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Based on observation, interview and record review, the facility failed to ensure that a licensed physician was physically present and available to provide immediate medical intervention to patients within the mobile CT unit where CT scans were performed with and without contrast by Radiology Technicians. This failure had the potential to contribute in the increased risk of injury to the patient in the event of an adverse reaction or anaphylactic shock during procedures performed in the mobile CT unit.

Findings:

The California Health and Safety Code, section 106985 states, "(a) Notwithstanding Section 2052 of the Business and Professions Code or any other provision of law, a radiologic technologist certified pursuant to the Radiologic Technology Act (Section 27) may, under the general supervision of a licensed physician and surgeon, perform venipuncture in an upper extremity to administer contrast materials, manually or by utilizing a mechanical injector, if the radiologic technologist has been issued a certificate, as described in subdivision (b)....

(c) "General supervision," for purposes of this section, means the direction of procedures authorized by this section by a licensed physician and surgeon who shall be physically present within the facility and available within the facility where the procedures are performed, in order to provide immediate medical intervention to prevent or mitigate injury to the patient in the event of adverse reaction.

On 4/25/12 at 9 AM, a tour of the Radiology Department was conducted to verify that the department maintains, or has available at all times, organized radiology services that meets the needs of the patients in accordance with accepted standards of practice to meet the needs of the patients.

During a tour of the department, an interview with the Department Head (DH) revealed that there was a CT scan room with a non-functioning CT scan machine, however there was a rental mobile CT scan unit outside of the building.

During a concurrent interview on 4/25/12 at 9:10 AM, the DH was asked, "Who administers the IV (intravenous: within or administered into a vein) contrast?", she responded that, "The Rad Tech (Radiologic Technologist) does it". The DH was asked, "Besides the Rad Tech and the patient, who else is in the mobile CT unit?", she responded, "No one else. When the patient is critical, the patient is accompanied by an RN and a Respiratory Therapist (RT)."

Observation of the CT scan mobile unit revealed it was located approximately 10-15 ft from the nearest door to the building. There were approximately 5 iron steps leading up to the door of the mobile CT unit. This door was narrow and was not used for patient entry into the mobile CT unit. There was another wider door for the patient's passage into the mobile unit which was accessible by a manually operated lift.

At approximately 2:30 PM on 4/25/12, a second observation of the mobile unit with an additional surveyor was conducted, accompanied by the Lead Radiology Technician (LRT) and the Maintenance Supervisor (MS).

The LRT was asked how she would handle an emergency by herself in the event of an adverse reaction by the patient to the IV contrast media, she stated that she would call to the emergency room for help. When asked, "What will you do in case of power outage or when no one immediately picks up the phone?", the LRT stated that she would use the radio.

During this interview, the MS was asked if there was a provision for Rad Techs to have a radio in the mobile unit. The MS stated, "No, it's a good idea for them to have one." The MS was asked how far was the Emergency room from the mobile unit, he stated, it's in the middle of the building, about 200 feet."

The LRT was asked how comfortable was she while doing the CT scans with IV contrast injection by herself. The LRT answered that she had been doing the CT scan with IV contrast injection for four years and there have been no adverse reactions to contrast media. The Rad Tech explained that a test dose was introduced first for observation, if an allergic reaction (like itchiness, hives or difficulty of breathing) occurs during an examination, the examination would be stopped immediately.

As the interview continued, the LRT was asked if she knew how to use the life support equipment in the event that she had to initiate cardiopulmonary resuscitation (CPR) while waiting for assistance, her answer was "No".

According to the American College of Radiology Practice Guidelines for the use of Intravascular Contrast Media (Revised 2007) 111. "The healthcare professional performing the injection maybe a certified and/or licensed radiologic technologist, nurse, physician assistant, physician, or other appropriately credentialed healthcare professional under the direct supervision of a radiologist or his or her physician designee if the practice is in compliance with institutional or state regulations. Training and proficiency in cardiopulmonary resuscitation are recommended for those who attend to patients undergoing contrast- enhanced examinations.

"Direct supervision means that the physician must be present and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room where the procedure is performed".

On 4/25/12 at 6:20 PM, an Immediate Jeopardy was called in the presence of the facility's Interim Chief Executive Officer (ICEO) and Interim Chief Nursing Officer (ICNO) due to:

(a) The facility's inability to provide immediate medical intervention or establish and secure airway to the patient in the event of adverse reaction to the intravascular contrast media injection. This failure to provide prompt medical attention to the patient had the potential to contribute in the serious harm of imminent brain damage or the death of the patient.

On 4/26/12 at 12:10 PM, the Immediate Jeopardy was abated (lifted) after receiving an acceptable plan of correction, which included:
(a) To suspend CT scan service until the hospital can fully comply with regulations for patient safety.
(b) The facility would inform the Physicians, the Emergency and Radiology Departments, neighboring hospitals as well as local ambulance providers that no CT scan service is available for as long as there is no physician immediately available where the procedures are performed.

Based on observation, interview and record review, the facility failed to follow its nursing (untitled) policy and procedure (P&P), that noted: Purpose: "To assist in facilitating and implementing decisions concerning the withholding or withdrawing of life sustaining treatment or resuscitation support." The facility also failed to follow its policy titled, "Advance Health Care Directive." For 1 of 13 sampled patients (Patient 29) that presented to the Emergency Department (ED) via ambulance on 4/23/12 at 2:45 PM with an altered mental status (as evidenced by confusion, disorientation and hypoxia [a deficiency of oxygen reaching the tissues of the body]) and difficulty breathing. In addition, while in the ED, Patient 29 suffered an acute myocardial infarction (AMI-[heart attack] occurs when low blood flow causes the heart to lack for oxygen. The heart muscle dies or becomes permanently damaged).

This failure contributed to Patient 29 not receiving emergency medical treatment or being transferred to a higher level of care where the patient's needs could have been met due to the facility's inability to ascertain the patient's Advance Directive (AD) status upon admission and subsequently instituting a Do Not Resuscitate (DNR) physician's order which contributed to the patient's death on 4/24/12 at 12:18 AM.

Findings:

AD- a written legal document, such as a living will or durable power of attorney for health care, recognized under State law, signed by a competent (capable) person to provide guidance for medical and health-care decisions in the event the person becomes incompetent to make such decisions. These directives pertain to treatment preferences and the designation of a surrogate (one that serves as a substitute) decision-maker in the event that a person should become incapacitated.

On 4/23/12 at 3:45 PM, a tour of the ED was conducted with Registered Nurse (RN) 8. Patient 29 was observed in bed #2. The patient was on oxygen (O2) at 15 liters per min (LPM) via a non-re-breather mask (NRBM, a device placed over the nose and mouth to deliver oxygen). The patient was noted to have shallow (displacing little air) respirations with periods of apnea (no respirations). RN 8 stated that Patient 29 was a do not resuscitate (DNR) patient.

On 4/24/12, a review of Patient 29's medical record was conducted.

A review of the "Emergency Room Outpatient Record," dated 4/23/12, for Patient 29 was conducted. The patient, presented to the ED via ambulance with a chief complaint of respiratory distress. The documentation did not identify a designate, a next of kin or a person to notify in case of an emergency. The documentation that would have indicated that the patient had an established AD was blank.

During a review of the "Physician Orders for Life-Sustaining Treatment," (POLST-physician orders for life-sustaining treatment)) document revealed the following:

"Follow these orders, then contact physician. This is an order sheet based on the person's current medical condition and wishes. Any section not completed implies full treatment for that section. Everyone shall be treated with dignity and respect."

The "Completing POLST" section revealed that the POLST must be completed by health care professional based on patient preferences and medical indications. The POLST must be signed by a physician and the patient/decision maker to be valid..."

There were three sections A, B and C (each section required one response) by the patient and/or decision maker. Section D required signatures and a summary of the (patient's) medical condition.

In each of the sections the following was noted:

1). Section A: Cardiopulmonary Resuscitation (CPR- person has no pulse and is not breathing) - The response box that contained the statement, "Do Not Attempt Resuscitation/DNR" (allow natural death) was marked with a (X).

2). Section B: Medical Interventions (person has pulse and/or is breathing) - The response box that contained the statement, "Comfort Measures Only" (use medication by any route, positioning, wound care and other measures to relieve pain and suffering. Use oxygen, suction and manual treatment of airway obstruction as needed for comfort. Antibiotics only to promote. Transfer if comfort needs cannot be met in current location) was marked with a (X).

3). Section C: Artificially Administered Nutrition (offer food by mouth if feasible and desired) - The response box that contained the statement, "No artificial nutrition by tube" was marked with a (X).

4). Section D: The section for the Signatures and Summary of Medical Condition- "Discussed with" showed that the "Patient" and "other" boxes were marked with a (X) which indicated that the decisions in Sections A, B and C (do not resuscitate, comfort measures only and no artifical nutrition by tube) were discussed with the patient and someone else (other).

The section for the Signature of Physician (for the physician's name, phone number, date, physician signature [required] and license number) was left blank.

The section for the Signature of Patient, Decision maker, Parent of Minor or Conservator (by signing this form, the legally recognized decision maker acknowledges that this request regarding resuscitative measures is consistent with the known desires of, and with the best interest of, the individual who is the subject of this form) was signed by MD 1. The required signature line was not signed by the patient or a designated decision maker.

The section for the "Summary of the Medical Condition" showed "Premorbid" (occurring or existing before the development of physical disease).

A review of the "Physical Exam," dated 4/23/12, that was completed by MD 1 was conducted and revealed that the patient was unresponsive. The patient's chief complaint was decreased mental status, confusion and a history of end stage lung cancer. The section for "Progress" showed that the patient was a "DNR."

During a review of the patient's "Pre-Hospital Patient Care Report," (ambulance personnel documentation) dated 4/23/12, was conducted and the following was noted:

Initial Assessment:

Bilateral (both) Lung sounds- rales (rattling), rhonchi (coarse or gravel like [normal- clear breath sounds])

Respiratory rate (RR)- 26 (normal [n] 12-20) and shallow

Oxygen saturation (SPO2) 78% ([n 95 to 100%]) hypoxia- a lower-than-normal concentration of oxygen in arterial blood).

Blood pressure (B/P) 70/40 ([the top number is the systolic that represents the pressure in the arteries as the muscle of the heart contracts and pumps blood into them] n 90 to 140 millimeters of mercury [mmHg]); [the bottom number is the diastolic blood pressure that represents the pressure in the arteries as the muscle of the heart relaxes following its contraction] n 60 to 90 mmHg) (B/P- is the force exerted by circulating blood on the walls of blood vessels. Blood pressure is generated by the heart pumping blood into the arteries modified by the response of the arteries to the flow of blood).

Heart rate (HR) was 131 (normal 60 - 100 beats per minute)

Heart rhythm was atrial fibrillation (arrhythmia- an alteration in the normal rhythm of the heartbeat)

Interventions: Oxygen (O2) at 15 liters per minute (LPM) via a NRBM and Intravenous (IV- administered by entering a vein) fluids

Reassessment: SPO2 93% (n 95 to 100%) and B/P 131/70 (normal)

Further review of the "Pre-Hospital Patient Care Report," documentation showed that the patient was in moderate distress due to difficulty breathing. The patient verbalized that it was "hard to breathe." The documentation revealed that the patient's DNR status was unknown. The patient was transported to the facility by ambulance for further emergency care services.

A review of the "Emergency Department Ongoing Nursing Assessment Notes", dated 4/23/12 at 2:45 PM, was conducted and revealed the following:

Patient 29 was received via ambulance. The patient was on O2 at 15 LPM via NRBM, had shortness of breath (SOB) and a 40 second apneic (no respirations) episode on arrival. The patient's vital signs showed SPO2 95%, HR 110 and B/P 106/62. The documentation showed, "caregiver was at bedside- pt. (patient) is a DNR." The nursing documentation failed to establish how the patient's DNR status was verified by the nurse. There was no evidence in the medical record that showed the patient had the mental capacity to make medical treatment decisions.

A review of the "ED Respiratory Nursing Assessment notes," dated 4/23/12 at 2:48 PM revealed that the patient was confused, disoriented and had SOB. The physical assessment revealed that the patient had decreased and/or absent lung sounds and heart arrhythmias.

Further review of the patient's "ED Ongoing Nursing Assessment Notes," dated 4/23/12 revealed the following:

At 3:02 PM, the patient received Morphine (MS-a pain medication that may cause adverse effects [AE] such as respiratory depression, cardiac arrest) 2 milligrams (mg) via intravenous (IVP) and Zofran (antiemetic that may cause AE such as heart arrhythmias-an alteration in rhythm of the heartbeat either in time or force) 4 mg IVP.

At 3:04 PM, the patient received MS 2 mg IVP; the patient had an AMI that was observed via bedside electrocardiogram (EKG- heart monitoring device).

At 3:05 PM, the patient received an additional dose of MS 2 mg IVP.

At 3:08 PM, the patient received an additional dose of MS 2 mg IVP.

There was no documented evidence in the medical record to show that the patient received emergency medical treatment or procedures when the AMI was identified, on 4/23/12 at 3:02 PM.

The patient's troponin I (a troponin test measures the levels of certain proteins called troponin T and troponin I in the blood. These proteins are released when the heart muscle has been damaged, such as during a heart attack) level was 0.82 (high = 0.07)

A review of the "ED Nursing Ongoing Assessment," dated 4/23/12 and timed from 3:13 PM through 7:20 PM, showed that the patient's nursing interventions included, O2 at 15 LPM via NRBM and medication administration (Morphine and Zofran [IVP]. The patient's medical condition continued to decline as evidenced by the following unstable vital signs (B/P, HR, RR and SPO2), apnea (no respirations) and/or arrhythmias (an alteration in rhythm of the heartbeat either in time or force):

At 3:13 PM- HR 105 (high); SPO2 97% (normal); B/P 86/58 (low); RR 22 (low)

At 4 PM- HR 113 (high); SPO2 92% (low); apnea SPO2 79% (low); B/P 58/42 (low); the patient received Zofran 4 mg IVP (Zofran- may cause arrhythmias)

At 4:01 PM- the patient received MS 2 mg IVP (MS- may cause respiratory depression)

At 4:10 PM- apnea (no respirations) 20-30 seconds; RR 4-6 (low); SPO2 45% (low)

4:20 PM- HR 108 (high); SPO2 86% (low); B/P 65/45 (low); arrhythmia (HR 20-40); SPO2 28% (low); mottled skin (a condition in which the skin becomes discolored I irregular patches and can indicate impending death).

4:28 PM- apnea (no respirations); mottled skin; HR 109 (high); SPO2 80% (low); B/P 45/38 (low); arrhythmia

4:30 PM- SPO2 56% (low)

5:09 PM- RR 10 (low); HR 108 (high); SPO2 34% (low); B/P 55/36 (low)

5:28 PM- restless; RR 6-10 (low) with apnea (no respirations); HR 90; B/P 77/54 (low); the patient received MS 4 mg IVP (MS- may cause respiratory depression)

5:33 PM- apnea (no respirations) 30- 40 seconds

6 PM- quiet; RR 6-8 (low)

6:30 PM- B/P 82/54 (low); SPO2 84% (low)

7 PM- HR 39 (low); B/P 42/27 (low); RR 10 (low)

7:15 PM- HR 94; B/P 49/29 (low); arrhythmias (HR in the 30's); agonal (of, or relating to agony-a struggle that precedes death) respirations

7:20 PM- HR 90; B/P 80/59 (low)

A review of the "Order Procedure Form, Pulmonary Emergencies," dated 4/23/12, was conducted and revealed that the patient received a total of 14 mg of Morphine IVP (a total of 10 mg within one hour) and a total of 8 mg (within one hour) of Zofran IVP as evidenced by the following:

At 3:02 PM- Morphine 2 mg IVP; Zofran 4 mg IVP

At 3:04 PM- Morphine 2 mg IVP

At 3:05 PM- Morphine 2 mg IVP

At 3:08 PM- Morphine 2 mg IVP

At 4 PM- Zofran 4 mg IVP

At 4:01 PM- Morphine 2 mg IVP

At 5:28 PM- Morphine 4 mg IVP

The ED documentation failed to show that the patient received emergency medical treatment for the AMI and increased respiratory distress (difficulty breathing).

The documentation failed to show that the ED staff verified in writing, with the patient and/or a designated decision maker that the patient had an Advance Directive that showed a DNR status. There was no evidence in the medical record that showed that the patient had the mental capacity to make medical treatment decisions.

The ED documentation failed to show that the patient's POLST (physician orders for life-sustaining treatment) decisions to forgo life sustaining treatment were made in collaboration with the patient or a designated decision maker. There was no evidence in the medical record that showed the patient had the mental capacity to make medical treatment decisions.

MD 1 did not discuss with patient his diagnosis, prognosis, proposed "No Code" order, alternatives and risks and benefits of each alternative.

A review of Physicians' Order Sheet, dated 4/23/12 at 7:30 PM, revealed orders that included, observation (for) and DNR (do not resuscitate). The patient's diagnoses included, lung cancer and premorbid (occurring or existing before the development of physical disease).

The documentation revealed that the patient was transferred to the Medical/Surgical Unit (MSU) at approximately 7:45 PM with a physician's order for DNR status.

A review of the Medical/Surgical Nursing Flow sheet, dated 4/23/12 at 7:40 PM, showed that the patient arrived to floor from the ED, lethargic with mild to moderate respiratory distress on O2 at 15 LPM via NRBM. The patient was accompanied by friends and caregiver.

A review of the Medical/Surgical Admission Data Base documentation, dated 4/23/12, at 7:40 PM, revealed that the patient's vital signs were B/P 83/54 (low), SPO2 92% (low), RR 15, as the patient continued on O2 at 15 LPM via NRBM. The reason for the patient's hospitalization was end-stage cancer, respiratory distress and AMI. There was an emergency contact person listed.

During a review of the facility's "Advance Directives" document that was completed by the MSU staff, dated 4/23/12 at 8:05 PM, revealed that the patient had California Advance Directive (AD) and that a copy of the AD was requested. The section that stated, "If copy not already on chart or not immediately available, the patient's wishes are," was reviewed and showed "withhold all resuscitative measures." The document was signed by the emergency contact person that was listed on the Medical/Surgical Admission Data Base documentation and a RN.

A review of the Medical/Surgical Nursing Flow sheet, dated 4/23/12 was conducted and revealed that at 8:15 PM, the admission interview was completed with the caregiver. The patient was unable to offer input. DNR status was requested per the caregiver as reported to be the patient's wishes. Requested copy of Advance Directive for chart, otherwise documented as expressed (by caregiver).

There was no documented evidence in the medical record to show that the patient had designated a decision-maker to make medical treatment decisions on the patient's behalf.

A review of physicians' order sheet, dated 4/23/12 at 8:30 PM, revealed an order that showed that the patient was a no code (DNR). This order was written by the admitting physician.

A review of the History and Physical Exam, dated 4/23/12 at 8:30 PM, was conducted and revealed that the patient was unresponsive with Cheyne Stokes breathing (cyclic breathing marked by a gradual increase in the rapidity of respiration followed by a gradual decrease and total cessation from 5 to 50 seconds), terminal lung cancer, premorbid, DNR. The plan for treatment revealed pain control, comfort care and a no code (DNR).

Further review of the Medical/Surgical Nursing Flow sheet, dated 4/23/12 was conducted and the following were noted:

At 8:50 PM, the patient's respiratory patterns varied with periods of Cheyne Stokes.

At 10:15 PM, the patient appeared uncomfortable, SPO2 decreased to 70% (low), HR 103 (high). Morphine 2 mg IVP was administered.

At 11:20 PM, the patient did not respond to oral care, SPO2 96% (normal), HR 95 (normal).

At 11:40 PM, when the patient was repositioned, he opened his eyes, SPO2 96% and HR 96.

At 12:15 AM, very agitated, hands active, head rolled from side to side, SPO2 decreased to 70% or less.

At 12:18 AM, "all activity and responses ceased."

A review of the progress notes, dated 4/24/12 at 12:18 AM, was conducted and revealed that the patient was pronounced dead.

Patient 29's medical record documentation failed to show that the facility obtained a copy of the patient's Advance Directive that would have indicated that the patient's wishes for withholding or withdrawing of life sustaining treatment of resuscitation support. The medical record documentation failed to show that patient's DNR status was specified in writing, with the patient and/or a designated decision maker.

Patient 29's medical record documentation failed to show that the POLST- DNR decision was made in collaboration with the patient or designated decision maker. The medical record failed to show that MD 1 discussed with patient his diagnosis, prognosis, proposed "No Code" order, alternatives and risks and benefits of each alternative.

On 4/24/12 at 10 AM, an interview was conducted with RN 2 (the House Supervisor). RN 2 was interviewed regarding Patient 29's course of emergency medical treatment, she stated that the patient had lung cancer and that he was "full of metastasis (the process by which cancer cells spread from the original site to other organs or parts of the body)." She stated that she was informed by the ED staff that the patient had an AD for a DNR status, and that there was also a DNR physicians order.

On 4/25/12 at 2 PM, a follow-up interview was conducted with RN 2. She acknowledged and confirmed that, after her investigation, the patient did not have an established AD that indicated a DNR status.

On 4/26/12 at 9 AM, an interview was conducted with RN 4 regarding verifying AD prior to implementing a DNR status for a patient that presented to the ED. She stated that the AD would have to be in writing. RN 4 stated that the patient would be considered a full code until the patient and/or family can establish otherwise. She further stated, we don't ask a patient with a stumped toe if they have an advanced care directive; we don't ask patients in ED if they have an Advance Directive. RN 4 further stated, "There's nothing in charting that states we have to ask patients about their wishes."

On 4/26/12 at 9:10 AM, an interview was conducted with RN 5 that received Patient 29 on 4/23/12 at 2:45 PM. She verified that the patient presented to the ED in respiratory distress, confused and disoriented and had a history of terminal lung and brain cancer. RN 5 acknowledged and confirmed that the patient had an AMI while in the Emergency Department (ED). RN 5 acknowledged and confirmed that the medical record failed to show that the patient had the mental capacity to make emergency medical treatment decisions. She confirmed that there was no designated decision maker present to make medical decisions for Patient 29.

During the interview, RN 5 stated that she called the medical records department to obtain the patient's medical records from his previous admissions. RN 5 stated that she was informed by the admitting clerk that Patient 29 was a DNR. RN 5 acknowledged and confirmed that she did not see the AD to verify the patient had an AD in place and/or what the AD documentation showed.

RN 5 stated that the patient was asked by the ED staff if he wanted to have the staff "pound (to strike or hit heavily) on his chest and/or put a tube down his throat" in the attempt to provide life sustaining treatment. The patient said, "no." RN 5 stated, "I followed the doctor's order, which was to make the patient comfortable."

On 4/26/12 at 9:15 AM, an interview was conducted with the Medical Director (MD 2), who was also the Chief of Staff, regarding the medical treatment provided for Patient 29 as directed by the DNR physicians order. MD 2 was informed that the patient presented to the ED with altered mental status (confused and disoriented). When asked how the ED staff concluded that the patient was mentally stable to make an informed decision to refuse life sustaining medical treatment, MD 2 stated that he was not familiar with Patient 29. When asked what the ED physician (MD 1) should have based his decision on to make the patient a DNR, MD 2 replied that the decision was possibly based on a previous visit or from the community, "we are a small town." He stated that usually if the patient was brought in by an ambulance, the ED staff would check with the ambulance personnel to see if an Advance Directive was sent by the family.

MD 2 stated, "I can't imagine not having an appropriate DNR order." However, the medical record should provide a reason why the DNR order was written for the patient. MD 2 stated that he would review the patient's medical record and follow-up with the surveyor.

On 4/26/12 at 10:17 AM, a follow-up interview was conducted with MD 2. MD 2 stated that after reviewing the patient's medical record. "The patient's DNR status wasn't known when he came in, even with the ambulance personnel documentation. The DNR order was not handled appropriately. Had the patient signed the POLST and certified it, we wouldn't be having this conversation. The error was not completing the paper appropriately." MD 2 also stated, "I don't think the patient could have signed the POLST with the amount of morphine the patient received, the AMI and increased troponin level." MD 2 stated that if a patient came in with AMI, the patient would have been transferred out to a higher level of care, unless there was a DNR order.

MD 2 also stated that the ED staff submitted written statements regarding how the decision was made to make Patient 29's status a DNR. MD 2 stated that these written statements explained the situation clearly, but statements did not justify the facility's actions. He further stated that the ED staff thought that they had the caregiver at the bedside, but they did not.

A review of MD 1's written statement dated 4/24/12 was conducted in the presence of MD 2. The following was noted:

"(Patient's name, here) presented to the (facility name) emergency room via local ambulance with a history of dyspnea (difficulty breathing) and chest pain. He had a history of lung cancer with metastasis to his brain. On presentation he was severely hypoxic and not lucid (mentally clear). We repositioned the patient and upon presentation and started him on high flow oxygen by mask, and his pulse ox (oximeter- a device that measures the patient's oxygen saturation) improved and he awoke and began talking to us. He was aware of who he was and where he was. He was able to carry on a conversation at that time. I called two of his friends, who were there with him, and four of our nurses to his bedside to determine whether we were going to intubate him and transfer him to (the name of the transferring hospital, here) for further treatment, since we did not know his code status. (Name of RN 6, here), who knew him (the patient) from before, asked him if he wanted to be intubated with chest compressions should he stop breathing. He said, 'no' at which point I told him we would make him comfortable and support him symptomatically, which we did. He was admitted to (physician's name, here) and expired thereafter."

The above documentation was not contained in the patient's medical record.

MD 1's written statement was discussed with MD 2. MD 2 acknowledged that MD 1's written statement revealed that the RN asked the patient about chest compressions and intubation, not MD 1. MD 2 confirmed that MD 1 did not explain the risk and benefits of withholding life sustaining support to the patient. MD 2 stated that it was the physician's responsibility to explain heroic measures to the patient, not the RN.

A review of RN 5's (undated) written statement, was conducted and revealed that on 4/23/12 at approximately 2:45 PM the patient presented to the ED via ambulance. The patient was confused and disoriented, after being stabilized on oxygen the patient was able to answer yes or no questions. The patient's code status was not known by the ambulance personnel. The "caregiver" was asked about the patient's code status, but the caregiver did not know. The admitting clerk pulled the patient's medical record and AD from his last visit. "It was our understanding that the patient was a do not resuscitate." RN 6 asked the patient if he wanted his chest pounded (to strike or hit heavily) on, it was explained to the patient that he needed a breathing tube and that we would pound on his chest, if his heart stopped, he said "no." "It was at proxy (approximately) 1455 (2:55 PM) that patient was declared a DNR by (MD 1's name, here)."

The above documentation was not contained in the patient's medical record.

A review of RN 6's written statement dated 4/26/12 was conducted and revealed that on 4/23/12 at approximately 2:50 PM the patient presented to the ED in "poor condition." The visitors at the bedside were asked if the patient was a DNR, but they did not know. One of the visitors asked the patient if he was a DNR, but the patient did not answer. RN 6's statement noted, "I called (the) patient (by) name and asked him if he wanted to be pounded (to strike or hit heavily) on his chest and he said 'no' (the) question was repeated and he said 'no'."

The above documentation was not contained in the patient's medical record.

A review of Phlebotomist 1's written statement dated 4/26/12 was conducted and revealed that on 4/23/12 at 3 PM, she was at the patient's bedside drawing the patient's blood "the patient immediately embraced by (my) arm as if with a death grip." She documented that she heard the patient say, "I just want to be comfortable," in response to the caretaker's question regarding the staff performing cardiopulmonary resuscitation (CPR). Phlebotomist 1 also documented that the patient stated, "I don't want that" in response to RN 6's question regarding CPR. She also documented that she overheard the Respiratory Therapist that was at the bedside say, "I am not a doctor but according to EKG it looks like the patient is having a heart attack."

The above documentation was not contained in the patient's medical record.

On 4/26/12 at 11 :45 AM, during an interview with the Interim Chief Nursing Officer (ICNO), a request was made to review the hospital's policy and procedure (P&P) regarding the implementation of physicians orders for DNR patients. The ICNO submitted an untitled document and stated that it was the hospital's P&P that pertained to physician orders for DNR, which she had obtained from hospital's Nursing Policy/Procedure Manual.


A review of the policy showed the following:

A revised date in 6/2010 and a reviewed date in 7/2011.

The Purpose: "To assist in facilitating and implementing decisions concerning the withholding or withdrawing of life sustaining treatment or resuscitation support."

The hospital's Policy included:

1). It is the policy of the (facility name, here) to initiate standard resuscitation measures on any patient found to be in a state of cardiac or respiratory arrest, Unless a "No Code" order has been written by a physician.

2). The (facility name, here) recognizes that patients have an inherent right to continue their medical treatment, including the right to refuse life sustaining procedures. Competent patients are the ultimate decision makers with regard to the matter of forgoing life sustaining measures.

5). This policy is intended to cover situations in which consideration is being given to withhold/withdraw life sustaining treatment in patient care. "Do Not Resuscitate" or "No Code" orders would be included as authorization to withhold life sustaining procedures...

The "Who should decide" section revealed:

1). The patient- if competent, the patient is the ultimate decision maker regarding life sustaining treatment. "Competency" means the ability to understand and appreciate the nature and consequences of the medical treatment involved. The patient must understand the diagnosis, prognosis and treatment options. When a decision is being made regarding life sustaining treatment, including resuscitation, the patient must understand that refusal may hasten or lead to death.

2). Attending physician and consulting physician

3). Patient's Family and other interested persons- In some instances, the patient's family may be relied upon as surrogate decision makers when the patient is incompetent (incapable due to a mental or physical condition).

4). Surrogate (an adult, other than a patient's agent pr conservator) decision makers- where a surrogate maker is involved the patient should be permitted to participate in the treatment decision as fully as possible.

The Factors Affecting "No Code" decision/considerations section revealed:

2). "No Code" orders should not be used (d.) The patient is incompetent (incapable due to a mental or physical condition) and has no surrogate to give informed consent.

The "Procedure for using an order to withhold or withdraw life Support"

Documenting orders to withhold life sustaining treatments section:

1). Initiation:

(a). If a physician determines that a "No Code" order is appropriate he/she should discuss the matter with the patient/guardian/family.

(b). If a patient/guardian/family member requests a "No Code" order, the nurse should document the date and time of the request and immediately inform the primary physician.

2). The physician must discuss with patient/guardian/family the patient's diagnosis, prognosis, proposed "No Code" order, alternatives and risks and benefits of each alternative. Informed consent must be given by the appropriate party, as follows:

b). If the patient is incompetent, informed consent should be obtained from the appropriate surrogate: (1). A person designated in a Durable Power of Attorney for Healthcare (Advance Directive).

4). Documentation in the Physician's Progress Notes should include, but not limited to:

A summary of the medical situation which specifically addresses the patient's situation. This must include reference to the patient's mental status, diagnosis, and prognosis at the time of the order.

A review of the facility's policy and procedure titled, "Advance Health Care Directive," that was last reviewed in 9/2010, was conducted and revealed the following:

Purpose: To provide direction and assistance to the facility's employees in abiding with local and federal government as well as regulatory agency requirements concerning advance health Care Directives.

Policy: The (facility name) shall abide by state and federal law concerning Advance Health Directive, which recognizes a patient's right to participate in medical decisions and to make advance health care directives, including a health care power of attorney and a living will.

Procedure #4. If the patient has any health Care Directives, a copy will be requested for the hospital and placed in the medical record.

Procedure #5. If the advance directive is present but not immediately available, the substance of the directive will be determined from the patient and/or family and will be documented. This will be noted by the RN or Licensed Vocational Nurse and signed by the patient, Power of Attorney, or surrogate.

Based on observation, interview and record review, the hospital failed to ensure that the Emergency Department's (ED) emergency medical equipment was maintained and/or readily available for use. This failure, created the potential for all patients that presented to the ED to not have their emergency treatment needs met in a timely manner.

Findings:

On 4/24/12 at 9 AM, a tour of the ED was conducted with Registered Nurse (RN) 4 and RN 9.

1). A review of the facility's April 2012, Emergency Room Check List was reviewed with RN 4 and RN 9. RN 4 stated that the listed items were checked every shift (every 12 hours).

The check list showed a fetal heart monitor (FHM- a device used to continuously monitor the fetal heart rate) the item was highlighted with a line drawn through it with a hand written note indicating "non-applicable (n/a)." When asked why non-applicable (n/a) was documented for the FHM, RN 4 and RN 9 stated, "because we don't have a fetal heart monitor, and if we did we would not know how to use it." RN 4 and RN 9 further stated that they were not obstetric nurses.

During this interview, RN 4 and RN 9 acknowledged and confirmed that the hospital provides emergency care services for obstetric (relating to childbirth) patients. They also acknowledged that there was a potential for a pregnant woman to present to the ED that may require fetal heart rate monitoring via FHM.

On 4/24/12 at 11:15 AM, an interview was conducted with RN 2 (the House Supervisor). RN 2 was informed that RN 4 and RN 9 stated that they did not have a FHM onsite. She was also informed that the two RN's stated that they were not obstetric nurses and they were not knowledgeable on how to use the FHM.

During this interview, when asked why the ED staff weren't aware that they had access to FHM, RN 2 stated that the facility did have a FHM and that she would locate it. When asked why the ED staff were not checking the FHM every 12 hours as the check list noted, RN 2 stated that she was not aware that the FHM was not being checked every 12 hours. She stated that the FHM should have been checked every 12 hours to ensure that the device was maintained and functioning. RN 2 was unable to provide documented evidence to show that the ED staff had been in-serviced on the use of the FHM.

A review of the facility's 2012, Scope of Service and Practice for the Emergency Department, revealed that the unit was designed to care for those patients with emergent medical, obstetric, surgical and traumatic conditions requiring a higher level of care that can be provided by the primary physician in his or her office.

2. During the same ED tour on 4/24/ 12 at 9 AM with RN 4, the Pediatric and the Adult Crash Carts (contents usually consist of emergency medications, defibrillator, intubation equipment, oxygen) were observed. The daily logs were reviewed with RN 4, the daily logs failed to show that either crash cart had been checked by the day shift at the time of the tour. RN 4 stated that the ED had been so busy that the staff had not had a chance to check the crash carts.

Crash Carts are used during a code blue situations (a state of medical emergency and call for medical personnel and equipment to attempt to resuscitate a patient especially when in cardiac arrest or respiratory distress or failure).

On 4/24/12 at 11:45 AM, an interview was conducted with RN 2, she stated that the Pediatric and the Adult Crash Carts should have been checked at the start of the day shift (7 AM) to ensure that they were functioning in the event of a cardiac or respiratory arrest.

A review of the facility's 2012, Scope of Service and Practice for the Emergency Department, revealed that the unit was designed to care for those patients with emergent medical, obstetric, surgical and traumatic conditions requiring a higher level of care than can be provided by the primary physician in his or her office.

Based on observation, interview and record review, the facility failed to ensure that the crash cart in the mobile CT unit was checked at the start of the shift for a universe of 3 patients. This failure had the potential to contribute to an untoward event outcome during an emergency due to the emergency equipment not being maintained.

Findings:

An observation was made on 4/25/12 at 2:30 PM of the mobile CT unit located outside the facility. A review of the Crash Cart log revealed that there were no initials listed indicating that the crash cart was checked for the following dates: 2/8/12, 2/9/12, 2/10/12, 3/23/12 and 3/31/12. There was no documented evidence on the crash cart log indicating that the mobile CT unit was closed on these dates.

Record review of the Performance Evaluation System and Position Description for the Radiology Technologist revealed in the Critical Competency section under Quality, "Assess the maintenance of a safe patient environment by always checking the Crash Cart, Defib/Code supplies and equipment prior to start of shift."

Record review of the facility's policy and procedure titled, "Crash Carts", dated 1/12, revealed that the crash cart check list would be located on the top or the side of the Crash Cart, it would be completed and initialed every (24) twenty-four hours, unless the unit was dark. If the unit was dark, the word "CLOSED" was to be written on the Check List.

During an interview on 4/25/12 at 3:14 PM, the Lead Radiology Technician (LRT) who was covering for the Radiology Manager (RM) confirmed that the crash cart was not checked on the dates discovered during the survey process.

Based on observation, interview and record review the facility failed to meet the Condition of Participation for Physical Plant and Environment by failing to do the following:

1. Ensure that its mobile CT unit was maintained to ensure the safety and well being of patients by failing to ensure that preventive maintenance and ongoing testing activities were being performed on its back-up generator that services the mobile CT unit. This failure had the potential to result in equipment failure in an emergency situation which would threaten the health and safety of patients. (Refer to C222).

An IJ was called on 4/25/12 at 6:20 PM in the presence of the facility's ICEO and ICNO.

The facility failed to ensure that a physician was physically present and available in the mobile CT unit to provide immediate medical intervention to patients in the event of an adverse reaction to IV contrast administered during CT Scans. Radiological technicians were administering IV contrast during ordered CT scans without documentation of the procedure in the patients medical record. There was no system in place for staff to communicate needs by telephone in the event of an emergency power outage. The Maintenance Supervisor (MS) did not have access to the back-up generators and no recorded testing had been performed on the generator. (Refer to C150).

The IJ was abated on 4/26/12 at 12:10 PM after a plan of correction was accepted by the survey team. The facility's plan of correction was validated by the surveyors prior to the abatement of the IJ.

The cumulative effect of these systemic problems resulted in the facility being unable to ensure that high quality healthcare was provided in a safe environment.

Based on observation, interview and document review, the facility failed to ensure that its mobile CT unit was maintained to ensure the safety and well being of patients by failing to ensure that preventive maintenance and ongoing testing activities were being performed on its 12 V (volt) back-up battery that services the mobile CT unit. This failure had the potential to contribute in equipment failure in an emergency situation which would threaten the health and safety of patients within the mobile CT unit.

Findings:

During an interview on 4/25/12 at 3:15 PM, the Maintenance Supervisor (MS) stated that the lift on the mobile CT unit could not be operated manually without power and operated off the 12 V backup battery in the event there was a power outage. There was no system in place for the mobile CT unit to be provided with a backup communication system in the event that the phone is down during a power outage. The MS stated that the technicians would have to use their personal cell phones to communicate in the event of an emergency because one was not provided by the facility. The MS confirmed that in the event of a power outage, there would be no way that the staff in the mobile CT unit could communicate their needs.

During an interview on 4/25/12 at 3:18 PM, the Lead Radiology Technician (LRT) who was covering for the Radiology Manager stated that all patients must be lifted onto the ramp in order to enter the mobile CT unit. The LRT stated that was the only way for patients receiving CT scans to enter into the mobile CT unit.

On April 25, 2012, at 3:28 PM, during a tour of the mobile CT unit, the MS stated that he does not test the backup battery for the mobile CT unit and that he does not even have a key to access the backup battery (it was located at the back of the trailer in a locked compartment).

At 3:40 p.m., during review of the preventive maintenance logs for the mobile CT unit, no documentation was provided to indicate the backup battery was tested or being maintained.

Based on interview and record review, the hospital failed to ensure that the Nursing policy and procedure that was developed to assist with facilitating and implementing decisions concerning the withholding or withdrawing of life sustaining treatment or resuscitation support was approved by the Governing Body (GB). This failure had the potential for all patients that presented to the hospital for services to not have their healthcare decisions honored.

Findings:

On 4/26/12 at 11 AM, during an interview with the CNO, a request was made to review the hospital's policy and procedure (P&P) regarding the implementation of physicians orders for DNR patients. The CNO submitted an untitled document and stated that it was the hospital's P&P that pertained to DNR physician orders, which she had obtained from hospital's Nursing Policy/Procedure Manual.

A review of the policy showed the following:

A revised date in 6/2010 and a reviewed date in 7/2011.

The Purpose: "To assist in facilitating and implementing decisions concerning the withholding or withdrawing of life sustaining treatment or resuscitation support."

The hospital's Policy included:

1). It is the policy of the (facility name, here) to initiate standard resuscitation measures on any patient found to be in a state of cardiac or respiratory arrest, Unless a "No Code" order has been written by a physician.

2). The (facility name, here) recognizes that patients have an inherent right to continue their medical treatment, including the right to refuse life sustaining procedures. Competent patients are the ultimate decision makers with regard to the matter of forgoing life sustaining measures.

5). This policy is intended to cover situations in which consideration is being given to withhold/withdraw life sustaining treatment in patient care. "Do Not Resuscitate" or "No Code" orders would be included as authorization to withhold life sustaining procedures...

On 4/26/12 at 4:10 PM, an interview and a record review was conducted with the Medical Staff Coordinator (MSC). The MSC stated that the GB Committee Meetings were held monthly. She stated that all revised P&Ps were discussed and approved by the GB at these monthly meetings. She stated that the Nursing P&P manuals were reviewed annually by the GB and approved at that time. The MSC stated that all P&Ps should be approved by the GB prior to their implementation throughout the facility.

The MSC reviewed the policy that was retrieved from the hospital's Nursing Policy/Procedure Manual that noted: "To assist in facilitating and implementing decisions concerning the withholding or withdrawing of life sustaining treatment or resuscitation support. She acknowledged and confirmed that the policy showed that it was revised in 6/2010 and was last reviewed in 7/2011.

During the same interview, the MSC reviewed the GB Committees' Meeting Minutes that was conducted in 7/2010 to show documented evidence that the policy revision(s) that was conducted in 6/2010 was approved by the GB. The MSC was unable to show documented evidence that the 6/2010 policy revision(s) was approved by the GB during their monthly meeting in 7/2010. She confirmed that the policy revision(s) should have been approved by the GB in 7/2010. She was also unable to show evidence that the policy revision(s) that were conducted in 6/2010 had been approved by the GB when the Nursing Policy/Procedure Manual was reviewed in 7/2011. The MSC stated that the Nursing policy should have been approved by the GB prior to the implementation by the nursing department.

Based on observation, interview, and record review, the facility failed to meet the Condition of Participation for Provision of Services by failing to:

1. Ensure that registered nurses (RN) were conducting accurate nutritional assessments on patients admitted to the facility and in need of a nutritional consult for 4 of 13 sampled patients (Patients 26, 30, 2 and 5) according to facility policy. (Refer to C271).

2. Ensure that physicians included pain parameters and indications for all orders for pain medications for 1 of 13 sampled patients (Patient 26). (Refer to C276).

3. Ensure that a licensed physician shall be physically present within the facility and immediately available where the CT scan with contrast procedures were performed, in order to provide immediate medical intervention to prevent or mitigate injury to the patient in the event of an adverse reaction or anaphylactic shock. The inability to immediately provide medical interventions to the patient had the potential to cause serious harm, brain damage and death. (Refer to C283).

4. Ensure that for 1 of 13 sampled patients (Patient 26), nursing services supervised and evaluated the nursing care delivered. This failure contributed in Patient 26 not having his infected surgical abdominal wound that reopened continually assessed, measured, photographed and evaluated for progression or deterioration of the wound throughout his 7 day hospital stay. (Refer to C296).

5. Ensure that a Registered Nurse (RN) supervised and evaluated the nursing care for patients who presented to the facility's mobile CT unit for CT scans with and without contrast administered by a Radiology Technician without a physician available in the mobile unit to provide immediate medical intervention in the event of an adverse reaction. This failure had the potential for the patient to experience an adverse reaction to IV contrast without RN supervision to assess, evaluate, and implement appropriate emergency procedures such as ACLS (Advanced Cardiac Life Support) in the event of an emergency. (Refer to C296).

6. Ensure that an RN evaluated the behaviors for 1 of 13 sampled patients (Patient 25) prior to the administration of a medication (Ativan) ordered for agitation. This failure resulted in Patient 25 receiving Ativan for agitation without documentation by the RN of the patients behaviors that warranted administration of the medication. (Refer to C296).

The cumulative effect of these systemic problems resulted in the hospital's inability to provide appropriate provision of services.

Based on interview and record review, the facility failed to ensure that registered nurses (RN) were conducting accurate nutritional assessments on patients admitted to the facility and in need of a nutritional consult for 4 of 13 sampled patients (Patients 26, 30, 2 and 5) according to facility policy.

This failure contributed in the following patients being discharged from the facility without receiving necessary nutritional support services:

Patient 26 who was admitted with an infected surgical wound that reopened (dehiscence);

Patient 30 who was admitted with a history of congestive heart failure, hypertension and renal failure;

Patient 2 who was admitted with a gastrointestinal bleed and a history of cirrhosis of the liver and inadequate nutritional intake; and

Patient 5 who was dependent on artificial nutrition through a tube for his nutrition with a history of throat cancer.

Findings:

1. Patient 26 was admitted to the facility on 4/16/12 at 5:45 PM with a diagnosis of wound infection with partial dehiscence (a surgical complication in which a wound breaks open along the surgical suture line). Patient 26 was discharged from the facility on 4/23/12.

Record review of the Interdisciplinary Progress Notes, dated 4/17/12 at 9:20 AM documented by the Cook Manager (CM), revealed an entry indicating that the patient was currently on a regular diet. Will continue to monitor patient prn (as needed). Good Appetite. There was no other documentation found in the medical record by the CM acknowledging or addressing the abdominal wound that Patient 26 had.

Record review of the Emergency Department (ED) Primary Nursing Assessment form for Patient 26, dated 4/16/12 revealed documentation of a vertical suture line on the abdomen with no indication of the size and type of wound, or if it was a laceration, bruise, or abrasion in the musculoskeletal section of the form.

Record review of Patient 26's albumin level (a test used to evaluate nutritional status; low serum albumin levels occur in protein malnutrition or active inflammation) revealed the following albumin levels:

4/16/12 at 5:30 PM: 2.3 (low)
4/17/12 at 5:20 AM: 2.1 (low)

Normal albumin levels for this lab was 3.4-5 g/dL (grams/deciliter).

Record review of the Admission Orders, dated 4/16/12 revealed the following documentation of the diagnosis by the physician, "Wound infection, partial dehiscence s/p (status post: occurring after) diaphragmatic hernia repair". In the Diet section of this same form was a box checked for a regular diet and the box located next to Dietician consult was noted to be blank.

Record review of the Admission Data Base, dated 4/16/12 at 7 PM, and completed by RN 1 revealed the following assessment in the Nutritional Screening section of this form: A box was checked indicating that the patient denied any problems related to nutrition. There was also a list of symptoms in this section that advised if any were checked, to refer to a dietitian for further assessment. One of the symptoms listed was Pressure sore/wound. This box was not checked. At the bottom of this section was a place for the licensed nurse to initial indicating that a referral was made. This was noted to be blank.

Record review of the facility's policy and procedure titled, Wound Care Management, reviewed 1/12, revealed the following:

"Procedure: 1. Upon admission a Registered Nurse will assess the skin condition of all patients and with the intent to identify at risk patients."

"Nursing Interventions: 7. Promote hydration and adequate nutrition."

"Photo Documentation: 1. Photograph existing wounds on discovery and discharge or changes noted. Photograph are to contain measurement, time and date."

"Treatment section: 3. Notify the Dietitian."

Record review of the photograph of Patient 26's abdominal wound, dated 4/17/12 (one day after admission) did not include a time that the picture was taken and there was no documented evidence of the measurement of the abdominal wound.

During an interview on 4/25/12 at 5:20 PM, RN 2, who was the House Supervisor (HS) stated that Patient 26 should have been referred to the dietitian due to the abdominal wound. The HS confirmed that there was no time or measurements of the wound documented on the photograph taken one day after admission. The HS further stated that the Wound Care Flowsheet should have the measurements of the wound and confirmed that it did not. The HS also confirmed that there was no description of the wound documented by the admitting nurse (RN 1) to the acute care unit. Additionally, the HS confirmed that ER Nursing assessment did not include a measurement of the abdominal wound.

2. Record review revealed that Patient 30 was admitted to the facility on 2/23/12 and discharged on 2/28/12 with diagnoses that included respiratory distress (trouble breathing) and possible laryngeal stenosis (a narrowing of the airway).


Record review of the Emergency Physician Record, dated 2/23/12 in the HPI (history of present illness) section revealed documentation that Patient 30 had renal failure (12/26/11) and had received dialysis (two months prior to admission to the facility).

Record review revealed the following diet orders throughout Patient 30's hospitalization:

Admission Orders dated 2/23/12 at 8:45 PM: Regular diet.

Physician's Order Sheet, dated 2/26/12 at 11:40 AM: Change diet to 2gm (gram) sodium.

Physician Order Sheet, dated 2/26/12 at 6 PM: NPO (nothing by mouth) after midnight.

Post Op (Operative) Orders, dated 2/27/12 (no time documented): Regular diet.

Physician's Order Sheet, dated 2/27/12 at 4:30 PM: Change diet to 2 gm Sodium.

Record review of the Patient Discharge Instructions Attestation form for Patient 30, dated 2/28/12 revealed the following:

"Diagnosis: ...Tracheal Stenosis, s/p (occurring after) renal failure, congestive heart failure and hypertension."

"Diet: Regular, As before hospitalization."

There was no documented evidence in the medical record showing that Patient 30 received a nutrition consult or was given instructions upon discharge to continue the 2g sodium diet ordered prior to discharge for the diagnosis of hypertension and congestive heart failure.

Record review of the Progress Note, dated 2/23/12 at 8:40 PM revealed the following documentation by Physician A revealed the following entry: "...Self extubated off ventilator 12/25 and then developed renal failure and required dialysis three times per week for another one month ... ".

Record review of the Interdisciplinary Progress Notes, dated 2/27/12 at 9:25 AM by the Cook Manager (CM) revealed the following entry: Patient currently on a regular diet. Will continue to monitor patient prn (as needed). Diet has been changed to NPO (nothing by mouth) due to procedure. Will continue to monitor prn.

There was no documentation found by the dietitian addressing possible recommendations for a low sodium diet for the patients diagnosis of hypertension, CHF (congestive heart failure: the inability of the heart to supply sufficient blood flow to meet the needs of the body), and a previous history of acute renal failure requiring the patient to receive dialysis three times per week for one month.

Hypertension, also known as high blood pressure is defined as a consistently elevated blood pressure exceeding 140/90.

Record review of Patient 30's vital signs from 2/23/12 through 2/28/12 revealed the following elevated blood pressure readings

2/23/12: 153/99
2/24/12: 139/108, 140/96
2/25/12: 152/113, 148/96, 157/102, 148/98
2/26/12: 147/101, 151/100, 151/103
2/27/12: 152/101, 148/108, 136/98
2/28/12 (day of discharge): 141/104, 144/97

Record review of the Medication Administration Record throughout Patient 30's hospital stay revealed the patient was receiving multiple medications for blood pressure and congestive heart failure maintenance.

Record review of the patient education Patient 30 received upon discharge on 2/28/12 was for the following conditions with corresponding recommendations from the handout:

Congestive Heart Failure: Occurs when your heart cannot pump enough blood to your body and is a life threatening disease. To manage this conditions, the handout recommended eating a low salt diet (2-3 grams per day).

Record review of the facility's policy and procedure titled: Assessment and Reassessment of Patients, revised 1/12, revealed the following:

"I. Purpose: B. To develop a database of information regarding the patient in order to provide the necessary information to plan, coordinate, delegate, and supervise the care of the patient."

"II. Policy: D. A registered nurse shall assess the patient's need for nursing care in all settings where nursing care is provided."

"III. Procedure: A. Nursing, 1. Initial Assessment: Assessment will be performed by a Registered Nurse (RN) and include the following as appropriate to the care setting: vii. Nutritional Status Screen; xi. Anticipated Discharge Planning Needs".

"III. Procedure: C. Nutritional Services. 1. Initial Assessment. A. The purpose of the nutritional assessment is to evaluate the patient's nutritional status, develop a plan of nutritional care, and evaluate the efficacy of nutritional support. The need for a nutritional assessment is determined following a nutritional screening process completed by nursing during the initial patient assessment."

During an interview on 4/26/12 at 6:15 PM, RN 2 who was also the House Supervisor confirmed the documentation regarding the elevated blood pressures for Patient 30 and stated the patient should have been instructed to continue the 2 gram sodium diet upon discharge. The HS confirmed that there was no nutrition consultation recommended by the RN due to the patient's history of hypertension, congestive heart failure, and having an acute episode of renal failure requiring dialyses three times per week prior to admission to the facility. Additionally, the HS stated that Patient 30 was on a regular diet prior to admission.



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3. A review of the medical record for Patient #5 revealed that the patient was admitted to the hospital on 3/15/12 with diagnoses that included throat cancer and cellulitis to the face. Cellulitis is an inflammation or infection of the tissue. The patient was dependent on a feeding tube for his nutrition. During the 4 day hospital stay, the patient was fed by the tube and was unable to eat by mouth. A review of the Nutritional Screening on the Admission Data Base (nursing initial assessment) dated 3/15/12 revealed that a dietitian referral was not made. The form indicated that if a patient was on a tube feeding, a referral to the RD was supposed to be made for further assessment. This was not done. The patient was 5 foot 6 inches tall and weighed 123 pounds (less than 90% of his ideal body weight). There was no nutrition assessment of Patient #5 in the medical record.

During an interview with the Nursing Supervisor (NS) on 4/25/12 at 2:40 PM, she confirmed the finding and stated that a nursing referral should have been made to the RD for a nutrition assessment.

4. A review of the medical record for Patient #2 revealed that the patient was admitted to the hospital on 2/3/12 with diagnoses that included a gastrointestinal bleed, cirrhosis of the liver, anemia and complaints of vomiting blood (moderate to severe). A review of the physician orders showed that a clear liquid diet was ordered on 2/3/12. The patient's diet was not advanced to full liquids until 2/7/12, four days later. A clear liquid diet provides minimal nutrition content. A review of the Nutritional Screening on the Admission Data Base dated 2/3/12 revealed that a dietitian referral was not made. The patient's height was documented as 5 feet 4 inches and weight was 109.8 pounds, less than 85% of his ideal body weight. No referral was made to the RD during the patient's hospital stay. No nutrition assessment of Patient #2 was completed.

During an interview with the DM on 4/24/12 at 4:30 PM, she verified that the patient was on a clear liquid diet greater than 3 days and no referrals were made to the RD for a nutrition assessment.

A review of the hospital's policy titled, "Nutritional Screening/Monitoring" dated 11/11, revealed that there was to be an initial screen of each patient's nutritional status to determine the nutritional risk and need for nutritional care monitoring. It further stated that the initial nutrition screening will be completed by the Registered Nurse upon assessment and referred to the Nursing Admission Data Base for Criteria. It stated that the RD will be consulted by nursing via the computer when indicated by the Initial Nutrition Screen.

A review of the Nutritional Screening on the Nursing Admission Data Base, any of the following items checked require a referral to the Dietitian for further assessment: vomiting > 3 days, NPO (nothing by mouth) > 3 days, diarrhea > 3 days, unintentional weight change > 10 pounds in a month, Enteral (tube feeding)/Parenteral (IV nutrition) feeding, pressure sore/wound, new onset diabetes, hyperemesis, or swallowing/chewing difficulties.

When the hospital system is dependent on the Nursing staff to complete an initial nutrition screen and then based on that screen, make a referral to the RD and that doesn't occur, the patients are at risk for further decline in their nutrition status. Patients at nutrition risk, who are not assessed and monitored by the RD, are at risk for further decline in their nutritional status and overall medical status.

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

1. Ensure that physicians included pain parameters and indications for all orders for pain medications for 1 of 13 sampled patients (Patient 26).

2. Ensure that the Emergency Department's Adult Crash Cart medications expirations dates were the same as the medication manufacturer's listed expiration dates.

These deficient practices increased the risk of harm to the patients by the facility administering medications that may not meet the needs of the patients.

Findings:

1. Patient 26 was admitted to the facility on 4/16/12 at 5:45 PM with a diagnosis of wound infection with partial dehiscence (a surgical complication in which a wound breaks open along the surgical suture line). Patient 26 was discharged from the facility on 4/23/12.

Record review revealed the following Physician Orders (PO) for pain medications without evidence of established pain intensity parameters:

a. PO dated 4/22/12 at 7:50 AM: Demerol 25 mg (milligrams)/0.5 ml (milliliters) IVP (intravenous push) for pain PRN (as needed) q2h (every two hours).

b. PO dated 4/19/12 at 10:35 AM: Demerol 25 mg IV every 2 hours prn pain.

c. PO dated 4/19/12 at 2:50 PM: Demerol 25 mg IV now (no indication documented).

d. PO dated 4/18/12 (no time documented): Dilaudid 2 mg IV every 3 hours PRN pain.

e. Admission Orders dated 4/16/12 at 5:45 PM: Demerol 25 mg IV every 3 hours (no indication documented).

During an interview on 4/23/12 at 3:35 PM, RN 3 stated that she does not normally see pain medications ordered by the physician that included parameters for mild, moderate or severe pain.

Record review of the facility's, "Orders: Drugs" Policy dated 1/12, revealed the following: "Content of Drug Orders: each drug order shall include: ... PRN orders must include maximum frequency and be qualified (i.e. indications) (e.g. PRN pain is NOT acceptable. QX [every specified] hrs PRN pain is acceptable). ..."

Record review of the facility's Pain Management Policy, dated 8/05 revealed the purpose of the policy was to describe the process for optimally managing pain in all patients. The goals were: "...2. To provide guidelines for health care professionals to promote adequate pain management."

During an interview on 4/25/12 at 6:08 PM, the House Supervisor (HS) stated that the Registered Nurse (RN) should have clarified the range orders with the physician prior to administering the medication to the patient. The HS confirmed that there were no qualifiers indicated in the physician order for mild, moderate or severe pain and there were no indications documented by the physician for the pain medications ordered on 4/16/12 and 4/19/12 for Patient 26.



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2. On 4/24/12 at 9 AM, a tour of the Emergency Department (ED) was conducted with Registered Nurse (RN) 4 and RN 9.

During the ED tour on 4/24/12 at 9 AM with RN 4, the Adult Crash Cart (CC-contents: emergency medications, defibrillator, intubation equipment, oxygen) was observed.

Crash Carts are used during a code blue situations (a state of medical emergency and call for medical personnel and equipment to attempt to resuscitate a patient especially when that patient is in cardiac arrest or respiratory distress or failure).

During the tour, the Crash Cart contents were observed. The hospital's Adult Crash Cart Medication List contents was noted to have multiple medications and with expiration dates that were scratched out with a new expiration date entered. RN 4 confirmed the finding.

Further review of the document showed that there were five vials of Adenosine (antidysrhythmic medication) 6 milligrams (mg)/2 milliliters (ml) available for use. The Adenosine vials manufactures' expiration date was 6/30/12. According to the Medication List the Adenosine originally expired on 6/30/12, however the date was changed to 7/1/12.

On 4/24/12 at 9:35 AM, an interview was conducted with the facility's Pharmacist regarding the discrepancies between the Adenosine vial manufactures' expiration date (6/30/12) and the expiration date (7/1/12) listed on the Medication List. The Pharmacist stated that the Adenosine would not expire until 6/30/12 at midnight, which would be 7/1/12.

A review of the facility's 2012, Scope of Service and Practice for the Emergency Department, revealed that the unit was designed to care for those patients with emergent medical, obstetric, surgical and traumatic conditions requiring a higher level of care than can be provided by the primary physician in his or her office.

Based on observations, record reviews and staff interviews the hospital failed to:

A. Ensure patient food was stored, prepared and distributed in a safe and sanitary manner;

B. Ensure the nutrition needs of the patients were assessed and met in accordance with recognized dietary standards; and

C. Ensure the quality of the nutritional services program was evaluated so that performance improvement would be assured.

These failures had the potential to contribute in an outbreak of food borne illness. They also resulted in the nutrition needs of the patients not being met and allowed for the deficient practices to continue.

Because the hospital failed to:

? Ensure a Registered Dietitian provided oversight over the Food and Nutrition Services department so that safe food handling practices were observed;

? Ensure the patients at nutrition risk received nutrition assessment and appropriate interventions by a Registered Dietitian so that their nutrition status was not compromised;

? Ensure that the Dietary Manager was competent and knowledgeable in her duties to appropriately make referrals to the Registered Dietitian for patients requiring nutrition assessment and interventions;

? Ensure the nursing nutrition screening of patients was accurate and appropriate referrals were made to the Registered Dietitian for patients at nutrition risk,

Immediate Jeopardy was called on 4/24/12 at 5:45 PM in the presence of the ICEO (Interim Chief Executive Officer) and the ICNO (Interim Chief Nursing Officer).

On 4/26/12 at 3:00 PM, the ICEO and ICNO presented a plan of corrective action to the survey team. The plan of corrective action consisted of the following elements:

1. The contract with the consulting dietitian was revised to include a Registered Dietitian on-site visit weekly to oversee safe food handling in the Food and Nutrition Services Department to commence on 4/30/12. It also included off-site consultation of patient menus, development or revision of department policy and procedures, planning and conducting in-service education programs for the dietary services staff.

2. Immediate training was provided on 4/25/12 to all dietary staff and the ICNO via teleconference by the consultant Registered Dietitian which included: safe cooling of cooked potentially hazardous foods; storage/shelf life of foods and when to discard food; and a plan for the nutrition analysis of the patient menus.

3. The consultant dietary services contract included on-site training of dietary staff one to two times per week until knowledge of sage food handling and storage was demonstrated to be at an acceptable level to the Registered Dietitian. Education was to include reinforcement training to the nursing and medical staff regarding nutrition assessments of patients and when to consult the dietitian.

4. Immediate nurse staff training was conducted on nutrition assessment of patients and when to consult a dietitian according to the current policy and procedure. Training conducted by Nursing Administration.

5. Nursing Administration will monitor patient records daily to ensure that the dietary needs of the patients were being met. Monitoring was to include proper completion of the nutrition assessment tool, ordering of dietary consults and follow-through.

6. The in-house admission form was changed, referring staff to a separate Nutrition Status Evaluation Form to be completed on admission, after open surgery and as needed.

7. All products were immediately dated with receipt dates and "use-by" dates. Expired products were discarded.

On 4/26/12 at 3:17 PM, the survey team met with the ICEO and the ICNO and informed them the Immediate Jeopardy was abated.

Findings:

A. Food Safety and Sanitation:

1. According to the 2009 FDA Food Code, cooked, potentially hazardous food (PHF) shall be cooled within 2 hours from 135 degrees F to 70 degrees F, and within a total of 6 hours from 135 degrees F to 41 degrees F. It further states that if food is not cooled in accordance to this Code requirement, pathogens may grow to sufficient numbers to cause food-borne illness.

During the initial tour of the kitchen on 4/23/12 between 1:20 and 2:30 PM, several previously cook PHF were noted in the refrigerator and the freezer:

a). A container of ground beef dated 4/22/12 in the refrigerator,
b). A container labeled spicy sauce in the freezer,
c). A container of chicken stir fry in the freezer,
d). A container of baked beans in the freezer,
e). A container of Salisbury steaks in the freezer and
f). Sliced turkey breast

During a concurrent interview with the Dietary Manager (DM), she stated that all the items were cooked in the facility then placed in the refrigerator or freezer for storage. When asked if the items were monitored for safe, rapid cooling, she stated no. She further stated that the only food that the facility monitors the cooling for was roasts and they don't cook roasts very often. She stated that she didn't know that these leftover foods also needed to be monitored for safe cooling.

A review of the hospital's document titled, "Cooling Monitoring Form" (undated) revealed a blank form. The directions on the form stated, "Put hot food to be chilled on an ice bath in small portions. May leave uncovered to chill. Must be to an internal temperature of 41 degrees (Fahrenheit) in 4 hours. Take temperature every hour." There were no instructions to ensure that cooked PHF was cooled from 135 degrees Fahrenheit (F) to 70 degrees F within 2 hours per the food code requirements.

The 2009 Food Code stated: "The initial 2-hour cool is a critical element of this cooling process."

During continued interview with the DM, she stated that, not only did she not know that all PHF must be monitored for safe cooling, she didn't know that these foods needed to be cooled from 135 degrees F to 70 degrees F within 2 hours. She stated that although she had been through Professional Food Manager training and was certified for this training, she had received the training in 2009 and didn't remember about this requirement. She further stated that the contracted registered dietitian (RD) never in-serviced the staff on safe cooling of all PHF.

During a telephone interview with the contracted RD, she stated that had not been to the hospital since November 2011. She was not aware that the dietary manager and staff did not know safe cooling procedures for PHF.

The lack of staff and management knowledge with regard to safe cooling had the potential to result in an outbreak of food borne illness. Also a lack of documented monitoring of the cooling process meant that there was no way to ensure that the food was safely cooled within the required timeframes. Therefore there was no way to ensure the food was safe and would not cause food borne illness.

2. During the initial tour of the kitchen between 1:20 and 2:30 PM, many food items were not dated once they were opened or when they were removed from their original packaging:

a.) A package of frozen pancakes, removed from the original package with no date;
b.) An open bag of french fries, removed from the original package with no date;
c.) An open bag of hash browns in the freezer, removed from the original package with no date;
d). An open half gallon carton of liquid egg product labeled "keep frozen", thawed in the refrigerator with no thaw or "use-by" date; and
e). An open box of uncooked bacon with no date.

Also noted were many food items that were past the manufacturer's expiration dates:

a). A case of 27 individual servings of thickened orange juice expired 9/27/11;
b). A case of 27 individual servings of thickened vanilla flavored milk expired 10/7/11;
c). A case of 27 individual servings of thickened milk expired 9/29/11;
d). 23 eight ounce bottles of honey thick apple juice expired 4/18/11; and
e). One case plus 13 eight ounce bottles of Boost Plus expired 4/13/12.

And there were food items with inappropriate "use by" dates or no staff guidance for the length of the shelf life for the product once it was opened:

a). A container of tuna salad made in the facility labeled use by 4/30/12,
b). A container of egg salad made in the facility labeled use by 5/22/12,
c). A gallon size open container of Italian salad dressing labeled opened on 10/31/11, no "use by" date.

During a concurrent interview with the DM, she was unable to explain how the staff was able to track the shelf life of the food when there was no manufacturer's expiration or "use by" dates. She was also unable to explain how the staff monitored the shelf life of foods when they were removed from their original packaging and were not dated.

She further stated that it was her responsibility to monitor the expiration dates on the products that had expired. The DM was unable to explain how product that had expired up one year ago was still being stored and had not been discarded. She didn't know that the Boost Plus labeled, "expires 13 APR 12" meant 4/13/12, not 4/12/13. She verified that it did expire on 4/13/12.

The DM stated that she did not know the shelf life of the liquid egg product labeled "keep frozen" once it was thawed. She stated that she didn't know what the shelf life was for the salad dressing once it was opened. She stated that it was the usual practice of the facility to keep the tuna salad and egg salad for one week after it was made. She was unable to state the reference used to determine that the tuna and egg salad lasts for one week. She further stated that the egg salad labeled "use by 5/22/12" was mislabeled and should have read "use by 4/22/12".

The standard of practice for the storage of prepared mayonnaise based salads is 3 days.

A review of the hospitals policies and procedures did not produce any staff guidance regarding the shelf life of the above items without a manufacturer's expiration date. The DM confirmed that there was no policy that provided this guidance.

Without a system for monitoring the shelf life of products, there was a potential that foods served to patients would not be wholesome or safe. Also foods and nutritional supplements stored past their expiration date have the potential to be served to patients and cause food borne illness.

B. Nutrition Care of the Patients:

1. A review of the medical record for Patient #1 revealed that the patient was admitted to the hospital on 4/22/12 with diagnoses that included malnutrition, alcohol dependence, swelling of the feet and low potassium level. A review of the Nutritional Screening on the Admission Data Base dated 4/22/12 revealed that the patient denied any problems. No referral was made to the RD at that time.

Further review of the medical record revealed that on 4/23/12, the Registered Dietitian (RD) was consulted. The Initial Nutrition Assessment dated 4/23/12 was signed by the DM and timed 11:55 AM. There was no RD signature on the assessment. There was no diagnosis or pertinent medical history for the patient on the form. The form was faxed to the RD without the information; the RD completed the assessment without all the information and faxed it back to the hospital on 4/25/12.

During an interview with the DM, on 4/24/12 at 10:40 AM, she stated that she filled out information on the form that she obtained from the patient's medical record including the patient's height and weight, laboratory data, diet order percent meal intake and an interview of the patient regarding appetite and food preferences. She stated that she faxed this information to the RD who completed the rest of the form and faxed it back. The RD didn't call to request additional information. She verified that the RD did not sign, date or time the assessment. She also verified that the form did not have a diagnosis or pertinent medical history of the patient on the form.

During a phone interview with the RD on 4/24/12 at 2:30 PM, she verified that when she completed the nutrition assessment she didn't have the patient's diagnosis or his pertinent medical history. She further stated that she should have signed, dated and timed the assessment. She stated that if she had known the pertinent medical history and current medical problems, she would have recommended a salt restricted diet.

Based on the RD recommendations from the assessment, a physician order for a nutritional supplement 3 times a day dated 4/24/12 was noted. A second nutritional consult was ordered on 4/25/12. A review of the nutrition assessment dated 4/26/12 showed that the patient's diet order was listed as Regular. The diet order on the assessment did not show that the supplements had been ordered. It also listed the patient's weight as 109.4 pounds when the nursing notes indicated that the patient's weight on 4/25 /12 was 105 pounds and indicated a 4 pound weight loss since the patient was admitted. The information was faxed to the RD. The RD completed her assessment and faxed it back to the hospital. The estimated protein needs for the patient were errantly documented as "1.5 grams" instead of 75 grams. The RD recommendations were noted to be "(nutritional) supplement TID (3 times a day)". She was not aware that a nutritional supplement was already ordered 3 times a day because the information provided to her was not complete.

During an interview with RN B on 4/26/12 at 1:15 PM, she stated that patient was refusing to drink the supplements. She further stated that the patient was having diarrhea the previous few days, but was better today. Also, the patient's ammonia level had been elevated (elevated blood ammonia level occurs when the kidneys or liver are not optimally working, allowing waste to remain in the bloodstream). She verified that none of this information was communicated to the RD in order for her to complete a comprehensive nutrition assessment.

A review of the hospital's policy titled, "Nutritional Assessment of the Patients by the Clinical Dietitian" dated 11/11 revealed that the purpose of the policy was to evaluate the nutritional needs of individuals based upon appropriate biochemical (lab work), anthropometric (height, weight, etc), physical and dietary data. It further stated the purpose was to monitor and document the progress and effectiveness of nutrition interventions. Nutrition assessment may include the diagnosis, diet order and weight. It further stated that the nutritional assessment was a collaborative process involving information obtained from all members of the healthcare team to assure a comprehensive assessment.

During an interview with the DM on 4/26/12 at 2:30 PM, she stated that she collected the information provided to the RD. She further stated that she was not aware of all the information that should have been given the RD in order for her to make a comprehensive nutrition assessment.

2. A review of the medical record for Patient #5 revealed that the patient was admitted to the hospital on 3/15/12 with diagnoses that included throat cancer and cellulitis to the face. Cellulitis is an inflammation or infection of the tissue. The patient was dependent on a feeding tube for his nutrition. During the 4 day hospital stay, the patient was fed by the tube and was unable to eat by mouth. A review of the Nutritional Screening on the Admission Data Base (nursing initial assessment) dated 3/15/12 revealed that a dietitian referral was not made. The form indicated that if a patient was on a tube feeding, a referral to the RD was supposed to be made for further assessment. Also the patient was 5 foot 6 inches tall and weighed 123 pounds (less than 90% of his ideal body weight). There was no nutrition assessment of Patient #5 in the medical record to determine if the tube feeding ordered met the nutrition needs of the patient.

During an interview with the Nursing Supervisor (NS) on 4/25/12 at 2:40 PM, she confirmed the finding and stated that a referral should have been made to the RD for a nutrition assessment.

A review of the medial record for Patient #3 revealed that the patient was admitted to the hospital on 4/16/12 with diagnoses that included a large abdominal open wound from a recent abdominal surgery, and cellulitis. A review of the Nutritional Screening on the Admission Data Base revealed that a dietitian referral was not made. The form indicated that if a patient had a wound, a referral to the RD was supposed to be made for further assessment. There was no RD referral and no nutrition assessment to ensure the nutrition plan met the increased needs that the patient required for healing.

During an interview with the NS on 4/25/12 at 5:20 PM, she stated that a referral to the RD should have been made for a nutrition assessment. She stated that patients with wounds have greater nutrition needs to aid with healing. These needs were not assessed during the patient's hospital stay to ensure they were being met.

A review of the medical record for Patient #2 revealed that the patient was admitted to the hospital on 2/3/12 with diagnoses that included a gastrointestinal bleed, cirrhosis (scarring) of the liver, anemia and complaints of vomiting blood (moderate to severe). A review of the physician orders showed that a clear liquid diet was ordered on 2/3/12. The patient's diet was not advanced to full liquids until 2/7/12, four days later. A clear liquid diet provides minimal nutrition content. A review of the Nutritional Screening on the Nursing Admission Data Base dated 2/3/12 revealed that a dietitian referral was not made. The patient's height was documented as 5 feet 4 inches and weight was 109.8 pounds, less than 85% of his ideal body weight. No referral was made to the RD during the patient's hospital stay. No nutrition assessment of Patient #2 was completed.

During an interview with the DM on 4/24/12 at 4:30 PM, she verified that the patient was on a clear liquid diet greater than 3 days and no referrals was made to the RD for nutrition assessment.

A review of the hospital's policy titled, "Nutritional Screening/Monitoring" dated 11/11, revealed that there was to be an initial screen of each patient's nutritional status to determine the nutritional risk and need for nutritional care monitoring. It further stated that in addition to the initial Nutrition Screening (done by nursing), the Registered Dietitian would monitor all admit diagnosis and diet orders from the daily census to identify those in need for nutrition assessment. High risk patients would be assessed within 2 calendar days of identification. Indicators of high nutrition risk included clear liquid diet greater than or equal to 3 consecutive days, tube fed patients and patients with wounds. It further stated that the procedure when a Clinical Dietitian was unavailable: "Food and Nutrition personnel will monitor the Daily Census for high risk indicators and make a referral to the on-call Dietitian. The on-call Dietitian will respond as indicated. NOTE: On-call Registered Dietitian will be notified of patients who are NPO (nothing by mouth) or on clear liquids 3 consecutive days."

During a phone interview with the RD on 4/24/12 at 2:30 PM, she stated that she had not done any nutrition assessments of the patients at the hospital since the first of December, 2011. She stated that she was aware that the hospital did not utilize another dietitian besides herself. She was unable to explain why she hadn't contacted the hospital to inquire why she was not receiving referrals. She stated that the contract for her services with the hospital was on an as needed basis only.

During an interview with the DM on 4/24/12 at 2:50 PM, she stated that she did not call the dietitian like she should have. The DM stated that she should have called the RD to refer patients to her but this was not done.

A review of the contract between the hospital and the Consulting Dietitian service, dated 8/24/11, revealed that the Consulting Dietitian service agreed to provide services and materials to the hospital as specifically requested at the request of the Facility. All contracted services were to be done at the request of the facility.

The DM and Nursing did not request the services of the Consultant Dietitian services from 11/30/11 until 4/24/12 when the surveyors were in the building reviewing the nutrition care of the patients.

3. During an observation and concurrent interview with RN A on 4/24/12 at 10:30 AM, she stated that Patient #1 was drinking a Boost Plus (a liquid nutritional supplement) that he received on his breakfast tray. When asked to observe the supplement, it was noted that the expiration date on the supplement was 4/13/12, 11 days earlier. RN A stated she didn't notice the expiration date when she gave the patient his breakfast tray. The supplement was about half gone when the date was noted.

A review of Patient #1's medical record revealed that there was no physician order for the nutritional supplement, only a recommendation from the RD.

RN A stated that she didn't know that nutritional supplement required a physician order. She stated that the usual practice at the hospital was to follow the RD recommendations, whether or not there was an order from the physician.

During an interview with the DM on 4/24/12 at 10:40 AM, she verified that the expiration date for the Boost Plus was noted the previous day during the initial tour of the kitchen with the surveyor. She was unable to explain why the expired product had not been discarded and was served to the patient. She further confirmed that it was the usual practice at the hospital to send nutritional supplements to patients without a physician order.

A review of Patient #5's medical record revealed that the patient was on a tube feeding (artificial feeding through a tube). The nursing flowsheet dated 3/17/12 revealed that the patient was given "1 can of Prune juice given via tube". A review of the physician orders revealed that there was no order for prune juice for Patient 5.

During an interview with the NS on 4/25/12 at 3:13 PM, she verified that the nursing flowsheet indicated that the patient was given prune juice via the feeding tube. She further verified that there was no physician order for the prune juice. She stated that the prune juice should not have been given without an order.

Therapeutic diets must be prescribed by the practitioner responsible for the care of the patient. Nutritional supplements were used for therapeutic interventions and were therefore considered a component of a therapeutic diet. Providing a patient with a supplement or a tube fed patient with prune juice without the physician's knowledge or consent may jeopardize the overall medical care of the patient.

4. During an interview with the DM on 4/23/12 at 2:55 PM, she stated that the hospital utilized the American Dietetic Association's Nutrition Care Manual (ADA NCM) as their diet manual. She stated that this manual was available to all medical, nursing and dietary staff on the computer system. She also stated that the RD placed an electronic copy of the 2010 Idaho Diet Manual on the computer in the DM office and stated that this was the hospital's diet manual. It was not available to the nursing or medical staff.

A review of the hospital's policy titled, "Diet Manual" dated 11/30/11, revealed that "The approved diet manual is the 2010 Idaho Diet Manual." It further stated that the diet manual was reviewed annually by the Clinical Dietitian and approved every three years by a Clinical Dietitian, Director of Food and Nutrition Services, Chief Executive Officer and the Executive Committee of the Medical Staff. The last page of the policy included a signature page signed by only the RD and the DM and dated 11/30/11. It was not signed by the Chief Executive Officer and the Executive Committee of the Medical Staff as evidenced that it had been approved.

During a concurrent document review and interview with the DM, she produced an "Institutional Approval Form" for the ADA NCM approved for use in the hospital. The form was signed by the Chief of the Medical Staff on 6/2/11 and the Hospital Board Representative on 7/7/11. She stated that the document was the approval form for use of the ADA NCM as the hospital's diet manual. She verified that the form was not signed by the RD. She stated that when the RD was last at the hospital on 11/30/11, she loaded an electronic version of the Idaho Diet Manual on the DM's computer, but not on the hospital's computer system.

Further review of the online ADA NCM revealed a general manual that was not specific to the diets that the hospital routinely provides. The ADA NCM provided patient education material, but did not provide guidance to the medical, nursing and dietary staff regarding the hospital specific diets or define the hospital's diets. One patient at the hospital had a physician order for a low protein diet (Patient #6) and the ADA NCM did not provide guidance or define this diet order.

The purpose of a hospital diet manual was to be consistently used as a guide for ordering and preparing patient diets. It should have included the different types of therapeutic diets and the definitions of those diets that were routinely ordered at the hospital. The diet manual should also be approved by the RD, medical staff and the governing body. Neither of the manuals used at the facility had the required approvals.

5. During an interview with the DM on 4/24/12 at 10:40 AM, she stated that she was not aware of any nutrition analysis of the hospital's menus.

During a phone interview with the RD on 4/24/12 at 2:30 PM, she stated that she also was not aware of a nutrition analysis of the hospital's menus. The RD stated she had approved the hospital menus. She stated that she evaluated the menus to be sure they were "ok" for calories, protein, carbohydrates and Vitamin C. She did not evaluate the menus to determine if they met the Recommended Daily Allowances (RDAs) or the Dietary Reference Intakes (DRI's) for other vitamin and minerals or fiber when she approved them.

Recognized dietary practices include ensuring the menus follow current national standards for recommended dietary allowances such as the current RDAs or the DRIs of the Food and Nutrition Board of the National Research Council. This was not done.

C. Performance Improvement

During an interview with the DM on 4/26/12 at 1:45 PM, she stated that the performance improvement plan for her department did not include monitoring any of the deficient practices noted during the survey. She stated that the department was monitoring patient satisfaction with the meals and was also monitoring the completeness of the department's temperature logs. She was unable to explain why the deficient practice found during the survey were not brought to the Quality Committee and included in the plan for remediation of the problems.

Based on observation, interview and reference review, the facility failed to ensure that a licensed physician shall be physically present within the facility and immediately available where the CT scan with contrast procedures are performed, in order to provide immediate medical intervention to prevent or mitigate injury to the patient in the event of an adverse reaction or anaphylactic shock.

The inability to immediately provide medical interventions to the patient had the potential to cause serious harm or death.

Findings:

On 4/25/12 at 9 AM, a tour of the Radiology Department was conducted to verify that the department maintains, or has available, organized radiology services that meets the needs of the patients in accordance with accepted standards of practice and available at all times to meet the patients needs.

Continued observation tour of the department and interview with the Department Head revealed that there was a CT scan room with an non-functioning CT scan machine however there was a rental CTscan mobile unit outside of the building.

During a concurrent interview the Department Head was asked, "Who administers the contrast?", she stated that, "The Rad Tech (Radiologic Technologist) does it".

The Department Head was asked, "Beside the Rad Tech and the patient, who else is in the mobile unit?" She stated, "No one else. When the patient is critical, the patient is accompanied by an RN and a Respiratory Therapist".

Observation of the CT scan mobile unit revealed it was located approximately 10-15 ft from the nearest door to the building. There were approximately 5 iron steps leading up to the door of the mobile CT unit. This door was narrow and was not used for patient entry into the mobile CT unit. There was another wider door for the patient's passage into the mobile unit which was accessible by a manually operated lift.

Inside the mobile unit is a CT scan table, crash cart, monitor/defibrillator, suction machine (it was not set-up and ready for use, accessories were in the bag), Ambu bags and an oxygen tank. The telephone was within reach on the other side of the CT scan table.

At approximately 2:30 PM a second look of the mobile unit with another surveyor was made accompanied by the Lead Radiology Tech and the Maintenance Supervisor.

The Lead Tech was asked how she would handle an emergency by herself in the event of an adverse reaction of the patient to the contrast media, she stated, she would call the emergency room for help. The Lead Tech was then asked, "What will you do in case of power outage or when no one immediately picks up the phone?", she stated, she would use the radio.

The Maintenance Supervisor was asked if there was a provision for the Rad Tech to have a radio in the mobile unit. The Maintenance Supervisor stated, "No, it's a good idea for them to have one." The Maintenance Supervisor was asked how far was the Emergency room from the mobile unit. He stated that it was in the middle of the building, about 200 feet."

The Lead Tech was asked, how comfortable she was doing the CT scan with IV contrast injection by herself, she answered that she had been doing the CT scan with IV contrast injection for four years and that there were no adverse reaction to contrast media. The Rad Tech, explained that the test dose was introduced first for observation, if an allergic reaction like itchiness, hives or difficulty of breathing occurred during an examination, the examination would be stopped immediately.

The Lead Tech was asked if she knew how to use the life support equipment, if she had to initiate cardiopulmonary resuscitation (CPR) while waiting for help, her answer was "No".

According to the American College of Radiology Practice Guideline for the use of Intravascular Contrast Media (Revised 2007) 111. The healthcare professional performing the injection may be a certified and/or licensed radiologic technologist, nurse, physician assistant, physician, or other appropriately credentialed healthcare professional under the direct supervision of a radiologist or his or her physician designee if the practice is in compliance with institutional or state regulations. Training and proficiency in cardiopulmonary resuscitation are recommended for those who attend to patients undergoing contrast- enhanced examinations.

Direct supervision means that the physician must be present and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room where the procedure is performed.

The California Health and Safety Code, section 106985 states:

"(a) Notwithstanding Section 2052 of the Business and Professions Code or any other provision of law, a radiologic technologist certified pursuant to the Radiologic Technology Act (Section 27) may, under the general supervision of a licensed physician and surgeon, perform venipuncture in an upper extremity to administer contrast materials, manually or by utilizing a mechanical injector, if the radiologic technologist has been issued a certificate, as described in subdivision (b)....

(c) "General supervision," for purposes of this section, means the direction of
procedures authorized by this section by a licensed physician and surgeon who shall be physically present within the facility and available within the facility where the procedures are performed, in order to provide immediate medical intervention to prevent or mitigate injury to the patient in the event of adverse reaction."

On 4/25/12 at 6:20 PM, an Immediate Jeopardy was called in the presence of the facility administrator and administrative staff due to the following:

(a) The facility's inability to provide immediate medical intervention or establish and secure airway to the patient in the event of adverse reaction to the intravascular contrast media injection.

(b) Radiological technicians were administering IV contrast during ordered CT scans without documentation of the procedure in the patients medical record.

(c) There was no system in place for staff to communicate needs by telephone in the event of an emergency power outage.

(d) The Maintenance Supervisor (MS) did not have access to the back-up 12 V (volt) battery that services the mobile CT unit and there were no recorded testings that had been performed on the backup battery.

Failure to provide prompt medical attention to the patient had the potential to contribute to serious patient harm.

On 4/26/12 at 12:10 PM, the Immediate Jeopardy was lifted after receiving an acceptable plan of correction by the facility, which included:

(a) As of 7:15 PM on April 25, 2012, Colorado River Medical Center suspended all CT services until the hospital can fully comply with state regulations for patient safety. The Physician's, the Emergency and Radiology Departments and Neighboring hospitals were notified as well as local ALS and BLS providers at 7:40 PM, April 25, 2012.

(b) Patients will temporarily be deferred to other out of state facilities to which Colorado River Medical Center has a transfer agreement.

The IJ was abated on 4/26/12 at 12:10 PM after an acceptable plan of correction was accepted by the survey team. The facility's plan of correction was validated by the surveyors prior to abatement of the IJ.

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

1. Ensure that for 1 of 13 sampled patients (Patient 26), nursing services supervised and evaluated the nursing care delivered. This failure contributed in Patient 26 not having his infected surgical abdominal wound that reopened continually assessed, measured, photographed and evaluated for progression or deterioration of the wound throughout his 7 day hospital stay.

2. Ensure that a Registered Nurse (RN) supervised and evaluated the nursing care for patients who presented to the facility's mobile CT unit for CT scans with and without contrast administered by a Radiology Technician without a physician available in the mobile unit to provide immediate medical intervention in the event of an adverse reaction. This failure had the potential for the patient to experience an adverse reaction to IV contrast without RN supervision to assess, evaluate, and implement appropriate emergency procedures such as ACLS (Advanced Cardiac Life Support) in the event of an emergency.

3. Ensure that an RN evaluated the behaviors for 1 of 13 sampled patients (Patient 25) prior to the administration of a medication (Ativan) ordered for agitation. This failure resulted in Patient 25 receiving Ativan for agitation without documentation by the RN of the patients behaviors that warranted administration of the medication.

Findings:

1. Patient 26 was admitted to the facility on 4/16/12 at 5:45 PM with a diagnosis of wound infection with partial dehiscence (wound dehiscence: a surgical complication in which a wound breaks open along the surgical suture). Patient 26 was discharged from the facility on 4/23/12, 7 days later.

Record review of the facility's policy and procedure titled, Wound Care Management dated 11/10 revealed the following in the Procedure section:

"1. Upon admission a Registered Nurse will assess the skin condition of all patients and with the intent to identify at risk patients.

2. Documentation is accomplished via completion of the assessment tool and nursing notes and care plan.

4. All patients will be observed by nursing staff and skin assessed no less than daily and preventive measures will be implemented."

Photo Documentation:

"1. Photograph existing wounds on discovery and discharge or changes noted. Photograph are to contain measurement, time and date."

Documentation:

"4. Document in Care Plan."

Assessment: Wound assessment will be performed with every dressing change. The assessment of the wound will include: location, shape, size (measure in cm, length, width, surface area and depth), describe edges, general appearance (color), characteristics of drainage, and the absence or presence of pain in wound and surrounding tissues.

Record review of the Emergency Department (ED) Primary Nursing Assessment, dated 4/16/12 in the Musculoskeletal section revealed the following documentation: Location: "abdomen", Size: "suture line vertical ABD" (ABD: abdomen).

Record review of the Emergency Physician Record, dated 4/16/12 revealed the following documentation by Physician A in the Progress section: "Pt (patient) presents with large amount of purulent drainage from midline wound in mid portion. ... and then 1% Lidocaine instilled in wound and wound opened. Pus approx 16 oz (ounces) drained and wound packed with 4 X 4's (gauze). Admit for care." The diagram of the body showed no documentation of the wound location, it was blank. There were no measurements of the wound documented on this form.

The Clinical Impression section located at the bottom of this same form revealed documentation of a partial dehiscence with large deep wound abscess.

Record review of the ED Ongoing Nursing Assessment, dated 4/16/12, in the section titled, Nursing Diagnosis which showed a preprinted note to number in order of priority revealed the following:

X Comfort, Alteration in.
X Infection, Potential
Skin Integrity Impairment

There was an X documented next to 2 of 20 preprinted diagnoses. Skin Integrity Impairment was not checked. The two checked boxes were not numbered according to priority as indicated on the form.

In the Goal section of this same form (ED Ongoing Nursing Assessment) revealed a check next to Pain Control and Infection Control. The box next to Maintain skin/tissue integrity was not noted to be checked.

Record review of the Admission Data Base dated 4/16/12 at 7 PM and documented by RN 1 revealed a diagram of the front and back sides of an adult body. There were instructions to indicate the location and size of the skin integrity breakdown, however this section was not completed by RN 1.

A review of the photograph of Patient 26's abdominal wound revealed an open wound, dated 4/17/12. There is no time or measurements recorded on the photograph per facility policy.

Record review of the Wound Care Flow Sheet for Patient 26 that was lacking a date on page 2 of 2 revealed a box checked next to surgical wound, surgery date 3/22/12. In the box below, titled wound location revealed documentation to "see pictures in chart".

Record review of the Wound Care Flow Sheet for Patient 26 on page 3 of 3 revealed that pictures were obtained on 4/17/12.

The following 3 entries were documented on the grid located at the bottom of page 3 of 3 of the Wound Care Flow Sheet and gave these descriptions of Patient 26's wound:

a. 4/17/12 at 9:30 AM, surgical wound, midline upper abdomen. The diameter, depth and drainage had a line through the box and documentation to change dressing wet to dry daily and PRN (as needed). There were no documented measurements of the wound.

b. 4/17/12 at 8 PM, surgical wound, midline upper abdomen, and documentation to change dressing wet to dry. The diameter, depth and drainage had zeroes in the three boxes. There were no documented measurements of the wound.

c. 4/18/12 at 8 AM, midline abdomen, dressing D/I (dry and intact). The diameter and depth had a line through the two boxes and drainage had a zero documented in the box. Also there was documentation to change dressing daily and PRN. Patient to go to OR (operating room) today. There were no documented measurements of the wound.

2. During an interview on 4/25/12 at 9 AM, the Department Head (DH) was asked, "Who administers the contrast?", she stated that, "The Rad Tech (Radiologic Technologist) does it." The DH was asked, "Besides the Rad Tech and the patient, who else is in the mobile unit?", she stated, "no one else. When the patient is critical, the patient is accompanied by an RN and a Respiratory Therapist (RT)."

At approximately 2:30 PM on 4/25/12, a second look of the mobile unit with another surveyor was made accompanied by the Lead Radiology Technologist (LRT) and the Maintenance Supervisor (MS).

At this time, the LRT was asked how she would handle an emergency by herself in the event of an adverse reaction of the patient to the contrast media. She stated that she would call the emergency room for help. "What will you do in case of power outage or when no one immediately picks up the phone?" She stated, she would use the radio.

The MS, who was also present during this interview, was asked if there was a provision for Rad Techs to have a radio in the mobile unit. The MS stated, "No, it's a good idea for them to have one." The MS was asked how far was the Emergency Room (ER) from the mobile CT unit, he stated that the ER was in the middle of the building, about 200 feet."

The LRT was asked, how comfortable was she performing CT scans with IV contrast injection by herself. She answered, that she had been doing the CT scans with IV contrast injection for four years and there have been no adverse reaction to the contrast media. The LRT, explained that the test dose was introduced first for observation, if an allergic reaction like itchiness, hives or difficulty of breathing occurred during an examination, the examination would be stopped immediately.

The LRT was asked if she knew how to use the life support equipment, if she had to initiate cardiopulmonary resuscitation while waiting for help. Her answer was "No".

According to the American College of Radiology Practice Guideline for the use of Intravascular Contrast Media (Revised 2007) 111. "The healthcare professional performing the injection maybe a certified and/or licensed radiologic technologist, nurse, physician assistant, physician, or other appropriately credentialed healthcare professional under the direct supervision of a radiologist or his or her physician designee if the practice is in compliance with institutional or state regulations. Training and proficiency in cardiopulmonary resuscitation are recommended for those who attend to patients undergoing contrast- enhanced examinations.

During an interview on 4/25/12 at 3:18 PM, the Lead Radiology Technician (LRT) stated that some technicians are with the patient alone in the mobile CT unit unless they come on a stretcher, then there would be two staff present. The LRT stated that once the patient arrives, the ordered procedure is performed, the table and equipment are cleaned, and the patient is transported back inside the facility.

As the interview continued, the LRT stated that they did not document progress notes on how the patient arrived to the unit (by ambulation, wheelchair, gurney, etc.), if the patient was alert, oriented or confused upon arrival, how the patient tolerated the procedure and if there was any reaction to the contrast for patients with IV (intravenous) contrast ordered with their CT scan. The LRT stated that the only documentation done on the patients receiving ordered CT scans was if they had an adverse reaction, and if that occurred, an Adverse Event Form would be completed.

During an interview on 4/25/12 at 3:25 PM, Radiology Technician 1 (RT 1) stated that she performs CT scans with and without contrast media alone on patients. RT 1 stated that the RN's will usually accompany patients with serious illnesses. RT 1 further stated that she only documented the procedure if there was an adverse event and added that she did not normally document the patients presentation to the mobile unit or how they tolerated the procedure and/or the IV contrast if it was ordered.

A review of the facility's Position Description for the Radiology Technician (RT) revealed the following:

"Position Summary: ... verifies doctors orders and patient ID when performing procedures; checks for allergies to iodine/contrast media when performing contrast studies; ..."

"Service: Critical Competency: Initiates, administers, monitors and documents oral and /or IV contrast in compliance with established policy and procedures."

Record review of the facility's Assessment and Reassessment of Patients Policy, dated 1/12 revealed the following under the Policy section:

"D. A registered nurse shall assess the patient's need for nursing care in all setting where nursing care is provided."

Review of this same policy, in the Procedure section revealed the following:

"2. Reassessment:
a. The patient will be reassessed:
i. To determine response to treatment/procedures.

b. Documentation of the reassessment will be located on unit specific documentation forms.

c. Reassessments are completed by RN's. ... Additionally, information for reassessment will be gathered from patients, families, other healthcare professionals and physician input."




26500

3. On 4/23/12, a review of Patient 25's medical record was conducted.

The patient was admitted to the facility on 4/22/12 with diagnoses that included alcohol abuse.

A review of the admitting Physicians' Orders, dated 4/22/12, was conducted and revealed an order for Ativan (antianxiety medication) 1 milligrams (mg) intravenous push (IVP) every 3 hours for agitation (a state of excessive psychomotor activity accompanied by increased tension and irritability).

A review of the nursing notes dated 4/22/12 at 6 PM, was conducted and revealed that patient received Ativan 1 mg IVP for increasing anxiety. There was no evaluation of the patient's behaviors prior to the administration of the medication for agitation. There were no documented interventions prior to the administration of the Ativan.

A review of the Nursing Notes dated 4/22/12 was conducted and revealed that patient received Ativan 1 mg IVP at 11:25 PM for agitation. There was no evaluation of the patient's behaviors prior to the administration of the medication for agitation. There were no documented interventions prior to the administration of the Ativan.

A review of the Nursing Notes dated 4/23/12 was conducted and revealed that patient received Ativan 1 mg IVP at 6:25 AM for increasing agitation. There was no evaluation of the patient's behaviors prior to the administration of the medication for agitation. There were no documented interventions prior to the administration of the Ativan.

On 4/23/12 at 3:20 PM, an interview and record review was conducted with RN 7. She confirmed that the physician's order showed that the Ativan 1 mg IVP was for the patient's agitation. RN 7 confirmed that the patient's behaviors that warranted the administration of Ativan for agitation were not documented on 4/22/12 at 6 PM and 11:25 PM or on 4/23/12 at 6:25 AM, prior to the administration of Ativan that was ordered for agitation. RN 7 stated the patient's behaviors should have been documented prior to the administration of the medication

Based on interview and record review, the facility failed to ensure that the Dictated Discharge Summary (DDS) for 1 of 13 sampled patients (Patient 30) contained complete information regarding the assessment of the patient's health status. This failure contributed in an inaccurate representation of the patient's health status.

Findings:

Record review revealed that Patient 30 was admitted to the facility on 2/23/12 and discharged on 2/28/12 with diagnoses that included respiratory distress (trouble breathing) and possible laryngeal stenosis (a narrowing of the airway).

A record review on 4/24/12 of the DDS for Patient 30 showed a discharge date of 2/28/12. The following information was incomplete upon record review, 56 days after discharge:

"Admitting Diagnoses ...2. Leuko [______]".
"Discharge Diagnoses ...3. Systemic leuko [______]".

Record review of the facility's policy and procedure titled, "Discharge Summary", last reviewed 1/12, revealed the following:

"All relevant diagnoses established by the time of discharge, as well as all operative procedures performed are recorded, ..."

"The Discharge Summary will concisely recapitulate the reason for hospitalization, the significant findings, ..., the condition of the patient on discharge, ...".

During an interview on 4/26/12 at 6:12 PM, RN 2 who was also the House Supervisor confirmed that the DDS was not completed for accuracy.

Based on interview and record review, the facility failed to ensure that Radiological Technicians (RT) performing ordered CT scans with and without IV (intravenous) contrast on patients documented the course of the procedure (e.g. how the patient presented to the mobile CT unit, whether by wheelchair, gurney or ambulation. Whether the patient was alert, oriented, confused, how the patient tolerated the procedure, and in cases where IV contrast was administered, if there were any adverse reactions) for a universe of 3 patients.

This failure contributed in necessary information not being included in the patient's medical record so that other health care staff involved in the patients care can have access to information necessary to monitor the patient's condition and provide appropriate care.

Findings:

An observation was made to the mobile CT unit on 4/25/12 at 3:10 PM.

During an interview on 4/25/12 at 3:18 PM, the Lead Radiology Technician (LRT) stated that some technicians are with the patient alone in the mobile CT unit unless they come on a stretcher, then there would be two staff present. The LRT stated that once the patient arrives, the ordered procedure is performed, the table and equipment are cleaned, and the patient is transported back inside the facility.

As the interview continued, the LRT stated that they do not document progress notes on how the patient arrived to the unit (by ambulation, wheelchair, gurney, etc.), if the patient was alert, oriented or confused upon arrival, how the patient tolerated the procedure and if there was any reaction to the contrast for patients with IV (intravenous) contrast ordered with their CT scan. The LRT stated that the only documentation done on the patients receiving ordered CT scans was if they had an adverse reaction, and if that occurred, an Adverse Event Form would be completed.

During an interview on 4/25/12 at 3:25 PM, Radiology Technician 1 (RT 1) stated that she performs CT scans with and without contrast alone on patients. RT 1 stated that the RN's will usually accompany patients with more serious illnesses. RT 1 further stated that she only documented the procedure if there was an adverse event and added that she did not normally document the patients presentation to the mobile unit or how they tolerated the procedure and/or the IV contrast if it was ordered.

A review of the facility's Position Description for the Radiology Technician (RT) revealed the following:

"Position Summary: ... verifies doctors orders and patient ID when performing procedures; checks for allergies to iodine/contrast media when performing contrast studies; ..."

"Service: Critical Competency: Initiates, administers, monitors and documents oral and /or IV contrast in compliance with established policy and procedures."

Based on interview and record review, the facility failed to ensure that medical record entries were timed and authenticated (verified) after the transcription by the physician for validity of content for 3 of 13 sampled patients, (Patients 26, 30 and 31). This failure had the potential to contribute in the inability to establish when an order was given, and by which practitioner. This serves as a baseline for future actions or assessments which is necessary to ensure patient safety and overall quality of care.

Findings:

1. Patient 26 was admitted to the facility on 4/16/12 at 5:45 PM with a diagnosis of wound infection with partial dehiscence. Patient 26 was discharged from the facility on 4/23/12.

Record review revealed the following medical record entries/photos that did not have a documented time:

a. Surgery Note documented on the Progress Notes, dated 4/17/12, and did not have a documented time.
b. A photo of an open abdominal wound, dated 4/17/12 with no documented time or measurements of the wound.
c. Post Op (Operative) Orders documented on the Physician's Orders Sheet, dated 4/18/12.

The following Physician's Orders Sheets did not have a time of entry:

4/16/12: " Consult .../Physician A for wound dehiscence (opening) " .
4/17/12: " Hold NPO (nothing by mouth) after breakfast tomorrow, ... "
4/20/12: " 1. DC (discontinue) Flagyl, ... "
4/21/12: " Slow IV (intravenous fluid) to 75 cc (cubic centimeters) per hour, ... " .

Record review revealed the following dictated report lacking a time of transcription and no evidence that the report was authenticated after transcription:

a. Discharge Summary for admission occurring on 4/16/12 through discharge on 4/23/12.

2. Record review revealed that Patient 30 was admitted to the facility on 2/23/12 and discharged on 2/28/12 with diagnoses that included respiratory distress (trouble breathing) and possible laryngeal stenosis (a narrowing of the airway).

Record review revealed the following medical record entries that did not have a documented time made by the physician:

a. Emergency Physician Record, dated 2/23/12.
b. Post Op (Operative) Orders, dated 2/27/12.

Record review revealed the following dictated report did not have a time of transcription and there was no evidence that the report was authenticated after transcription:

a. Operative Note: for a Laryngoscopy, tracheoscopy and bronchoscopy performed on 2/27/12.

During an interview on 4/25/12 at 5:52 PM, RN 2 who was also the House Supervisor confirmed the above findings did not have a medical entry time or a transcription time for the dictated reports for Patients 26 and 30.



26500

3. On 4/24/12, a review of Patient 31's medical record was conducted.

Patient 31 was admitted on 2/3/12 with diagnoses that included gastrointestinal bleed and anemia. The patient was discharged home on 2/10/12.

A review of the patient's discharge summary was conducted and revealed that the discharge summary did not include a dictation date and time and/or a transcription date and time. In addition, the physician's signature was not dated.

On 4/25/12 at 2:50 PM, an interview and a review of the discharge summary was conducted with the Director of Medical Records (DMR). She acknowledged and confirmed that the patient's discharge summary did not include the dictated date and time and/or a transcription date and time. The DMR stated that the discharge summary should have included the dictated date and time, as well as the transcribed date and time. She also confirmed that the physician signature was not dated. The DMR stated that the physician's signature should have been dated.

Based on observation and interview, the hospital failed to ensure that the outside medical records storage units provided safeguards against destruction (such as fire). This failure created the potential for all patient records stored in the outside units to be destroyed in the event of a fire.

Findings:

On 4/25/12 at 3:40 PM, a tour of the outside medical record storage was conducted with medical records clerk (MRC) 1. There were three large metal units located outside the facility. The units were locked. Upon entry of each unit, it was noted that they did not contain fire extinguishers and/or fire sprinkler system. MRC 1 confirmed the finding. The units had medical records dating back to 2005.

During an interview with MRC 1 on 4/25/12 at 3:55 PM, she confirmed that the hospital retained patient medical records in the units for approximately six years.

On 4/25/12 at 4 PM, after the tour of the outside medical records storage was conducted, an interview was conducted with the Director of Medical Records (DMR). The DMR stated that she was aware that the units did not contain a fire sprinkler system.

On 4/26/12 at 12 PM, an interview was conducted with Maintenance Supervisor. He acknowledged and confirmed that the units did not contain fire extinguishers and/or a fire sprinkler system. He also confirmed that the medical records would be destroyed in the event of a fire.

Based on observation, interview and policy review, the facility failed to implement written policies on:

a) Warming of fluids
b) Temperature and humidity of the operating room (OR)
c) Handling of specimens

Findings:

An initial visit to the operating room was conducted on 4/23/12 at 11:15 AM with the House Supervisor (HS) and the surgeon. The following were observed:

a). During a tour of Operating Room (OR) #2, the liquid warmer was observed to have 7 bags of one liter Lactated Ringers Solution (LRS- is a liquid solution of electrolytes. Electrolytes such
as sodium occur naturally in body fluids and help muscles and nerves function. Sodium is a major mineral that the body needs to maintain fluid balance and blood pressure) stored in it. The bags of LRS were warm to touch. The temperature on the warmer dial read 109 degrees Fahrenheit. A note posted on the warmer stated to keep the temperature between 94 to 110 degrees Fahrenheit.

The HS at the time of the observation tour was not sure how long the bags of LRS were in the warmer. She stated, "Those were prepared for the surgery last week but it was cancelled, the staff did not have the chance to put them away."

On 4/23/12, the facility's written policy on warming of fluids dated 11/11 was reviewed and read in part, "Purpose: To provide properly and safely warmed IV (Intravascular) and irrigation fluids the following guidelines are established: ... 4. Fluids will be stocked as needed. 5. Bags need to be dated when put in the warmer. A sticker with the date on it will be placed on the IV bags and bottles of irrigation. Fluids will be discarded after 2 weeks of being in the warmer."

There was no sticker on the 7 LRS bags to indicate when the bags were placed in the warmer.

b). During a review of the OR climate logs for April, the log showed no documentation of humidity readings on 4/18/12, 4/19/12, and 4/20/12, the dates that the facility was operating.

The facility policy, Temperature and Humidity Control in the OR (dated 2009) was reviewed on 4/23/12 and read in part, "All surgical procedures should be performed under the optimum conditions. The patient environment should reflect this goal. # 1. Room temperature should be between 68 to 72 degrees Fahrenheit. Humidity should be between 30 and 60% in accordance with AORN (Association of peri-Operative Registered Nurses) standards. # 5. Room temperature and humidity will be documented in log during normal business days, Monday through Friday".

During an interview with OR Tech on 4/24/12 at 9:30 AM, she confirmed that the temperature and humidity reading on 4/18/12, 4/19/12 and 4/20/12 were not documented.

The OR Tech was aware of the importance of maintaining the climate of the operating rooms within the temperature and humidity parameters required by national standards. She was aware that failure to control the OR climate per acceptable guidelines and the facility's own standards increased the risk of infection for patients using those rooms. She expressed her understanding that humidity and temperature are two factors that may contribute in the spread of infectious diseases amongst patients as well as a fire in the operating rooms.

c) A continued observation in the operating room included the process of handling the specimens. The specimen log book on the following dates: 2/23/12, 4/16/12, 4/18/12, 4/19/12, 12/15/11 and 9/15/11 revealed that there were no signatures of the designated Laboratory Department personnel who received the specimen.

On 9/15/11 four specimens were sent out to the Laboratory Department with no signature of the OR Staff sending the specimen and no signature of the Laboratory Staff who received the specimen that were documented.

On 9/16/11, the label was placed on the logbook but there was no documentation of the type of specimen that was sent to the Laboratory Department. There was no signature of the OR Staff sending the specimen and no signature of the Laboratory Staff who received the specimen that were documented.

The specimen logbook revealed the incomplete entry of information specified in the facility's Surgical Department Policy on handling specimens, revised 11/11.

On 4/24/12 at 4:30 PM, the House Supervisor and the OR Tech acknowledged the findings.

Based on interview and record review, the hospital failed to ensure that the Nursing policy and procedure that was developed to assist with facilitating and implementing decisions concerning the withholding or withdrawing of life sustaining treatment or resuscitation support was approved by the Governing Body (GB). This failure had the potential for all patients that presented to the hospital for services to not have their healthcare decisions honored.

Findings:

On 4/26/12 at 11 AM, during an interview with the CNO, a request was made to review the hospital's policy and procedure (P&P) regarding the implementation of physicians orders for DNR patients. The CNO submitted an untitled document and stated that it was the hospital's P&P that pertained to DNR physician orders, which she had obtained from hospital's Nursing Policy/Procedure Manual.

A review of the policy showed the following:

A revised date in 6/2010 and a reviewed date in 7/2011.

The Purpose: "To assist in facilitating and implementing decisions concerning the withholding or withdrawing of life sustaining treatment or resuscitation support."

The hospital's Policy included:

1). It is the policy of the (facility name, here) to initiate standard resuscitation measures on any patient found to be in a state of cardiac or respiratory arrest, Unless a "No Code" order has been written by a physician.

2). The (facility name, here) recognizes that patients have an inherent right to continue their medical treatment, including the right to refuse life sustaining procedures. Competent patients are the ultimate decision makers with regard to the matter of forgoing life sustaining measures.

5). This policy is intended to cover situations in which consideration is being given to withhold/withdraw life sustaining treatment in patient care. "Do Not Resuscitate" or "No Code" orders would be include as authorization to withhold life sustaining procedures...

On 4/26/12 at 4:10 PM, an interview and a review was conducted with the Medical Staff Coordinator (MSC). The MSC stated that the GB Committee Meetings were held monthly. She stated that all revised P&Ps were discussed and approved by the GB at these monthly meetings. She stated that the Nursing P&P manuals were reviewed annually by the GB and approved at that time. The MSC stated that all P&Ps should be approved by the GB prior to their implementation throughout the facility.

The MSC reviewed the policy that was retrieved from the hospital's Nursing Policy/Procedure Manual that noted: "To assist in facilitating and implementing decisions concerning the withholding or withdrawing of life sustaining treatment or resuscitation support. She acknowledged and confirmed that the policy showed that it was revised in 6/2010 and was last reviewed in 7/2011.

During the same interview, the MSC reviewed the GB Committees' Meeting Minutes that was conducted in 7/2010 to show documented evidence that the policy revision(s) that was conducted in 6/2010 was approved by the GB. The MSC was unable to show documented evidence that the 6/2010 policy revision(s) was approved by the GB during their monthly meeting in 7/2010. She confirmed that the policy revision(s)should have been approved by the GB in 7/2010. She was also unable to show evidence that the policy revision(s) that were conducted in 6/2010 had been approved by the GB when the Nursing Policy/Procedure Manual was reviewed in 7/2011. The MSC stated that the Nursing policy should have been approved by the GB prior to the implementation by the nursing department.

Based on observation, interviews and record reviews, the hospital failed to evaluate the quality, appropriateness and safety of the nutritional services program in light of the deficient practices noted during the course of the survey when the hospital failed to:

A. Ensure patient food was stored, prepared and distributed in a safe and sanitary manner;
B. Ensure the nutrition needs of the patients were assessed and met in accordance with recognized dietary standards; and
C. Ensure the quality of the nutritional services program was evaluated so that performance improvement would be assured.

These failures had the potential to result in an outbreak of food borne illness. They also resulted in the nutrition needs of the patients not being met and allowed for the deficient practices to continue because of the lack of evaluation. (cross refer C-0279)

Findings:

During an interview with the DM on 4/26/12 at 1:45 PM, she stated that the performance improvement plan for her department did not include monitoring any of the deficient practices noted during the survey. She stated that the department was monitoring patient satisfaction with the meals and was also monitoring the completeness of the department's temperature logs. She was unable to explain why the deficient practice found during the survey were not brought to the Quality Committee and included in the plan for remediation of the problems.