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Based on record review and staff interviews, the hospital failed to ensure the Director of Food and Nutrition Services met all the requirements of the California Health and Safety Code 1265.4, for a dietetic services supervisor. The Director failed to obtain at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations, as required in the Health and Safety Code. This failure could lead to a deficit in knowledge for dietary staff.

Findings:

During a record review of the employee file for the DFNS, there was no documented evidence of at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations as required in the Health and Safety Code (HSC).

During an interview with the DFNS on June 21, 2012, at 3:30 p.m., he stated he did not complete at least six hours of in-service specific to the California dietary service requirements contained in Title 22 of the California Code of Regulations, as required in the HSC. He thought he had met all the requirements of the HSC, but did not know that the in-service hours were required to be specific to Title 22 requirements.

During an interview with the hospital's RD on June 19, 2012, at 2:40 p.m., she stated she did not have full time responsibilities of the dietary services department. She provided consultation to the food services department, but did not oversee the day to day operations of the department. That was the responsibility of the DFNS.

According to the California Health and Safety Code 1265.4, a) A licensed health facility, as defined in subdivision (a), (b), (c), (d), (f), or (k) of Section 1250, shall employ a full-time, part-time, or consulting dietitian. A health facility that employs a registered dietitian less than full time, shall also employ a full-time dietetic services supervisor who meets the requirements of subdivision (b) to supervise dietetic service operations. The dietetic services supervisor shall receive frequently scheduled consultation from a qualified dietitian.

The dietetic services supervisor shall have completed at least one of the following educational requirements:

a. Is a graduate of a dietetic services training program approved by the Dietary Managers Association and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility...

During an interview with the DFNS on June 21, 2012, at 3:30 p.m., he verified he did not meet the requirements of the HSC.

Based on interview and record review, the Governing Body failed to ensure the facility functioned effectively, by failing to:

1. Ensure staff protected and promoted patients' rights by failing to ensure two of three patients who had an advance directive for CPR in the event their heart would stop beating or their respirations would cease, received CPR, resulting in the death of these two patients (A115); and,

2. Failed to ensure the Nursing Staff operated under the Bylaws approved by the Governing Body and was responsible for the quality of care provided to patients. (A0385, A392).

The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Governing Body, and failure to provide care to their patients in a safe environment.

Based on interview and record review, the facility failed to ensure two of three patients (Patient 113 and 312), who had an advance directive for CPR in the event their heart would stop beating or their respirations would cease, did not receive CPR, resulting in the death of these two patients (A132). Patient 113 had a change of condition, and she required CPR. The facility licensed staff obtained a consent from a non DPOA daughter, who did not obtain an order from the physician for a no code status.

Specifically the facility failed to:

a. Ensure one of three patients with orders to resuscitate (Patients 113 and 312), who had an advance directive indicating all resuscitative measures should be used, had a physician's order prior to the decision to declare the patient a DNR (do not do CPR if the heart stops), when the nursing staff made the decision independently; and,
b. Ensure one of three patients with DNR orders (Patient 312) had a verbal DNR order signed by two nurses according to the facility policy. (A132).

2. In an interview with RN 2, on June 19, 2012, at 10:30 a.m., RN 2 stated if there was no documentation in a patient's record about code status (desire for CPR and lifesaving procedures) then the patient was a full code, and all resuscitative measures were made.

A review of Patient 312's record was conducted on June 22, 2012. Patient 312 was admitted to the facility on May 2, 2012, with diagnoses that included sepsis secondary to pneumonia. Patient 312 was admitted to the intensive care unit with orders for intravenous antibiotics and vasopressors (medication to maintain or increase blood pressure). There were no documents in the record indicating the patient's code status when he was admitted. Patient 312's condition declined on May 3, 2012, at 11 p.m., and the patient was intubated (tube placed in the throat to facilitate breathing) and placed on a ventilator (breathing machine).

On May 3, 2012, at 5 p.m., the nurse documented in the "Progress Notes Report," the vasopressor was infusing at the maximum rate, the physician was notified and additional vasoactive medication was ordered. At 6 p.m., the nurse documented the physician was notified about the patient's troponin (test for heart attack) level and an order was received. At 5:45 a.m., the nurse documented the patient's remains were picked up by the mortuary.

On May 4, 2012, at 5:32 a.m., the respiratory therapist, documented the following in the "Progress Notes Report: "Pt. (patient) code status change to DNR @ 0345: Pt. expired at this time. Family at bedside at this time: Pt. pronounced by Dr. --- ER dr."

A review of the Physician's orders dated May 4, 2012, at 5 a.m., indicated a telephone order for "Full DNR as per family requested." The order had only one nurse's signature and contained no evidence a second nurse heard and verified the order.

In an interview with the CNO, on June 22, 2012, at 11:15 a.m., the CNO stated two nurses were required to verify a telephonic no code order. The CNO stated two signatures on the order form would signify the two person verification. The CNO stated there was only one signature on Patient 312's DNR order.

The facility policy and procedure titled, "Do Not Resuscitate," with a last reviewed date of September 2011, was reviewed on June 22, 2012. The policy indicated, "An order from a physician is required to be written prior to initiation of a Do Not Resuscitate (DNR) or No Code or No Cardiopulmonary Resuscitation (No CPR) code. If the Physician gives a telephone order, two licensed nurses must hear and verify the order."



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Based on interview and record review, the facility failed to ensure:

1. One of three patients with advance directives (Patient 113), indicating all resuscitative measures should be used, had a physician's order prior to the decision to declare the patient a DNR (do not do CPR if the heart stops), when the nursing staff made the decision independently without the physician's knowledge; and,

2. One of three patients with DNR orders (Patient 312) had a verbal DNR order signed by two nurses according to the facility policy.

These failures resulted in the death of both patients without resuscitation attempts, and without appropriate approval from the physicians.

Findings:

1. The record for Patient 113 was reviewed on May 11, 2012. Patient 113, a 90 year old female, was admitted to the facility on September 26, 2011, with diagnoses that included Sepsis, Hyponatremia (low sodium), Anemia (low blood count), and Dementia.

The record indicated the patient was transferred to the ICU on October 4, 2011, at 11:04 a.m, due to a decline in her condition.

A document titled, "Preferred Intensity of Treatment," dated July 17, 2007, indicated the family member who had DPOA (the right to make healthcare decisions on behalf of the patient) chose to have all resuscitative measures be given to the patient in the event of a cardiopulmonary arrest.

A document titled, "Preferred Intensity of Treatment," dated October 16, 2008, indicated the family member who had DPOA chose to have all resuscitative measures be given to the patient in the event of a cardiopulmonary arrest.

A document titled, "Physician Orders for Life Sustaining Treatment," dated March 31, 2011, indicated the family member who had DPOA chose to have all resuscitative measures be given to the patient in the event of a cardiopulmonary arrest.

The nursing notes written October 4, 2011, at 3:20 p.m., by RN 3, indicated a family member (who did not have DPOA) was at the patient's bedside when her heart rate decreased. The family member (who did not have DPOA) was asked by the nurse if she wanted the staff to take all life saving measures. The family member told the staff not to do any life saving measures.

According to the nurses' notes, within a matter of minutes, the patient's heart stopped beating. The nurse documented the charge nurse (RN 4) called the MD to inform him of the patient's death, and requested permission to pronounce the patient dead.

The Interdisciplinary Progress Notes, dated October 4, 2011, at 2:20 p.m., indicated, "no heart beat, no respirations, no corneal reflex (eye blink). Pronounced death at 1420 (2:20 p.m.) for (MD 1)."

A document titled, Request to Forego Resuscitative Measures," was reviewed on May 11, 2012. The document had a section titled, "Request Made By Legally Recognized Health Care Surrogate Decisionmaker." The document indicated a request to forego resuscitative measures on behalf of the patient, and was signed by the family member who did not have DPOA (and therefore no authority to make the decision) on October 4, 2011. It was witnessed by two nurses. The document was authenticated by MD 1 on October 28, 2011, 24 days after the patient died. There was no physician's order for a DNR prior to the nurses deciding to let the patient die without attempting resuscitative measures.

The physician's orders dated October 4, 2011, at 3:20 p.m., contained a verbal order, written by RN 4, that indicated, "nursing may pronounce death."

During an interview with RN 3 on May 9, 2012, at 3:25 p.m., RN 3 stated two nurses could sign a DNR form and then, "let the patient go." The RN stated there was no time to get a physician's order, and, "we can do that in ICU if death is imminent."

During a telephone interview with RN 4 on May 11, 2012, at 3:40 p.m., RN 4 stated ICU nurses were allowed to deem a patient a DNR without a physician's order.

The facility pamphlet handed out to all inpatients was reviewed on May 11, 2012. The pamphlet indicated the patient had the right to formulate an advance directive, including designating a decision maker if they were incapable of understanding a proposed treatment or became unable to communicate their wishes regarding care. The pamphlet indicated all patient rights applied to the person who had legal responsibility to make decisions regarding the patient's healthcare on behalf of the patient.

The person legally responsible for making healthcare decisions on behalf of Patient 113 expected to have all resuscitative measures performed, and the nursing staff allowed the patient to die without attempting any resuscitation.

On June 22, 2012, the facility policy and procedure titled, "Do Not Resuscitate," was reviewed. The policy revealed, "An order from a physician is required to be written prior to initiation of a Do Not Resuscitate (DNR) or No Code or No Cardiopulmonary Resuscitation (No CPR) code...Patients who suffer cardiac or respiratory arrest shall receive cardiopulmonary resuscitation unless a DNR order has been written on the patient's chart..."

Based on interview and record review, the facility failed to ensure nursing staff provided adequate and appropriate care, by failing to:

1. Ensure staff protected and promoted patients' rights by failing to ensure two of three patients who had an advance directive for CPR in the event their heart would stop beating or their respirations would cease, received CPR. (A115);

2. Ensure the Nursing Staff was responsible for providing quality care to patients. (A392);

3. Ensure medications were ordered, prepared, and administered in accordance with standards of practice, state laws and regulations and policy and procedure (A405); and,

4. Follow the facility policy and procedure for telephonic DNR orders, by failing for one patient (Patient 312) to ensure two nurses verified the physician's order to change the patient's status to DNR.

Based on interview and record review, the facility failed to ensure:

1. One of three patients with advance directives (Patient 113), indicating all resuscitative measures should be used, had a physician's order prior to the decision to declare the patient a DNR (do not do CPR if the heart stops), when the nursing staff made the decision independently without the physician's knowledge; and,

2. One of three patients with DNR orders (Patient 312) had a verbal DNR order signed by two nurses, according to the facility policy.

These failures resulted in the death of both patients without resuscitation attempts and without appropriate approval from the physicians.

Findings:

1. The record for Patient 113 was reviewed on May 11, 2012. Patient 113, a 90 year old female, was admitted to the facility on September 26, 2011, with diagnoses that included Sepsis, Hyponatremia (low sodium), Anemia (low blood count), and Dementia.

The record indicated the patient was transferred to the ICU on October 4, 2011, at 11:04 a.m, due to a decline in her condition.

A document titled, "Preferred Intensity of Treatment," dated July 17, 2007, indicated the family member who had DPOA (the right to make healthcare decisions on behalf of the patient) chose to have all resuscitative measures be given to the patient in the event of a cardiopulmonary arrest.

A document titled, "Preferred Intensity of Treatment," dated October 16, 2008, indicated the family member who had DPOA chose to have all resuscitative measures be given to the patient in the event of a cardiopulmonary arrest.

A document titled, "Physician Orders for Life Sustaining Treatment," dated March 31, 2011, indicated the family member who had DPOA chose to have all resuscitative measures be given to the patient in the event of a cardiopulmonary arrest.

The nursing notes written October 4, 2011, at 3:20 p.m., by RN 3, indicated a family member (who did not have DPOA) was at the patient's bedside when her heart rate decreased. The family member (who did not have DPOA) was asked by the nurse if she wanted the staff to take all life saving measures. The family member told the staff not to do any life saving measures.

According to the nurses' notes, within a matter of minutes, the patient's heart stopped beating. The nurse documented the charge nurse (RN 4) called the MD to inform him of the patient's death, and requested permission to pronounce the patient dead.

The Interdisciplinary Progress Notes, dated October 4, 2011, at 2:20 p.m., indicated, "no heart beat, no respirations, no corneal reflex (eye blink). Pronounced death at 1420 (2:20 p.m.) for (MD 1)."

A document titled, Request to Forego Resuscitative Measures," was reviewed on May 11, 2012. The document had a section titled, "Request Made By Legally Recognized Health Care Surrogate Decisionmaker." The document indicated a request to forego resuscitative measures on behalf of the patient, and was signed by the family member who did not have DPOA (and therefore no authority to make the decision) on October 4, 2011. It was witnessed by two nurses. The document was authenticated by MD 1 on October 28, 2011, 24 days after the patient died. There was no physician's order for a DNR prior to the nurses deciding to let the patient die without attempting resuscitative measures.

The physician's orders dated October 4, 2011, at 3:20 p.m., contained a verbal order, written by RN 4, that indicated, "nursing may pronounce death."

During an interview with RN 3 on May 9, 2012, at 3:25 p.m., RN 3 stated two nurses could sign a DNR form and then, "let the patient go." The RN stated there was no time to get a physician's order, and, "we can do that in ICU if death is imminent."

During a telephone interview with RN 4 on May 11, 2012, at 3:40 p.m., the RN stated ICU nurses were allowed to deem a patient a DNR without a physician's order.

The facility pamphlet handed out to all inpatients was reviewed on May 11, 2012. The pamphlet indicated the patient had the right to formulate an advance directive, including designating a decision maker if they were incapable of understanding a proposed treatment or became unable to communicate their wishes regarding care. The pamphlet indicated all patient rights applied to the person who had legal responsibility to make decisions regarding the patient's healthcare on behalf of the patient.

The person legally responsible for making healthcare decisions on behalf of Patient 113 expected to have all resuscitative measures performed, and the nursing staff allowed the patient to die without attempting any resuscitation.

On June 22, 2012, the facility policy and procedure titled, "Do Not Resuscitate," was reviewed. The policy revealed "An order from a physician is required to be written prior to initiation of a Do Not Resuscitate (DNR) or No Code or No Cardiopulmonary Resuscitation (No CPR) code...Patients who suffer cardiac or respiratory arrest shall receive cardiopulmonary resuscitation unless a DNR order has been written on the patient's chart..."

2. In an interview with RN 2, on June 19, 2012, at 10:30 a.m., RN 2 stated if there was no documentation in a patient's record about code status (desire for CPR and lifesaving procedures) then the patient was a full code, and all resuscitative measures were made.

A review of Patient 312's record was conducted on June 22, 2012. Patient 312 was admitted to the facility on May 2, 2012, with diagnoses that included sepsis secondary to pneumonia. Patient 312 was admitted to the intensive care unit with orders for intravenous antibiotics and vasopressors (medication to maintain or increase blood pressure). There were no documents in the record indicating the patient's code status when he was admitted. Patient 312's condition declined on May 3, 2012, at 11 p.m., and the patient was intubated (tube placed in the throat to facilitate breathing) and placed on a ventilator (breathing machine).

On May 3, 2012, at 5 p.m., the nurse documented in the "Progress Notes Report," the vasopressor was infusing at the maximum rate, the physician was notified and additional vasoactive medication was ordered. At 6 p.m., the nurse documented the physician was notified about the patient's troponin (test for heart attack) level and an order was received. At 5:45 a.m., the nurse documented the patient's remains were picked up by the mortuary.

On May 4, 2012, at 5:32 a.m., the respiratory therapist, documented the following in the "Progress Notes Report: "Pt. (patient) code status change to DNR @ 0345: Pt. expired at this time. Family at bedside at this time: Pt. pronounced by Dr. --- ER dr."

A review of the Physician's orders dated May 4, 2012, at 5 a.m., indicated a telephone order for "Full DNR as per family requested." The order had only one nurse's signature and contained no evidence a second nurse heard and verified the order.

In an interview with the CNO, on June 22, 2012, at 11:15 a.m., the CNO stated two nurses were required to verify a telephonic no code order. The CNO stated two signatures on the order form would signify the two person verification. The CNO stated there was only one signature on Patient 312's DNR order.

The facility policy and procedure titled, "Do Not Resuscitate," with a last reviewed date of September 2011, was reviewed on June 22, 2012. The policy indicated, "An order from a physician is required to be written prior to initiation of a Do Not Resuscitate (DNR) or No Code or No Cardiopulmonary Resuscitation (No CPR) code. If the Physician gives a telephone order, two licensed nurses must hear and verify the order."

Based on observation, interview, and document review, the facility failed to ensure medications were ordered, prepared, and administered in accordance with standards of practice, state laws and regulations and policy and procedure.

The facility staff failed to clarify incomplete vasopressor medication orders with the prescribing physician for three of 42 patients (Patients 303, 312, 313). This failed practice resulted in the licensed staff administering vasopressor medication (used to increase the blood pressure) without orders for concentration, starting dose, specific instructions about titration, and maximum infusion rate parameter.

These failures had the potential to result in medication errors, which could lead to harm, disability and death of patients.

Findings:

1. On June 19, 2012, at 10:45 a.m., Patient 303 was observed in an ICU bed. Patient 303 had multiple intravenous medications infusing, including Levophed (a vasoactive medication to increase or maintain blood pressure).

In an interview with RN 2, on June 19, 2012, at 10:45 a.m., the nurse stated Patient 303 was receiving a minimal dose of Levophed.

On June 19, 2012, Patient 303's record was reviewed. Patient 303 was admitted to the hospital on June 16, 2012 with diagnoses including pneumonia. On June 17, 2012, at 8:20 p.m., the following order was written: "Levophed gtt (drops) titrate to MAP (Mean Arterial Pressure) > 65." There were no additional orders for Levophed in the record.

Mean Arterial Pressure is the best measure of perfusion pressure to an organ. If the MAP falls, end organs may not get enough blood flow and become ischemic (tissue destruction occurs).

In an interview with RN 2, on June 19, 2012, at 10:45 a.m., the RN was unable to find additional orders for Levophed for Patient 303 in the record. RN 2 stated the order as written directed her to titrate the medication to maintain Patient 303's MAP greater than 65. RN 2 stated the order did not specify a concentration, a starting dose, an incremental change dose or a maximum dose. RN 2 stated the maximum dose was 20 mcg/min. The RN stated there was no protocol for administering vasopressors (including Levophed). The RN stated there was an order form, but it was not used if the physician did not use it.

A document titled "ICU Vasopressor Protocol," was reviewed on June 19, 2012. The form contained instructions for "Vasopressor guidelines." Four medications Dopamine, Levophed, Vasopressin, and Dobutamine were listed on the document. Starting parameters, titration rates, maximum rates and reasons to notify the physician were included on the document. The form could be used by a physician or by a nurse in obtaining telephonic orders.

On June 19, 2012, at 11 a.m., RN 2 was asked to demonstrate the process for setting up a Levophed infusion. The RN stated the concentration of the medication was input into the IV pump. The pump had a preset menu for medications that were selected according to concentration. The RN stated the concentration depended upon the mix, sometimes it was 4 mgs per 250 mls, sometimes 8 mgs or 16 mgs per ml. The RN stated she would start the Levophed somewhere around 10 mcg/min. The RN stated the medication could be obtained from the ADC and mixed on the unit without pharmacy input.

In an interview with the Director of ICU, on June 19, 2012, at 11 a.m., the Director stated if Levophed was ordered after hours, two nurses were required to withdraw the medications. The Director reviewed the order for Patient 303's Levophed and stated the order needed to be more specific. The Director stated there was no policy for Vasopressor infusion; staff could review references on the computer or other sources if needed.

On June 19, 2012, at 11 a.m., the bag of Levophed currently infusing was observed with the Director of ICU and the Pharmacist. The bag had a typed label that indicated Levophed "Titrate as directed."

The Medication Administration Records (MAR) dated June 17 through June 19, 2012, were reviewed. The MAR indicated "norEPINEphrine Bitartrate 1 MG/ML [Levophed]." Dose of 4 mg/4 ml with a frequency of "TITRATE AS DIRECTED."

The directions on the MAR did not include:

The rate of infusion for Levophed;
The starting rate for Levophed;
The incremental titration rate for Levophed; and
The maximum rate for Levophed.

On June 20, 2012, Patient 303's MAR was reviewed with RN 3. RN 3 stated the order for Patient 303's Levophed was written at 8:20 p.m., and verified by pharmacy. RN 3 could not find documentation in the record to indicate when the first bag of Levophed was started. There was no documentation in the MAR that indicated when the medication was increased or decreased until June 18, 2012, at 6:45 a.m., when it was documented "MAP 81 decreased Levophed gtt to 2.5 mcg/min." RN 3 stated there was no way to determine start time, initial dose, incremental changes, or maximum dose between June 17, 2012, at 8:20 p.m., and June 18, 2012, at 6:45 a.m.

RN 3 stated there was an ICU "Vasopressor Protocol," that gave staff parameters for administering medication. RN 3 stated he could also look up the medication on "lexicomp," or call the pharmacy if there were questions about the medication rate. RN 3 agreed if the medication was ordered by a physician, it was an emergency and the medication needed to be started without delay.

RN 3 stated if the Levophed was started too fast it could cause the "patient's blood pressure to rise rapidly and if started too low, could cause kidney damage due to lack of perfusion to the kidneys."

On June 21, 2012, at 10:30 a.m., the override report (list of medications obtained from the ADC without pharmacist review) for the ICU dated June 17, 2012, indicated there was an override for Levophed 4 mg/4 ml one vial on June 18, 2012, at 3:21 a.m. This override occurred seven hours after the medication was ordered by the physician.

A review of the patient's vital sign report for June 17 at 8:30 p.m., through June 18, 2012, at 6:45 a.m., indicated vital signs were recorded every fifteen minutes. The recorded VS indicated that Patient 303's MAP at 9 p.m., was below 65 and the MAP remained below 65 until 11:30 p.m., when a reading of 65 was obtained. According to the VS record, Patient 303 had 26 MAP readings below 65 from June 17 at 8:30 p.m., through June 18, 2012, at 6:45 a.m. Readings after 3:20 a.m., indicated an improvement in the patient's MAP to 67.

A document titled, "Injectable Medication Manual & High Alert list," was reviewed, on June 21, 2012. The document indicated Norepinephrine (Levophed) could be given in the ER and ICU and BP should be checked every 2 minutes until stable then every 5 minutes during therapy.

Lexicomp, a drug resource website utilized by facility staff, indicated blood pressure should be checked every 2 minutes from the time the norepinephrine infusion is started until the desired effect is achieved, then every 5 minutes while the drug is being infused.

2. A review of Patient 312's record was conducted on June 22, 2012. Patient 312 was admitted to the facility on May 2, 2012 with diagnoses that included sepsis secondary to pneumonia. Patient 312 was admitted to the intensive care unit with orders for intravenous antibiotics and vasopressors (medication to maintain or increase blood pressure). An order dated, May 2, 2012, at 10:50 p.m., indicated the following, "Levophed drip-titrate to keep SBP (systolic blood pressure) greater than 90. A second order dated May 3, 2012, indicated, "Start Levophed 16 mg in 250 ccs normal saline titrate to keep MAP > 65 mm HG."

A review of the record failed to reveal additional orders clarifying the Levophed order.

3. A review of Patient 313's record was conducted on June 22, 2012. The record indicated Patient 313 was admitted to the ICU from the ED on April 29, 2012, with diagnoses that included cardiogenic shock and cardiac arrest. Initial orders at 3:12 p.m., included Dobutamine GTT starting at 10 mcg/kg/min titrate to keep MAP greater than 65. At 4:05 p.m., the ER MD ordered Levophed gtt starting at 10 mcg/kg/min titrate to SBP greater than 95 mmHg. At 4:14 p.m., an order for neosynephrine drip was written and at 4:40 p.m., the ER MD ordered an epinenphrine drip at 0.1mcg/kg/min titrate to keep SBP greater than 95 mm Hg, with a maximum of 35 mcg/minute. Following stabilization, the patient was transferred to the ICU.

A review of the "Physician Admission Orders," dated April 29, 2012, at 5:30 p.m., revealed orders to "Continue all pressors with ICU Protocol," and the following titration parameters:

Titrate Levophed to SBP>90
Titrate Neo (neosynephrine) to SBP >90
Titrate Dobutamine to SBP >90
Titrate epinephrine to SBP >90.

The record did not contain a copy of the ICU Vasopressor Protocol. Patient 313 remained on these medications throughout his hospitalization and there was no evidence the orders were clarified to include maximum rates and parameters for physician notification.

The policy titled, "Medication Administration," with a last revised date of March 2012, was reviewed on June 21, 2012. The policy indicated:

"...Before administering a medication, the licensed independent practitioner or appropriate health care professional administering the medication does the following:"

"... Verifies the medication is being administered at the proper time, the prescribed dose..."

"...Discusses any unresolved, significant concerns about the medication with the patient's physician, prescriber, and/or relevant staff involved with the patient's care, treatment, and service."

The policy titled, "Medication Titration and Tapering," with a last reviewed date of January 2012, was reviewed on June 21, 2012. The policy indicated:

"It is the policy of this institution to allow orders for medication titration, which is the progressive increase or decrease of the medication dose in response to the patient's clinical status."

Procedure for Titration:

"Orders for medication that require titration must include the desired state the prescriber desires for the patient..."

"...Medications ordered for titration must be approved by the Pharmacy and Therapeutics Committee..."

"...A dose limit maximum and minimum limits at which the physician must be called for each titrated medication must be set..."

"..Accepting orders for titration of medication without dose limits is unsafe. Therefore orders received for titrated mediations without dose limits will not be prepared or dispensed. The Pharmacist will contact the prescriber to obtain dose limits..."

"... Dose limits must be clearly documented on all labels of titrated solutions..."

On June 21, 2012, at 2 p.m., the Director of Quality Improvement was interviewed about the "ICU Vasopressor Protocol." The Director stated she was not involved in the protocol education and did not know if data about its use was collected.

In an interview with the Director of ICU on June 21, 2012, at 2:15 p.m., the Director stated she was unaware staff were not using the Vasopressor protocol.

Based on interview and record review, the facility failed to follow their policy and procedure for telephonic DNR orders, by failing for one patient (Patient 312) to ensure two nurses verified the physician's order to change the patient's status to DNR.

Findings:

In an interview with RN 2, on June 19, 2012, at 10:30 a.m., RN 2 stated if there was no documentation in a patient's record about code status (desire for CPR and lifesaving procedures) then the patient was a full code, and all resuscitative measures were made.

A review of Patient 312's record was conducted on June 22, 2012. Patient 312 was admitted to the facility on May 2, 2012, with diagnoses that included sepsis secondary to pneumonia. Patient 312 was admitted to the intensive care unit with orders for intravenous antibiotics and vasopressors (medication to maintain or increase blood pressure). There were no documents in the record indicating the patient's code status when he was admitted. Patient 312's condition declined on May 3, 2012, at 11 p.m., and the patient was intubated (tube placed in the throat to facilitate breathing) and placed on a ventilator (breathing machine).

On May 3, 2012, at 5 p.m., the nurse documented in the "Progress Notes Report," the vasopressor was infusing at the maximum rate, the physician was notified and additional vasoactive medication was ordered. At 6 p.m., the nurse documented the physician was notified about the patient's troponin (test for heart attack) level and an order was received. At 5:45 a.m., the nurse documented the patient's remains were picked up by the mortuary.

On May 4, 2012, at 5:32 a.m., the respiratory therapist, documented the following in the "Progress Notes Report: "Pt. (patient) code status change to DNR @ 0345: Pt. expired at this time. Family at bedside at this time: Pt. pronounced by Dr. --- ER dr."

A review of the Physician's orders dated May 4, 2012, at 5 a.m., indicated a telephone order for "Full DNR as per family requested." The order had only one nurse's signature and contained no evidence a second nurse heard and verified the order.

In an interview with the CNO, on June 22, 2012, at 11:15 a.m., the CNO stated two nurses were required to verify a telephonic no code order. The CNO stated two signatures on the order form would signify the two person verification. The CNO stated there was only one signature on Patient 312's DNR order.

The facility policy and procedure titled "Do Not Resuscitate," with a last reviewed date of September 2011, was reviewed on June 22, 2012. The policy indicated "An order from a physician is required to be written prior to initiation of a Do Not Resuscitate (DNR) or No Code or No Cardiopulmonary Resuscitation (No CPR) code. If the Physician gives a telephone order, two licensed nurses must hear and verify the order."

Based on record review and staff interviews, the hospital failed to ensure two pharmacy orders were dated and signed. This failure had the potential to result in errors in the administration of the orders.

Findings:

During a record review for Patient 403, one pharmacy order for TPN was noted to be without a date and time. A second order for TPN was noted to be without a date.

During an interview with the Director of Pharmacy on June 21, 2012, at 2:30 p.m., he stated the orders should be dated and timed. He verified the two TPN orders were not dated and one did not have either a date or a time. He was unable to state why the two orders were not complete. He verified without a date and time, he was unable to determine when the orders were written and should have been carried out.

A review of the hospital's Medical Staff Bylaws dated 2012 revealed that all Member orders shall be accurately and legibly dated and timed.

Based on observation, interview, and document review, the facility failed to ensure medications were controlled and distributed in accordance with applicable standards of practice. The facility failed to ensure intravenous vasopressor medications (a drug that induces vasoconstriction and thereby elevates mean arterial pressure), included the concentration, starting dose, specific instructions about titration, and maximum infusion rate parameter. The facility pharmacy staff failed to clarify IV vasopressor medication orders when received from the prescribing physician. The facility failed to control the dispensing of medications that allowed the RNs to practice outside of their scope of practice, by determining the infusion rate of the vasopressor medications given to the patients, without clarifying the order from the physician.

Findings:

According to the California Nursing Practice Act ? 2725.1, "...Notwithstanding any other provision of law, a registered nurse may dispense drugs or devices upon an order by a licensed physician and surgeon if the nurse is functioning within a licensed clinic..."

According to the California Code of Regulations, Title 22, Division 5, ? 70263(g), "No drugs shall be administered except by licensed personnel authorized to administer drugs and upon the order of a person lawfully authorized to prescribe or furnish..."

1. On June 19, 2012, at 10:45 a.m., Patient 303 was observed in an ICU bed. Patient 303 had multiple intravenous medications and fluids infusing, including Levophed (a vasopressor medication to increase or maintain blood pressure).

In an interview with RN 2, on June 19, 2012, at 10:45 a.m., the nurse stated Patient 303 was receiving a minimal dose of Levophed.

On June 19, 2012, Patient 303's record was reviewed. Patient 303 was admitted to the hospital on June 16, 2012 with diagnoses including pneumonia. On June 17, 2012, at 8:20 p.m., the following order was written: "Levophed gtt (drops) titrate to MAP (Mean Arterial Pressure) > 65." There were no additional orders for Levophed in the record.

Mean Arterial Pressure is the best measure of perfusion pressure to an organ. If the MAP falls, end organs may not get enough blood flow and become ischemic (tissue destruction occurs).

In an interview with RN 2, on June 19, 2012, at 10:45 a.m., the RN was unable to find additional orders for Levophed for Patient 303 in the record. RN 2 stated the order as written directed her to titrate the medication to maintain Patient 303's MAP greater than 65. RN 2 stated the order did not specify a concentration, a starting dose, an incremental change dose or a maximum dose. RN 2 stated the maximum dose was 20 mcg/min. The RN stated there was no protocol for administering vasopressors (including Levophed). The RN stated there was an order form, but it was not used if the physician did not use it.

A document titled "ICU Vasopressor Protocol," was reviewed on June 19, 2012. The form indicated "Vasopressor guidelines," and the goal was to maintain MAP of 65.

On June 19, 2012, at 11 a.m., RN 2 was asked to demonstrate the process for setting up a Levophed infusion. The RN stated the concentration of the medication was input into the IV pump. The pump had a preset menu for medications that were selected according to concentration. The RN stated the concentration depended upon the mix, sometimes it was 4 mgs per 250 mls, sometimes 8 mgs or 16 mgs per ml. The RN stated she would start the Levophed somewhere around 10 mcg/min. The RN stated the medication could be obtained from the ADC and mixed on the unit without pharmacy input.

In an interview with the Director of ICU, on June 19, 2012, at 11 a.m., the Director stated if Levophed was ordered after hours, two nurses were required to withdraw the medications. The Director reviewed the order for Patient 303's Levophed and stated the order needed to be more specific.

On June 19, 2012, at 11 a.m., the bag of Levophed currently infusing was observed with the Director of ICU and the Pharmacist. The bag had a typed label that indicated Levophed "Titrate as directed."

The Medication Administration Record (MAR) dated June 17 through June 19, 2012, was reviewed. The MAR indicated "norEPINEphrine Bitartrate 1 MG/ML [Levophed]." Dose of 4 mg/4 ml with a frequency of "TITRATE AS DIRECTED."

The directions on the MAR did not include:

The rate of infusion for Levophed;
The starting rate for Levophed;
The incremental titration rate for Levophed; and
The maximum rate for Levophed.

On June 20, 2012, Patient 303's MAR was reviewed with RN 3. RN 3 stated the order for Patient 303's Levophed was written at 8:20 p.m., and verified by pharmacy. RN 3 could not find documentation in the record to indicate when the first bag of Levophed was started. There was no documentation in the MAR that indicated when the medication was increased or decreased until June 18, 2012, at 6:45 a.m., when it was documented "MAP 81 decreased Levophed gtt to 2.5 mcg/min." RN 3 stated there was no way to determine start time, initial dose, incremental changes, or maximum dose between June 17, 2012, at 8:20 p.m., and June 18, 2012, at 6:45 a.m.

A review of the Vital Sign Report for June 17, 2012, at 8:20 p.m., through June 18, 2012, at 6:45 a.m., indicated the patient's vital signs were documented every 15 minutes. There was no evidence in the MAR that Levophed titration should have occurred at the following times:

9:30 p.m., MAP=61;
9:45 p.m., MAP=59;
10 p.m., MAP=57;
10:15 p.m., MAP=57;
10:30 p.m., MAP=62;
10:45 p.m., MAP=61;
11 p.m., MAP=57;
11:15 p.m., MAP=58;
11:30 p.m., MAP=57;
11:45 p.m., MAP=61;
12:30 a.m., MAP=59;
12:45 a.m., MAP=58; and,
1 a.m., MAP=60.

RN 3 stated there was an ICU "Vasopressor Protocol," that gave staff parameters for administering medication. RN 3 stated he could also look up the medication on "lexicomp," or call the pharmacy if there were questions. RN 3 stated if the Levophed was started too fast it could cause the "patient's blood pressure to rise rapidly and if started too low, could cause kidney damage due to lack of perfusion to the kidneys."

The policy titled, "Medication Administration," with a last revised date of March 2012, was reviewed on June 21, 2012. The policy indicated:

"...Before administering a medication, the licensed independent practitioner or appropriate health care professional administering the medication does the following:"

"... Verifies the medication is being administered at the proper time, the prescribed dose..."

"...Discusses any unresolved, significant concerns about the medication with the patient's physician, prescriber, and/or relevant staff involved with the patient's care, treatment, and service."

The policy titled, "Medication Titration and Tapering," with a last reviewed date of January 2012, was reviewed on June 21, 2012. The policy indicated:

"It is the policy of this institution to allow orders for medication titration, which is the progressive increase or decrease of the medication dose in responsive to the patient's clinical status."

"...A dose limit maximum and minimum limits at which the physician must be called for each titrated medication must be set..."

"..Accepting orders for titration of medication without dose limits is unsafe. Therefore orders received for titrated medications without dose limits will not be prepared or dispensed. The Pharmacist will contact the prescriber to obtain dose limits..."

"... Dose limits must be clearly documented on all labels of titrated solutions..."

2. A review of Patient 313's record was conducted on June 22, 2012. The record indicated Patient 313 was admitted to the ICU from the ED on April 29, 2012, with diagnoses that included cardiogenic shock and cardiac arrest. Initial orders at 3:12 p.m., included Dobutamine GTT starting at 10 mcg/kg/min titrate to keep MAP greater than 65. At 4:05 p.m., the ER MD ordered Levophed gtt starting at 10 mcg/kg/min titrate to SBP greater than 95 mmHg. At 4:14 p.m., an order for neosynephrine drip was written and at 4:40 p.m., the ER MD ordered an epinenphrine drip at 0.1mcg/kg/min titrate to keep SBP greater than 95 mm Hg, with a maximum of 35 mcg/minute. Following stabilization, the patient was transferred to the ICU.

A review of the "Physician Admission Orders," dated April 29, 2012, at 5:30 p.m., revealed orders to "Continue all pressors with ICU Protocol," and the following titration parameters:

Titrate Levophed to SBP>90
Titrate Neo (neosynephrine) to SBP >90
Titrate Dobutamine to SBP >90
Titrate epinephrine to SBP >90.

The record did not contain a copy of the ICU Vasopressor Protocol. Patient 313 remained on these medications throughout his hospitalization and there was no evidence the orders were clarified to include maximum rates and parameters for physician notification.

The policy titled, "Medication Administration," with a last revised date of March 2012, was reviewed on June 21, 2012. The policy indicated:

"...Before administering a medication, the licensed independent practitioner or appropriate health care professional administering the medication does the following:"

"... Verifies the medication is being administered at the proper time, the prescribed dose..."

"...Discusses any unresolved, significant concerns about the medication with the patient's physician, prescriber, and/or relevant staff involved with the patient's care, treatment, and service."

The policy titled, "Medication Titration and Tapering," with a last reviewed date of January 2012, was reviewed on June 21, 2012. The policy indicated:

"...A dose limit maximum and minimum limits at which the physician must be called for each titrated medication must be set..."

"..Accepting orders for titration of medication without dose limits is unsafe. Therefore orders received for titrated mediations without dose limits will not be prepared or dispensed. The Pharmacist will contact the prescriber to obtain dose limits..."

"... Dose limits must be clearly documented on all labels of titrated solutions..."

3. A review of Patient 313's record was conducted on June 22, 2012. The record indicated Patient 313 was admitted to the ICU from the ED on April 29, 2012, with diagnoses that included cardiogenic shock and cardiac arrest. Initial orders at 3:12 p.m., included Dobutamine GTT starting at 10 mcg/kg/min titrate to keep MAP greater than 65. At 4:05 p.m., the ER MD ordered Levophed gtt starting at 10 mcg/kg/min titrate to SBP greater than 95 mmHg. At 4:14 p.m., an order for neosynephrine drip was written and at 4:40 p.m., the ER MD ordered an epinephrine drip at 0.1mcg/kg/min titrate to keep SBP greater than 95 mm Hg, with a maximum of 35 mcg/minute. Following stabilization, the patient was transferred to the ICU.

A review of the "Physician Admission Orders," dated April 29, 2012, at 5:30 p.m., revealed orders to "Continue all pressors with ICU Protocol," and the following titration parameters:

Titrate Levophed to SBP>90
Titrate Neo (neosynephrine) to SBP >90
Titrate Dobutamine to SBP >90
Titrate epinephrine to SBP >90.

The record did not contain a copy of the ICU Vasopressor Protocol. Patient 313 remained on these medications throughout his hospitalization and there was no evidence the orders were clarified to include maximum rates and parameters for physician notification.

The policy titled, "Medication Administration," with a last revised date of March 2012, was reviewed on June 21, 2012. The policy indicated:

"...Before administering a medication, the licensed independent practitioner or appropriate health care professional administering the medication does the following:"

"... Verifies the medication is being administered at the proper time, the prescribed dose..."

"...Discusses any unresolved, significant concerns about the medication with the patient's physician, prescriber, and/or relevant staff involved with the patient's care, treatment, and service."

The policy titled, "Medication Titration and Tapering," with a last reviewed date of January 2012, was reviewed on June 21, 2012. The policy indicated:

"...A dose limit maximum and minimum limits at which the physician must be called for each titrated medication must be set..."

"..Accepting orders for titration of medication without dose limits is unsafe. Therefore orders received for titrated mediations without dose limits will not be prepared or dispensed. The Pharmacist will contact the prescriber to obtain dose limits..."

"... Dose limits must be clearly documented on all labels of titrated solutions..."

Based on record reviews and interviews, the hospital failed to ensure nutrition needs of the patients were met when:

1. They did not have a nutrition analysis of their menu that showed the menus met the basic needs of the patients;
2. One of four patients reviewed for nutrition care who were at nutrition risk when admitted, did not receive a nutrition assessment in a timely manner. The delay resulted in a four day delay in the initiation of a nutrition plan of care (Patient 401); and
3. One of four patients reviewed for nutrition care, the diet provided was not consistent with the physician order which delayed the provision of adequate nutrition for three days for Patient 402.
These failures resulted in, or had the potential to result in, a further decline in the nutrition and medical status of the patients.

Findings:

1. During an interview with the RD on June 19, 2012, at 2:40 p.m., she stated the hospital did not have a nutrition analysis of their menus. She stated she ensured the menus had six ounces of protein rich foods, four servings of starches and four servings of fruits and vegetables offered each day. She was unable to state how she was able to determine the menus met the Recommended Dietary Allowances and the Dietary Reference Intakes of the Food and Nutrition Board of the National Research Council. Without a nutritional analysis, the hospital could not ensure all the vitamin, mineral and fiber needs of the patients were met.

2. A review of the medical record for Patient 401 revealed the patient was admitted to the hospital on May 31, 2012, with diagnoses that included poor nutritional intake, a pressure ulcer, dehydration, pneumonia and dementia. The nutrition screen completed by nursing indicated the patient was at nutrition risk due to the bed sore and swallowing problems. A nutrition consult was ordered on May 31, 2012 based on the nutrition screen indicating the patient was at nutrition risk. A review of the physician orders revealed the patient was not on a diet or receiving nutrition support from May 31 until June 4, 2012.

A review of the RD notes revealed a nutrition assessment was not done until June 4th, four days after a nutrition consult was ordered. The assessment indicated the patient was a "Priority 1", or nutritionally compromised/malnourished. It further indicated the patient had been NPO for four days.

A review of the physician orders revealed a tube feeding was started on June 4, 2012, four days after the patient was admitted and determined to be at nutrition risk.

During an interview with the RD on June 19, 2012, at 3 p.m., she stated the on-call RD did not do the nutrition assessment on June 1, 2012 when it should have been done. Due to the weekend, the delay was not noted until Monday, June 4, 2012. She verified the patient was at high nutrition risk and should have received a nutrition assessment within 24 to 48 hours of the consult order. She further verified that the patient would have benefitted from earlier nutrition intervention, especially in light of his nutrition risk level and increased nutrition needs.

A review of the hospital's policy titled, "Nutritional Screening/ Nutritional Assessment", dated July 2010, revealed the RD assessment will be completed within 24 to 48 hours of receiving a consult.

3. A review of the medical record for Patient 402 revealed the patient was 95 years old and was admitted to the hospital on June 13, 2012 with a hip fracture. The patient had surgery on June 14th. The nutrition screen completed by nursing indicated the patient was at nutrition risk because she was underweight and had a poor appetite.

A review of the physician orders revealed an order on June 14, 2012, for a clear liquid diet (a diet containing minimal nutrition, usually ordered initially after surgery). On June 15, 2012, there was an order for a regular diet. On June 18, 2012, there was an order to advance the diet to a full liquid diet with a nutritional supplement three times a day with meals. A full liquid diet had an increased nutritional content and combined with a nutritional supplement three times a day would have better met the needs of the patient.

A review of the nutrition assessment completed by the RD dated June 15, 2012, revealed the patient was a "Level 1", or nutritionally compromised/malnourished.

During an interview with the RD on June 20, 2012, at 10:25 a.m., she stated the regular diet ordered on June 15, 2012, was not entered in the computer. She stated a regular diet was not sent to the patient and she remained on a clear liquid diet for three days longer than she should have. She verified the clear liquid diet provided only minimal nutrition for the patient during those three days. She further verified Patient 402 was nutritionally compromised and would have benefitted from increased nutrition during those three days.

6. A tour of the ER was conducted on June 19, 2012, at 10:06 a.m. A small sink and counter area was observed across from the nurses' station . A paper towel dispenser was on the wall on the left side of the sink. On multiple occasions, staff were observed washing their hands at the sink. Above the paper towel dispenser a sign read, "IV ADMIX ".

The counter space on the right side of the sink was approximately two feet wide by two feet deep. Attached to the wall above the counter were two biohazard containers (one for liquid waste and one for syringes and needles). On the counter were three eight inch by eight inch plastic containers. Two of the containers were directly beneath the biohazard containers. The containers were filled with multiple supplies. Some supplies were in sterile paper packages including culture swabs, tongue blades, lab assay collection package, and syringes containing 0.9 % saline solution. The lab assay collection package was crumpled and had brownish water discoloration marks. One of the plastic containers on the counter had thick-caked brownish residue around the rim of the container.

In a concurrent interview, RN 1 stated the area was used to mix IVs. She stated, "The IV mixing area is next to the sink, I didn't think it was a problem as long as the inside of the syringe was sterile, I didn't think it mattered if the outside of the syringe was wet."

In an interview, on June 19, 2012, at 10:20 a.m., ICC stated, " I understand the supplies should not be all together next to the sink."

The facility failed to maintain a sanitary environment by placing sterile supplies in an area subject to splashing water from hand washing. This increased the risk of spreading infection from the use of contaminated supplies.

7. On June 19, 2012, at 2:26 p.m., during a tour of the MS unit, a sign on the wall near the door entrance indicated "Contact Isolation" (infection transmitted by contact). A visitor was observed approaching an isolation cart next to the room in the hallway. The visitor took a disposable isolation gown from the cart, tied the string around her neck and went into the room of the patient in isolation with the sleeves of isolation gown hanging down on either side. A second visitor approached the isolation cart and put on an insolation gown, placing her arms through the sleeves. When asked why she was putting on the isolation gown, the visitor replied, " No one told me to suit up, my (patient) told me. The person at the desk didn't tell me. The visitor stated the unit clerk at the nursing station did not know the patient was in isolation.

In an interview on June 19, 2012, at 3:35 p.m., the RRN stated the patient was in isolation for C-diff. (an infection spread by contaminated surfaces and hand contact) When informed of the visitor entering the isolation room without appropriate isolation attire, the RRN stated we have communication issues.



25624

Based on observation, interview, and record review, the facility failed to ensure facility staff were:
1. Knowledgeable in contact times for disinfectants they used;
2. Aware of patients that had positive lab values for organisms for one patient (Patient 104), and if PPE should be used;
3. Washing their hands after patient care and removing gloves;
4. Knowledgeable in infection control measures to prevent the development of food borne illness and cross contamination regarding food services;
5. Knowledgeable in a thorough infection control surveillance system that monitored the conditions and practices of the dietetic services staff. By not having these measures and a thorough surveillance system, potentially hazardous foods had been stored, prepared and distributed under unsafe and unsanitary conditions;
6. To separate sterile supplies from the sink area where staff washed their hands; and,
7. Educating visitors that entered isolation rooms on proper isolation protocol.

These failed practices could contribute to the spread of microorganisms and food borne illness.

Findings:

1. a. On June 19, 2012, at 10:10 a.m., EVS staff 1 was interviewed. EVS staff 1 was unsure of the contact time (wet time on a surface to promote disinfection) for a disinfectant. The staff was unsure of what C diff. (bacteria in the intestines) was;

On June 21, 2012, the personnel file for EVS staff 1 was reviewed. There was no competency for infection control in the file. The Human Resources Coordinator was present, and she was unable to find any competency for infection control.

b. On June 19, 2012, at 2:50 p.m., a rehabilitation staff stated the contact time for a disinfectant cleaner was 15 seconds. The label indicated five minutes.


2. On June 19, 2012, at 12:25 p.m., a tour was conducted of the medical surgical floor. A sign outside the door indicated Patient 104 was to be on daily weights. There was no isolation sign or isolation cart outside the door.

On June 19, 2012, the record was reviewed for Patient 104. Patient 104 was admitted to the facility on June 15, 2012, with diagnoses that included shortness of breath. A lab test, titled "Microbiology", collected June 15, 2012, was released on June 17, 2012. The lab test revealed Patient 104 had Extended spectrum beta-lactamases (ESBL-an enzyme that is found in some bacteria. It is an MDRO) in the urine. A form titled, "Critical Result(s) Notification," dated June 17, 2012, was in the Interdisciplinary Progress Notes. The result revealed ESBL in the urine.

On June 21, 2012, at 11:15 a.m., the Infection Control Director was interviewed. The Director stated there was no facility policy and procedure for ESBL. She stated all patients with MDRO's would be put in isolation, on contact precautions.

On June 22, 2012, there was no isolation sign or cart observed outside Patient 104's room.

On June 22, 2012, at 10:35 a.m., CNA 1 was interviewed. CNA 1 stated he had assisted in the care of Patient 104. CNA 1 stated he was notified today that Patient 104 had an organism in her urine.

On June 22, 2012, the facility policy and procedure titled, "Infection Control," was reviewed. The policy revealed, "...Contact Precautions patients known or suspected to be infected or colonized with epidemiologically important microorganisms that can be transmitted by direct contact with the patient (hand or skin-to-skin contact that occurs when performing patient-care activities that require touching the patient's dry skin) or indirect contact (touching) with environmental surfaces or patient-care items in the patient's environment. Review surface contact time for disinfectants..."

3. On June 19, 2012, at 10:45 a.m., RN 3 was observed removing his gloves after patient care, and not washing his hands. RN 3 then went to the nurses' station to review a medical record.

On June 22, 2012, at 3 p.m., the Infection Control Director was interviewed. The Director stated it was facility protocol for staff to remove gloves and wash their hands after patient care.

On June 22, 2012, the facility policy and procedure titled, "Infection Control", was reviewed. The policy revealed, "...Wash hands after touching blood, body fluids, secretions, excretions, and contaminated items, whether or not gloves are worn..."


4. During the initial tour of the kitchen on June 19, 2012, at 9:20 a.m., in the walk-in refrigerator, a container of cooked pasta, a pan of cooked roast beef in gravy and two pans of cooked meat loaf were observed. All were PHF.

According to the 2009 FDA Food Code, cooked, PHF shall be cooled within two hours from 135 degrees F to 70 degrees F, and within a total of six hours from 135 degrees F to 41 degrees F. It further revealed that if food was not cooled in accordance to this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness.


During a concurrent interview with the Chef, he stated all items had been previously cooked and then stored in the refrigerator prior to that day. He stated the dietary staff maintained a cooling log to document the cooling of cooked foods that were refrigerated.

A review of the hospital's "Hot Food Cooling Log", dated May 27 through June 18, 2012, revealed the PHF items noted in the walk-in were not listed on the log.

During an interview with the DFNS on June 19, 2012, at 10 a.m., he stated the dietary staff monitored the cooling of meats and soups, but not pasta. He could not explain why the meatloaf and the roast beef in gravy were not monitored for safe cooling. He verified pasta was a PHF once it was cooked, due to its increased water content. The pasta would therefore need to be monitored to ensure safe cooling. He verified that it was not.

A review of the hospital's policy titled, "Leftovers - Usage and Storage," dated April 2012, revealed if a leftover was to be saved for use another day...they would be cooled down and temperatures would be documented. It also revealed food safety guidelines for cooling down leftovers would be enforced.

Cooked PHF required monitoring of the cooling to ensure they are cooled according to the Food Code requirements, to prevent pathogens from growing to sufficient number to cause food borne illness in the patients.

5. a. During an observation of the ice machine in the kitchen on June 19, 2012, at 10:25 a.m., a clean paper towel swipe of the interior of the ice storage bin produced a moderate amount of pink, gelatinous substance and a black/brown residue along the bottom of the water trough, where water is circulated as it formed the ice. This finding was concurrently verified by the DFNS.

During a concurrent interview with the DFNS, he stated the dietary staff cleaned the ice machine bin monthly, and the last cleaning was done on May 4, 2012. He stated when the staff cleaned it they did not remove the ice deflector. The deflector was a guard that prevented the ice from filling up at the front of the bin where ice needed to be removed, avoiding spillage of the ice. Unless it was removed during cleaning, the bottom of the water trough cannot be reached for cleaning.

During a concurrent interview with Engineering Staff 1, he stated they do a quarterly preventative maintenance on the ice machines. He stated the quarterly preventative maintenance included cleaning and sanitizing the ice machine. He was unable to explain why there was a moderate amount of the residue observed.

A review of the "Summary of Preventative Maintenance" log for the ice machine, revealed the last preventative maintenance was completed on March 19, 2012, three months earlier. He verified the water trough, where the residue was observed, was where the water used to form ice, cycles through the ice making process. He further verified the presence of the residue was not desirable.

The 2009 Food Code revealed in equipment, such as ice bins and enclosed components of equipment such as ice machines, surfaces shall be cleaned at a frequency necessary to preclude accumulation of soil or mold.

Soil and mold accumulation on parts of an ice machine had the potential to cause food borne illness in the patients.

b. During the tour of the kitchen on June 19, 2012, at 10:20 a.m., there was a pipe under the ice machine, draining into a floor drain where an air gap was not maintained. The finding was concurrently verified by the KL.

During a concurrent interview with the KL, she stated the pipe had been moved and she did not know why. She stated an air gap should have been maintained to prevent a backflow of waste water during a negative water pressure event.

According to the 2009 Food Code, an air gap between the water supply inlet and the flood level rim of the plumbing fixture, equipment or non-food equipment, shall be at least twice the diameter of the water supply inlet and may not be less than one inch.

A potential for backflow of waste water into the ice machine had the potential to contaminate the ice served to patients and cause food borne illness.

c. During an observation on June 19, 2012, at 11:05 a.m., in the kitchen, dietary staff was observed drying patient food trays with a cloth. This observation was verified by the DFNS.

During a concurrent interview with the DFNS, he stated the trays did not get dry from the low temperature dish machine. He verified the trays should be allowed to air dry to prevent possible cross contamination. He stated they would have to find a way to allow the trays to air dry.

According to the 2009 Food Code, after cleaning and sanitizing, equipment and utensils shall be air-dried or used after adequate draining...before contact with food; and may not be cloth dried.

Food service trays that can be cross contaminated while drying with a cloth have the potential to cause food borne illness in patients.

d. During an observation in the kitchen on June 19, 2012, at 2:30 p.m., the two table mounted can openers were both noted to have cutting blades that were worn and not smooth. The observation was concurrently verified by the DFNS.

During a concurrent interview with the DFNS, he stated the can opener blades should be changed when they were worn and no longer had a smooth surface.

According to the 2009 Food Code, cutting or piercing part of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container was opened. It further revealed that multiuse food contact surfaces shall be smooth and free of crevices. Surfaces which have imperfections such as cracks, chips or pits allow microorganisms to attach and form biofilms that can release pathogens in the food. Biofilms are highly resistant to cleaning and sanitizing efforts.

These biofilms have the potential to cause food borne illness in patient.

e. During the tour of the kitchen on June 19, 2012, between 9:20 and 10:10 a.m., the following items were observed:

* A box of sausage links, labeled keep frozen, in the refrigerator with no date indicating the shelf-life of the sausage once thawed;
* Six flats of eggs, removed from the original box, not dated; and,
* Two containers of chipped beef, a container of lasagna and a container of soup, in the freezer, all removed from the original packaging and not dated.

During a concurrent interview with the KL, she stated the items above should have been dated with the products expiration dates. She confirmed the staff did not have a way of determining the shelf-life of the items unless they were dated.

A review of the hospital's policy titled, "Food Labeling & Storage of Leftovers or Open Containers," dated June 2012, revealed the purpose of the policy was to provide a means for the safe storage of refrigerated items that have been opened and may not be in their original containers. The policy revealed any food removed from original container will be properly labeled, dated and covered. Food will be labeled with the toss out date.

Serving food beyond its expiration date had the potential to cause food borne illness in patients.

During an interview with the Director of Infection Control on June 21, 2012, at 2:40 p.m., she stated she was not aware of the above findings in the kitchen.

A review of the hospital's Infection Prevention and Control Plan, dated 2012, revealed the purpose of the program was the prevention, control, surveillance and reporting of the spread of infections and infectious diseases within the hospital. It revealed as an integral part of the hospital system, the Infection Prevention & Control Program had a responsibility to work with all hospital departments, including ancillary services.

Based on interview and record review, the facility failed to delineate surgical privileges in accordance with competencies, failed to review and update the surgical privileges at least every two years, and failed to reappoint and inform departments of the privileges granted for two of two RNFAs (RNFA 1 and RNFA 2). These failures created the risk of substandard healthcare services provided to patients having surgery.

Findings:

On June 19, 2012, at 1:45 p.m., accompanied by RNC 1, a tour was conducted of the perioperative area. In an interview, RNC 1 stated she was a RNFA and so was RNC 2. She stated the medical staff had credentialed them in 2006. RNC 1 stated she did not know how frequently they needed to be credentialed. RNC 1 stated she was sometimes the first assistant to surgeons during surgery. Responsibilities included closing various layers of tissue such as fascia, muscle, subcutaneous tissue (immediately below the skin in the abdomen) and skin.

On June 21, 2012, at 9 a.m., the DOMSS was interviewed. The DOMSS stated she had been employed at the facility for almost six years. She stated she did not know the facility had RNFAs. The DOMSS stated she thought it was "talked about" in a meeting in 2008 or 2009.

The personnel files for RNFA 1 and RNFA 2 were reviewed on June 21, 2012. There were no competencies, performance evaluations, or job descriptions for RNFA in the personnel files.

On June 21, 2012, at 4 p.m., the HRD stated there was no competency or job description for RNFA.

A document titled, "...Credentialing/Nominating Committee, July 27, 2006 ...Agenda" was reviewed. It was indicated under "3.10 Interdisciplinary Practice Committee Approvals - RNFA Delineation of Privileges and packets (for RNC 1 and RNC 2)." The item was approved and forwarded to MEC and the GB. The "packet" included RNFA "Scope of Service" and "Request for Practice Privileges".

A review of a performance evaluation for the position "Surgery Registered Nurse" was dated and signed on December 14, 2011, by RNC 1. The documentation on the evaluation included, "...acts as an RNFA to any surgery and demonstrates her excellent surgical skills ... " There was no RNFA job description or protocol in RNC 1's file.

A review of a performance evaluation for the position "Surgery Registered Nurse" was dated and signed on December 14, 2011 by RNC 2. The documentation on the evaluation included, "...is both a PICC nurse as well as an RNFA, demonstrating highly proficient clinical skills ..." There was no RNFA job description or protocol in RNC 2's file.

A document presented by the DSS, titled, "RN First Assistant (RNFA)" included polices, qualifications, types of cases utilizing RNFA, performance protocols and scope of service." The document was initiated "12/06" and was reviewed "7/08 and 9/11". The performance protocols referenced in the document were not observed in either RNFA personnel file.

The AORN Position Statement on RNFA with revision March 2010 indicated, " ...evaluating current and continued competency in the RNFA role."

According to the Board of Registered Nursing, "The RN as First Assistant to the Surgeon - Guidelines for developing standardized procedures" indicate, "... (b) (5) Establish a method for initial and continuing evaluation of the competency of those registered nurses authorized to perform standardized procedure functions."

Based on observation, interview, and record review, the facility failed to ensure surgical services were designed to assure and maintain high standards of patient care. The facility failed to monitor relative humidity levels and ensure they were within acceptable ranges in the room used for endoscopy procedures and endoscopy storage; and by failing to ensure the safe use of two free-standing humidifiers in the operating rooms.

These failures had the potential to result in the endoscopy procedure rooms environment to be at risk for creating an environment with a higher risk for growth of microorganisms and aerosolize (diffuse) these microorganisms into the clean environment, which may result in patient infection(s).

Findings:

On June 19, 2012, at 2 p.m., a tour of the surgical department was conducted with RNC 1 and RNC 2. The first suite entered was identified as the "scope room," by staff. The endoscopy room (Endoscopy refers to looking inside the body for medical reasons using an endoscope, an instrument used to examine the interior of a hollow organ or cavity of the body) had a thermometer for monitoring room temperature, but there was no device observed in the room to monitor relative humidity. The room also contained a cabinet for storage of endoscopes. The cabinet was enclosed and vented to allow for drying of the endoscopes after processing.

During a concurrent interview with RNC 1, the nurse stated the relative humidity of the endoscopy room was not monitored.

Operating Room 2 was observed on June 19, 2012, at 2:10 p.m. This room had wall mounted gauges for checking temperature and relative humidity. The room also contained a free-standing humidifier.

Operating Room 1 was observed on June 19, 2012, at 2:20 p.m. Room 1 was not in use at the time of the observation. The relative humidity in room 1 was 58 %. There was a free-standing humidifier in the room.

The "OR Schedule," for June 20, 2012, was reviewed on June 20, 2012. The schedule indicated there were seven endoscopic procedures scheduled for that day in the endoscopy room.

The facility's policy and procedure with a last reviewed date of September 2011, was reviewed. The policy indicated the perioperative nurse was responsible for monitoring the room temperature and humidity levels of the surgical suites.

According to the AORN (a professional organization of perioperative nurses involved in standards for perioperative care) potential hazards associated with HVAC systems in the practice setting should be identified, and safe practices should be established. V.b. indicated:

"Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas."

According to AORN, high humidity increased the risk of microbial growth in areas where sterile supplies were stored or procedures were performed. In addition:

V.b.1. Free-standing humidifiers should not be used because they could harbor microorganisms in fluid reservoirs and aerosolize these microorganisms into the clean environment.

V.b.2. Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system.