The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

RENAISSANCE HOSPITAL TERRELL 1551 HWY 34 S TERRELL, TX Nov. 15, 2012
VIOLATION: GOVERNING BODY Tag No: A0043
Based on document review and interview the governing body failed to:

A. Provide Registered Nurses for supervision, assessments and timely interventions of patient care for 4 of 4 patients (#'s 1, 10, 12 and 14) experiencing change in conditions with two incidents resulting in patient deaths (#'s 1 and 10). The facility failed to provide Registered Nurses for supervision and assessment and to be immediately available to the nursing units. Licensed vocational nurses (LVN) were allowed to work the Emergency Department (ED), Intensive care unit (ICU), and Medical- Surgical unit without Registered Nurse supervision. The facility failed to ensure nursing staff were competent in required certification and annual specialized training in 5 of 5 (CNO, 5, 12, 14, and 16) Emergency Department (ED) and 4 of 4 (CNO, 5, 16 and 25) Intensive care unit (ICU) employee files reviewed.

Refer to tags A0392 and A0397

B. Provide surgical services with qualified supervision, a safe and sanitary environment for patients receiving surgery, safe post-operative care, properly processed supplies and instruments which placed patients at risk for infections and possible death. The Surgical Department had performed 82 cases from 6/6/2012 through 11/12/ 2.

Refer to A0941, A0942, A0944, A0956, A0957

C. Provide evidence of an Infection Control Program. The facility failed to provide Infection Control Policies and Procedures, including a system for identifying, reporting and investigating healthcare associated infections. The facility also failed to maintain a log of all reportable diseases. A review was done of the Governing Board Committee Meeting Minutes for January 26, 2012, February 23, 2012, March 29, 2012, April 26, 2012, May 17, 2012, June 21, 2012, July 26, 2012, August 23, 2012 and September 27, 2012 and these documents revealed no Infection Control being reported.

During interviews with CNO (Chief Nursing Officer), who identified himself as the Infection Control Nurse, on 11/14/2012 at 10:00 AM in the Doctor's Lounge, there were multiple requests made of him to provide evidence by way of policy and procedures outlining the facility's Infection Control Program. No policies were provided by CNO. CNO was asked to provide documentation/reports that the facility was providing infection control training, monitoring infections of patients or employees. CNO confirmed there were no reports. CNO provided a notebook containing lab reports and he confirmed these reports were not being tracked or trended into a report.

D. Ensure the facility had a Quality Assessment Performance Improvement Program (QAPI). The facility was unable to provide evidence of an ongoing, hospital wide, data driven QAPI program.

Requests were made of CNO to provide documentation and/or evidence of a QAPI (Quality Assurance Performance Improvement). No written QAPI plan was provided.
An interview was conducted with CNO on 11/14/2012 at 10:00 AM in the Doctors' Lounge to provide insight into the facility's QAPI Program. CNO confirmed the governing body does not set the frequency and detail of data collected. CNO revealed the department managers make the decisions on the quality indicator's they feel appropriate for their department. The manager chooses one indicator to monitor. The manager monitors the indicators for the length of time they feel appropriate to resolve the issue. CNO confirmed there was no QAPI Committee. CNO revealed if there was a safety issue an incident report would be generated. CNO collects the incident reports once the managers complete the follow up. The incident reports are placed in a notebook/ binder. CNO confirmed once the incident reports are placed in the binder the incident is closed and the facility has no system in place to track, monitor or analyze the incidents. CNO confirmed there was no evidence the facility was tracking health care associated infections, medication errors or the appropriateness of care and treatment.

E. Failed to protect and promote patient's rights by not:

1. Providing patients with RN assessments and RN supervision of their care.

Refer to tag A0395 and A0397

2. Providing the required daily safety checks to cardiac equipment and the required preventative maintenance for patient care equipment.

Refer to tag A0724
VIOLATION: OPERATING ROOM CIRCULATING NURSES Tag No: A0944
Based on record review and interview the facility failed to ensure supervision by an experienced surgical registered nurse in the surgical cases being performed at this facility. There were 4 of 5 (CNO, #5, #16, #20, and #22) nurses that have worked in the Surgery Department without experience or competencies in surgery. One (#16) of 4 (CNO, #5, #20, and #22) was a Licensed Vocational Nurse.

Review of records revealed one scrub technician full time and no Registered Nurse in the Surgery Department.

Review of record titled "Register of Operations " from June 2012 thru November 2012 revealed 5 different nurses as the circulator nurse in the operating room. One of the 5 is a Licensed Vocational Nurse (#16) and the other 4 Registered Nurses (CNO, #5, #20, and #22) revealed no documented surgical job description or surgical competencies for working in the Surgery Department.

Review personnel file for CNO (Chief Nursing Officer) revealed a job description for a Chief Nursing Officer with no signature and no surgical competencies for the Surgery Department and no documented experience of ever working in a Surgery Department. Personnel file revealed no documentation of current Advanced Cardiac Life Support which is required by facility.

Review personnel file for Staff #5 revealed a job description for the Emergency Department and Medical /Surgical Unit with no signature and no competencies/orientation for the Surgical Department or experience of ever working in a Surgery Department.

Review personnel file for Staff #16 revealed a signed job description for LVN/ Medical/Surgical Unit with no date, no documented competencies for the Surgery Department, or experience of ever working in a Surgery Department. The file revealed no documented training for the procedure for processing scopes using Cidex. Staff #16 is Licensed Vocational Nurse not a Registered Nurse. File revealed no documentation of current Advanced Cardiac Life Support or CPR (Cardiopulmonary resuscitation) which is required by facility.

Review personnel file for Staff #20 revealed a job description for the Emergency Department and Medical /Surgical Unit with no signature and no competencies/orientation for the Surgery Department. No documented experience of ever working in a Surgery Department.

Review personnel file for Staff #22 revealed a job description for the Emergency Department and Recovery RN with no signature and no documented competencies/orientation for the Surgery Department. The file revealed no documented experience of ever working in a Surgery Department.

Interview with CNO on 11/13/2012 at 11:00 AM, confirmed surgical department consisted of one scrub technician. CNO reported the Director of Surgery left in June 2012. CNO confirmed the nurses working in surgery are part-time, pulled from other units in the facility, and do not have experience/competencies in surgery.
VIOLATION: REQUIRED OPERATING ROOM EQUIPMENT Tag No: A0956
Based on record review, observation, and interview the surgical department failed to provide preventative maintenance (safety inspections) on the equipment in the operating room suites while surgical cases were being performed. The cardiac monitor had not been checked daily per the facility policy.

Observed on tour of the surgical suite on 11/13/2012 at 11:00 AM, the cardiac monitor and defibrillator safety checks were last completed on 7/12/2012. Observed in the equipment storage area the surgical equipment being used during the surgical cases has not had safety inspections since 7/2012. The facility had received a new piece of equipment for Laparoscopic cases (the set-up, which is composed of air insufflator, camera processor, and printer) had never been inspected by a Bio-Medical company.

The facility Surgical Department has performed 61 surgical cases from 7/13/2012 thru 11/12/2012 without the preventative maintenance inspections being completed.

Interview on 11/14/2012 at 2:00 PM with Staff #2, confirmed the cardiac monitor, defibrillator, and operating room equipment had not had preventive maintenance (safety inspections) since 7/12/2012. The new piece of Laparoscopic equipment had never been inspected by the Bio-Medical company.

Review of the record titled "Resuscitation Cart Checklist" (the log for checking the emergency crash in the surgery department) revealed the cart had not been checked daily per facility policy.

* July cart had not been checked 28 of 31days
* August cart had not been checked 2 of 31days
* September cart had not been checked 15 of 30 days
* October cart had not been checked 24 of 31 days
* November cart had not been checked 10 of 15 days

Review of facility policy titled "Crash Carts" revealed
PURPOSE:
To provide standards for use in stocking, checking, and securing hospital emergency (crash) carts. To ensure that all crash carts are ready for use for all cardiac or respiratory arrests.

POLICY:
1. The crash carts and Broselow pediatric crash cart are inspected, secured controlled, and restocked according to the following procedure. These activities shall he documented on the "Crash Cart Check List."
2. The crash carts and Broselow pediatric crash cart are checked daily and as needed.
3. Each department that maintains a crash cart has a designated staff member check the cart daily as appropriate. If the department is closed it must be noted on the appropriate date and the cart moved from accessibility.
4. Crash carts contents will not be added to or deleted from the standardized crash carts without the approval of the Code Blue Committee and the appropriate Medical Staff.
5. Crash cart locks are issued by the Pharmacy. Each time the crash cart is opened a new lock is issued and a new medication drawer, if utilized.
6. A locked Standardized Adult crash cart will be available for use in the following patient care areas of the hospital:

Day Surgery unit
OR holding area
emergency room
ICU
Med/Surg 200 Hall
Med/Surg Peds
Med/Surg 100 Hall
Labor and Delivery

Daily:
1. Crash carts will be checked daily on the units during hours of operation.
2. Supplies on top side of the Adult and Pedi crash carts, and the oxygen tank level (designated areas) will be checked for availability, expiration date, and documented (see emergency Cart- Daily Check list) each morning by the Charge Nurse and after each restocking by nursing personnel.
3. Inspect the physical condition of defibrillator/monitor for foreign substance, damage or cracks, low battery connect to AC power messages, and service indicator message.
4. Inspect power source for: AC power connector plugged into unit and AC power source LED is lit. Battery charged LED is lit.
5. Press ON button and CHARGE defibrillator to 200 joules and discharge SHOCK button. Assure the 200 joules were delivered.
6. Check EKG printer for adequate paper supply and ability to print.
7. Verify that the lock is intact. Record lock number on daily checklist form.
8. Initial the daily checklist.

Interview on 11/14/2012 at 2:00 PM with Staff #2 confirmed the cardiac monitor had not been checked daily per the facility policy.
VIOLATION: CHIEF EXECUTIVE OFFICER Tag No: A0057
Based on document review and interview the governing body failed to follow the established governing board bylaws for appointing and approving the chief executive officer.

The review of the document titled, "Governing Board Bylaws, Article VI Administration" contained the follwing in Section 1. "Chief Executive Officer... shall employ a competent, experienced Chief Executive Officer (CEO) of the Hospital (whose appointment shall be reviewed and approved by the Governing Board) .... The authority and duties of the Chief Executive Officer include: L. Designate, in writing, other individuals by name or position that are, in order of succession, authorized to act for him during any period of his absence from the hospital."
A review of the document titled, "Governing Board Committee Meeting Minutes for April 26, 2012" contained the following in Section VII. "New business- A. Administrative Changes: CNO (Chief Nursing Officer) informed the committee that we currently had interim CEO, staff #6, explaining to the members that he is not able to be on-site Monday thru Friday at this time; CNO, staff #3 and staff #4 can contact him at all times and will be the administrative representatives available at the hospital." There was no evidence in this document of staff #6 being present at the April meeting. Review of the meetings for May 17, June 21, July 26, August 23, September 27 and October revealed no evidence staff #6 was present at these Governing Board Meetings. There was no evidence the Governing Board reviewed or approved the appointment of the interim CEO. No written document was made available for review giving authority to CNO, staff #3 or staff #4 to act on behalf of the CEO (Staff #6).
An interview was conducted with the staff #6 (CEO/Interim Administrator) in the Doctor's Lounge on 11/14/2012 at 1:00PM. Staff #6 was asked how often he was in the facility. Staff #6 stated it had been 6 weeks since his last visit to the facility.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observation, document review and interview the governing body failed to:

A. Provide Registered Nurses for supervision, assessments and timely interventions of patient care for 4 of 4 (#'s 1, 10, 12 and 14) patients experiencing change in conditions with two incidents resulting in patient deaths (#'s 1 and 10). The facility failed to provide Registered Nurses for supervision and assessment and to be immediately available to the nursing units. Licensed vocational nurses (LVN) were allowed to work the Emergency Department (ED), Intensive care unit (ICU), and Medical- Surgical unit without Registered Nurse supervision. The facility failed to ensure nursing staff were competent in required certification and annual specialized training in 5 of 5 (CNO, 5, 12, 14, and 16) Emergency Department (ED) and 4 of 4 (CNO, 5, 16 and 25) Intensive care unit (ICU) employee files reviewed.

Refer to tag A0395 and A0397

B. Failed to provide surgical services with qualified supervision, a safe and sanitary environment for patients receiving surgery, safe post-operative care, properly processed supplies and instruments which placed patients at risk for infections and possible death.

Refer A940, A942, A944, A956, A957

C. Provide the required daily safety checks to cardiac equipment and the required preventative maintenance for patient care equipment.

Refer to tag A0724

It was determined this deficient practice created an Immediate Jeopardy situation and placed patients at risk of potential harm, serious injury, and subsequent death. These failures had the potential to affect all patients admitted to the facility.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to ensure nursing provided RN supervision of care to 3 of 3 (#s 10, 12 and 14) patients.

The facility failed to ensure nursing staff were competent In required certifications and annual specialized training in 5 of 5 (CNO, #'s 5, 12, 14, and 16) Emergency Department (ED) and 4 of 4 (CNO, #'s 5, 16, and 25) Intensive care unit (ICU) employee files reviewed.

This deficient practice caused harm in 2 of 2 (#1 and #10) patients and had the potential to cause harm to all patients.

Review of the "MASTER STAFFING PLAN" policy dated March 2007 revealed the following:

*Staffing of each nursing unit/service was developed to provide a sufficient number of personnel. To assure prompt recognition of changes in the patient's condition with appropriate intervention. Staffing was accomplished using Registered Nurses and support staff including, as applicable, Licensed Vocational Nurses, Nurses ' Aides, Unit Secretaries, and other staff classifications as needed based on unit services.

*Staffing will be sufficient to provide for adequate numbers of competent Registered Nurses to provide for initial and ongoing assessments and prompt recognition of any untoward changes in a patient's condition.

1. Review of the Emergency Department (ED) nurses record dated 09/05/12 revealed Patient #1 was a [AGE] year old male who was admitted at 4:57 p.m. with a chief complaint of aspiration, and a history of CVA (cerebral vascular accident) with Aphasia (inability or difficulty swallowing). Vital signs were 167/81 blood pressure, 126 pulse, 27 respirations, no temperature was documented.

An x-ray report dated 09/05/12 at 6:31 p.m. revealed, "likely atelectasis (collapse of lung) less likely pneumonia. Short interval follow up is recommended to evaluate for resolution."

Review of the ED physician notes dated 09/05/12 revealed Patient #1 had shortness of breath, fever, and decubitus ulcers. On assessment Patient #1 had rales (a sound heard over fluid in the bronchial tubes in the lungs) and was tachycardic (a rapid heart rate.)

Physician orders sent to the medical-surgical floor dated 09/05/12 revealed Patient #1 had diagnoses of aspiration pneumonia, acute renal failure, dehydration, hypernatremia, and decubitus ulcers. There were orders for an IV (intravenous fluids), IV Antibiotics, breathing treatments every 4-6 hours and every 2 hours prn (as needed), aspiration precautions, and gastrostomy tube flush with free water of 150cc every 6 hours.

Review of nursing assessment notes dated 09/05/2012 10:00 p.m. revealed Patient #1 was received to the medical-surgical floor with no documentation of baseline vital signs on admission to the floor. Further review revealed Patient #1 had a wet cough and crackles (sounds heard on auscultation of the chest as a result of inflammation) to the right lower lobe. At 11:15 p.m. nursing documentation revealed "Checked the placement for peg tube. Not functioning well. Held free water flush and due meds." The nurse documented that medications were held on 9/5/2012 at 2100. There was no documentation of physician notification or nursing interventions to attempt to resolve G-tube functioning.

A telemetry strip dated 9/5/2012 at 11:57 p.m. showed Patient #1 had a heart rate of 107 and was Sinus Tachycardia (a steady, rapid heart rate). A telemetry strip dated 09/06/12 at 8:20 a.m. showed Patient #1 had an increased heart rate of 114 and was Sinus Tachycardia. Further review of the telemetry rhythm strip record revealed, "DC ' d off tele." with no time or date it was discontinued. There was no nursing assessment of cardiac/respiratory status documented.

Review of the written statement of the patient's daughter written 9/7/12 revealed the nurse practitioner was under the impression the patient was still on a heart monitor. She stated, "Sir, you are not monitoring my dad for nothing. He looked at the nurse and asked her was he on a heart monitor? The nurse stated no. We don't have any at this time they were all on the floor. She left and got one somewhere." Nursing notes documented on 9/8/2012 1130, "put patient on telemetry." No documentation was found on cardiac/respiratory status. No telemetry strips were documented. In an interview on 11/14/2012 at 7:20 p.m. Staff #25 (RN) reported she placed Patient #1 on telemetry but did not remember having any issues.

A review of physician orders dated 09/06/12, 08:30 a.m., revealed orders to obtain an x-ray of the abdomen for G-tube placement, "labs for the am, roll the patient every two hours to prevent bed sores and can have ice chips or popsicles every 6 hours by mouth".

A review of nursing assessment notes dated 09/06/12, 8:30 a.m. RN revealed the patient had a blood pressure of 178/72, pulse 89, temperature of 97.8. There were no documented respirations or lung sounds. The oxygen was infusing at 3L/NC and the IV was still infusing at 100cc per hour. The only documentation about the G-tube at this time was that it was intact. Review of nursing progress notes dated 09/06/12, 4:30 p.m. revealed Patient #1 developed a temperature of 100.1, a pulse of 118, respirations 16, blood pressure 120/69 and the doctor was notified. No further assessment or nursing intervention was documented.

Review of nursing progress notes dated 9/6/12 at 7:05 p.m. revealed a Jevity feeding was started per G-tube and infusing at 50 ml/hr. via feeding pump. The nurse charted the following: "3cc of stomach content was checked, the G-tube was flushed with 30cc of air with stomach gurgling heard, elevated the head of the patient's bed, stomach content every four hours with less than 5cc stomach content drawn and G-tube flushed with 200cc free water every four hours".

A verbal physician order was written on 9/6/12 at 8:35 p.m. for Tylenol 10ml every four hours as needed for fever or pain and to start G-tube feeding Jevity 50 ml/hr. The patient was given Tylenol five hours after temperature was documented. There was no documentation that patient had been reassessed for fever, cardiac, or respiratory status/interventions. Review of lab results dated 9/7/2012 revealed an elevated white blood cell count of 12.8, indicating an infection.

Review of nursing progress notes dated 9/07/12 at 10:00 a.m. revealed the patient was suctioned and Jevity was noticed on the side of the bed from the G-tube leaking, tube feedings were stopped and the physician called.

Review of a physician's order dated 9/7/12 at 1:45 p.m. revealed, "start Jevity at 25cc/hr., increase to 40cc after 6 hours if he tolerates it, CBC and Chemistry 7 in the AM. Reduce IV fluids to 50cc hr. Hospitalist/- will see patient tomorrow and day after (Saturday and Sunday)."

Review of physician progress notes dated 09/07/12 revealed, "patient non communicative. Nurse says peg tube was leaking and was displaced. Patient does not seem to be in pain. Also had fever." Further documentation revealed, "Peg tube repositioned and is in stomach. No edema."

Review of nursing assessment notes dated 09/07/12 at 4:30 p.m. revealed, "doctor was here and irrigated peg tube with 100cc of water. After repositioning we find that the peg tube was still intact according to physician Staff #29." The doctor gave new orders to decrease the Jevity feedings to 25cc/hr. for 6 hours then increase up to 40cc if patient tolerated it. In addition to this information the nurse documented the patient was suctioned at 0710, 0800, 0830, 1000, 1030, 1215, 1300, 1530, and 1730. However, there was no documentation on why the patient needed to be suctioned or respiratory status.

Review of nursing progress notes dated 09/07/12 at 7:15 p.m. revealed the nurse checked the G-tube placement with air, elevated the head of the patient's bed and Jevity was running at 40cc/hr. The nurse documented at 11:30 p.m. the family was in the room and patient resting. The nurse also documented vital signs were checked and temperature had increased to 100.4 and that the patient was suctioned. At 11:55 p.m. the RN documented the patient began showing signs of pain and agitation. There was no documentation of an assessment of pain intensity or location, G-tube placement, or when feedings were increased. There were no nursing interventions documented.

Review of nursing progress notes dated 09/07/12 at 11:55 p.m. revealed that the family requested pain meds, so the nurse called the doctor. New orders were obtained for Vicodin 5/500mg. Vicodin and Ativan were administered per G-tube. Documentation revealed " patient temperature rechecked 100.4 noticed patient is grimacing and making small noise. Given Tylenol 650mg and Vicodin 5/500 as per order." There was no assessment of the locale or intensity of the pain. Further review revealed there was no documentation of an assessment of the patient's pain from 09/07/12 11:55 p.m. until 09/08/12 at 10:45 a.m.

Review of nursing progress notes dated 09/08/12 at 11:00 a.m. revealed Staff #8 (NP) was notified the family was requesting to see him. On 09/08/12 at 11:15 a.m. the nurse documented Staff #8 (NP) was talking to the family about the patient ' s disease process and new orders to put the patient on telemetry. There was documentation the patient was put on telemetry at 11:30 a.m. but no documentation or assessment of cardiac or respiratory status was found.

Review of nursing progress notes dated 09/8/12 at 1:00 p.m. documented the patient suddenly was having breathing difficulties, respirations were at 26, oxygen saturation was 81%, blood pressure 108/100, pulse 148, temperature 98.9 with mild perspirations. At 1:08 p.m. Staff #8 (NP) was called and came to the patient's room. New orders were received to move the patient to ICU. There were no interventions documented on cardiac or respiratory status and no telemetry documentation.

In an interview on 11/14/2012 at 7:20 p.m. Staff #25 (RN) stated, "I worked the 7:00 p.m.-7:00 a.m. shift on 9/7/2012. I had no relief the next morning 9/8/2012 at 7:00 a.m. CNO (Chief Nursing Officer) told me to stay another shift due to no relief and I could go home around 4:00 p.m. if it was slow. He said he was unable to find coverage for me and my LVN. I was the only RN for the Medical surgical floor and the ICU was closed due to no staff."

A physician's order dated 09/08/12, Staff #8 (NP) documented, "Transfer patient to ICU stat, ABG's now, CT to the head without contrast, CT of the chest without contrast, C. E. and (ineligible word) EKG (electrocardiogram ) per protocol, need todays labs ASAP, CBC, CMP (comprehensive metabolic panel) and BNP(basic metabolic panel) at 1600 hours and call results. Stat D-Dimer (used to see if a blood clot is present) Consult cardiology with Dr. -. "

In an interview on 11/15/2012 at 8:54 a.m., Staff #8 (NP) stated, "I had seen Patient #1 earlier that morning around 11:00 a.m. and talked with the family. I felt the patient was not critical enough to go to ICU. I spent a good length of time talking with the family and the patient was stable at that time. The patient had a change in vitals and respiratory status on second visit sometime after 12:00 p.m. I wrote orders to move the patient to ICU for closer observation. I'm not always secure with the knowledge that the current nursing staff has enough experience to let me or the other doctors know when a patient is declining. I did know there was no nursing staff available for ICU and there would be a delay in transferring the patient. I left the facility to go to another hospital but had instructed the nursing staff to let ER physician or the on call hospitalist know if there was a change in condition on the patient. I didn't know the patient had expired until the next day."

Review of nursing progress notes dated 09/08/12 at 1:10 p.m., revealed respiratory therapy had been called to intervene and perform ABG's (arterial blood gas). At 1:15 p.m. ABGs were collected and oxygen was increased to 4L per nasal cannula. At 1:25 p.m. the patient was transferred to ICU and report was given to the ICU nurse (CNO).

Review of nursing progress notes dated 09/08/12, at 1:02 p.m. CNO revealed, "patient arrived in ICU. Lying in supine position, labored breathing @ 40 respiration rate. Blood pressure 62/40, pulse 141, respirations 40, temp 96.9, Oxygen saturation 83%, sinus tachycardia at 141, lethargic, skin w/d, will continue to monitor." At 1:30 p.m. CNO documented he spoke with the family about "DNR, (do not resuscitate) or full code status. Will continue to monitor. Tube feeding and IV running." There were no nursing or respiratory interventions documented on respiratory status. At 2:00 p.m. CNO documented, "patient turned to left side by nurse tech suctioned small amount of clear secretion orally. Blood pressure 74/38, pulse 144, respirations 42, Oxygen sats 96% and temp 97.2. Will continue to monitor."

Review of nursing progress notes dated 09/08/12 2:38 p.m., revealed documentation patient #1's blood pressure was 68/36 and Dopamine 5meq/ kg/min started at 1:30 p.m. CNO documented he called Staff #10 (Dr.) from the ER to assist with care and Staff #29 (Dr.) had been called twice with no response. At 3:30 p.m. CNO increased the Dopamine drip to 10meq and documented patient #1's blood pressure as 72/31, pulse 152, respirations 40, and temperature 97.0. Review of the physician's orders revealed no documentation for the order of Dopamine. There was no further nursing documentation noted on this chart.

Review of the physician progress notes dated 09/08/12 at 5:25 p.m. revealed Staff #10 (Dr.) responded to the code and documented "the patient had stopped breathing and had no pulse." Further review revealed Staff # 11 (Dr.) had already responded, intubated the patient, and initiated ACLS (advanced cardiac life support). Patient #1 was in a Pulseless Electrical Activity rhythm (has a heart rhythm that is not creating a pulse.); pupils were fixed with no reaction and he was placed on a ventilator. The patient continued to decline and had a femoral blood pressure of 34/13. A Dopamine bolus was given. Patient #1 continued to deteriorate and expired at 5:24 p.m. Staff #10 (Dr.) discussed the patient's situation with the family and the patient was then removed from the ventilator. Staff #10 documented cause of death was "Aspiration pneumonia, lead to respiratory arrest, then cardiac arrest and cerebral anoxia."

In an interview with CNO on 11/14/2012 at 9:20 a.m., he stated "I do not remember this patient. I just heard about him yesterday." He was then given the patient's chart to review. Upon reviewing the nurse's notes he stated. "Oh yes I remember this patient. The patient was transferred to ICU because of a breathing problem. We were short staffed so the ICU was closed. I was notified by Staff #25 that she had ICU orders. I had to take on the role of ICU nurse because I had absolutely no one that would come in and work. I tried calling everyone. The NP had written orders for ICU and he had left. I didn't know physician Staff #29 (Dr.) was out of town and that Staff #8 (NP) was covering." The CNO was asked if he remembered the family asking to put the patient on the vent. CNO stated, "I don't recall that". CNO was asked where the order was for the Dopamine he had started in the ICU and what physician gave him the order. CNO stated, "I did call the nurse practitioner and I tried to call Staff # 29 (Dr.) twice but he did not answer. Then I had to call the ER doctor. I know there was an order it must be missing." Further review of the medical record revealed the CNO's nursing notes ended at 3:30 p.m. The patient did not expire until 5:24 p.m. CNO stated "the nurse's notes from 3:30 p.m. on must be missing, I am sure I wrote more". Upon further questioning CNO stated, "I didn't document on nurses notes past 1530." CNO stated, "I was trying to get the family to tell me if they wanted to make their father a DNR. It was very confusing and difficult to get them to make a decision." When questioned about the possibility of transferring the patient to a higher level of care, CNO stated, "a transfer was never discussed and it is frowned upon by administration." CNO was questioned on what interventions he performed to save this patient. He paused for a long period of time and shrugged his shoulders. He became emotional and tearful. CNO shook his head no. He stated, "I realize this is a horrible mess. I did not do everything I could to help this patient."

Review of personnel files revealed CNO, with a hire date of 04/22/11, did not have a current ACLS (Advanced Cardiac LIfe Support) and there were no current nursing or Intensive Care competencies .






2. Review of the emergency department (ED) nurses record revealed Patient #10 was a [AGE] year old male who presented to the ED 10/30/12 at 6:46 p.m. with complaints of sore feet. The triage notes revealed the patient had a pain level of 1 out of a scale of 1-10 and vital signs of 138/96 blood pressure, 92 pulse, 16 respirations and an oral temperature of 98.7.

Review of an ED physician assessment dated [DATE] revealed the initial clinical impression on Patient #10 was an "abnormal EKG (echocardiogram), leg pain, Non ST (myocardial infarction) and congestive heart failure." The patient was complaining of "hurting".

Review of an ED physician history and physical dated 10/30/12 revealed the "patient appeared uncomfortable. He is lying in the floor in the ER complaining that his feet are hurting." He had "bilateral basal rales to his mid chest. He looked anxious and was dry. His extremities had "2+ edema."

There was no documentation of any medications administered or nursing interventions put into place to address the anxiety or pain.

Review of the ED nurses record dated 10/30/12 at 8:50 p.m., revealed Patient #10 was discharged to the medical-surgical floor and was documented as being improved and stable.

Review of nursing progress notes dated 10/30/12, 8:57 p.m. revealed the patient was moved to a room closer to the nursing station because "he was yelling out and going to others rooms." There was documentation he had "bilateral pedal edema, patient refused to go to bed, sitting in the floor, laying under the bed, continuing to yell out and refused the exam."

Review of a Registered Nurse admission assessment dated [DATE], 9:00 p.m. revealed the patient had "anxiety, complained of shortness of breath and had diminished breath sounds." He complained of "abdominal pain, hypoactive bowel sounds and distended abdomen." Patient #10 was "complaining of hurting all over his body." There was documentation at the bottom of the assessment the physician was notified at 9:00 p.m. There was no documentation why physician was notified. There were no nursing interventions implemented to address the pain, shortness of breath nor the anxiety.
Review of a physician's order dated 10/30/12 at 9:11 p.m. revealed Patient #10 was being admitted with diagnoses of congestive heart failure exacerbation, non ST- myocardial infarction, acute renal failure and hypernatremia. There were physician orders for the pain medication agent Demerol 12.5 milligrams (mgs) intravenously (IV) every 4- 6 hours prn and the anti-anxiety agent Ativan 1mgs IV every 4-6 hours prn, the diuretic agent Lasix 40 mg IV BID (twice a day), respiratory treatments, and Duonebs every 4-6 hours. There were no orders for oxygen therapy listed.

Review of nursing progress notes dated 10/30/12 written by Staff #28 (LVN) revealed the following:

*At 10:30 p.m. the patient was "given Ativan 1mg IV due to him yelling for 30 minutes."

*At 11:30 p.m. the patient was put "back to bed with assist."

*At 11:34 p.m. the patient was "back on the floor."

Review of nursing progress notes dated 10/31/12 written by Staff #28 (LVN) revealed the following:

*At 1:30 a.m. the patient was "incontinent of feces and back into the floor."

*At 2:10 a.m. the patient was given "Ativan 1mg IV, was yelling out occasionally and very uncooperative."

*At 3:10 a.m. the patient was "put back to bed twice." Staff documented they "watched the patient for 5 minutes and he crawled back to the floor twice, was rolling on the floor and then slept. He would yell out occasionally and would not stay in bed."

*At 6:00 a.m. the patient was "back on the floor and refused to stay in bed " ....

*At 6:10 a.m. the patient "verbally refused vital signs and blood draw."

*At 6:50 a.m. the patient was "on the floor foaming from the mouth" and the doctor was notified.

There was no documentation of a continued nursing assessment of vital signs, pain, abdominal status or respiratory by nursing after admission. There was no documentation nursing interventions were attempted, no notification to the physician, no pain medication administered, and no documentation that Staff #28(LVN) reported to an RN of the patient's condition, between 10:30 pm, 10/30/12, and 6:50 am, 10/31/12.

Review of nursing progress note dated 10/31/12 which was written by Staff #30 revealed the following:

*At 0700 a.m. "the patient lying in the floor, moving from side to side, non-verbal, grunting and was foaming at the mouth. He was placed back into the bed with assist and the doctor was called". There was no documentation of a nursing assessment of vital signs, pain, abdominal status or respiratory status.

*At 7:40 a.m. (40 minutes later),"the patient's blood pressure was 140/112, heart rate was 121, unable to get the oxygen saturation, and respiratory called. Treatment and oxygen placed on, patient suctioned, Lasix 40 mg IV given, Catapress patch ordered and placed on and his sister was called." Review of respiratory notes dated 10/31/12 timed 7:50 a.m. confirmed the information about the oxygen saturation, breathing treatments and suctioning.

*At 8:15 a.m. the patient's "sister arrived and talked to the patient who was still turning from side to side and trying to get up, Foley catheter was placed after Lasix given, respiratory treatments, oxygen and suctioning still going on. Patient stopped breathing and sister stated she wanted no intervention. Patient was pronounced dead by the doctor."

Review of the medication administration record for 10/30/12 and 10/31/12 revealed no pain medication was administered to the patient during the hospitalization . There was no nursing assessment of his pain level documented after the initial nursing assessment at 9:00 p.m. on 10/30/12.

During an interview on 11/20/12 at 8:35 a.m., Staff #28 reported he was the patient's nurse when he got to the floor on 10/30/12. The patient was "up and down, refusing care and I did not know what was wrong with him. Other staff was telling me that was how the patient usually acted when he was a patient here before." Staff #25 "had not passed the information onto me that the patient was having pain. I did not give him any pain medication during my shift. When I was giving report to Staff #30 we found the patient in the floor, not responding, incontinent and foaming at the mouth. We put him back to bed and I went and called the doctor. Afterwards Staff #30 took over the patient's care."

During an interview on 11/15/12 at 4:35 p.m., Staff #30 reported she relieved Staff #28 at 6:45 a.m. on 10/31/12. "While taking report we found the patient laying on the floor and grunting. Something was wrong with him. We put him back to bed and called respiratory. Respiratory could not get oxygen saturation." Staff #30 confirmed "none of the patient's pain medication had been administered."

During an interview on 11/15/12 at 4:25p.m., the CNO reported "I knew about the incident. The patient was up and down all night and complaining of pain. The staff should have done more than just put him back to bed." CNO reported "I was just looking into the incident this week (which occurred two weeks prior), but could not do any investigation because the surveyors were in the building."

Review of a death summary dated 10/31/12 revealed the patient had an "acute cardiopulmonary arrest and was in respiratory distress." The doctor documented that "Early morning, I came in to see the patient. He was out of the bed and not cooperating. He was desaturating to 60 percent. He was put on Duoneb treatment and suctioned, he improved to 70 percent, but he was with a thick secretion. He never regained consciousness, never talked to me and he was agitated and belligerent. I contacted the family members including the sister and discussed resuscitation plan. At 8:50 a.m. the patient was pronounced deceased ".
VIOLATION: QAPI Tag No: A0263
Based on interview the governing body failed to ensure a Quality Assessment Performance Improvement Program (QAPI). The facility was unable to provide evidence of an ongoing, hospital wide, data driven QAPI program.
Requests were made of CNO to provide documentation and/or evidence of a QAPI Program. No written QAPI plan was provided.
An interview was conducted with CNO (Chief Nursing Officer) on 11/14/2012 at 10:00 AM in the Doctor's Lounge to provide insight into the facility's QAPI Program. CNO confirmed the governing body does not set the frequency and detail of data collected. CNO revealed the department managers make the decisions on the quality indicator's they feel appropriate for their department. The manager chooses one indicator to monitor. The manager monitors the indicators for the length of time they feel appropriate to resolve the issue. CNO confirmed there was no QAPI Committee. CNO revealed if there was a safety issue an incident report would be generated. CNO collects the incident reports once the managers complete the follow up. The incident reports are place in a notebook/ binder. CNO confirmed once the incident reports are placed in the binder the incident is closed and the facility has no system in place to track, monitor or analyze the incidents. CNO confirmed there was no evidence the facility was tracking health care associated infections, medication errors or the appropriateness of care and treatment.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on observation, interview and record review the facility failed to provide Registered Nurses for supervision, assessments and timely interventions of patient care for 4 of 4 (#'s 1, 10, 12, and 14) patients experiencing change in conditions with two incidents resulting in patient deaths (#'s 1 and 10). The facility failed to provide Registered Nurses for supervision and assessment and to be immediately available to the nursing units. Licensed vocational nurses (LVN) were allowed to work the Emergency Department (ED), Intensive care unit (ICU), and Medical- Surgical unit without Registered Nurse supervision. The facility failed to ensure nursing staff were competent in required certification and annual specialized training in 5 of 5 (CNO, 5, 12, 14, and 16) Emergency Department (ED) and 4 of 4 (CNO, 5, 16 and 25) Intensive care unit (ICU) employee files reviewed.

Refer to tag A0392 and A0397 for additional information.


It was determined this deficient practice created an Immediate Jeopardy situation and placed patients at risk of potential harm, serious injury, and subsequent death. These failures had the potential to affect all patients admitted to the facility.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on document review and interviews the facility failed to provide Registered Nurses for supervision and assessment of patient care and provide an RN to be immediately available to the nursing units.

Review of the document titled, Master Staffing Plan, revealed: 1."At least one (1) Registered Nurse will be on duty on each unit for each operational shift. Operational shift is defined as the hours of shifts during which the unit is open and available for patient care. A Licensed Vocational Nurse may assume responsibility for the unit with a Registered Nurse immediately available to the unit. "

Observational tour of the facility was conducted on 11/13/2012 at approximately 11:15 AM with CNO, who was functioning as the Chief Nursing Officer (CNO) and House Supervisor. While in the emergency room the nurse staffing was one Registered Nurse (RN) and one Licensed Vocational Nurse (LVN). CNO was asked, "if the RN has to leave the ER unit for any reason, for example take a lunch break, triage of a patient presenting to the ER, bathroom, is needed to go with the patient to X-ray, how do you insure a RN is immediately available to the LVN/ER unit?" CNO responded, he would be the backup RN. While touring the Medical Surgical Unit, CNO was asked if LVNs were left in charge of the unit. CNO confirmed the unit was staffed with only LVNs at times and the House Supervisor would be available if the unit needed an RN. CNO confirmed LVNs were also staffed in the Intensive Care Unit (ICU) with the House Supervisor being available to the unit. CNO confirmed the House Supervisor, who is always a RN is the person that would be available to the units staffed with LVNs. At the end of the tour in the Doctor's Lounge in an attempt to confirm the findings, CNO was asked, "when using LVNs to staff the ICU and Medical Surgical Units the facility considers the House Supervisor to be the RN immediately available to these units along with being the backup RN for the ER?" CNO reported this was true up until October but the owner discontinued the use of a House Supervisor at night.

During the complaint investigation on 09/13/2012, an attempt was made to establish who was staffed in the facility on 09/08/2012. A review was done of the monthly staffing schedule for the Medical Surgical unit and the monthly staffing schedule for the House Supervisors. The monthly schedules were then compared to the daily staffing schedules. The daily schedules indicate that staff #25 and staff #33 both worked 24 hour shifts starting on 09/07/2012 at 7PM and was scheduled through 09/08/2012 at 7PM. On 09/08/2012 there was not a House supervisor scheduled for the 7AM till 7PM shift.

On 11/15/2012 at 8:54 AM an interview was conducted with Medical Staff #8 in the Doctor ' s Lounge. Staff #8 confirmed the ICU and Medical Surgical unit were often staffed with LVNs and no RN supervision. Staff #8 voiced concerns that LVNs were not qualified to care for patients in the ICU. The LVNs lack of assessment skills and critical thinking were questioned by staff #8 along with the ability of the LVNs to identify changes in the patient before they became critical. Staff #8 revealed that the LVN staff has voiced their concern of feeling uncomfortable being staffed as the primary nurse in the ICU.

An interview was conducted with staff #25 on 11/14/2012 at 6:40 PM. Staff #25 was asked about her nursing experience. Staff #25 had been a nurse for 1? years. During the interview it was established staff #25 had worked 24 hours on 09/07/2012 to 09/08/2012. Staff #25 was scheduled to work on 09/07/2012 from 7pm to7am. Staff #25 was told at the end of her scheduled shift the morning of 09/08/2012 by CNO there was no relief and staff #25 had to work the next shift. Staff #25 established that she would often be the only nurse in ICU and would have more than one patient. Staff #25 reported there have been times when she was the only nurse staffed on the Medical Surgical Floor as well.

An interview was conducted with CNO on 11/14/2012 at 11:45 on the Medical Surgical Unit in regards to the House Supervisors Schedule for the date of 09/08/2012. The interview was conducted to confirm the inconsistencies with the daily staffing schedules. CNO was shown the daily schedule for the date of 09/08/2012 the 7AM till 7PM shift. CNO confirmed there was no House Supervisor scheduled for that date and shift. CNO was asked if he covered that day and shift as the House Supervisor. CNO stated, "No."

An interview with staff #16 on 11/15/2012 at approximately 3:00 PM reported she is a LVN (Licensed Vocational Nurse) who works in Surgery, ICU (Intensive Care Unit), emergency room , and the Medical /Surgical Unit wherever she is assigned. Questioned have you ever worked in the Intensive Care Unit without a Registered Nurse? Staff #16 responded, "yes, but I make sure there are no ventilation patients."

A review was done of the employee time sheets to determine staffing for 09/07/2012 through 09/08/2012. The employee time sheets did not correlate with the daily staffing schedules. Due to the inconsistencies between the employee time sheets and the monthly staffing schedules, inconsistencies in information reported in interviews, and lack of documentation, it was determined the facility failed to provide adequate staffing for the dates of 09/07/2012 through 09/08/2012.
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to ensure nursing provided RN supervision of care to 3 of 3 (#s 10, 12 and 14) patients.

The facility failed to ensure nursing staff were competent In required certifications and annual specialized training in 5 of 5 (CNO, 5, 12, 14, and 16) Emergency Department (ED) and 4 of 4 (CNO, 5, 16, and 25) Intensive care unit (ICU) employee files reviewed.

This deficient practice caused harm in 2 of 2 (#1 and #10) patients and had the potential to cause harm to all patients.

Review of the "MASTER STAFFING PLAN" policy dated March 2007 revealed the following:

*Staffing of each nursing unit/service was developed to provide a sufficient number of personnel. To assure prompt recognition of changes in the patient's condition with appropriate intervention. Staffing was accomplished using Registered Nurses and support staff including, as applicable, Licensed Vocational Nurses, Nurses ' Aides, Unit Secretaries, and other staff classifications as needed based on unit services.

*Staffing will be sufficient to provide for adequate numbers of competent Registered Nurses to provide for initial and ongoing assessments and prompt recognition of any untoward changes in a patient's condition.

Based on observation, interview, and record review, the facility failed to ensure nursing provided RN supervision of care to 3 of 3 (#s 10, 12 and 14) patients.

The facility failed to ensure nursing staff were competent In required certifications and annual specialized training in 5 of 5 (CNO, #'s 5, 12, 14, and 16) Emergency Department (ED) and 4 of 4 (CNO, #'s 5, 16, and 25) Intensive care unit (ICU) employee files reviewed.

This deficient practice caused harm in 2 of 2 (#1 and #10) patients and had the potential to cause harm to all patients.

Review of the "MASTER STAFFING PLAN" policy dated March 2007 revealed the following:

*Staffing of each nursing unit/service was developed to provide a sufficient number of personnel. To assure prompt recognition of changes in the patient's condition with appropriate intervention. Staffing was accomplished using Registered Nurses and support staff including, as applicable, Licensed Vocational Nurses, Nurses ' Aides, Unit Secretaries, and other staff classifications as needed based on unit services.

*Staffing will be sufficient to provide for adequate numbers of competent Registered Nurses to provide for initial and ongoing assessments and prompt recognition of any untoward changes in a patient's condition.

1. Review of the Emergency Department (ED) nurses record dated 09/05/12 revealed Patient #1 was a [AGE] year old male who was admitted at 4:57 p.m. with a chief complaint of aspiration, and a history of CVA (cerebral vascular accident) with Aphasia (inability or difficulty swallowing). Vital signs were 167/81 blood pressure, 126 pulse, 27 respirations, no temperature was documented.

An x-ray report dated 09/05/12 at 6:31 p.m. revealed, "likely atelectasis (collapse of lung) less likely pneumonia. Short interval follow up is recommended to evaluate for resolution."

Review of the ED physician notes dated 09/05/12 revealed Patient #1 had shortness of breath, fever, and decubitus ulcers. On assessment Patient #1 had rales (a sound heard over fluid in the bronchial tubes in the lungs) and was tachycardic (a rapid heart rate.)

Physician orders sent to the medical-surgical floor dated 09/05/12 revealed Patient #1 had diagnoses of aspiration pneumonia, acute renal failure, dehydration, hypernatremia, and decubitus ulcers. There were orders for an IV (intravenous fluids), IV Antibiotics, breathing treatments every 4-6 hours and every 2 hours prn (as needed), aspiration precautions, and gastrostomy tube flush with free water of 150cc every 6 hours.

Review of nursing assessment notes dated 09/05/2012 10:00 p.m. revealed Patient #1 was received to the medical-surgical floor with no documentation of baseline vital signs on admission to the floor. Further review revealed Patient #1 had a wet cough and crackles (sounds heard on auscultation of the chest as a result of inflammation) to the right lower lobe. At 11:15 p.m. nursing documentation revealed "Checked the placement for peg tube. Not functioning well. Held free water flush and due meds." The nurse documented that medications were held on 9/5/2012 at 2100. There was no documentation of physician notification or nursing interventions to attempt to resolve G-tube functioning.

A telemetry strip dated 9/5/2012 at 11:57 p.m. showed Patient #1 had a heart rate of 107 and was Sinus Tachycardia (a steady, rapid heart rate). A telemetry strip dated 09/06/12 at 8:20 a.m. showed Patient #1 had an increased heart rate of 114 and was Sinus Tachycardia. Further review of the telemetry rhythm strip record revealed, "DC ' d off tele." with no time or date it was discontinued. There was no nursing assessment of cardiac/respiratory status documented.

Review of the written statement of the patient's daughter written 9/7/12 revealed the nurse practitioner was under the impression the patient was still on a heart monitor. She stated, "Sir, you are not monitoring my dad for nothing. He looked at the nurse and asked her was he on a heart monitor? The nurse stated no. We don't have any at this time they were all on the floor. She left and got one somewhere." Nursing notes documented on 9/8/2012 1130, "put patient on telemetry." No documentation was found on cardiac/respiratory status. No telemetry strips were documented. In an interview on 11/14/2012 at 7:20 p.m. Staff #25 (RN) reported she placed Patient #1 on telemetry but did not remember having any issues.

A review of physician orders dated 09/06/12, 08:30 a.m., revealed orders to obtain an x-ray of the abdomen for G-tube placement, "labs for the am, roll the patient every two hours to prevent bed sores and can have ice chips or popsicles every 6 hours by mouth".

A review of nursing assessment notes dated 09/06/12, 8:30 a.m. RN revealed the patient had a blood pressure of 178/72, pulse 89, temperature of 97.8. There were no documented respirations or lung sounds. The oxygen was infusing at 3L/NC and the IV was still infusing at 100cc per hour. The only documentation about the G-tube at this time was that it was intact. Review of nursing progress notes dated 09/06/12, 4:30 p.m. revealed Patient #1 developed a temperature of 100.1, a pulse of 118, respirations 16, blood pressure 120/69 and the doctor was notified. No further assessment or nursing intervention was documented.

Review of nursing progress notes dated 9/6/12 at 7:05 p.m. revealed a Jevity feeding was started per G-tube and infusing at 50 ml/hr. via feeding pump. The nurse charted the following: "3cc of stomach content was checked, the G-tube was flushed with 30cc of air with stomach gurgling heard, elevated the head of the patient's bed, stomach content every four hours with less than 5cc stomach content drawn and G-tube flushed with 200cc free water every four hours".

A verbal physician order was written on 9/6/12 at 8:35 p.m. for Tylenol 10ml every four hours as needed for fever or pain and to start G-tube feeding Jevity 50 ml/hr. The patient was given Tylenol five hours after temperature was documented. There was no documentation that patient had been reassessed for fever, cardiac, or respiratory status/interventions. Review of lab results dated 9/7/2012 revealed an elevated white blood cell count of 12.8, indicating an infection.

Review of nursing progress notes dated 9/07/12 at 10:00 a.m. revealed the patient was suctioned and Jevity was noticed on the side of the bed from the G-tube leaking, tube feedings were stopped and the physician called.

Review of a physician's order dated 9/7/12 at 1:45 p.m. revealed, "start Jevity at 25cc/hr., increase to 40cc after 6 hours if he tolerates it, CBC and Chemistry 7 in the AM. Reduce IV fluids to 50cc hr. Hospitalist/- will see patient tomorrow and day after (Saturday and Sunday)."

Review of physician progress notes dated 09/07/12 revealed, "patient non communicative. Nurse says peg tube was leaking and was displaced. Patient does not seem to be in pain. Also had fever." Further documentation revealed, "Peg tube repositioned and is in stomach. No edema."

Review of nursing assessment notes dated 09/07/12 at 4:30 p.m. revealed, "doctor was here and irrigated peg tube with 100cc of water. After repositioning we find that the peg tube was still intact according to physician Staff #29." The doctor gave new orders to decrease the Jevity feedings to 25cc/hr. for 6 hours then increase up to 40cc if patient tolerated it. In addition to this information the nurse documented the patient was suctioned at 0710, 0800, 0830, 1000, 1030, 1215, 1300, 1530, and 1730. However, there was no documentation on why the patient needed to be suctioned or respiratory status.

Review of nursing progress notes dated 09/07/12 at 7:15 p.m. revealed the nurse checked the G-tube placement with air, elevated the head of the patient's bed and Jevity was running at 40cc/hr. The nurse documented at 11:30 p.m. the family was in the room and patient resting. The nurse also documented vital signs were checked and temperature had increased to 100.4 and that the patient was suctioned. At 11:55 p.m. the RN documented the patient began showing signs of pain and agitation. There was no documentation of an assessment of pain intensity or location, G-tube placement, or when feedings were increased. There were no nursing interventions documented.

Review of nursing progress notes dated 09/07/12 at 11:55 p.m. revealed that the family requested pain meds, so the nurse called the doctor. New orders were obtained for Vicodin 5/500mg. Vicodin and Ativan were administered per G-tube. Documentation revealed " patient temperature rechecked 100.4 noticed patient is grimacing and making small noise. Given Tylenol 650mg and Vicodin 5/500 as per order." There was no assessment of the locale or intensity of the pain. Further review revealed there was no documentation of an assessment of the patient's pain from 09/07/12 11:55 p.m. until 09/08/12 at 10:45 a.m.

Review of nursing progress notes dated 09/08/12 at 11:00 a.m. revealed Staff #8 (NP) was notified the family was requesting to see him. On 09/08/12 at 11:15 a.m. the nurse documented Staff #8 (NP) was talking to the family about the patient ' s disease process and new orders to put the patient on telemetry. There was documentation the patient was put on telemetry at 11:30 a.m. but no documentation or assessment of cardiac or respiratory status was found.

Review of nursing progress notes dated 09/8/12 at 1:00 p.m. documented the patient suddenly was having breathing difficulties, respirations were at 26, oxygen saturation was 81%, blood pressure 108/100, pulse 148, temperature 98.9 with mild perspirations. At 1:08 p.m. Staff #8 (NP) was called and came to the patient's room. New orders were received to move the patient to ICU. There were no interventions documented on cardiac or respiratory status and no telemetry documentation.

In an interview on 11/14/2012 at 7:20 p.m. Staff #25 (RN) stated, "I worked the 7:00 p.m.-7:00 a.m. shift on 9/7/2012. I had no relief the next morning 9/8/2012 at 7:00 a.m. CNO (Chief Nursing Officer) told me to stay another shift due to no relief and I could go home around 4:00 p.m. if it was slow. He said he was unable to find coverage for me and my LVN. I was the only RN for the Medical surgical floor and the ICU was closed due to no staff."

A physician's order dated 09/08/12, Staff #8 (NP) documented, "Transfer patient to ICU stat, ABG's now, CT to the head without contrast, CT of the chest without contrast, C. E. and (ineligible word) EKG (electrocardiogram ) per protocol, need todays labs ASAP, CBC, CMP (comprehensive metabolic panel) and BNP(basic metabolic panel) at 1600 hours and call results. Stat D-Dimer (used to see if a blood clot is present) Consult cardiology with Dr. -. "

In an interview on 11/15/2012 at 8:54 a.m., Staff #8 (NP) stated, "I had seen Patient #1 earlier that morning around 11:00 a.m. and talked with the family. I felt the patient was not critical enough to go to ICU. I spent a good length of time talking with the family and the patient was stable at that time. The patient had a change in vitals and respiratory status on second visit sometime after 12:00 p.m. I wrote orders to move the patient to ICU for closer observation. I'm not always secure with the knowledge that the current nursing staff has enough experience to let me or the other doctors know when a patient is declining. I did know there was no nursing staff available for ICU and there would be a delay in transferring the patient. I left the facility to go to another hospital but had instructed the nursing staff to let ER physician or the on call hospitalist know if there was a change in condition on the patient. I didn't know the patient had expired until the next day."

Review of nursing progress notes dated 09/08/12 at 1:10 p.m., revealed respiratory therapy had been called to intervene and perform ABG's (arterial blood gas). At 1:15 p.m. ABGs were collected and oxygen was increased to 4L per nasal cannula. At 1:25 p.m. the patient was transferred to ICU and report was given to the ICU nurse (CNO).

Review of nursing progress notes dated 09/08/12, at 1:02 p.m. CNO revealed, "patient arrived in ICU. Lying in supine position, labored breathing @ 40 respiration rate. Blood pressure 62/40, pulse 141, respirations 40, temp 96.9, Oxygen saturation 83%, sinus tachycardia at 141, lethargic, skin w/d, will continue to monitor." At 1:30 p.m. CNO documented he spoke with the family about "DNR, (do not resuscitate) or full code status. Will continue to monitor. Tube feeding and IV running." There were no nursing or respiratory interventions documented on respiratory status. At 2:00 p.m. CNO documented, "patient turned to left side by nurse tech suctioned small amount of clear secretion orally. Blood pressure 74/38, pulse 144, respirations 42, Oxygen sats 96% and temp 97.2. Will continue to monitor."

Review of nursing progress notes dated 09/08/12 2:38 p.m., revealed documentation patient #1's blood pressure was 68/36 and Dopamine 5meq/ kg/min started at 1:30 p.m. CNO documented he called Staff #10 (Dr.) from the ER to assist with care and Staff #29 (Dr.) had been called twice with no response. At 3:30 p.m. CNO increased the Dopamine drip to 10meq and documented patient #1's blood pressure as 72/31, pulse 152, respirations 40, and temperature 97.0. Review of the physician's orders revealed no documentation for the order of Dopamine. There was no further nursing documentation noted on this chart.

Review of the physician progress notes dated 09/08/12 at 5:25 p.m. revealed Staff #10 (Dr.) responded to the code and documented "the patient had stopped breathing and had no pulse." Further review revealed Staff # 11 (Dr.) had already responded, intubated the patient, and initiated ACLS (advanced cardiac life support). Patient #1 was in a Pulseless Electrical Activity rhythm (has a heart rhythm that is not creating a pulse.); pupils were fixed with no reaction and he was placed on a ventilator. The patient continued to decline and had a femoral blood pressure of 34/13. A Dopamine bolus was given. Patient #1 continued to deteriorate and expired at 5:24 p.m. Staff #10 (Dr.) discussed the patient's situation with the family and the patient was then removed from the ventilator. Staff #10 documented cause of death was "Aspiration pneumonia, lead to respiratory arrest, then cardiac arrest and cerebral anoxia."

In an interview with CNO on 11/14/2012 at 9:20 a.m., he stated "I do not remember this patient. I just heard about him yesterday." He was then given the patient's chart to review. Upon reviewing the nurse's notes he stated. "Oh yes I remember this patient. The patient was transferred to ICU because of a breathing problem. We were short staffed so the ICU was closed. I was notified by Staff #25 that she had ICU orders. I had to take on the role of ICU nurse because I had absolutely no one that would come in and work. I tried calling everyone. The NP had written orders for ICU and he had left. I didn't know physician Staff #29 (Dr.) was out of town and that Staff #8 (NP) was covering." The CNO was asked if he remembered the family asking to put the patient on the vent. CNO stated, "I don't recall that". CNO was asked where the order was for the Dopamine he had started in the ICU and what physician gave him the order. CNO stated, "I did call the nurse practitioner and I tried to call Staff # 29 (Dr.) twice but he did not answer. Then I had to call the ER doctor. I know there was an order it must be missing." Further review of the medical record revealed the CNO's nursing notes ended at 3:30 p.m. The patient did not expire until 5:24 p.m. CNO stated "the nurse's notes from 3:30 p.m. on must be missing, I am sure I wrote more". Upon further questioning CNO stated, "I didn't document on nurses notes past 1530." CNO stated, "I was trying to get the family to tell me if they wanted to make their father a DNR. It was very confusing and difficult to get them to make a decision." When questioned about the possibility of transferring the patient to a higher level of care, CNO stated, "a transfer was never discussed and it is frowned upon by administration." CNO was questioned on what interventions he performed to save this patient. He paused for a long period of time and shrugged his shoulders. He became emotional and tearful. CNO shook his head no. He stated, "I realize this is a horrible mess. I did not do everything I could to help this patient."

Review of personnel files revealed CNO, with a hire date of 04/22/11, did not have a current ACLS (Advanced Cardiac LIfe Support) and there were no current nursing or Intensive Care competencies .






2. Review of the emergency department (ED) nurses record revealed Patient #10 was a [AGE] year old male who presented to the ED 10/30/12 at 6:46 p.m. with complaints of sore feet. The triage notes revealed the patient had a pain level of 1 out of a scale of 1-10 and vital signs of 138/96 blood pressure, 92 pulse, 16 respirations and an oral temperature of 98.7.

Review of an ED physician assessment dated [DATE] revealed the initial clinical impression on Patient #10 was an "abnormal EKG (echocardiogram), leg pain, Non ST (myocardial infarction) and congestive heart failure." The patient was complaining of "hurting".

Review of an ED physician history and physical dated 10/30/12 revealed the "patient appeared uncomfortable. He is lying in the floor in the ER complaining that his feet are hurting." He had "bilateral basal rales to his mid chest. He looked anxious and was dry. His extremities had "2+ edema."

There was no documentation of any medications administered or nursing interventions put into place to address the anxiety or pain.

Review of the ED nurses record dated 10/30/12 at 8:50 p.m., revealed Patient #10 was discharged to the medical-surgical floor and was documented as being improved and stable.

Review of nursing progress notes dated 10/30/12, 8:57 p.m. revealed the patient was moved to a room closer to the nursing station because "he was yelling out and going to others rooms." There was documentation he had "bilateral pedal edema, patient refused to go to bed, sitting in the floor, laying under the bed, continuing to yell out and refused the exam."

Review of a Registered Nurse admission assessment dated [DATE], 9:00 p.m. revealed the patient had "anxiety, complained of shortness of breath and had diminished breath sounds." He complained of "abdominal pain, hypoactive bowel sounds and distended abdomen." Patient #10 was "complaining of hurting all over his body." There was documentation at the bottom of the assessment the physician was notified at 9:00 p.m. There was no documentation why physician was notified. There were no nursing interventions implemented to address the pain, shortness of breath nor the anxiety.
Review of a physician's order dated 10/30/12 at 9:11 p.m. revealed Patient #10 was being admitted with diagnoses of congestive heart failure exacerbation, non ST- myocardial infarction, acute renal failure and hypernatremia. There were physician orders for the pain medication agent Demerol 12.5 milligrams (mgs) intravenously (IV) every 4- 6 hours prn and the anti-anxiety agent Ativan 1mgs IV every 4-6 hours prn, the diuretic agent Lasix 40 mg IV BID (twice a day), respiratory treatments, and Duonebs every 4-6 hours. There were no orders for oxygen therapy listed.

Review of nursing progress notes dated 10/30/12 written by Staff #28 (LVN) revealed the following:

*At 10:30 p.m. the patient was "given Ativan 1mg IV due to him yelling for 30 minutes."

*At 11:30 p.m. the patient was put "back to bed with assist."

*At 11:34 p.m. the patient was "back on the floor."

Review of nursing progress notes dated 10/31/12 written by Staff #28 (LVN) revealed the following:

*At 1:30 a.m. the patient was "incontinent of feces and back into the floor."

*At 2:10 a.m. the patient was given "Ativan 1mg IV, was yelling out occasionally and very uncooperative."

*At 3:10 a.m. the patient was "put back to bed twice." Staff documented they "watched the patient for 5 minutes and he crawled back to the floor twice, was rolling on the floor and then slept. He would yell out occasionally and would not stay in bed."

*At 6:00 a.m. the patient was "back on the floor and refused to stay in bed " ....

*At 6:10 a.m. the patient "verbally refused vital signs and blood draw."

*At 6:50 a.m. the patient was "on the floor foaming from the mouth" and the doctor was notified.

There was no documentation of a continued nursing assessment of vital signs, pain, abdominal status or respiratory by nursing after admission. There was no documentation nursing interventions were attempted, no notification to the physician, no pain medication administered, and no documentation that Staff #28(LVN) reported to an RN of the patient's condition, between 10:30 pm, 10/30/12, and 6:50 am, 10/31/12.

Review of nursing progress note dated 10/31/12 which was written by Staff #30 revealed the following:

*At 0700 a.m. "the patient lying in the floor, moving from side to side, non-verbal, grunting and was foaming at the mouth. He was placed back into the bed with assist and the doctor was called". There was no documentation of a nursing assessment of vital signs, pain, abdominal status or respiratory status.

*At 7:40 a.m. (40 minutes later),"the patient's blood pressure was 140/112, heart rate was 121, unable to get the oxygen saturation, and respiratory called. Treatment and oxygen placed on, patient suctioned, Lasix 40 mg IV given, Catapress patch ordered and placed on and his sister was called." Review of respiratory notes dated 10/31/12 timed 7:50 a.m. confirmed the information about the oxygen saturation, breathing treatments and suctioning.

*At 8:15 a.m. the patient's "sister arrived and talked to the patient who was still turning from side to side and trying to get up, Foley catheter was placed after Lasix given, respiratory treatments, oxygen and suctioning still going on. Patient stopped breathing and sister stated she wanted no intervention. Patient was pronounced dead by the doctor."

Review of the medication administration record for 10/30/12 and 10/31/12 revealed no pain medication was administered to the patient during the hospitalization . There was no nursing assessment of his pain level documented after the initial nursing assessment at 9:00 p.m. on 10/30/12.

During an interview on 11/20/12 at 8:35 a.m., Staff #28 reported he was the patient's nurse when he got to the floor on 10/30/12. The patient was "up and down, refusing care and I did not know what was wrong with him. Other staff was telling me that was how the patient usually acted when he was a patient here before." Staff #25 "had not passed the information onto me that the patient was having pain. I did not give him any pain medication during my shift. When I was giving report to Staff #30 we found the patient in the floor, not responding, incontinent and foaming at the mouth. We put him back to bed and I went and called the doctor. Afterwards Staff #30 took over the patient's care."

During an interview on 11/15/12 at 4:35 p.m., Staff #30 reported she relieved Staff #28 at 6:45 a.m. on 10/31/12. "While taking report we found the patient laying on the floor and grunting. Something was wrong with him. We put him back to bed and called respiratory. Respiratory could not get oxygen saturation." Staff #30 confirmed "none of the patient's pain medication had been administered."

During an interview on 11/15/12 at 4:25p.m., the CNO reported "I knew about the incident. The patient was up and down all night and complaining of pain. The staff should have done more than just put him back to bed." CNO reported "I was just looking into the incident this week (which occurred two weeks prior), but could not do any investigation because the surveyors were in the building."

Review of a death summary dated 10/31/12 revealed the patient had an "acute cardiopulmonary arrest and was in respiratory distress." The doctor documented that "Early morning, I came in to see the patient. He was out of the bed and not cooperating. He was desaturating to 60 percent. He was put on Duoneb treatment and suctioned, he improved to 70 percent, but he was with a thick secretion. He never regained consciousness, never talked to me and he was agitated and belligerent. I contacted the family members including the sister and discussed resuscitation plan. At 8:50 a.m. the patient was pronounced deceased ".
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observation, document review, and interview the facility failed to:

A. Enforce the established police for daily check of crash carts.

A review of the nursing policy titled, Crash Carts, documented, 1."Crash carts will be checked daily on the units during hours of operation."

A review of the documents titled, "Resuscitation Cart Checklist" (Crash Cart), revealed the crash carts were not being checked daily to ensure the carts in working order and ready if an emergency occurred.

The Surgical Crash Cart was not checked as required for the months of:
July not checked 28 days of the required 31 days.

August not checked 2 days of the required 31 days.

September not checked 10 days of the required 30 days.

October not checked 24 days of the required 31 days.

November not checked 10 days of the required 15 days.

The Intensive Care Crash Cart was not checked as required for the months of:
May not checked 13 days of the required 31 days.

No documentation for the month of June.

No documentation for the month of July.

August not checked 27 days of the required 31 days.

September not checked 2 days of the required 30 days.

October not checked 6 days of the required 31 days.

November not checked 7 days of the required 15 days.

The Medical Surgical Unit housed two adult crash carts. For the purpose of the report the carts will be labeled Crash Cart #1 and Crash Cart #2.

The Medical Surgical Unit's Crash Cart #1 had all the required checks.

The Medical Surgical Unit's Crash Cart #2 did not have the required checks for the months of:
June not checked 5 of the required 30 days.

July was checked 31days of the required 31 days.

August was checked 31 days of the required 31 days.

September not checked 2 days of the required 30 days.

No documentation the cart was checked for the month of October.

No documentation the cart was being checked for the month of November.


B. Ensure preventative maintenance was being done for patient care equipment.

While touring the facility and throughout the investigation conducted on 09/13/2012 until 09/15/2012, random equipment was checked for preventative maintenance.

During observations on 11/13/12 the following equipment did not have current preventative maintenance checks:

Medical Surgical Unit
11:20 a.m., Two adult defibrillator/monitor on the crash cart #1 and #2 were due for inspection.

Operating Room
11:22 a.m., a defibrillator/monitor on the crash cart was due an inspection 07/12.

11:30 a.m., a heart monitor was due to be inspected 10/11

Day Surgery Room
12:00 p.m., intravenous pump was due an inspection 07/12 and a heart monitor in the same room was due an inspection 07/12.

12:05 p.m., a heart monitor was due an inspection 07/12.

12:07 p.m., a heart monitor was due an inspection 07/12.

During an interview on 11/13/12 at 12:05 p.m., CNO (Chief Nursing Officer) said the company who did the inspections on the equipment came out every 3 months or every 6 months. He was not really sure.

Respiratory equipment storage room
At 1:45 p.m. a Bi-PAP machine was due an inspection 07/12.

emergency room
During observations on 11/15/12 the following equipment did not have current preventative maintenance checks:

At 9:10 a.m. a defibrillator/monitor was on the crash cart in Treatment room #2 and was due an inspection 07/12.

At 9:15 a.m. a defibrillator/monitor was on the crash cart in Treatment room #1 and was due an inspection 07/12.

At 9:35 a.m., an intravenous pump in Treatment room #2 had an inspection sticker dated 01/11.

Interview and review of emails with the Bio Medical Company that provides the preventative maintenance revealed the facility owes $2706.25 for services rendered and will not provide any other service for the facility until payment is made.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on document review and interview, the facility failed to provide evidence of an Infection Control Program. The facility failed to provide Infection Control Policies and Procedures, including a system for identifying, reporting and investigating healthcare associated infections. The facility also failed to maintain a log of all reportable diseases.

A review was done of the, Governing Board Committee Meeting Minutes for January 26, 2012, February 23, 2012, March 29, 2012, April 26, 2012, May 17, 2012, June 21, 2012, July 26, 2012, August 23, 2012 and September 27, 2012 and these documents revealed no Infection Control being reported.

On tour of the Scope Procedure Room on 11/13/2012 at 11:00 AM with CNO (Chief Nursing Officer) and staff # 2, the endoscopy scopes were observed hanging in the endoscopy cabinet touching the floor of the cabinet. On the floor of the scope cabinet was a green towel where brown substance had leaked onto the towel from the scope. Also observed on the scope processing machine, there was a bottle of water that supplies the water irrigation to the scope during the procedure. The bottle was still present from the endoscopy procedure done on 11/9//2012. The sterile water irrigation bottle that replenishes the water in the bottle on the machine had expired 10/15/2012.


The endozyme instrument brush for cleaning the scopes was found stored in a cabinet where the scopes are cleaned. The scope brushes had all expired. One brush expired 5/2010, ten brushes expired 6/2010, and six brushes expired 8/2010. The container holding all the brushes had approximately 4 used brushes in with the expired bushes. There were no endozyme sponges used to clean scopes, found in the processing room.


Interview with staff #2 on 11/13/2012 at 12:30 confirmed leak testing of the scopes was not being done, brushes that were expired and used brushes had been reused to clean scopes, and there were no available sponges for cleaning the scopes.


It was observed in the Processing Room, a pan of Cidex OPA (Cidex solution) for high disinfection of the endoscopy scopes. Staff #2 was not able to produce the CIDEX OPA Solution Test Strips that are needed for checking the concentration of ortho-phthalalldehyde in the Cidex solution. There was no log documenting the Cidex was being checked and/or monitored.


Review of the manufacturer's recommendation for use of the Cidex revealed, "CIDEX OPA Solution may be reused for up to a Maximum of 14 days provided the required conditions of ortho-phthalaldehyde concentration and temperature exist based upon monitoring described in the Direction for use. Do not rely solely on day in use. Concentration of this product during its reuse life must be verified by the CIDEX OPA Solution Test Strips prior to each use to determine that the concentration of orto-phthalaidehyde if above the MEC of 3%. The product must be discarded after 14 days."


Staff #2 was interviewed throughout the tour of the Surgical Department on 11/13/2012. Staff #2 confirmed there was no log being maintained for the monitoring of when the Cidex was being tested for the effectiveness of the concentration. Staff #2 reported that the active ingredient ortho-phthalaldehyde in the Cidex solution was not being monitored because the facility had not purchased the required Cidex OPA Solution Test Strips in over 2 months. When questioning Staff #2 about the log for testing the Cidex solution, he stated, "I did not know that a monitoring log of the Cidex solution had to be kept." Staff #2 confirmed the last endoscopy procedure was done on 11/09/2012 and the endoscopy scope was processed in the Cidex solution that had never been tested for the effectiveness of concentration. There were 18 completed scheduled endoscopy cases done in the facility from June 18, 2012 thru November 9, 2012 without the Cidex solution being tested for the effectiveness of the concentration.


Interview with Staff #2 on 11/13/2012 at 12:00 PM confirmed no processing of the scopes prior to the surgical procedure.


Review of the Association of Peri-Operative Registered Nurses (AORN) "2009 Peri-Operative Standards and Recommended Practices", AORN recommended that flexible endoscopes be reprocessed before use if unused for more than 5 days.


During the tour and interview with staff #2, questioned if scopes are reprocessed prior to the surgical procedure. Staff #2 reported scopes are cleaned after the procedure and hung back on the endoscopy cabinet till the next scheduled case. No prior cleaning is done before the case. Review of operating log /register and interview with Staff #2 revealed scheduled cases for the last 6 months have been (6) in June, ( 1) in July, (1) in August, (8) in September, (1) in October, (1 ) in November in which confirms storage of the scopes have been longer than 7 days between cases.


During the tour with CNO and #2 on 11/13/2012 at 12:00 PM observed expired supplies, broken equipment, and equipment with preventive maintenance inspections due 7/12/2012.


Gastrointestinal Lab
Bite block expired 8/2011
Endoscopy tubing 10/2012
Pentax EPK -1000 Laparoscopic processing machine and camera had preventive maintenance due 7/2012
Anesthesia Machine had preventive maintenance due 7/2012, observed on the anesthesia machine tubing with brown substance and along the base of anesthesia machine was a brown splattered substance.

Day Surgery
Intravenous pump had preventive maintenance due 7/2012
#1 Heart Monitor had preventive maintenance due 7/2012
#2 Heart Monitor had preventive maintenance due 7/2012
Cardiac Monitor was broken and the defibrillator paddles were missing
Open circumcision tray was lying on top of the crash cart
#1 Suction canister was found with dried pink substance at the bottom of it which appeared to be sputum, and a clear plastic bag covering it with tubing attached.
#2 Suction canister was found with dried brown substance at the bottom of it which appeared to be sputum, and a clear plastic bag covering it with tubing attached.

Sterile Processing Room
Two large card board boxes filled with various types of expired surgical supplies (available to staff for patient use)

Supply Closet in Surgery
Sterile water 3000cc bag X 2 expired 10/2012 on the shelf.
Sterile water 3000cc bag X 1 expired 10/2012 found in the warmer.
Card board boxes were found in the supply closet in the surgery suite.

Interview with CNO on 11/13/2012 at 1:00 PM confirmed Gastrointestinal
Lab, Day Surgery, Sterile Processing Room, and the supply closet in surgery had expired supplies, broken equipment and preventive maintenance inspections that were not current on equipment, and dirty supplies available to staff for patient use.

Observed on tour of the facility, the washer for the instruments had a graph showing if the washer reached a certain water temperature for proper cleaning. The graph had been left there without being replaced. The red circle was a solid red circle with no elevated lines showing the water temperature of the washer. Questioned staff #2 why the graph paper was never changed and he reported the facility did not have any more graph paper.

Interview with staff #2 on 11/14/2012 at 2:00 PM confirmed the autoclave inspection labels read July 2012 on both autoclaves and the graph paper has not been changed in the washer due to insufficient supplies by the facility. Staff #2 confirmed that he has no idea if the washer is reaching the water temperature recommended by the manufacture.

Review of facility policy titled "Decontamination, Sorting, and Sterilization of Contaminated Instruments and Equipment:"

PROCEDURE: PACKAGING. WRAPPING, STERILIZATION AND STORAGE OF SURGICAL INSTRUMENTS.
1. Assembles instrument sets according to established lists.
2. Places sterilization indicators in densest area of the package.
3. Wraps/contains instruments using nonwoven CSR wrap (two layers), peel pouches, or rigid case.
4. Labels package with name of instrument or set, tags with load lot number and records on autoclave load record.

Review of record titled "3M Attrest load list and Process Monitor Documentation System" revealed sterilization log did not include load identification, indicator results, and identification of the contents of the load when using the autoclave in the Surgery Department. In the sterile processing room surveyor observed a tray with instruments and numerous sterilization strips that had not been recorded in the "3M Attrest Load List and Process Monitor Documentation System.

Interview with staff #2 on 11/14/2012 at 2:00 PM confirmed, the improper use of the sterilization log would cause a problem in identifying contaminated instruments from a load not logged properly. Staff #2 also confirmed the sterilization log was not being done on all loads of surgical instruments being processed.

On tour of the decontamination area on 11/14/2012 at 2:00 PM observed contaminated instruments sitting on the counter top, in the sink, and in the cart (the cart is used to carry clean instruments to the surgical suite from sterile processing area). The cart was found in the decontamination area with sterile and contaminated instruments inside it. The decontamination room had contaminated instruments that remained in the same place during the survey for 3 consecutive days. Survey dates were 11/13-15/2012. The last surgical case was completed on 11/12/2012.

The washer for the instruments has a graph showing if the washer reaches a certain water temperature for proper cleaning. The graph had been left there without being replaced. The red circle was a solid red circle with no elevated lines showing the water temperature of the washer. Questioned staff #2 why the graph paper was never changed and he reported the facility did not have any more graph paper.

Interview with staff #2 on 11/14/2012 at 2:00 PM confirmed the contaminated instruments have been sitting in the decontamination room since 11/12/2012 when the case was completed. Staff #2 also confirmed the graph paper has not been changed in the washer due to insufficient supplies by the facility. Staff #2 confirmed that he has no idea if the washer is reaching the water temperature recommended by the manufacture.

Review of the facility's Surgery policies revealed no policy on recording temperature and humidity in the area where sterile supplies are stored.

Review of the AORN (Perioperative Standards and Recommended Practices), "Temperature should be maintained between 68 degrees F to 73 degrees F. These recommendations apply to both operating rooms and sterile processing areas. A relative humidity level of 30 to 70 percent is acceptable. Room temperature, humidity, and ventilation of each work area should be monitored and recorded daily."
Review of record with the temperature and humidity recorded revealed the following:
Operating Room #1
July--21 of 31 days temperature/humidity was not monitored
August --20 of 31 days temperature/humidity was not monitored
September--19 of 30 days temperature/humidity was not monitored
October--26 of 31 days temperature/humidity was not monitored
November --10 of 15 days temperature/humidity was not monitored

Operating Room #2
July--20 of 31 days temperature/humidity was not monitored
August --22 of 31 days temperature/humidity was not monitored
September--22 of 30 days temperature/humidity was not monitored
October--26 of 31 days temperature/humidity was not monitored
November --10 of 15 days temperature/humidity was not monitored

Operating Room #3
The months July through November 15th the temperature/humidity was never monitored for operating room #3.

Sterilization Room
The months July through November 15th the temperature/humidity was never monitored and there was no documented record that the sterilization room was ever monitored.

Interview with staff #2 confirmed temperatures and humidity was not being recorded daily for Operating Room #1, #2, #3, and/or the sterilization room.

During interviews with CNO, who identified himself as the Infection Control Nurse, on 11/14/2012 at 10:00 AM in the Doctor's Lounge, there were multiple requests made of him to provide evidence by way of policy and procedures outlining the facility's Infection Control Program. No policies were provided by CNO. CNO was asked to provide documentation/reports that the facility was providing infection control training, monitoring infections of patients or employees. CNO confirmed there were no reports. CNO provided a notebook containing lab reports and he confirmed these reports were not being tracked or trended into a report.

It was determined this deficient practice created an Immediate Jeopardy situation and placed patients at risk of potential harm, serious injury, and subsequent death. These failed practices had the potential to affect all patients admitted to the facility
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on record review, observation, and interview the facility failed to:

A. provide a sanitary environment to prevent infections in the surgical setting.

On tour of the Scope Procedure Room on 11/13/2012 at 11:00 AM with CNO (Chief Nursing Officer) and staff # 2, the endoscopy scopes were observed hanging in the endoscopy cabinet touching the floor of the cabinet. On the floor of the scope cabinet was a green towel where brown substance had leaked onto the towel from the scope. Also observed on the scope processing machine, there was a bottle of water that supplies the water irrigation to the scope during the procedure. The bottle was still present from the endoscopy procedure done on 11/9//2012. The sterile water irrigation bottle that replenishes the water in the bottle on the machine had expired 10/15/2012.

An interview and record review of the cleaning process of the endoscopy scopes with staff #2 revealed leak testing of the scopes is not done. The endozyme instrument brush for cleaning the scopes was found stored in a cabinet where the scopes are cleaned. The scope brushes had all expired. One brush expired 5/2010, ten brushes expired 6/2010, and six brushes expired 8/2010. The container holding all the brushes had approximately 4 used brushes in with the expired bushes. There were no endozyme sponges found in the processing room.

Interview with staff #2 on 11/13/2012 at 12:30 p.m. confirmed leak testing of the scopes was not being done, brushes that were expired and used brushes had been reused to clean scopes, and there were no available sponges for cleaning the scopes.

It was observed in the Processing Room, a pan of Cidex OPA (Cidex solution) for high disinfection of the endoscopy scopes. Staff #2 was not able to produce the CIDEX OPA Solution Test Strips that are needed for checking the concentration of ortho-phthalalldehyde in the Cidex solution. There was no log documenting the Cidex was being checked and/or monitored.

Review of the manufacturer's recommendation for use of the Cidex revealed, "CIDEX OPA Solution may be reused for up to a Maximum of 14 days provided the required conditions of ortho-phthalaldehyde concentration and temperature exist based upon monitoring described in the Direction for use. Do not rely solely on day in use. Concentration of this product during its reuse life must be verified by the CIDEX OPA Solution Test Strips prior to each use to determine that the concentration of orto-phthalaidehyde if above the MEC of 3%. The product must be discarded after 14 days."

Staff #2 was interviewed throughout the tour of the Surgical Department on 11/13/2012. Staff #2 confirmed there was no log being maintained for the monitoring of when the Cidex was being tested for the effectiveness of the concentration. Staff #2 reported that the active ingredient ortho-phthalaldehyde in the Cidex solution was not being monitored because the facility had not purchased the required Cidex OPA Solution Test Strips in over 2 months. When questioning Staff #2 about the log for testing the Cidex solution, he stated, "I did not know that a monitoring log of the Cidex solution had to be kept." Staff #2 confirmed the last endoscopy procedure was done on 11/09/2012 and the endoscopy scope was processed in the Cidex solution that had never been tested for the effectiveness of concentration. There were 18 completed scheduled endoscopy cases done in the facility from June 18, 2012 thru November 9, 2012 without the Cidex solution being tested for the effectiveness of the concentration.

Interview with Staff #2 on 11/13/2012 at 12:00 PM confirmed no processing of the scopes prior to the surgical procedure.

Review of the Association of Peri-Operative Registered Nurses (AORN) "2009 Peri-Operative Standards and Recommended Practices", AORN recommended that flexible endoscopes be reprocessed before use if unused for more than 5 days.

During the tour and interview with staff #2, questioned if scopes are reprocessed prior to the surgical procedure. Staff #2 reported scopes are cleaned after the procedure and hung back on the endoscopy cabinet till the next scheduled case. No prior cleaning is done before the case. Review of operating log/register and interview with Staff #2 revealed scheduled cases for the last 6 months have been (6) in June, (1) in July, (1) in August, (8) in September, (1) in October, (1) in November in which confirms storage of the scopes have been longer than 7 days between cases.

During the tour with CNO and Staff #2 on 11/13/2012 at 12:00 PM observed expired supplies, broken equipment, and equipment with preventive maintenance inspections due 7/12/2012.

Gastrointestinal Lab
Bite block expired 8/2011
Endoscopy tubing 10/2012
Pentax EPK -1000 Laparoscopic processing machine and camera had preventive maintenance due 7/2012
Anesthesia Machine had preventive maintenance due 7/2012, observed on the anesthesia machine tubing with brown substance and along the base of anesthesia machine was a brown splattered substance.

Day Surgery
Intravenous pump had preventive maintenance due 7/2012
#1 Heart Monitor had preventive maintenance due 7/2012
#2 Heart Monitor had preventive maintenance due 7/2012
Cardiac Monitor was broken and the defibrillator paddles were missing
Open circumcision tray was lying on top of the crash cart
#1 Suction canister was found with dried pink substance at the bottom of it which appeared to be sputum, and a clear plastic bag covering it with tubing attached.
#2 Suction canister was found with dried brown substance at the bottom of it which appeared to be sputum, and a clear plastic bag covering it with tubing attached.

Sterile Processing Room
Two large card board boxes filled with various types of expired surgical supplies (available to staff for patient care usage)

Supply Closet in Surgery
Sterile water 3000cc bag X 2 expired 10/2012 on the shelf.
Sterile water 3000cc bag X 1 expired 10/2012 found in the warmer.
Card board boxes were found in the supply closet in the surgery suite.

Interview with CNO on 11/13/2012 at 1:00 PM confirmed Gastrointestinal Lab, Day Surgery, Sterile Processing Room, and the supply closet in surgery had expired supplies, broken equipment and preventive maintenance inspections that were not current on equipment, and dirty supplies available to staff for patient use.

B. provide and maintain an environment for sterile processing of surgical instruments with a qualified staff member over the sterilization department, proper use of external chemical indicators and biological testing, recording of sterilization logs, and continued education and training for the staff on sterilization of supplies. The Surgical Department has performed 82 cases from 6/6/2012 thru 11/12/2012.

Review of records revealed no supervision of the sterile processing room.

Interview with CNO and Staff #2 on 11/14/2012 at 3:00 PM confirmed there was no one over the sterilization room with any training or experience to oversee the processing was done according manufacturer's guidelines.

Review of personnel record for staff #2 revealed no documentation of education on sterilization of supplies and/or processing of scopes. The personnel record dated 9/27/2011 of the job description and the only record in the file is written by the evaluator that staff #2 needs to "look at continuing education to enhance knowledge in sterile processing through certification program." The employee wrote, "there is a lot of space for improvement regarding new methods of packing, sterilizing, education which can be done with frequent orientation." The personnel file reveals no education or training in the sterilization area or the processing of the endoscopy scopes.

Interview with CNO on 11/15/2012 at 3:30 PM confirmed he had not taken any type of education courses on sterilization of supplies and equipment since being hired at the facility. CNO also confirmed education courses for sterilization of supplies had not been provided by the facility.

Observed on tour of the sterile processing room on 11/14/2012 at 2:00 PM with staff #2, the autoclave last inspection was on July 2012. The autoclave in the Surgery department last inspection was also July 2012.

The washer for the instruments has a graph showing if the washer reaches a certain water temperature for proper cleaning. The graph had been left there without being replaced. The red circle was a solid red circle with no elevated lines showing the water temperature of the washer. Questioned staff #2 why the graph paper was never changed and he reported the facility did not have any more graph paper.

Interview with staff #2 on 11/14/2012 at 2:00 PM confirmed the autoclave inspection labels read July 2012 on both autoclaves and the graph paper had not been changed in the washer due to insufficient supplies by the facility. Staff #2 confirmed that he had no idea if the washer was reaching the water temperature recommended by the manufacturer.

Review of facility policy titled, "Decontamination, Sorting, and Sterilization of Contaminated Instruments and Equipment:"

PROCEDURE: PACKAGING. WRAPPING, STERILIZATION AND STORAGE OF SURGICAL INSTRUMENTS.
1. Assembles instrument sets according to established lists.
2. Places sterilization indicators in densest area of the package.
3. Wraps/contains instruments using nonwoven CSR wrap (two layers), peel pouches, or rigid case.
4. Labels package with name of instrument or set, tags with load lot number and records on autoclave load record.

Review of record titled "3M Attrest load list and Process Monitor Documentation System" revealed sterilization log did not include load identification, indicator results, and identification of the contents of the load when using the autoclave in the Surgery Department. In the sterile processing room surveyor observed a tray with instruments and numerous sterilization strips that had not been recorded in the "3M Attrest Load List and Process Monitor Documentation System.

Interview with staff #2 on 11/14/2012 at 2:00 PM confirmed, the improper use of the sterilization log would cause a problem in identifying contaminated instruments from a load not logged properly. Staff #2 also confirmed the sterilization log was not being done on all loads of surgical instruments being processed.

On tour of the decontamination area on 11/14/2012 at 2:00 PM observed contaminated instruments sitting on the counter top, in the sink, and in the cart (the cart is used to carry clean instruments to the surgical suite from sterile processing area). The cart was found in the decontamination area with sterile and contaminated instruments inside it. The decontamination room had contaminated instruments that remained in the same place during the survey for 3 consecutive days. Survey dates were 11/13-15/2012. The last surgical case was completed on 11/12/2012.

The washer for the instruments has a graph showing if the washer reaches a certain water temperature for proper cleaning. The graph had been left there without being replaced. The red circle was a solid red circle with no elevated lines showing the water temperature of the washer. Questioned staff #2 why the graph paper was never changed and he reported the facility did not have any more graph paper.

Interview with staff #2 on 11/14/2012 at 2:00 PM confirmed the contaminated instruments have been sitting in the decontamination room since 11/12/2012 when the case was completed. Staff #2 also confirmed the graph paper had not been changed in the washer due to insufficient supplies by the facility. Staff #2 confirmed that he had no idea if the washer was reaching the water temperature recommended by the manufacturer.

Review of the facility's Surgery policies revealed no policy on recording temperature and humidity in the area where sterile supplies are stored.
Review of the AORN (Perioperative Standards and Recommended Practices), "Temperature should be maintained between 68 degrees F to 73 degrees F." These recommendations apply to both operating rooms and sterile processing areas. A relative humidity level of 30 to 70 percent is acceptable. "Room temperature, humidity, and ventilation of each work area should be monitored and recorded daily."

Review of record with the temperature and humidity recorded revealed the following:
Operating Room #1

July--21 of 31 days temperature/humidity was not monitored

August --20 of 31 days temperature/humidity was not monitored

September--19 of 30 days temperature/humidity was not monitored

October--26 of 31 days temperature/humidity was not monitored

November --10 of 15 days temperature/humidity was not monitored


Operating Room #2

July--20 of 31 days temperature/humidity was not monitored

August --22 of 31 days temperature/humidity was not monitored

September--22 of 30 days temperature/humidity was not monitored

October--26 of 31 days temperature/humidity was not monitored

November --10 of 15 days temperature/humidity was not monitored


Operating Room #3
The months July through November 15th the temperature/humidity was never monitored for operating room #3.

Sterilization Room
The months July through November 15th the temperature/humidity was never monitored and there was no documented record that the sterilization room was ever monitored.

Interview with staff #2 confirmed temperatures and humidity was not being recorded daily for Operating Room #1, #2, #3, and/or the sterilization room.

C. ensures the organizational chart within the Surgical Department delegates the authority and responsibility of running the Surgery Department.
Refer to A0941

D. provides operating room supervision.
Refer to A0942

E. ensures supervision by an experienced surgical registered nurse in the surgical cases being performed at this facility. There were 4 of 5 (CNO, #5, #16, #20, and #22) nurses that have worked in the Surgery Department without experience or competencies in surgery. One (#16) of 4 (CNO, #5, #20, and #22) was a Licensed Vocational Nurse.
Refer to A0944

F. provides preventative maintenance (safety inspections) on the equipment in the operating room suites while surgical cases were being performed. The cardiac monitor had not been checked daily per the facility policy.

Refer to A0956

G. provides available staff, equipment, supplies, and clean space for postoperative patient care area.

Refer to A957

H. provide an ongoing process of the QAPI (quality assurance performance improvement) program that measures, analyzes, tracks adverse patient events, infection control, and other aspects of performance improvement for the surgical department.

Review of meetings titled, "P&T, Infection Prevention & Control & Employee Health Quality Report dated February 21, 2012 thru September 12, 2012 revealed no evidence of routine collection, organization, follow-up, and evaluation of data being processed from the surgical department for quality assurance.

There was no evidence of documentation that any staff member had taken responsibility for collecting, measuring, analyzing, or tracking performance improvement in the surgical department for the facility.

An interview with CNO and Staff #2 on 11/15/2012 at approximately 2:30 PM confirmed no QAPI (quality assurance performance improvement) had been collected, measured, analyzed, or tracked in the surgical department for the facility.

It was determined this deficient practice created an Immediate Jeopardy situation and placed patients at risk of potential harm, serious injury, and subsequent death. These failed practices had the potential to affect all patients admitted to the facility.
VIOLATION: ORGANIZATION OF SURGICAL SERVICES Tag No: A0941
Based on record review and interview the facility failed to ensure the organizational chart within the Surgical Department to who has the authority and responsibility of running the surgery Department.

Review of records revealed no surgical organizational chart for the department delegating who is responsible the running of the Surgical Department.

Review personnel file for CNO (Chief Nursing Officer) revealed a job description for a Chief Nursing Officer with no signature and no surgical competencies for the Surgery Department and no documented experience of ever working in a Surgery Department. Personnel file revealed no documentation of current Advanced Cardiac Life Support which is required by facility.

Interview with CNO on 11/14/2012 at 3:00 PM confirmed the Director of Surgery left in June 2012. CNO reported he was responsible for the Surgery Department at this time.
VIOLATION: OPERATING ROOM SUPERVISION Tag No: A0942
Based on record review and interview the facility failed to provide operating room supervision.

Review of records revealed one scrub technician for the surgical department. This is the only staff member for the Surgery Department. The Surgery Department does not have a Director of Surgery, the last Director left in June 2012.

Review of records and interview with CNO (Chief Nursing Officer) and #2 on 11/14/2012 at 3:00 PM revealed the staff members used in the surgical department is pulled from different units in the facility.

Interview with CNO on 11/14/2012 at 3:00 PM, confirmed surgical department consisted of one scrub technician. CNO reported the Director of Surgery left in June 2012. CNO confirmed the nurses working in surgery are part-time from the other units in the facility and do not have experience or competencies in surgery.
VIOLATION: POST-OPERATIVE CARE Tag No: A0957
Based on record review, observation, and interview the facility failed to provide available staff, equipment, supplies, and clean space for postoperative patient care area.

Review of personnel files for nurses that have worked in the surgical department according to the record titled, "Register of Operations" revealed there were 5 different nurses that have worked in the surgical department since the Director of Surgery left.

One of the 5 staff members is a Licensed Vocational Nurse (#16) and the other 4 Registered Nurses (CNO, #5, #20, and #22) have no signed job descriptions for working in the Recovery Room, Recovery Room competencies, or experience in working in a Recovery Room.

Review personnel file for CNO (Chief Nursing Officer) revealed a job description for a Chief Nursing Officer with no signature and no recovery competencies for the Recovery Room. No documented experience of ever working in a Recovery Room. File revealed no documentation of current Advanced Cardiac Life Support which is required by facility.

Review personnel file for Staff #5 revealed a job description for the Emergency Department and Medical /Surgical Unit with no signature and no documented competencies for the Recovery Room. File reveals no documented experience of ever working in a Recovery Room.

Review personnel file for Staff #16 revealed a signed job description for LVN/ Medical/Surgical Unit with no date and no documented competencies for the Recovery Room or documented experience of ever working in a Recovery Room. Staff #16 is a Licensed Vocational Nurse, not a Registered Nurse. File revealed no documentation of current Advanced Cardiac Life Support or CPR (Cardiopulmonary resuscitation) which is required by facility.

Review personnel file for Staff #20 revealed a job description for the Emergency Department and Medical/Surgical Unit with no signature and no documented competencies for the Recovery Room. File reveals no documented experience of ever working in a Recovery Room.

Review personnel file for Staff #22 revealed a job description for the Emergency Department and Recovery Room, with no signature and no documented competencies for the Recovery Room. File reveals no documented experience of ever working in a Recovery Room.

Interview with CNO on 11/13/2012 at 3:00 PM, confirmed that the 5 nurses (CNO,#5, #16, #20, and #22) had no job descriptions for the Recovery Room, experience, or competencies for working in the Recovery Room area in this facility.

Observed on tour of the Recovery Room area on 11/13/2012 at 12:00 PM, revealed bag of Ambu bags (resuscitation equipment) and suction tubing in a plastic bag on the floor of the recovery room in the1st bay area where patients are to be cared for. Questioned CNO and staff #2 on why the bag was on the floor and neither staff member could give an explanation why the bag of supplies was on the floor. The cardiac monitor in the recovery room area was due to have preventative maintenance on 10/2011. Intravenous pump at the 1st bay area was due to have preventative maintenance on 7/2012.

The Recovery Room warmer was filled with intravenous fluids x 10 and irrigation solutions x 5 without being dated as to how long fluids had been in the warmer.

Review of the "Association for Professionals in Infection Control" recommendations revealed fluids were not to be stored more than 14 days in the warmer if dated and the temperature less than 104 degrees.

An interview with CNO and staff #2 on 11/13/2012 at 12:00 PM revealed they did not know how long the fluids had been in the warmer.

In the 3rd bay of the recovery room area, a stack of papers (approximately 3 inches thick) was observed which consisted of infection control sheets, patient lab reports, and patient occurrence reports. Questioned CNO why these papers were laid out on the patient care beside table and CNO reported the Infection Control Nurse left in May 2012 and no one has looked at those papers since she left.

An interview with CNO on 11/13/2012 at 12:00 PM reported the Recovery Room was in disarray, and he had not looked at the original paperwork of lab reports, occurrence reports, or the infection control sheets since the Infection Control Nurse left in May 2012.