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Based on observation, interview and record review, the facility failed to ensure one patient was free from all forms of abuse or neglect by failing to ensure Patient 5's injury of unknown origin was investigated and was not a result of abuse or neglect.

This had the potential to result in additional patient injury.

Findings:

On November 18, 2013, at 9:40 a.m., Patient 5's relative reported the patient was having a lot of pain and the facility staff, "were not medicating the patient prior to performing wound care."

In an interview with the Patient Advocate (PA), on November 18, 2013, at 9:45 a.m., the PA stated Patient 5's complaints were relayed to the Case Manager.

On November 18, 2013, at 9:45 a.m., the Director of Case Management (DCM) was interviewed. The DCM stated a family meeting was conducted on Friday, November 15, 2013, due to multiple issues with Patient 5.

During observations conducted on November 18, 2013, at 2:20 p.m., the wound care nurse entered Patient 5's room and inquired about performing the patient's wound care. The patient was previously medicated for pain, but declined the wound care at that time.

On November 18, 2013, at 2:30 p.m., during an interview with Patient 5, the patient was noted to have purplish bruising to the fourth and fifth fingers of her left hand. The bruising, noted on the inner aspect of each of the fingers, extended to the first knuckle. The purple colored bruise met at the junction of the two fingers. The top of Patient 5's left hand appeared more swollen than the right hand.

During a concurrent interview with Patient 5, she reported she did not know how she got the bruise. Patient 5 stated, "My hand is swollen," but, "It does not hurt." Patient 5 also stated she was not receiving pain medications, and the night shift staff, "Closed the door on me when I was screaming in pain."

On November 18, 2013, at 2:45 p.m., Licensed Vocational Nurse (LVN) 1 was observed giving Patient 5 her medications. The bruising to Patient 5's left hand was shared with LVN 1, who stated, "Maybe she had an intravenous line placed there."

On November 18, 2013, at 3 p.m., House Supervisor (HS) 1 stated she had not heard about Patient 5's bruising or her issues with the night shift.

On November 19, 2013, at 9 a.m., the Nurse Manager (NM) was interviewed about Patient 5's complaints. The NM stated he spoke with the staff about attending to Patient 5's needs and ensuring pain medications were provided as ordered. The NM denied hearing about Patient 5's injury or complaint about the night shift.

Patient 5's left hand was observed with the NM, on November 19, 2013, at 9 a.m. The NM stated, "It looked like a bruise, could be staff were trying to put an intravenous line in." The NM stated he did not know how the injury occurred. The NM stated the origin of the injury should be investigated by speaking with the patient, bedside nurse and family. The NM stated,after the bedside nurse began the investigation, the House Supervisor would follow up. The NM was unable to find any documentation about an investigation of this injury of unknown origin.

On November 20 and 21, 2013, Patient 5's record was reviewed. Patient 5 was admitted to the facility on November 4, 2013, with diagnoses including "pressure ulcer, unspecified site." The "History and Physical," dated November 5, 2013, indicated the patient had skin lesions to both thighs dating back to March 2013.

A "Progress Note," dated November 18, 2013, indicated the patient was awake, alert, and, "tearful...The patient thinks she is not getting enough pain medications...she had no other issues at this time."

A "Progress Note," dated November 19, 2013, indicated the patient was more comfortable on that date. In addition, "There are no other issues at this time."

A "Nephrology Progress Note," dated November 18, 2013, indicated: "Patient is awake. Complaint of moderate pain. Hemodialysis today without incident."

There was no documentation in Patient 5's record about the bruising to her left hand. There was no evidence an investigation was conducted to determine if the cause could be determined and to ensure the injury was not a result of abuse or neglect.

On November 21, 2013, at 8:30 a.m., the Chief Clinical Officer (CCO) was interviewed. The CCO stated her expectations for injuries of unknown origin were that the nurse and the physician would be notified and the injury would be assessed.

On November 21, 2013, the facility policy and procedure titled "Abuse of Patient Elder, Child by Staff Identification-Response and Reporting," with a last revised date of August 2013, was reviewed. The policy indicated it's purpose was: "to communicate Hospital Division policy prohibiting abuse and to describe the procedures for preventing and responding to allegations of abuse, neglect or mistreatment of a patient." The policy indicated: "...supports the patient's right to receive care in a safe setting and will act to protect vulnerable patients, including protection of the patient's emotional and physical health and safety...investigate allegations of abuse promptly in accordance with state law..." The following was documented as procedures:

"...the hospital treats any allegation seriously...notify the Chief Clinical Officer (CCO), Nursing Supervisor, or clinical area Manager immediately in any instance of reported, observed, or suspected patient abuse neglect,mistreatment and/or exploitation...Nursing will be responsible for appropriate documentation on the admission assessment and the nursing progress notes assessment findings using the criteria below as guideline for assessment:...Type Physical Abuse...scratches...bruises... Physical examination will be conducted promptly...the patient's medical record will include documentation of the physical examination, treatment rendered, referrals to other care providers..."

There was no documentation in Patient 5's record about the bruising to her left hand. There was no evidence in the record indicating supervisory staff were notified, a physical examination was conducted, or a referral to other providers was made.

Based on observation, interview, and record review, the facility failed for three of thirty-four sampled patients (Patients 4, 5 and 7) to ensure the nursing staff developed and kept current, a plan for nursing care. The facility failed to ensure:

1) The care plan for Patient 4's altered nutritional status was kept current when facility staff failed to administer enteral feeding at the prescribed rate. This had the potential to cause a deterioration in Patient 4's nutritional status;

2) The care plan for Patient 5's pain management was implemented and the physician was notified about the patient's lack of relief with the current medications. This resulted in Patient 5's inadequate pain relief and her refusal to turn and cooperate with staff; and,

3) Patient 7 was reweighed/reassessed when she had an 17 pound weight loss in one 24 hours period. Patient 7's care plan for altered nutritional and physician order for daily weights, were not implemented. This had the potential for Patient 7 to experience additional weight loss.

Findings:

A nursing care plan is based on assessing the patient's nursing care needs (not solely those needs related to the admitting diagnosis) and developing appropriate nursing interventions in response to those needs. The nursing care plan is kept current by ongoing assessments of the patient's needs and the patient's response to interventions, and updating or revising the patient's nursing care plan in response to assessments.

1. On November 18, 2013, at 10:30 a.m., Patient 4 was observed lying in bed with his eyes open. Patient 4 had a tracheostomy and was mechanically ventilated (use of a machine to assist with breathing). Patient 4 had a gastrostomy tube (tube inserted into the stomach through the abdomen to administer food and fluids), and was unable to take foods and fluids orally. Patient 4 was receiving Jevity 1.2 Cal (an enteral feeding solution given via the gastrostomy tube) at 55 milliliters (ml) per hour via an infusion pump.

On November 18, 2013, Patient 4's record was reviewed. Patient 4's record indicated the patient was "NPO (nothing by mouth) except for tube feeding," since October 11, 2013. On October 21, 2013, an order was written for the patient to receive Jevity 1.2 Cal at 75 ml per hour.

In an interview with the Nurse Manager (NM) on November 18, 2013, at 10:40 a.m., the NM verified Patient 4's current enteral feeding was infusing at 55 ml per hour. The NM stated if the patient was not tolerating the ordered dose, the rate might be decreased. The NM was unable to find documentation in the record indicating Patient 4's tube feeding rate should be decreased.

On November 18, 2013, at 11 a.m., Registered Nurse (RN) 4 was interviewed. RN 4 verified that Patient 4's enteral feeding was infusing at 55 ml per hour. The RN stated if the solution was not infusing at the ordered rate, she would check the record to see if the patient was tolerating the current rate.

On November 18, 2013, at 11:10 a.m., Patient 4's record was reviewed with the Registered Dietitian (RD). The RD stated the goal (order) for Patient 4 was 75 ml per hour. The RD stated if the solution was infusing at 20 ml less per hour the patient could receive 576 fewer calories per day. The RD stated she did not see evidence of high residuals (enteral tube feeding solution still in the patient's stomach) for this patient.

Patient 4's record was reviewed and the following was noted:

a. Patient 4 was admitted to the facility on October 11, 2013, with diagnoses that included respiratory failure;

b. The "History and Physical," dated October 12, 2013, indicated the patient had an altered level of consciousness, and a stroke had left him with mild dysphagia (difficultly swallowing);

c. Patient 4's care plan included "Altered Nutrition: less than body requirements: dysphagia." The desired outcome for Patient 4 was to maintain/gain weight as measured by weekly weights. Interventions included "Initiate enteral feedings."

A "Diet Progress Note," dated November 15, 2013, indicated the patient was NPO except for tube feeding. The RD documented Jevity 1.2 Cal at 75 ml per hour would provide 2160 calories, 100 grams of protein, and would meet 100% of the patient's estimated nutritional needs. The RD indicated the patient had difficulty swallowing related to his comatose/vegetative state and required an alternate nutritional route.

On November 21, 2013, the "Job Description," for the Registered Nurse (RN) was reviewed and indicated the following: "Provides planning and delivery of direct and indirect patient care through the nursing process of Assessment, Planning, Intervention, and Evaluation....Develops nursing care plan of assigned patient on admission, updates plan of care as needed and ensures plan of care is coordinated with patient, family, and other members of the team. Revises the plan of care as indicated by the patient's response to treatment, and evaluates overall plan daily for effectiveness..."

Patient 4's tube feeding was not infusing at the physician ordered rate and the care plan interventions were not consistent(current) with the physician's orders.

2. On November 18, 2013, at 9:40 a.m., Patient 5's relative reported the patient was having a lot of pain and the facility staff "were not medicating the patient prior to performing wound care."

In an interview with the Patient Advocate (PA), on November 18, 2013, at 9:45 a.m., the PA stated Patient 5's complaints were relayed to the Case Manager.

On November 18, 2013, at 9:45 a.m., the Director of Case Management (DCM) was interviewed. The DCM stated a family meeting had been conducted due to multiple issues with Patient 5. The DCM stated the patient often refused wound care and received medication for pain.

On November 18, 2013, at 2:20 p.m., the wound care nurse entered Patient 5's room to inquire about wound care. The patient was previously medicated, but now declined wound care.

On November 18, 2013, at 2:30 p.m., Patient 5 was interviewed. Patient 5 stated she was not receiving pain medications, and night shift staff had "closed the door on me when I was screaming in pain."

On November 18, 2013, at 2:45 p.m., Licensed Vocational Nurse (LVN) 1 was observed giving medications to Patient 5. According to the description of medications given by LVN 1, Patient 5 did not receive pain medications at this time.

On November 18, 2013, at 3 p.m., House Supervisor (HS) 1 stated Patient 5's pain medications were often held due to her low blood pressure, or the patient's own refusal to take the medication.

On November 19, 2013, at 9 a.m., the Nurse Manager (NM) was interviewed about Patient 5's complaints. The NM stated he had spoken with the staff about attending to Patient 5's needs and ensuring pain medications were provided as ordered. The NM reviewed the record and was unable to find documentation regarding the reason for Patient 5's inadequate pain management. There was no evidence in the record the nursing staff had notified the physician about Patient 5's complaints.

On November 20, and 21, 2013, Patient 5's record was reviewed. Patient 5 was admitted to the facility on November 4, 2013, with diagnoses including, "...pressure ulcer, unspecified site." The "History and Physical," dated November 5, 2013, indicated Patient 5 had skin lesions to both thighs since March 2013.

A "Progress Note," dated November 18, 2013, indicated the Patient 5 was awake, alert and "tearful...The patient thinks she is not getting enough pain medications...she had no other issues at this time."

A "Nephrology Progress Note," dated November 18, 2013, indicated: "Patient is awake. Complaint of moderate pain. Hemodialysis today without incident."

A "Progress Note," dated November 19, 2013, indicated the patient was more comfortable today. "There are no other issues at this time."

Patient 5's care plan for "Alteration in comfort: pain related to disease process," indicated the desired outcome was for the patient to "have total pain control..." Interventions included, "... offer prescribed analgesics."

A review of the Physician orders for Patient 5 included the following:

a. Morphine sulfate controlled/sustained release, orally, 15 mg at 9 a.m., daily. (Hold if systolic (first number) blood pressure less than 80);

b. Morphine sulfate IV (Intravenous), 4 milligram (mg), push (directly into a vein), give before wound treatment; and

c. Morphine sulfate IV (Intravenous), 4 milligram (mg), push (directly into a vein), every four hours PRN (as needed) for pain.


The Medication Administration Record (MAR) for Patient 5 was reviewed and the following noted:

The Morphine sulfate controlled/sustained release, 15 mg tablet at 9 a.m., daily was not given on November 13, 14, 15, and 17, 2013 (four of six days).

The Morphine sulfate IV (Intravenous), 4 milligram (mg), push medication scheduled to be given prior to wound care was held on the following days for the following reasons:

November 7, 2013-not done-patient refused;
November 8, 2013-not done (PRN morphine was given);
November 9, 2013-not done (pt BP (Blood Pressure) 82/54 will not give {although BP was not below parameter of 80 systolic});
November 10, 2013-not done (BP= 70 /50);
November 12, 2013-not done (Pt BP 98/58{not below 80 systolic});
November 13, 2013-not done (was not given due to pt BP 90/54 {not below 80 systolic});
November 14, 2013-not done (B/P +/- criteria to administer);
November 15, 2013-not done ( Physician aware Pt. had refused Morphine); and
November 17, 2013- not done (Pt received PRN [as needed] morphine at 0800).


On November 21, 2013, the "Job Description," for the Registered Nurse (RN) was reviewed and indicated the following: "Provides planning and delivery of direct and indirect patient care through the nursing process of Assessment, Planning, Intervention, and Evaluation...Maintain the standard of nursing care and implements policies and procedures of the hospital and nursing department...Develops nursing care plan of assigned patient on admission, updates plan of care as needed and ensures plan of care is coordinated with patient, family, and other members of the team. ...Assesses and reassess pain. Utilize appropriate pain management techniques...Revises the plan of care as indicated by the patient's response to treatment, and evaluates overall plan daily for effectiveness."

The facility policy and procedure titled "Pain Management Plan," with an effective date of August 2013, was reviewed. The policy indicated the following: "[The facility] recognize a patient's right to be free of pain and promotes pain relief...the licensed nurse shall communicate the adequacy of pain management and/or changes in pain significance to the physician during the patient's length of stay...A registered nurse shall develop the plan of care for patients. The plan of care shall be documented in the patient medical record and updated as needed."

3. The facility's policy and procedure titled "Weight Measurement," with a release date of August 2013, was reviewed. The policy indicated: "Weight...used in conjunction with other information to calculate energy, protein and fluid needs...Weight change over time is an important indicator of nutritional status and fluid status...Weight measurement is scheduled as follows: Physician orders...Weigh patient on the appropriate scale...Note: If patient has a 5 pound or more difference from the most recent weight, the scale shall be re-balanced, the "rough-calibration" completed, and the weight taken again to confirm accuracy..."

On November 18, 2013, at 2:30 p.m., facility staff entered Patient 7's room and informed the patient that she was to be weighed. The bed did not have a bed scale (bed with a built in scale), so the staff returned with a mechanical lift scale to weigh the patient. Patient 7 declined to be weighed at that time.

On November 20, 2013, Patient 7's record was reviewed. Patient 7 was admitted to the facility on November 2, 2013, for treatment of complications following abdominal surgery. Physician's progress notes indicated the following:

November 13, 2013-Assessment and plan: severe malnutrition and hypoalbuminia (low albumin level);.

November 14, 2013-Malnutrition with low albumin;

November 15, 2013-Severe malnutrition and hypoalbuminemia;

November 16, 2013-Malnutrition with low albumin...

The Physician's Orders were reviewed on November 20, 2013. On November 3, 2013, a physician order was written to weigh Patient 7 daily. The order was discontinued and changed to weekly weights on November 20, 2013.

Patient 7's care plan for "Altered nutrition: less than body requirements:related to: GI (gastrointestinal) disorders," was reviewed on November 20, 2013. The desired outcome included the patient would maintain/gain weight as measured by weekly weights.

Patient 7's patient care flow sheets were reviewed on November 20, 2013, and the following weights were noted:

November 3, 2013-120 pounds;
November 4, 2013-120.4 pounds;
November 5, 2013-118.10 pounds;
November 6, 2013-123.5 pounds (A five pound difference in weight from the previous reading);
November 7, 2013-no weight;
November 8, 2013-119.80 pounds;
November 9, 2013-117.60 pounds;
November 10, 2013-no weight;
November 11, 2013-no weight;
November 12, 2013-115.20 pounds;
November 13, 2013-116.20 pounds;
November 14, 2013-98.70 pounds (17.5 pound weight loss - five pound difference in weight from the previous reading);
November 15, 2013-99 pounds;
November 16, 2013-97.20 pounds;
November 17, 2013-99.80 pounds; and
November 19, 2013-98.40 pounds.

A "Diet Progress note," dated November 18, 2013, indicated the patient's weight was 99.8 pounds "requested re-weigh to verify down 17.8 pounds since weight of 11/9...Reassessment pending re-weigh." There was no documentation in the progress notes prior to this date about the patient's weight loss.

The record was reviewed with the House Supervisor on November 20, 2013. There was no evidence in the record to indicate the scale was re-balanced and the patient reweighed on November 14, 2013. There was also no evidence the physician or the dietitian was notified about the patient's seventeen pound weight change on November 14, 2013. During the record review, it was noted an interdisciplinary team meeting was held on November 14, 2013. There was no evidence the Patient 7's recent weight loss was discussed during the meeting.

During an interview with the Chief Clinical Officer (CCO) on November 21, 2013, at 8:30 a.m., the CCO stated she would expect the patient to be reweighed and the physician to be notified.

Patient 7's care plan was not consistent with physician's orders.

Based on observation, interview, and document review, the facility failed to administer medications in accordance with the facility's policy and procedure, manufacturer's recommendations, and standards of practice by failing to:

1. Administer an injectable medication as recommended by the manufacturer and in accordance with the approved facility guidelines;

2. Administer medications via feeding tube individually in accordance with the policy and procedure; and,

3. Document administration of high-risk, high-alert medications in accordance with the facility's policy and procedure, not allowing documentation of verification of the medication dose (witnessing) by the second nurse.

These failed practices resulted in the potential for patient harm due to unsafe medication administration and medication errors and diversion of high-risk, high-alert medications.

Findings:

1. Medication pass observation was conducted on November 19, 2013, starting at 9:40 a.m., with RN (Registered Nurse) 5 who administered morning medications for Patient 18. It was observed that RN 5 prepared injectable Protonix (medication used to reduce stomach acid production) 40 mg (milligrams) vial for administration via IV (intravenous) Push into the patient's vein. It was noted RN 5 administered the medication in less than five seconds.

Review of the facility's document titled, "Intravenous Push (IVP) List - Approved for RN Administration" indicated Pantoprazole (Protonix) should be administered at a maximum rate of 40mg over two minutes.

Review of the manufacturer's package insert for Protonix indicated there should be a, "Two Minute Infusion." The insert indicated Protonix IV for Injection should be reconstituted (mixed) with 10 ml (milliliters) of 0.9% Sodium Chloride Injection, USP (United States Pharmacopeia), to a final concentration of approximately 4 mg per ml.The insert indicated the reconstituted solution may be stored for up to 24 hours at room temperature prior to IV infusion and did not need to be protected from light. The insert indicated Protonix IV for Injection should be administered intravenously over a period of at least two minutes.

During an interview on November 19, 2013, at 10 a.m., the Pharmacist in Charge (PIC) indicated that Protonix 40 mg via IV Push needed to be infused for at least two minutes.

During an interview on November 19, 2013, at 3 p.m., RN 5 acknowledged that Protonix 40 mg via IV Push was infused too fast, and that she should have infused it slower.

2. Medication pass observation was conducted on November 19, 2013, starting at 9:40 a.m., with RN 5, who administered morning medications for Patient 18. It was observed that RN 5 prepared the following medications in a medication cup mixed in water:

a. One crushed tablet of levothyroxine (supplement for low thyroid level) 75 mcg (micrograms);
b. One crushed tablet of furosemide (water pill to remove excess water) 40 mg;
c. One crushed tablet of lisinopril (medication for high blood pressure) 10 mg;
d. One crushed tablet of Vitamin C (supplement) 500 mg; and,
e. 5-ml liquid MVI (multi-vitamin supplement).

It was observed that RN 5 administered the mixture (including all of the medications) into the patient's feeding tube and flushed with water afterwards.

Review of the facility's policy and procedure titled, "Administration of Medications," indicated the following should be done when administering medications via feeding tube:

(1). Flush feeding with at least 30 ml of warm water before administering medications, unless contraindicated;

(2). After administering the medication, rinse the medication cup with 10 -20 ml of water and pour the water into the syringe to rinse and ensure that all medication has been given; and,

(3). To administer more than one medication, give each separately, and flush between medications with 15 mL of water.

During an interview on November 19, 2013, at 10:30 a.m., the Pharmacist in Charge (PIC) indicated that the medications administered feeding tube needed to be administered one medication at a time.

During an interview on November 19, 2013, at 3 p.m., RN 5 acknowledged that she should have administered medications via the feeding tube one at a time.

3a. During a review of the EMR (electronic medical record) for Patient 23, a physician's order was noted for Heparin (a blood thinner) IV (intravenous) inj(ection), 3800 units, prn (as needed), to be given with hemodialysis only (a process for cleansing the blood using a machine that acts as an artificial kidney). The order contained the instruction, "Look-Alike Sound-Alike, High Risk" (indicating the medication dosage prepared for administration should be witnessed by a second nurse). The EMR indicated the heparin was administered as follows:

(1). November 16, 2013, at 12:26 a.m., 3800 units administered by the Dialysis RN; and,
(2). November 19, 2013, at 5:15 p.m., 3800 units administered by the Dialysis RN.

There was no evidence that a second nurse was verifying the administration of the medication by the dialysis nurse.

3b. During a medication pass observation conducted with RN 5 on November 19, 2013, starting at 9:40 a.m., it was noted that a second nurse was present during the preparation of Heparin for Patient 18 for verification of the order.

During a concurrent interview, RN 5 stated that a second nurse verification was required, and proceeded to document the verification in the EMR by entering the name of the second nurse who was verifying the order.

During a medication pass observation conducted with LVN (Licensed Vocational Nurse) 2 on November 19, 2013, starting at 8:40 a.m., it was noted that a second nurse was present during the preparation of Heparin for Patient 16 for verification of the order.

During a concurrent interview, LVN 2 indicated that a second nurse verification of the order was documented in the ProTouch EMR by LVN 2.

3c. The EMR (electronic medical record) for Patient 1 was reviewed on November 21, 2013. The record indicated the physician ordered Heparin 5000 units to be given every 12 hours. According to the record, Heparin was administered as follows:

(1). November 16, 2013, at 9 a.m., 5000 units administered by the RN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order;

(2). November 16, 2013, at 9:17 p.m., 5000 units administered by the LVN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order;

(3). November 17, 2013, at 10:22 a.m., 5000 units administered by the RN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order;

(4). November 17, 2013, at 8:58 p.m., 5000 units administered by the RN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order;

(5). November 18, 2013, at 8:46 a.m., 5000 units administered by the LVN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order;

(6). November 18, 2013, at 9:52 p.m., 5000 units administered by the LVN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order;

(7). November 19, 2013, at 9 a.m., 5000 units administered by the RN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order;

(8). November 20, 2013, at 8:22 p.m., 5000 units administered by the LVN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order; and,

(9). November 21, 2013, at 8:54 a.m., 5000 units administered by the RN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order.

There were no signatures by the nurses who were documented as the witnesses to the preparation and order verification of the high-alert, high-risk medication.

The EMR further indicated the physician ordered insulin (to treat high blood sugar) six units to be given daily. The order contained the instruction, "Look-Alike Sound-Alike, High Alert" (indicating the medication dosage prepared for administration should be witnessed by a second nurse). The EMR indicated the insulin was given as follows:

(1) November 16, 2013, at 9 a.m., 6 units administered by the RN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order;

(2). November 17, 2013, at 10:22 a.m., 6 units administered by the RN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order;

(3). November 18, 2013, at 8:54 a.m., 6 units administered by the LVN. There was no indication a second nurse witnessed the preparation and verified the order;

(4). November 19, 2013, at 8:47 a.m., six units administered by the RN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order;

(5). November 20, 2013, at 8:31 a.m., six units administered by the RN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order; and,

(6). November 21, 2013, at 9:09 a.m., six units administered by the RN, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order.

There were no signatures by the nurses who were documented as the witnesses to the preparation and order verification of the high-alert, high-risk medication.

3d. The EMR (electronic medical record) for Patient 3 was reviewed on November 21, 2013. The record indicated the physician ordered Heparin 2300 units to be given with dialysis. According to the record, Heparin was administered as follows:

(1). November 19, 2013, at 1:35 a.m., 2300 units administered by the dialysis nurse, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order; and,

(2). November 19, 2013, 2300 units administered by the dialysis nurse, who documented both the administration and the name of the nurse who witnessed the preparation and verified the order.

There were no signatures by the nurses who were documented as the witnesses to the preparation and order verification of the high-alert, high-risk medication.

During an interview on November 21, 2013, at 10:30 p.m., the Pharmacist in Charge (PIC) indicated that Heparin was one of the listed High-Alert, High-Risk medications that required another nurse to witness the dosage prepared for administration. The PIC also indicated that dialysis nurses were not exempt from this requirement.

Review of the facility's policy and procedure titled, "High-Alert Medications," indicated the following:

(1). At a minimum, the following medications will be on the High Alert Medications List ...Heparin, Insulin;

(2). If a High-Alert medication required a second nurse verification, that verification must be documented in the patient's medical record. That could be done by the nurse charting the medication administration, or by the nurse that verified the medication. In the EMR, the nurse was to execute the order with comments to include the staff member that verified the medication; and,

(3). A double check system was in place whereby one nurse prepared the medication and one nurse verified the dose with the order.

During a group discussion with the facility's administrative staff, present to discuss QA (Quality Assurance), on November 19, 2013, starting at 1 p.m., it was explained by the surveyor that the facility's policy and procedure currently would make the first (administering) nurse chart on the EMR for the verifying nurse to indicate the second nurse had verified and witnessed the medication preparation and order. It was further explained to the administrative staff there was potential for charting the verification by the second nurse without actual verification of the order by the second nurse.

During the same group discussion, the Director of Quality Management indicated that the facility was aware of the issue, but the current system would not allow the second nurse that verified the order for the first nurse to document himself/herself with his/her own ID and password. The Director acknowledged that there was a need for the documentation to take place by the person verifying the order.

Based on observation, interview, document review, the facility failed to ensure safe and effective use of medications in accordance with the facility's policy and procedure by failing to:

1. Ensure a review process for questionable non-FDA indicated physican orders was in place and implemented for determining safe use of medications;

2. Ensure a pharmacist verification order took place prior to administration of the first dose of medications in accordance with the facility's policy and procedure and standard of practice; and,

3. Ensure surface cleaninig of the LAFW (Laminar Airflow Workbench) was performed in accordance with the facility's policy and procedure.

These failed practices resulted in the potential for medications to be used for unintended purposes, medication errors, and spread of infection from contaminated medications.

Findings:

1. During review of EMRs for Patient 3 and Patient 15 on November 19, 2013, the following was noted:

a. There was a physician's order entered on November 12, 2013, at 11:32 a.m., for Fentanyl Citrate (narcotic pain medication) IV (intravenous) continuous infusion 1000 mcg (micrograms)/100 ml (milliliters), may titrate (increase and decrease) up or down 25 mcg every 30 min(ute) to maintain peak inspiratory pressure (PIP) below 50; and,

b. There was a physician's order entered on November 18, 2013, at 11:42 a.m., for Fentanyl Citrate IV continuous infusion, start at 25 mcg may titrate up or down 25 mcg per 15 minutes to lower RR (respiratory rate) less than 25.

Review of the well-known pharmacy reference Lexi-Comp indicated Fentanyl was to be used for, "Injection: Relief of pain, preoperative medication, adjunct to general or regional anesthesia."

During an interview on November 19, 2013, at 1:30 p.m., the Chief of Staff (COS) stated that he could only postulate the order was to control the patients' pain and sedation, and could not explain why the physician ordered Fentanyl continuous infusion in such a way.

The COS also added that he was not aware of Fentanyl being used with the indication to titrate to RR or PIP. The COS also stated that the facility was working on the policy and procedure on use of Fentanyl continuous IV infusion. He stated that there was a process in place to review for safe use of medications, but indicated he was not made aware of Fentanyl being ordered in such a way.

During an interview on November 19, 2013, at 11 a.m., RPH 1 stated that above orders were reviewed and verified, but did not indicate the ordering physicians were contacted for clarification of the orders.

During an interview on November 19, 2013, at 3:30 p.m., the PIC did not indicate that the pharmacy followed the process to communicate questionable orders for use of medications, such as Fentanyl to titrate to RR or PIP, to the Chief of Medical Staff. She did not indicate there was a committee review process to determine safe and appropriate use of Fentanyl continuous IV infusion.

During an interview on November 20, 2013, at 11:10 a.m., MD 2, the ordering physician, indicated that the Fentanyl order should have been ordered differently, and that he would change the order looking back. MD 2 indicated that the order was placed for Patient 19 to control pain and sedation, and that additional communication should have been placed with the order to safely carry out the order.

2. Patient 1's EMR was reviewed on November 21, 2013, with the PIC, and the following was noted:

a. On November 10, 2013, at 5:22 p.m., a physician's order was entered in the EMR for Meropenem (antibiotic) IVPB (intravenous piggyback) inj(ection), 1 gm (gram) ...q8h (every 8 hours) to start on November 11, 2013, at 01:00 (1 a.m.);

b. There was documentation of the first dose of Meropenem 1 gm administered by a nurse on November 11, 2013, at 00:45 (seven hours and 23 minutes after the order was written).

There was documentation of a pharmacist verification of the Meropenem 1 gm order on November 11, 2013, at 5:21 a.m. (11 hours and 59 minutes after the order was written, and four hours and 34 minutes after the first dose was administred) .

During an interview on November 21, 2013, at 10 a.m., the PIC acknowledged that the medication was administered prior to pharmacist verification of the order, and indicated that the order should have been verified by a pharmacist first.

During an interview on November 21, 2013, at 11 a.m., RPH 1 did not know why the order was not verified sooner, and stated that the possible reason would be that the order was entered in the system during the time the Pharmacy was transitioning to the remote off-site Pharmacy Services. RPH 1 stated that during the last hour prior to the main Pharmacy closing it could be too busy.

Review of the facility's policy and procedure titled Review of Medication Orders indicated, "All medication orders will be reviewed by a licensed pharmacist (OR nursing supervisor and the administering nurse if the pharmacy is closed) prior to dispensing and administering the medication ..."

Review of the facility's policy and procedure titled Dispensing of Medications indicated, "All medication orders must be checked by a Pharmacist before dispensing."

The American Society of Health-System Pharmacists (ASHP), a nationally recognized pharmacist organization, published a guideline titled, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals" which included the following:

"All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergency situations in which the treatment of the patient would be significantly compromised by the delay that would result from pharmacist review of the order. There shall be a procedure for retrospective review of these orders."

3. During a tour of the facility's Pharmacy Department on November 18, 2013, at 9 a.m., it was noted there was a laminar flow IV hood (LAFW) located in an area away from the medication dispensing area.

During a concurrent interview, the PIC indicated that the LAFW was cleaned twice a day, once in the morning and once before closing, and that the Pharmacy was open from 8 a.m. to 6 p.m. on weekdays and 8 a.m. to 5 p.m. on weekends.

During an interview on November 18, 2013, at 10 a.m., PT 1 stated that there were two Pharmacy Technicians (PTs) working each day, one opening shift PT and one closing PT. PT 1 indicated cleaning of the LAFW was done by the opening PT and the closing PT each day.

Review of the facility's "CSP Quality Assurance Log" indicated the following:

a. The cleaning was performed once a day as indicated by only one signature under column labeled, "Hood/Surfaces Cleaned Twice Daily (AM/PM)" consistently over the past month;

b. For Medication Preparation - Compounding of Sterile Products (IV Admixtures) - "The LAFW will be cleaned on a scheduled routine at the beginning of the workday and at closing. An appropriate disinfectant (e.g. 70% isopropyl alcohol or 70% ethanol) will be used to clean the LAFW. The technician cleaning the LAFW will be responsible for documenting these cleaning on the "CSP Quality Assurance Log;" and,

Quality Assurance for Compounded Sterile Products (CSPs) - "Cleaning Logs of the LAFW and the buffer/clean area will be maintained. The cleaning, sanitizing, and organizing of the direct and contiguous compounding areas (DCCA) is the responsibility of trained operators (pharmacists and technicians) following written procedures and is performed at the beginning of each shift (twice daily). Twice daily cleanings and sanitizing of the DCCA will be recorded on the CSP Quality Assurance Log."

During an interview on November 18, 2013, at 10 a.m., the PIC acknowledged that there should have been two signatures for each day to indicate the cleaning of the LAFW was performed twice a day.

Based on observation, interview, and record review, the facility failed to ensure emergency laboratory functions, being performed by alternate personnel, were monitored for accuracy and safety when:

1. Laboratory results, including critical values, were provided to the healthcare team by RTs (Respiratory Therapists) for purposes of treating patients on the medical surgical and critical care units; and,

2. The Nursing Supervisor was responsible for obtaining blood for transfusion after hours and releasing it to the nurse.

These failed practices resulted in the potential for errors in reporting laboratory values to go unrecognized, incorrect critical values to be reported, blood transfusion reactions, and patients to receive unnecessary or unsafe treatment.

Findings:

1. During a tour of the laboratory (lab) on November 19, 2013, at 8:55 a.m., accompanied by the Chief Clinical Officer (CCO), the door entering the lab was observed with a touchpad above the door handle. The door to the lab opened only after a combination of numbers was entered into the touchpad. Multiple facility staff were observed entering and exiting the lab. The lab contained equipment and machines used for analyzing specimens and reporting their results. Included in the equipment was an i-STAT machine (a handheld analyzer) sitting on a counter top.

During a concurrent interview with the CCO and CLS (Clinical Lab Specialist) 1 on November 19, 2013, the operations of the lab were described as follows:

A. All routine labs were drawn between 11 p.m. and midnight by a phlebotomist, and the lab tubes were picked up between 2 a.m. and 3 a.m. by a courier service and taken to the, "core," lab to be analyzed and resulted by a CLS. The lab results were reported the same day, at around 8 a.m.;

B. During the hours of 5:30 a.m. and 2 p.m., non-routine (STAT) hematology testing (involving blood cells such as RBCs [red blood cells] and WBCs [white blood cells]) was conducted by the CLS in the lab. After hours non-routine (STAT) hematology testing was done by drawing the blood and sending it via courier to the core lab, where it was analyzed and resulted by a CLS;

C. Non-routine (STAT) chemistry testing was done by having the nurse draw the blood and hand the blood tube to a RT who went to the lab and performed the analysis of the blood using the i-STAT machine. After results were obtained, the RT manually entered the blood chemistry results in the EMR (electronic medical record). Non-routine (STAT) chemistry included the following lab tests:

a. Glucose - to measure the amount of sugar in the blood;
b. BUN (Blood Urea Nitrogen) - to measure kidney function and hydration status;
c. Creatinine - to measure kidney function;
d. Na (Sodium) - To measure the amount of sodium in the blood;
e. K (Potassium) - To measure the amount of potassium in the blood;
f. Cl (Chloride) - To measure the amount of chloride in the blood;
g. TCO2 (Carbon Dioxide) - To measure the amount of carbon dioxide in the blood;
h. Anion Gap - To determine the cause of acidic blood;
i. Ca (Calcium) - To measure the amount of calcium in the blood;
j. Hgb (Hemoglobin) - To measure the oxygen carrying capability of the blood;
k. Hct (Hematocrit) - To measure the percentage of RBCs in the blood;
l. PT (Prothrombin Time) - To measure how long it took for the blood to clot;
m. INR (International Normalized Ratio) - To measure how long it took the blood to clot; and;
n. Troponin - To determine the presence or absence of a heart attack; and,

D. The CLS in the lab performed all of the functions of the blood bank (where patient blood was tested to reduce the risk of transfusion related reactions, and blood to be used for transfusion was stored). The CLS was on site to perform blood bank functions from 5:30 a.m. to 2 p.m., and on call to come in for the blood bank after hours.

During an interview with the Director of Cardiopulmonary Services on November 19, 2013, at 9:30 a.m., the director stated when a STAT lab was ordered for chemistry, PT, INR, or troponin, the nurse placed the order in the computer, then drew the blood and gave it to the RT. He stated the RT took the blood to the lab and analyzed it using the i-STAT machine. He stated after the results were obtained, the RT shared the results with the nurse. He stated either the nurse or the RT could enter the results in the EMR, and they had to be entered manually, as the i-STAT computer and the facility EMR did not interface. He stated the nurse was responsible for notifying the physician if there were critical values. The director stated all of the RTs (24) were trained and expected to perform lab tests, and their competency had been verified. He stated if the RT received a critical lab value from the machine, there was no requirement to attempt to verify the results before giving them to the nurse. He stated that was not part of the training for the RTs.

The quality data for RT in the lab was reviewed with the Director of Cardiopulmonary Services on November 19, 2013, at 11:30 a.m. The data collected included timeliness of entering the lab results and notifying the physician of critical values. There was no data being collected on the accuracy of the test results that were entered in the computer manually (correct patient, correct values). The director stated he reviewed every lab test done by RT on a daily basis when he was there. He stated his work schedule was Monday through Friday with weekends off. He stated tests that were done on Monday, Tuesday, Wednesday, and Thursday were reviewed the following day, but tests that were done on Friday, Saturday, and Sunday were not reviewed until Monday. He stated the most common problem he found was failure to notify the physician of critical lab values in a timely manner. The director stated he found results entered on the wrong patient one time. He stated he used to collect, analyze, and report the data annually, but he started collecting it daily, "because compliance was so bad." He stated he reported the data to the lab monthly.

The facility policy titled, "Critical Value Reporting I-Stat," was reviewed on November 19, 2013. The policy indicated the following:

1. Recognizing critical lab values and taking prompt follow-up action was the responsibility of each CLS and RT involved in performing and reporting lab reports;

2. Critical lab values should be verified for accuracy before reporting. Examples of confirmation were:
a. Repeat analysis;
b. Verify QC was within acceptable limits;
c. Observe specimen for integrity and proper collection and handling;
d. Visually check for random instrument error;
e. Confirm with the physician or nurse to see if results matched patient diagnosis or clinical symptoms; and,
f. Recollect the specimen if the result or the specimen integrity was highly suspect.

The facility policy titled, "Training of Personnel i-STAT," was reviewed on November 19, 2013. The policy indicated personnel qualified to perform tests using the i-STAT included CLS staff and Nursing Supervisors with demonstrated competency in the use of the machine. Attached to the policy was the document used for competency verification (the same document used to verify the competency of the RTs). The document did not contain information regarding verification of critical lab values. There was no evidence the staff who were performing non-routine lab tests using the i-STAT machine demonstrated competence in verification of critical lab values.

During an interview with CLS 1 on November 19, 2013, at 3 p.m., the CLS stated when she recieved a critical lab value, the key was to, "understand what the lab values represent." She stated before she would release the results into the EMR, she would look at the patient's history to see if the results were, "inconsistent," inspect the specimen and the equipment, verify that QC (Quality Control) had been done on the machine, call the nurse or physician to discuss the patient with them, and have the nurse redraw the blood and repeat the test if she felt it was necessary.

During an interview with RT 1 on November 20, 2013, at 2:10 p.m., the RT explained the process she used for performing non-routine lab tests using the i-STAT machine. The RT stated she checked the computer for the order, received the blood from the nurse, went to the lab, put the required information and the blood into the i-STAT machine, analyzed the blood, and printed the results. She stated she then took the slip with the results to the nurse's station, and let the nurse know the results had been entered into the EMR. She stated she notified the nurse if the EMR indicated the results were critical values. She stated she did not follow any procedure for verification of results if she received a critical value. She stated, "I trust the machine."

The employee file for RT 1 was reviewed on November 21, 2013. The competency verification for use of the i-STAT machine, dated May 16, 2013, did not contain information regarding verification of critical lab values. There was no evidence the RT demonstrated competence in verification of critical lab values.

There was no evidence the RT was performing the same as the CLS, or the laboratory leadership was providing oversight of this high risk procedure.

2. During a tour of the laboratory (lab) on November 19, 2013, at 8:55 a.m., accompanied by the Chief Clinical Officer (CCO), the door entering the lab was observed with a touchpad above the door handle. The door to the lab opened only after a combination of numbers was entered into the touchpad. Multiple facility staff were observed entering and exiting the lab. The lab contained equipment and machines used for analyzing specimens and reporting their results.

The employee file for the Nurse Manager was reviewed on November 21, 2013. The file included competency verification for After Hours Blood Bank Release (releasing blood from the blood bank for transfusion).

During an interview with CLS 1, on November 21, 2013, at 3:05 p.m., the CLS stated the blood bank CLS on call after hours was not on call to release blood, only to perform a type and crossmatch (prepare blood for transfusion). She stated after hours (from 2 p.m. through 5:30 a.m.), the Nursing Supervisor was responsible for obtaining blood for transfusion from the blood bank refrigerator and releasing it to the nurse.

The CLS showed a square shaped refrigerator that contained three bags filled with blood on the top shelf. Each bag had a paper attached to it with the name of a patient.

She stated the nursing supervisor could go into the lab after hours, get blood out of the refrigerator, and sign it out using a clipboard supplied by the lab. She stated the Nursing Supervisor would verify the necessary information regarding the patient and the blood, perform a visual inspection of the blood bag, and release the blood to the nurse. The CLS stated there was no monitoring of the process on a daily basis to verify the process was working safely and effectively. She stated, "We don't have any transfusion reactions, so we know it's working." The CLS stated she did not know why the person on call for the blood bank was not called in for this procedure.

During a review of the laboratory quality data on November 21, 2013, there was no evidence the safety and effectiveness of the after hours blood bank procedure (a high risk procedure) was being monitored by the lab.

There was no evidence the laboratory leadership was providing oversight of this high risk procedure.

Based on observation, interview, and record review, the facility failed to meet nutritional needs of the patients when:

1. One patient's (Patient 11) nutrition needs were not met during extended periods of his two month hospital stay, resulting in the potential for poor wound healing and an overall decline in medical status;

2. Two patients (Patients 12 and 13) were served whole pieces of meat when the physician order was for chopped or ground meat, resulting in the potential for choking or reduced meal intake;

3. Physician's orders for enteral tube feedings (delivery of enteral products via an enteral access device into a functioning gastrointestinal tract) were not followed for two patients (Patients 4 and 1), resulting in the patients receiving less than the prescribed nutritional support and the potential for deterioration of the patients' nutritional status;

4. One patient (Patient 4) who was not able to take food or fluids orally was not identified as being "NPO (receiving nothing by mouth)," resulting in the potential for choking and respiratory distress or arrest if he was provided with food to eat;

5. One patient (Patient 15) transitioned from an oral diet to a tube fed only diet and the patient care plan was not updated to reflect the change, resulting in the potential for an oral diet fed to a patient without a physician's order; and,

6. The nutrition analysis of the hospital's menus indicated that the regular diet did not provide the required amounts of daily dietary fiber, vitamin K, magnesium and zinc, resulting in the potential for inadequate nutrition in a medically vulnerable patient population.

Findings:

1. The medical record for Patient 11 was reviewed on November 18, 2013. The patient was admitted to the hospital on September 14, 2013, with diagnoses that included acute respiratory failure, end stage renal (kidney) disease, and status post septic shock (a medical condition as a result of severe infection). On admission the patient also had pressure ulcers (bedsores) on the right heel, right buttock and the coccyx (tailbone).

A review of the Dietary Initial Assessment dated September 16, 2013, completed by the Registered Dietitian (RD), indicated the patient's daily nutrition needs were 1714-2056 calories and 101-127 grams protein. The patient was on a tube feeding that provided 1980 calories and 89 grams of protein. The assessment recommended adding one packet of protein supplement three times a day. This provided an additional 18 grams of protein for a total of 107 grams protein.

A review of the physician's orders indicated on September 16, 2013, an order for the protein powder as recommended was written. It was stopped on September 18, 2013.

An RD note dated September 23, 2013, indicated that the tube feeding at that time provided 1188 calories and 53 grams protein. It further indicated that this met 69% of the patient's estimated calorie needs and 52% of the estimated protein needs.

An RD note dated September 27, 2013, indicated that the patient did not tolerate the tube feeding. A parenteral feeding (feeding directly into the blood stream) was started and provided 612 calories and 51 grams protein.

An RD note dated September 30, 2013, indicated that the same parenteral nutrition was infusing which met 48% of the patient's estimated calorie needs and 50% of the estimated protein needs.

An RD note dated October 7, 2013, indicated that the parenteral feeding at the time provided 1726 calories on average a day and 72 grams protein. This met 100% of the estimated calorie needs and 71% of the estimated protein needs.

From September 18 through October 14, 2013, Patient 401's calorie needs were met for 10 of the 27 days and his protein needs were not met for all 27 days.

The record included a physician's order, dated October 14, 2013, for a Mechanical Soft/Ground (easy to chew) diet with 100 grams of protein a day. The order was stopped on October 27, 2013. A review of the documented meal intakes during this time showed that in 28 of the 39 meals, the patient ate less than 25% of the meal. He was not able to meet his nutrition needs with the oral diet and the parenteral nutrition during this time.

An RD note dated October 17, 2013, indicated that the patient was on the above diet and parenteral nutrition. The parenteral nutrition provided an average calorie intake of 1726 calories a day and 72 grams of protein a day. This met 100% of the estimated calorie needs and 70% of the estimated protein needs.

RD notes, dated October 24 and 30, 2013, indicated that the patient remained on parenteral nutrition which met only 70% of his estimated protein needs. Both notes stated "I (intervention): continue current nutrition therapy." There was no recommendation to increase the protein content of the parenteral nutrition to meet the needs of the patient.

A review of the physician's orders indicated there was an order for tube feeding starting on November 4 and stopping on November 13, 2013.

A review of the patient's lab results for albumin and prealbumin (proteins in the blood that can sometimes indicate nutrition status) showed overall decline in both proteins. On September 15, 2013 the albumin was 3.7 milligrams/deciliter (mg/dl - normal was greater than or equal to 3.5 mg/dl). On November 19, 2013 the albumin was 2.0 mg/dl. On October 1, 2013 the prealbumin was 11.6 mg/dl (normal was greater than or equal to 18 mg/dl). On November 19, 2013, the prealbumin was 8 mg/dl.

During an interview with the RD on November 19, 2013, at 11:30 a.m., she stated that the hospital only had the ability to use standard parenteral solutions that didn't allow an increase in the protein content. She stated that the standard parenteral solutions that the facility used did not meet the patient's protein needs. She stated that she always anticipated that the patient's oral diet or tube feeding would be advanced to meet his needs. She confirmed that the patient was not able to tolerate an oral diet or tube fed diet for very long during his stay. The parenteral nutrition never met the patient's protein needs.

During an interview with the wound care nurse, on November 19, 2013 at 11:50 a.m., she stated that Patient 11 had pressure ulcers on his coccyx and right heel. She stated that protein was important in healing wounds.


2. During a trayline (patient meal tray assembly) observation on November 18, 2013, at 12:00 p.m., the meal trays for Patients 12 and 13 were observed with whole pieces of roast beef on the plates. At 12:10 p.m., the patient diet orders were verified by the licensed nursing staff, by comparing the diet list from dietary with the most current diet list from nursing. An observation of the actual meal trays by the licensed nursing staff was not observed. At 12:20 p.m., both patients were served the trays with the whole pieces of meat. Patient 12 was observed eating her food.

A review of the medical record for Patient 12, the same day, showed a physician's order dated November 15, 2013, for a mechanical soft/ground diet with special instructions for chopped diet. A review of the medical record for Patient 13, the same day, showed a physician's order dated November 1, 2013, for an oral gratification diet of mechanical soft/ground with special instructions for chopped diet, ground meat.

During an interview with the Director of Nutrition Services (DNS), the same day, at 12:20 p.m., she verified that the patients were served the wrong consistency of meat. She verified that the meat should have been ground or chopped. She stated that the dietary staff responsible for reviewing the patient menus did not write "chopped" or "ground" on the menus. She verified that when the licensed nursing staff verified the physician diet orders, they did not check the meal trays to ensure that the physician ordered diet was followed.

Further review of Patient 12's medical record showed an RD assessment dated November 15, 2013. The assessment indicated that the patient had difficulty chewing regular texture food. Further review of Patient 13's medical record showed that the patient had a swallow dysfunction and required diet texture modification. The Speech Therapy (the health professional that treats swallow impairments) note, dated October 29, 2013, indicated that the diet recommendation for Patient 13 was ground meats and chopped food.

3a. On November 18, 2013, at 10:30 a.m., Patient 4 was observed in room 7. Patient 4 was lying in bed with his eyes open. Patient 4 had a tracheostomy and was mechanically ventilated. Patient 4 had a gastrostomy tube (tube inserted into the stomach through the abdomen to administer food and fluids), and was unable to take foods and fluids orally. Patient 7 was receiving Jevity 1.2 Cal (an enteral feeding solution given via the gastrostomy tube) at 55 milliters (ml) per hour via an infusion pump. There was no identification on the outside of Patient 7's room that he was not to receive anything by mouth.

On November 18, 2013, Patient 4's record was reviewed. Patient 4's record indicated the patient was "NPO except for tube feeding," since October 11, 2013. On October 21, 2013, an order was written for the patient to receive Jevity 1.2 Cal at 75 ml per hour.

The NM verified the rate of Patient 4's current enteral feeding was infusing at 55 ml per hour. The NM stated if the patient was not tolerating the ordered dose, the rate might be decreased. The NM was unable to find documentation in the record indicating Patient 4's tube feeding rate should be decreased.

On November 18, 2013, at 11 a.m., Registered Nurse (RN) 4 was interviewed. RN 4 verified that Patient 4's enteral feeding was infusing at 55 ml per hour. The RN stated if the solution was not infusing at the ordered rate, she would check the record to see if the patient was tolerating the current rate.

On November 18, 2013, at 11:10 a.m., Patient 4's record was reviewed with the Registered Dietitian (RD). The RD stated the goal (order) for Patient 4 was 75 ml per hour. The RD stated if the solution was infusing at 20 ml less per hour the patient could receive 576 fewer calories per day. The RD stated she did not see evidence of high residuals (enteral tube feeding solution still in the patient's stomach) for this patient.

Patient 4's record was reviewed and the following was noted:

(1). Patient 4 was admitted to the facility on October 11, 2013, with diagnoses that included Respiratory Failure;

(2). The "History and Physical," dated October 12, 2013, indicated the patient had an altered level of consciousness, and a stroke had left him with mild dysphagia (difficultly swallowing);

(3). Patient 4's assessment indicated he was in a comatose vegetative state;

(4). Patient 4's care plan included interventions for "Altered Nutrition: less than body requirements:dysphagia."

A "Diet Progress Note," dated November 15, 2013, indicated the patient was NPO except for tube feeding. The RD documented Jevity 1.2 Cal at 75 ml per hour would provide 2160 calories, 100 grams of protein, and would meet 100% of the patient's estimated nutritional needs. The RD indicated the patient had difficulty swallowing related to his comatose/vegetative state and required an alternate nutritional route.

3b. During a tour of the ICU (Intensive Care Unit) on November 19, 2013, at 10:20 a.m., Patient 1 was observed lying in bed on a ventilator (breathing machine) with an enteral feeding (directly into the stomach through a tube) of Diabetisource 1.2 infusing at 55 ml per hour.

The record for Patient 1 was reviewed on November 20, 2013. Patient 1 was admitted to the facility on October 14, 2013, with diagnoses that included respiratory failure and sepsis. The record indicated Patient 1 was being fed through a gastrostomy tube (tube inserted into the stomach through the abdomen to administer food and fluids), and was unable to take foods and fluids orally. A physician's order dated November 6, 2013, indicated the patient was to start on an enteral feeding of Diabetisource AC at a rate of 35 ml per hour, and the rate of the feeding was to be increased by 15 ml every hour until a rate of 65 ml per hour was achieved. There was no evidence in the record the nurses had made attempts to increase the rate to 65 ml per hour.

During an interview with RN (Registered Nurse) 1 on November 21, 2013, at 9 a.m., the RN reviewed the order and stated she had not made any attempts to increase the feeding. She stated she did not know the feeding goal was to increase incrementally to reach the target rate of 65 ml per hour. The RN stated the patient did not have any residual feeding left in the stomach when she checked. She stated there was no reason the feeding rate could not be increased, and the feeding had been at that 55 ml per hour rate, "for awhile."

An anylasis of the Diabetisource AC 1.2 Cal feeding formula indicated the following:

(1). Every ml of feeding contained 1.2 calories, 0.06 grams of fat, and 0.06 grams of protein;

(2). At a rate of 55 ml per hour, Patient 1 was reveiving 66 calories, 3.3 grams of fat, and 3.3 grams of protein every hour;

(3). At the ordered rate of 65 ml per hour, Patient 1 should have been receiving 78 calories, 3.9 grams of fat, and 3.9 grams of protein every hour; and,

(4). Patient 1 was receiving 288 calories, 14.4 grams of fat, and 14.4 grams of protein less than the physician ordered every day.

The facility policy titled "Enteral Nutrition," with a revised date of April 2013, was reviewed on November 21, 2013. The policy indicated: "Patient specific enteral nutrition orders will include: Administration method and rate..."

4. On November 18, 2013, between 9:30 a.m., and 10:30 a.m., a tour of the medical surgical unit was conducted. A sign was noted outside the door of room 15. The sign indicated the patient was "NPO (nothing by mouth) except for tube feeding." The patient in room 15 had a tracheostomy (surgical opening in the throat with a tube placed to provide and secure an open airway) and was mechanically ventilated (a machine was providing artificial respirations for the patient). This patient was receiving nutrition via a intravenous line. Several other rooms were observed to have "NPO," signs posted outside the entrance to the room.

On November 18, 2013, at 10:30 a.m., Patient 4 was observed in room 7. Patient 4 was lying in bed with his eyes open. Patient 4 had a tracheostomy and was mechanically ventilated. Patient 4 had a gastrostomy tube (tube inserted into the stomach through the abdomen to administer food and fluids), and was unable to take foods and fluids orally. Patient 7 was receiving Jevity 1.2 Cal (an enteral feeding solution given via the gastrostomy tube) at 55 milliters (ml) per hour via an infusion pump. There was no identification on the outside of Patient 7's room indicating the patient was not to receive anything by mouth.

On November 18, 2013, Patient 4's record was reviewed. Patient 4's record indicated the patient was "NPO except for tube feeding," since October 11, 2013.

In an interview with the Nurse Manager (NM) on November 18, 2013, at 10:40 a.m., the NM stated Patient 4 was not to receive anything by mouth. The NM stated signs were used to alert staff that patient was not to receive oral feeding. The NM stated patients can be moved from one room to another and the sign may not follow them. The NM stated there was the possibility a diet could be given to a patient who was to receive nothing by mouth.

5. A review of the medical record for Patient 15, on November 20, 2013, indicated that the patient was admitted to the hospital on October 30, 2013. The patient was admitted with diagnoses that included chronic respiratory failure. A review of the physician orders indicated the patient was on an oral diet when admitted.

A review of the RD note dated November 11, 2013, indicated that the patient had a change in condition that required being placed on a ventilator (breathing machine). The oral diet was stopped and a tube feeding was started.

A review of the patient care plan for Patient 15, dated November 8, 2013, indicated interventions to monitor food and snack intake. The care plan had not been updated to indicate that the patient was no longer on an oral diet and was on a tube feeding for 100% of his nutrition.

During an interview with RD on November 20, 2013, at 12:30 p.m., she stated that she usually updated the patient care plans whenever she saw a patient. She stated that she must have forgotten to update Patient 15's care plan when she saw him on November 11 and 15, 2013. She verified that the care plan indicated to monitor food and snack intake when the patient was no longer on an oral diet.

6. A review of the hospital's nutrition analysis of their menus on November 21, 2013, indicated that the regular menu provided 20 grams of dietary fiber, 290 milligram (mg) of magnesium, 8.8 mg of zinc and 85 grams of vitamin K.

A review of the Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes (AIs) for Vitamins, Minerals and Macronutrients, from the Food and Nutrition Board, Institute of Medicine, National Academies indicated that the DRI's for dietary fiber for males 50 years old or greater was 30 grams of fiber a day. The hospital menu provided 20 grams. The DRI for magnesium was 420 mg a day for males 50 years old or greater, and the hospital menu provided 290 mg. The DRI for zinc for males 50 years old or greater was 11 mg, and the menu provided 8.8 mg. The DRI for vitamin K was 120 mg for males 50 years old or greater, and the menu provided 85 grams.

A review of the hospital patient population during the survey showed a majority of both the male and female patients were 50 years old or greater.

During an interview with the Director of Nutrition Services on November 21, 2013, at 9:15 a.m., she stated that she was aware that the menus did not meet the DRI's for dietary fiber. She stated that most patients admitted to the hospital needed a lower fiber diet. She was unable to state how she would meet the fiber needs of patients who did not require a fiber restriction. She also verified that the hospital had a "soft" diet which would be appropriate for patients who required a lower fiber content diet. She was unable to explain why the menus did not meet the DRIs for magnesium, zinc, or Vitamin K.



22764

Based on observation, interview, and record review, the facility failed to maintain a system for controlling sources of infections in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and applicable regulations, when:

1. Manufacturer's disinfecting wet contact time was not in accordance with the instructions for use and a bucket that contained disinfectant was not labeled;

2. Laryngoscopes were not stored in a manner to prevent recontamination;

3. Endoscopes were not stored in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility;

4. Tape residue was observed on the pad of an Operating Room table;

5. Surgical instruments were not reprocessed and maintained in accordance with facility policy and procedure and the nationally recognized infection control guidelines adopted by the facility:

a. Surgical instrument marking tape was not used in accordance with manufacturer's guidelines;

b. The inner peel pack of double peel packs was folded;

c. Peel packs were stained;

d. A peel pack contained 16 instruments;

e. Surgical instruments were engraved; and,

f. 3 clamps were in the closed and locked position.

6. The facility's policy and procedure for event related sterility was not in accordance with applicable State regulation or the facility's adopted, nationally recognized infection control guidelines;

7. The facility's quality management program did not evaluate the care of instruments to improve patient safety in accordance with its nationally recognized infection control guidelines; and,

8. The ice machine in the kitchen was noted to have a significant accumulation of a black gelatinous residue around the chute where the ice dropped from the ice maker into the storage bin.

These failed practices resulted in the potential for facility acquired infections and food borne illness to be spread throughout the facility to a medically vulnerable population.

Findings:

1a. On November 18, 2013, at 10:15 AM, during a concurrent observation and interview with EVS (Environmental Services Worker) 3, a bucket containing disinfectant, on an EVS cleaning cart, was not labeled. The EVS supervisor confirmed that containers of disinfectants must be labeled.

According to Waxie (manufacturer) Disinfectant Cleaner, Solution 700, Ready-to-Use Container Label: This label is intended solely for identification of diluted solutions ...

According to Waxie product representative (800-995-4466) the Ready-to-Use Container Label should be applied to any secondary container of disinfectants for identification and safety.

b. On November 18, 2013, at 10:56 a.m., during a concurrent observation and interview with the XRT, Sani-Cloth Bleach (disposable disinfectant wipes) was applied to a portable X-ray machine. At 10:59 a.m., theree minutes later, the portable X-ray machine was dry. The XRT stated the manufacturer's instructions for use required surfaces to remain wet for four minutes. The XRT stated a disinfectant with bleach was used when portable equipment was taken into a patient room that may have C. diff (Clostridium Difficile, a spore forming bacteria).

(1). According to the Sani Cloth Bleach manufacturer's label: Treated surfaces must remain visibly wet for a full four minutes. Use additional wipe(s) if needed to assure continuous four minute wet contact time.

(2). According to the facility policy manual, Infection Control, Management of the Patient with Clostridium Difficile:

A. Non-dedicated patient care equipment used in the room must be cleaned with a hospital approved product containing a 1:10 dilution of bleach solution, as recommended by the CDC (Centers for Disease Control), before removing them from the room; and,

B. Manufacturer's recommendation for contact times for environmental surface disinfection must be followed.

(3). According to CDC / HICPAC (Healthcare Infection Control Practices Advisory Committee), Guideline for Disinfection and Sterilization in Healthcare Facilities (2008):

A. Antimicrobials are regulated by the EPA (Environmental Protection Agency) and FDA Food and Drug Administration);

B. Any substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest (including microorganisms) must be registered and users must explicitly follow the labeling directions on each product, i.e; and,

C. "It is a violation of federal law to use this product in a manner inconsistent with its labeling." Thus, health-care workers must follow the safety precautions and use directions on the labeling of each registered product. Failure to follow the specified use-dilution, contact time, method of application, or any other condition of use is considered a misuse of the product and potentially subject to enforcement action.

(4). According to HICPAC, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008), by law, users must follow all applicable label instructions of products registered by the Environmental Protection Agency, including the surface description.

2. On November 19, 2013, at 9:35 AM, during concurrent observation and interview in OR #1, 1 laryngoscope blade and 2 laryngoscope handles were unpackaged and uncovered in an anesthesia cart.

a. According to the facility Central Sterile Services Policy & Procedure Manual: Sterile supplies will be considered sterile until packaging is opened....

b. On November 18, 2013, at 1:30 p.m., during an interview, IP (Infection Preventionist) 1 stated the facility followed AORN (Association of Perioperative Registered Nurses) infection control guidelines.

According to AORN Perioperative Standards and Recommended Practices, Recommended Practices for Selection and Use of Packaging Systems for Sterilization (2013):

(1). Paper-plastic pouch packages should provide a seal of proven integrity;

(2). A break in the seal may allow microorganisms to enter and contaminate package contents; and,

(3). Paper-plastic pouch packages should be inspected for intact seals and barrier integrity before use.

3. On November 19, 2013, at 9:45 a.m., during a concurrent observation and interview with the OR Tech, endoscopes were stored in a cabinet, the sections from the control body to the light source connectors were in a non-vertical position. The OR Tech stated that the sections from the control body to the light source connectors were not required to be hung vertically, which was not in accordance with manufacturer's (Pentax) instructions for use or the facility's nationally recognized infection control guidelines (AORN).

a. According to the Pentax (endoscope manufacturer) poster, Manual Reprocessing Instructions for Pentax GI Video Endoscopes, MK 214.1, provided by the facility:

(1). The poster/chart was only a summary of the complete instructions found in the corresponding Reprocessing Manual of GI endoscopes or fiberscopes - and the manual and other recent Pentax documents should be used as a primary source of reference; and,

(2). Scope Handling. Storage. The endoscope should be stored fully extended ...freely hung up ...to prevent deformation or kinking damage and allow the scope to drain.

b. According to Pentax Internet-based endoscope reprocessing instructions:

(1). Prior to storage, the staff should ensure that all internal channels, scope components, instrument surfaces and accessories were thoroughly dry;

(2). A dry instrument was essential to prevent bacteria colonization and/or infections associated with waterborne microorganisms. Such infections were more likely to occur when wet/contaminated instruments were used;

(3). The endoscope should be hung in a clean, dry, well-ventilated storage cabinet; and,

(4). The insertion tube and light guide cable should be hung and kept as straight as possible during storage.

c. On November 18, 2013, at 1:30 p.m., during an interview, IP 1 stated the facility followed AORN infection control guidelines.

According to AORN Perioperative Standards and Recommended Practices, Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories (2013):

(1). Flexible endoscopes should be cleaned and stored in accordance with the manufacturer's written instructions;

(2). Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes microbial contamination;

(3). Flexible endoscopes should be stored in a closed cabinet with adequate height to allow flexible endoscopes to hang in a secure vertical position, without touching the bottom of the cabinet;

(4). When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential development of an environment conducive to microbial growth in the endoscope;

(5). Proper storage facilitates drying and decreases potential for contamination; and,

(6). Improper drying creates an environment conducive to growth of microorganisms, an environment favorable for microbial growth if the flexible endoscope is not dry and cannot hang straight.

d. Notably, according to SGNA (Society for Gastroenterology Nurses and Associates), Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2012):

(1). Endoscopes should be stored in a manner that will protect them from contamination, hanging in a vertical position to facilitate drying ...Note that drying the endoscope after every reprocessing cycle, both between patient procedures and before storage is a requisite practice crucial to the prevention of bacterial transmission and nosocomial infection; and,

(2). Drying is as important to the prevention of disease transmission and nosocomial infection as cleaning and high level disinfection.

4. On November 19, 2013, at 9:40 a.m., during a concurrent observation and interview with the OR Tech, tape residue was observed on the pad of an Operating Room table (OR #2).

On November 18, 2013, at 1:30 p.m., during an interview, IP 1 stated the facility followed AORN infection control guidelines.

a. According to AORN Perioperative Standards and Recommended Practices, Recommended Practices for Environmental Cleaning in the Perioperative Setting (2013):

(1). The patient should be provided a clean, safe environment. Health care-associated infections have been linked to external sources, which can include environmental surfaces;

(2). The perioperative registered nurse should assess the perioperative environment frequently for cleanliness and take action to implement cleaning and disinfection procedures if needed;

(3). Cleanliness means the absence of visible debris;

(4). Environmental surfaces can serve as a means of secondary transmission by providing a reservoir for infectious organisms, showing the importance of environmental cleaning and disinfection as part of an infection prevention process in reducing microbial bio-burden in the environment, thereby interrupting microorganism transmission.

b. Notably, according to HICPAC, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008), environmental surfaces can become contaminated with infectious agents and contribute to the spread of health-care-associated infections. The surface type affects cleaning effectiveness because surface irregularities can shield microorganisms from disinfection products.

5. On November 19, 2013, at 11:30 a.m., during a concurrent observation and interview with the OR Tech, the following were noted:

a. A single peel pack containing two clamps with three sections of surgical instrument marking tape (red, white, and blue) adjacent to each other. The tape was creased, lifting, peeling, wrapped more than one and one half times, and the three sections overlapped each other. No documented monitoring of the surgical identification tape was provided by the facility.

According to Key Surgical Identification Tape Application Instructions:

(1). Wrap tape around the shank one to one and one half times ONLY-do not overlap tape;

(2). Tape should lay flat without gaps;

(3). Inspect tape each time the instrument is processed; and,

(4). Replace tape when it starts to chip, flake, or lift off the instrument.

b. The inner peel pack (paper-plastic pouch to contain surgical instruments for re-sterilization and protect from contamination) of two double peel packs was folded. One peel pack was dated 10-30-08, contained two sponge sticks, and was labeled: "Sterilized. Indefinite shelf life unless damaged or opened." The second peel pack was dated 3-6-11, contained two clamps, and was labeled: "Sterilized. Indefinite shelf life unless damaged or opened."

On November 18, 2013, at 1:30 p.m., during an interview, IP 1 stated the facility followed AORN infection control guidelines.

According to AORN Perioperative Standards and Recommended Practices, Recommended Practices for Selection and Use of Packaging Systems for Sterilization (2013), double paper-plastic pouch packages should be used in such a manner as to avoid folding the inner package to fit into the outer package. Folding the edges of inner peel packages may entrap air and inhibit the sterilization process. Double paper-plastic pouch packaging is not routinely required for sterilization.

c. A single peel pack, dated, "09 May 2012", labeled, "Sterilized. Indefinite shelf life unless damaged or opened," was stained with a tan-colored tint in multiple areas.

On November 20, 2013, at 9:40 AM, during an interview, the OR Tech stated the integrity of the peel pack was not acceptable, possibly due to a wet pack, and the instrument should be repackaged and re-sterilized.

According to AORN Perioperative Standards and Recommended Practices, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment (2013):

(1). Surgical instruments should be inspected for cleanliness and proper working order after decontamination;

(2). Inspecting instruments for sterilization before assembly of trays provides an opportunity to identify those instruments that require additional cleaning or repair before use;

(3). Instruments should be inspected for ...removal of moisture;

(4). Instruments can become damaged during use or decontamination;

(5). Sterilization may not occur in the presence of soil or water;

(6). Instruments should be thoroughly dried;

(7). Elimination of moisture helps prevent rust formation during instrument storage. The presence of moisture can impede the sterilization process; and,

(8). Moisture on instrument surfaces alters the moisture content of steam and can pose a challenge for effective heating of the instrument ... Moisture can pool on this material, causing a wet pack ...moisture that can serve as a medium for microbial growth.

d. A peel pack contained 16 instruments, verified by the OR Tech. According to AORN Perioperative Standards and Recommended Practices, Recommended Practices for Selection and Use of Packaging Systems for Sterilization (2013), Paper-plastic pouch packages should be used only for small, lightweight, low-profile items (e.g., one or two clamps, scissors) ...because problems (e.g., wet packages following sterilization) and sterility maintenance problems (e.g., package seal break) may occur.

e. Surgical instruments were engraved.

(1). According to AORN Perioperative Standards and Recommended Practices, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment (2013), instruments should be inspected for corrosion, pitting, burrs, nicks, and cracks ...surface corrosion damage (i.e., pitting) over time ...can inhibit sterilization ...abrasives can damage the protective surfaces of instruments, contribute to corrosion, and impede sterilization.

(2). Notably, according to International Association of Healthcare Central Service Material Management, dot peen marking systems ...to engrave ...instruments ...damages the surface of the instrument and creates a place for microorganisms to grow. Therefore, this type of etching system should not be used to mark surgical instruments.

f. Three clamps in peel packs were in the closed and locked position, verified by the OR Tech.

According to AORN Perioperative Standards and Recommended Practices, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment (2013):

(1). Instruments with hinges should be opened and those with removable parts should be disassembled;

(2). Instruments should be kept in the open and unlocked position;

(3). Proper organization and adequate drying will facilitate sterilant contact on all surfaces;

(4). Sterilization occurs only on surfaces that have direct contact with the sterilant; and,

(5). Disassembly of multiple-part instruments and those with sliding parts enables the sterilant to contact all surfaces.

6. According to the facility Central Sterile Services Policy & Procedure Manual, Event Related Sterility, sterile supplies will be considered sterile until packaging is opened or damaged in any way. These items will no longer need an expiration date.

a. However, an expiration date (i.e., outdating) is required in accordance with California Code of Regulation, Title 22, Section 70833, Autoclaves and Sterilizers;

(c) Written procedures shall be developed, maintained and available to personnel responsible for sterilization of supplies and equipment that include, but are not limited to the following;

(3) Dating and outdating of materials sterilized.

b. According to AORN Perioperative Standards and Recommended Practices, Recommended Practices for Selection and Use of Packaging Systems for Sterilization (2013):

1. Sterilized packages should be considered sterile until an event occurs to compromise the package barrier integrity...Events that may affect the sterility of a package include, but are not limited to;

A. Multiple handling that leads to seal breakage or loss of package integrity;

B. Compression during storage;

C. Moisture penetration;

D. Exposure to airborne and other environmental contaminants;

E. Storage conditions (e.g., type of shelving, cleanliness, temperature, humidity, traffic control);

F. Type and configuration of packaging materials used; and,

G. Use of sterility maintenance covers and method of sealing.

2. Sterile packages should be stored under environmentally controlled conditions. Sterile storage area temperature should be controlled and not exceed 75° F. The humidity should not exceed 70%. There should be a minimum of four air exchanges per hour, and the air flow should be under positive pressure in relation to adjacent areas.

7. On November 18, 2013, at 1:30 p.m., during an interview, IP 1 stated the facility followed AORN infection control guidelines.

a. According to AORN Perioperative Standards and Recommended Practices, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment (2013):

(1). The health care organization's quality management program should evaluate the care of instruments to improve patient safety;

(2). A quality management program should be in place, and manual cleaning should be evaluated at periodic intervals determined by the health care organization;

(3). Personnel should identify and respond to opportunities for improvement; and,

(4). Periodic testing provides an opportunity to evaluate the performance of personnel, as cleaning is a learned skill and subject to human error.

b. According to AORN Perioperative Standards and Recommended Practices, Recommended Practices for Selection and Use of Packaging Systems for Sterilization (2013), health care organizations should determine the best methods and materials for packaging sterile items, based upon the anticipated storage, handling, and environmental events that may be encountered.

On November 19, 2013, at 1 p.m., during an interview with the Governing Body and Performance Improvement representatives, the group stated they were unaware of the facility's policy and procedure regarding event related sterility, and could not recall discussing the policy in relation to the unique conditions of the facility and its population, for example, the facility has a limited surgical schedule therefore surgical instrument turnover may be lengthy (viz., one sterile peel pack was more than five years old).

8. During an observation of the ice machine, in the facility's kitchen, on November 18, 2013, at 9:40 a.m., a significant accumulation of a black gelatinous residue was noted. The residue was noted on the ceiling of the ice storage bin and around the chute where the ice dropped into the bin. The Director of Nutrition Services (DNS) and the Lead Engineer (LE) were present during the observation and verified the finding.

During a concurrent interview with the LE and Engineering Staff (ES), they stated that the ice machine was checked every week to ensure it drained correctly and it was clean. It was checked monthly to clean the coils and check the filter. They also stated that every six months the ice machine was taken apart and cleaned from the inside using just water. ES stated that last time the ice machine was cleaned was August 28, 2013. ES further stated that when he cleaned the ice machine, he would usually see the same residual build-up that was observed. He stated that it should probably be cleaned more often.

During a concurrent interview with the DNS she stated that she did not inspect the ice machine, and depended on the engineering staff to clean it. She stated the dietary staff cleaned the ice storage bin once a month, but they did not clean the ceiling of the bin.

During an interview with the Area Director for Infection Control, on November 21, 2013, at 11:25 a.m., she stated that the ice machine was inspected during Environment of Care rounds twice a year. She could not explain why there was a build-up of the black gelatinous residue seen on November 18, 2013.

According to the USDA 2009 Food Code, equipment such as ice bins and enclosed components of equipment such as ice makers shall be cleaned at a frequency necessary to preclude accumulation of soil or mold.