HospitalInspections.org

Based on observation, interview and document review, the Governing Body did not fulfill its responsibilities in the conduct of the hospital as an institution. The following deficient practices were identified:

1 a. Failing to ensure that 6 one-liter bags (on 7 South, Medical Surgical Unit) of sterile water for injection (SWFI, which had intravenous (IV) delivery set ports and looked similar to the IV solutions for hydration and electrolyte replacement such as normal saline (NS) 0.9%, dextrose 5% in water (D5W), etc.) and 11 one-liter bags of SWFI (in 7 North Medical Surgical Unit) were not available for patient use without appropriate safeguards in place to prevent inadvertent administration of the product. Safeguards such as precautionary labels, restricted access, inclusion in high risk policy and procedures, etc. were not implemented and oversight was not provided by the hospital's Pharmacy Department (Refer to A-500).

1 b. Failing to ensure that the hospital did not have pre-drawn Propofol (a medication used to sedate a patient during surgery) and that pre-spiked (opened and prepared to use for a later time) Normal Saline (NS or sodium chloride 0.9 %, an IV fluid) intravenous (IV) solutions were not used beyond one hour of preparation. The hospital's failure had the potential for risk of contamination and IV associated infections for patients (Refer to A-500).

2. Failing to ensure that the Director of Pharmacy (DOP 2) kept an accurate record of the movement of the controlled substance, Morphine (a schedule II - narcotic pain medication with a high potential for abuse), that the Pharmacy had in possession after record of waste was documented in the Pharmacy computer system about eight months ago (refer to A-494).


The cumulative effect of these systemic problems resulted in the possibility of patient harm in a universe of 382 patients and therefore failed to meet the conditions of participation for Governing Body.

Based on observation, interview, and record review the hospital failed to have a well-organized nursing service to provide 24-hour nursing services to all patients by failing to:

1. Ensure that 1 of 86 sampled patients (Patient 50) with a community acquired pressure ulcer (an area of skin that breaks down when constant pressure/with shear and/or friction, is placed against the skin) was identified and assessed in the Emergency Department (ED) on April 24, 2014. This failure had the potential to result in the worsening of the pressure ulcer resulting in negative outcomes for the patient. (Refer to A-395)

2. Develop and implement policies and procedures for the safe handling of enteral feedings (tube feeding in which nutrition is delivered to the patient in a liquid form through a
tube placed through the outer abdomen into the stomach for a gastrostomy tube (G- tube) or passed through the nose and the esophagus to the stomach for a nasal gastric tube (NG tube) ending in the stomach or small intestines). This failure had the potential to result in enteral formulas, with unacceptable levels of bacteria, to be delivered to the patients and result in infections in 32 patients receiving enteral formula feedings (Refer to A 395).

3. Evaluate one of 86 sampled patients (Patient 27) who did not have a bowel movement for 9 days. The physician was not informed of the lack of bowel movement so appropriate interventions could have been ordered. This failure had the potential to result in gastrointestinal symptoms such as nausea, vomiting, abdominal distention, pain and rectal pain or bleeding. (Refer to A 395)

4. Ensure that nursing staff followed the orders of the physician. Two of 86 sampled patients (Patients 39 and 40) were not weighed daily as ordered by their physicians. (Refer to A 395)

5. In the Chemical Dependency Unit, ensure one of 86 sampled patients (Patient 41) was accurately screened to determine nutrition risk and a dietitian referral was made. The lack of accurate nutrition screening and subsequent dietitian referral resulted in a lack of nutrition assessment and possible delay in nutrition interventions that could affect the nutrition status of the patient. (Refer to A 395)

The cumulative effect of these systemic problems resulted in the hospital being unable to provide safe and effective patient care.

Based on interview and record review, the hospital failed to ensure that the registered Nurse (RN) evaluated the care for each patient by failing to:

1. Ensure that 1 of 86 sampled patients (Patient 50) with a community acquired pressure ulcer (an area of skin that breaks down when constant pressure/with shear and/or friction, is placed against the skin) was identified and assessed in the Emergency Department (ED) on April 24, 2014. This failure had the potential to result in the worsening of the pressure ulcer resulting in negative outcomes for the patient.

2. Develop and implement policies and procedures for the safe handling of enteral feedings (tube feeding in which nutrition is delivered to the patient in a liquid form through a tube ending in the stomach or small intestines). The hospital failed to follow manufacturer's guidelines for the length of time the open enteral formula could be hung at the patient's bedside (known as "hang time"). This failure had the potential to result in enteral formulas, with unacceptable levels of bacteria, to be delivered to the patients and result in infections in 32 patients receiving enteral formula feedings.

3. Evaluate 1 of 86 sampled patients (Patient 27) who did not have a bowel movement for 9 days. The physician was not informed of the lack of bowel movement so appropriate interventions could have been ordered. This failure had the potential to result in gastrointestinal symptoms such as nausea, vomiting, abdominal distention, pain and rectal pain or bleeding.

4. Ensure that nursing staff followed the orders of the physician to weight patients daily for 2 of 86 sampled patients (Patients 39 and 40) This failure had the potential to result in inaccurate monitoring of the patient resulting inaccurate care and treatment.


5. In the Chemical Dependency Unit, ensure one of 86 sampled patients (Patient 41) was accurately screened to determine nutrition risk and a dietitian referral was made. The lack of accurate nutrition screening and subsequent dietitian referral resulted in a lack of nutrition assessment and possible delay in nutrition interventions that could affect the nutrition status of the patient.

Findings:

1. During a review of Patient 50's clinical record on April 29, 2014, it noted that the patient arrived at the hospital's Emergency Department (ED) on April 24, 2014, at 4:33 PM. The chief complaints were weakness, fatigue (tired easily) and depression (a state of unhappiness and hopelessness).

A review of a Registered Nurse (RN 42) ED assessment dated April 24, 2014, at 4:50 PM, noted that Patient 50 was awake, lethargic (not easily aroused), oriented to person, place, with slurred (unclear) speech. The assessment indicated that Patient 50's skin was intact and had no pressure ulcers, wounds or skin irritations.

A review of RN 42's ED notes dated April 24, 2014, at 7:15 PM, noted, that RN 43 assumed care of Patient 50 and indicated that the patient had no wounds or skin breakdown.

A review of RN 42's ED assessment dated April 24, 2014, at 7:57 PM, noted, that Patient 50 was incontinent of urine and that the patient's wife reported that he had a dressing on the coccyx region (tail bone). RN 42's documentation indicated that the dressing was placed by a wound care nurse who was providing care to the patient for skin breakdown on the coccyx (tail bone). There was no documented evidence that Patient 50's wound was assessed by RN 42 after it had been reported by the wife that the patient had a dressing on the coccyx.

A review of Patient 50's Medical Doctor (MD I) hospital admission history and physical dated April 24, 2014, at 10:36 PM, noted that Patient 50 had no pressure ulcers on admission and the skin was normal.

A review of the inpatient wound consultation assessment completed by RN 44, dated April 25, 2014, at 11:56 AM, noted: "Wound care consult for pt admitted with pressure ulcer to coccyx (tail bone). Mepilex (an all-in-one foam dressing that effectively absorbs and retains wound fluid (exudate) but keeps the wound sufficiently moist) removed and pt noted to have a 2 x 2 (cm) healing superficial stage III pressure ulcer (full thickness tissue loss) to coccyx ..."

A review was conducted of a Medical Surgical (M/S) Registered Nurse's notes (RN 45), completed on April 25, 2014, at 1:15 AM. RN 45's entry noted under section: "Pressure Ulcer Coccyx Assessment," that Patient 50 had a "Pressure ulcer Stage II..." (partial thickness loss of skin presenting as a shallow open ulcer). RN 45's entry also indicated that the appearance of the pressure ulcer was red, pink and the length was 0.5 centimeter (cm) and the width was 0.5 (cm) {1.5 cm difference in length and width from the assessment that the wound care consultant documented, approximately 1.5 hours earlier the same day}. The entry also indicated that Patient 50's Stage II's pressure ulcer had exudate (drainage), a mild odor and the physician was notified.

A review was conducted with the Director of Emergency Department (DED) of Patient 50's Stage II pressure ulcer photograph, dated April 25, 2014 at 2:36 AM. The photograph was taken on the M/S unit and noted a Stage II pressure ulcer to the coccyx, measuring 0.5 cm in length x 0.5 cm in width.

During an interview on May 6, 2014, at 8:50 AM, with RN 42, he acknowledged and stated that he did not assess Patient 50's pressure ulcer in the ED on April 24, 2014. He stated that he completed a head to toe frontal assessment but did not turn the patient over to check his back side. He stated that his priority was assessing the patient for a stroke (the sudden death of brain cells in a localized area due to inadequate blood flow).

A concurrent review of Patient 50's ED assessment and interview was conducted on May 6, 2014, at 9:10 AM, with the DED (Director of the Emergency Department). The DED acknowledged and stated that the skin assessments completed in the ED by the RNs and the admission history and physical completed by MD I, did not accurately reflect the patient's skin condition/pressure ulcer. The DED further stated that once the pressure ulcer was identified in the ED, an assessment and photographs of the pressure ulcer should have been completed to reflect the pressure ulcer status on admission so that it did not raise questions of whether the pressure ulcer developed or worsened in the hospital.

2 a. During a review of Patient 49's medical record conducted on April 29, 2014, at approximately 4:40 PM, it noted that the patient was admitted to the facility on March 12, 2014. The diagnoses included diabetes mellitus (increased glucose in the blood and acute renal failure (the kidneys were unable to filter waste products from your blood). A review of the physician orders noted the following:

"NPO (nothing by mouth except for tube feeding"
"Tube feeding: Diabeticsource AC (a liquid nutritional formula), goal rate 75 ml/hour (hr), continuous ..."

During an observation of Patient 49's tube feeding on April 29, 2014, at 4:30 PM, with Registered Nurse (RN) 39, assigned to provide care for the patient, the Diabeticsource AC tube feeding was infusing at 75 milliliters (mL) an hour via an open tube feeding system. The hang date on the feeding bag was dated April 28, 2014 at 7:39 PM and approximately 200 mL of feeding remained in feeding bag.

During an interview on April 29, 2014, at approximately 4:30 PM, with RN 39, she confirmed that the current tube feeding bag and tubing were hung on April 28, 2014, at 7:39 PM, almost 21 hours ago. She stated that the feeding bag and tubing were hung and changed by the night shift nurses every 24 hours. RN 39 stated that on April 29, 2014, at approximately 2:00 PM, she added a can of Diabeticsource formula (240 ml) to the infusing formula in the feeding bag. RN 39 was asked if the feeding bag was empty prior to her adding the can of Diabeticsource formula. RN 39 stated that there was about 100 mL of formula remained in the feeding bag. RN 39 further stated that she did not allowed the existing formula to completely infused prior to adding more formula because she did not want air to enter the feeding tube.

A review of the hospital policy titled "Enteral Tube Feeding" (Revision Date: January 2013). The hospital policy noted "Collaborating Department(s) or Committee(s): Registered Nurses, Food and Nutrition Services Personnel, and Pharmacy Personnel." A review of the policy noted, "The feeding bag will be changed every 24 hours and labeled with date, initials, time bag hung, type of formula, and rate of infusion. Maximum amount of formula hung at one time is 4 hours." The policy did not include directions to the staff to rinse the feeding bag at any time during the 24 hours.


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2 b. During a review of the clinical record for Patient 16 on April 29, 2014, the face sheet noted that Patient 16 was admitted to the acute care hospital on September 13, 2014, with current diagnoses that included but not limited to respiratory failure and a percutaneous endoscopic gastrostomy (PEG) tube placement (a surgical procedure in which a tube is passed into a patient's stomach through the abdominal wall).

The "Order History" dated April 28, 2014, noted Patient 16 had a physician's order, dated March 26, 2014, to receive a liquid nutrition formula (Isosource) at a goal rate of 70 milliliters per hour (mL/hr).

During an observation on April 29, 2014, at 1:25 PM, Patient 16 was observed, in his room, receiving a liquid nutrition formula (Isosource), via his PEG tube, at the rate of 70 mL/hr, with an open tube feeding bag system. Observation of the feeding bag showed there was 280 mL of formula in the bag and there was no documented time on the label, to indicate what time the bag had been hung.

During an interview with Registered Nurse 11 (RN 11), on April 29, 2014, at 1:25 PM, RN 11 stated Patient 16's feeding bag had been prepared and hung by a nurse on the night shift. RN 11 stated the feeding bag and tubing should be changed every 24 hours. RN 11 stated she did not know the exact time the feeding bag had been hung and verified there was no documented hang time on the feeding bag label. RN 11 stated that the time the feeding bag had been hung, should be documented on the label. RN 11 verified she did not know this information, and there was no documentation to show exactly when the feeding bag should be changed.

2 c. During a review of the clinical record for Patient 13, on April 29, 2014, the face sheet noted that Patient 13 was admitted to the acute care hospital on April 27, 2014, with current diagnoses that included, but not limited to, clostridium difficile (a highly contagious bacterial infection of the colon that causes inflammation, watery loose stools and dehydration).

The "Order History" dated April 28, 2014, noted Patient 13 had an physician ' s order to receive a liquid nutrition formula (Diabeticsourse) at a goal rate of 50 mL/hr.

During an observation on April 29, 2014, at 1:05 PM, Patient 13 was observed, in his room, receiving a liquid nutrition formula (Diabeticsource), through a nasal gastric tube (a plastic tube inserted in to the patient's nose down into the stomach), at the rate of 50 milliliters per hour (mL/hr), with an open feeding bag system.

Observation of the feeding bag showed there was 200 mL of feeding in the bag and there was not documented time on the label, to indicate what time the feeding bag was changed and hung.

During an interview with Registered Nurse 8 (RN 8), on April 29, 2014 at 1:05 PM, RN 8 stated Patient 13's feeding bag was prepared and hung by a nurse on the night shift, but she did not know the exact time. RN 8 stated that the feeding bag and tubing was changed every 24 hours. RN 8 stated she did not know the exact time the feeding bag had been hung and verified there was no documented hang time on the feeding bag label. RN 8 verified she did not know what time the bag should be changed. RN 8 stated that there should only be enough feeding in the bag to infuse over a 4 hour period of time. RN 8 stated that she had not added any formula to Patient 13's feeding bag, even though there was 200 mL of formula remaining in the bag, infusing at 50 mL/hr. RN 8 stated the time the feeding bag had been hung, should be documented on the label. RN 8 stated there was no documentation in the clinical record to indicate what time the feeding bags were hung, nor was there documentation to indicate when additional formula was added to refill the bags.


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2 d. During an observation on April 29, 2014, at 1:00 PM, Patient 29, was observed to be receiving a gastronomy tube (GT tube, a feeding tube inserted through the skin of the abdominal wall and directly into the stomach) feeding at 35 mL per hour. Patient 29 had been admitted to the hospital, on March 17, 2014, with the diagnoses that included pneumonia (infection of the lungs), stroke (interruption of blood flow to the brain), chronic kidney disease, malnutrition (condition that develops when the body is deprived of vitamins, minerals and other nutrients) and diverticulosis of colon (an abnormal outpouching of the intestinal wall where fecal material can become trapped in the pouch and cause infection).

During an interview with RN 9, caring for Patient 29, on April 29, 2014, at 1:00 PM, RN 9 stated, "The GT feedings are started at midnight by the night shift nurses. The night shift pour enough formula to last throughout the next day. When I got here this morning, at 7:00 AM, this patient's GT feeding bag had 600 mL of formula in it, it has 300 mL of formula left. Her feeding is running at 35 mL an hour. If the formula started to run low, I would pour more formula into the bag on top of what was left in the bag. When we need to add more formula to the feeding bags, we don't take the bag down or rinse it out, we just pour more formula into the bag. The feeding bags are changed once a day by the night shift, unless there is a change in the physician's order. If the physician ordered a different formula, then the nurse would take the old feeding bag down, and hang a new bag with the new order."

2 e. During an observation on April 29, 2014, at 2:45 PM, Patient 30, was observed to be receiving a gastronomy tube (GT tube) at 50 mL per hour. Patient 30 was admitted to the facility, on April 24, 2014, with diagnoses including pneumonia, chronic respiratory failure (a long term condition of the inability of the lungs to diffuse enough oxygen into the bloodstream to meet the body's need), stroke, pressure sore (skin breakdown) to coccyx (tailbone) and malnutrition.

During an interview with RN 11, caring for Patient 30, on April 29, 2014, at 2:45 PM, RN 11 stated, "This GT feeding was started at 4:00 AM, by the night shift nurses. The night shift poured enough formula in the feeding bag for the next day. There is still 400 mL of formula left in her bag. It has been running at 50 mL an hour. If the bag were to start to get low I would pour some more formula directly into the bag. We don't change the bags on this shift, that is done on the night shift. When we need to add more formula we just add it to the bag. We don't pour out the formula that is left in the bag before adding the new formula. The bags are not taken down and rinsed before adding more formula to the bag. We don't have anywhere that we document when we need to add more formula into the feeding bags."


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2 f. A review of the medical record for Patient 19 indicated that the patient was admitted to the hospital on April 20, 2014, with diagnoses that included possible viral encephalitis (an infection in the brain), leukopenia (low white blood cells, the disease fighting cells of the blood) and altered level of consciousness. The physician orders included an order dated April 28, 2014, for a tube feeding of Nutren Pulmonary (a liquid nutritional formula) at 20 mL (milliliters, a measure of volume) per hour (rate of administration).

During an observation on April 29, 2014, at 11:30 AM, in Patient 19's room, a tube feeding bag labeled Nutren Pulmonary (liquid nutritional formula), 20 mL/hour, April 29, 2014, and 0610 (6:10 AM). The bag contained approximately 400 mL of formula.

During a concurrent interview with Registered Nurse 5 (RN 5), Patient 19's nurse, she stated that the usual practice was that the night shift nurses changed the formula bag and tubing every day. She further stated that the night shift nurse added the formula to the enteral formula bag for the day. She stated that the only time she, a day shift nurse, would be required to handle the enteral formula was if the physician's order for the tube feeding changed, requiring a different formula or more formula to be added to the bag. She also stated that the time on the bag in Patient 19's room indicated the time that the formula was poured into the bag and hung at the bedside.

During a concurrent interview with Registered Dietitian 1 (RD 1), Director of Food and Nutrition Services (DFNS) and Assistant Director of Food and Nutrition Services 1 (ADFNS 1), no one was able to state the hospital policy or the manufacturer's guidelines for the hang time of the enteral formula using an open system (using reconstituted powders or ready-to-use liquids poured from the original manufacturer's container into a feeding bag).

On April 29, 2014, at 12:00 PM, the DFNS presented the hospital policy titled "Enteral Tube Feeding" (Revision Date: January 2013). The hospital policy noted "Collaborating Department(s) or Committee(s): Registered Nurses, Food and Nutrition Services Personnel, and Pharmacy Personnel." A review of the policy noted, "The feeding bag will be changed every 24 hours and labeled with date, initials, time bag hung, type of formula, and rate of infusion. Maximum amount of formula hung at one time is 4 hours." The policy did not include directions to the staff to rinse the feeding bag at any time during the 24 hours.

A review of the manufacturer's guidelines provided by the DFNS titled, "Nestle Nutrition, Hang Time: Open and Closed Systems", dated 2010, note, "Higher degrees of contamination have been found in reconstituted formulas and in open systems allowed to hang for extended periods of time (greater than 21 hours)." It further noted, "The A.S.P.E.N. (American Society for Parenteral and Enteral Nutrition) Enteral Practice Recommendations provides the following hang time recommendations: For reconstituted powdered formula or a formula with additives, a 4-hour hang time is recommended; For a commercially sterile,liquid formulas decanted (poured) from a can or brik-pak (similar to a juice box), an 8-hour hang time is recommended. These hang time recommendations assume the formula is kept at room temperature and is subject to minimal handling and manipulation. This information also indicates that the bag and administration set (tubing) should be flushed with water before adding additional formula." It further noted that, "Nestle HealthCare Nutrition follows the hang time guidelines based on best practice."

2 g. A review of the medical record for Patient 20 noted that the patient was admitted to the hospital on April 27, 2014 with diagnosis that included altered level of consciousness. The physician's order included an order dated April 28, 2014, for a tube feeding of Glytrol (a liquid nutritional formula) at 5 mL per hour.

During an observation on April 29, 2014, at 1:10 PM, in Patient 20's room, a tube feeding bag labeled Glytrol, 5 mL/hour, April 29, 2014 at 0000 (midnight) contained approximately 200 mL of formula was observed. The formula was hanging for greater than 13 hours.

During a concurrent interview with RN 6, she stated that she did not add any formula to the tube feeding bag on her day shift. She could not explain why there was approximately 200 mL of formula in the bag when it would take greater than 24 hours to use that much formula.

2 h. A review of the medical record for Patient 26 noted that the patient was admitted to the hospital on April 16, 2014, with diagnoses that included severe sepsis (whole body infection) and respiratory failure (difficulty breathing). The physician's orders noted an order dated April 28, 2014 for a tube feeding of Nutren 1.0 Fiber (a liquid nutritional formula) at 55 mL per hour.

During an observation on April 29, 2014, at 1:15 PM, in Patient 26's room, a tube feeding bag labeled Nutren 1.0 Fiber at 55 mL/hr (no time written on the label) contained approximately 300 mL of formula was observed.

During a concurrent interview with RN 6, she stated that the tube feeding bag did not indicate a time that the bag was hung. She further stated that she usually pours the formula in the tube feeding bag, mixing the older formula with the new formula without rinsing the bag first. She stated that she did not know when the tube feeding formula was hung for Patient 26 since it was not labeled with a time.

2 i. A review of the medical record for Patient 18 noted the patient was admitted to the hospital on April 8, 2014 with diagnosis that included severe sepsis. The physician's orders noted an order dated April 25, 2014 for a tube feeding of Nutren Pulmonary (a liquid nutritional formula) at 40 mL per hour.

During an observation on April 29, 2014, at 1:30 PM, in Patient 18's room, a tube feeding bag labeled Nutren Pulmonary at 40 mL/hr, dated April 29, 2014 at 0100 (1:00 AM) was noted. The bag contained approximately 200 mL of formula.

During a concurrent interview with RN 2, she stated that whenever the formula in the bag got low, she added another (250 mL) container of formula to the bag. She further stated that she added additional formula in the bag without rinsing the bag first. RN 2 stated that she did not document when she added formula to the bag or how much she added. RN 2 stated that the tube feeding bag in Patient 18's room was hung at 1:00 AM, more than 12 hours earlier.

During an interview the the Director of Infection Control (DIC) on April 29, 2014, at 1:45 PM, she stated that her department was not monitoring the nursing practice as it related to tube feedings. The DIC stated she was not aware of the manufacturer's recommendations for no greater than an 8 hour hang time for open systems. The DIC stated that her department was not as involved as they should have been in ensuring the open tube feeding system was handled according to the manufacturer's recommendations. The DIC stated, "The hospital Enteral Tube Feeding policy did not even come through Infection Control."

2 j. Patient 37 was admitted to the hospital on April 13, 2014, with diagnoses including nausea and vomiting, perforated appendicitis. Physician's order included Nutren at 20 ml per hour.

On April 29. 2014, at approximately 2:52 PM, a feeding bag hung was observed in the patient's room with approximately 10 ml of a light brown colored liquid left in the bag. Closer observation revealed a label indicating that the bag was hung "4/29/14 at 0000" . The tube feeding rate was at 20 ml per hour. At the time the observation, the bag had been hung for approximately 15 hours.

In a concurrent interview with RN 12 she indicated that she added approximately 80 cc of formula to make four hours of feeding. She was not sure what time she had added the feeding. A check of the pump that dispenses the feeding showed that information on time and amount poured had not been entered into the machine. She stated also that she knows the feeding bag is changed daily.

3. A review of the medical record for Patient 27 on April 29, 2014 indicated that the patient was admitted to the hospital on April 20, 2014 with diagnoses that included sepsis (whole body infection) due to a urinary tract infection and gallstones. According to the intake and output record for the entire stay, Patient 27 had not had a bowel movement (BM) in 9 days. According to Registered Nurse 1's (RN 1) note dated April 29, 2014, at 11:21 AM, it stated "no BM since admit. No PRN (as needed) laxative or stool softener noted ..."

During an interview with RN 1 on April 29, 2014 at 11:10 AM, she stated that the RNs usually document if a patient has or has not had a BM every shift. When a patient had not had a BM for a few days, the RN would ask the patient what their BM routine was at home (how often they typically had a BM at home). She stated that when a patient has not had a BM for 9 days, "that was a problem."

During an interview with Nurse Manager 1 (NM 1) on April 29, 2014 at 11:20 AM, she stated that the RNs should have been giving a report at the patient's bedside to the next shift RN on how long the patient has gone without having a BM. She stated that she would look in the medical record to determine if the physician had been informed that Patient 27 had not had a BM since admission, 9 days ago.

During a follow-up interview with NM 1 on April 30, 2014 at about 2:30 PM, she stated that there was no documentation that the physician was informed that Patient 27 had not had a BM until it was brought to the RN 1's attention by the surveyor. She stated that the facility did not have a policy and procedure that directed the nursing staff on when to alert the physician for patients that do not have BMs for extended periods of time. She stated that the physician had ordered a CT (computerized tomography - a series of x-ray views taken from many angles and computer processing to create images of soft tissue and bones) of the chest, abdomen and pelvis on April 28, 2014. A review of the order indicated that the reason the test was ordered indicated "elevated LFT's (liver function tests)", not for constipation. NM 1 agreed that there was no evidence that the physician was informed of Patient 27's lack of BM for 9 days.


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4 a. A review of the medical record for Patient 39 indicated that the patient was admitted to the hospital on April 27, 2014 with diagnoses including severe anemia (condition in which there are not enough healthy red blood cells to carry adequate oxygen to the body), edema all over body (swelling caused by excess fluid trapped in body's tissue), diabetes (elevated blood sugar), hypertension (high blood pressure) and pancreatic cancer (cancer of the pancreas). His physician order included 2 gram sodium, low potassium, low phosphorous diet and daily weights.

Electronic medical record review indicated that patient weighed 231 pounds on admission. Evaluating weight is one of the methods the physician would use to evaluate the progress of the treatment of the edema. The only weight that was recorded in the record was on May 4, 2014, Patient 39 weighed 230 lbs. The nursing staff did not weigh the patient for seven days. The hospital provided no explanation as to why the physician's order was not followed.


4 b. A review of the medical record for Patient 40 indicated that the patient was admitted on April 22, 2014 for chemotherapy (a cancer treatment). Her physician orders included regular diet, TPN (Total Parenteral Nutrition - a solution containing nutrients including protein, fat, calories, vitamins, and minerals, is infused over the course of several hours, into a vein) and daily weights.

Electronic medical records review showed that based on her BMI (body mass index) percentile categories she was classified as underweight. BMI is a measure of human body shape based on an individual's weight and height. It "provides a reliable indicator of body fatness for most people and is used to screen for weight categories that may lead to health problems." Further review indicated that the patient had lost greater than 7.5% of her body weight the previous three months. It also showed that weights were recorded sporadic, not daily as was ordered by the physician. There were weights for April 28, 2014 -101 pounds; May 1, 2014- 105 pounds; May 2, 2014 - 107 pounds; May 3, 2014 - 106 pounds; May 5, 2014 - 104 pounds. Patient 40 was not weighed on April 29, April 30 and May 4, 2014.

Evaluating weights was one of the methods the physician would have used to evaluate the effectiveness of diet and TPN treatment to prevent further weight loss. The hospital nursing staff failed to follow the orders of the physician to weigh the patient daily.

5. A review of the medical record for Patient 41 indicated that the patient was admitted to the chemical dependency unit of the hospital on May 1, 2014 with diagnoses including alcoholism, uncontrolled diabetes (elevated blood sugar), COPD (a lung disease), depression and hyperlipidemia (high cholesterol). Her physician orders included an 1800 calorie diet and daily glucose (blood sugar) check.

Review of the electronic medical record showed that Patient 41 was screened by an RN (Registered Nurse) to determine among other issues her nutritional risk. She was documented as 5 feet 10 inches and 154 pounds. The record did not indicate if the documented weight was an actual, measured weight, since 154 pounds was documented as her stated weight. In the History and Physical completed on May 1, 2014, the physician, it documented "recent hypotension (low blood pressure) due to diarrhea and malnutrition". The nursing initial assessment completed on May 1, 2014 stated that Patient 41 stated she had lost 30 pounds in past 6 months. In the section of the assessment titled "Required referral to Dietary/Food/Nutrition", the form indicated "No".

Review of the hospital document titled "Food & Nutrition Services- Patient Priority Visitation Criteria: Adults" showed that Patient 41 would have qualified as Priority I in the priority Level on initial assessment due to her diagnosis of malnutrition. Patients on Priority I classification were to be assessed within 24 hours. Unintentional weight loss of 30 pounds in 6 months and diagnosis of malnutrition would generally result in nutrition assessment by a registered dietitian.

During an interview on May 2, 2014. at approximately 1:00 PM, Assistant Director of Food and Nutrition Services 1 (ADFNS 1) stated that patients in this unit were generally not assessed unless the registered dietitian received a referral for a nutrition consult. RD 2 stated in a concurrent interview that the only intervention provided to patients in the unit was healthy eating classes twice a month.

The lack of referral by the nurse to the dietitian resulted in a delay of nutritional intervention(s) to Patient 41.

Based on record review and interview, the hospital failed to ensure that a signed consent was scanned into the closed record for 1 of 82 patients (Patient 88). This resulted in an incomplete medical record for Patient 88.

Findings:

A review on May 2, 2014, of Patient 88 closed (after discharge/transfer, the hospital has 14 days to ensure that the record was complete) computerized medical record, noted that the patient was admitted to the hospital on August 7, 2013, in cardiac arrest (temporary or permanent cessation of the heartbeat). On August 10, 2013, the patient was pronounced brain dead (irreversible loss of all functions of the brain). The patient was discharged from the hospital and admitted to OneLegacy (an organ procurement entity) for organ donation and recovery. There was no documented evidence in the computerized medical record of a signed consent by the family authorizing the donation of Patient 88's organs/body after death.

A concurrent clinical record review and an interview was conducted on May 2, 2014, at 11:20 AM, with a Registered Nurse (RN 46), in charge of the hospital's organ donation program. After reviewing Patient 88's medical record, RN 46 was unable to locate the signed organ donation consent in the closed computerized medical record. She stated that the consent should have been scanned into the medical record.


During an interview on May 5, 2014, at 2:55 PM, with the Health Information Manager (HIM), she stated that if the consent was received in the scanning department, it would have been scanned into the computerized medical record within 72 hours.

A review of the hospital policy and procedure titled, "Contribution of Anatomical Gift (donation of parts or all of a patient's body after death)", revised March 2010, noted under the section: "Documentation: 2. The completed consent for organ donation (provided by OneLegacy) remains in the patient's medical record."

Based on observation, interview, and record review, the hospital failed to ensure the provision of pharmaceutical services and care met the needs of the patients as evidenced by:

1. The hospital failed to store frozen vancomycin (an intravenous antibiotic to treat serious infections) and lorazepam injection vials (a controlled medication to treat anxiety or seizures) at temperature settings specified by the manufacturers [refer to A-0491].

2. The hospital failed to keep an accurate record of the movement of the controlled substance, Morphine (a schedule II - narcotic pain medication with a high potential for abuse), that the Pharmacy had in possession after record of waste was documented [refer to A-0494].

3. The hospital failed to ensure that 6 one-liter bags of sterile water for injection (SWFI, which had intravenous (IV) delivery set ports and looked similar to plain IV solutions) were not kept on patient care units without appropriate safeguards in place to prevent inadvertent administration of the product. The lack of appropriate safeguards had the potential for SWFI bags to be mistakenly administered intravenously, which could put patients at risk for harm due to hemolysis (breakdown of red blood cells) [refer to A-0500].

4. The hospital failed to ensure that 6 one-liter bags of SWFI solution were not stocked and distributed by the Materials Management Department without the oversight by the Pharmacy Department as per accepted professional guidelines [refer to A-0500].

5. The hospital failed to develop and implement policy and procedures for dosing and monitoring of Heparin (a blood thinner) infusion that ensured consistency with minimal variability in rate of infusion changes and the frequency of monitoring ordered by pharmacists. This failure resulted in delay in reaching the therapeutic goal for Patient 31 [refer to A-0500].

6. The hospital failed to distribute in patient care areas only usable medications in an orderly manner that prevented crowding and could be readily retrieved for administration to patients in accordance with the hospital's policy and procedure [refer to A-0500].

7. The hospital failed to complete the controlled substance use audit of high users with feedback from the nursing managers monthly in accordance with the hospital's policy and procedures [refer to A-0500].

8. The hospital failed to store non-medications away from the medications in the medication refrigerator located in Emergency Department Medication Room in accordance with the hospital's policy and procedures [refer to A-0500].

The cumulative effects of these systemic problems resulted in the hospital's pharmacy inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutory-mandated Conditions of Participation for Pharmaceutical Services.

Based on observation, interviews, and document review, the hospital failed to:

1. Ensure one of two pharmacy freezers containing frozen vancomycin (an intravenous antibiotic to treat serious infections) was set at the temperature range specified by the manufacturer to maintain drug integrity, stability, and effectiveness; and,

2. Ensure lorazepam injection vials (a controlled medication to treat anxiety or seizures) were stored in the refrigerator per manufacturer's specification.

The hospital's failures had the potential to expose patients to the ineffective treatment due to the use of expired and/or less than labeled strength medications.

Findings:1. During a tour of the hospital main pharmacy on April 28, 2014 at 11:25 AM with the Director of Pharmacy (DOP) 1 and Pharmacist 1, three medication freezers were identified, two (Freezers A and B) of which contained numerous counts of frozen vancomycin. Freezer A had a temperature reading of -19.1°C (negative 19.1 degrees Celsius). The vancomycin manufacture storage instructions on the frozen vancomycin indicated to store them at or below -20°C (-4°F), thus, -19.1°C was outside of the manufacturer's specified temperature range. Pharmacist 1 said pharmacy staff were supposed to store frozen vancomycin in Freezer B only, which was designated to store vancomycin.

On April 28, 2014 at 3:40 PM, Pharmacist 1 stated she contacted the Engineering Department and was informed the temperature setting for Freezer A had been set to run between -13°C and -26°C. She and the DOP 1 agreed that setting did not meet vancomycin's manufacture specification for storage of frozen vancomycin.

On April 29, 2014 at 4:50 PM, DOP 1 stated that since the vancomycin in Freezer A had been stored at a higher temperature range than the manufacturer's specified range, they would have been considered stored at a "refrigeration" temperature and therefore, be discarded 30 days from April 19, 2014 (vs. if they were stored at the manufacturer's specified freezing temperatures, which would have been good until manufacturer's expiration date).

The hospital's policy and procedures titled "Medication Storage and Security," dated January 2013, indicated "freezer temperature is less than 5°F (less than -15°C) unless otherwise specified by the manufacturer."

2. A tour was conducted on April 28, 2014 at 4 PM of the hospital's Pediatric Unit in the presence of DOP 1, Pharmacist 1, and Nurse Manager (NM) 5. During a random inspection of the medications in a Pyxis (an automated dispensing cabinet), 12 lorazepam 2 milligrams/milliliter vials, were stored at room temperature. Four of 12 had an expiration date sticker but the other 8 had none. DOP 1 said the "recent direction" from the hospital was to store them in the refrigerator. The manufacturer's storage instruction on the lorazepam vial indicated to keep them in a refrigerator, between 2°C to 8°C. DOP 1 and Pharmacist 1 acknowledged the lorazepam vials were not stored at the temperature specified by the manufacturer.

Based on observation, interview, and document review, the facility failed to keep an accurate record of the movement of the controlled substance, Morphine (a schedule II - narcotic pain medication with a high potential for abuse), that the Pharmacy had in possession after record of waste was documented in the Pharmacy computer system about eight months ago. This failure had the potential for the saved drug (which had been recorded as being wasted), to be used instead of wasted.


Findings:

During a tour of the hospital's Pharmacy Controlled Substance (CS) Room on April 28, 2014 at 11 AM, in the overstock room located inside the CS Room, a black plastic box labeled "Save for [DOP 2]" was found. The box contained an injectable carpuject® syringe containing Morphine 4 mg/ml.

During a concurrent interview, DOP 2 stated that he was saving the syringe because it was opened but then returned it to the pharmacy instead of allowing nursing staff to waste it. He stated that the ED Manager was made aware of the opened CS that was returned for him to investigate.

According to DOP 2, the syringe was not destroyed because he wanted to keep it as physical evidence in case there were any similar incidences that could occur.

During an interview on April 28, 2014 at 11:30 AM, Pharmacist 3 stated that the document in the CII (scheduled II medicines that are very addictive and tightly controlled) safe indicated that there were 2 pharmacists that acknowledged the returned morphine was wasted and stated that she (Pharmacist 3) was one of the pharmacists who acknowledged the waste. She also stated that she gave the syringe to DOP 2, who kept it in the plastic container labeled, "Save for [DOP 2]." As a result of documenting the waste and not actually wasting the syringe, there was a discrepancy of one extra syringe that the Pharmacy could not account for. Furthermore, that saved syringe might end up being used for someone other than it was intended.


During an interview on April, 28, 2014, at 1:10 PM, DOP 2 stated that there was no follow up or further investigation or that he did not send the syringe to the lab to analyze for purity and integrity.

DOP 2 did not clearly state how long he intended to keep the opened morphine syringe which was previously recorded as being wasted and was returned to the pharmacy approximately 8 months ago.

The Pharmacy document titled, "Review Expire, Waste, & Recall Report" was reviewed and it indicated that 2 pharmacists witnessed the Morphine 4 mg/ml carpuject® syringe as being wasted.

The facility's policy and procedure titled, "Drug Disposition, revised date of "10/08" was reviewed, which indicated the following,

"All drugs returned to the pharmacy which are not unit dose, have been opened, and are not pharmaceutically elegant will be deposited in an appropriate pharmaceutical waste container ...

All expired drugs shall be stored in a separate area of the pharmacy in such a manner that they are clearly marked to be returned by our vendor and are segregated from the working inventory ...

Controlled Drugs in Schedules II, III, and IV ...

Destroys the drugs by rendering them unusable and depositing the drug in an appropriate pharmaceutical waste container if appropriate. If such destruction is not appropriate, secures drugs and identifies them to be sent to the reverse distributor for proper destruction.

Documents the destruction of the drugs in the "Drug Destruction Log" indicating the date, the name of the drug, quantity, pharmacist's name and signature and the name and signature of the witness (pharmacist or registered nurse)."

Based on observation, interview, and record review, the hospital failed to control and distribute drugs and biologicals in a safe manner to protect the patient safety when:

1a. 6 one-liter bags of sterile water for injection (SWFI, which had intravenous (IV) delivery set ports and looked similar to the IV solutions for hydration and electrolyte replacement such as normal saline (NS) 0.9%, dextrose 5% in water (D5W), etc.) were available on patient care units without appropriate safeguards in place to prevent inadvertent administration of the product. Safeguards such as precautionary labels, restricted access, inclusion in high risk policy and procedures, etc. were not implemented. The hospital reported the product was intended for Respiratory Therapy (RT) use only. There were no indications the SWFI bags were isolated or designated for RT use only.

1b. Multiple one-liter bags of SWFI solution were stocked and distributed by the Materials Management Department without the oversight by the Pharmacy Department. The lack of appropriate safeguards and pharmacy oversight had the potential for SWFI bags to be mistakenly administered intravenously, which could put patients at risk for harm due to hemolysis (breakdown of red blood cells).
2a. Medications such as IV famotidine (a medication to protect the stomach) ordered for neonatal and pediatric patients were modified to a vial containing 10 milligrams/milliliter (mg/ml). This practice required nursing to calculate and draw up the amount to be given before administration, when they were ordered and should have been dispensed in ready-to-administer syringes, as in accordance with the guidelines from American Academy of Pediatrics.

2b. A review of pediatric records revealed certain pharmacy modified orders had conflicting information, such as having two different medication concentrations and two administration amounts, on the medication administration record (MAR). These practices could result in medication administration errors.

3. The hospital failed to ensure the implementation of policy and procedures for the preparation parenteral (for injection) medications in the anesthesia. Pre-drawn Propofol and pre-spiked NS (or sodium chloride 0.9%) solutions were used beyond one hour of preparation; the pre-spiked NS could be used up to 24 hours. The hospital's failure had the potential for risk of contamination and IV associated infections for patients.

4. The hospital failed to develop and implement policy and procedures for dosing and monitoring of Heparin (a blood thinner) infusion that ensured consistency with minimal variability in rate of infusion changes and the frequency of monitoring ordered by pharmacists. This failure resulted in delay in reaching the therapeutic goal for Patient 31.

5. The hospital failed to distribute in patient care areas only usable medications in an orderly manner that prevented crowding and could be readily retrieved for administration to patients in accordance with the hospital's policy and procedure. This failure had the potential for delay in timely retrieval of medications to administer to right patients the potential for discontinued medications to be administered. This failure could also indicate there were potential issues with the adequate space necessary to provide the pharmacy services in the medication room.

6. The hospital failed to complete the controlled substance use audit of high users with feedback from the nursing managers monthly in accordance with the hospital's policy and procedure. This failure had the potential for the hospital not to be aware of potential issues regarding controlled substance medications which could affect patient safety.

7. The hospital failed to store non-medications away from the medications in the medication refrigerator located in Emergency Department Medication Room in accordance with the hospital's policy and procedure. This failure had the potential for delay in retrieving correct medications

Findings:.

1a. On April 29, 2014 at 8:50 AM, inspection of one medication room at the Seven South (7 South, a medical/surgical unit) Unit was conducted with the Director of Pharmacy (DOP) 1, Pharmacist 1, and Assistant Clinical Director (ACD) 1. Six SWFI bags were identified in the storage area where the plain IV solutions (such as NS 0.9%, D5W, Lactate Ringers, etc.) were stored. One of the SWFI bags was found in the mix of the D5/0.2 NS bags (5% dextrose in 0.2% normal saline, a hydration solution). The SWFI bags looked similar to the plain IV solutions except the SWFI had a small box (about 2.75 x 1.25 inch in size) of red lettering warning on its labeling, which read: "Hypotonic [reduced pressure/tone] and hemolytic [relating to or involving the rupture or destruction of red blood cells]. Do not inject until made approximately isotonic by addition of appropriate solute." The small font warning could easily be blended in with other text and could be overlooked. The SWFI bags were also the same size (1-liter bags), had the same labeling font and the content (colorless solution) of the SWFI bags were the same as the other IV solutions. Furthermore, they had the delivery set ports (adminstration delivery method) that could easily accommodate regular IV tubing and could be mistakenly infused intravenously. When asked what the SWFI bags were for, ACD 1 could not provide an answer.

During an interview on April 29, 2014 at 9:25 AM, the Critical Care Services Director (CCD) said the SWFI bags were used for "high flow oxygen therapy," a non-emergent respiratory therapy procedure which was not used often on the medical/surgical floor.

1b. A tour was conducted on April 29, 2014 at 9:40 AM, of the Seven North (7 North, a medical/surgical unit) Unit with DOP 1, Pharmacist 1, and Nurse Manager (NM 2). found 11 one-liter bags of SWFI stored adjacent to the plain IV solutions in two of two 7 North medication rooms. When asked what they were used for, NM 2 said they were used for flushing feeding tubes. However, Charge Nurse (CN) 2 said that the 11 one-liter bags of SWFI were not for flushing feeding tubes but that they were for mixing medications that were incompatible with NS or D5W. DOP 1, Pharmacist 1 and NM 2, agreed the SWFI bags looked similar to the plain IV solutions and could potentially be overlooked and be administered intravenously by mistake. They said Materials Management (MM) Department supplied the SWFI bags to the patient care units.

During a visit to the MM Department on April 29, 2014 at 11:20 AM with DOP 1, Pharmacist 1, and MM Director (MMD), several boxes of SWFI bags were observed stored on the shelf approximate to the other IV solutions such as NS 0.9%, D5W, D5/0.45%NS, etc. There were no indications the SWFI bags were isolated or designated for RT use only. MMD said the MM Department had supplied SWFI bags to the designated nursing units and others on request basis for years. MMD provided a report that showed four designated patient care units (excluding pharmacies). Another report, provided the same day, showed four additional patient care units (total of eight locations) where SWFI bags were supplied to. Neither of the two reports included 7 South or 7 North, where the SWFI 1-liter bags were found by the surveyor.

On April 29, 2014 at 2:15 PM, an interview was conducted with multiple hospital staff including the Department Administrator of Respiratory Care (DARC), the Chief Nursing Executive (CNE), and DOP 1. The DARC said the SWFI bags were used by RT staff for "high flow oxygen system," a respiratory procedure where the SWFI bag was hooked up to a device called Vapotherm to provide support for patients in respiratory distress. During the interview, CNE, DARC, and DOP 1 acknowledged the potential for harm to the patients if the SWFI solutions were inadvertently administered intravenous and proceeded to remove the bags.


A review of the hospital's policy and procedure titled "High Alert Medication Safety Practices," dated January 2013, reflected no inclusion SWFI as one of the high alert medications, and no oversight by the Pharmacy Department.

The Institute for Safe Medication Practices (ISMP, a nationally recognized organization) wrote the following in its September 18, 2013 Medication Safety Alert:
"In several newsletters (January 22, March 6, March 20, 2003), we've mentioned errors related to the IV administration of sterile water for injection, and the serious patient harm that resulted from hemolysis... We've since learned of a few ways that bags of sterile water could wind up on patient care units, and be mistaken as IV solutions," and, "hospitals have reported concern that any unused or partially used bags of the solution may find their way into IV stock or be hung as an IV solution..."

As a result, ISMP made the following recommendations: "Review the list of items that patient care units can order (or those that are automatically stocked) through purchasing to ensure that there are no pharmaceutical products (including sterile water bags) that can be provided without prior pharmacy agreement and supervision. Also develop guidelines so that purchasing staff understand which items should be considered 'pharmaceuticals' (For example, purchasing staff may not consider plain IV solutions or even over-the-counter medications as 'pharmaceutical' products.) Set up a system to ensure that pharmacy is consulted if substitutions that may involve a pharmaceutical product are needed for backordered or discontinued items. Share reports of this error (and other related errors) with purchasing staff to increase awareness of the potential for these kinds of errors," and, "pharmacists and technicians trained in safe drug storage need to make regular rounds on patient care units (and other departments like respiratory where medications may be stored or given) to assess the storage of medications and solutions. Pharmacy oversight of drug storage can reduce the risk of an error."

In the List of High-Alert Medications, ISMP listed sterile water for injection in bags of 100 ml or more as one of its high-alert medications, those that bear a heightened risk of causing significant patient harm when they are used in error.

2a. During a visit to the main hospital pharmacy on April 28, 2014 at 2 PM, an interview with DOP 1, Pharmacist 1, and Pharmacist 2 revealed the pharmacy had been auditing the modified weight-based orders for patients in the Pediatric Intensive Care Unit (PICU) since February 2014. The March 2014 audit reflected a total of 54 modified weight-based orders, 17 (or 31%) of which were modified famotidine (a medication to protect the stomach) orders. Following certain specific conditions, the hospital policy allowed pharmacists to modify a provider's order entry, such as changing product dosage form (liquid vs. tablet), drug delivery system (syringe vs. minibag), etc.

A review of one of the patients (Patient 63) listed on the March 2014 audit reflected Patient 63 was a two-month old, 3.91 kilograms (kg) patient admitted to the PICU for pneumonia. Patient 63 was transferred to the Pediatrics Unit before being discharged. On March 2, 2014, the physician ordered famotidine 0.5 mg/kg/24 hours, to be given every 12 hours in a syringe of 2.44 ml of normal saline, at a concentration of 0.4 mg/ml. By calculating the weight-based dosing multiplied by the patient weight, each dose turned out to be 0.98 mg.

The record showed the pharmacy modified the order to have the famotidine drawn from a vial containing 20 mg (2ml of 10 mg/ml), which was available in the Pyxis (an automated dispensing cabinet located in each nursing unit). As a result, the nursing staff had to draw up the amount of 0.98 mg from the 20 mg vial. The calculated amount was 0.098 ml (less than 0.1ml). The record showed Patient 63 received 17 doses of famotidine during this stay.

On April 28, 2014 at 4:30 PM in the presence of DOP 1 and Pharmacist 1, a recurrent interview and review of Patient 63's electronic medical record (eMR) was conducted at the Pediatrics Unit with NM 5, the Clinical Nurse Specialist (CNS), and a PICU nurse (RN 37, who reportedly gave a famotidine dose to the Patient 63 during her stay). When asked how famotidine was given to Patient 63, NM 5 and CNS said it was given by infusion but they were uncertain, given the amount was miniscule (very small). RN 37 said she did not remember and stated, "I think the pharmacy sent the syringe." When RN 37 was informed that the pharmacy did not send the syringe, RN 37 said she must have used the 1-ml syringe and drew up a tiny amount (0.098ml) to give to the patient. DOP 1, Pharmacist 1, and the present nursing staff acknowledged that this practice had caused confusion and presented a potential for administration errors for patients.

The American Academy of Pediatrics, in a Policy Statement titled "Prevention of Medication Errors in the Pediatric Inpatient Setting," dated August 2003, wrote the following under Pharmacy Actions and Guidelines:
"Dispense medication in a timely fashion using a unit-dose, ready-to-administer form whenever possible."

2b. On April 30, 2014 at 1:45 PM, a review of three PICU eMRs from the March 2014 modified weight-based order audit (as mentioned above) with Pharmacist 1 and Pharmacist 2 revealed certain modified orders had two different medication concentrations and two administration amounts on the medication administration record (MAR).

Patient 72 had an order for hydralazine (for high blood pressure) 0.1 mg/kg/dose x 16.8 kg (patient weight); this equaled 1.68 mg per dose. The original order was to give 1.68 ml (or 1.68 mg) of 1 mg/ml. The modified order by pharmacy was to give 0.084 ml (or 1.68 mg) of 20 mg/ml. The record showed both directions (amount and concentration) appeared on the MAR.

Similarly, Patient 73 had an order famotidine 0.5 mg/kg/24 hours (given every 12 hours) x 16 kg (patient weight); this equaled 3.75 mg per dose. The ordered direction was to give 3.75 mg of famotidine in 9.375 ml of NS to make a concentration of 0.4 mg/ml. The modified version instructed to give 0.375 ml (or 3.75 mg) of the 10 mg/ml. Both directions appeared on the MAR. Both Pharmacist 1 and Pharmacist 2 acknowledged this practice could cause confusion for the nursing staff and could lead to instructions to be misread, resulting in administration errors.

On May 1, 2014 at 5:20 PM, during an interview with a PICU nurse (RN 38), when shown Patient 72's hydralazine and Patient 73's famotidine directions on the MAR, RN 38 agreed the way they were presented on the MAR could be confusing for nursing staff and presented a potential for medication administration error.

3. Under Standard Operating Procedures, the hospital policy and procedure titled "Intravenous Admixture Process and Sterile Compounding Preparations," dated January 2013, indicated: "Single dose containers (vials, bags, bottles opened or needle punctured) in less than ISO class 5 air quality shall be used within one hour." ISO (International Organization for Standardization - the worlds largest developer of International which provides state of the art specifications for products, services and good practice) class 5 environment is defined as a "critical area," such as the IV hood (where sterile IV medications are prepared), where air flow is unidirectional, and the air quality would normally yield no microbiological contaminants.

On May 1, 2014 at 10:30 AM, during a visit to the Operating Room with DOP 1, Pharmacist 1, and the Assistant Director or Anesthesia (ADA), random inspection of the Pyxis in one OR suite found a pre-drawn syringe of Propofol (IV medication for sedation during a procedure); its label indicated it was drawn on May 1, 2014 at 9:10 AM. ADA explained that the practice had been that the anesthesiologist would draw up the Propofol (from a single dose vial) into the syringes in the OR suite label them, and they would be good for six hours. Thus, the medication was drawn up in the non-ISO Class 5 (an ISO Class 5 environment is required for the compounding {mixing} of patient preparations), environment and was kept for use longer than 1 hour from preparation, contrary to the hospital policy

On May 1, 2014 at approximately 11 AM, a visit to the Anesthesia Workroom with DOP 1, Pharmacist 1, and ADA found eight IV sodium chloride 0.9% (NS) bags hanging on two IV poles (each pole had multiple hooks) at room temperature. ADA explained they were set-ups called "A-line"(arterial line, to replace fluids) and "hot-line" (to infuse warm fluid into body to help warm the patient). Each NS bag was pre-spiked (pre-attached with appropriate IV tubing and pre-primed) in the Anesthesia Workroom in anticipation of use. She stated the NS bags were normally set up in the morning and left hanging on the IV pole until needed, and if unused, would be discarded at the end of the day. ADA stated this set-up could be good for 24 hours. The label on each bag's tubing indicated they were prepared on May 1,2014 at 5 AM, and to be discarded the next day. ADA stated this practice had been in place for at least three years.

On May 1, 2014 at 4:10 PM, during an interview in the presence Pharmacist 1, and ADA, DOP 1 agreed using pre-drawn Propofol and pre-spiked NS IV solution beyond one hour was in accordance with the the hospital policy and procedures, and presented a potential risk for contamination of the prepared products.

The manufacturer's prescribing information for Propofol indicated it was a single-use parenteral medication, and not an antimicrobially preserved product (preservatives put into products to kill or prevent the growth of microorganisms) under USP Standards (U.S. Pharmacopeia - the official list of medicinal drugs of the United States that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide).

The manufacturer's prescribing information for sodium chloride 0.9% injection indicated it was a solution for fluid and electrolyte replenishment in single dose containers for IV administration. It contained no bacteriostatic or antimicrobial agents for the inhibition of microbial replication (agents used to limit the growth of bacteria).

The Centers for Disease Control and Prevention (CDC) indicated medications that lack antimicrobial preservatives can become contaminated and serve as a source of infection when they are used inappropriately.

During an interview on May 2, 2014 at 10 AM, DOP 1 and Pharmacist 1 said they were not aware of the A-line and hot-line set up practice.

On May 2, 2014 at 10:20 AM, the Department Administrator of Anesthesia (DAA) confirmed the hospital's practice had been in place for at least three years. She said there were no hospital policies and procedures that were specific to the practice of A-line/hot-line set up, and said, "We follow pharmacy policy and procedures."



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4. During a review of Patient 31's electronic Medical Record (eMR) on May 1, 2014, the following was noted:

There was a physician order dated April 27, 2014 at 7:40 PM, for Heparin (injectable blood thinner) per Protocol (a system of rules that explains the correct conduct and procedures to be followed) that was started on April 27, 2014 at 7:45 AM.


Pharmacist 6 initiated the per protocol order with a bolus (a large dose of a substance given by injection for the purpose of rapidly achieving a needed therapeutic concentration in the bloodstream) of Heparin 5000 units and infusion started thereafter with 800 units per hour to start at 8 PM.

The Heparin infusion was started on April 27, 2014 at 8:48 PM at 800 units per hour according to the electronic Medication Administration Record (eMAR).

The Heparin infusion rate was changed by Pharmacist 7 on April 28, 2014 at 6:04 AM to 1000 units per hour according to the eMAR for the corresponding aPTT (activated prothrombin time, a measure of blood clotting time (with the normal range between 25 to 35 seconds)of 44 seconds.

The Heparin infusion rate was changed again by Pharmacy 8 on April 29, 2014 at 6:31 AM to 1100 units per hour according to eMAR for the corresponding aPTT of 50 seconds.

There was an aPTT of 106 seconds on April 30, 2014 at 3 AM according the eMAR.

The Heparin infusion was discontinued on April 30, 2014 at 9:36 AM.

The Platelet Count (a laboratory test to measure blood clot with the normal range of 150 to 450 x1000) was trending down from 149 on April 27, 2014 to 68 (below normal range with significant delay clot formation to stop bleeding) on April 30, 2014 at 3 AM.

Facility's policy and procedure titled, "Inpatient Pharmacy Anticoagulation - Heparin" was reviewed and it indicated,

"...Policy Statements:
The Inpatient Pharmacy Department will monitor all patients receiving Heparin per Pharmacy. This will include the screening of initial orders and review of concurrent/interacting medications per the guidelines contained herein. These monitoring activities, as well as other objective data regarding the patient's status will be recorded in the "Doc Flowsheets" contained within the patient's electronic chart...

Provisions/Procedure:
Pharmacist Specialist to order STAT aPTT, PT/INR and CBC, NO DIFF (if not already done) for baseline data ...

Pharmacist Specialist to collect and evaluate the following baseline data that may be used to adjust initial and subsequent doses...


Pharmacist Specialist shall adjust heparin therapy to within this therapeutic goal unless specified otherwise by the physician.

Adjustment of initial infusion rate:
CONSIDER empirically (derived from or guided by experience or experiment) reducing heparin rate by 20% for patient's age > 70 ...
If initial INR is 1.1-1.3 = give 80% of initial calculated heparin rate ...
NOTE: These are empiric adjustments ...

For PE patients who might not have received optimal initial heparin therapy, CONSIDER re-bolusing and increasing the infusion rate prior to the result of the first aPTT result...

After infusion rate change, aPTT MAY be repeated in 4-6 hrs if clinically indicated
NOTE: The above rate adjustments are GUIDELINES ONLY and MAY NOT apply in some cases. The Pharmacist Specialist shall USE CLINICAL JUDGMENT ..."

From the above policy and procedure the following issues were identified:

· Baseline data were to be collected but the pharmacist may or may not use the data.
· Empirically (derived from experience) reducing heparin rate by 20% for patient's age > 70 was to be considered but not required.
· For PE patients who might not have received optimal initial heparin therapy, re-bolusing and increasing the infusion rate prior to the result of the first aPTT result was to be considered but not required.
· Order aPTT for 8 hours after the heparin infusion is started if a bolus is given. If a bolus is not given, aPTT SHOULD (but not required) be ordered at 6 hours after starting the heparin. Daily aPTT and PT SHOULD (but not required) be ordered for all heparin infusion.
· After infusion rate change, aPTT may be repeated in 4-6 hours if clinically indicated. The policy again does not require a pharmacist to order aPTT and does not clearly define when it is clinically indicated to order aPTT by a pharmacist.
· The above rate adjustments are GUIDELINES ONLY and MAY NOT apply in some cases. The Pharmacist Specialist shall USE CLINICAL JUDGMENT which leads to the question, why do you have the guideline, a rule or instruction, in the protocol, when the pharmacist specialist can use his clinical judgment?
· Pharmacist Specialists are only required in the policy and procedure to use his or her sound clinical judgement in changing rate and ordering aPTT however they want whether they may or may not have used his or her sound clinical judgment back by evidence-based standards of practice.
· The policy and procedure is a guideline only and by not using prescriptive language, pharmacists don't have to follow the policy and procedure.

To illustrate the variability (differences) of pharmacist's clinical judgment, the following interviews were conducted:

On May 1, 2014, at 5 PM, Pharmacist 6 stated that after the Heparin rate change she would order an aPTT 4 hours after the rate change.

On May 2, 2014, at 9:57 AM, Pharmacist 2 stated that after the Heparin rate change, she would have no problem ordering aPTT 24 hours after the rate change.

On May 2, 2014, at 10:10 AM, Pharmacist 5 stated that after the Heparin rate change, he would have ordered aPTT 6 hours after.

Review of the Patient 31's eMR indicated the patient was admitted with the diagnosis that included acute renal (kidney). The eMR also indicated that Pharmacist 7, following the initial rate determined by Pharmacist 6, did not follow the dosing adjustment guideline for Heparin but Pharmacist 8 did. Both Pharmacists ordered daily aPTT after the rate change. As a result of the daily monitoring of aPTT, the therapeutic goal for Heparin was not reached even after 3 days when aPTT resulted to 106 seconds, almost twice the therapeutic goal.

During an interview, Pharmacist 2 and Pharmacist 5 were not able to explain the reason for not following the guidelines and for ordering daily aPTT after rate adjustment.

During an interview with Pharmacist 6 on May 1, 2014 at 5 PM, she stated that there was no baseline aPTT for Patient 31.

The review of the Patient 31's eMR did not show documented evidence that the target therapeutic range or goal for heparinizing patient was reached even after 3 days with the aPTT resulting to 106 seconds (almost twice the therapeutic goal per the facility's guideline) while being unmonitored for 24 hours.

According to "Antithrombotic Therapy for Venous Thromboembolic Disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)", published in Chest Journal in 2008 by Jack Hirsh, CM, MD, FCCP; Robert Raschke, MD, MS:

"The starting dose of IV UFH (Unfractionated Heparin) for the treatment of DVT (Deep Vein Thrombosis or blood clot) is either of the following: (1) a bolus dose of 5,000 U, followed by a continuous infusion of at least 30,000 U for the first 24 h; or (2) a weight-adjusted regimen of a 80 U/kg bolus, followed by 18 U/kg/h. With both of these regimens, the infused dose of UFH should be adjusted using a standard nomogram to rapidly reach, and maintain, the APTT at levels that correspond to therapeutic heparin levels."

According to Lexicomp online, a well-known pharmacy drug reference used by the hospital, indicated:

"Dosing: Adult...
Check aPTT every 4-6 hours..."

5. During a tour and inspection of the hospital's Intensive Care Unit (ICU) Medication Room on May 1, 2014 at 10:30 AM, it was noted that there was a red bin containing eleven patient's medications that were mixed together which included Diprivan (drug used for sedation) for 2 patients, Ofirmev (pain medication) for two patients, and Precedex (drug used for sedation) for 2 patients.

Also observed was a patient-specific 50-ml pre-mix infusion IVPB containing KCl (potassium chloride, an electrolyte supplement important for maintaining correct heart rhythm) 20 MEq that was discontinued on the morning of April 30, 2014, mixed with other usable medications in the bin.

During a concurrent interview, Pharmacist 5 stated that the medications that were place in the red bin were non refrigerated IVPBs and bulky items that did not fit inside the patients' cassettes. He added that the available space in the Medication Room could be an issue and acknowledged that storage of patient specific meds were disorderly and would be difficult for nurses to be able to find the medications they needed for patients.

"Medication Storage and Security"

The hospital's policy and procedures titled "Medication Storage and Security," indicated, "Medications will be stored in an orderly manner, in adequately lighted cabinets, shelves, drawers or carts of sufficient size to prevent crowding and excessive light exposure."

6. The facility's policy and procedure titled, "Automated Dispensing Machine (Pyxis): Controlled Drug Accountability" was reviewed and it indicated,

"Anomalous Usage Reports

The Inpatient Pharmacy Director, or designee, will provide anomalous usage reports to the nursing and department managers monthly for review.

The nursing managers will review narcotic utilization for any staff member whose usage is outside the upper limit of the range established by the report.

The inpatient Pharmacy Director, or designee, will provide a user-specific "drill-down" report (a more detailed report showing access of all controlled substances for each staff to help the Pharmacy and the Nursing Clinical Managers review and analyze for identifiable patterns of abuse or misuse) for the nurse manager, as requested, as an aid in the investigation."

During an interview on April 30, 2014, 2:30 PM, DOP 2 stated that monthly Pandora (a pharmacy-specific, third party analytic tool that searches for patterns of medication diversion and allows for on-demand access of information, as well as automatic alerts) reports that analyzed the use of controlled substances and identified high users compared to their peers were generated and emailed to the clinical managers of the nursing units.

DOP 2 stated that the "fingerprint" or "drill-down" report, to look even more closely at the activities (Pyxis access for every controlled substances) of each individual on the monthly Pandora report, would be attached to the email sent to the clinical managers monthly.

DOP 2, however, stated that he did not receive any feedback communication from the managers so he did not know whether or not there were issues or unusual findings after investigation, or the reports were even reviewed and investigated at all by the managers.

DOP 2 stated that he did not receive any response from the managers to whom the emails were sent for the month of February and January 2014, and December, November, October, and September 2013.

DOP 2 added that the Pharmacy audited on its own high users of controlled substances that appeared on the monthly Pandora report for 3 consecutive months in the event that the Pharmacy did not receive the feedback from the clinical managers.

The facility's policy and procedure titled, "Automated Dispensing Machine (Pyxis): Controlled Drug Accountability" was reviewed, which indicated,

"The nurse managers or designee shall report their findings/actions to the Inpatient Pharmacy Director after receiving the drill-down report."

7. During a tour of the Emergency Department (ED) on April 29, 2014, at 2:50 AM, there was a medication refrigerator in the Medication Room that contained following testing agents:

One Universal Viral Transport for Viruses, Chlamydiae, Mycoplasmas, and Ureaplasmas (micro-organisms that cause serious infections).

One ESwab Collection and Transport System (collecting tubes that keep alive collected micro-organisms for transport and testing).

Two boxes of MAS US Control Liquid Assayed Urinalysis Control (quality control solution used to monitor urine dipstick).

During a concurrent interview, RN 35 and the DOP 2 indicated that they were not medications and acknowledged that they were stored in the same medication refrigerator along with medications.

The facility's policy and procedure titled, "Medication Storage and Security" was reviewed and it indicated,

"Medications, reagents and chemicals shall be segregated and stored to promote safe medical practices ...

Test agents, disinfectants, germicides, and other housekeeping products shall be stored separately from medications."

Based on observation, interview, and document review, the hospital failed:

1. To ensure intravenous (IV) medication expiration dating was consistent;

2. To ensure compounded medications were labeled with an expiration date;

3. To ensure pharmaceuticals removed from the manufacturer's protective overwrap had an expiration date from removal date; and

4. To ensure unusable medications were not available for patient use.

5. To ensure that a used vial of midazolam (a medication used for sedation and for reducing pain), which was not ordered by the patient's physician, was not left in the patient's medication cassette drawer.

The hospital failures had the potential for patients to receive expired or less than labeled strength medications and also had the potential for patients to receive medications that were not intended for the patient.

Findings:

1. A tour was conducted of the main pharmacy's Intravenous (IV) Room with the Director of Pharmacy (DOP) 1 on April 28, 2014 at 12:30 PM. During the tour, multiple pre-mixed IV bags were found in the medication refrigerator and on the medication cart with two expiration dates. One IV bag contained an expiration date on a small sticker affixed to the bag, the second expiration date was printed on the pharmacy label and the two dates did not match. The sticker that was affixed to the IV bag indicated that the IV bag expired on May 23, 2014, while its pharmacy label reflected that it expired on May 26, 2014. DOP 1 agreed that the expiration date labeling had conflicting expiration dates, which would lead to confusion for the user (i.e. nursing staff), and had the potential for the medication to be used beyond its true expiration date.

During an inspection of one of the medication rooms at the Seven North Unit (7North, a Medical/Surgical Unit) in the presence of DOP 1 and Charge Nurse (CN) 2 on April 29, 2014 at 10:10 AM, four IV bags contained two conflicting expiration dates. CN 2 was asked when the IV bags would expire, she responded with the expiration date printed on the pharmacy label. When shown that the sticker had a shorter expiration date than the one on the pharmacy label, she said she would use whichever was shorter. The DOP and CN 2 acknowledged it was confusing to have two expiration dates on one product.

2. During the same visit to the 7North Medication Room on April 29, 2014 at 9:30 AM in the presence of DOP 1 and Pharmacist 1, two compounded (mixed) acyclovir (an antiviral medication) IV bags were found in the medication refrigerator without an expiration date. Pharmacist 1 said the pharmacy staff failed to put an expiration date on the pharmacy label before dispensing the medication.

The hospital policy and procedures titled "Medication Labeling," dated May 2012, indicated, "Medications shall be properly labeled" and "all medications prepared in the hospital are correctly labeled with... expiration date when not used within 24 hours."

3. On April 29, 2014 at 3:10 PM, during a visit to the Emergency Department (ED) with DOP 1, Pharmacist 1, and Assistant Clinical Director (ACD) 2, two IV solution minibags of D5NS (dextrose 5% in normal saline, for mixing with medication to deliver via infusion) were found without the overwrap and without a labeled expiration date. When asked about the labeled expiration date, ACD 2 said the product was good till the manufacturer's expiration date on the bag. Pharmacist 1 said they were only good for 14 days outside of the overwrap.

The U.S. Food and Drug Administration documented the following in the Patient Safety News, dated December 2003, Show #22:
"Once IV bags are removed from their overwraps and exposed to room air, the rate of evaporation increases. And over time, the drug's concentration will increase because the amount of drug in the bag stays the same while amount of fluid decreases...Manufacturers do have recommendations on how long an IV bag can be used after the overwrap is removed,...Some companies say that certain bags should be discarded after several days if they don't have an overwrap...The time span depends on the material used for the IV bag, the volume of solution, and drug in the solution."


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4. During a tour of the hospital's Pharmacy's IV (intravenous) Room, a place sterile medications are made for injection to patients by vein, on April 28, 2014 at 3:20 PM, eleven 10-ml injectable vials of Sodium Phosphate (electrolyte supplement) were identified as past the expiration date on the vials labeled with "Discard after 4/26/14."

During a concurrent interview, the DOP 2 and Pharmacist 4 acknowledged that the vials were expired two days ago and should have been removed.

The facility's policy and procedure titled, "Drug Disposition" was reviewed and it indicated,

"All expired drugs shall be stored in a separate area of the pharmacy in such a manner that they are clearly marked to be returned by our vendor and are segregated from the working inventory."

5. During the inspection of the Medication Room of the ICU (Intensive Care Unit) on May 1, 2014 at 10 AM, it was noted that there was a vial of midazolam 2mg/ml vial with 0.2 ml of residual left in the vial that was left in the patient's cassette drawer along with other medications for the patient.

During a concurrent interview, RN 36 was not able to determine, after her investigation, why the used vial of midazolam was placed in the patient's cassette since there was no physician order for that patient to receive that medication.

During a concurrent interview, Pharmacist 5 acknowledged that the vial should not have been inside the patient's cassette and that it should have been discarded.

The facility's policy and procedure titled, "Drug Disposition" was reviewed and it indicated,

"All expired drugs shall be stored in a separate area of the pharmacy in such a manner that they are clearly marked to be returned by our vendor and are segregated from the working inventory."

Based on review of electronic medical record, hospital documents and staff interviews, the hospital failed to ensure that one sampled patient was properly screened to determine her nutritional risk. Errors in screening result in lack of nutritional assessment and possibly delay nutrition therapy that could affect the nutrition status of one of 86 sampled patients (Patient 41).

Finding:

A review of the medical record for Patient 41 indicated that the patient was admitted to the chemical dependency unit of the hospital on May 1, 2014 with diagnoses including alcoholism, uncontrolled diabetes (elevated blood sugar), COPD (a lung disease), depression and hyperlipidemia (high cholesterol). Her physician orders included 1800 calorie diet and daily glucose check.

Review of the electronic medical record showed that Patient 41 was screened by an RN (Registered Nurse) to determine among other issues her nutritional risk. She was documented as 5 feet 10 inches and 154 pounds. The record did not indicate if the documented weight was an actual, measured weight, since 154 pounds was documented as her stated weight. In the History and Physical completed on May 1, 2014, the physician documented " recent hypotension due to diarrhea and malnutrition " . The nursing initial assessment completed on May 1, 2014 states that Patient 41 stated she had lost 30 pounds in past 6 months. In the column about " Required referral to Dietary/Food/Nutrition " , the admitting nursing indicated " No " .

Review of the hospital document titled " Food & Nutrition Services- Patient Priority Visitation Criteria: Adults " showed that Patient 41 would have qualified as Priority I in the priority Level on initial assessment due to her diagnosis of malnutrition. Patients on Priority I classification were to be assessed within 24 hours. Unintentional weight loss of 30 pounds in 6 months and diagnosis of malnutrition would generally result in nutrition assessment by a registered dietitian.

On May 2, 2014 at approximately 1:00 PM, Assistant Director of Food and Nutrition Services 1 (ADFNS 1) stated that patients in this unit are generally not assessed unless the registered dietitian receives a referral for a nutrition consult. Registered Dietitian 2 (RD 2) stated in a concurrent interview that the only intervention provided to patients in the unit was healthy eating classes twice a month. The lack of referral by the nurse to the dietitian resulted in the delay of nutritional intervention to this patient.

Based on observation, interview and document review, the hospital did not fulfill its responsibilities by failing to ensure that the safety of the patients were maintained. The following deficient practices were identified:
1. The hospital failed to ensure there was adequate food supply on hand for use in a widespread disaster. The hospital had on hand food supplies for 382 patients when it was licensed for 667 beds. (Refer to A-701)
The cumulative effect of this systemic problem resulted in the possibility of patient harm in a universe of 382 patients.

Based on observations and interview the hospital failed to ensure there was adequate food supply on hand for use in a widespread disaster. The hospital had on hand food supplies for 382 patients when it was licensed for 667 beds. Failure to maintain adequate food supplies may compromise the safety and well-being of patients and the ability for staff to care for patients in a widespread disaster.

Finding:

During emergency food storage observations on May 5, 2014, at approximately 12:15 PM, the DFNS (Director of food and Nutritional Services) stated that the hospital's plan was to prepare food for 382 patients in the event of a disaster and provide hospital staff military MREs (meals ready to eat). The hospital had recently purchased dehydrated food products to be used in the event of a disaster. The amount of food was for 326 patients for four days.

During a concurrent interview, in response to the question on the provision of food for less than the hospital was licensed for, the Director of Risk stated that they had planned for only the number of patients based on their average census and "active" beds. She stated that the hospital was licensed for 667 beds.

In the event of a widespread disaster whereby the number of admitted patients might exceed their average census, the amount of food on hand would be inadequate to meet their needs.

Based on observation, interview, and record review, the Hospital failed to provide a sanitary environment to avoid sources and transmission of
infections and communicable diseases. The Hospital failed to conduct an active surveillance program for the prevention, control, and investigation of infections and communicable diseases in the Sterile Processing Department and enteral formula feeding affecting 32 patients. The Condition of Participation for Infection Control was not met when the Hospital failed to:

1. Develop and implement policies and procedures for the safe handling of enteral feedings (tube feeding in which nutrition is delivered to the patient in a liquid form through a tube placed through the outer abdomen into the stomach for a gastrostomy tube (G- tube) or passed through the nose and the esophagus to the stomach for a nasal gastric tube (NG tube) ending in the stomach or small intestines). The hospital failed to follow manufacturer's guidelines for the length of time the open enteral formula could be hung at the patient's bedside (known as "hang time"). The hospital allowed hang times of up to 24 hours when the manufacturer's guidelines were for no greater than 8 hours. This failure had the potential to result in enteral formulas, with unacceptable levels of bacteria, to be delivered to the patients and result in infections in 32 patients receiving enteral formula feedings. (Refer to A-0749)

2. Ensure that the Sterile Processing Department (SPD), followed the manufacturer's guidelines and standards of practice (accepted infection control guidelines) for the maintenance for the fifteen hospital (15) steam sterilizers (a device used to sterilize [to clean something by destroying germs or bacteria] equipment and supplies by subjecting them to high pressure saturated steam at 249.8 degrees Fahrenheit) and seven (7) washer-disinfector machines. (The sterile processing department (SPD) in a hospital is responsible for the cleaning, decontamination, disinfection and sterilization of surgical instrumentation and medical devices to remove bioburden (bacteria living on a surface) that can cause healthcare-acquired infections {HAIs}). This failure had the potential to result in an increased risk for developing hospital acquired infections to a universe of 382 patients receiving care and treatment with the instruments, supplies and equipment processed in the SPD. (Refer to A-0749)


3. Ensure that the temperature and relative humidity (the amount of moisture in the air) of the sterile supply room(s) were maintained in accordance with Nationally Recognized Standards of accepted infection control guidelines (The hospital had been following the AORN (Association of peri-operative Registered Nurses) standards). This failure had the potential to result in an increased risk for developing hospital acquired infections to a universe of 382 patients receiving care and treatment with the instruments, supplies and equipment stored and processed in the SPD. (Refer to A-0749)

4. Ensure sanitary conditions in the dietary service department when food service equipment was not kept clean, frozen food was not stored appropriately to prevent cross-contamination, proper hand hygiene was not practiced by staff during dish washing, final sanitizing rinse temperatures were not achieved during warewashing of patients dishes and to prevent pest harborage. These practices had the potential to result in food borne illness in a medically vulnerable patient population. (Refer to A-0749)

5. Ensure that pediatric formula was prepared using aseptic techniques to minimize bacterial growth. This had the potential to result in food borne illness in an already medically vulnerable infant and pediatric patient population. (Refer to A-0749)



The cumulative effect of these deficient practices had the potential for transmission and cross contamination of infectious microorganisms on 32 patients receiving enteral formula feeding and affecting surgical and medical instruments sterilized in the Sterile Processing Department; affecting the health and safety of those patients receiving surgical and medical treatment in the hospital, in a universe of 382 patients.

Based on observations, staff interviews, and record reviews, the hospital failed to maintain an effective infection control program for the minimization of infections and communicable diseases in accordance with nationally accepted infection control guidelines as evidenced by the hospital's failure to:

1. Develop and implement policies and procedures for the safe handling of enteral feedings (tube feeding in which nutrition is delivered to the patient in a liquid form through a tube ending in the stomach or small intestines). The hospital failed to follow manufacturer's guideline, for the length of time the open enteral formula could be hung at the patient's bedside (known as "hang time"). The hospital allowed hang times of up to 24 hours when the manufacturer's guidelines were for no greater than 8 hours. This failure had the potential to result in enteral formulas, with unacceptable levels of bacteria, to be delivered to the patients and result in infections in 32 patients receiving enteral formula feedings.


2. Ensure that the Sterile Processing Department (SPD), followed the manufacturer's guidelines and standards of practice (accepted infection control guidelines) for the maintenance for the fifteen hospital (15) steam sterilizers (a device used to sterilize [to clean something by destroying germs or bacteria] equipment and supplies by subjecting them to high pressure saturated steam at 249.8 degrees Fahrenheit) and seven (7) washer-disinfector machines. (The sterile processing department (SPD) in a hospital is responsible for the cleaning, decontamination, disinfection and sterilization of surgical instrumentation and medical devices to remove bioburden (bacteria living on a surface) that can cause healthcare-acquired infections {HAIs}). This failure had the potential to result in an increased risk for developing hospital acquired infections to a universe of 382 patients receiving care and treatment with the instruments, supplies and equipment processed in the SPD.

3. Ensure that the temperature and relative humidity (the amount of moisture in the air) of the sterile supply room(s) were maintained in accordance with Nationally Recognized Standards of accepted infection control guidelines (The hospital had been following the AORN (Association of peri-operative Registered Nurses) standards). This failure had the potential to result in an increased risk for developing hospital acquired infections to a universe of 382 patients receiving care and treatment with the instruments, supplies and equipment stored and processed in the SPD.


4. Ensure sanitary conditions in the dietary service department when food service equipment was not kept clean, frozen food was not stored appropriately to prevent cross-contamination, proper hand hygiene was not practiced by staff during dish washing, final sanitizing rinse temperatures were not achieved during warewashing of patients dishes and to prevent pest harborage. These practices had the potential to result in food borne illness in a medically vulnerable patient population.

5. Ensure that pediatric formula was prepared using aseptic techniques to minimize bacterial growth. This had the potential to result in food borne illness in an already medically vulnerable infant and pediatric patient population.


Findings:

1a. A review of the medical record for Patient 19 indicated that the patient was admitted to the hospital on April 20, 2014, with diagnoses that included possible viral encephalitis (an infection in the brain), leukopenia (a risk factor for infections in which there are low white blood cells) and altered level of consciousness. The physician orders included an order dated April 28, 2014, for a tube feeding of Nutren Pulmonary (a liquid nutritional formula) at 20 mL (milliliters, a measure of volume) per hour (rate of administration).

During an observation on April 29, 2014, at 11:30 AM, in Patient 19's room, a tube feeding bag labeled Nutren Pulmonary (liquid nutritional formula), 20 mL/hour, April 29, 2014, and 0610 (6:10 AM). The bag contained approximately 400 mL of formula.

During a concurrent interview with Registered Nurse 5 (RN 5), Patient 19's nurse, she stated that the usual practice was that the night shift nurses changed the formula bag and tubing every day. She further stated that the night shift nurse added the formula to the enteral formula bag for the day. She stated that the only time she, a day shift nurse, would be required to handle the enteral formula was if the physician's order for the tube feeding changed, requiring a different formula or more formula to be added to the bag. She also stated that the time written on the bag in Patient 19's room indicated the time (6:10 AM) that the formula was poured into the bag and hung at the bedside.

During a concurrent interview with Registered Dietitian 1 (RD 1), Director of Food and Nutrition Services (DFNS) and Assistant Director of Food and Nutrition Services 1 (ADFNS 1), no one was able to state the hospital policy or the manufacturer's guidelines for the hang time of the enteral formula using an open system (using reconstituted powders or ready-to-use liquids poured from the original manufacturer's container into a feeding bag).

On April 29, 2014, at 12:00 PM, the DFNS presented the hospital policy titled "Enteral Tube Feeding" (Revision Date: January 2013). The hospital policy noted "Collaborating Department(s) or Committee(s): Registered Nurses, Food and Nutrition Services Personnel, and Pharmacy Personnel." A review of the policy noted, "The feeding bag will be changed every 24 hours and labeled with date, initials, time bag hung, type of formula, and rate of infusion. Maximum amount of formula hung at one time is 4 hours." The policy did not include directions to the staff to rinse the feeding bag at any time during the 24 hours.

A review of the manufacturer's guidelines provided by the DFNS titled, "Nestle Nutrition, Hang Time: Open and Closed Systems", dated 2010, note, "Higher degrees of contamination have been found in reconstituted formulas and in open systems allowed to hang for extended periods of time (greater than 21 hours)." It further noted, "The A.S.P.E.N. (American Society for Parenteral and Enteral Nutrition) Enteral Practice Recommendations provides the following hang time recommendations: For reconstituted powdered formula or a formula with additives, a 4-hour hang time is recommended; For a commercially sterile,liquid formulas decanted (poured) from a can or brik-pak (similar to a juice box), an 8-hour hang time is recommended. These hang time recommendations assume the formula is kept at room temperature and is subject to minimal handling and manipulation. This information also indicates that the bag and administration set (tubing) should be flushed with water before adding additional formula." It further noted that, "Nestle HealthCare Nutrition follows the hang time guidelines based on best practice."

1b. A review of the medical record for Patient 20 noted that the patient was admitted to the hospital on April 27, 2014 with diagnosis that included altered level of consciousness. The physician's order included an order dated April 28, 2014, for a tube feeding of Glytrol (a liquid nutritional formula) at 5 mL per hour.

During an observation on April 29, 2014, at 1:10 PM, in Patient 20's room, a tube feeding bag labeled Glytrol, 5 mL/hour, April 29, 2014 at 0000 (midnight) contained approximately 200 mL of formula was noted. The formula was hanging for greater than 13 hours.

During a concurrent interview with RN 6, she stated that she did not add any formula to the tube feeding bag on her day shift. She could not explain why there was approximately 200 mL of formula in the bag when it would take greater than 24 hours to use that much formula.

1c. A review of the medical record for Patient 26 noted that the patient was admitted to the hospital on April 16, 2014, with diagnoses that included severe sepsis (whole body infection) and respiratory failure (difficulty breathing). The physician's orders noted an order dated April 28, 2014 for a tube feeding of Nutren 1.0 Fiber (a liquid nutritional formula) at 55 mL per hour.


During an observation on April 29, 2014, at 1:15 PM, in Patient 26's room, a tube feeding bag labeled Nutren 1.0 Fiber at 55 mL/hr (no time written on the label) contained approximately 300 mL of formula was observed.


During a concurrent interview with RN 6, she stated that the tube feeding bag did not indicate a time that the bag was hung. She further stated that she usually pours the formula in the tube feeding bag, mixing the older formula with the new formula without rinsing the bag first. She stated that she did not know when the tube feeding formula was hung for Patient 26 since it was not labeled with a time.

1d. A review of the medical record for Patient 18 noted the patient was admitted to the hospital on April 8, 2014 with diagnosis that included severe sepsis. The physician's orders noted an order dated April 25, 2014 for a tube feeding of Nutren Pulmonary (a liquid nutritional formula) at 40 mL per hour.

During an observation on April 29, 2014, at 1:30 PM, in Patient 18's room, a tube feeding bag labeled Nutren Pulmonary at 40 mL/hr, dated April 29, 2014 at 0100 (1:00 AM) was noted. The bag contained approximately 200 mL of formula.

During a concurrent interview with RN 2, she stated that whenever the formula in the bag got low, she added another (250 mL) container of formula to the bag. She further stated that she added additional formula in the bag without rinsing the bag first. RN 2 stated that she did not document when she added formula to the bag or how much she added. RN 2 stated that the tube feeding bag in Patient 18's room was hung at 1:00 AM, more than 12 hours earlier.

During an interview with the Director of Infection Control (DIC) on April 29, 2014, at 1:45 PM, she stated that her department was not monitoring the nursing practice as it related to tube feedings. The DIC stated she was not aware of the manufacturer's recommendations for no greater than an 8 hour hang time for open systems. The DIC stated that her department was not as involved as they should have been in ensuring the open tube feeding system was handled according to the manufacturer's recommendations. The DIC stated, "The hospital Enteral Tube Feeding policy did not even come through Infection Control."

1e. During a review of the clinical record for Patient 16 on April 29, 2014, the face sheet noted that Patient 16 was admitted to the acute care hospital on September 13, 2014, with current diagnoses that included but not limited to respiratory failure and a percutaneous endoscopic gastrostomy (PEG) tube placement (a surgical procedure in which a tube is passed into a patient's stomach through the abdominal wall).

The "Order History" dated April 28, 2014, noted Patient 16 had a physician's order dated March 26, 2014, to receive a liquid nutrition formula (Isosource) at a goal rate of 70 milliliters per hour (mL/hr).

During an observation on April 29, 2014, at 1:25 PM, Patient 16 was observed, in his room, receiving a liquid nutrition formula (Isosource), via his PEG tube, at the rate of 70 mL/hr, with an open tube feeding bag system. Observation of the feeding bag showed there was 280 mL of formula in the bag and there was no documented time on the label, to indicate what time the bag
was hung.

During an interview with Registered Nurse 11 (RN 11), on April 29, 2014, at 1:25 PM, RN 11 stated Patient 16's feeding bag was prepared and hung by a nurse on the night shift. RN 11 stated the feeding bag and tubing should be changed every 24 hours. RN 11 stated she did not know the exact time the feeding bag was hung and verified there was no documented hang time on the feeding bag label. RN 11 stated that the time the feeding bag was hung, should be documented on the label. RN 11 verified she did not know, and there was no documentation to show exactly when the feeding bag should be changed.

1f. During a review of the clinical record for Patient 13, on April 29, 2014, the face sheet noted that Patient 13 was admitted to the acute care hospital on April 27, 2014, with current diagnoses that included, but not limited to, clostridium difficile (a highly contagious bacterial infection of the colon that causes inflammation, watery loose stools and dehydration).

The "Order History" dated April 28, 2014, noted Patient 13 had an physician's order to receive a liquid nutrition formula (Diabeticsourse) at a goal rate of 50 mL/hr.

During an observation on April 29, 2014, at 1:05 PM, Patient 13 was observed, in his room, receiving a liquid nutrition formula (Diabeticsource), through a nasal gastric tube (a plastic tube inserted into the patient's nose down into the stomach), at the rate of 50 milliliters per hour (mL/hr), with an open feeding bag system. Observation of the feeding bag showed there was 200 mL of feeding in the bag and there was not documented time on the label, to indicate what time the feeding bag was changed and hung.

During an interview with Registered Nurse 8 (RN 8), on April 29, 2014 at 1:05 PM, RN 8 stated Patient 13's feeding bag was prepared and hung by a nurse on the night shift, but she did not know the exact time. RN 8 stated that the feeding bag and tubing was changed every 24 hours. RN 8 stated she did not know the exact time the feeding bag was hung and verified there was no documented hang time on the feeding bag label. RN 8 staled she did not know what time the bag should be changed. RN 8 stated that there should only be enough feeding in the bag to infuse over a 4 hour period of time. RN 8 stated that she had not added any formula to Patient 16's feeding bag, even though there was 200 mL of formula remaining in the bag, infusing at 50 mL/hr. RN 8 stated the time the feeding bag was hung, should be documented on the label. RN 8 stated there was no documentation in the clinical record to indicate what time the feeding bags were hung, nor was there documentation to indicate when additional formula was added to refill the bags.

1g. During an observation on April 29, 2014, at 1:00 PM, Patient 29, was observed to be receiving a gastronomy tube (GT tube, a feeding
tube inserted through the skin and directly into the stomach) feeding at 35 mL per hour. Patient 29 had been admitted to the hospital, on March 17, 2014, with the diagnoses that included pneumonia (infection of the lungs), stroke (interruption of blood flow to the brain), chronic kidney disease, malnutrition (condition that develops when the body is deprived of vitamins, minerals and other nutrients) and diverticulosis of colon (an abnormal outpouching of the intestinal wall where fecal material can become trapped in the pouch and cause infection).

During an interview with RN 9, caring for Patient 29, on April 29, 2014, at 1:00 PM, RN 9 stated, "The GT feedings are started at midnight by the night shift nurses. The night shift pour enough formula to last throughout the next day. When I got here this morning, at 7:00 AM, this patient's GT feeding bag had 600 mL of formula in it, it has 300 mL of formula left. Her feeding is running at 35 mL an hour. If the formula started to run low, I would pour more formula into the bag on top of what was left in the bag. When we need to add more formula to the feeding bags, we don't take the bag down or rinse it out, we just pour more formula into the bag. The feeding bags are changed once a day by the night shift, unless there is a change in the physician's order. If the physician ordered a different formula, then the nurse would take the old feeding bag down, and hang a new bag with the new order."

1h. During an observation on April 29, 2014, at 2:45 PM, Patient 30, was observed to be receiving a gastronomy tube (GT tube) at 50 mL per hour.

A review of the medical record for Patient 30 indicated that the patient was admitted to the facility on April 24, 2014, with diagnoses including pneumonia (a lung infection), chronic respiratory failure (a long term condition of the inability of the lungs to diffuse enough oxygen into the bloodstream to meet the body's need), stroke, pressure sore (skin breakdown) to coccyx (tailbone) and malnutrition.

During an interview with RN 11, caring for Patient 30, on April 29, 2014, at 2:45 PM, RN 11 stated, "This GT feeding was started at 4:00 AM, by the night shift nurses. The night shift poured enough formula in the feeding bag for the next day. There is still 400 mL of formula left in her bag. It has been running at 50 mL an hour. If the bag were to start to get low I would pour some more formula directly into the bag. We don't change the bags on this shift, that is done on the night shift. When we need to add more formula we just add it to the bag. We don't pour out the formula that is left in the bag before adding the new formula. The bags are not taken down and rinsed before adding more formula to the bag. We don't document when we add more formula into the feeding bags."

1i. During a review of Patient 49's medical record conducted on April 29, 2014, noted that the patient was admitted to the facility on March 12, 2014. The diagnoses included diabetes mellitus (increased glucose in the blood) and acute renal failure (the kidneys are unable to filter waste products from the blood).

A review of the physician's orders noted the following:

"NPO (nothing by mouth except for tube feeding."

"Tube feeding: Diabeticsource AC (liquid nutrition), goal rate of 75 ml/hour (hr), continuous ..."

During an observation of Patient 49 on April 29, 2014, at 4:30 PM, with RN 39, the Diabeticsource AC formula was infusing at 75 mL an hour via an open tube feeding system. The hang date on the feeding bag was dated April 28, 2014 at 7:39 PM and approximately 200 mL of formula remained in feeding bag.

During an interview on April 29, 2014, at approximately 4:30 PM, with RN 39, she confirmed that the current tube feeding bag and tubing were hung on April 28, 2014 at 7:39 PM, almost 21 hours ago. She stated that the feeding bag and tubing were hung and changed by the night shift nurses every 24 hours. RN 39 stated that on April 29, 2014, at approximately 2:00 PM, she added a can of Diabeticsource formula (240 mL) to the infusing formula in the feeding bag. RN 39 was asked if the feeding bag was empty prior to her adding the can of Diabeticsource formula. RN 39 stated that about 100 mL of formula remained in the feeding bag. RN 39 further stated that she did not allow the existing formula to completely infuse prior to adding more formula because she did not want air to enter the feeding tube.

1j. A review of the medial record for Patient 37 indicated that the patient was admitted to the hospital on April 13, 2014, with diagnoses that included nausea and vomiting, perforated appendicitis. Physician's order included Nutren at 20 ml per hour.

On April 29. 2014, at approximately 2:52 PM, a feeding bag hung was observed in the patient's room with approximately 10 mL of a light brown colored liquid left in the bag. The label indicated that the bag was hung April 29, 2014, at 0000 (midnight). The tube feeding rate was at 20 mL per hour. At the time the observation, the bag had been hung for approximately 15 hours.

In a concurrent interview with RN 12 she stated that she added approximately 80 mL of formula to make four hours of feeding. She was not sure what time she had added the feeding. A check of the feeding machine pump with RN 12 did not reflect the information provided by RN 12. She also stated that the feeding bags were changed daily.

1k. A review of the medical record for Patient 38 indicated that the patient was admitted to the hospital on February 27, 2014, with diagnoses including right leg ischemia (insufficient blood flow), diabetes (elevated blood sugar levels), leg amputation above knee.

During observation on April 29, 2014,at approximately 4:45 PM, in the patient ' s room, approximately 250 mL of a light brown colored fluid (Diabetisource) was left in the feeding bag. The label on the feeding bag indicated that the bag was hung on 4/29/14 at 0001 (12:01 am). Based on the information on the label, the bag had been hanging for approximately 16 hours 45 minutes.

During a concurrent Interview with RN 13, he stated that there was feeding left in the bag when he reported for his shift that morning. He stated " about less than half of the bag " was in the bag and about an hour earlier he added one box (240 mL) Diabeticsource into the bag.

The survey team identified an immediate jeopardy situation on April 29, 2014, at 6:00 PM as a result of the hospital's failure to follow manufacturer's guidelines to ensure safe administration of enteral formula when using an open system with hang times up to 24 hours. This practice had the likely potential to result in enteral formulas with unacceptable levels of bacteria delivered to the patients and result in infections in 32 patients receiving enteral feedings. The immediate jeopardy was called in the presence of the survey team and the hospital leadership which included the Chief Executive Officer, the Chief Operating Officers 1 and 2, the Chief of Hospitalist Physicians, The Director of Accreditation and Compliance 1 and 2, the Director of Infection Control, The Assistant Hospital Administrator for Performance Improvement and the Chief Nursing Executive 2.

An acceptable corrective action was received and agreed upon by the survey team on April 30, 2014, at 5:32 PM. The immediate jeopardy was concurrently abated in the presence of the survey team and the Director of Accreditation and Compliance 1. The hospital's corrective action included a revised policy and procedures for patients receiving tube feedings, staff education and monitoring of the "hang time" to ensure the times did not exceed the manufacturer's guidelines.


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2a. During an observation on April 29, 2014 at 10:55 AM, with the Clinical Director of Perioperative Services (CDPS) and the Manager of the Sterile Processing Department (MSPD) for the hospital's main sterile processing department's (SPD) decontamination room four (4) large automatic washer/disinfector machines were observed mounted onto the wall. (The automatic washer/disinfector machines are a method of cleaning surgical instruments and medical devices).

The sterile processing department's (SPD) is an area where reusable surgical equipment, surgical instruments, and surgical supplies were cleaned and decontaminated [the process of cleansing to remove contaminants such as micro-organisms and infectious diseases. The purpose of decontamination is to prevent the spread of micro-organisms] by means of manual or mechanical cleaning processes and chemical disinfection.

During an interview on, April 29, 2014, at 11:00 AM, with the Sterile Processing Technician (SPT 1) working in the decontamination room, she stated that the workers in the decontamination room did not service and did not conduct daily cleaning of the automatic washer/disinfector machines. SPT 1 stated that the sterile processing department (SPD) staff did not complete records or logs regarding service or daily cleaning of the automatic washer/disinfector machines.

During an interview on, April 29, 2014, at 11:10 AM, with the Clinical Director of Perioperative Services (CDPS), when asked what Nationally Recognized Infection Control Organizational standard of practice that was being implemented by the hospital's sterile processing department, she stated, "The AORN (Association of peri-operative Registered Nurses) standards."

According to the AORN (Association of Preoperative Registered Nurses), under the title, "Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment", dated 2014, recommended the following:

a. Section X.c.12. Automated washer decontaminators or disinfectors and washer sterilizers should be used according to the manufacturer's written instructions.

b. Recommendation XX: Documentation should be completed to enable the identification of trends and demonstrate compliance with regulatory and accrediting agency requirements. Documentation provides a source of data to review processes and evaluate corrective actions.

c. Section XX.a. Documentation should include maintaining records of the cleaning of instruments including, but not limited to: ... testing results on mechanical instrument washers ...Records of washer testing provide a source of evidence for review when investigating clinical issues, including surgical site infections.

d. Section XX.b. Records should be maintained for a time period specified by the health care organization and in compliance with local, state, and federal regulations.

During an interview on April 29, 2014, at 3:00 PM, with the MSPD, he stated that the SPD staff did not maintain any documentation regarding the SPD staff's service or daily cleaning of the automatic washer/disinfector machines.

During a record review, on April 30, 2014 at 11:30 AM, with the Manager of the Sterile Processing Department (MSPD) present, the washers/disinfector machine instruction manual noted:

On page 5 "Daily servicing work on the device must be carried out regularly and in accordance with regulations (see Chapter 14 "Daily servicing and cleaning work")".

On page 6 "Process validation. The aim of process validation is to achieve a high level of safety in the reconditioning of medical devices in order to afford the operators and patients the greatest possible protection ...routine testing / Annual requalification".

On pages 25, 26 and 27 noted, "Daily servicing and cleaning work ....The owner is responsible for carrying out servicing and cleaning work ...".

During a record review, on April 30, 2014, at 11:30 AM, with the MSPD present, the Preventive Maintenance (PM) (scheduled servicing, inspections, and machine repairs to prevent potential problems) inspections by hospital's contracted service representative's documentation, titled "[hospital name] - New SPD - WO (work order) History 5/1/2013 - 4/30/2014", for the washers/disinfector machines noted:

Each of washers/disinfector machine located in the hospital's main decontamination room, machines #1, #2, #3 and #4, did not receive one (1) of the four (4) manufacture's recommended Preventive Maintenance inspections during the past 12 months.

During an interview on, April 30, 2014 at 1:00 PM, with the MSPD, he stated that the hospital had three (3) additional washers/disinfector machines located in the hospital's on-site ancillary decontamination room. The requested documented, Preventive Maintenance (PM) inspections were not provided for review of the three (3) additional washers/disinfector machines in this location.

During an interview on, April 30, 2014 at 1:00 PM, with the MSPD, acknowledged that he had not been aware that the Preventive Maintenance (PM) inspections, provided by the contacted service representatives, to the washers/disinfector machines were not completed, as directed by the manufacture's recommendations.


During an interview, on May 5, 2014 at 2:40 PM with the Director of Infection Control (DIC) she stated that she had conducted the surveillance in the sterile processing department.

The DIC stated that she was not aware that the SPD staff did not document the daily cleaning and servicing of the washers/disinfector machines.


A record review, on May 1, 2014, of the hospital policy and procedure titled "Equipment Cleaning" for the sterile processing department, dated January 2013, noted "Accountable Department or Committee: Infection Control Committee". The hospital policy and procedure noted "Purpose: To establish the process for cleaning Sterile Processing equipment. Policy Statement(s): 2. The washer/decontaminator drain screen will be cleaned weekly or as needed by the Sterile Processing technician....Provisions/Procedure: Manufacture's guidelines will be followed."


2b. During an observation on April 29, 2014, at 2:00 PM, with the Clinical Director of Perioperative Services (CDPS) and the Manager of the Sterile Processing Department (MSPD) for the hospital's main sterile processing department's (SPD) clean room, (an area where the cleaned reusable surgical equipment and surgical instruments are received from the decontamination area) four (4) steam sterilization autoclave machines (a device used to sterilize equipment and supplies by subjecting them to high pressure saturated steam at 249.8 degrees Fahrenheit) were observed in the clean room. The steam sterilization autoclave machine labeled #1 had a sign posted that noted "Out of Service - Do Not Use -Service Rep Called."

During an interview on April 29, 2014, at 2:15 PM, with the MSPD, he stated that the sterilization autoclave machine labeled #1 had not been working for "a few days" and the Service Representative had been notified.

During an interview on April 29, 2014, at 3:00 PM, with the MSPD, he stated that the SPD staff did not did not maintain any documentation regarding the SPD staff's service or daily cleaning of the steam sterilization autoclave machines.

During an interview on, April 29, 2014, at 3:00 PM, with the Clinical Director of Perioperative Services (CDPS), when asked what Nationally Recognized Infection Control Organizational standard of practice that was being implemented by the hospital's sterile processing department, she stated, "The AORN (Association of peri-operative Registered Nurses) standards."

According to the AORN (Association of Preoperative Registered Nurses), under the title, "Recommended Practices for Sterilization", dated 2014, recommended the following:

a. Section VI.a. Manufacturers' written instructions for operating steam sterilizers should be followed.

b. Section XIX.c. The sterilizer manufacturer's written instructions for cleaning, operation, and maintenance should be reviewed and reflected in instrument processing policies and procedures.

c. Section XIX.c.1. User manuals for all sterilization equipment should be readily available to the sterilizer operators. As new sterilization technologies are introduced for use in perioperative practice settings, it is imperative that health care personnel strictly follow manufacturers' written instructions for the operation and maintenance of sterilization equipment ...

d. Section XX.b. All sterilizer failures and corrective actions should be documented and reported to the infection preventionist, quality assurance or risk management committee, and to administrators.

During a record review on April 29, 2013, at 3:00 PM, of the user's manual for the steam sterilization autoclave machines, with the MSPD present, the manual noted:

On page 9 "...daily maintenance to be completed before the start of sterilization ...".

On page 10 "... Weekly Maintenance ....No maintenance message is displayed for weekly tests ...work to be performed by user ..."

On page 11 "...Maintenance interval 650 hours (Quarterly) ..." items to be serviced [listed services], work to be performed [listed work] & performed by a test person (contracted service)..."

On page 32 "Logging the maintenance worked carried out. Logging may be carried out either by operating personnel or by building services management. The maintenance work carried out by the authorized expert ...must be confirmed by a 'brief report or log'."

During an interview on April 29, 2014, at 3:00 PM, with the MSPD, he stated, the SPD staff did not have any documentation or a system to track daily or weekly maintenance as listed in the user manual. The MSPD stated "we feel that due to the new machines (first used on May 17, 2013), we do not need to do the maintenance" as listed in the user manual.

During a record review, on April 30, 2014, at 11:30 AM, with the MSPD present, the Preventive Maintenance (PM) (scheduled servicing, inspections, and machine repairs to prevent potential problems) inspections by the hospital's contracted service representative's documentation, titled "[hospital name] - New SPD - WO (work order) History 5/1/2013 - 4/30/2014", noted for the hospital's steam sterilization autoclave machines located in the hospital's main sterile processing department's clean area:

Sterilizer machine #1 -did not receive three (3) of the four (4) manufacture's recommended Preventive Maintenance inspections during the past 12 months.

Sterilizer machine #2 - did not receive two (2) of the four (4) manufacture's recommended Preventive Maintenance

Based on interview and record review, the hospital failed to ensure that the registered Nurse (RN) evaluated the care for each patient by failing to:

1. Ensure that 1 of 86 sampled patients (Patient 50) with a community acquired pressure ulcer (an area of skin that breaks down when constant pressure/with shear and/or friction, is placed against the skin) was identified and assessed in the Emergency Department (ED) on April 24, 2014. This failure had the potential to result in the worsening of the pressure ulcer resulting in negative outcomes for the patient.

2. Develop and implement policies and procedures for the safe handling of enteral feedings (tube feeding in which nutrition is delivered to the patient in a liquid form through a tube ending in the stomach or small intestines). The hospital failed to follow manufacturer's guidelines for the length of time the open enteral formula could be hung at the patient's bedside (known as "hang time"). This failure had the potential to result in enteral formulas, with unacceptable levels of bacteria, to be delivered to the patients and result in infections in 32 patients receiving enteral formula feedings.

3. Evaluate 1 of 86 sampled patients (Patient 27) who did not have a bowel movement for 9 days. The physician was not informed of the lack of bowel movement so appropriate interventions could have been ordered. This failure had the potential to result in gastrointestinal symptoms such as nausea, vomiting, abdominal distention, pain and rectal pain or bleeding.

4. Ensure that nursing staff followed the orders of the physician to weight patients daily for 2 of 86 sampled patients (Patients 39 and 40) This failure had the potential to result in inaccurate monitoring of the patient resulting inaccurate care and treatment.


5. In the Chemical Dependency Unit, ensure one of 86 sampled patients (Patient 41) was accurately screened to determine nutrition risk and a dietitian referral was made. The lack of accurate nutrition screening and subsequent dietitian referral resulted in a lack of nutrition assessment and possible delay in nutrition interventions that could affect the nutrition status of the patient.

Findings:

1. During a review of Patient 50's clinical record on April 29, 2014, it noted that the patient arrived at the hospital's Emergency Department (ED) on April 24, 2014, at 4:33 PM. The chief complaints were weakness, fatigue (tired easily) and depression (a state of unhappiness and hopelessness).

A review of a Registered Nurse (RN 42) ED assessment dated April 24, 2014, at 4:50 PM, noted that Patient 50 was awake, lethargic (not easily aroused), oriented to person, place, with slurred (unclear) speech. The assessment indicated that Patient 50's skin was intact and had no pressure ulcers, wounds or skin irritations.

A review of RN 42's ED notes dated April 24, 2014, at 7:15 PM, noted, that RN 43 assumed care of Patient 50 and indicated that the patient had no wounds or skin breakdown.

A review of RN 42's ED assessment dated April 24, 2014, at 7:57 PM, noted, that Patient 50 was incontinent of urine and that the patient's wife reported that he had a dressing on the coccyx region (tail bone). RN 42's documentation indicated that the dressing was placed by a wound care nurse who was providing care to the patient for skin breakdown on the coccyx (tail bone). There was no documented evidence that Patient 50's wound was assessed by RN 42 after it had been reported by the wife that the patient had a dressing on the coccyx.

A review of Patient 50's Medical Doctor (MD I) hospital admission history and physical dated April 24, 2014, at 10:36 PM, noted that Patient 50 had no pressure ulcers on admission and the skin was normal.

A review of the inpatient wound consultation assessment completed by RN 44, dated April 25, 2014, at 11:56 AM, noted: "Wound care consult for pt admitted with pressure ulcer to coccyx (tail bone). Mepilex (an all-in-one foam dressing that effectively absorbs and retains wound fluid (exudate) but keeps the wound sufficiently moist) removed and pt noted to have a 2 x 2 (cm) healing superficial stage III pressure ulcer (full thickness tissue loss) to coccyx ..."

A review was conducted of a Medical Surgical (M/S) Registered Nurse's notes (RN 45), completed on April 25, 2014, at 1:15 AM. RN 45's entry noted under section: "Pressure Ulcer Coccyx Assessment," that Patient 50 had a "Pressure ulcer Stage II..." (partial thickness loss of skin presenting as a shallow open ulcer). RN 45's entry also indicated that the appearance of the pressure ulcer was red, pink and the length was 0.5 centimeter (cm) and the width was 0.5 (cm) {1.5 cm difference in length and width from the assessment that the wound care consultant documented, approximately 1.5 hours earlier the same day}. The entry also indicated that Patient 50's Stage II's pressure ulcer had exudate (drainage), a mild odor and the physician was notified.

A review was conducted with the Director of Emergency Department (DED) of Patient 50's Stage II pressure ulcer photograph, dated April 25, 2014 at 2:36 AM. The photograph was taken on the M/S unit and noted a Stage II pressure ulcer to the coccyx, measuring 0.5 cm in length x 0.5 cm in width.

During an interview on May 6, 2014, at 8:50 AM, with RN 42, he acknowledged and stated that he did not assess Patient 50's pressure ulcer in the ED on April 24, 2014. He stated that he completed a head to toe frontal assessment but did not turn the patient over to check his back side. He stated that his priority was assessing the patient for a stroke (the sudden death of brain cells in a localized area due to inadequate blood flow).

A concurrent review of Patient 50's ED assessment and interview was conducted on May 6, 2014, at 9:10 AM, with the DED (Director of the Emergency Department). The DED acknowledged and stated that the skin assessments completed in the ED by the RNs and the admission history and physical completed by MD I, did not accurately reflect the patient's skin condition/pressure ulcer. The DED further stated that once the pressure ulcer was identified in the ED, an assessment and photographs of the pressure ulcer should have been completed to reflect the pressure ulcer status on admission so that it did not raise questions of whether the pressure ulcer developed or worsened in the hospital.

2 a. During a review of Patient 49's medical record conducted on April 29, 2014, at approximately 4:40 PM, it noted that the patient was admitted to the facility on March 12, 2014. The diagnoses included diabetes mellitus (increased glucose in the blood and acute renal failure (the kidneys were unable to filter waste products from your blood). A review of the physician orders noted the following:

"NPO (nothing by mouth except for tube feeding"
"Tube feeding: Diabeticsource AC (a liquid nutritional formula), goal rate 75 ml/hour (hr), continuous ..."

During an observation of Patient 49's tube feeding on April 29, 2014, at 4:30 PM, with Registered Nurse (RN) 39, assigned to provide care for the patient, the Diabeticsource AC tube feeding was infusing at 75 milliliters (mL) an hour via an open tube feeding system. The hang date on the feeding bag was dated April 28, 2014 at 7:39 PM and approximately 200 mL of feeding remained in feeding bag.

During an interview on April 29, 2014, at approximately 4:30 PM, with RN 39, she confirmed that the current tube feeding bag and tubing were hung on April 28, 2014, at 7:39 PM, almost 21 hours ago. She stated that the feeding bag and tubing were hung and changed by the night shift nurses every 24 hours. RN 39 stated that on April 29, 2014, at approximately 2:00 PM, she added a can of Diabeticsource formula (240 ml) to the infusing formula in the feeding bag. RN 39 was asked if the feeding bag was empty prior to her adding the can of Diabeticsource formula. RN 39 stated that there was about 100 mL of formula remained in the feeding bag. RN 39 further stated that she did not allowed the existing formula to completely infused prior to adding more formula because she did not want air to enter the feeding tube.

A review of the hos

Based on observation, interview, and record review, the hospital failed to control and distribute drugs and biologicals in a safe manner to protect the patient safety when:

1a. 6 one-liter bags of sterile water for injection (SWFI, which had intravenous (IV) delivery set ports and looked similar to the IV solutions for hydration and electrolyte replacement such as normal saline (NS) 0.9%, dextrose 5% in water (D5W), etc.) were available on patient care units without appropriate safeguards in place to prevent inadvertent administration of the product. Safeguards such as precautionary labels, restricted access, inclusion in high risk policy and procedures, etc. were not implemented. The hospital reported the product was intended for Respiratory Therapy (RT) use only. There were no indications the SWFI bags were isolated or designated for RT use only.

1b. Multiple one-liter bags of SWFI solution were stocked and distributed by the Materials Management Department without the oversight by the Pharmacy Department. The lack of appropriate safeguards and pharmacy oversight had the potential for SWFI bags to be mistakenly administered intravenously, which could put patients at risk for harm due to hemolysis (breakdown of red blood cells).
2a. Medications such as IV famotidine (a medication to protect the stomach) ordered for neonatal and pediatric patients were modified to a vial containing 10 milligrams/milliliter (mg/ml). This practice required nursing to calculate and draw up the amount to be given before administration, when they were ordered and should have been dispensed in ready-to-administer syringes, as in accordance with the guidelines from American Academy of Pediatrics.

2b. A review of pediatric records revealed certain pharmacy modified orders had conflicting information, such as having two different medication concentrations and two administration amounts, on the medication administration record (MAR). These practices could result in medication administration errors.

3. The hospital failed to ensure the implementation of policy and procedures for the preparation parenteral (for injection) medications in the anesthesia. Pre-drawn Propofol and pre-spiked NS (or sodium chloride 0.9%) solutions were used beyond one hour of preparation; the pre-spiked NS could be used up to 24 hours. The hospital's failure had the potential for risk of contamination and IV associated infections for patients.

4. The hospital failed to develop and implement policy and procedures for dosing and monitoring of Heparin (a blood thinner) infusion that ensured consistency with minimal variability in rate of infusion changes and the frequency of monitoring ordered by pharmacists. This failure resulted in delay in reaching the therapeutic goal for Patient 31.

5. The hospital failed to distribute in patient care areas only usable medications in an orderly manner that prevented crowding and could be readily retrieved for administration to patients in accordance with the hospital's policy and procedure. This failure had the potential for delay in timely retrieval of medications to administer to right patients the potential for discontinued medications to be administered. This failure could also indicate there were potential issues with the adequate space necessary to provide the pharmacy services in the medication room.

6. The hospital failed to complete the controlled substance use audit of high users with feedback from the nursing managers monthly in accordance with the hospital's policy and procedure. This failure had the potential for the hospital not to be aware of potential issues regarding controlled substance medications which could affect patient safety.

7. The hospital failed to store non-medications away from the medications in the medication refrigerator located in Emergency Department Medication Room in accordance with the hospital's policy and procedure. This failure had the potential for delay in retrieving correct medications

Findings:.

1a. On April 29, 2014 at 8:50 AM, inspection of one medication room at the Seven South (7 South, a medical/surgical unit) Unit was conducted with the Director of Pharmacy (DOP) 1, Pharmacist 1, and Assistant Clinical Director (ACD) 1. Six SWFI bags were identified in the storage area where the plain IV solutions (such as NS 0.9%, D5W, Lactate Ringers, etc.) were stored. One of the SWFI bags was found in the mix of the D5/0.2 NS bags (5% dextrose in 0.2% normal saline, a hydration solution). The SWFI bags looked similar to the plain IV solutions except the SWFI had a small box (about 2.75 x 1.25 inch in size) of red lettering warning on its labeling, which read: "Hypotonic [reduced pressure/tone] and hemolytic [relating to or involving the rupture or destruction of red blood cells]. Do not inject until made approximately isotonic by addition of appropriate solute." The small font warning could easily be blended in with other text and could be overlooked. The SWFI bags were also the same size (1-liter bags), had the same labeling font and the content (colorless solution) of the SWFI bags were the same as the other IV solutions. Furthermore, they had the delivery set ports (adminstration delivery method) that could easily accommodate regular IV tubing and could be mistakenly infused intravenously. When asked what the SWFI bags were for, ACD 1 could not provide an answer.

During an interview on April 29, 2014 at 9:25 AM, the Critical Care Services Director (CCD) said the SWFI bags were used for "high flow oxygen therapy," a non-emergent respiratory therapy procedure which was not used often on the medical/surgical floor.

1b. A tour was conducted on April 29, 2014 at 9:40 AM, of the Seven North (7 North, a medical/surgical unit) Unit with DOP 1, Pharmacist 1, and Nurse Manager (NM 2). found 11 one-liter bags of SWFI stored adjacent to the plain IV solutions in two of two 7 North medication rooms. When asked what they were used for, NM 2 said they were used for flushing feeding tubes. However, Charge Nurse (CN) 2 said that the 11 one-liter bags of SWFI were not for flushing feeding tubes but that they were for mixing medications that were incompatible with NS or D5W. DOP 1, Pharmacist 1 and NM 2, agreed the SWFI bags looked similar to the plain IV solutions and could potentially be overlooked and be administered intravenously by mistake. They said Materials Management (MM) Department supplied the SWFI bags to the patient care units.

During a visit to the MM Department on April 29, 2014 at 11:20 AM with DOP 1, Pharmacist 1, and MM Director (MMD), several boxes of SWFI bags were observed stored on the shelf approximate to the other IV solutions such as NS 0.9%, D5W, D5/0.45%NS, etc. There were no indications the SWFI bags were isolated or designated for RT use only. MMD said the MM Department had supplied SWFI bags to the designated nursing units and others on request basis for years. MMD provided a report that showed four designated patient care units (excluding pharmacies). Another report, provided the same day, showed four additional patient care units (total of eight locations) where SWFI bags were supplied to. Neither of the two reports included 7 South or 7 North, where the SWFI 1-liter bags were found by the surveyor.

On April 29, 2014 at 2:15 PM, an interview was conducted with multiple hospital staff including the Department Administrator of Respiratory Care (DARC), the Chief Nursing Executive (CNE), and DOP 1. The DARC said the SWFI bags were used by RT staff for "high flow oxygen system," a respiratory procedure where the SWFI bag was hooked up to a device called Vapotherm to provide support for patients in respiratory distress. During the interview, CNE, DARC, and DOP 1 acknowledged the potential for harm to the patients if the SWFI solutions were inadvertently administered intravenous and proceeded to remove the bags.


A review of the hospital's policy and procedure titled "High Alert Medication Safety Practices," dated January 2013, reflected no inclusion SWFI as one of the high alert medications, and no oversight by the Pharmacy Department.

The Institute for Safe Medica

Based on observation, interview, and document review, the hospital failed:

1. To ensure intravenous (IV) medication expiration dating was consistent;

2. To ensure compounded medications were labeled with an expiration date;

3. To ensure pharmaceuticals removed from the manufacturer's protective overwrap had an expiration date from removal date; and

4. To ensure unusable medications were not available for patient use.

5. To ensure that a used vial of midazolam (a medication used for sedation and for reducing pain), which was not ordered by the patient's physician, was not left in the patient's medication cassette drawer.

The hospital failures had the potential for patients to receive expired or less than labeled strength medications and also had the potential for patients to receive medications that were not intended for the patient.

Findings:

1. A tour was conducted of the main pharmacy's Intravenous (IV) Room with the Director of Pharmacy (DOP) 1 on April 28, 2014 at 12:30 PM. During the tour, multiple pre-mixed IV bags were found in the medication refrigerator and on the medication cart with two expiration dates. One IV bag contained an expiration date on a small sticker affixed to the bag, the second expiration date was printed on the pharmacy label and the two dates did not match. The sticker that was affixed to the IV bag indicated that the IV bag expired on May 23, 2014, while its pharmacy label reflected that it expired on May 26, 2014. DOP 1 agreed that the expiration date labeling had conflicting expiration dates, which would lead to confusion for the user (i.e. nursing staff), and had the potential for the medication to be used beyond its true expiration date.

During an inspection of one of the medication rooms at the Seven North Unit (7North, a Medical/Surgical Unit) in the presence of DOP 1 and Charge Nurse (CN) 2 on April 29, 2014 at 10:10 AM, four IV bags contained two conflicting expiration dates. CN 2 was asked when the IV bags would expire, she responded with the expiration date printed on the pharmacy label. When shown that the sticker had a shorter expiration date than the one on the pharmacy label, she said she would use whichever was shorter. The DOP and CN 2 acknowledged it was confusing to have two expiration dates on one product.

2. During the same visit to the 7North Medication Room on April 29, 2014 at 9:30 AM in the presence of DOP 1 and Pharmacist 1, two compounded (mixed) acyclovir (an antiviral medication) IV bags were found in the medication refrigerator without an expiration date. Pharmacist 1 said the pharmacy staff failed to put an expiration date on the pharmacy label before dispensing the medication.

The hospital policy and procedures titled "Medication Labeling," dated May 2012, indicated, "Medications shall be properly labeled" and "all medications prepared in the hospital are correctly labeled with... expiration date when not used within 24 hours."

3. On April 29, 2014 at 3:10 PM, during a visit to the Emergency Department (ED) with DOP 1, Pharmacist 1, and Assistant Clinical Director (ACD) 2, two IV solution minibags of D5NS (dextrose 5% in normal saline, for mixing with medication to deliver via infusion) were found without the overwrap and without a labeled expiration date. When asked about the labeled expiration date, ACD 2 said the product was good till the manufacturer's expiration date on the bag. Pharmacist 1 said they were only good for 14 days outside of the overwrap.

The U.S. Food and Drug Administration documented the following in the Patient Safety News, dated December 2003, Show #22:
"Once IV bags are removed from their overwraps and exposed to room air, the rate of evaporation increases. And over time, the drug's concentration will increase because the amount of drug in the bag stays the same while amount of fluid decreases...Manufacturers do have recommendations on how long an IV bag can be used after the overwrap is removed,...Some companies say that certain bags should be discarded after several days if they don't have an overwrap...The time span depends on the material used for the IV bag, the volume of solution, and drug in the solution."


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4. During a tour of the hospital's Pharmacy's IV (intravenous) Room, a place sterile medications are made for injection to patients by vein, on April 28, 2014 at 3:20 PM, eleven 10-ml injectable vials of Sodium Phosphate (electrolyte supplement) were identified as past the expiration date on the vials labeled with "Discard after 4/26/14."

During a concurrent interview, the DOP 2 and Pharmacist 4 acknowledged that the vials were expired two days ago and should have been removed.

The facility's policy and procedure titled, "Drug Disposition" was reviewed and it indicated,

"All expired drugs shall be stored in a separate area of the pharmacy in such a manner that they are clearly marked to be returned by our vendor and are segregated from the working inventory."

5. During the inspection of the Medication Room of the ICU (Intensive Care Unit) on May 1, 2014 at 10 AM, it was noted that there was a vial of midazolam 2mg/ml vial with 0.2 ml of residual left in the vial that was left in the patient's cassette drawer along with other medications for the patient.

During a concurrent interview, RN 36 was not able to determine, after her investigation, why the used vial of midazolam was placed in the patient's cassette since there was no physician order for that patient to receive that medication.

During a concurrent interview, Pharmacist 5 acknowledged that the vial should not have been inside the patient's cassette and that it should have been discarded.

The facility's policy and procedure titled, "Drug Disposition" was reviewed and it indicated,

"All expired drugs shall be stored in a separate area of the pharmacy in such a manner that they are clearly marked to be returned by our vendor and are segregated from the working inventory."

Based on observations, staff interviews, and record reviews, the hospital failed to maintain an effective infection control program for the minimization of infections and communicable diseases in accordance with nationally accepted infection control guidelines as evidenced by the hospital's failure to:

1. Develop and implement policies and procedures for the safe handling of enteral feedings (tube feeding in which nutrition is delivered to the patient in a liquid form through a tube ending in the stomach or small intestines). The hospital failed to follow manufacturer's guideline, for the length of time the open enteral formula could be hung at the patient's bedside (known as "hang time"). The hospital allowed hang times of up to 24 hours when the manufacturer's guidelines were for no greater than 8 hours. This failure had the potential to result in enteral formulas, with unacceptable levels of bacteria, to be delivered to the patients and result in infections in 32 patients receiving enteral formula feedings.


2. Ensure that the Sterile Processing Department (SPD), followed the manufacturer's guidelines and standards of practice (accepted infection control guidelines) for the maintenance for the fifteen hospital (15) steam sterilizers (a device used to sterilize [to clean something by destroying germs or bacteria] equipment and supplies by subjecting them to high pressure saturated steam at 249.8 degrees Fahrenheit) and seven (7) washer-disinfector machines. (The sterile processing department (SPD) in a hospital is responsible for the cleaning, decontamination, disinfection and sterilization of surgical instrumentation and medical devices to remove bioburden (bacteria living on a surface) that can cause healthcare-acquired infections {HAIs}). This failure had the potential to result in an increased risk for developing hospital acquired infections to a universe of 382 patients receiving care and treatment with the instruments, supplies and equipment processed in the SPD.

3. Ensure that the temperature and relative humidity (the amount of moisture in the air) of the sterile supply room(s) were maintained in accordance with Nationally Recognized Standards of accepted infection control guidelines (The hospital had been following the AORN (Association of peri-operative Registered Nurses) standards). This failure had the potential to result in an increased risk for developing hospital acquired infections to a universe of 382 patients receiving care and treatment with the instruments, supplies and equipment stored and processed in the SPD.


4. Ensure sanitary conditions in the dietary service department when food service equipment was not kept clean, frozen food was not stored appropriately to prevent cross-contamination, proper hand hygiene was not practiced by staff during dish washing, final sanitizing rinse temperatures were not achieved during warewashing of patients dishes and to prevent pest harborage. These practices had the potential to result in food borne illness in a medically vulnerable patient population.

5. Ensure that pediatric formula was prepared using aseptic techniques to minimize bacterial growth. This had the potential to result in food borne illness in an already medically vulnerable infant and pediatric patient population.


Findings:

1a. A review of the medical record for Patient 19 indicated that the patient was admitted to the hospital on April 20, 2014, with diagnoses that included possible viral encephalitis (an infection in the brain), leukopenia (a risk factor for infections in which there are low white blood cells) and altered level of consciousness. The physician orders included an order dated April 28, 2014, for a tube feeding of Nutren Pulmonary (a liquid nutritional formula) at 20 mL (milliliters, a measure of volume) per hour (rate of administration).

During an observation on April 29, 2014, at 11:30 AM, in Patient 19's room, a tube feeding bag labeled Nutren Pulmonary (liquid nutritional formula), 20 mL/hour, April 29, 2014, and 0610 (6:10 AM). The bag contained approximately 400 mL of formula.

During a concurrent interview with Registered Nurse 5 (RN 5), Patient 19's nurse, she stated that the usual practice was that the night shift nurses changed the formula bag and tubing every day. She further stated that the night shift nurse added the formula to the enteral formula bag for the day. She stated that the only time she, a day shift nurse, would be required to handle the enteral formula was if the physician's order for the tube feeding changed, requiring a different formula or more formula to be added to the bag. She also stated that the time written on the bag in Patient 19's room indicated the time (6:10 AM) that the formula was poured into the bag and hung at the bedside.

During a concurrent interview with Registered Dietitian 1 (RD 1), Director of Food and Nutrition Services (DFNS) and Assistant Director of Food and Nutrition Services 1 (ADFNS 1), no one was able to state the hospital policy or the manufacturer's guidelines for the hang time of the enteral formula using an open system (using reconstituted powders or ready-to-use liquids poured from the original manufacturer's container into a feeding bag).

On April 29, 2014, at 12:00 PM, the DFNS presented the hospital policy titled "Enteral Tube Feeding" (Revision Date: January 2013). The hospital policy noted "Collaborating Department(s) or Committee(s): Registered Nurses, Food and Nutrition Services Personnel, and Pharmacy Personnel." A review of the policy noted, "The feeding bag will be changed every 24 hours and labeled with date, initials, time bag hung, type of formula, and rate of infusion. Maximum amount of formula hung at one time is 4 hours." The policy did not include directions to the staff to rinse the feeding bag at any time during the 24 hours.

A review of the manufacturer's guidelines provided by the DFNS titled, "Nestle Nutrition, Hang Time: Open and Closed Systems", dated 2010, note, "Higher degrees of contamination have been found in reconstituted formulas and in open systems allowed to hang for extended periods of time (greater than 21 hours)." It further noted, "The A.S.P.E.N. (American Society for Parenteral and Enteral Nutrition) Enteral Practice Recommendations provides the following hang time recommendations: For reconstituted powdered formula or a formula with additives, a 4-hour hang time is recommended; For a commercially sterile,liquid formulas decanted (poured) from a can or brik-pak (similar to a juice box), an 8-hour hang time is recommended. These hang time recommendations assume the formula is kept at room temperature and is subject to minimal handling and manipulation. This information also indicates that the bag and administration set (tubing) should be flushed with water before adding additional formula." It further noted that, "Nestle HealthCare Nutrition follows the hang time guidelines based on best practice."

1b. A review of the medical record for Patient 20 noted that the patient was admitted to the hospital on April 27, 2014 with diagnosis that included altered level of consciousness. The physician's order included an order dated April 28, 2014, for a tube feeding of Glytrol (a liquid nutritional formula) at 5 mL per hour.

During an observation on April 29, 2014, at 1:10 PM, in Patient 20's room, a tube feeding bag labeled Glytrol, 5 mL/hour, April 29, 2014 at 0000 (midnight) contained approximately 200 mL of formula was noted. The formula was hanging for greater than 13 hours.

During a concurrent interview with RN 6, she stated that she did not add any formula to the tube feeding bag on her day shift. She could not explain why there was approximately 200 mL of formula in the bag when it would take greater than 24 hours to use that much formula.

1c. A review of the medical record for Patient 26 noted that the patient was admitted to the hospital on April 16, 2014, with diagnoses that included severe sepsis (whole body infection) and respiratory failure (difficulty breathing). The physician's orders noted an order dated April 28, 2014 for a tube feeding of Nutren 1