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Based on interview and record review, the facility's food and nutrition services failed to ensure that the nutritional needs of patients were met in accordance with acceptable standards of practice, to identify opportunities for improvement, and to ensure proper sanitization of the ice machine and other kitchen surfaces.

1. The facility failed to ensure that the nutritional needs of one of seven sampled patients at risk for nutritional compromise were met which resulted in severe weight loss as well as the potential to result in a delay in the healing of a wound. (Patient 5) (Refer to A 630)

2. The facility failed to ensure that physician's orders for nutritional supplements for a patient with severe weight loss were implemented in a timely manner. (Patient 5) (Refer to A 630)

3. The facility failed to ensure that an accurate comprehensive nutritional reassessment was completed, as required in its policy and procedure, for three of seven sampled patients at risk for nutritional compromise. (Patients 1, 4, and 5) (Refer to A 630)

4. The facility failed to ensure that physicians were notified of a significant decline involving decreased intake and weight loss for one of seven patients. This resulted in a delay in obtaining and implementing physician's orders to address this issue and a delay in revising the patient's plan of care. (Patient 5) (Refer to A 396)

5. The facility failed to ensure that there was a valid diet order for tube feeding for one of seven sampled patients at risk for nutritional compromise. (Patient 4) (Refer to A 630)

6. The facility failed to ensure that there was an adequate emergency food supply and organized detailed plan to meet the needs of patients in the event of a disaster. (Refer to A 701)

7. The facility failed to analyze collected data from Nutrition Services in an effort to identify opportunities for improvement and implement changes as part of its Quality Assessment Performance Improvement program. (Refer to A 276)

8. The facility failed to ensure that the Diet Manual was specific to the diets that the hospital routinely ordered. (Refer to A 631)

9. The facility failed to ensure that the ice machines were sanitized, according to the manufacturer's directions, and sanitization solution for cleaning kitchen surface areas was kept at the proper concentration. (Refer to A 749)

The cumulative effects of these systemic problems resulted in the inability of the facility's food and nutrition services to direct staff in such a manner to ensure organized dietetic services, to ensure needs of patients were met and resulted in the facility's failure to comply with the statutorily mandated Condition of Participation: Food and Dietetic Services.

Based on observation and interview, the facility failed to ensure that records were stored in an area that only authorized personnel had access to the records for one patient outside the sample (Patient 30). The potential outcome could result in unauthorized personnel reviewing patient's records without permission from the patient.

Findings:

On 3/14/12 at 10:35 am, Room 272 was observed to have a metal cabinet, 2 feet high by 3 feet wide, just inside the room on the right side of the wall. The cabinet was opened with Patient 30's record available to be viewed. Patient 30 was resting in the first bed in the room and was unable to see if anyone was looking at her record. The room was observed every 2 to 3 minutes for 30 minutes. Several visitors were walking in the hallway.

In an interview on 3/14/12 at 11:05 am, Administrative Nurse C stated that the metal cabinets were to remain closed for confidentiality and should only be opened when the chart was reviewed by authorized personnel.

On 3/14/12 at 11:06 am, a certified nurses aide (CNA) was observed to enter Room 272 briefly and then stepped out of the room. The metal wall unit was observed to be partially closed, but the record was still observed from the hallway. The CNA confirmed that the metal unit had been opened and she had just attempted to close the metal wall unit. This was observed by Administrative Nurse C.

Based on staff interview and record review, the facility failed to ensure that one of 29 sampled patients (Patient 19) was free from physical restraints. An order for putting up the bed rails was written on the day of admission "at family request." There was no documented justification for the use of the bed rails or evidence that the facility tried alternative measures before resorting to the use of restraints. This failure impacted the patient 's right to be free from restraints and may result in harm to the patient, including death by entrapment.

Findings:

On 3/12/12, the clinical record for Patient 19 was reviewed. The record revealed that Patient 19 was a 74-year-old who was admitted on 2/23/12. On 2/23/12, an order for "4 rails up @ family request" was written. On top of the order form, there were five items on a checklist for the "Clinical Indications for Restraints," and none were checked. On 3/15 /12 at 11 a.m., the record was reviewed with Admin Nurse A. It revealed a nurse's note, written on 2/24/12 at 3:20 a.m., that indicated patient's "family requests four rails up for safety."

The order for restraints, four rails up, was renewed on 2/24/12. The time the order was written was not legible. Similar to the order from the day before, none of the clinical indications was checked. In the nurses notes, on 2/25/12 at 1:53 a.m., it was also documented that patient's "family requests four rails up for safety." There was no documentation that the facility attempted to use "...alternative to restraints" as listed on the top of the restraint form.

Based on staff interview and document review, the medical staff failed to ensure that the bylaws included a statement of the duties and privileges of each category of medical staff.

Findings:

On 2/12/12, during the entrance conference commencing at 8:52 a.m., the medical staff bylaws and rules and regulations and other the medical staff bylaws and rules and regulations were requested of the hospital. The same afternoon at 2:05 p.m., the medical staff bylaws and rules and regulations were delivered and subsequently reviewed. During review, it was noted that the medical staff bylaws did not define the various categories of membership and did not specify the duties or privileges of the various medical staff categories. The current "Medical Staff Bylaws and Rules and Regulations" were adopted by the Medical Staff Executive Committee on 3/22/11 and approved by the Governing Board on 6/11/11. Article III, beginning on page 13, titled, "Categories of the Medical Staff" and section "3.1 - Categories" stated, "Each Medical Staff member shall be assigned to a Medical Staff category based upon the qualifications defined in the Rules (see Rule 1, Categories of Membership). The members of each Medical Staff category shall have the prerogatives and carry out the duties defined in the Bylaws and Rules ..." The "Rules and Regulations of the Medical Staff" is a separate document comprising 11 pages and consisting of 22 numbered rules. The first rule titled, "1. Meetings" begins on page 2 and has no information about the medical staff categories. There is no rule title that is similar to "Categories of Membership" and none of the various rules defines the categories or specifies any prerogative or duties for the medical staff members.

On 3/13/12 in an interview commencing at 3:45 p.m., the bylaws and rules and regulations were concurrently reviewed with the Medical Staff Coordinator (Admin Staff B). She acknowledged that there was no section in the rules and regulations that defined the medical staff categories or their corresponding prerogative or duties. She attributed this to a possible oversight during the drafting of amendments to these governance documents in early 2011.

Based on interview and record review, the facility failed to ensure that physicians were notified of a significant decline involving decreased intake and weight loss for one of seven sampled patients reviewed who were at risk for nutritional compromise. This resulted in a delay in obtaining and implementing physician's orders to address this issue and a delay in revising the patient's plan of care. (Patient 5)

Findings:

On 3/12/12, a review of Patient 5's record disclosed that he was admitted on 1/23/12 with a diagnosis that included a Stage IV (full thickness loss with exposed bone, tendon, or muscle) pressure ulcer (bedsore) and Downs Syndrome (a birth defect including mental retardation). Patient 5 had been on a regular diet without supplements since 1/29/12.

Patient 5's weight was checked on a weekly basis. On 1/29/12, Patient 5 weighed 51 kilograms (kg, one kg is equal to 2.2 pounds). On 2/19/12, Patient 5's weight remained stable at 51 kg, then decreased to 48.5 kg on 2/26/12. This represented a weight loss of 4.9% in one week. There were no documented interventions that addressed this weight loss.

On 3/4/12, Patient 5's weight had decreased further to 48.3 kg. This represented a weight loss of greater than 5% in two weeks. There were no documented interventions that addressed this weight loss.

On 3/13/12, Patient 5 weighed 46.5 kg. This represented a weight loss of greater than 8% body weight in less than four weeks.

On 3/14/12 at 7:35 am, Physician P (the physician who treated Patient 5's pressure ulcer) was informed by the surveyor that Patient 5 had lost a significant amount of weight and was on a regular diet, not a high protein diet. Physician P stated he was unaware of Patient 5's weight loss and stated that Patient 5 looked quite thin. He then wrote orders to increase protein intake with two protein supplements per day, increase to a maximum of four per day per tolerance and a nutrition consult.

During an interview on 3/15/12 at 10:25 am, Registered Nurse (LN) Q reviewed Patient 5's Kardex (a card in the patient's chart that included diet orders and other specific items in the patient's care plan) and stated that Patient 5 was not on dietary supplements. LN Q then reviewed the physician's orders and confirmed that Patient 5 supplements and a nutrition consult had been ordered the prior day.

During an interview on 3/14/12 at 9:45 pm, Admin Nurse C stated that the nurses should have notified the physicians of Patient 5's intake and weight loss because it was a change in condition and did not do so.

The facility policy titled, "Assessment and Reassessment," last revised 3/11, required the plan of care to be reviewed every shift and revised as the patient's condition or diagnosis changes. It required any changes in condition to be communicated to the multidisciplinary team.

Based on interview and record review, the facility failed to ensure that records were accurately written and completed for four of four sampled patients (Patients 4, 9, 10, and 11) who received conscious sedation (drug-induced, mild depression of consciousness) and for one of seven sampled patients who was at risk for nutritional compromise. (Patient 5). These failures resulted in incomplete and inaccurate documentation of services.

Findings:

1. On 3/13/12, Patient 4's record review was conducted. Patient 4 had conscious sedation for a Bronchoscopy (Visual inspection of the interior tracheobronchial tree of the lungs) on 12/2/11 as an inpatient. The following documentation was inaccurate or incomplete in the record:
a. The form, "History and Physical/Sedation Physician Documentation," documented that a re-assessment immediately prior to the procedure, dated 12/2/11, listed the pre-procedure diagnosis as pneumonia. Under physical examination, the respiratory assessment was documented "WNL (Within normal limits). A post procedural note by the same physician read, "Lungs; coarse breath sounds." The pre procedural respiratory examination did not reflect that Patient 4 had pneumonia.
b. The form, "Bronchoscopy Procedure Record," did not have height, weight, or respiratory therapist name and initials. The electrocardiogram (electrical tracing of the hearts rhythm, EKG) was at the bottom of the page, without date, time, patient's name, and interpretation of the heart rhythm. The post procedure did not have documentation of level of consciousness and pain score with every set of vital signs taken as per facility's policy. There was no evidence that cardiac monitoring continued during and after the procedure per policy and standard of practice. The last Aldrete score (numeric objective scoring system provides consistent verification of patient status) for discharge scored that Patient 4's blood pressure was similar to the pre procedure, however there was no documentation of the blood pressure at the time of discharge.
c. The physician's orders included 15 milliliters (ml) of Lidocaine 2% (localized anesthetic) via nares (external opening of the nose) (Patient had a tracheostomy, an opening into the trachea through the neck) to be given, but there was no documentation that the medication was given to Patient 4. There was no documentation of any medications that the respiratory therapist administered so that the patient could tolerate the insertion of a scope down the tracheostomy and into the lungs.

According to the policy "Sedation, Procedural: Adult," dated 1/09, under During Procedure/Administration of Sedation, the Registered Nurse must assess and document the following at least every 5 minutes during medication administration and for 30 minutes after medication administration: blood pressure, pulse, continuous cardiac monitoring, respiratory rate, continuous O2 saturation, continuous end tital CO2 if ordered by physician, level of consciousness, and pain intensity.

2. On 3/13/12, Patient 9's record review was conducted. Patient 9 had conscious sedation for a Bronchoscopy on 1/13/12 as an outpatient. The following documentation was incomplete in the record:
a. The history and physical was incomplete, dated 1/9/11. There was no systems review, such as physical limitations, past procedures, family history, and social history, The only systems reviewed were cardiac, pulmonary, and airway. There was no indication for the procedure Bronchoscopy.
b. The form, "Bronchoscopy Physician Documentation for Sedation," under re-assessment immediately prior to the procedure, was signed and dated 1/9/12. The procedure was conducted on 1/13/12, four days later.
c. The form, "Bronchoscopy Procedure Record," did not have baseline vital signs documented. The nurses progress notes documented a series of events without documented times of when the events occurred. The scoring of the level of consciousness was documented 15 and 14 during and after the procedure (different measurement scale used to evaluate level of consciousness) but the initial assessment scoring only reached "2." The last systolic (top number of the blood pressure, BP) BP documented 98 was the difference of 35 millimeter of Mercury from the first reading of 133. The last Aldrete score did not reflect the drop in BP. There was no evidence that cardiac monitoring continued during and after the procedure per policy and standard of practice.
d. There were two EKG tracings labeled "pre and post." The time, date, and interpretation was not documented.
e. There was no discharge order for the outpatient procedure.
f. The preoperative medication orders for Versed, Fentanyl, and Morphine were not specific orders, but gave ranges such as Versed 0.25 mg to 1 mg, and Fentanyl 25 mcg to 100 mcg, and Morphine Sulfate 5 mg to 10 mg. Only Versed and Fentanyl were documented given to the patient. Morphine was not given per physician's order.

According to the policy, "Sedation, Procedural: Adult," dated 1/09, under pre-procedure, the Registered Nurse must assess and document baseline vital signs. Under documentation, the nurse was to record the Aldrete score pre-sedation and a minimum of every 15 minutes for 30 minutes post-sedation and at discontinuation of post-sedation monitoring.

3. On 3/13/12, Patient 10's record review was conducted. Patient 10 had conscious sedation for a Bronchoscopy on 2/24/12 as an outpatient. The following documentation was incomplete in the record:
a. The history and physical was incomplete. The only systems reviewed were cardiac, pulmonary, and airway. There was no indication for the procedure.
b. The form, "Bronchoscopy Procedure Record," had no time documented when the vital signs were done immediate pre-sedation and sedation began. The scoring of the level of consciousness was documented 15 and 14 during and after the procedure, but the initial assessment scoring only reached "2." A different measurement scale was used to evaluate level of consciousness instead of the Aldrete score.
c. There was an EKG tracing without the time, date, and interpretation documented. There was no evidence that cardiac monitoring continued during and after the procedure, per policy and standard of practice.
d. The form, "Outpatient Bronchoscopy Nursing Record," had blanks for the amount of Versed (sedative) and Fentanyl (narcotic) administered during the procedure and blanks for start and stop time of these two medications.
e. There was no discharge order for the outpatient procedure.
f. The preoperative medication orders for Versed, Fentanyl, and Morphine were not specific orders, but gave ranges such as Versed 0.25 mg to 1 mg, and Fentanyl 25 mcg to 100 mcg, and Morphine Sulfate 5 mg to 10 mg. Only Versed and Fentanyl were documented given to the patient. Morphine was not given per physician's order.

4. On 3/13/12, Patient 11's record review was conducted. Patient 11 had conscious sedation for a Bronchoscopy on 12/2/11 as an outpatient. The following documentation was incomplete in the record:
a. The history and physical was incomplete. The only systems reviewed were cardiac, pulmonary, and airway. The indication for procedure was due to fibrosis (formation of scar tissue in connective tissue resulting in decreased breath sounds or prone to pneumonia) The documentation was that the lungs were within normal limits.
b. The form, "Bronchoscopy Procedure Record," did not have documentation of pain level during the procedure. The scoring of the level of consciousness was documented 15 and 14 during and after the procedure, but the initial assessment scoring only reached "2." A different measurement scale was used to evaluate the level of consciousness instead of the Aldrete score)
c. The form, "Outpatient Bronchoscopy Nursing Record," documented the medications, Versed and Fentanyl given throughout the 40 minute procedure starting at 10:20 am to 11 am. The form, "Bronchoscopy Procedure Record did not reflect that the medication was given throughout the procedure.
d. There was an EKG tracing after conscious sedation was administered without the interpretation documented. There was no evidence that cardiac monitoring continued during and after the procedure, per policy and standard of practice.
e. There was no discharge order for the outpatient procedure.

According to the policy, "Sedation, Procedural: Adult," under Documentation, "Attach baseline EKG strip and additional EKG strip(s) if rhythm change occurs."

According to AORN (Association of periOperative Registered Nurses) "Perioperative Standards and Recommended Practices," the recommended practices for managing the patient receiving moderate sedation/analgesia, Recommendation VI, reads, "The perioperative registered nurse should continuously monitor the patient throughout the procedure...VI.a. The perioperative registered nurse, at a minimum, should continuously monitor the patient's heart rate and function via electrocardiogram; oxygenation using pulse oximetry; respiratory rate and adequacy of ventilation; blood pressure; level of consciousness; comfort level; and skin condition ar regular intervals...Vital signs should be monitored before the start of the procedure, after administration of sedative or analgesic medications and at least every five minutes during the procedure based on the patient's condition, type and amount of medication administered and length of procedure.

In an interview on 3/15/12 at 7:30 am, Administrative Nurses A and C verified the missing and incomplete documentation for records of Patients 4, 9, 10, and 11.


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5 a. On 3/12/12, a review of Patient 5's record disclosed that he was admitted on 1/23/12 with a diagnosis that included a Stage IV (full thickness loss with exposed bone, tendon, or muscle) pressure ulcer (bedsore) and Downs Syndrome (a birth defect including mental retardation).

There was a physician's order, dated 3/7/12, to apply a wound vac (a treatment to improve wound healing) to the pressure ulcer.

During an interview on 3/15/12 at 8:45 am, Licensed Nurse R confirmed that the wound vac had been applied, as ordered on 3/7/12.

The physician's assistants who examined Patient 5 on a daily basis continued to write in their progress notes from 3/8 through 3/12/12 that Patient 5's wound vac had been discontinued.

During an interview on 3/15/12 at 12:45 pm, Admin Staff N confirmed that the notes from the physician's assistants were inaccurate.

5 b. The weekly nutritional intakes, as documented by nursing staff for the weeks from 2/21 through 2/27, 2/28 through 3/5, and 3/6 through 3/12, showed that Patient 5 ate less than 50% for five out of seven days for each of the three weeks.

Despite the consistently documented poor intake by nursing staff, the following was written by the physician's assistants who saw Patient 5 on a daily basis. On 3/8/12, it was noted that Patient 5 had a fair appetite. On 3/9/12, it was noted that Patient 5 had a good appetite and on 3/12/12, it was noted that he had a strong appetite.

During an interview on 3/15/12 at 12:45 pm, Admin Staff N confirmed that the notes from the physician's assistants were inaccurate.

During an interview on 3/15/12 at 7:15 am, Admin Nurse A confirmed that the physicians had been trained on the computer so they had access to information documented by the nurses.

Based on interview and record review, the facility failed to ensure that a complete history and physical examination (H & P) was documented within 30 days, prior to a procedure requiring anesthesia services, for 4 of 4 sampled patients who received conscious sedation (drug-induced, mild depression of consciousness) for a Bronchoscopy procedure (Visual inspection of the interior tracheobronchial tree of the lungs). (Patients 4, 9, 10, and 11). These failures could potentially result in not identifying risk for potential complications during and after the procedure.

Findings:

On 3/13/12, a review of Patients 4, 9, 10, and 11 records was conducted. The documentation of incomplete H & P examinations is as follows:
a. Patient 4's, "History and Physical/Sedation Physician Documentation," documented that on the day of the Bronchoscopy, 12/2/11, the patient had pneumonia. The physical examination, pulmonary was documented "WNL (Within normal limits). A post procedural note by the same physician read, "Lungs; coarse breath sounds." The respiratory examination did not reflect that Patient 4 had pneumonia. The only systems reviewed were cardiac, pulmonary, and airway.
b. Patient 9's H & P was incomplete. There was no systems review, such as physical limitations, past procedures, family history, and social history, The only systems reviewed were cardiac, pulmonary, and airway. There was no indication for the procedure, Bronchoscopy.
c. Patient 10's H & P was incomplete. The only systems reviewed were cardiac, pulmonary, and airway. There was no indication for the procedure.
d. Patient 11's H & P was incomplete. The only systems reviewed were cardiac, pulmonary, and airway. The indication for procedure was due to fibrosis (formation of scar tissue in connective tissue resulting in decreased breath sounds or prone to pneumonia). The pertinent physical findings for pulmonary was documented, "WNL."

In an interview on 3/15/12 at 7:30 am, Administrative Nurses A and C verified the missing and incomplete documentation in the H & Ps for Patients 4, 9, 10, and 11.

Based on interview and record review, that facility failed to ensure an updated examination of the patient prior to a procedure requiring anesthesia services for 1 of 4 sampled patients who received conscious sedation (drug-induced, mild depression of consciousness) (Patient 9). The potential outcome could result in unforeseen complications from the procedure.

Findings:

On 3/13/12, Patient 9's record review was conducted. Patient 9 had conscious sedation for a Bronchoscopy (Visual inspection of the interior tracheobronchial tree of the lungs) on 1/13/12, as an outpatient. There was no documented evidence that an updated examination was in the record within 24 hours, prior to the procedure. The form, "Bronchoscopy Physician Documentation for Sedation," under re-assessment immediately prior to the procedure, was signed and dated 1/9/12. However, the procedure was conducted on 1/13/12, four days later.

In an interview on 3/15/12 at 7:30 am, Administrative Nurses A and C verified that an updated examination within 24 hours, prior to the Bronchoscopy procedure, was not in Patient 9's record.

Based on observation, staff interview, and record and policy reviews, the facility failed to ensure that pharmaceutical services met the needs of patients when policies and procedures to provide safe and effective use of drugs were not developed or implemented as evidenced by:

1. Medications were not controlled, distributed, and administered to provide patient safety, which resulted in identification of Immediate Jeopardy situations for fentanyl use. In addition, facility's policies and procedures for monitoring medication storage, labeling medications, and documenting pain assessment were not implemented. (Refer to A 0500)

2. Medications were not administered in accordance with policy, acceptable standards of practice, or the order of the physician. (Refer to A 404)

3. Outdated and unusable medications and biologicals were available for patient use. (Refer to A 505)

4. An automatic stop order policy did not reflect the manufacturer's specification for Toradol when this pain medication was allowed to be used for more than 5 days, inconsistent with the boxed warning. (Refer to A 507)

5. Adverse drug reactions and medication errors were not immediately reported. (Refer to A 508)

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure the provision of quality pharmaceutical services, safely and effectively.

Based on observation, staff interview, and clinical record and document review, the facility failed to ensure patient safety when fentanyl patches were administered in a manner inconsistent with the manufacturer's recommendations for two of three sampled patients who were prescribed fentanyl patches (Patients 14 and 18). The facility failed to have a system to ensure consistent monitoring of refrigerated medications in L South medication room when four of four hospital staff were not aware of the changes in monitoring the medication refrigerator. The facility failed to ensure performance and documentation for pain assessment to ensure efficacy and prevent toxicity. The facility failed to implement their policy for labeling of inhalation medication so that it is used within specified dates. The facility failed to ensure implementation of its policy regarding medications that were brought from home to ensure the integrity of the medication and its appropriate use.

Findings:

Review of clinical records for patients receiving fentanyl patches revealed that Patients 14 and Patient 18 received fentanyl patches inconsistent with the manufacturer's specification.

The fentanyl patch, also known as fentanyl transdermal system, contains fentanyl, a potent synthetic opioid medication used to treat pain. This medication has a boxed warning which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the fentanyl patch documents that it has an associated risk of fatal overdose due to respiratory depression. It is indicated for the management of persistent moderate to severe chronic pain that requires continuous around-the-clock opioid (narcotic pain relievers derived from or having the pain relieving action of opium) administration for an extended period of time and that cannot be managed by other pain medications. Use of the patch is contraindicated in the treatment of postoperative pain. The boxed warning also documents that it should only be used in patients who are opioid-tolerant which is defined in the boxed warning as those patients who have taken at least 60 milligrams (mg) of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone daily for a week or longer or an equianalgesic dose of another opioid medication. Use of this patch to treat patients who are not opioid-tolerant is contraindicated because serious or life-threatening respiratory depression can occur.

a. On 3/14/12 at 10 a.m., the after-hours override list of medications accessed on 3/13/12, was reviewed. Override, is a function that allow nurses to remove medications from the medications automated dispensing cabinet (Med Dispense) without pharmacist review and evaluation of the appropriateness of such medication. The override list showed that a fentanyl patch 12 micrograms (mcg) was removed for Patient 14, on 3/13/12 at 10:23 p.m. Pharmacist S stated during interview, regarding fentanyl patches, that the pharmacists "key in the order and staff access it from Med dispense." On 3/14/12 at 10:20 a.m., he confirmed that fentanyl patches are available in the automated dispensing cabinets for override.

Pharmacist S was asked to demonstrate order entry for a fentanyl patch to find out the existence of any precautions or warnings. During the order entry demonstration, a pop up screen appeared, and it had language similar to that in the package insert warning to serve as a reminder for the pharmacist to ensure that patients are opioid tolerant. Pharmacist S, when asked about that warring, said, "I screen the patient's profile for the presence of orders for narcotics."
On 3/14/12 at 11 a.m., Pharmacist S confirmed that the order for fentanyl for Patient 14 was not evaluated by a pharmacist before the medication was obtained and applied. The pharmacy computer record showed that the patch was removed, on 3/13/12, at 22:25 (10:25 p.m.) by override. The Pharmacy Director stated that the pharmacists are supposed to calculate opioid use for patients to evaluate opioid tolerance, and therefore, the appropriate use of fentanyl patches. She said that they have a specific computer program to help them do the calculations.

On 2/14/12 at 2 p.m., the record for Patient 14 was reviewed with the Pharmacy Director. Patient 14 had an order, written on 3/13/12 at 1800 (6 p.m.) for fentanyl patch 12 mcg be changed every 72 hours. When the Pharmacy Director calculated the morphine equivalent dose for Patient 14, the dose came up to be about 20 mg not 60 mg, as specified in the package inserts.

Although Patient 14 had orders for pain medications which included Dilaudid (also known as hydromorphone), and Percocet, (a combination medication that has Tylenol like medication and oxycodone), he received opioid type medication for only four days not for seven days, as specified by the manufacturer labeling for the boxed warning. In addition, there was no information about Patient 14's history of opioid use before his hospital admission. Patient 14 had no evidence of being opioid tolerant and was prescribed the fentanyl patch for acute pain associated with burn. Despite the boxed warning that fentanyl is not indicated to control pain in patients who had not received around the clock opioid pain relieving medications at doses specified in the product labeling for at least a week, Patient 14 received a fentanyl patch.

b. On 3/14/112 at approximately 2 p.m., the record for Patient 18 was reviewed with the Pharmacy Director. The patient had an order for fentanyl patch 12 mcg/hour, written on 3/6/12 at 2:30 p.m. Evaluation of the amount of opioid medications (Norco), which Patient 18 received prior to the patch, was calculated by the Pharmacy Director. It was estimated that Patient 18 received about 25 mg of morphine equivalent from 2/29/12 until 3/6/12. According the package insert, Patient 18 was not considered opioid tolerant; therefore, he was not a candidate for receiving a fentanyl patch.

There was no documented evidence that the pharmacist processed the order or questioned fentanyl patch appropriateness especially considering patient's age (78-year-old) and his respiratory problems, which increases the risk of life-threatening hypoventilation (decrease in the rate respiration) associated with fentanyl patch use. Patient 18 received a fentanyl patch even though he had not received around the clock opioid pain relieving medications doses specified in the product labeling (at least 60 mg of oral morphine equivalent) for at least a week.

Review of the facility's policy for "Black Box Warnings," revised 11/10, revealed that "medications that have Black Box Warnings pose an additional challenge to patient safety in light of their potential for serious adverse consequences." The policy included fentanyl. Under warning, it was stated: " Use in opioid tolerant patients whose total daily dose is equivalent to morphine oral 60 mg/day. Not to be used in acute, intermittent, mild, or post-operative pain." The policy also indicated under "Clinical Monitoring" that "Pharmacist to review all orders and calculate dose for appropriateness ..."

Because of the facility's failure to have a system in place to protect patients from receiving medications that put them at risk for respiratory depression by using fentanyl patches in a manner that was inconsistent with directions stipulated by the Food and Drug Administration in the boxed warning, Immediate Jeopardy (IJ) was called to ensure immediate remedies.

Hospital management staff were informed of the IJ situation for fentanyl patch use, on 3/14/12, at 4 p.m. Hospital management staff presented a plan of corrective action on 3/14/12 at 5:55 p.m., to ensure appropriate use of fentanyl patches in all patients. The plan included the following elements:
1. 100 % of the Fentanyl patches have been removed form all med dispense machines.
2. The pharmacy staff will only dispense fentanyl patches during pharmacy hours.
3. The standard time for Fentanyl is currently 9AM. This time has been changed to 12 noon to assure pharmacy had adequate time to review the patient order and dispense as appropriate.
4. Notify physician and nursing staff of the change in policy.
5. All new Fentanyl patch orders occurring during non pharmacy hours will need to have an alternative pain medication.
6. All new Fentanyl patch ordered during non pharmacy hours will be dispensed during pharmacy hours.
7. Signage in the medication rooms will indicated fentanyl is only available during pharmacy hours.
8. If the patient had break-through pain, the physician will be notified.
9. This has been approved by the Chief of Staff and Governing Board member on 3/14/12

In addition, the plan of action, addressed the following two elements under "Monitoring Process to Prevent Recurrence:"

1. 100% review has been conducted on patients on Fentanyl patches. All doses have been administered per physician orders.
2. Initial Fentanyl orders will be reviewed by pharmacist to verify opioid history has been established per manufacturers' recommendations for Fentanyl Patch use.

On 3/15/12 at 5 p.m., after verification of various steps taken by hospital staff, such as removing fentanyl patches from the automated dispensing machines, informing staff of the changes in the process, and requiring pharmacists to evaluate and verify opioid tolerance before dispensing fentanyl, hospital management staff were informed that the Immediate Jeopardy was abated.

2. On 3/12/12 at 9 a.m., during tour with Pharmacist M, the L South medication room was inspected. Pharmacists M explained the hospital system for monitoring refrigerated medications. He pointed to a temperature-monitoring device on the outside top right side of the refrigerator, reading 69 degrees. He also pointed to a sheet of paper next to the monitoring device and explained that staff monitors the temperature each day, and write the minimum temperature that was reached, the maximum, and the actual temperature at time of inspection. At the time of inspection, the temperature display was observed increasing; it reached 74. It was also observed that the medication refrigerator did not have the round graphing paper where the temperature is automatically graphed. Pharmacist M said that they were not able to reorder the graphing paper.

At 9:30 a.m., the same morning, Charge Nurse L was interviewed about monitoring of refrigerated medications. She stated that the monitoring is done on a regular basis and presented a binder with monitoring sheets. The binder did not have monitoring sheets for refrigerators where medications were stored.

On 3/12/12, at 10:20 a.m., the Pharmacy Director was interviewed about the refrigerator; she explained that the device on the outside was to monitor room temperature. However, for the refrigerator temperature monitoring, there was an electronic device placed inside the refrigerator, which records the temperature every 5 minutes. The data is downloadable into a computer. She added that the device alarms with red light indicators when the temperature is out of range. There was no evidence that hospital staff knew about the new changes.

On 3/14/12 at 10:15 a.m., when Charge Nurse E, was interviewed about monitoring of the medication refrigerator, she pointed the temperature-monitoring device located on the refrigerator that displayed 69 degrees Fahrenheit. She also pointed to the monitoring sheet placed on top of the refrigerator. Charge Nurse E did not know about the device inside the refrigerator and that the temperature display was displaying room temperature not the refrigerator.

On 3/14/12 at 10:20 a.m., in the medication room, Pharmacy Technician T pointed to the display on the outside of the refrigerator to be the refrigerator temperature, although the temperature at that time was 74 degrees. She did not know about the device inside the refrigerator.

3. On 3/14/12, at 11 a.m., the clinical record for Patient 19 was reviewed with Admin Nurse A. Patient 19 had an order, dated 2/23/12, to receive Norco (5-325), one tablet every 4 hours as needed for pain. Norco is combination medication for pain that contains 5 milligrams (mg) of hydrocodone (morphine like medication) and 325 mg of acetaminophen (also known as Tylenol). Review of the record for Patient 19 revealed no documented evidence that pain assessment was performed for 7 out of 10 instances of administering pain medication. Over 3 days, from 3/10/12 to 3/12/12, there was documentation of removing Norco from the automated dispensing machine ten times. There was documentation on the medication administration record that the ten tablets of Norco were administered . However, there was no evidence of evaluating the effectiveness of the pain medication for seven out of 10 times Norco was given. Motioning therapy is essential to evaluate efficacy and prevent toxicity.

According to the Board of Registered Nursing for Pain Management Policy, proper management of patient's pain is a nursing function. Pain management includes assessing pain and evaluating response to pain management interventions; Documenting pain assessment, intervention, and evaluation activities in a clear and concise manner; And intervening to minimize drug side effects.

Facility's policy for "Pain Management," revised on 2/10, directed staff to conduct pain assessment and document results. The policy directly stated, "The effectiveness of pain management shall be documented on the Nursing Flowsheet." The policy also directed that "Treatment modification shall be made when the patient reports unrelieved pain."

4. On 3/12/12 at 9 a.m., during tour with Pharmacist M, the L South medication room was inspected. Two Advair Diskus (an inhalation medication for treatment of asthma or other respiratory diseases) were found without an expiration date on the label. The manufacturer's instruction for storage indicated,"Diskus ? device should be discarded 1 month after removal from foil pouch, or when dosing indicator reads "0" whichever comes first)."

The first Diskus was for Patient 22, and it was in use. The dosing indicator read, eight. Patient 22 had respiratory disease. The other Diskus was for Patient 17, and the device was also in use as the dosing indicator read, 14. The Pharmacy Director indicated that, per policy they give Advair Diskus, 28 days from dispensing, as the expiration date.

Review of facility's policy "Medication Management for Expiration Dates," revised 12/11, revealed that: "Multi-dose inhalers removed from an external wrapper will be labeled by Pharmacy with a 28 day expiration date."

5. On 3/12/12 at 9:30 a.m., during tour with the Pharmacy Director of L South, the medication cart was inspected. The drawer for Patient 21 contained two medication bottles for mesalamine that did not have pharmacy labels. Mesalamine is used for treatment of inflammation of the bowel (ulcerative colitis). The Director of Pharmacy said that the nurses must have put the medication in the drawer instead of taking them down to the pharmacy for identification and labeling.

Review of facility's policy, Medication Management, for Medications brought into the hospital by patients, revised 12/11, revealed that: "Medications should be inventoried, and documented on the form " Medication Brought Into Hospital Upon Admission." The bottom copy of the signed form "shall be sent to the Pharmacy along with the medications. If the Pharmacy is closed, store in a locked medications room until the Pharmacy opens."

Based on observation and staff interview, the facility failed to ensure medications were stored in locked compartments when a medication cart was observed to be unlocked. There were no nursing staff using the cart and it was not in clear view of nurses at the L South nursing station.

Findings:

On 3/13/12 at 4 p.m., the medication cart on L south nursing station was observed to be unlocked. The medication cart was outside the nursing station behind a chest high wall. The cart was not being used, and there was no nursing staff next to it. The cart was not in clear view of nurses. The concern was pointed out to Registered Nurse X who verified the deficient practice.

Based on observation, staff interview, and document review, the facility failed to ensure that expired medication was not available for patient's use. The facility allowed insulin (medication that control blood sugar) to be available for use beyond 28 days, as stipulated by facility's policy. Allowing expired medications to be used may result in treatment failure, i.e., patients may not receive the intended effects of the medication.


Findings:

On 3/12/12 at 9:30 a.m., during tour of L South with the Pharmacy Director, the medication cart was inspected. The drawer for Patient 1 contained a vial of regular insulin with no expiration date. The Pharmacy Director indicated that, per facility's policy, they give insulin 28 days from dispensing as the expiration date. Insulin is used to control blood sugar levels. The pharmacy label on the vial showed that the vial was dispensed on 2/8/12. That meant that the insulin was in use for 33 days. Allowing use of insulin beyond the indicated time will increase the risk of contamination due to multiple entries into the vial. In addition, manufacturer's do not guarantee efficacy beyond that date. Therefore, patients may not receive the intended effects of the medication.

Review of the facility's Medication Management policy, revised 12/11, for Labeling of Drug Products, revealed that: "All multi-dose vials of injectables shall be labeled with the date opened and a "Discard date" (expiration date) of 28 days unless otherwise stated by the manufacturer or Pharmacy Department."

Based on interview and policy review, the facility failed to ensure that its "Medication Management" policy, revised 12/11, for Automatic Stop/Renewal Orders, was consistent with the manufacturer's specifications for Ketorolac use. Ketorolac is a pain medication that according to its labeling, has a boxed warning limiting its use for five days. The facility's policy allowed use of this medication for 10 days. Extended use of ketorolac may lead to patient harm by increasing the risk of irritation, inflammation, ulceration, bleeding, and perforation of the stomach or the intestines.
Findings:
Ketorolac (also known as Toradol), is a medication used for pain that has a boxed warning indicating that " ... ketorolac is indicated for short term (less than or equal to 5 days) use in adults for treatment of moderately severe acute pain ... The combined therapy duration (oral and parenteral) should not exceed 5 days." A boxed warning is added by the Food and Drug Administrator (FDA) to the labeling of medications when certain contraindications or serious warnings, particularly those that may lead to death or serious injury, are identified based on clinical data.

On 3/12/12, review of facility's Medication Management policy, revised 12/11, for Automatic Stop/Renewal Orders, revealed "...Ketorolac reviewed after 10 days."

In an interview on 3/15/12, the Pharmacy Director said that when orders for Ketorolac are inputted into the pharmacy computer system, they are given 5 days. However, the facility's policy for Automatic Stop/Renewal Orders, Medication Management, did not reflect the facility practice and was not consistent with the warning outlined in the package insert for Ketorolac.

Based on staff interview and record review, the facility failed to ensure that adverse drug reactions were immediately reported to the hospital-wide quality assurance program when one of 29 sampled patients (Patient 19) experienced "extreme lethargy" (sleepiness), a side effect associated with hydromorphone (pain medication similar to morphine.) On 2/25/12, Patient 19 had to be administered another medication, Narcan (a drug used to reverse the effects severe sedation or respiratory depression caused by excessive use of morphine like medications), twice to reverse the adverse side effects. Failure to report the adverse drug reaction immediately placed Patient 19 at risk for experiencing the same adverse effect or respiratory depression, and will prevent the facility from using the information for performance improvement.
Findings:

On 3/12/12, the clinical record for Patient 19 was reviewed with hospital staff. The record revealed, on 2/25/12 at 9:50 a.m., a "now" order for 0.3 milligrams (mg) of Narcan. Patient 19 had an order for pain medication to be administered through a PCA (patient controlled analgesia), which is specific device that allows patients to self-administer pain medications (analgesics) based on need. The order for Dilaudid (pain medications) PCA was written on 2/24/12, to administer 0.4 mg every hour as continuous rate and a 0.4 mg on demand by the patient with a lock out interval of 10 minutes. The usual recommended demand dose for a healthy adult patient for Dilaudid (hydromorphone) by PCA is 0.1-0.2 mg with a range: 0.05-0.4 mg. Patient 19 was started on 0.4 mg, which is an excessive dose for a 74-year-old patient. Review of nurse's notes with Admin Nurse A revealed documentation that on 2/25/12 at 7:25 a.m., Patient 19 was "very lethargic." At 10 a.m., the same morning, it was documented that Patient 19 experienced "extreme lethargy;" that the physician was notified; the PCA was stopped; (and) 0.3 mg of Narcan was given twice.

On 3/15/12 at 1 p.m., Admin Nurse A confirmed that the 7:25 am adverse drug reaction to hydromorphone for Patient 19 was not reported when identified.

Review of the facility's policy for "Adverse Drug Reactions," revised 11/11, revealed: "Medications used for rescue use (to counteract adverse effects of medication,) i.e. ...Naloxone ..., will be investigated for potential adverse reactions." There was no evidence that the pharmacy department investigated or reported this incident.

Based on observation, interview, and document review, the facility failed to ensure that periodic inspections of equipment were done for the x-ray department. The potential outcome could result in using unsafe equipment, exposing patients to unnecessary radiation.

Findings:

On 3/12/12 at 10:05 am, the x-ray equipment in the Radiology Room did not have documented evidence that an inspection for safety had been conducted. In a concurrent interview, Radiology Technologist stated that the documentation was kept in the Quality Assurance Department. A request for the written documentation was made with the Radiology Technologist.

On 3/15/12 at 3:20 pm, Administrative Nurse A provided documentation that the x-ray equipment in the Radiology Room had been inspected on 3/14/12, however, she confirmed that there was no record of previous inspections since they had purchased the equipment in 2008.

Based on interview and record review, the facility failed to ensure that the nutritional needs of one of seven sampled patients at risk for nutritional compromise were met when interventions to address weight loss were not instituted in a timely manner, to ensure that the patient's physician was informed of the weight loss, as well as failure to start nutritional supplements in a timely manner, once physician's orders had been obtained. (Patient 5)

The above failures resulted in severe weight loss as well as the potential to result in a delay in the healing of a Stage IV (full thickness loss with exposed bone, tendon, or muscle) pressure ulcer (bedsore).

The facility failed to ensure that a comprehensive accurate nutritional reassessment was completed, as required by the facility's policy and procedure, for three of seven sampled patients at risk for nutritional compromise (Patients 1, 4, and 5) and to ensure there was a valid diet order for one sampled patient receiving tube feeding. (Patient 4)

The above failures have the potential to result in compromising the nutritional and clinical status of the patients.

Findings:

1a. On 3/12/12, a review of Patient 5's record disclosed that he was admitted on 1/23/12 with a diagnosis that included a Stage IV pressure ulcer and Downs Syndrome (a birth defect including mental retardation). Upon admission, Patient 5 had Ensure Plus ordered as a dietary supplement, but this was discontinued on 1/29/12. Since that time he had been on a regular diet without supplements.

Patient 5's weight in kilograms (kg, one kg equals 2.2 pounds) was checked on a weekly basis:
1/29/12 - 51 kg
2/19/12 - 51 kg
2/26/12 - 48.5 kg
There were no documented interventions that addressed this weight loss of 4.9% in one week:
3/4/12 - 48.3 kg
There were no documented interventions that addressed this weight loss of greater than 5% in two weeks.
3/13/12 - 46.5 kg
This represented a weight loss of greater than 8% body weight in less than four weeks.

On 3/14/12 at 11:40 am, the following weight loss parameters, which are a recognized standard of care, were discussed with Registered Dietitian (RD) H. Severe weight loss is considered to be 5% or greater loss of body weight within one month, 7.5% or greater loss within three months, or 10% or greater loss within six months. RD H stated he was aware of these parameters but was focused on outcome and did not view Patient 5's weight decrease from 51 kg to 48.5 kg on 2/26/12 as significant. He confirmed that from the time the Ensure was discontinued on 1/29/12 until Patient 5 was reweighed on 3/13/12, no other supplements were tried.

1b. A review of Physician O's (Patient 5's admitting physician) history and physical, dated 1/25/12, noted,"Protein-calorie malnutrition. . . Patient will require protein supplements."

A review of Physician P's (the physician treating Patient 5's pressure ulcer) consultation reports, dated 2/1/12 and 3/7/12, noted, "The patient will continue his high-protein diet."

During an interview on 3/13/12 at 4:45 pm, RD H stated that a regular diet provided about 100 grams of protein if 100% of all three meals was eaten. It was then discussed with RD H that the documented daily intakes showed that Patient 5 ate 50% or less for 50 of 63 meals during the preceding three week period from 2/12 through 3/12/12. When offered to review the weekly intakes in order to confirm percentages eaten, RD H declined to do so. RD H confirmed that according to his assessment, Patient 5 needed to eat 75% of all meals to meet his estimated protein needs.

On 3/14/12 at 7:35 am, Physician P was informed by the surveyor that Patient 5 had lost a significant amount of weight and was on a regular diet, not a high protein diet. Physician P stated he was unaware of Patient 5's weight loss and stated that Patient 5 looked quite thin. Physician P also stated that he had thought that Patient 5 was on a high protein diet. He then wrote orders to increase protein intake with two protein supplements per day, increase to a maximum of four per day per tolerance, and a nutrition consult.

During an interview on 3/14/12 at 9:45 am, Admin Nurse C stated that although it was a "team effort" between all disciplines in managing a patient, the RD had the primary responsibility to assess nutritional needs including nutritional intake and weight loss and discuss this with the patient's physicians.

During an interview the following day, on 3/15/12 at 10:15 am, the Dietary Staff Supervisor (DSS) confirmed that Patient 5 was on a regular diet with no supplements ordered. DSS confirmed there was no order for supplements. DSS stated that if he had an order for a protein powder shake it would take him only a few minutes to prepare it.

During an interview on 3/15/12 at 12 pm, Admin Staff N (RD H's supervisor) confirmed that the supplements had not been ordered and it was RD K's responsibility to ensure that the supplements were ordered from the dietary department.

The facility's document titled, "Position: Clinical Dietitian", last revised on 3/15/06, was reviewed. It read as follows, "implements nutrition therapy orders and verifies implementation of orders."

1c. The facility's policy titled, "Nutritional Assessment Process", last revised 5/10, was reviewed. It required the Clinical Dietitian to complete nutritional assessment on all new admissions and a "full comprehensive nutritional assessment for patients who experience a decline or change in condition."

RD H had completed an initial full assessment for Patient 5 on 1/24/12. This assessment included estimated calorie needs, protein needs, and fluid needs in addition to appetite, weight, lab results and diet. Weekly assessments by RD H included Patient 1's weight, diet, Albumin, (a lab test showing protein) and food intake. The assessments did not include calorie, protein and fluid needs or an accurate estimate of what Patient 5 was actually consuming in regards to calories, protein or fluids.

The weekly assessments by RD H included the following as intake percentages:
2/28/12 - 20 - 75%
3/6/12 - 25-75%
3/13/12 - 25-100%

The patient intakes as recorded by the nurses on a daily basis were reviewed. The weekly intakes for the weeks from 2/21 through 2/27, 2/28 through 3/5, and 3/6 through 3/12 showed that Patient 5 ate less than 50% for five out of seven days for each of the three weeks. The total fluid intakes showed Patient 5 received enough fluids, as assessed by RD H on 1/24/12, for six of 21 days from 2/21 through 3/12/12.

During an interview on 3/15/12 at 11 am, both Admin Staff N and Admin Nurse A confirmed that the nursing documentation regarding intakes was accurate.

RD H documented an assessment on 3/14/12 at 10:09 am that included the following: "On a regular diet, providing greater than two grams per kg of protein." This would have been accurate had Patient 5 been eating 100% of all meals, but according to the intakes documented by the nurses he usually ate less than 50%. This had been discussed with RD H on 3/13/12. RD H also wrote, "Patient has refused health shakes," despite the fact that health shakes had just been started at lunchtime the prior day, therefore Patient 5 had refused only one health shake.

Even though Patient 5 experienced significant weight loss and decline by 2/26/12, and Physician P ordered a nutritional consult on 3/14/12, a full comprehensive and accurate nutritional assessment had not been completed as of the time of the survey exit.



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2a. Patient 4 was readmitted on 1/9/12 with diagnoses that include mechanical ventilation, respiratory failure, and abdominal aortic aneurysm (the large blood vessel that supplies blood to the abdomen, pelvis, and legs becomes abnormally large or balloons outward).

Patient 4 was admitted weighing 132 pounds and was 68 inches with a Body Mass Index (BMI) of 20. (A BMI of 18.5 to 24.9 indicates a normal weight. BMI is a number calculated from a person's weight and height. BMI provides a reliable indicator of body fatness for most people and is used to screen for weight categories that may lead to health problems).

Review of the initial nutrition assessment, dated 1/10/12, indicated Patient 4 had unintentional weight loss of 5 or more pounds and was receiving tube feeding (TF) or total parental nutrition (nutrition being provided through the vein). The estimated calories were assessed to be 1500 calories (kcals) per day, 90 grams (g) of protein per day and 1500 ml of fluids per day. The TF order was 300 milliliters (ml) of Jevity 1.2 for five feedings per day. The TF provided 1440 kcals and 83 g of protein. The Registered Dietitian (RD) indicated Patient 4 was at high nutritional risk. The plan indicated to monitor the need for an elemental feeding, monitor stooling and protein, monitor wound, labs as well as weight and tolerance to feeding. The TF order as ordered did not meet his estimated nutrition needs. But there was no documented evidence the RD had any interventions to ensure Patient 4's nutritional needs were met.

Review of the Interdisciplinary Team (IDT) Meeting notes, dated 1/17/12, indicated Patient 4 had a stage I pressure ulcer to the coccyx. There was no documentation for the nutrition section indicating that the RD was aware and/or had reevaluated the patient's nutritional needs. Review of the IDT notes, dated 1/24/12, indicated that Patient 4's weight decreased to 56.5 kg, which is 4 kg or 8.8 pounds in approximately two weeks and 6.7% weight loss which is considered to be a severe weight loss. The RD indicated the TF had been changed to Peptamen 1.5 at 70 ml per hour times 16 hours. The RD noted the weight loss was likely an indication of increased absorption.

The relationship between increased tube feeding absorption and weight loss is unclear. Typically, increased absorption of formula or nutrients would result in better nutrition and possibly weight gain. The new tube feeding order provided 1680 calories and 75 grams of protein. There was no recommendation at this time and the RD did not note if the TF was meeting the estimated needs of the patient at this time.

Review of a Nutrition Note, dated 1/27/12, indicated the RD was asked to review TF due to the patient having high residuals (excess amount of stomach fluid). The RD noted Patient 4 was producing stool and the albumin was 2.3 grams (g) per deciliter (dL) (normal values 3.5 to 5 g/dL) and the calcium level was 10.9 milligrams (mg) per dL with the corrected calcium to be approximately 12.3 (normal values 8.4-10.2 mg/dL) which the RD indicated could cause decreased peristalsis and the RD discussed with the nurse. No interventions or recommendations were documented at this time.

Review of the IDT note, dated 1/31/12, indicated in the nutrition section that the TF was on hold due to possible aspiration. There were no interventions or recommendations documented. Review of the Nutrition Note, dated 2/3/12, indicated the RD received a Nutrition Consult regarding Patient 4 having intermittent emesis and TF being held. The RD noted the respiratory notes showed thick secretions. The RD indicated Reglan (Metoclopramide) is a medicine that increases the movements or contractions of the stomach and intestines) continued and that the gut was functional although it was slow. There was no intervention or recommendation on how to meet Patient 4's nutritional needs. Review of the IDT notes, dated 2/7/12, indicated in the nutrition section that there was a rapid response on 2/2 and TF off and resumed 2/5. Patient 4 was receiving TF of Peptamen 1.5 at 35 ml per hour. There was no mention if the TF was meeting the patient's estimated nutrition needs at this time. There was no intervention or recommendation documented.

Review of the Nutrition Note, dated 2/17/12, indicated the RD received a consult regarding Patient 4 for an order for TPN of 15% carbohydrate and 5% amino acid at 75 ml per hour plus 20% Intralipids at 10 ml per hour. TPN is used when the gastrointestinal system is not absorbing nutrients properly, functioning properly or if the bowel needs to rest. This order was not initiated because the patient pulled out the line, the route of administration. The RD indicated Patient 4 had received TF of Peptamen 1.5 at 50 ml without residuals on 2/16. Therefore, the tube feeding was not discontinued.

Review of two IDT notes, dated 2/21/12 and 2/28/12, indicated Patient 4 was receiving TF of Peptamen 1.5 at 50 ml per hour. This order was lower in calories and protein than the original Peptamen order of 2/5/12. On 2/28/12 the RD indicated Patient 4's weight was 54 kg and there was no change since 1/10. Document review did not support the documentation of stable weight. Review of the weight record, dated 1/10/12, indicated Patient 4 weighed 60.5 kg, and 2/26/12 was 54 kg. Patient 4 had a 14.3 pound and 10.7% weight loss in approximately 7 weeks. There was no comprehensive reassessment of the patient or mechanism documented for Patient 4 to regain the lost weight.

On 3/6/12 a new nutrition assessment was conducted. It indicated Patient 4 had unintentional weight loss and was on TF. The RD documented Patient 4 weighed 51 kg (112 lbs) at this time and had a BMI of 17 (which indicates the patient to be underweight). The estimated kcals were 1300 and estimated protein needs were 75 grams per day. The TF was Peptamen 1.5 at 50 ml per hour which provided 95 g of Protein and 1800 kcals per day. The RD indicated Patient 4 was underweight and had involuntary weight loss. The RD indicated a nutrition diagnosis of malnutrition with severe weight loss and low weight related to the disease process, intolerant to bolus feeds and peptide formulas as evidenced by poor tolerance, prior to Peptamen orders to Jevity 1.2 with high residuals and large emesis. The RD noted the patient to be at high nutrition risk. The estimated needs at this time were just to meet Patient 4's nutritional needs at this point in time not to regain the lost weight.

On 3/14/12 at 11:04 a.m. an interview was conducted with RD H. RD H stated he is problem oriented and that is how he charts, therefore, he only discusses what the current problems are. When asked, RD H agreed the standard of practice for an assessment and reassessment would include discussing what the TF, TPN or oral diet provides and how much of that is meeting the estimated nutrition needs of the patient. When asked why this wasn't done on Patient 4, RD H did not comment.

On 3/14/12 at 3:30 p.m. an interview was conducted with RD H. When asked, RD H agreed that as a RD he should be the nutrition expert and advocate for the patients nutritional status, therefore, he would need to document all things relating to the TF, TPN, and oral diet. RD H acknowledged the standard of practice is to document if the patient has had any weight loss especially if it was a severe weight loss and then to intervene and make a recommendation to correct the condition.

Review of the hospital policy titled, "Nutritional Assessment Process," revised 5/10, indicated the RD completes a nutrition assessment for all new admissions within 72 hours. The RD contributes to the Patient Care Plan and makes appropriate recommendations based on professional judgment and accepted standards of practice. It indicates additional medical record entries are made as often as required by the patient's condition. It indicates the RD completes a full comprehensive nutritional assessment for patients who experience a decline, or change in condition. The RD guidelines for determining levels of nutritional risk indicated a patient who is high risk will be reassessed every 72 hours, moderate risk every 5 days, and low risk every 7 days.

Review of the hospital policy titled, "Assessment and Reassessment," revised 3/11, indicated for clinical nutrition the time frame of reassessment is based on level of nutrition risk and the scope of reassessment is the response to treatment and medical interventions/orders; response to interventions noted in the patient's plan of care; need for communication to members of the care team.

2b. Review of Patient 4's physician's orders, dated 1/23/12 and timed 6:00 p.m., indicated to hold PEG feeds due to high residuals. Then to restart after three hours at 40 ml per hour and advance as tolerated to 60 ml per hour. (Percutaneous endoscopic gastrostomy is an endoscopic medical procedure in which a tube is passed into a patient's stomach through the abdominal wall, most commonly to provide a means of feeding when oral intake is not adequate). This order did not state the type of formula the patient was to receive.

Another physician's order, dated 1/27/12 and timed 3:30 p.m., indicated a telephone order verified by RD H when the TF is restarted to run at 45 ml per hour around the clock. This order did not state the type of formula the patient was to receive.

Review of the physician's orders, dated 1/30/12 and timed 8:00 a.m., indicated to hold tube feeding aspiration precautions. Review of the physician's orders, dated 2/14/12 and timed 7:30 p.m., indicated to restart the tube feeding at 30 ml per hour. This order did not state the type of formula the patient was to receive.

Review of the physician's orders, dated 2/14/12 and timed 4:00 pm., indicated to hold tube feeds overnight. Review of the physician's orders, dated 2/15/12 and timed 7:30 a.m., indicated to restart tube feeds at 50 ml per hour and check residual in four hours. This order did not state the type of formula the patient was to receive.

On 3/14/12 at 10:42 a.m. an interview was conducted with Charge Nurse E regarding physician's orders. Charge Nurse E stated when there is a tube feeding order to be restarted, it should include the type of formula and rate. Charge Nurse E stated that the physician's orders should have been clarified then rewritten in the orders.

Review of the hospital's policy titled, "Physician's orders," revised 5/10, indicated all orders must be written clearly, legibly, and completely.

Review of the scope of practice for nursing (provided by the hospital staff) for administering an intermittent feeding via gastric tube in the stomach, indicated to check the physician's order for type, amount and frequency of feeding.

3. Patient 1 was admitted to the hospital on 2/8/12 with diagnoses that included mechanical ventilation, respiratory failure and chronic obstruction pulmonary disease (COPD) exacerbation. Review of the History and Physical indicated Patient 1 was very thin and somewhat cachectic (physical wasting with loss of weight and muscle mass due to disease). Review of the physician's orders, dated 2/8/12, indicated a diet order for tube feeding of Jevity 1.2 infusing at 65 ml per hour with 250 ml of free water flushes every four hours. Review of the physician ' s orders, dated 2/9/12, indicated to discontinue Jevity 1.2 after the next bag hung and to start Crucial at 45 ml per hour with the same water flush.

Review of the Nutrition Assessment, dated 2/10/12, indicated Patient 1 was on TF or TPN. The RD indicated Patient 1 was 59 kg and 5 '11" with a BMI of 18. A BMI less than 18.5 indicates underweight. The estimated kcals were 1650 plus or minus 10% which is approximately 28 kcals per kg and 78-89 grams of Protein which is 1.3-1.5 g per kg. The RD indicated Patient 1 was receiving Crucial at 45 ml per hour with 250 ml water flush every 4 hours which provides 1620 kcals, 97 grams of Protein and 2255 ml free water. It indicated the patient is underweight and has a history of weight loss. It indicated Patient 1's usual body weight was 64 kg and was at high nutrition risk. The nutrition assessment indicated the estimated nutrition needs to meet Patient 1's needs this point in time, however, did not address a mechanism to regain the lost weight or to get back to the usual body weight of the patient. There was no documented evidence to show that Patient 1 should not regain the lost weight.

Review of the weight record, dated 2/9/12, indicated Patient 1 was 59 kg; 2/12/12 indicated Patient 1 was 60 kg; and 2/19/12 indicated Patient 1 was 54.5 kg. Patient 1 lost 9.9 pounds and had a 7.6% weight loss over 10 days which is a severe weight loss.

Review of the IDT note, dated 2/21/12, indicated in the nutrition section that the patient was 55 kg and was receiving Impact Peptide 1.5 at 45 ml per hour. There were no interventions or recommendations documented at this time. There was no mention of the weight loss. The current TF regimen provided 1620 kcals and 68 g Protein which was less than Patient 1's estimated needs to regain the lost weight.

On 3/14/12 at 3:30 p.m. an interview was conducted with RD H. When asked, RD H agreed that as a RD he should be the nutrition expert and advocate for the patients nutritional status, therefore, he would need to document all things relating to the TF, TPN and oral diet. RD H acknowledged the standard of practice is to document if the patient has had any weight loss especially if it was a severe weight loss and then to intervene and make a recommendation to correct the condition.

Based on staff interviews and document review, the hospital failed to have a therapeutic diet manual that was specific to the diets that the hospital routinely ordered and provided guidance to the medical, nursing, and food service staff for the ordering and preparation of patient meals. Lack of a comprehensive diet manual that reflected the hospital diets may result in inaccurate guidance to dietary and hospital staff when meeting the nutritional needs of the patients.

Findings:

Review of the hospital's diet list, dated 3/13/12, revealed there were a variety of diets being provided including: 2000 calorie ADA (diabetic) diet, 1800 ADA diet, CC/RCS (limited concentrated sweets), 2 gram sodium, and renal diets.

On 3/13/12 at 4:13 p.m., an interview was conducted with the Registered Dietitian (RD) H regarding the diet manual. RD H stated the hospital uses the American Dietetic Association's on-line Nutrition Care Manual (NCM) as their diet manual. RD H stated that the NCM provided nutrition information regarding many different diets for various diagnoses. When asked, RD H stated the NCM did not define many of the different diets provided by the hospital such as the 1800 calorie or 2000 calorie diabetic diet or how the hospital defines the Renal diet (in terms of the amounts of protein, sodium, potassium or phosphorus). RD H was unable to state how the NCM could be used as guidance for ordering or preparing patients diets.

Review of the hospital policy titled, "Diet Manual," revised 1/10, indicated the diet manual outlined current guidelines for regular, texture modified, and therapeutic diets and it shall be used as a reference in menu planning.

Based on observation, staff interviews, and document reviews, the facility failed to ensure the overall environment was developed and maintained in such a manner that assured the safety and well-being of the patients when the Dietary Staff Supervisor failed to maintain adequate disaster food supplies and an organized, detailed plan to meet the needs of the patients in the event of a disaster.

Findings:

On 3/12/12 beginning at 2:45 p.m., food service for disaster preparedness was reviewed. During a concurrent interview with the Dietary Staff Supervisor (DSS), he stated the plan was for 88 patient beds and 100 staff and they were providing a three day disaster menu consisting of non-perishable food items. The Disaster menu was reviewed and the inventory of the food items was checked. There was no inventory at the hospital for dry milk powder, canned chicken, or pureed meat. The disaster menu indicated canned chicken would be used for two meals on two different days. There were food items in the disaster storage area that were not on the planned menu or on the inventory list. It is uncertain how these items would be used during a disaster. Upon further review of the disaster menu for day two indicated they would serve yogurt and on day three they would serve hard cooked eggs. It is unclear how these food items would maintain the appropriate temperature of 41 degrees Fahrenheit or below. The disaster menu indicated shelf stable milk was to be served. The DSS stated they were trying to decide if they could order shelf stable milk or if they would have to use the dry milk powder.

On 3/13/12 at 8:55 a.m., an interview was conducted with the Registered Dietitian H (RD H) regarding the disaster menu. RD H stated the DSS had informed him of the yogurt being on the menu. The surveyor stated there were also hard cooked eggs on day three of the disaster menu. When asked, RD H stated he had not noticed those items were there and did not know how they were to maintain the proper temperature for that long. When asked about how the puree food items were to be pureed as the menu indicated, RD H stated he thought they had a hand crank or battery operated blender. At this time, he asked the DSS. The DSS stated they did not have one of those on hand. The DSS stated he planned to serve canned pureed meat and other puree items. The surveyor indicated those items were not listed on the disaster menu at this time.

Based on observation, staff interviews, and document review, the facility failed to ensure systems for the identification and control of the spread of bacteria and infection by failing to ensure: 1) the ice machines were maintained in a sanitary environment according to the manufacturer's directions; 2) sanitation buckets were maintained at the appropriate concentration; and to 3) implement its equipment cleaning policy governing control of infections and communicable diseases in the physical therapy department for 11 of 11 sampled patients (Patients 4, 5, 8, 19, 20, 21, 22, 25, and 27) and 7 outside of the sample patients (Patients 31 - 37), who were in contact isolation (containing an infective area with barriers) that received physical therapy and 6 of 6 sampled patients (Patients 2, 3, 6, 13, 14, and 28) that received physical therapy. This can result in the growth of microorganisms.

The facility failed to ensure that hospital staff was actively involved in controlling infections and communicable diseases of patients and personnel when Registered Nurse K administered medications to Patient 17 through a tube that goes directly to the stomach, and then moved directly, without removing the gloves or performing any hand hygiene, to provide oral care and administer intravenous medications (medications by injection through the veins). This failure posed a risk for Patient 17 to develop infections from to the spread of bacteria.

Findings:

1a. On 3/12/12 at 11:25 a.m., a white thick substance was observed on the bin and water trough of the ice machine located in the kitchen. An interview was conducted at this time with Engineering Staff F regarding the cleaning of the ice machine. Engineering Staff F stated they only clean the coils and the filter and the rest is done by the kitchen staff.

On 3/12/12 at 2:30 p.m., an interview was conducted with Dietary Staff I regarding the cleaning of the ice machine. Dietary Staff I stated he cleans the interior of the ice machine once a month. He stated he uses a warm water soap solution then he wipes it dry, rinses it with water then dries it. After that he uses a spray sanitizer that contains quaternary ammonia. When asked, Dietary Staff I stated he doesn't clean any part of the ice machine that requires a screw driver which is the top part of the ice machine.

Review of the ice machine cleaning schedule posted by the ice machine indicated it was cleaned in January, February and March.

Review of the hospital policy titled, "Cleaning Procedures: Equipment," reviewed 3/07, indicated the interior of the ice machine should be washed with detergent solution then rinsed with clean water and a clean cloth. Then apply sanitizing solution with a spray bottle and allow to air dry.

Review of the Manitowoc manufacturer's directions indicated the cleaning procedures were to use only the Manitowoc Ice Machine Cleaner for removal of lime scale or other mineral deposits. The cleaning solution of the ice machine cleaner is 16 ounces of cleaner to one gallon of warm water and to remove build up from the top, sides and bottom extrusions, the inside of the ice machine panels and the entire inside of the ice bin. It indicated to clean the evaporator surface by adding two ounces of cleaner to the water trough and allow solution to circulate a maximum of 10 minutes then thoroughly rinse trough with clean water. Then sanitize ice machine after cleaning. It indicated to add one ounce of sanitizer to water trough and allow solution to circulate a minimum of one minute then to thoroughly rinse trough with clean water and to wash all surfaces requiring sanitizing (ice machine and bin) with a solution of one ounce of sanitizer to up to four gallons of water.

1b. On 3/13/12 at 3:25 p.m., in nourishment room 261, a joint observation was made with the Director of Engineering, in which the chute of the ice machine had a white substance located around the bottom of the chute. The chute also contained a black substance located on one side. A concurrent interview was conducted at this time with the Director of Engineering regarding the cleaning of the ice machines in the nourishment rooms. The Director of Engineering stated they clean the ice machine with spraying bleach and water in the bin and then they flush with water. When asked, the Director of Engineering stated they do not use an ice machine cleaner just the bleach. The Director of Engineering stated the environmental services should do daily cleaning of the chute and the outside of the ice machine.

On 3/13/12 at 3:45 p.m., in nourishment room 293, an observation was made of the chute of the ice machine which had light brown spots located towards the top of the chute.

Review of the hospital policy titled, "Ice Machine Cleaning Instructions," reviewed 8/11, indicated the ice machine shall be cleaned monthly by the Plant Operations Department. It indicates to clean the ice machine with a cleaning solution of one teaspoon of chlorine bleach in one gallon of water. Then it shows to sanitize the ice machine by using one teaspoon of chlorine bleach in one gallon of water.

Review of the Scotsman manufacturer's directions indicated to schedule the sanitation, cleaning and de-mineralization on a regular basis to keep the ice clean, mix eight ounces of Scotsman Ice Machine Cleaner and three quarts of hot potable water and pour into the reservoir, wait 15 minutes for the cleaner to dissolve the minerals inside the evaporator, and then it indicated to use a sanitizing solution by mixing one ounce of household bleach with two gallons of clean, warm water.

2. On 3/13/12 at 2:38 p.m., Dietary Staff I was asked to check the concentration of one of the sanitation buckets located in the prep sink in the cold prep area. When Dietary Staff I checked the concentration, it was observed to show 0 parts per million (ppm). Dietary Staff I stated he thought it could be 100 ppm. Dietary Staff I stated that was not his sanitation bucket. Dietary Staff I then took the concentration of his sanitation bucket which was located in the prep sink in the cook area. The concentration was observed to be 0 ppm. Dietary Staff I stated he filled up his bucket when he came on shift which was at 12 noon and he should have changed it out at 2:00 p.m.

On 3/13/12 at 2:40 p.m., the surveyor asked the Dietary Staff Supervisor (DSS) to check the sanitation bucket in the cook area. The DSS stated it was at 0 ppm which was not appropriate. The DSS went to the three compartment sink where the staff fills up the buckets with sanitizer. The DSS filled up a bucket with sanitizer and it still read 0 ppm. The DSS stated there were air bubbles in the line where the sanitizer comes out. He let it run for a few minutes until the bubbles went away and then filled up the bucket. At that time, the sanitizer read 400 ppm.

Review of the Mt Hood Solutions pro quaternary 100 test procedures, located on the wall above the three compartment sink, indicated the appropriate concentration for the quaternary ammonia is 200-400 ppm.

On 3/14/12 at 4:20 p.m., an interview was conducted with the Infection Control Nurse (ICN). The ICN stated she goes into the kitchen to do the environmental care rounds and the rounds are rotated with three other administration staff so she is in there about every four weeks. The ICN stated she looks at overall cleanliness of the kitchen, temperature logs, sanitation logs, ice machine logs, expiration dates of the foods and spices, and storage rooms. When asked, the ICN stated that she only looks at the logs of the ice machine and sanitation but hasn't ever checked the condition or levels. The ICN stated she would add those things to her rounds now.

Review of the Environment of Care Rounds for the kitchen, dated 3/8/12, 2/3/12, 12/8/11, 10/7/11, and 8/4/11, did not indicate any items relating to the ice machine, sanitation logs or concentration of sanitation buckets to be checked during the rounds.


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3. In an interview on 3/14/12 at 7:30 am, the Infection Control Nurse (ICN) stated that Sani Cloth Plus Wipes (germicidal disposable wipes) were to be used on equipment between patient use. The equipment should be wet for 5 minutes between patients.

On 3/14/12 at 10:20 am, Physical Therapist Assistant U was observed to wipe down the metal bars immediately after patient use, one time with Sani Cloth Plus Wipes (germicidal disposable wipes). Two minutes later another patient was using the bars. Physical Therapist (PT) V was observed to wipe down bars one time and then place the bar on a large brown table. At 11:10 am, PT J was observed to wipe down the parallel bars twice with wipes and followed by wiping down the bars a minute and a-half later with a paper towel. The Physical Therapy Supervisor was in the department when these observations occurred.

According to the directions on the label, the Sani Cloth Plus Wipes should be used to wipe down equipment once to clean and then to follow with a second wipe to disinfect the equipment and allow to air dry. The area was to remain wet for 3 minutes to disinfect (free from pathogenic organisms) the equipment.

In an interview on 3/15/12 at 10 am, Physical Therapy Supervisor stated that the method to clean the equipment in PT would be to wipe down all equipment after use and air dry for 5 minutes and then store the equipment if necessary. He stated that he was aware of the observed practice on 3/14/12 of PT staff.

According to the policy, "Equipment Cleaning and Disposal," dated 5/10, under Policy, "All equipment (vital sign machines, poles, pumps, respiratory equipment, etc.) will be cleaned between patients and whenever soiled. Equipment will be cleaned with a germicidal detergent...Use one wipe to clean the surface, then a second to disinfect the surface, with a wet time (the length of time the item must stay wet) of 5 minutes. Let air dry."


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4. On 3/12/12 at 8:14 a.m., Registered Nurse K was observed administering Patient 17's morning medications through the "PEG" tube. Percutaneous Endoscopic Gastrostomy, (PEG) is a flexible tube inserted through the skin to the stomach, held in place with a balloon like tip, and the other end is taped to the skin outside. The PEG tube may be used for food, liquid, or to give medicine. The nurse with gloved hands administered the medications through the PEG, flushed the tube with water, disconnected the syringe, opened an oral care kit, attached a brush to the suction tube, cleaned the patient's mouth, and applied medication to the inside of the mouth with the brush. The nurse then proceeded to give a dose of vancomycin through the patient's vein. The nurse did not remove the gloves that she used to administer medication through the PEG or perform hand hygeine.

The nurse was stopped and Admin Staff N was consulted about the practice.

The policy for administering medication though tubes was requested, and Charge Nurse L presented the facility's procedure. The facility used "Clinical Nursing Skills (2008), Seventh Edition," as their procedures. On page 383 of the book, the procedure for administering medication through tubes was reviewed, it listed ten different steps; the last step # 10 instructed to "Remove gloves and perform hand hygiene."

On 3/15/12, at 4 p.m., the Infection Control Nurse presented the facility's policy on "Handwashing," revision date 10/04. The policy listed that if hands are not visibly soiled, alcohol based waterless antiseptic agent may be used for routinely decontaminating hands. The policy listed one of the conditions for use of alcohol agent:as "...c. After moving hands from a contaminated body site to a clean body site." The policy also indicated that hand washing "shall also be done when: ... c. After handling patient utensils or personal articles."

Based on staff interview and document review, the hospital failed to implement written protocols related to its organ procurement responsibilities.

Findings:

The hospital had not developed or implemented any written protocols related to organ procurement responsibilities; as a result the hospital had no written protocols to ensure that hospital staff members were encouraged to be discreet and sensitive with respect to the circumstances, views and beliefs of families of potential organ tissue donors. (Refer to A890)

Based on staff interview and document review, for organ and tissue donors, for seven of seven administrative documents provided and reviewed, the hospital failed to develop or implement written protocols to ensure that hospital staff members were trained and encouraged to use discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential organ donors.

Findings:

On 3/13/12 at 9:00 a.m., the hospital's policies, procedures, protocols, contracts and training logs pertaining to organ, tissue and eye procurement were requested. Within an hour some documents were delivered and others were brought forward on 3/13 at 3:15 p.m. and on 3/14 at 2:35 p.m.

Those initially presented (on 3/13/12 at 9:00 a.m.) consisted of three documents:
1) The Policy and Procedure (P/P) titled "Anatomical Donations For Transplantation," created in September 2002 and revised in August 2006.
2) A contract with an OPO1 (Organ Procurement Organization number 1) signed on 1/26/12 by an officer of the OPO1 and on 2/1/12 by the hospital Chief Operating Officer, and
3) A report from OPO1 titled "(name of the OPO1) Hospital Reports for (name of hospital)" containing data from 2011 and with an attachment letter dated 2/15/12.

Four additional documents were presented later (on 3/13/12 at 3:15 p.m. and 3/14/12 at 2:35 p.m.):
4) "Notice of Expiration", a form used to assure that all necessary tasks are completed after a patient dies,
5) "Annual ReOrientation 2011" - an annually required module intended to give the (employee) an overview of important information on general safety guidelines,
6) "Annual ReOrientation 2012" - the same module updated for 2012, and
7) 'New employee orientation packet' - information given to all newly hired hospital employees.

On 3/13/12 commencing at 10:10 a.m., the Director of Quality Management (Admin Nurse A) was interviewed and concurrently reviewed the first three documents provided. She explained that the P/P was outdated, because it refers to two organ procurement organizations (OPO) whereas currently only one OPO exists. The fact that the other organ procurement organization (OPO2) had gone out of existence was not discovered until late 2011 when OPO2 failed to provide their customary annual report and failed to respond to telephone calls. She explained that the new contract with OPO1, entered into in February 2012 had OPO1 assuming the duties previously shared by both OPO1 and OPO2. During that same interview, Admin Nurse A acknowledged that the presented P/P was the only existing written directive to the hospital staff pertaining to organ, tissue or eye procurement. Also, that P/P does not contain any guidance that directs the staff to be trained and/or encouraged to use discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential organ donors. Also during that interview, Admin Nurse A stated that the only written instructive material provided to hospital staff member, pertaining to organ procurement, was given to them with their orientation packet when first being hired and then on an annual basis in the employee's annual re-orientation

In a subsequent interview at 3:15 p.m. on 3/13/12, additional relevant documents were provided and Admin Nurse A was joined by the R.N. Clinical Supervisor (Admin Nurse D) in an interview during which the additional documents were explained. Admin Nurse A acknowledged that the hospital did not have an established training program or other protocols to ensure the hospital staff were trained to be sensitive and discrete when working with families of potential donors. However she asserted that the orientation manual and the annual re-orientation packets did have some information that instructed staff to be sensitive to the needs of the families of potential organ donors.


On 3/14/12 at 2:50 p.m., the new employee orientation packet and the two annual re-orientation modules were inspected in detail. The new employee orientation packet contained no information concerning the organ procurement process or related requirements. The two annual re-orientation modules are 16 and 20 pages respectively. Each is designed as a "self-learning module" and includes a 45 or 40 answers (respectively) questionnaire. In these two re-orientation modules the only organ procurement information stated the following: "Organ Donation: Upon the death of a patient/resident, contact the (name of OPO1). The (OPO1) will assess for eligibility of organ/tissue donation. If donation is deemed appropriate, their staff will discuss donation options with the family and/or decision maker."

Based on interview and document review, the facility failed to ensure the implementing of policy and standard of practice for documenting continuous cardiac monitoring prior, during, and after for those who have received conscious sedation (drug-induced, mild depression of consciousness) and using the Hepa filter (air purifier) during Bronchoscopy procedures (Visual inspection of the interior tracheobronchial tree of the lungs) for 4 of 4 sampled patients (Patients 4, 9, 10, and 11). These failures resulted in heart rhythms not being interpreted, and compromised air exchanges increased the risk for fires, infections, and poor surgical outcomes to patients.

Findings:

On 3/13/12, a review of Patient's 4, 9, 10, and 11 records were conducted. Each of the patients had conscious sedation during a Bronchoscopy procedure. The following was identified:

a. There were tracings of the electrocardiogram (EKG, heart rhythm) in the records, but did not have a baseline (prior to conscious sedation) tracing of the EKG, or documented date, time and interpretation of the heart rhythm. There was no evidence that continuous cardiac monitoring occurred prior, during, and after the administration of conscious sedation.

In an interview on 3/15/12 at 7:30 am, Administrative Nurse A and C stated that Patient's 4, 9, 10, and 11 were missing either the baseline EKG tracing, date, time, or interpretation of the heart rhythm during the administration of conscious sedation and there was no documentation when cardiac monitoring was discontinued.

According to the policy, "Sedation, Procedural: Adult," dated 1/09, under During Procedure/Administration of Sedation, read, "The Registered Nurse must assess and document the following at least every 5 minutes during medication administration and for 30 minutes after mediation administration...Continuous cardiac monitoring. Attach baseline EKG strip and additional EKG strips if rhythm change occurs."

According to the AORN (Association of periOperative Registered Nurses) "Perioperative Standards and Recommended Practices 2012 Edition," the recommended practices for managing the patient receiving moderate sedation/analgesia, Recommendation VI, reads, "The perioperative registered nurse should continuously monitor the patient throughout the procedure...VI.a. The perioperative registered nurse, at a minimum, should continuously monitor the patient's heart rate and function via electrocardiogram (cardiac monitoring); oxygenation using pulse oximetry; respiratory rate and adequacy of ventilation; blood pressure; level of consciousness; comfort level; and skin condition ar regular intervals...Vital signs should be monitored before the start of the procedure, after administration of sedative or analgesic medications and at least every five minutes during the procedure based on the patient's condition, type and amount of medication administered and length of procedure.

b. Patient 4's procedure was from 12:35 to 12:48 pm. The Hepa filter was turned on at 12:25 and off at 12:50 pm.

Patient 9's procedure was from 11:05 to 11:25 am. The Hepa filter was turned on at 7 am, but there was no documentation when the system was turned off.

Patient 10's procedure was from 9:30 to 9:35 am. The Hepa filter was turned on at 7 am, but the documentation when the system was turned off was illegible.

Patient 11's procedure was from 10:20 to 11 am. The Hepa filter was turned on at 9 am, but the documentation when the system was turned off was illegible.

In an interview on 3/15/12 at 7:30 am, Administrative Nurses A and C stated that Patient 4's documentation indicated that the Hepa filter was not turned on and off according to policy and Patients 9, 10, and 11 were unknown due to the lack or illegibility of the documentation.

According to the policy, "Bronchoscopy, Fiberoptic (type of transfer of images)," dated 4/11, under Policy, "All bronchoscopies must be done in the Radiology Suite with portable Hepa filter unit running for 15 minutes before, during, and for 15 minutes after the procedure is completed."

According to the AORN (Association of periOperative Registered Nurses) "Perioperative Standards and Recommended Practices 2012 Edition, under Safe Environment of Care, Recommendation V, "Potential hazards associated with HVAC (heating, ventilation, and air conditioning) systems in the practice setting should be identified, and safe practices should be established...V.d.1. The minimum rate of total air exchanges per hour should be maintained at a constant level as follows. Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges...Postanesthesia care unit: 6 air exchanges per hour...Sterile storage area: 4 air exchanges per hour."

Based on interview and document review, the facility failed to ensure that there were discharge orders, evidence that the patient was discharged with a responsible adult, and written discharge instructions did not include the follow up appointment for 3 of 3 sampled patients (Patients 9, 10, and 11) who had received conscious sedation (drug-induced, mild depression of consciousness) for outpatient procedures. These failures could result in an unsafe discharge from the facility.

Findings:

On 3/13/12, a review of Patients 9, 10, and 11 records were conducted. The following was identified:
a. The form, "Bronchoscopy Physician Orders," did not have a discharge order for outpatients.
b. The form, "Post Procedure," did not have evidence that patients receiving conscious sedation were discharged with an adult to drive them home.
c. The form, "Bronchoscopy Discharge Instructions," used to review discharge instructions, did not include the follow up appointment with the physician and that written discharge instructions were given to the patient.

In an interview on 3/15/12 at 7:30 am, Administrative Nurses A and C reviewed Patients 9, 10, and 11 records and stated that there were no discharge orders, no documented evidence that an adult accompanied the patients home, evidence that written instructions were given upon discharge, and no documented evidence that the patients were informed of the follow up visit with the physician.

According to the AORN (Association of periOperative Registered Nurse) Perioperative Standards and Recommended Practices 2012 Edition, under Postoperative Patient Care, regarding Discharge Instructions, read, "Written postoperative and follow-up care instructions should be provided to each patient and should reflect the patient's individual informational needs specific to home care, response to unexpected events, and follow-up by the physician. Discharge instructions should be reviewed with the patient and a responsible adult before discharge."

Based on staff interview and document review, the facility failed to track quality indicators, including adverse patient events, and other aspects of performance that evaluate processes of care. The facility failed to ensure that adverse drug reactions were immediately reported to the hospital-wide quality assurance program and that the facility's policy for investigating use of rescue agents, such as Narcan, for potential adverse reactions was implemented. The facility failed to ensure that all potential errors and near misses were reported, tracked, and analyzed for identification of potential areas for improvement to reduce errors and ultimately improve patient safety.

Findings:

On 2/25/12 at 9:50 a.m., Patient 19 had a "now" order for 0.3 milligrams (mg) of Narcan, also known as naloxone, which is used to reverse the effects severe sedation or respiratory depression caused by excessive use of morphine like medications. Patient 19 had an order for pain medication to be administered through a PCA (patient controlled analgesia), which is a specific device that allows patients to self-administer pain medications (analgesics) bases on need. The order for Dilaudid (pain medication) PCA was written on 2/24/12, to administer 0.4 mg every hour as a continuous rate and 0.4 mg on demand by the patient with a lock out interval of 10 minutes. The usual recommended demand dose for a healthy adult patient for Dilaudid by PCA is 0.1-0.2 mg with a range: 0.05-0.4 mg. Patient 19 was started on 0.4 mg, which is an excessive dose for a 74-year-old patient. Review of nurse's notes with Admin Nurse A revealed documentation that on 2/25/12 at 7:25 a.m., Patient 19 was "very lethargic." At 10 a.m., the same morning, it was documented that Patient 19 experienced "extreme lethargy;" that the physician was notified; the PCA was stopped;and 0.3 mg of Narcan was given twice.

On 3/15/12 at 1 p.m., Admin Nurse A confirmed that this incident was not reported.

Review of the facility's policy for "Adverse Drug Reactions," revised 11/11, revealed "Medications used for rescue use (to counteract adverse effects of medication,) i.e. ...Naloxone ..., will be investigated for potential adverse reactions." There was no evidence that the pharmacy department investigated or reported this incident.

In an interview on 3/15/12 at 11:40 a.m., Admin Nurse A stated that the facility's medication error report was two errors for every thousand doses dispensed (0.2%) compared to the Corporate rate of less than 2%. The Director of Pharmacy explained that near misses and potential errors that do not reach patients were not reported or included in the calculations. By not including the near misses and potential errors, tracking, trending, or evaluating them, the hospital did not evaluate potential system weaknesses, and therefore, did not identify opportunities for improvement.

Based on staff interview and document review, the facility failed to monitor the effectiveness and safety of services provided when the facility did not ensure that patients or their physicians were contacted when recalled medications were potentially used, and that the contract for Radiological Services was written in a manner consistent with state regulation, so that the hospital is ultimately responsible for care of the patients.

Findings

1. On 2/12/12 at 2 p.m., the Pharmacy Director was interviewed about the facility's drug recall policy. Review of the facility's policy "Medication Management: Drug Recall or Discontinuation" revealed the following: "All Patient Medication Profiles will be reviewed by a pharmacist to see if inpatients are receiving recalled drugs." The policy did not include any follow up measures such as informing patients or their physicians that they may have received a recalled drug product, associated risks, or steps to be taken. The Pharmacy Director confirmed that there were situations where the pharmacy had to pull recalled medications off the shelf and that patients may have received a recalled product.

2. On 12/15/12 at 11 a.m., the contract for Radiological Services was reviewed with Admin Nurse A. The contract did not specify that the hospital retains professional and administrative responsibility for the service rendered. Such clause is specified in California Code of Regulation, Title 22, section, 70713.

Based on staff interview and document review, the facility failed to analyze collected data from Nutrition Services, track performance improvement, and develop performance improvement plans in an effort to identify opportunities for improvement and implement changes to improve patient care.

Findings:

On 3/14/12 at 3:30 p.m., an interview was conducted with Registered Dietitian (RD) H regarding the Quality Assurance Performance Improvement (QAPI) program for the Nutrition Services Department. RD H stated they do not track any performance improvement for clinical nutrition. RD H stated he does tray assessments each month and he reports them to the Standards of Care Committee. RD H stated he checks 30 trays each month to make sure the diets match the diet orders, as well as check the diet orders with the physician's orders in the medical records.

Review of the Standards of Care Committee meeting minutes for 2011 indicated RD H will review the reports on a quarterly basis. Review of the tray accuracy reports, dated 2011, indicated in three of the six reports most of the errors in the diet orders in the chart that did not match the diet orders on the diet sheet were Tube Feeding (TF) orders. However, there was no analyzing or developing a plan on the data on how to improve.

Further review of the tray accuracy reports, dated January 2011 to September 2011, indicated the threshold was 95% for all of the food service quality probes. Two out of the 8 months the threshold was not met for the food texture was appropriate for the diet. Four out of the 8 months the threshold was not met for food and condiments matching the therapeutic diet. One out of the 8 months the threshold was not met for the food on the tray matching the selection on the tray card. Five out of the 8 months the threshold was not met for the diet orders matching the diet order on the diet sheet.

There were nutrition care issues identified during the survey where patients had not been comprehensively assessed by the RD during their admissions severe weight losses and changes in condition were not comprehensively assessed by the RD (Refer to A 630 for additional information). The hospital failed to accurately identify areas of opportunities for improvement that could be analyzed and implement changes and mechanisms that could be put in place to bring about improvements in nutrition care.

On 3/14/12 at 4:05 p.m., an interview was conducted with Admin Nurse A. Admin Nurse A stated RD H presents tray line accuracy information and the plan for 2012 was to continue with that same data. Admin Nurse A stated if issues get brought up during surveys then that would be included in the QAPI plan for them. Admin Nurse A confirmed there was no clinical nutrition Performance Improvement data being reported at this time.

Based on staff interview and document, medical record, and policy reviews, the facility failed to focus their performance improvement on high-risk or problem-prone areas. The facility allowed fentanyl patches, a high risk medication with boxed warning (the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems that can lead to serious injury or death), to be accessible on override without a system in place to ensure patient safety and without assurance that the policy for ensuring appropriate use was implemented.

Findings:

Review of clinical records for patients receiving fentanyl patches revealed that two out of three patients (Patient 14 and Patient 18) received fentanyl patches inconsistent with the manufacturer's specification.

The fentanyl patch, also known as fentanyl transdermal system, contains fentanyl, a potent synthetic opioid medication used to treat pain. This medication has a boxed warning which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. The boxed warning for the fentanyl patch documents that it has an associated risk of fatal overdose due to respiratory depression. The boxed warning also documents that it should only be used in patients who are opioid-tolerant which is defined in the boxed warning as those patients who have taken at least 60 milligrams (mg) of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone daily for a week or longer or an equianalgesic dose of another opioid medication. Use of this patch to treat patients who are not opioid-tolerant is contraindicated because serious or life-threatening respiratory depression can occur.

a. On 3/14/12 at 10 a.m., the after-hours override list of medications accessed on 3/13/12, was reviewed. Override, is a function that allows nurses to remove medications from the medication automated dispensing cabinet (Med Dispense) without pharmacist review and evaluation of the appropriateness of such medication. The override list showed that a fentanyl patch 12 micrograms (mcg) was removed for Patient 14, on 3/13/12 at 10:23 p.m. Pharmacist S stated during interview, regarding fentanyl patches that the pharmacists "key in the order and staff access it from Med dispense." On 3/14/12 at 10:20 a.m., he confirmed that fentanyl patches are available in the automated dispensing cabinets for override.

On 3/14/12 at 11 a.m., Pharmacist S confirmed that the order for fentanyl for Patient 14 was not evaluated by a pharmacist before the medication was obtained and applied. The pharmacy computer record showed that the patch was removed, on 3/13/12, at 22:25 (10:25 p.m.) by override.

On 3/14/12 at 2 p.m., the record for Patient 14 was reviewed with the Pharmacy Director. Patient 14 had an order, written on 3/13/12 at 1800 (6 p.m.) for fentanyl patch 12 mcg be changed every 72 hours. Patient 14 had orders for pain medications which included Dilaudid (also known as hydromorphone), and Percocet, (a combination medication that has Tylenol like medication and oxycodone). He received opioid type medication for only four days not for seven days, as specified by the manufacturer labeling for the boxed warning. In addition, there was no information about Patient 14's history of opioid use before his hospital admission. When the Pharmacy Director calculated the morphine equivalent dose for Patient 14, the dose came up to be about 20 mg not 60 mg, as specified in the package insert.

b. On 3/14/12 at 2 p.m., the record for Patient 18 was reviewed with the Pharmacy Director. The patient had an order for fentanyl patch 12 mcg/hour, written on 3/6/12 at 2:30 p.m. Evaluation of the amount of opioid medications (Norco), which Patient 18 received prior to the patch, was calculated by the Pharmacy Director. It was estimated that Patient 18 received about 25 mg of morphine equivalent from 2/29/12 until 3/6/12. According the package insert, Patient 18 was not considered opioid tolerant; therefore, he was not a candidate for receiving a fentanyl patch.

There was no documented evidence that the pharmacist processed the order or questioned fentanyl patch appropriateness especially considering patient's age (78-year-old) and his condition of respiratory failure. Patient 18, with documentation of shoulder pain, was prescribed fentanyl patch with no evidence of opioid tolerance (receiving at least 60 mg of oral morphine for one week). Patient 18 was 78 years old and his diagnosis included respiratory problems, which increases the risk of life-threatening hypoventilation (decrease in the rate respiration) associated with fentanyl patch use.

Review of the facility's policy for "Black Box Warnings," revised 11/10, revealed that "medications that have Black Box Warnings pose an additional challenge to patient safety in light of their potential for serious adverse consequences." The policy included fentanyl. Under warning, it was stated: " Use in opioid tolerant patients whose total daily dose is equivalent to morphine oral 60 mg/day. Not to be used in acute, intermittent, mild, or post-operative pain." The policy also indicated under "Clinical Monitoring" that "Pharmacist to review all orders and calculate dose for appropriateness ..."

Based on observation, staff interview, and record review, the facility failed to ensure that medications were given, as ordered by a physician, for one of 29 sampled patients (Patient 17). Patient 17 received 500 milligrams (mg) of vancomycin (an antibiotic) in the absence of a physician order, and Patient 17 did not receive a treatment with gentamycin topical cream for skin infection. These failures posed a risk for Patient 17 to receive an unnecessary medication or experience adverse drug side effects and worsened skin infection.

The facility failed to ensure that medications were administered in accordance with policy and acceptable standards of practice for 3 of 4 sampled patients (Patients 9, 10, and 11) who had received conscious sedation (drug-induced, mild depression of consciousness). The potential outcome could result in unsafe medication administration and adverse outcomes for patients who have had conscious sedation.

Findings:

1. On 3/13/12 at 9 a.m., Registered Nurse K was observed administering 500 mg of vancomycin through the veins (intravenously) to Patient 17. Vancomycin (vanco) is used to treat infections. On 3/13/12, the medical record for Patient 17 was reviewed with the Pharmacy Director. The record revealed an order, dated 3/6/12, for vancomycin 750 mg to be given daily. There was no order for vanco 500 mg. The Pharmacy Director said that pharmacy staff was managing this patient's vanco therapy and that the order, in response to vanco level on 3/10/12, was not written.

2. On 3/13/12 at 8:14 a.m., Registered Nurse K was observed administering Patient 17's morning medications. Review of the medical record revealed an order, dated 3/8/12, for gentamycin topical cream to be applied to sacral (lower back) wound twice every day for ten days. Registered Nurse K did not apply any topical medications to Patient 17. When interviewed at 11:40 a.m., Registered Nurse K confirmed that she did not apply the gentamycin.



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3. On 3/13/12, Patient 11's record review was conducted. Patient 11 received conscious sedation for a Bronchoscopy procedure (Visual inspection of the interior tracheobronchial tree of the lungs) on 12/1/11. The documented procedure start time was 10:20 am and the end time was 11 am. The following was identified:
a. Patient 11 was given four doses of 0.5 milligram (mg) (totaling 2 mg) of Versed, a sedative, within the time frame of 10:20 am and 10:25 am and then nine doses (totaling 4.5 mg) within the time frame of 10:25 am and 10:30 am. The amount documented in increments totaled 6.5 mg of Versed given, however the total amount that was documented and circled was for 7.5 mg. One mg of Versed was not documented as given to Patient 10. The specific times of the administered doses were not documented. The physician's order was for up to 1 mg of Versed.
b. Fentanyl, a narcotic, was given in 10 doses of 10 microgram (mcg), within the time frame of 10:20 am and 10:25 am. The specific times of the administered doses were not documented.
c. Normal Saline via intravenous (IV) administration was documented every 10 minutes, 10 ml times three. The documentation was not clear if patient was receiving 10 ml per hour, as the physician's order indicated, or the patient received 30 ml total during the 40 minute procedure.
d. The preoperative medication orders for Versed, Fentanyl, and Morphine were not specific dosage orders, but gave ranges such as Versed 0.25 mg to 1 mg, Fentanyl 25 mcg to 100 mcg, and Morphine Sulfate 5 mg to 10 mg. Only Versed and Fentanyl were documented given to the patient. Morphine was not given per physician's order.
e. The medication orders for Respiratory Therapy were not specific dosage orders, but gave ranges: 3 ml to 5 ml of Lidocaine 4% (local anesthesia) via small volume nebulizer; 3 ml to 5 ml Neo-Synephrine 1% (decreases nasal congestion); 15 ml of Lidocaine 2% via nares or bronchoscope; 5 ml to 10 ml Lidocaine 4% atomized (nebulization) via bronchoscope; normal saline one liter bottle for irrigation; and 3 ml to 5 ml of Epinephrine 1:1000 (constricting blood vessels) diluted to 1:20,000 during procedure. The total amount of 30 milliliters (ml) from these medications: Neo-Synephrine 1%, Lidocaine 4%, and Lidocaine 2% were documented without a time and dosage of each medication administered.

4. On 3/13/12, Patient 10's record review was conducted. Patient 10 received conscious sedation for a Bronchoscopy procedure on 2/24/12. The documented procedure start time was 9:30 am and the end time was 9:35 am. The following was identified:
a. Patient 10 was given four doses of 0.5 mg of Versed, within the time frame of 9:30 am and 9:35 am (five minutes). The times of administered doses were not specifically documented.
b. Fentanyl was given in five doses of 10 mcg, within the time frame of 9:30 am and 9:35 am. The times of administered doses were not specifically documented.
c. The preoperative medication orders for Versed, Fentanyl, and Morphine were not specific dosage orders, but gave ranges such as Versed 0.25 mg to 1 mg, and Fentanyl 25 mcg to 100 mcg, and Morphine Sulfate 5 mg to 10 mg. Only Versed and Fentanyl were documented given to the patient. Morphine was not given per physician's order.
d. The medication orders for Respiratory Therapy were not specific dosage orders, but gave ranges: 3 ml to 5 ml of Lidocaine 4% via small volume nebulizer; 3 ml to 5 ml Neo-Synephrine 1%; 15 ml of Lidocaine 2% via nares or bronchoscope; 5 ml to 10 ml Lidocaine 4% atomized via bronchoscope; normal saline one liter bottle for irrigation; and 3 ml to 5 ml of Epinephrine 1:1000 diluted to 1:20,000 during procedure. The total amount of 10 ml from these medications: Neo-Synephrine 1%; Lidocaine 4%; and Lidocaine 2% were documented without a time and dosage of each medication.

5. On 3/13/12, Patient 9's record review was conducted. Patient 9 received conscious sedation for a Bronchoscopy on 1/13/12. The documented procedure start time was at 11:05 am and the end time was at 11:25 am. The following was identified:
a. Patient 9 was given 8.5 mg of Versed, and 140 mcg of Fentanyl, documented time given was written between the time frame of 11:30 am and 11:35 am, 25 minutes after the start of the procedure. The times of the doses were not specifically documented.
b. The physician's order for intravenous (IV) fluids were at 10 ml/ hr. The IV was started just before the beginning of the procedure at 10:40 am and the time of discharge at 12:15 pm. The total amount documented was for 50 ml, 35 ml more than ordered by the physician.
c. The preoperative medication orders for Versed, Fentanyl, and Morphine were not specific dosage orders, but gave ranges such as Versed 0.25 mg to 1 mg, and Fentanyl 25 mcg to 100 mcg, and Morphine Sulfate 5 mg to 10 mg. Only Versed and Fentanyl were documented given to the patient. Morphine was not given per physician's order.
d. The medication orders for Respiratory Therapy were not specific dosage orders, but gave ranges: 3 ml to 5 ml of Lidocaine 4% via small volume nebulizer; 3 ml to 5 ml Neo-Synephrine 1%; 15 ml of Lidocaine 2% via nares or bronchoscope; 5 ml to 10 ml Lidocaine 4% atomized via bronchoscope; normal saline one liter bottle for irrigation; and 3 ml to 5 ml of Epinephrine 1:1000 diluted to 1:20,000 during procedure. The total amount of 30 ml Lidocaine 4% and 9 ml Epinephrine documented 15 minutes after the start of the procedure without a specific time administered.

According to Mosby's Drug Guide for Nurses, Eighth Edition, Versed needs to be given over two minutes, not by rapid bolus (all at once or 30 seconds, considered anesthesia induction). Fentanyl needs to be given 0.5 to 1 mcg/kilogram (kg)/dose, may repeat after 30 to 60 minutes. Patient 9 was 136 kg and received 140 mcg of Fentanyl.

In an interview on 3/15/12 at 7:30 am, Administrative Nurses (ANs) A and C stated that the documentation reflected the total amount of each medication given and not the actual time each dose of medication was given. The specific time the medication was administered was not clearly documented.

According to the policy, "Sedation, Procedural: Adult," dated 1/09, under documentation, "Document on the appropriate Procedure Monitoring Record: Dosage, route, time and effects of all drugs or agents administered."