on 5/6/11. Patient 33 was administered 4 mg of IV hydromorphone and 20 mg of oral morphine sulfate on 5/7/11. Therefore Patient 33 had only received opioid pain relievers for two and one-half days (not seven days as per the product labeling) before a nurse applied the fentanyl patch to her.

A review of the nursing notes contained in the Adult Patient Care Summary for 5/7/11 documented Patient 31 expired at 9:35 p.m. on 5/711. A review of the "Certificate of Death" signed on 5/10/11 by Physician J documented that the "Immediate Cause of Death" was "Respiratory Failure" and that the "Underlying Cause (diseases or injury that initiated the events resulting in death)" was "End Stage Dementia", "Dysphagia", and "Severe Osteoporosis."

Based on foodservice observations, dietary and contract staff interview and dietary document review the hospital failed to ensure safe food handling practices as evidenced by 1) lack of comprehensive cooldown monitoring of potentially hazardous foods; 2) cross contamination during meal delivery ; 3) storage of expired nutritional supplements; 4) lack of comprehensive diet manual to include all diets that are being provided; 5) no preventative maintenance of the ice machines and 6) lack of physician orders for a nutritional supplement for Patient 1 reviewed for nutrition care; 7) lack of documentation that the physician reviewed RD recommendations for Patient 1; 8) lack of the appropriate amount of enteral nutrition (tube feeding) to meet the estimated nutritional needs for Patient 5 ; 9) and lack of timely follow up for Patient 3. Failure to ensure comprhensive dietetic services systems may put patients at risk for foodborne illness. Lack of physicians' orders for supplements may result in lack of physician awareness of patient clinical status.

Findings:

Foodservice

1. During general food storage observations on 8/22/11 beginning at 11 am, it was noted that in the walk-in freezer there were bins filled with individual containers of meat sauce prepared on 7/1 and 8/19/11. It was also noted that there was a second bin that contained individual containers of Alfredo sauce dated 7/2/11, all of which are considered as potentially hazardous foods (PHF). PHF's are those foods capable of supporting the growth of bacteria associated with foodborne illness. PHF's retained for use at a later time must be monitored for cooldown. The standard of practice for cooldown would be to ensure that foods reached 70?F within 2 hours and below 41?F within an additional 4 hours. Foods that do not reach 70?F within 2 hours must be either reheated to 165?F for 15 seconds or discarded (Food Code, 2009).

In an interview on 8/22/11 at 11:45 with DS A, the employee responsible for preparing the meat sauce dated 8/9, the surveyor asked him to describe how, as the cook he would ensure the food was safe to be reserved. He stated that after the item was cooked he cooled it down. He stated that he started the cooldown process when the item was 160?F and that after 2 hours he thought it was 74?F and after an additional 2 hours the temperature was 34?F. He also stated that he wrote the temperatures on the cooldown log. Concurrent review of the hospital document titled "Production and Service Record" dated 8/19/11 failed to document any cooldown entries for the meat sauce. Additional review of the production sheets dated 7/1 and 7/2 failed to document cooldown monitoring of the additional meat sauce or the Alfredo sauce.

In an interview on 8/23/11 at 10:10 am, with Contract Staff (CS) B she stated that on a daily basis a daily walk-through of the kitchen was completed by either the food service manager of the Registered Dietitian (RD). Review on 8/22/11 at 3 pm, in the presence of CS B of the hospital forms titled "Food Safety Daily Walk-Through Checklist" dated 7/1, 7/2 and 8/19 respectively noted that the RD was responsible for evaluating cooldown of potentially hazardous foods; however the RD failed to identify that the observed PHF's were not monitored for cooldown.

2. On 8/19/11 beginning at 12:15 pm, DS C was observed delivering patient meals. She was observed taking the patients' tray from the cart, walking into the room then placing it on the overbed table. She was also observed to frequently touch the patients' overbed table prior to helping him remove the protective covering from the tray and beverages. It was also noted that the patient requested a straw. Prior to leaving the room DS C used a gel hand sanitizer. DS C returned with a straw. She was observed removing the wrapper from the straw and touching the unwrapped end while inserting it into the beverage. DS C again utilized a hand sanitizer prior to leaving the room. There was no use of hand sanitizer prior to entering the room.

Review of hospital policy titled "Hand Hygiene Policy" dated 12/9 revealed that the hospitals' policy guided staff to either use hand sanitizer or hand washing "...before and after routine patient care activities and after hand contaminating activities."

3. On 8/24/11 at 8:50 am, food storage practices were reviewed in the nutrition pantry in the nursing units. It was noted that there was a nutritional supplement that expired on 6/2011. In a concurrent interview with CS C she stated she was unsure whether nursing or dietary staff were responsible for monitoring the nutrition pantry areas. In a follow up interview on 8/24/11 at 9:10 am, she stated dietary services were responsible for monitoring food storage at the nursing units.

4. During initial tour of the kitchen on 8/22/11 at 11:10 a.m., eight- one liter bags of Nutren Pulmonary (tube feeding) were observed in the dry storage area with an expiration date of 8/4/11.

An interview was conducted on 8/22/11 at 1:15 p.m. with Contract Staff B regarding the tube feeding. The Contract Staff B stated a dietary staff maintains the tube feeding products in a first in, first out basis. The staff places an order twice a week on Tuesdays and Thursdays and at this time they should be checking products and should discard expired products at the time. The Contract Staff B stated the tube feeding should have already been discarded once it expired.

5. Review of the hospital diet manual showed to be outdated in terms out current standards of practice. It was not comprehensive and limited number of diets for patients on renal and diabetic diets. The information provided by the diet manual was not descriptive on its use and therefore was not beneficial in determining who the diet was appropriate for. The diet manual had information on diabetic exchange lists for adult men and non-pregnant women which explained diabetic exchange lists and showed references dating from the years of 1988 and 1990. The current standard of practice is the use of carbohydrate counting. The American Dietetic Association discouraged the use of caloric restriction in the treatment of diabetes.

The kitchen was serving diets not available in the diet manual. On 8/22/11 at 11:30 a.m., the patient diet list was reviewed and it showed there was a patient on a 2000 calorie carbohydrate controlled diet (CCD DIABETIC) and another patient on a 2400 calorie carbohydrate controlled diet. These diets were not identified in the diet manual as diets that could be ordered in the hospital. There was no mention of the diet being referred to as CCD DIABETIC or any amounts of calories or carbohydrates for each type of CCD DIABETIC diet the facility provided. The only sample calorie level showed was 1800 calorie diabetic diet.As a result, the list of facility diets for renal and diabetic patients were requested.

Review of the facility diets in the foodservice computer system, showed the following diets were available for patients who may have the diagnosis of diabetes :1200 (calorie) CCD DIABETIC, 1500(calorie) CCD DIABETIC, 1600 (calorie) CCD DIABETIC, 1800(calorie) CCD DIABETIC, 2000 (calorie) CCD DIABETIC, 2200(calorie) CCD DIABETIC, 2400 (calorie) CCD DIABETIC. These diets were available for patients with renal disease: Low Protein 40 grams, Low Protein, Potassium Renal Dialysis, and Renal diets.

Since the diet manual did not provide information on the diet being offered, on 8/22/11 at 2:50 p.m. an interview was conducted with the Registered Dietitian (CONTRACT STAFF G). CONTRACT STAFF G on the two diabetic diets that were observed. She stated that the 2000 CCD DIABETIC diet provided four carbohydrates (one carbohydrate equals 15 grams) at each meal and the 2400 CCD DIABETIC provided five carbohydrates at each meal. CONTRACT STAFF G stated they would provide a bedtime snack that is 2 carbohydrates. CONTRACT STAFF G also stated they are working on a new diet manual and will be implemented once the Contract Staff B gets back from vacation.

Review of the nutrient analysis for the non-select diets (if the patients would not select anything specific from the menu),showed the 2400 CCD DIABETIC diet would provide 1775 calories and 167 grams carbohydrate. This translates to 3-4.5 carbohydrates per meal instead of 5 per meal or 11 per day and as described by the registered dietitian. This diet would provide approximately 625 less calories per day. According to the nutrient analysis, the 2200 CCD DIABETIC would provide 1300 calories and 121 grams carbohydrate. This also translates to 8 carbohydrates per day instead of 12 per day. This is approximately 900 calories less than would have been ordered by the physician.

The 2000 CCD DIABETIC would provide 1300 calories, 80 grams carbohydrate or 6 carbohydrates per day instead of 12 per day as described by the registered dietitian and 700 calories less than was ordered by the physician. Other CCD Diabetic diets (1800 CCD DIABETIC;The 1600 CCD DIABETIC;The 1500 CCD DIABETIC and The 1200 CCD DIABETIC ), showed similar discrepancies between what the diet analysis stated and what the dietitian stated should have been provided.


Review of the nutrient analysis for the non-select renal diets ( if the patients would not select anything specific from the menu), showed the Renal Dialysis diet would provide 1,180 milligrams (mg) sodium, 2,095 mg potassium, 51 grams Protein while the Renal diet would provide 2,836 mg sodium, 2,336 mg potassium, and 37 grams Protein. It was unclear what the difference was between both diets.

Further review of the diet manual, showed there was a protein modified diet for pre-end stage renal disease and that if no protein level was specified, a 40 gram protein diet would be provided initially until the dietitian can properly assess the protein needs of the patient. It showed for the diet for hemodialysis patients, that the diet would need to specify the sodium, potassium and fluid restrictions desired. If a renal diet is ordered, 2 gram (2,000 milligrams) sodium, 2 gram potassium, and 1,500 milliliters fluid would be provided. The information in the diet manual was confusing. The references for the information were dating from the years of 1986, 1987, and 1991.

The hospital diet manual was not comprehensive to include all diets that are being provided by the kitchen. It was outdated and confusing. Staff did not utilize the diet manual in provision of diets. The food provided could have the potential to provide the patients in the hospital with inadequate nutrition which could affect the nutritional status of the patients receiving these types of diets. Patients on diabetic and renal diets had the potential of receiving less calories and nutrients than was ordered by their physicians.The lack of a current and comprehensive diet manual had the potential to result in the provision of inadequate nutrition of the patients receiving these types of diets resulting increased length of stay in the hospital due to poor nutritional status.

6. On 8/22/11 at approximately 2:30 p.m. an interview was conducted with the Contract Staff B regarding the ice machine. The Contract Staff B stated all the cleaning of the ice machines is done by an outside company. On 8/23/11 she provided documentation on the servicing of the ice machines. During the interview was conducted on 8/23/11, at 9:30 a.m., with Contract Staff B, regarding the ice machine, she stated she was unsure how often the contract company comes to clean and sanitize the ice machine.

Review of the ice machine invoices dated 8/26/10 and 7/25/11, showed the ice machine was cleaned and sanitized. Review of the invoices dated 9/3/10, showed the ice maker was down and they replaced the bad parts. Review of the invoice, dated 11/8/10, showed they reset the ice machine and cleared out the coil.

In an interview on 8/23/11 beginning at 9:30 am, with Contract Vendor H, was asked to describe the process for ice machine maintenance. He stated that he checked the air filter every 3-6 months. He also stated that he cleaned the ice holding bin with nu-Calgon sanitizer. He also stated that he would spray a descaler on the ice machine grate after which he would wipe it off. He also stated that he would spray the same sanitizer on the grate. The surveyor also asked if this was the only method of chemical use on the interior of the machine, to which he replied that it was. When asked how frequently he did this, he stated when the food service staff would call him to let him know it needed to be cleaned.

Review of the hospital's policy and procedure titled Ice Machine, dated 6/14/95, revised 1/08 and reviewed 1/11, showed every three months maintenance to clean and sanitize will be done and every six months maintenance to replace the water filter, clean and descaler the water pump, float valve, distribution tube, ice thickness probe and and the evaporator surface. The hospital failed to follow its policy on cleaning the sanitizing the ice machine on a regular basis (every three months). The machines were cleaned only when the outside vendor was called in or when it was being repaired.

Lack of proper cleaning and sanitizing could result in the growth of microorganisms and mold that could result in a water-borne infection for patients who may already be immumo-compromised.

Nutrition Care

1. Patient 1 was admitted with diagnosis including sepsis (an infection in the blood) and diabetes. Admission diet order dated 8/10/11 was NPO (nothing by mouth. Follow up diet orders dated 8/12 was a clear liquid and 8/12 a consistent carbohydrate diet. An admission nutrition screen dated 8/10/1 noted that the patient had decreased intake. A comprehensive nutrition assessment dated 8/12/11 noted that Patient 1 was eating well; however had decreased mental function. She also recommended the diet change to a 2200 calorie consistent carbohydrate diet. Patient 1 was classified at high nutritional risk.

A follow up nutrition assessment dated 8/14/11 at 10:30 am, noted that the patient was eating well. Review of dietary intake from 8/13-8/18/11 (17 meals) revealed that 2 of 17 meals had a recorded dietary intake. It was also noted that the average intake of these 2 meals was 20% per meal. On 8/16/11 nursing staff recorded that Patient 1 was receiving a nutritional supplement; however there was no documented order from the physician for the supplement. It was also noted there was no additional documentation that the RD was notified of the change in the patients' nutritional status.

Review of hospital policy titled "I&O-Intake and Output 24-hour Record" dated 5/11 revealed that while the hospital had a policy that encompassed the recording of fluid intake and output the policy did not address recording of dietary intake. Review of hospital policy titled "Assessment/Reassessment (Patient)-Hospitalwide" dated 5/11 revealed it was the responsibility of the RD to document the "Progress toward nutrition intervention goals ..."

2. Patient 3 was admitted with diagnosis including pneumonia and a stage 3 pressure ulcer. Admission height was 6 feet 1 inch and weight was 166 pounds. An admission nutrition screening dated 6/4/11 demonstrated that the patient was at nutritional risk. Admission diet order dated was an 1800 calorie diet. Additional diet orders were as follows: 6/5/11- regular diet; 6/6/11 2200 calorie mechanical soft diet; 6/8/11-American Diabetes Association diet.

A comprehensive nutrition assessment dated 6/5/11 noted that the patient had poor dietary intake prior to admission and continued to have poor intake; was at high nutritional risk and recommended a nutritional supplement and a multi-vitamin/mineral supplement. A follow up assessment dated 6/6/11 noted that the patient received the nutritional supplement; however there was no indication that the vitamin/mineral supplement was either reviewed or implemented by the physician. The RD documented a goal of dietary intake of 75-100%.

Review of dietary intake from 6/6/11-6/11/11 revealed an average dietary intake of 10% per meal for 12 meals. There was no indication that the RD provided follow up care prior to discharge despite poor dietary intake and classification of high nutritional risk. Review of hospital policy titled "Nutrition Assessment & Reassessment" dated 1/2011 revealed that the purpose of the reassessment is to evaluate the effectiveness and appropriateness of nutrition therapy. While nutritional interventions were implemented on 6/5/11 there was no assessment of the effectiveness of interventions or the development of additional interventions for Patient 3 who had poor dietary intake and required increased nutritional intake related to patients' current condition. In an interview on 8/24/11 at 10 am, with CS D she stated that in recent weeks issues surrounding the delivery of clinical nutrition care were identified and the management contract they would be developing a plan to address them.

3. Review of the clinical record was initiated for Patient 5 on 8/22/11. Patient 5 was admitted to the hospital on 8/10/11 with diagnoses that included Parkinson's disease, dementia, and pneumonia.

Review of the physician's orders dated 8/10/11 at 10:00 p.m., showed an order for gastrostomy tube feeding from 7:00 p.m. until 7:00 a.m. at 80 milliliters (ml) per hour. It did not include the type of feeding. Review of the physician ' s orders dated 8/11/11 at 8:30 a.m., showed the tube feeding was Fibersource and to elevate the head of bed during feeding.

Review of the nutrition assessment dated 8/11/11 at 12:20 p.m., showed the tube feeding being provided was Jevity 1.2 at 80 ml per hour and would provide 1152 calories, 53 grams protein, 774 ml free water. It showed Patient 5 had two stage II pressure ulcers to the coccyx (tailbone) and Patient 5's height was 5'10" and 138 pounds. The estimated nutrition needs were 1570 to 1889 calories (25 to 30 calories per kilogram current body weight), and 94 to 126 grams Protein (1.5 to 2 grams Protein per kilogram). The nutritional diagnosis was increased nutrient needs (protein) related to wound healing as evidenced by two stage II pressure ulcers and wounds to the bilateral extremities per wound care. The RD recommended to change the tube feeding formula to Two Cal HN (two calories per ml and high protein) (7:00 p.m. to 7:00 a.m.) at 75 ml per hour to provide 1800 calories, 75 g Protein and 630 ml free water.

On 8/12/11 the physician order was changed to Two Cal HN at 75 ml per hour from 1900 to 0700. The amount of protein in the tube feeding being infused was less than the recommended estimated protein needs calculated by the registered dietitian. The recommnded protein needs was 94 to 126 gms, the feeding provided 75 grams which is 19 to 51 less grams of protein per day than his assessed needs.

An interview was conducted with the Registered Dietitian (CONTRACT STAFF D) on 8/23/11 at 1:40 p.m. CONTRACT STAFF D stated she changed the tube feeding formula because the family reported the patient was previously on a high calorie formula before coming to the hospital. When asked by the surveyor why the protein needs were not being met by the tube feeding formula recommendation, CONTRACT STAFF D stated she was not aware the protein needs were not being met however they should have been. CONTRACT STAFF D stated she was new to the hospital and was not used to having such a small formulary (list of drugs and tube feeding) to choose from. When asked by the surveyor, CONTRACT STAFF D stated she was not familiar with protein modulars and how to add to tube feeding in order to meet the protein needs of the patient. Review of the hospital formulary at this time, showed there was Resource beneprotein (protein modular) and one scoop or package provides 25 calories and 6 grams of protein. The indications for use shows wound prevention and treatment programs. The addition of a protein modular product will increase the protein content of the feeding.



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Foodservice:

Expired Tube Feeding

During initial tour of the kitchen on 8/22/11 at 11:10 a.m., eight- one liter bags of Nutren Pulmonary (tube feeding) were observed in the dry storage area with an expiration date of 8/4/11.

An interview was conducted on 8/22/11 at 1:15 p.m. with Contract Staff B regarding the tube feeding. The Contract Staff B stated a dietary staff maintains the tube feeding products in a first in, first out basis. The staff places an order twice a week on Tuesdays and Thursdays and at this time they should be checking products and should discard expired products at the time. The Contract Staff B stated the tube feeding should have already been discarded once it expired.

Diet Manual

Review of the hospital diet manual showed to be outdated in terms out current standards of practice. It was not comprehensive and limited number of diets for patients on renal and diabetic diets. The information provided by the diet manual was not descriptive on its use and therefore was not beneficial in determining who the diet was appropriate for. The diet manual had information on diabetic exchange lists for adult men and non-pregnant women which explained diabetic exchange lists and showed references dating from the years of 1988 and 1990. The current standard of practice is the use of carbohydrate counting. The American Dietetic Association discouraged the use of caloric restriction in the treatment of diabetes.

The kitchen was serving diets not available in the diet manual. On 8/22/11 at 11:30 a.m., the patient diet list was reviewed and it showed there was a patient on a 2000 calorie carbohydrate controlled diet (CCD DIABETIC) and another patient on a 2400 calorie carbohydrate controlled diet. These diets were not identified in the diet manual as diets that could be ordered in the hospital. There was no mention of the diet being referred to as CCD DIABETIC or any amounts of calories or carbohydrates for each type of CCD DIABETIC diet the facility provided. The only sample calorie level showed was 1800 calorie diabetic diet.As a result, the list of facility diets for renal and diabetic patients were requested.

Review of the facility diets in the foodservice computer system, showed the following diets were available for patients who may have the diagnosis of diabetes :1200 (calorie) CCD DIABETIC, 1500(calorie) CCD DIABETIC, 1600 (calorie) CCD DIABETIC, 1800(calorie) CCD DIABETIC, 2000 (calorie) CCD DIABETIC, 2200(calorie) CCD DIABETIC, 2400 (calorie) CCD DIABETIC. These diets were available for patients with renal disease: Low Protein 40 grams, Low Protein, Potassium Renal Dialysis, and Renal diets.

Since the diet manual did not provide information on the diet being offered, on 8/22/11 at 2:50 p.m. an interview was conducted with the Registered Dietitian (CONTRACT STAFF G). CONTRACT STAFF G on the two diabetic diets that were observed. She stated that the 2000 CCD DIABETIC diet provided four carbohydrates (one carbohydrate equals 15 grams) at each meal and the 2400 CCD DIABETIC provided five carbohydrates at each meal. CONTRACT STAFF G stated they would provide a bedtime snack that is 2 carbohydrates. CONTRACT STAFF G also stated they are working on a new diet manual and will be implemented once the Contract Staff B gets back from vacation.

Review of the nutrient analysis for the non-select diets ( if the patients would not select anything specific from the menu),showed the 2400 CCD DIABETIC diet would provide 1775 calories and 167 grams carbohydrate. This translates to 3-4.5 carbohydrates per meal instead of 5 per meal or 11 per day and as described by the registered dietitian. This diet would provide approximately 625 less calories per day. According to the nutrient analysis, the 2200 CCD DIABETIC would provide 1300 calories and 121 grams carbohydrate. This also translates to 8 carbohydrates per day instead of 12 per day. This is approximately 900 calories less than would have been ordered by the physician.

The 2000 CCD DIABETIC would provide 1300 calories, 80 grams carbohydrate or 6 carbohydrates per day instead of 12 per day as described by the registered dietitian and 700 calories less than was ordered by the physician. Other CCD Diabetic diets (1800 CCD DIABETIC;The 1600 CCD DIABETIC;The 1500 CCD DIABETIC and The 1200 CCD DIABETIC ), showed similar discrepancies between what the diet analysis stated and what the dietitian stated should have been provided.


Review of the nutrient analysis for the non-select renal diets ( if the patients would not select anything specific from the menu), showed the Renal Dialysis diet would provide 1,180 milligrams (mg) sodium, 2,095 mg potassium, 51 grams Protein while the Renal diet would provide 2,836 mg sodium, 2,336 mg potassium, and 37 grams Protein. It was unclear what the difference was between both diets.

Further review of the diet manual, showed there was a protein modified diet for pre-end stage renal disease and that if no protein level was specified, a 40 gram protein diet would be provided initially until the dietitian can properly assess the protein needs of the patient. It showed for the diet for hemodialysis patients, that the diet would need to specify the sodium, potassium and fluid restrictions desired. If a renal diet is ordered, 2 gram (2,000 milligrams) sodium, 2 gram potassium, and 1,500 milliliters fluid would be provided. The information in the diet manual was confusing. The references for the information were dating from the years of 1986, 1987, and 1991.

The hospital diet manual was not comprehensive to include all diets that are being provided by the kitchen. It was outdated and confusing. Staff did not utilize the diet manual in provision of diets. The food provided could have the potential to provide the patients in the hospital with inadequate nutrition which could affect the nutritional status of the patients receiving these types of diets. Patients on diabetic and renal diets had the potential of receiving less calories and nutrients than was ordered by their physicians.The lack of a current and comprehensive diet manual had the potential to result in the provision of inadequate nutrition of the patients receiving these types of diets resulting increased length of stay in the hospital due to poor nutritional status.

Ice machine

#. On 8/22/11 at approximately 2:30 p.m. an interview was conducted with the Contract Staff B regarding the ice machine. The Contract Staff B stated all the cleaning of the ice machines is done by an outside company. On 8/23/11 she provided documentation on the servicing of the ice machines. During the interview was conducted on 8/23/11, at 9:30 a.m., with Contract Staff B, regarding the ice machine, she stated she was unsure how often the contract company comes to clean and sanitize the ice machine.

Review of the ice machine invoices dated 8/26/10 and 7/25/11, showed the ice machine was cleaned and sanitized. Review of the invoices dated 9/3/10, showed the ice maker was down and they replaced the bad parts. Review of the invoice, dated 11/8/10, showed they reset the ice machine and cleared out the coil.

In an interview on 8/23/11 beginning at 9:30 am, with Contract Vendor H, was asked to describe the process for ice machine maintenance. He stated that he checked the air filter every 3-6 months. He also stated that he cleaned the ice holding bin with nu-Calgon sanitizer. He also stated that he would spray a descaler on the ice machine grate after which he would wipe it off. He also stated that he would spray the same sanitizer on the grate. The surveyor also asked if this was the only method of chemical use on the interior of the machine, to which he replied that it was. When asked how frequently he did this, he stated when the food service staff would call him to let him know it needed to be cleaned.

Review of the hospital's policy and procedure titled Ice Machine, dated 6/14/95, revised 1/08 and reviewed 1/11, showed every three months maintenance to clean and sanitize will be done and every six months maintenance to replace the water filter, clean and descaler the water pump, float valve, distribution tube, ice thickness probe and and the evaporator surface. The hospital failed to follow its policy on cleaning the sanitizing the ice machine on a regular basis (every three months). The machines were cleaned only when the outside vendor was called in or when it was being repaired.

Lack of proper cleaning and sanitizing could result in the growth of microorganisms and mold that could result in a water-borne infection for patients who may already be immumo-compromised.

Nutrition Care:

#. Review of the clinical record was initiated for Patient 5 on 8/22/11. Patient 5 was admitted to the hospital on 8/10/11 with diagnoses that included Parkinson ' s disease, dementia, and pneumonia.

Review of the physician ' s orders dated 8/10/11 at 10:00 p.m., showed an order for gastrostomy tube feeding from 7:00 p.m. until 7:00 a.m. at 80 milliliters (ml) per hour. It did not include the type of feeding. Review of the physician ' s orders dated 8/11/11 at 8:30 a.m., showed the tube feeding was Fibersource and to elevate the head of bed during feeding.

Review of the nutrition assessment dated 8/11/11 at 12:20 p.m., showed the tube feeding being provided was Jevity 1.2 at 80 ml per hour and would provide 1152 calories, 53 grams protein, 774 ml free water. It showed Patient 5 had two stage II pressure ulcers to the coccyx (tailbone) and Patient 5 ' s height was 5 ' 10 " and 138 pounds. The estimated nutrition needs were 1570 to 1889 calories (25 to 30 calories per kilogram current body weight), and 94 to 126 grams Protein (1.5 to 2 grams Protein per kilogram). The nutritional diagnosis was increased nutrient needs (protein) related to wound healing as evidenced by two stage II pressure ulcers and wounds to the bilateral extremities per wound care. The RD recommended to change the tube feeding formula to Two Cal HN (7:00 p.m. to 7:00 a.m.) at 75 ml per hour to provide 1800 calories, 75 g Protein and 630 ml free water.

On 8/12/11 the physician order was changed to Two Cal HN at 75 ml per hour from 1900 to 0700. The amount of protein in the tube feeding being infused was less than the recommended estimated protein needs calculated by the registered dietitian. The recommnded protein needs was 94 to 126 gms, the feeding provided 75 grams which is 19 to 51 less grams of protein per day than his assessed needs.

An interview was conducted with the Registered Dietitian (CONTRACT STAFF D) on 8/23/11 at 1:40 p.m. CONTRACT STAFF D stated she changed the tube feeding formula because the family reported the patient was previously on a high calorie formula before coming to the hospital. When asked by the surveyor why the protein needs were not being met by the tube feeding formula recommendation, CONTRACT STAFF D stated she was not aware the protein needs were not being met however they should have been. CONTRACT STAFF D stated she was new to the hospital and was not used to having such a small formulary (list of drugs and tube feeding) to choose from. When asked by the surveyor, CONTRACT STAFF D stated she was not familiar with protein modulars and how to add to tube feeding in order to meet the protein needs of the patient. Review of the hospital formulary at this time, showed there was Resource beneprotein (protein modular) and 1 scoop or package provides 25 calories and 6 grams of protein. The indications for use shows wound prevention and treatment programs. The addition of a protein modular product will increase the protein content of the feeding.

The hospital failed to ensure one of # patients received the appropriate amount of protein (tube feeding) to meet the estimated nutritional needs of the patient. This has the potential to affect the nutritional status of the patient (Patient 5).

Based on medical record review and nursing staff interview the hospital failed to ensure a comprehensive care plan for 2 patients (Patients 1 and 3) and that fully described all elelments of delivered patient care and failed to identify a change in nutritonal status

Findings:

1. Patient 1 was admitted with diagnosis including sepsis (an infection in the blood) and diabetes. Admission diet order dated 8/10/11 was NPO (nothing by mouth. Follow up diet orders dated 8/12 was a clear liquid and 8/12 a consistent carbohydrate diet. An admission nutrition screen dated 8/10/1 noted that the patient had decreased intake. A comprehensive nutrition assessment dated 8/12/11 noted that Patient 1 was eating well; however had decreased mental function. Patient 1 was classified at high nutritional risk.

Review of dietary intake from 8/13-8/18/11 (17 meals) revealed that only 2 of 17 meals were recorded. It was also noted that the average intake of these 2 meals was 20% per meal. It was also noted there was no additional documentation that the RD was notified of Patients' 1 decreased nutritional intake.

Review of hospital document titled "Interdisciplinary Plan of Care/Discharge Plan" dated 8/11/11 revealed that nursing staff identified 4 care areas of concern. They included the sepsis, fall risk, cellulitis and ineffective coping. There was no care plan developed for Patient 1's diagnosis of diabetes or his high risk nutritional status. It was also noted that the patient goal was documented as "as written" for the identified care areas; however there was no documentation of what those goals might be.

In an interview on 8/23/11 at 1:20 pm, with CS D she stated that the RD's were no documenting nutrition related problems, goals and/or outcomes on the comprehensive patient care plan.

In an interview on 8/23/11at approximately 1:30 pm, with AS E she stated the hospital implemented a new care planning system in preparation for the development of an electronic medical record. She stated that upon admission nursing staff identified care areas. Based on the identified care areas nursing staff would implement the pre-printed clinical practice guideline. She also stated that the goals/outcomes were pre-printed on the multi-page practice guideline; however that guideline did not become part of the permanent medical record.

In an interview on 8/24/11 at 11:30 am, with RN F she stated that the hospital was no longer developing measurable outcome statements as part of care planning. She also stated that on a daily basis nursing would document the patients' response to interventions on the "Adult Patient Care Summary." She further stated that there were no clinical practice guidelines for issues surrounding clinical nutrition care such as poor dietary intake.

Based on the standards for acute and critical care nursing practice, which includes standards of professional performance, the American Association of Critical Care Nurses (2009) guides that standards of nursing practice would include assessment, diagnosis and outcome identification among other elements. The standard for outcome identification would ensure that outcomes are measurable and should include a time estimate for attainment, if possible and that outcomes are documented in a retrievable form (American Association of Critical Care Nurses).

2. Patient 3 was admitted with diagnosis including pneumonia and a stage 3 pressure ulcer. Admission height was 6 feet 1 inch and weight was 166 pounds. An admission nutrition screening dated 6/4/11 demonstrated that the patient was at nutritional risk. A comprehensive nutrition assessment dated 6/5/11 noted that the patient had poor dietary intake prior to admission and continued to have poor intake; was at high nutritional risk and had a recommendation for a nutritional and a multi-vitamin/mineral supplement.

Review of hospital document titled "Adult Patient Care Summary" dated 6/7 and 6/8/11. The RD documented a goal of dietary intake of 75-100% however there was no development of a comprehensive plan on how the desired goal would be achieved or the timeframe for the achievement. It was also noted that there was no care plan developed for Patient 3's pressure ulcer.

Based on the standards for acute and critical care nursing practice, which includes standards of professional performance, the American Association of Critical Care Nurses (2009) guides that standards of nursing practice would include assessment, diagnosis and outcome identification among other elements. The standard for outcome identification would ensure that outcomes are measurable and should include a time estimate for attainment, if possible and that outcomes are documented in a retrievable form (American Association of Critical Care Nurses).

Based on medical record review and nursing staff interview the hospital failed to ensure patient medical records were complete as evidenced by the development of a care planning system that did not document all pertinent information in the medical record. Failure to fully document patient care activities may result in inconsistent nursing care and further compromise clinical condition

Findings:

Patient 1 was admitted with diagnosis including sepsis (an infection in the blood) and diabetes. Review of hospital document titled "Interdisciplinary Plan of Care/Discharge Plan" dated 8/11/11 revealed that nursing staff identified 4 care areas of concern. They included the sepsis, fall risk, cellulitis and ineffective coping. It was also noted that the patient goal was documented as "as written" for the identified care areas; however there was no documentation in the medical record of what those goals might be.

In an interview on 8/23/11at approximately 1:30 pm, with AS E she stated the hospital implemented a new care planning system in preparation for the development of an electronic medical record. She stated that upon admission nursing staff identified care areas. Based on the identified care areas nursing staff would implement the pre-printed clinical practice guideline. She also stated that the goals/outcomes were pre-printed on the multi-page practice guideline; however that guideline did not become part of the permanent medical record.


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