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Based on observation, interview and record review, the hospital failed to ensure to have an effective Governing Body (GB) to oversee the overall functioning of the hospital as evidenced by:

Findings:

* Failure to ensure the medical staff bylaws included a process to ensure a physician was on duty or on call at all times. Without a designated physician for staff to provide medical care and onsite supervision in case of emergencies, there was the potential for a delay in emergency treatment. See A 49.

* Failure to provide anesthesia and radiology services in an organized manner. No documentation could be provided to show a qualified physician was acting in the role as Director as defined in the Medical Staff bylaws. See A 347 #2.

* Failure to ensure the patient's right to informed decision making was facilitated for six of 31 sampled patients (Patients 34, 36, 37, 42, 43, and 58). See A 131.

* Failure to ensure patients received care in a safe and sanitary setting regarding the physical environment and infection control in the ORs and implementation of infection control practices. See A 144.

* Failure to have an effective QAPI system for identifying problem areas. This resulted in the failure to correct safety issues in the OR which resulted in a power outage during a surgical procedure. The GB failed to ensure the QAPI program monitored and analyzed data regarding the process of daily physician documentation for the necessity of continuing the use of a central catheter. See A 951 #1 and A 748 # 1.

* Failure to ensure nursing services were provided in an effective manner when the competency testing for three of the three RNs reviewed (RN L, P and H), who's job duties included participating in high risk procedures, for the practice of high risk procedures such as medication administration, sedation care and the assessment of heart rhythms was unable to be provided. There was no documentation provided to show follow up was conducted for RN L who was placed on probation for multiple medication errors. During probation, RN L was allowed to transfer to a critical care unit without documentation of competency in that area for six months. See A 397.

* Failure of Pharmaceutical Services to ensure medication orders for a high risk drug were reviewed prior to administration to prevent medication errors. See A 500 #1.

* Failure of Pharmaceutical Services to ensure a medication labeled "refrigerate" was properly stored in the refrigerator. See A 500 #2.

* Failure to ensure compliance with NFPA 70 (1999 edition) as evidenced by: failure to maintain electrical wiring and equipment; failure to respond to past electrical problems; failure to plug high wattage appliances directly into electrical receptacles; and failure to maintain the corridor doors for 3 of 11 smoke compartments. See A 709.

* Failure to ensure an active infection control program was in place and the OR rooms were maintained and sanitary. Holes were observed in the floors and patched holes in the walls were left unpainted, mattresses on the OR tables were ripped and torn, small white pieces of debris were observed on equipment, on top of the sheets on the OR tables and under the sheets on the mattresses. Air vents and the corners of the floor were dirty and equipment was rusting. See A 951 #2.

* Failure to prevent the use of free-standing humidifiers and de-humidifiers in the OR rooms to keep the humidity in the operating rooms within limits. This practice was contrary to the 2010 AORN Perioperative Standards and Recommended Practices, which showed free-standing humidifiers should not be used because they can harbor germs in the fluid reservoirs and aerosolize these germs into the clean environment. See A 951 #4.

* Failure to ensure contracted dialysis nurses followed infection control practices when giving care to patients in the hospital. See A 748 # 5.

* Failure to ensure the respiratory services policies and procedures addressed the complexity of the patient population and RP (Respiratory Practitioner) roles, responsibilities, and under what circumstances procedures such as intubation (placement of a breathing tube) could be performed. See A 1152.

* Failure to ensure contracted dialysis services were provided in a safe manner, materials were stored properly, and quality assessment was provided to ensure safe patient care. A 084.

The cumulative effect of these systemic practices resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview and record review, the hospital failed to ensure patients were cared for in a safe and sanitary environment as evidenced by:

* Failure to ensure patients undergoing surgical procedures received safe care when an electrical failure occurred during a surgical procedure due to a circuit breaker being overloaded by equipment. A loss of electricity to operating rooms could potentially result in injury or death for patients undergoing surgery/procedures. See A 951 #1.

*Failure to ensure the physical environment in the OR rooms was safe for patients. Observation of the OR suites showed patient equipment that was rusted and mattresses that were ripped and torn; floors and walls were damaged so that disinfection could not be assured; equipment in the OR rooms was covered in a layer of white lint dust; and humidifiers and de humidifiers were being used to correct the humidity levels in the ORs contrary to accepted standards of practice. See A 951 #2.

* Failure to ensure two of two ice machines were cleaned and sanitized according to the manufacturer's recommendations or the policies approved by the infection control oversight committee. This resulted in the potential for patients to be at risk for food borne illness. See A 749.

* Failure to ensure the drain hose containing all the waste products removed from the patient's blood during dialysis treatments were drained in a manner to prevent contamination of handwashing sinks and the possible spread of infection from one patient to another. See A 748 # 5b.

* Failure to ensure the environment was free from hazards that could cause a visitor or a staff member to trip and fall. See A 144 #1.

* Failure to ensure a patient's right to informed decision making was facilitated for six of 31 sampled patients. (Patients 34, 36, 37, 42, 43, and 58). This could potentially result in violating the patient's right to participate in their care decisions. See A 131.

The cumulative effect of these systemic practices resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview and record review, the hospital failed to have an effective QAPI program that involved all hospital departments and services to identify problem areas, focused on indicators to improve health outcomes and included actions to correct environmental safety issues as evidenced by:

* The failure to correct safety issues in the OR which resulted in a power outage during a surgical procedure, putting the patient at risk. See A 951 #1.

* Failure to identify safety issues with the physical environment and infection control in the OR. See A 951 #2, 3, 4 and 5.

* Failure to identify hospital wide safety issues in the physical environment. See A 709 and A 724.

* Failure to identify as a patient safety issue that no organized process was in place to provide a physician on-duty/call 24 hours/day which could potentially result in no physician available for patient emergencies. See A 347 #1.

*Failure to identify as a patient safety issue when no documentation could be provided to show qualified physicians were acting in the role as Directors of Anesthesia and Radiology as defined in the Medical Staff bylaws. See A 347 #2.

* Failure to show Code Blue outcomes were analyzed to identify areas for improvement regarding the intubation of patients by a RP (Respiratory Practitioner). See A 267 #4.

* Failure to ensure the QAPI program monitored and analyzed data regarding the process of daily physician documentation for the necessity of continuing the use of a central catheter. This resulted in the potential for increased infections relating to the use of central catheters. See A 267 # 3.

*Failure to monitor the services of the contracted dialysis provider. See A 84.

The cumulative effect of these systemic practices resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview and record review, the hospital failed to ensure there was an organized medical staff responsible for the quality of care delivered to patients as evidenced by:

Findings:

* Failure to ensure an organized process was in place to provide a physician on-duty/call 24 hours/day which could potentially result in no physician available for patient emergencies. See A 347 #1.

* Failure to ensure there clear organizational expectations for service medical staff department directors when no documentation could be provided to show qualified physicians were acting in the role as Directors of Anesthesia and Radiology as defined in the Medical Staff bylaws. See A 347 #2.

* Failure to provide oversight to ensure surgical services were provided in accordance with acceptable standards of practice regarding infection control and the physical environment. See A 951.

* Failure to provide oversight to ensure the respiratory services P&Ps addressed the complexity of the patient population and RP (Respiratory Practitioner) roles, responsibilities, and under what circumstances procedures, such as intubation, could be performed. See A 1152.

The cumulative effect of these systemic practices resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the hospital failed to ensure nursing services were provided in an organized effective manner as evidenced by:

* Failure to ensure the competency of three RNs for the practice of high risk procedures such as medication administration, sedation care and the assessment of heart rhythms. See A 397.

* Failure to provide documentation follow up was conducted for a RN placed on probation for multiple medication errors. During probation, the RN was allowed to transfer to a critical care unit without documentation of competency in that area for six months. See A 397 #1.

* Failure to ensure two licensed nurses checked the dosage of a high risk medication, heparin, prior to administration. See A 404 #1.

* Failure to ensure a care plan was developed to address dialysis treatments for five of the six patients reviewed (Patients 9, 32, 39, 43 and 54) receiving dialysis on the Medical Surgical unit. See A 396.

* Failure to ensure the access sites of hemodialysis patients were consistently and comprehensively assessed for signs and symptoms of infection, bleeding and patency. See A 395.

*Failure to ensure the hemodialysis access sites of three of the six dialysis patients reviewed (Patients 9, 32, and 54) were consistently assessed for signs of infection, bleeding and patency. See A 395.

The cumulative effect of these systemic practices resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview and record review, the hospital failed to maintain the physical environment to ensure the safety of patients, visitors and staff as evidenced by:

* Failure to ensure surgical services was maintained in a manner to promote the safety of patients undergoing surgical procedures. See A 951 #1.

* Failure to ensure compliance with NFPA 70 (1999 edition) as evidenced by: failure to maintain the electrical wiring and equipment; failure to respond to past electrical problems; failure to plug high wattage appliances directly into electrical receptacles; and failure to maintain the corridor doors for 3 of 11 smoke compartments. See A 709.

* Failure to ensure the designated smoking area of the hospital was located more than 50 feet away from the liquid oxygen tank storage area. See A 709.

* Failure to ensure fire safety regulations were followed when linen was piled up to less than five inches from the fire sprinkler. See A 710.

*Failure to ensure a biohazardous agent was properly contained. See A 724.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview and record review, the hospital failed to ensure an active program was in place to prevent and control the transmission of infections as evidenced by:

Findings:


* Failure to ensure the ORs were well maintained when holes were observed in the floors and patched holes in the walls were left unpainted, mattresses on the OR tables were ripped and torn, small white pieces of debris was observed on equipment, on top of the sheets on the OR tables and under the sheets on the mattress pads. Air vents and the corners of the floor were dirty and equipment was rusting.
See A 951 #2.

* Failure to prevent the use of free-standing humidifiers and de humidifiers in the ORs to keep the humidity within limits. This practice was contrary to the 2010 Perioperative Standards and Recommended Practices, which showed free-standing humidifiers should not be used because they can harbor microorganisms in the fluid reservoirs and aerosolize these microorganisms into the clean environment. See A 951 #4.

* Failure to ensure dialysis nurses followed infection control practices when giving care to patients in the hospital. See A 748 #4

* Failure to ensure the infection control officer monitored the process requiring daily physician documentation of the necessity for continuing a central catheter. This increased the potential for infection in patients for whom the central catheters were no longer necessary. See A 748 #11.

* Failure to ensure the infection control officer developed a system for identifying potential food borne illnesses in the hospital when two of the two hospital ice machines were not cleaned and sanitized according to the manufacturer's recommendations or the policies approved by the infection control oversight committee. This resulted in the potential for patients to be at risk for food borne illness. See A 748 #11.

* Failure to ensure staff implemented the infection control policys of the hospital to disinfect equipment used in an isolation and the wearing and removal of PPE. See A 748 # 5, 7, 8 and 9.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview, and record review the hospital failed to ensure surgical services were provided in accordance with acceptable standards of practice as evidenced by:

* The AORN's Position Statement on Patient Safety, in the 2010 Perioperative Standards and Recommended Practices, showed the operative setting is one of the most potentially hazardous of all clinical environments. The patient is vulnerable with diminished/absent defense mechanisms and the complications that can occur include hemorrhage, burns, and injury.

On 1/26/11 at 0740 hours, an endoscopic procedure (a way of looking inside the body through the esophagus using a flexible tube with a small camera on the end of it) was being observed in OR 1. At 0750 hours, the power to the room went out. The room lights and surgical equipment in the room, which included IV pumps, suction equipment, endoscopic equipment and the computer system, all stopped working and the room was dark. ST 1 told the Director of Surgery to go down the OR hallway to a circuit panel on the left hand side and reset the circuit. The Director of Surgery left the room and after approximately one minute the lights and equipment came back on. At that time ST 1 stated the amount of equipment being used in the OR room had overloaded the electrical capacity of the room.

The endoscopic procedure was the only procedure/surgery scheduled for that day. The Life Safety Surveyors were informed of the event.

On 1/26/11 at 1430 hours, after a further interview of the hospital's surgical staff members and plant operations staff, the survey team notified Administration of Immediate Jeopardy (IJ) to the health and safety of surgical patients. The hospital voluntarily ceased the performance of surgical procedures.

On 1/28/11 at 1205 hours, the hospital's written plan of action to abate the IJ was reviewed and accepted by the survey team. The plan of correction included written evidence provided by a licensed electrician to show repair/replacement of a main circuit breaker and load testing of each OR room with full equipment. The IJ was abated on 1/28/11 at 1205 hours. See A 951 #1.

* The hospital failed to ensure the OR rooms were well maintained when holes were observed in the floors and patched holes in the walls were left unpainted, mattresses on the OR tables were ripped and torn, small white pieces of debris was observed on equipment, on top of the sheets on the OR tables and under the sheets on the mattress pads. Air vents and the corners of the floor were dirty and equipment was rusting.
See A 951 #2.

* Free-standing humidifiers and de humidifiers were used in the OR rooms as needed to keep the humidity in the operating rooms within limits. This practice was contrary to the AORN 2010 Perioperative Standards and Recommended Practices, which showed free-standing humidifiers should not be used because they can harbor microorganisms in the fluid reservoirs and aerosolize these microorganisms into the clean environment. See A 951 #4.

* Surgical staff were observed during a surgical procedure to not completely cover hair and beards per The AORN's 2010 "Perioperative Standards and Recommended Practices, Surgical Attire." See A 951 #5.

The cumulative effect of these systemic practices resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the hospital failed to provide anesthesia services in a well organized manner. No documentation could be provided to show a qualified physician was acting in the role of Director as defined in the Medical Staff bylaws.

Findings:

A review of the hospital's Medical Staff Bylaws showed Service Directors duties included reviewing physicians for hospital privileges, formulating recommendations for general medical staff rules and regulations, giving guidance for policies and procedures, directing and supervising all clinical activities within a service and reporting such activities, including QAPI to the appropriate medical staff committees. In addition a Service Director would serve as a member of the Medical Executive Committee and give guidance on the overall P&Ps of the medical staff and make specific recommendations regarding P&Ps to be utilized in his/her service.

On 1/27/11 at 0935 hours, during an interview, MD M stated he had been the Director of Anesthesiology but was no longer acting in the that role. According to MD M, he had not been acting in the director role for several months. He stated he still was available when needed and would help schedule other anesthesiologists.

On 2/1/11 at 0905 hours during an interview, the hospital's Chief Medical Director stated they regarded MD M as the Director, but realized there was difference of opinion.

A review of the quarterly Department of Surgery meetings for the months August 2010 and November 2010 showed MD M did not attend these meetings.

Based on interview and record review the Governing Body failed to ensure the medical staff bylaws were in compliance with these regulations to provide medical care and onsite supervision in case of emergencies resulting in the potential for a delay in emergency treatment.

Findings:

Review of the medical staff by-laws and rules and regulations failed to show any defined expectation for physicians to respond to emergencies while in the hospital. There was no defined call list of physicians available at all times for emergency care of patients in the hospital.

During an interview on 1/25/11 at 0850 hours, the Nursing Director of ICU stated from 0730 hours until 1900 hours daily, the hospital relied on physicians who happened to be in the hospital at the time to respond to emergencies, or staff called the patient's attending physician. The nurses from the ICU responded to patient emergencies.

On 2/1/11 at 0905 hours during interview, MD O, the hospital's Medical Director, stated the hospital had teams of nurses to respond to medical emergencies. MD O stated the physicians who were in the hospital would respond and/or the patient's primary physician would be contacted and would come in within an hour from their office if needed. See A 067.

Based on interview and record review, the hospital's governing body failed to ensure there was a physician on-duty/call 24 hours/day which could potentially result in no physician available for patient emergencies. The hospital failed to ensure there were clear organizational expectations for department directors which potentially resulted in the lack of oversight of the quality of care in the Anesthesia and Radiology Departments.

Findings:

1. During an interview on 1/25/11 at 0850 hours, the Nursing Director of ICU stated from 1900 hours to 0730 hours, there was an in-house physician on duty. From 0730 hours until 1900 hours, she stated the hospital relied on physicians who happened to be in the hospital at the time to respond to emergencies or staff called the patient's attending physician. The nurses from the ICU responded to patient emergencies (Code Blue - cardiac or respiratory arrest). The charge nurse was the nurse who usually responded to the emergency.

On 2/1/11 at 0905 hours during interview, MD O, the hospital's Medical Director, stated the hospital had teams of nurses to respond to medical emergencies. MD O stated the physicians who were in the hospital would respond and/or the patient's primary physician would be contacted and would come in within an hour from their office if needed. On weekends, when physician offices were closed, MD O stated he was always available. When asked how nurses would know who to call in an emergency if MD O was not available, MD O stated nurses knew the chain and after him there were several pulmonologists available (pulmonologists are physician specialists in the respiratory system).

Review of the medical staff by-laws and rules and regulations failed to show any defined expectation for physicians to respond to emergencies while in the hospital during the hours of 0730 until 1900 hours or for physicians to have ALS (Advanced Life Support) training. The hospital's Code Blue P&P showed any in-house physician with ALS was a Code Blue team member.

On 2/1/11 at 0930 hours, RN Q stated for medical emergencies on the week-ends, the staff would call the patient's primary physician first. The RN stated if the primary physician was unable to respond, staff would then begin calling the patient's consulting physicians. At 0950 hours, RN H was interviewed and she responded with the same sequence as RN Q. Both nurses interviewed functioned as charge nurses.

2. A review of the hospital's Medical Staff Bylaws showed Service Directors duties included, among other duties, reviewing physicians for hospital privileges, formulating recommendations for general medical staff rules and regulations, giving guidance for policies and procedures, and directing and supervising all clinical activities within a service, and reporting such activities, including QAPI to the appropriate medical staff committees. In addition a Service Director would serve as a member of the Medical Executive Committee and give guidance on the overall P&Ps of the medical staff and hospital and make specific recommendations to the Medical Executive Committee regarding P&Ps to be utilized in his/her service.

On 1/27/11 at 0935 hours, during an interview, MD M stated he had been the Director of Anesthesiology but was no longer acting in the that role. According to MD M, he had not been acting in the Director role for several months. He stated he still was available when needed and would help schedule other anesthesiologists.

On 2/1/11, a review of the Officers of the Medical Staff November 1, 2010 to October 31, 2012 showed MD M as the Medical Director of Anesthesiology.

On 2/1/11 at 0905 hours during an interview, the hospital's Chief Medical Director stated they regarded MD M as the Director, but realized there was difference of opinion.

On 2/1/11 at 1535 hours, an interview was conducted with the CEO and CNO/COO regarding the status of the Director of Anesthesiology. The CEO stated MD M was assuming the role of Director, but did not like to refer to it.

A review of the quarterly Department of Surgery meetings for the months August 2010 and November 2010 showed MD M did not attend these meetings.

3. On 2/2/11 at 1530 hours, the Medical Staff Services Director was interviewed. According to the Medical Staff Service's Director, medical services were divided into two departments, Surgery and Medicine. Radiology Services was part of Medicine which met quarterly. A review of the "Officers of the Medical Staff November 1, 2010 to October 31, 2012" showed the Medical Director of Radiology role was a shared role between MD N and MD R. A review of Medicine's medical staff meeting minutes showed MD N and MD R had not attended any meetings for the past year. During interview the Medical Staff Services Director confirmed the physicians had not attended any meetings.

Based on interview and record review, the hospital failed to ensure there was a physician on duty or on call at all times. This could potentially result in a delay or absence of a physician response to patient medical emergencies.

Findings:

Review of the medical staff by-laws and rules and regulations failed to show any defined expectation for physicians to respond to emergencies while in the hospital or for physicians to have ALS (Advanced Life Support) training. The hospital's Code Blue P&P showed any in-house physician with ALS was a Code Blue team member. There was no defined call list of physicians available to staff for emergencies.

During an interview on 1/25/11 at 0850 hours, the Nursing Director of ICU stated from 1900 hours to 0730 hours, there was an in-house physician on duty. From 0730 hours until 1900 hours, she stated the hospital relied on physicians who happened to be in the hospital at the time to respond to emergencies, or staff called the patient's attending physician. The nurses from the ICU responded to patient emergencies (Code Blue - cardiac or respiratory arrest). The charge nurse was the nurse who usually responded to the emergency.

On 2/1/11 at 0905 hours during interview, MD O, the hospital's Medical Director, stated the hospital had teams of nurses to respond to medical emergencies. MD O stated the physicians who were in the hospital would respond and/or the patient's primary physician would be contacted and would come in within an hour from their office if needed. On weekends, when physician offices were closed, MD O stated he was always available. When asked how nurses would know who to call in an emergency if MD O was not available, MD O stated nurses knew the chain and after him there were several pulmonologists available (pulmonologists are physician specialists in the respiratory system).

On 2/1/11 at 0930 hours, RN Q stated for medical emergencies on the week-ends, the staff would call the patient's primary physician first. The RN stated if the primary physician was unable to respond staff would then begin calling the patient's consulting physicians. At 0950 hours, RN H was interviewed and she responded with the same sequence as RN Q. Both nurses interviewed functioned as charge nurses.

Based on observation, interview and policy review, the hospital failed to ensure contracted dialysis services were provided in a safe manner, materials were stored properly, and quality assessment was provided to ensure safe patient care.

Findings:

1. The contracted dialysis provider's policies, used by dialysis staff when giving care in the hospital, were reviewed on 1/26/11. The policies were kept in a binder on the Medical Surgical Unit's nursing station as a reference for all staff. Policy 7-03-01 for Infection Control in the Hospital Dialysis Setting, revised 9/10, showed that items taken into the dialysis station should be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before taken to a common area or used on another patient.

On 1/25/11 at 0900 hours, the storage rooms for the contracted dialysis provider were observed. On the top of the two dialysis machines, which are used between patients, were opened boxes of gloves. Rolls of tape were attached to the IV poles of both machines. Attached to the back of each machine was a large gray plastic container which contained extra supplies, including packages of blood lines, packaged dialyzers, test strips, and a clipboard with blank treatment sheets attached.

On the storage shelves in a box containing bottles of machine test strips was a box containing a 100 mL (milliliter) vial of 25% albumin. The vial had never been opened. The prescription label on the box had partially been removed, but the label showed it was from the hospital.

During an interview with Dialysis Nurse B on 1/25/11 at 1105 hours, she acknowledged the gloves and the tape should not be stored on the machines. The nurse also stated albumin was a medication which should not be stored in the dialysis supply room. If the medication was not used, it should be returned to the pharmacy.

2. Policy 7-15-04, Bleach Policy, revised 9/09, showed that bleach was to be stored separate from other chemicals.

On 1/25/11 at 0900 hours, the storage rooms for the contracted dialysis provider were observed. There were two one-gallon plastic bottles of vinegar (which is an acid) and a one-gallon bottle of bleach on the bottom shelf of a storage unit. These items were to be stored separately. Bleach and an acid, if accidently mixed together, formed a toxic chlorine gas.

During an interview with Dialysis Nurse B on 1/25/11 at 1105 hours, the nurse stated she was not aware these two items should be stored separately. She stated she did not know what would happen if there was an accident and they were mixed together.

3. Provided dialysis services were not monitored by the Governing Body to ensure the contracted staff members were implementing infection control policies when rendering care to dialysis patients. See A 748 # 5.

Based on interview and record review, the hospital failed to ensure the patient's right to informed decision making was facilitated for six of 31 sampled patients. (Patients 34, 36, 37, 42, 43, and 58). This could potentially result in violating the patient's right to participate in their care decisions.

Findings:

Review of the hospital's policy and procedure for informed consent showed it was the physician's responsibility to obtain informed consent from a patient. The consent form should list the name of the practitioner(s) performing the procedure and the name of the physician who informed the patient. Questions regarding the patient's competency to sign a consent should be referred to the physician.

1. On 1/26/11 at 1000 hours, Patient 34's medical record was reviewed.

a. On the outside of the front of Patient 34's medical record was the following handwritten note: patient "wants Doctor to explain process to him before he will sign the consent form."

Further review of the record showed a physician's order, written on 1/24/11, "Consent for Trach" (tracheostomy - a hole cut into the neck to the windpipe to assist with breathing). On 1/25/11 at 0430 hours, the nursing documentation in the narrative notes showed the patient refused to sign the consent for the trach.

The Director of ICU, who was present during the medical record review, was unable to locate documentation by the physician the planned surgery was discussed with the patient.

On 1/26/11 at 1120 hours during an interview, Patient 34 stated he had still not spoken with the physician about the surgery.

b. Review of Patient 34's record showed a surgical consent form for placement of a left chest tube. The form was signed by the patient and witnessed by a hospital employee on 1/21/11 at 1305 hours. The section of the form for the name of the surgeon performing the procedure was blank. When this was shown to RN F on 1/27/11 at 1115 hours, she stated the name of the surgeon performing the procedure should have been on the consent form.


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2. The medical record for Patient 37 was reviewed on 1/25/11 at 1330 hours. Review of an Informed Consent form for the insertion of a PICC line on 1/20/11 was reviewed with the Director of the Medical Surgical Unit. There was no documentation on the form to show the name of the practitioner who would be inserting the PICC line. The Director stated the consent should contain the name of the contracted company who inserted the PICC lines for the hospital so the patient would know to whom he was giving consent for the procedure.

3. The medical record for Patient 42 was reviewed on 1/25/11 at 1355 hours. The patient was admitted to the hospital on 1/6/11. Review of the physician's History and Physical dated 1/6/11, showed dementia was listed as a diagnosis for the patient. Review of the Condition of Admission form showed a family member had the Power of Attorney for the patient.

Review of an Informed Consent form dated 1/25/11, for the insertion of a PICC line, showed the form was signed by Patient 42 at 1235 hours. There was no documentation on the form to show the name of the practitioner who would be inserting the PICC line. On page one of the consent form was a box with a thick black border which stated "Do not sign this consent if you have not read the entire content or do not understand." In the area for Explanation, the name of the physician who had informed the patient of the risks, benefits and alternatives of treatment was blank, and the box had had not been marked off as completed. The area for the physician's signature to document verification the patient received informed consent was not completed.

Patient 42 was interviewed on 1/25/11 at 1415 hours. The patient was asked if she had signed a consent form for a procedure to be done that day. The patient stated she signed a form, but she was unable to remember exactly for what procedure. When asked if her physician had explained to her what was to be done, Patient 42 stated she did not remember.

RN J and the Director of the Medical Surgical Unit were interviewed on 1/25/11 at 1425 hours. RN J stated Patient 42's physician had written the procedure on the consent form the night before. The RN confirmed the physician had not completed the informed consent verification on the form. RN J stated the physician should sign the informed consent form before the procedure was done to verify he had spoken with the patient. RN J stated she had the patient sign the form and thought the patient had understood. The Director of the Medical Surgical Unit stated the name of the contracted company who inserted the PICC lines for the hospital should be on the form so the patient would know to whom she was giving consent to for the procedure. Documentation the patient had a power of attorney for healthcare was reviewed with the Director. The Director was asked to show documentation the patient was competent to make her own decisions for healthcare. The Director stated the patient was documented as alert but was sometimes confused. The Director confirmed she was unable to locate documentation to show the patient's decision making capability.

4. Review of the P&P for Interpreter Services dated 10/10, showed if a form or consent was available in the patient's preferred language, this would be used. If the form or consent was not available, the following would occur: the English form would be translated for the patient by the interpreter. The interpreter would verify that interpretation services were provided by making a brief chart entry .

a. The medical record for Patient 43 was reviewed on 1/25/11 at 1430 hours. The patient was admitted to the hospital on 1/6/11. Review of an Informed Consent form dated 1/7/11, showed the patient signed the form, written in English, to undergo Hemodialysis by MD F. On page one of the consent form was a box with a thick black border which stated "Do not sign this consent if you have not read the entire content or do not understand." In the area for Explanation, the name of the physician who had informed the patient of the risks, benefits and alternatives of treatment was blank and the box had not been marked as completed. The area for the physician's signature to document verification the patient received informed consent showed the RN witness signed a telephone order from the physician.

The informed consent form for Patient 43 was reviewed with RN J on 1/25/11 at 1445 hours. RN J was asked if MD F was going to provide the dialysis treatment. The RN stated no, the treatments were given by a contracted dialysis company and the consent should indicate this. When asked about the telephone order, the RN stated if the physician's verification of patient informed consent was received by telephone. She was unsure if the physician had discussed the dialysis with the patient. RN J stated the patient spoke two foreign languages but little English. When asked if the form had been translated to the patient by an interpreter, RN J stated she was not sure, as the area on the form used to document the translation of the consent was not completed.



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b. Review of the medical record for Patient 58 on 1/26/11, showed the patient had been admitted to the hospital on 1/11/11, for a surgical procedure. The Multidisciplinary Admission Assessment showed Patient 58's primary language was not English.

An informed consent for Patient 58, written in English, showed the patient had consented to a surgical procedure dated 1/12/11 at 1020 hours. The signature area had been initialed by the patient, but the area to document translation had been crossed out. In the area of the consent where the risks, benefits and alternatives had been explained to Patient 58, no physician name had been entered on the form.

5. Review of the informed consent for hemodialysis for Patient 36 on 1/26/11, did not show the name of the physician who had explained the risks, benefits and alternatives of treatment.

Based on observation, interview and medical record review, the hospital failed to ensure patients were assured a safe environment while in the hospital as evidenced by:

* Failure to ensure patients undergoing surgical procedures received safe care when an electrical failure occurred during a surgical procedure due to a circuit breaker being overloaded by equipment. A loss of electricity to operating rooms could potentially result in injury or death for patients undergoing surgery/procedures. The surgeon would be potentially unable to complete the surgery or the anesthesiologist be unable to maintain anesthesia. The hospital had performed nine surgeries in the month of December 2010 and eleven in January 2011.

* Failure to ensure the physical environment in the OR was safe for patients. Observation of the OR suites showed patient equipment that was rusted and mattresses that were ripped and torn; floors and walls were damaged so that disinfection could not be assured; equipment in the OR rooms was covered in a layer of white dust; and humidifiers and de-humidifiers were being used to correct the humidity levels in the ORs contrary to accepted standards of practice.

* Failure to ensure two of two ice machines were cleaned and sanitized according to the manufacturer's recommendations or the policies approved by the infection control oversight committee. This resulted in the potential for patients to be at risk for food borne illness.

* Failure to ensure the waste products removed from the patient's blood during dialysis treatments was drained in a manner to prevent handwashing sink contamination and the potential spread of infection to other patients.

* Failure to ensure the environment was free from hazards that could cause a patient, visitor or a staff member to trip and fall.

Findings:

1. On 1/26/11 at 0740 hours, an endoscopic procedure (a way of looking inside the body through the esophagus using a flexible tube with a small camera on the end of it) was being observed in OR 1. At 0750 hours, the power to the room went out. The room lights and surgical equipment in the room, which included IV pumps, suction equipment, endoscopic equipment and the computer system, all stopped working and the room was dark. ST 1 told the Director of Surgery to go down the OR hallway to a circuit panel on the left hand side and reset the circuit. The Director of Surgery left the room and after approximately one minute, the lights and equipment came back on. At that time ST 1 stated the amount of equipment being used in the OR room had overloaded the electrical capacity of the room.

On 1/26/11, a review of the surgical log showed surgeries performed in the hospital's OR included tracheostomies (a hole in the throat to help with breathing), spinal surgery, permanent pacemaker insertion, throat surgery and hernia surgery.

On 1/27/11 at 0820 hours, ST 1 was interviewed. The ST stated the power outages to the OR suites had occurred 11 times over the past six years. The most recent one occurred seven or eight months ago. According to ST 1 the outages had occurred in various OR suites (there were five OR suites). The ST stated staff had notified a former Director of Quality, but nothing to correct the situation had been done.

On 1/27/11 at 0930 hours, RN O stated during an interview she was unaware of power outages. However, the RN stated the staff had to be careful and know which electrical outlet to plug in equipment. The staff would check with the ST before plugging in equipment. RN O stated sometimes the OR equipment had to be plugged into outlets in the hallway outside the OR suite in use.

On 1/27/11 at 0935 hours, MD M, an anesthesiologist, confirmed during interview that power outages had previously occurred, especially in OR 3. MD M stated to the best of his recollection outages had occurred seven to ten times.


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2. At 1330 hours on 1/25/11, in the ICU, Dialysis Nurse B was observed caring for Patient 36. The patient was on contact isolation (precautions included the wearing of PPE, gowns, gloves and a mask, to prevent transmission of infectious agents which are spread by direct/indirect contact with the patient or his environment). The Nurse was preparing to start Patient 36's dialysis treatment. The dialysis machine had been placed in the isolation room next to the patient's bed. Coming out of the isolation room entrance were hoses from the the dialysis machine. The hoses went out the door of the patient's room and across the main hallway floor for approximately 13 feet. The hoses were attached to the water faucet in the clean hand washing sink in the hallway. The water was needed to operate the dialysis machine. The drain hose, for all the waste products removed from the patient's blood, had also been placed to drain into the clean hand washing sink. Towels had been wrapped around the hoses in several areas. The hoses ran across the hallway in the ICU which caused staff and visitors to step across the hoses to enter two patient rooms or other areas at the end of the hallway. The placement of the hoses in a main traffic area created a hazard that could cause visitors or staff to trip and fall. The hoses also prevented Patient 36's room door from being closed in case of an emergency.

3. On 1/26/11 at 1530 hours, Dialysis RN C was observed performing a dialysis treatment in the medical/surgical area. It was observed the doors to the dialysis patient's room and the patient room next to the dialysis patient's room were observed as open. The water supply hoses and the waste drain hose were coming out of the dialysis patient's room and going into the sink of the patient's room next door. There was a patient in the room. The clean hand washing sink for this room was inside the door to the left. The drain hose for the waste products removed from the dialysis patient during treatment had also been placed in the other patient's clean hand washing sink.

When asked, Dialysis Nurse C stated the right connectors for the dialysis water supply were not in place on the handwashing sink in the dialysis patient's room. The sink in the next room had the right connectors so the nurse stated he hooked up the water hoses there. When asked why the contaminated waste removed from the dialysis patient was draining into the other patient's sink, Dialysis Nurse C stated he had been told they could not drain the waste products down the toilet and had to use the clean hand washing sinks. The nurse added the dialysis patient used the bathroom so he had to leave the toilet free. The hoses crossed the entrances of the two patient rooms and provided a hazard that could possibly cause visitors, patients and staff to trip and fall, and prevented the doors of both rooms from being closed in case of fire.

On 2/1/11 at 0825 hours, an interview was done with the Director of Infection Control. He stated he visually monitored the contracted dialysis staff for their infection control practices. When asked, the Director stated he had not been aware of the draining of dialysis waste into the clean hand washing sinks until he was informed of the surveyor's observations.

4. During observation of the hospital's operating suites, the following was noted: white debris was found on the surfaces of equipment and the operating tables; penetrations were observed in floor tiles; patched penetrations in the walls had not been painted, leaving porous surfaces; paint was chipped on doors, equipment and supply cabinets, exposing the porous surfaces underneath; dirt buildup on floors was observed in corners of each of the OR suites; penetrations were found in the OR table pads; an OR table was rusted; and humidifiers and de-humidifiers were used in the operating rooms to control humidity levels. See A 951 #2, 3,and 4.

Based on interview and record review, the hospital's medical staff failed to ensure an organized process was in place to provide a physician on-duty/call 24 hours/day which could potentially result in no physician available for patient emergencies. In addition the medical staff failed to ensure there were clear organizational expectations for Medical Directors which could potentially affect the quality of patient care.

Findings:

1. Review of the medical staff by-laws and rules and regulations did not show a defined expectation for physicians to respond to emergencies while in the hospital during the hours of 0730 until 1900 hours or for physicians to have ALS (Advanced Life Support) training. The hospital's Code Blue P&P showed any in-house physician with ALS was a Code Blue team member.

On 2/1/11 at 0905 hours during interview, MD O, the hospital's Medical Director, stated the hospital had teams of nurses to respond to medical emergencies. MD O stated the physicians who were in the hospital would respond and/or the patient's primary physician would be contacted and would come in within an hour from their office if needed. On weekends, when physician offices were closed, MD O stated he was always available. When asked how nurses would know who to call in an emergency if MD O was not available, MD O stated nurses knew the chain and after him there were several pulmonologists available (pulmonologists are physician specialists in the respiratory system).

On 2/1/11 at 0930 hours, RN Q stated for medical emergencies on the week-ends, the staff would call the patient's primary physician first. The RN stated if the primary physician was unable to respond staff would then begin calling the patient's consulting physicians. At 0950 hours, RN H was interviewed and she responded with the same sequence as RN Q. Both nurses interviewed functioned as charge nurses.

2. A review of the hospital's Medical Staff Bylaws showed Service Directors duties included, among other duties, reviewing physicians for hospital privileges, formulating recommendations for general medical staff rules and regulations, giving guidance for policies and procedures, and directing and supervising all clinical activities within a service and reporting such activities, including QAPI to the appropriate medical staff committees. In addition a Service Director would serve as a member of the Medical Executive Committee and give guidance on the overall P&Ps of the medical staff and hospital and make specific recommendations to the Medical Executive Committee regarding P&Ps to be utilized in his/her service.

On 1/27/11 at 0935 hours, during an interview, MD M stated he had been the Director of Anesthesiology but was no longer acting in the that role. According to MD M, he had not been acting in the director role for several months. He stated he still was available when needed and would help schedule other anesthesiologists.

On 2/1/11, a review of the Officers of the Medical Staff dated November 1, 2010 to October 31, 2012, showed MD M as the Medical Director of Anesthesiology.


On 2/1/11 at 0905 hours during an interview, the hospital's Chief Medical Director stated they regarded MD M as the Director, but realized there was difference of opinion.

A review of the quarterly Department of Surgery meetings for the months August 2010 and November 2010 showed MD M did not attend these meetings. See A 049.

3. On 2/2/11 at 1530 hours, the Medical Staff Services Director was interviewed. According to the Medical Staff Service's Director, medical services were divided into two areas, Surgery and Medicine. Radiology Services was part of Medicine which met quarterly. A review of the "Officers of the Medical Staff November 1, 2010 to October 31, 2012" showed the Medical Director of Radiology role was a shared role between MD N and MD R. A review of the Medicine's medical staff meeting minutes showed MD N and MD R had not attended any meetings for the past year. During interview the Medical Staff Services Director confirmed the physicians had not attended any meetings.

Based on interview and review of medical records, the hospital failed to ensure the hemodialysis access sites of three of the six hemodialysis patients reviewed (Patients 9, 32, and 54) were consistently assessed for signs of infection, bleeding and patency. This resulted in the potential for a delay in treatment if complications with a hemodialysis access site was not promptly determined.

Findings:

The hemodialysis process consists of a machine which removes wastes from the blood stream and regulates the body's fluid and chemical balances. A vascular access device connects the patient's blood stream, or circulation, to the machine. Blood flows from the patient to the machine, is cleansed, and returned. Temporary access devices are plastic tubes (catheters) which are inserted directly into a large vein. More permanent access is obtained by creating a high flow connection between an artery and a vein, typically in the patient's arm, which can be hooked up quickly and easily to the hemodialysis machine, called a shunt, graft or fistula.

1. The medical record for Patient 9 was reviewed on 1/26/11 at 0935 hours. The patient was admitted to the hospital on 7/3/10 with diagnoses which included End Stage Renal Disease. The patient received hemodialysis treatments three days a week. Documentation showed the patient had a right femoral (groin) vein catheter for hemodialysis access. On 1/5/11, a catheter was inserted into the upper chest. The femoral catheter was discontinued by the physician on 1/15/11.

Review of the Patient Care Record flowsheets for Patient 9 dated 1/15 - 1/25/11, did not show documentation the catheter in the left chest was consistently assessed by nursing. There was no documentation found to show the catheter was assessed on the night shift 1/15 and 1/16/11, and the day and night shift on 1/17, 1/18, 1/21, 1/22, and 1/23/11.

RN M was interviewed on 1/26/11 at 1000 hours. The RN stated the presence of Patient 9's catheter should be documented in the "IV" portion of the flowsheet each shift. The RN stated the dressing changes were done by the hemodialysis nurse after hemodialysis treatments. She stated the unit nurse should document the presence of the catheter and assess for any drainage, and if not, document the dressing as dry and intact.

2. The medical record for Patient 32 was reviewed on 1/26/11 at 0830 hours. The patient was admitted to the hospital on 1/14/11, with diagnoses which included End Stage Renal Disease with hemodialysis. The patient had an AV (arterio-venous) shunt in the left arm for hemodialysis access.

Review of the Patient Care Record flowsheets for Patient 32 dated 1/15-1/25/11, did not show documentation the patient's AV shunt was consistently assessed each shift for bleeding and patency. There was no documentation found to show the AV shunt was assessed on the the night shift on 1/16 and 1/20/11, the day and night shifts for 1/17, 1/18, and 1/19, 1/21, 1/22 and 1/24/11. The assessments documented on the day shift on 1/20 and 1/23/11, showed only the presence of the left arm AV shunt. There was no documentation to show a positive bruit or thrill was present in the shunt (a pulse in the artery to show blood flow was present).

The Director of Quality Management and Infection Control was interviewed on 1/26/11 at 0845 hours. The Director was asked to review the medical record for Patient 32 in order to locate documentation of the patient's hemodialysis access site. The Director stated the AV shunt should be documented on the area of the flowsheet used for documentation of IVs. The Director stated he was unable to find where this was done consistently. In addition, the Director confirmed the patency of the AV shunt should be checked by assessing for a bruit or thrill in the shunt and documenting this each shift.

3. The closed medical record for Patient 54 was reviewed on 1/27/11 at 0900 hours. The patient was admitted to the hospital on 11/29/10, with diagnoses that included End Stage Renal Disease with hemodialysis. The patient was assessed on admission to have an AV shunt in the upper arm.

Review of the Patient Care Record flowsheets for Patient 54 dated 11/30- 12/3/10, did not show consistent assessment of the patient's hemodialysis access site and patency. The right AV shunt was documented as present, but there was no documentation to show the patency of the AV shunt on the day shift for 12/1/10 and on the night shift for 12/3/10. There was no documentation of an AV shunt on night shift for 12/2/10 and the day shift of 12/3/10.

The CNO was interviewed on 1/27/11 at 0910 hours. The CNO was asked to review the medical record for Patient 54 in order to locate consistent documentation the patient's AV shunt was assessed for patency, infection and/or bleeding by the licensed nurse on each shift. The CNO stated she was unable to locate documentation Patient 54's AV shunt was assessed on each shift. The CNO stated an AV shunt should be assessed each shift for bleeding and the presence of a positive blood flow by checking for a bruit or thrill, and the assessment documented.

Based on interview and review of the medical record, the hospital failed to ensure the plan of care for 5 of 31 sampled patients (Patients 9, 32, 39, 43 and 54) included plans to address the patients' needs for care in areas like hemodialysis and nutrition. The failure to develop a care plan for these patients presented the risk for a decline in the their medical condition.

Findings:

1. The medical record for Patient 32 was reviewed on 1/26/11 at 0830 hours. The patient was admitted to the hospital on 1/14/11, with diagnoses which included End Stage Renal Disease with hemodialysis and diabetes. The patient had an AV (arterio-venous) shunt in the left arm for hemodialysis access. Review of the nurses' notes dated 1/20/11 at 1230 hours, showed the patient had been found almost unresponsive, with an unstable blood sugar and severe edema. The physician ordered an extra hemodialysis treatment and put the patient on a fluid restriction of 1200cc a day for the edema. The nurses' notes showed a half eaten box of cookies, brought in by the family, was found at the bedside.

Review of the plan of care for Patient 32 did not show a care plan had been developed to address the patient's need for hemodialysis and care of the AV shunt. The care plan for "Alteration in Nutritional Status as a result of End Stage Renal Disease and diabetes" dated 1/17/11, had not been updated to include the need for fluid restrictions and education of the patient regarding food brought into him from home.

RN S was interviewed on 1/26/11 at 0850 hours. The RN reviewed the plan of care of Patient 32 and confirmed no care plan had been developed to address the patient's need for hemodialysis. The RN viewed the care plan addressing the patient's nutritional status and confirmed the need for fluid restrictions for the patient had not been added when ordered by the physician. The RN stated nursing had spoken to the patient regarding eating sweets brought from home but this had not been addressed in the care plan.

2. The medical record for Patient 9 was reviewed on 1/26/11 at 0935 hours. The patient was admitted to the hospital on 7/3/10 with diagnoses which included End Stage Renal Disease. The patient received hemodialysis treatments three days a week. Documentation showed the patient had a right femoral (groin) catheter for hemodialysis access. On 1/5/11, a catheter was inserted into the left subclavian (upper chest) vein. The groin catheter was discontinued by the physician on 1/15/11.

On 1/26/11, review of the plan of care for Patient 9 on 1/26/11, did not show a care plan had been developed to address the patient's need for hemodialysis or the care required for the hemodialysis access catheters.

RN M was interviewed on 1/26/11 at 1000 hours. The RN reviewed the plan of care for Patient 9 and confirmed there was no care plan developed to address hemodialysis or catheter care for the patient. When asked, RN M stated hemodialysis would be considered a "problem" area for the patient and should be included in the plan of care.

3. The medical record for Patient 43 was reviewed on 1/25/11 at 1430 hours. The patient was admitted to the hospital on 1/6/11 with diagnoses which included End Stage Renal Disease with hemodialysis. A left forearm AV shunt was in place for hemodialysis access.

Review of the plan of care for Patient 43 did not show a care plan for hemodialysis had been developed for the patient to address the patient's need for hemodialysis or the care required for the AV shunt.

RN J was interviewed on 1/25/11 at 1445 hours. When asked to review the plan of care for Patient 43, the RN stated she was unable to find a care plan developed to address the patient's hemodialysis needs. The RN confirmed hemodialysis was an area of care which should be care planned for the patient.

4. The medical record for Patient 39 was reviewed on 1/25/11 at 1100 hours. The patient was admitted to the hospital on 1/24/11 with diagnoses which included hemodialysis treatments scheduled three times a week. An AV shunt was present in the right arm for hemodialysis access.

Review of the plan of care developed on admission did not show a care plan for hemodialysis for Patient 39.

RN M and the Director of the Medical Surgical unit were interviewed on 1/25/11 at 1145 hours, and were asked to review the plan of care for Patient 39. RN M stated hemodialysis had not been included in the plan of care for Patient 39. The Director stated patients on hemodialysis needed to have care plans developed to address their individual needs and care of the access site.

5. The closed medical record for Patient 54 was reviewed on 1/27/11 at 0900 hours. The patient was admitted to the hospital on 11/29/10, with diagnoses that included End Stage Renal Disease with hemodialysis. The patient was assessed on admission to have an AV shunt for hemodialysis access.

The plan of care for Patient 54 was reviewed with the CNO on 1/27/11 at 0910 hours. hemodialysis was listed on the front page of the plan of care as a continuing care need for the patient. However, when asked, the CNO was unable to show a care plan was developed to address hemodialysis.

Based on interview and record review, the hospital failed to ensure the competency of three of three RNs reviewed (RN L, P and H) whose job duties included participating in high risk procedures such as medication administration, sedation care, and the assessment of heart rhythms. The hospital was unable to provide documentation follow up was conducted for RN L, who was placed on probation for medication errors. This put patients at risk for medical errors.

Findings;

1. Review of the P&P for Management of Sedation Care, last review date 12/04, showed a certified RN may be responsible for sedation care. Sedation care was defined as an IV administration of a medication to maintain a state of depressed consciousness but in which the patient maintains his/her protective reflexes, the ability to breathe continuously and respond to physical stimulation and /or verbal commands. Nursing staff qualifications and requirements were listed to include a yearly monitoring of knowledge and skills and passing of the medication exam with a score of 80% or better.

The personnel record for RN L was reviewed on 2/1/11. The RN had been employed by the hospital since 2007. A personnel action form dated 2/4/10, showed while assigned to the Medical Surgical Unit, RN L had been put on 90 day probation for "multiple medication errors." There was no further documentation to show the RN had been reevaluated after 90 days. Further review of the record showed RN L had been transferred to the PACU (Post Anesthesia Care Unit) on 3/21/10, where she would be caring for patients requiring a higher level of care, when coming directly from surgery.

Review of a Competency Assessment form for the OR/PACU department for RN L, dated 9/13/10, showed the RN was signed off as "demonstrating competence with the specified equipment/skills/procedures in conformance with the guidelines and practices of the Hospital." RN L had completed the self assessment portion of the form and indicated the need for training in 25 of the possible 102 areas. The six page form showed instructions to the evaluator to use a specific abbreviation to describe the method used for evaluation of the RN. The RN was signed off on all six pages of responsibilities, equipment and procedures on one day, 9/13/10. This was six months after RN L's transfer to the PACU. There was an abbreviation to indicate supervised practice was used as a method of evaluation for the 25 areas in which RN L stated she required training. However, there was no documentation to show how the RN was evaluated in the remaining 77 areas. In the section for competency in conscious sedation, it showed the RN would need to pass a medication quiz.

The Director of Quality Management and Infection Control was interviewed on 2/1/11 at 1120 hours. The Director stated that although he was acting as the CNO (Chief Nursing Officer) for the hospital during February/March 2010, he was unsure of the follow up regarding RN L's probation.

The Director of the ICU and the Vice President of Quality/Risk Management were interviewed on 2/1/11 at 1125 hours. The Director of ICU stated RN L should have had a reevaluation of her competency at the end of her 90 day probation for the medication errors. The Vice President stated RN L also should have had a 90 day probationary period following her transfer to the PACU. After review of RN L's personnel file, the two staff were unable to show documentation RN L's competency was reevaluated. The Vice President stated the supervisor who had initiated the probation for the medication errors was no longer employed by the hospital. When asked, the Vice President was unable to state why RN L was transferred to a unit providing a higher level of care during her probationary period or when transferred, why the PACU competency form was dated six months following the RN's transfer.

RN L was interviewed on 2/1/11 at 1330 hours. When asked, the RN stated as part of her probation for the medication errors, she had completed a RN Refresher Course. RN L stated she was also supervised by her charge nurse regarding medications. When asked the name of the charge nurse, RN L stated the charge nurse was no longer employed by the hospital. When asked, RN L stated the competency form for the PACU was not completed until 9/13/10, because the OR department was closed down during the summer and there was no work. However, RN L stated she had worked in the ICU during that time period.

RN L was asked her training for conscious sedation. RN L stated she had taken a medication test.

The competency form which showed RN L had demonstrated the knowledge of MH was reviewed with RN L. (Malignant Hyperthermia, an inherited disease that causes a rapid rise in body temperature (fever) and severe muscle contractions when the affected person receives general anesthesia agents). RN L confirmed she had been trained regarding MH. RN L was then asked to state the signs and symptoms of MH. RN L was unable to verbalize any of the symptoms and seemed confused as to whether it was hyper (high) or hypo (low) thermia. MH was defined and the cause explained to RN L. However, the RN continued to be unable to state the availability of the medications used for treatment of MH or the chilled saline that was available in the OR that would be used to cool the patient.

The CNO was interviewed on 2/1/11 at 1400 hours. The CNO reviewed the personnel file for RN L. The CNO stated she had been unable to locate a test taken by RN L to show competency in conscious sedation. When asked, the CNO was unable to state how a RN could be signed off as competent on six pages of 102 different tasks, procedures and skills in a one day period.


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2. On 1/26/11 beginning at 0740 hours, RN P monitored Patient 47 for conscious sedation during a procedure in the OR. On 2/1/11, a review of RN P's personnel file showed no competencies for conscious sedation had been signed off and no medication test for conscious sedation was found in the RN's file. The absence of these documents was verified by the Director of ICU.

3. On 1/25/11 at 0850 hours, during a tour of the ICU, RN H was interviewed. The RN was the charge nurse for the ICU that day and stated he had no patient assignment. He stated his role as charge nurse included responding to emergencies in the hospital.

On 2/1/11, a review of the "Basic Dysrhythmia Competency Exam" for RN H dated 10/5/10, was reviewed. Basic dysrhythmia exams test the RN's competency for monitoring and recognizing heart rhythms, especially abnormal ones, a critical skill for ICU nurses. The front of the exam showed the passing score was 85%. A review of the test for RN H failed to show it was scored. Several answers were left blank. Other questions were answered incorrectly but not marked as such. On 2/1/11 at 1010 hours the Director of ICU confirmed the exam was not scored and the nurse was not verfied as competent.

Based on interview and review of the medical record, the hospital failed to ensure a complete and accurate medical record for two of 31 sampled patients (Patients 34 and 40). For Patient 40 a DNR (Do Not Resuscitate) Physician's Order and Progress Note form was not completed to show documentation by the physician of the patient's capacity for decision making and discussion with the family. This resulted in a potential for a miscommunication of the patient's wishes for treatment. For Patient 34, a five page list of medications received as a telephone order from the physician had not been reviewed and signed within a 48 hour time frame. This resulted in the potential for an error in medication administration.

Findings:

1. The medical record for Patient 40 was reviewed on 1/25/11 at 1110 hours. The patient was admitted to the hospital on 1/21/11. Review of the physician's H&P dated 1/21/11, showed documentation the patient was alert but confused.

Review of the physician's orders for Patient 40 showed a telephone order dated 1/23/11, for a DNR order. In addition the order showed no interventions or medications were to be administered to the patient in case of low blood pressure. The telephone order was signed by the physician on 1/25/11 at 0600 hours. The second page of the DNR order form contained a progress note for documentation of the patient's condition, prognosis, reason for DNR orders, the patient's capacity for decision making, and details of their discussion with the patient, relative(s), and others. The progress note was not completed by the physician.

RN D was interviewed on 1/25/11 at 1145 hours. When asked to review the DNR order for Patient 40, the RN stated the physician had just come in that morning and signed the order. The RN stated page two of the order set needed to be completed by the physician. RN D stated Patient 40 was confused but the RN stated he had a son who had been signing the consents.


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2. On 1/25/11, Patient 34's medical record was reviewed. There were five pages of printed medication orders with check boxes by each medication to continue or discontinue the medication. The box by each medication was checked. On the last page of the orders, by the signature section, was documentation the orders were telephone orders by MD P on 1/20/11. As of 0910 hours on 1/25/11 the physician had not signed the orders to show they were reviewed and correct.

Based on interview and medical record review, the hospital failed to ensure the informed consent forms for six of 31 sampled patients (Patients 34, 36, 37, 42, 43 and 58), were fully completed to show the name of the practitioner providing the service and/or the name of the physician who provided the informed consent. In addition, for Patients 43 and 58, there was no documentation to show the English language form was translated for them. This resulted in the potential for the patients not to be fully informed of the procedures for which they gave consent.

Findings:

1. The Medical record for Patient 37 was reviewed on 1/25/11 at 1330 hours. Review of an Informed Consent form for the insertion of a PICC line on 1/20/11 was reviewed with the Director of Medical Surgical. There was no documentation on the form to show the name of the practitioner who would be inserting the PICC line. The Director stated the consent should contain the name of the contracted company who inserted the PICC lines for the hospital so the patient would know to whom he was giving consent for the procedure.

2. The medical record for Patient 42 was reviewed on 1/25/11 at 1355 hours. The patient was admitted to the hospital on 1/6/11. Review of the physician's History and Physical dated 1/6/11, showed dementia was listed as a diagnosis for the patient. Review of the Condition of Admission form showed a family member had the Power of Attorney for the patient.

Review of an Informed Consent form dated 1/25/11, for the insertion of a PICC line, showed the form was signed by Patient 42 at 1235 hours. There was no documentation on the form to show the name of the practitioner who would be inserting the PICC line. On page one of the consent form was a box with a thick black border which stated "Do not sign this consent if you have not read the entire content or do not understand." In the area for Explanation, the name of the physician who had informed the patient of the risks, benefits and alternatives of treatment was blank and the box had had not been marked off as completed. The area for the physician's signature to document verification the patient received informed consent was not completed.

Patient 42 was interviewed on 1/25/11 at 1415 hours. The patient was asked if she had signed a consent form for a procedure to be done that day. The patient stated she had signed a form but she was unable to remember exactly for what procedure. When asked if her physician had explained to her what was to be done, Patient 42 stated she did not remember.

RN J and the Director of Medical Surgical were interviewed on 1/25/11 at 1425 hours. RN J stated Patient 42's physician had written the procedure on the consent form the night before during his rounds. The RN confirmed the physician had not completed the informed consent verification on the form. RN J stated stated the physician should sign the informed consent form before the procedure was done to verify he had spoken with the patient. RN J stated she had the patient sign the form and thought she had understood. The Director of Medical Surgical stated the name of the contracted company who inserted the PICC lines for the hospital should be on the form so the patient would know to whom she was giving consent for the procedure. Documentation the patient had a Power of Attorney for Healthcare was reviewed with the Director. The Director was asked to show documentation the patient was competent to make her own decisions for healthcare. The Director stated the patient was documented as alert but was sometimes confused. The Director confirmed she was unable to locate documentation to show the patient's decision making capability.

3. Review of Patient 34's medical record on 1/26/11 at 1000 hours, showed a surgical consent form for placement of a left chest tube. The form was signed by the patient and witnessed by a hospital employee at 1/21/11 at 1305 hours. The section of the form with the name of the surgeon performing the procedure was blank. When this was shown to RN F on 1/27/11 at 1115 hours, she stated the name of the surgeon performing the procedure should have been on the consent form.

4. Review of the P&P Interpreter Services dated 10/10, showed if a form or consent was available in the patient's preferred language, this would be used. If the form or consent was not available, the following would occur: the English form would be translated for the patient by the interpreter. The interpreter would verify that interpretation services were provided by making a brief chart entry .

a. The medical record for Patient 43 was reviewed on 1/25/11 at 1430 hours. The patient was admitted to the hospital on 1/6/11. Review of an Informed Consent form dated 1/7/11, showed the patient signed the form, written in English, to undergo hemodialysis by MD F. On page one of the consent form was a box with a thick black border which stated "Do not sign this consent if you have not read the entire content or do not understand." In the area for Explanation, the name of the physician who had informed the patient of the risks, benefits and alternatives of treatment was blank and the box had not been marked as completed. The area for the physician's signature to document verification the patient received informed consent showed the RN witness signed a telephone order from the physician.

The informed consent form for Patient 43 was reviewed with RN J on 1/25/11 at 1445 hours. RN J was asked if MD F was going to give the hemodialysis treatment. The RN stated no, the treatments were given by a contracted hemodialysis company and the consent should indicate this. When asked about the telephone order, the RN stated the physician's verification of patient informed consent was received by telephone. She was unsure if the physician had discussed the hemodialysis with the patient. RN J stated the patient spoke two foreign languages but little English. When asked if the form had been translated to the patient by an interpreter, RN J stated she was not sure, as the area on the form used to document the translation of the consent was not completed.


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b. Review of the medical record for Patient 58 on 1/26/11, showed the patient had been admitted to the facility on 1/11/11 for a surgical procedure. The Multidisciplinary Admission Assessment showed Patient 58's primary language was not English.

An informed consent for Patient 58, written in English, showed the patient had consented to a surgical procedure dated 1/12/11 at 1020 hours. The signature area had been initialed by the patient, but the area to document translation had been crossed out. In the area of the consent where the risks, benefits and alternatives had been explained to Patient 58, no physician name had been entered on the form.

5. Review of the informed consent for hemodialysis for Patient 36 on 1/26/11, did not show the name of the physician who had explained the risks, benefits and alternatives of treatment.

Based on observation, interview, medical record review and review of P&Ps, the hospital failed to ensure the pharmaceutical services promoted a safe medication use process and provided oversight to ensure the needs of the patients in the hospital were met.

Findings:

1. Pharmaceutical Services failed to ensure medication orders for a high risk drug were reviewed to prevent medication errors. See A 500 #1.

2. Pharmaceutical Services failed to ensure a medication labeled "refrigerate" was properly stored in the refrigerator per the manufacturer's recommendation. See A 500 #2.

3. Pharmaceutical Services failed to ensure the implementation of policies and procedures for patient safety when the dose of a high alert drug was not checked by two nursing staff. See A 500 #3.

4. Pharmaceutical Services failed to ensure IV medications in the pharmacy night locker were stored in an orderly manner. This increased the potential for medication errors when nursing staff obtained medications when the pharmacy was closed. See A 500 #6.

5. Pharmaceutical Services failed to ensure the safe storage of sterile tuberculin testing solution in the laboratory. See A 500 #7.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on medical record review and interview, the hospital's pharmaceutical service:

* Failed to monitor a prescribed drug ordered for three of three sampled patients (Patients 37, 40, and 49). The drug is contraindicated in patients with any level of heart failure and should be administered on an empty stomach. This had the potential for adverse consequences to occur in the three patients for whom it was prescribed;

* Failed to store lorazepam-Baxter (Ativan? - an injectable drug for the treatment of severe agitation) at the proper temperature, which allowed the potential administration of a sub-potent medication;

* Failed to ensure two licensed personnel checked and initialed the concentration and rate of IV heparin prior to infusion, which potentially could have led to an incorrect dose of heparin - a drug which can cause bleeding if given at the wrong dose;

* Failed to ensure IV tubing was dated and initialed as required by the hospital policy, which potentially exposed patients to medications administered via contaminated IV tubing;

* Failed to ensure a medication administered internally was not stored in the pharmacy in the section designated for external use medications. This increased the potential for the administration of medications by the wrong route;

* Failed to store IV Minibag-Plus (a small IV bag used for administering medications) in the pharmacy night locker in an organized fashion, increasing the potential for medication errors when nursing staff obtained medications when the pharmacy was closed.

* Failed to store sterile medication vials in an environment which could possibly affect the sterility or stability of the product.

Findings:

1. A review of the ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals (American Society of Hospital Pharmacists) indicated, "All prescriber's medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed. Any questions regarding the order must be resolved with the prescriber at this time, and a written notation of these discussions must be made in the patient's medical record or pharmacy copy of the prescriber's order."

The P&P for Medication Events was reviewed. The P&P indicated, "Examples of Medication Errors include but are not limited to ...Doses Administered Outside Parameters ... and Contraindicated Drug." The P&P also indicated, "Medication errors shall be reported in a timely manner to the practitioner who ordered the drug."

Review of the FDA-approved package literature for cilostazol (Pletal? - a drug used for pain in the legs (called intermittent claudication, a condition of the blood vessels), showed the presence of a U.S Boxed Warning, which indicated: "The use of this drug is contraindicated in patients with heart failure of any severity. Phosphodiesterase inhibitors (a class of drugs which includes cilostazol) have decreased survival rates in patients with class III-IV heart failure. Use with caution in patients with underlying heart disease." In addition, the package literature stated the dose of cilostazol should be given, "at least 30 minutes before or 2 hours after breakfast and dinner."

a. On 1/26/11 at 0810 hours, the medical record for Patient 37 was reviewed. The drug Cilostazol was ordered on 12/13/10, by MD E to be given twice daily with meals. The Medication Administration Record (MAR) indicated cilostazol had been administered twice daily at 0730 and 1730 hours since 12/13/10. Both of these times were either during or shortly after meals were served.

On 1/26/11 at 1535 hours, the Director of Medical Surgical was interviewed. The Director stated meals were normally served at approximately 0730 and 1700 hours daily, about the time the medication would be administered.

Cilostazol was administered with meals as ordered by MD E, however the order was written contrary to the FDA-approved package literature - which recommended the drug to be administered on an empty stomach.

Review of Patient 37's medications showed the patient was receiving Digoxin and furosemide by mouth daily. Both of these drugs are commonly used, either individually or in combination, to treat patients with congestive heart failure (CHF).

On 1/26/11 at 1145 hours, the Pharmacist in Charge (PIC) was interviewed. The PIC said he personally reviewed and transcribed Patient 37's orders for cilostazol, digoxin, and Lasix (furosemide) at the time they were ordered. When asked, the PIC acknowledged that he was not aware of the dosage recommendation or the contraindications in the cilostazol package literature. He acknowledged he did not alert MD E regarding the wrong dosage time and/or the potential contraindication in patients with congestive heart failure.

On 1/26/11 at 1535 hours, MD E was interviewed. MD E stated that Patient 37 did not have CHF. He said the patient was originally treated with digoxin to treat an irregular heart beat.

A review of the medical record on 1/26/11, revealed that cilostazol was discontinued by MD E at 1556 hours on 1/26/11.

On 1/27/11 at 0930 hours, the names of all patients in the facility currently receiving cilostazol were requested from the Interim DOP. Two additional patients currently receiving cilostazol were identified: Patient 40 and Patient 49.

b. On 1/27/11 at 0945 hours, the medical record for Patient 49 was reviewed. Cilostazol 50 mg had been order twice daily at 0700 and 1700 hours, by MD Q on 12/28/10. The order did not specify to give the drug on an empty stomach. The clinical summary in the record indicated that Patient 49 had a history of atrial fibrillation (an irregular heart beat) and heart failure. Patient 49 had also been receiving furosemide IV every 12 hours, and digoxin daily for the same period of time.

On 1/27/11 at 1050 hours, MD Q was interviewed regarding Patient 49. MD Q stated Patient 49 had an ejection fraction (a measure of the efficiency of the heart) of 65% and did not have congestive heart failure. He stated the digoxin for Patient 49 was administered for atrial fibrillation (irregular heart beat).

On 1/27/11, a review of the Patient 49's medical record indicated that MD Q discontinued cilostazol for Patient 49 at 1118 hours. The physician ordered another medication, Trental, (pentoxifylline - a drug for intermittent claudication but which does not have a boxed warning).

c. On 1/27/11 at 1030 hours, the medical record for Patient 40 was reviewed. The MAR and the physician's orders indicated that MD B ordered cilostazol 100 mg twice daily at 0700 and 1700 hours on 1/22/11. The cilostazol order did not specify that the drug should be given on an empty stomach. Two separate physician referrals for consults were written/dictated by MD B and both indicated that Patient 40 had a past medical history of congestive heart failure. The "Impression" listed on each request for a consult included, "congestive heart failure." A pre-admission clinical evaluation dated 1/21/11, listed CHF as a secondary diagnosis.

On 1/27/11 at 1100 hours, MD B was interviewed by phone. MD B stated Patient 40 did not currently have congestive heart failure.

Further review of the medical record for Patient 40 showed the PIC had documented a telephone order from MD B on 1/26/11 at 1658 hours, to discontinue cilostazol.

On 1/26/11 at 1145 hours, the PIC was interviewed. The PIC searched pharmacy copies of physician's orders and could not find any notes to suggest that a pharmacist had discussed cilostazol dosage recommendations or contraindications with the prescriber for Patients 37, 40 and 49. The PIC acknowledged that he did not inform the physician of medication order irregularities in a timely manner.

2. The pharmacy night locker located on the Medical Surgical Unit was observed on 1/25/11 at 1510 hours (medications stored in the night locker are accessed by nursing during the hours the pharmacy was closed). Numerous vials of lorazepam (Ativan?) were found stored at room temperature in the ADC (Automatic Dispensing Cabinet). Each vial was hand dated with an expiration date 28 days after the day it had been moved from the refrigerator in the pharmacy to room temperature in the ADC.

The PIC and the Interim DOP were interviewed at 1520 hours on 1/25/11. The PIC acknowledged the lorazepam was Baxter lorazepam injection 2 mg/ml (milligram per milliliter), 1 ml vials. The lot number imprinted on each lorazepam label was 110309, with an expiration of 11/20/12. The PIC acknowledged the pharmacy assumed that lorazepam was stable at room temperature for 28 days, based upon data in Trissel's Handbook. The information from Trissel's Handbook of Injectable drugs indicated that the Wyeth-Ayerst brand of lorazepam was stable for up to 2 two weeks - and possibly 60 days -- at room temperature. However, no stability data or package literature recommendation regarding storage at room temperature was available for the Baxter brand of lorazepam. The official FDA-approved Baxter lorazepam carton label indicated, "Store in Refrigerator;" the FDA-approved lorazepam Baxter label on the vial indicated, "Refrigerate."

The PIC was unable to provide data from Baxter which confirmed the 28 day-stability of lorazepam (Baxter) at room temperature.

3. The Pharmacy P&P for the Administration of Medications, last revised 7/10, was reviewed. The policy indicated for the administration of the drug heparin, "Two licensed nurses must verify accuracy of insulin (a drug to lower blood sugar) and heparin (a drug to prevent blood clots) before administration. These two nurses will verify by initialing on the Medication Administration Record (MAR)".

The MAR for Patient 37 was reviewed on 1/26/11 at 1000 hours. Documentation showed the patient received heparin 25,000 units per 250 ml (milliliters) IV (intravenously) at a rate of 7 ml per hour on 1/26/11 at 0915 hours. The MAR was initialed by only one nurse.

The Director of the Medical Surgical unit and RN T were interviewed at 1005 hours on 1/26/11. Both nurses reviewed the MAR and confirmed only one nurse had initialed the MAR to verify the accuracy of the heparin dose.

4. The P&P for IV Therapy, last revised 11/10, was reviewed. Documentation showed "All IV sites and tubing are dated. All IV tubing shall be changed at least every 96 hours ..."

On 1/26/11 at 0810 hours, IV sets currently used for administration of medications for Patients 37 and 42 were observed. For Patient 42, none of the IV tubings used for administering medications had been dated and/or initialed. Tags had been attached to the tubing and indicated, "Change on Wednesday," or "Change on Thursday." For Patient 37, one of the IV tags contained a change date which indicated the IV tubing should have been changed on the previous night shift at 0545 hours on 1/26/11.

At 1000 hours on 1/26/11, The Director of Medical Surgical and RN T were interviewed. Both nurses confirmed all IV tubings should be labeled with the date of expiration. In addition the nurses stated the IV tubing for Patient 37 should have been changed during the previous night shift.

5. During a tour of the main pharmacy on 1/25/11 at 1145 hours, three 2 oz. bottles of Castor Oil (an oral liquid laxative) were observed in the pharmacy section labeled for external medications. Other drugs stored along with castor oil in the same, "externals" section included a variety of external ointments and a bottle of liquid Calamine lotion (a liquid medication used for external treatment of itching).

At 1150 hours on 1/25/11, the PIC was interviewed. The PIC acknowledged that Castor Oil should have been stored in the oral liquid medications section rather than with the external medications.

6. During a tour of the Pharmacy night locker on the Medical Surgical Unit on 1/25/11 at 1510 hours, Minibag-Plus IV containers with medication vials attached were found disorganized and stacked on a shelf near the floor.

At 1515 hours on 1/25/11, the PIC was interviewed. The PIC stated the Minibag's should have been better organized in order to allow nurses to quickly and accurately select a drug for administration during hours when the pharmacy was closed.


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7. The P&P for Medication:Storage, last revised 9/10, showed drugs should be stored under the proper conditions of sanitation, temperature, light, moisture, ventilation, organization, segregation, safety and security.

On 1/25/11 at 1510 hours, during observation of the laboratory area with the Laboratory Director and Manager, two vials of sterile tuberculin testing solution were found in a refrigerator with a biohazard label on the door. The refrigerator contained blood samples and other contaminated body wastes that were stored prior to being transported to an outside laboratory for processing. The temperature range for the refrigerator was 1 to 6 degrees Centigrade. The storage temperature listed on the medication was 2 to 8 degrees Centigrade.

The Director stated the medications were stored in the biohazard refrigerator since the laboratory technician was the person administering the tuberculin tests to the staff. The Director stated she was not aware sterile medications should not be stored in a biohazard refrigerator.

Based on observation and interview, one Mini-bag plus (a small IV bag used for administering medications) with a vial of medication attached was found expired in the pharmacy night locker. This had the potential to allow the use of an expired IV administration container.

Findings:

On 1/25/11 at 1435 hours, an observation of the pharmacy night locker was conducted. One Minibag-Plus container with the drug ceftriaxone attached was found to have expired on 1/24/11.

On 1/25/11 at 1440 hours, the Director of Medical/Surgical was interviewed. She confirmed the container was expired.

Based on observation, record review and interview, the hospital failed to ensure compliance with NFPA 70 (1999 edition) as evidenced by:

* Failure to maintain the electrical wiring and equipment;

* Failure to respond to past electrical problems;

* Failure to plug high wattage appliances directly into electrical receptacles;

* Failure to maintain the corridor doors for 3 of 11 smoke compartments.

* Failure to ensure the designated smoking area of the hospital was located more than 50 feet away from the liquid oxygen tank storage area.

These findings have the potential for loss of electrical power, for electrical shock, and the spread of smoke and fire throughout the hospital. These findings increase the risk of injury to patients, visitors and staff in the event of an emergency. See the LSC (Life Safety Code) survey K 18, K 66, and K 147.

Based on observation, the hospital failed to ensure fire safety regulations were followed. This could potentially result in a fire.

Findings:

The 2010 California Fire Code, Title 24, Part Nine Fire Code 903.3.3 Obstructed locations shows automatic sprinklers shall be installed with due regard to obstructions that will delay activation or obstruct the water distribution pattern. Automatic sprinklers shall be installed with not less than a 3-foot clearance maintained between automatic sprinklers and the top of piles of combustible fibers.

On 1/25/11 at 0900 hours, the linen room in the ICU was inspected. Linen was piled up to less than five inches from the sprinkler. When this was shown to the ICU Director the linen was removed.

Based on observation and interview, the hospital:

* Failed to ensure the electricity in the OR was maintained in a manner to promote the safety of patients undergoing surgical procedures. A loss of electricity in the operating room could potentially result in injury or death to patients undergoing surgery/procedures. The hospital had performed nine surgeries in the month of December 2010, and eleven in January of 2011, including the one on 1/26/11, where the electrical power in the OR suite was temporarily out of order;

* Failed to ensure the physical environment for four of four OR rooms and OR equipment was maintained for safety and quality. This resulted in the potential for infection, as the cleanliness of broken surfaces could not be assured;

* Failed to ensure a biohazardous agent was properly contained. This could potentially result in staff/patient exposure to a hazardous chemical.

Findings:

1. On 1/26/11 at 0740 hours, an endoscopic procedure (a way of looking inside the body through the esophagus using a flexible tube with a small camera on the end of it) was being observed in OR 1. At 0750 hours, the power to the room went out. The room lights and surgical equipment in the room, which included IV pumps, suction equipment, endoscopic equipment and the computer system, all stopped working and the room was dark. ST 1 told the Director of Surgery to go down the hallway to a circuit panel on the left hand side and reset the circuit. The Director of Surgery left the room and after approximately one minute the lights and equipment came back on. At that time ST 1 stated the amount of equipment being used in the OR room had overloaded the electrical capacity of the room. See A 951 #1.

2. The 2010, AORN Perioperative Standards and Recommended Practices showed the environment should be assessed for cleanliness. Cleanliness means the absence of visible dust, debris, soil or body substances.

a. During observation of the hospital's operating rooms with the Director of Surgery on 1/26/11 at 0700 hours, the following was found for ORs 1, 2, 3 and 4:

* The outer moisture-resistant covering of the mattress pads on the OR tables in rooms 2, 3, and 4 had splits, tears and large missing areas on the corners of the pads. The porous material underneath was exposed, making it difficult to ensure disinfection of the pads.

* Small white pieces of debris were observed in all OR rooms, on the equipment, on top of the sheets on the operating tables and under the sheets on the pads.

* There were areas on the walls that had been patched, but not painted (leaving the porous patched surfaces exposed).

* The bases of the metal supply storage cabinets had areas where the paint had chipped off and the metal underneath was exposed. Some of the exposed metal was getting rusty.

* The wooden entry doors into the operating rooms and into the sub-sterile areas were observed to have areas where the paint had been chipped off exposing the wood underneath.

* There were penetrations in the dark brown floor tiles in all the rooms.

* In Room 4, the air vents near the ceiling, and the arms on the overhead lights, had areas of chipped paint exposing the metal underneath. In some areas the metal was becoming rusty.

* The sub-sterile room located between OR 3 and 4, had entry doors leading from the main OR area hall and from OR 3 and 4. To the left of the main entry door was a long metal counter. The entire length of the counter, where the metal counter met the overhead cabinets, was rusty. The bottom of the steam sterilizer was rusty. There was an accumulation of dirt observed in the corners by the doors. An area of exposed porous cement was noted between the control panel and the warming cabinet above the floor. The metal plate on the floor under the door which opened to OR 3 to was rusty and dirty. The bottom of the wood cabinet underneath the sink was covered with small pieces of rusty metal that had flaked off the underside of the metal sink. There was an open hole in the wall at the back of the cabinet.

* OR 3 had a dirt build up in the corners of the floor by the entry door and along the top of the metal edge that covered the end of the tiles, where the tile had been extended up the wall 2-3 inches. The base of the operating table and the metal bar in the middle of the operating table were rusty. The stainless steel bars attached to the sides of the operating table were rusty and dirty. The arms of the large overhead light had missing areas of paint.

* In OR 2 the OR table had areas of chipped paint and penetrations in the wall. The patched areas on the walls in this room had rust showing through the patching material.

* The metal plate on the floor at the bottom of the door into the sub-sterile area between OR 1 and 2 was rusty. There was a dirt build up in the corners of the floor by the main entry door, and on the metal edge that covered the end of the tiles where the tile had been extended up the wall 2-3 inches.

* OR 1 had two large laminate covered storage cabinets in the back of the room. There were two large areas where the laminate had chipped off exposing the porous wood underneath. The black laminate-covered cart holding the computer had missing laminate on the corners, exposing the porous wood underneath. The wheels on the cart marked "soiled linen" had rusty wheels.

3. On 1/26/11 at 1450 hours, a five gallon container of 10% Neutral Buffered Formalin was observed in a specimen preparation alcove in the OR. Formalin is a solution made of a formaldehyde and water. Exposure to formaldehyde by inhalation can result in watery eyes, headache, a burning sensation in the throat, respiratory difficulty and can be toxic, allergenic, and carcinogenic. The container's spigot had multiple pieces of tape securing it to the container and the entire container had tape wrapped around it. When it was brought to the attention of the Director of the OR, he stated he would discard it.

Based on observation, interview and record review, the infection control officer:

* Failed to provide oversight of employees and contracted dialysis staff to ensure infection control procedures were being implemented for seven of 31 sampled patients and in four of four ORs ( Patients 31, 32, 36, 37, 40, 43 and 47). This resulted in the potential for the transmission of infections.

* Failed to monitor the process requiring daily physician documentation of the necessity for continuing a central catheter for three patients (Patients 37, 40, and 43). A central catheter is a tube that is placed into a patient's large vein, usually in the neck, chest, arm, or groin. The catheter is often used to draw blood or give fluids or medications. It may be left in place for several weeks. This failure to ensure assessment of the continuing need for the catheter increased the potential for infection in patients for whom the central catheters were no longer necessary.

* Failed to develop and implement a P&P for ice machine cleaning and sanitation for two of the two hospital ice machines. This resulted in the potential for patients to be at risk for food borne illness.

Findings:

1. Review of the CDC Central Line associated Bloodstream Infections in Non ICU Settings Toolkit, 2009, showed one of the core prevention strategies to avoid or reduce central catheter infections was to remove unnecessary central lines. A bloodstream infection can occur when bacteria or other germs travel down a central line and enter the blood. Intravascular catheter-related bloodstream infections are an important cause of illness and excess medical cost. In prospective studies, the relative risk for a catheter-related bloodstream infection is 2 to 855 times higher with central venous catheters than peripheral venous catheters. The CDC toolkit recommended daily assessments for the need of a central line be performed and to promptly discontinue those that are no longer required. Nursing staff should be encouraged to notify physicians of central catheters that were unnecessary.

The minutes of the Medical Executive Committee dated 8/27/08, were received for review on 1/25/11. Documentation showed new business: Central Line Insertion Practice (CLIP) Reporting requirements: The Director of Infection Control informed the committee beginning 7/1/08, the State required hospitals to monitor certain infection control processes. The first process selected was central line insertion practices. In addition, the Director informed the committee the hospital was required to do daily assessments for the necessity of a central catheter. A stamp was selected by the committee to be used on physician's progress notes. On a daily basis the physician was to complete the information requested. The stamp allowed the physician to indicate if the central catheter was to be continued, and if so, the reason for it's continuance. This process was not currently being implemented as follows:

a. The medical record for Patient 37 was reviewed on 1/25/11 at 1330 hours with the Director of the Medical Surgical Unit. The patient was admitted to the hospital on 12/28/10. A PICC line was inserted on 1/20/11. Review of the physician's progress notes did not show the physician documented the patient's daily continuing need for a PICC line. The Director stated the documentation by the physician should be done daily to show justification for the central catheter.

b. The medical record for Patient 40 was reviewed on 1/25/10 at 1110 hours. The patient was admitted to the hospital on 1/21/11 with a PICC line. A physician's progress form dated 1/24/11, showed a stamped request for the physician to document if the patient's central catheter was to be continued. If the answer was yes, the reason for continuation was to be checked off. Reasons pre printed on the stamp included poor peripheral access, hemodynamically unstable, long term intravenous treatment, or other. The physician had documented only to continue the PICC; however no reason was given.

RN D was interviewed on 1/25/11 at 1115 hours. When asked, the RN stated the physician was to document daily the continuing need for a central catheter. The RN confirmed Patient 40 had a PICC line on admission. RN D stated the night shift was supposed to put the stamp with the pre printed documentation on the progress notes for the following day. RN D reviewed the progress notes for Patient 40 and stated the progress notes dated 1/24/11 did contain a stamp, however it was incomplete. The RN could find no other documentation from the physician justifying the continuing need for the PICC.

c. The medical record for Patient 43 was reviewed on 1/25/11 at 1430 hours. The patient was admitted to the hospital on 1/6/11. The patient had a central catheter in the right jugular vein (vein in the neck) on admission.

Review of the physician's progress notes dated 1/7 through 1/24/11, for Patient 43 showed a stamped pre printed form to document the necessity for continuing the patient's central catheter. The stamped form was blank and there was no other documentation from the physician regarding the central catheter on 1/8, 1/9, and 1/12/11. On 1/14 and 1/16/11, the stamped form was signed but did not indicate to continue or not to continue the catheter. On 1/22 and 1/24/11, the physician checked to continue the central catheter but did not give a reason. The stamp for 1/23/11 was not signed until 1/25/11, and was not completed. There was no stamped progress note dated 1/25/11, and no other documentation was found to show the physician reviewed the necessity of continuing the central catheter..

RN J was interviewed on 1/12/11 at 1445 hours. When asked, the RN confirmed the physician was not consistently documenting the daily necessity for continuing Patient 43's central catheter.

The Director of Infection Control was interviewed on 2/1/11 at 0825 hours. The Director stated the hospital had reviewed the rate of central catheter infections and had found no problems at the time of insertion. The Director stated they had found if there was an infection, it occurred at a later date. He stated consistent site care was thus being addressed. The observations regarding the inconsistent documentation by the physician of a daily necessity for continuing the central catheter were shared with the Director. The Director stated the hospital did not have a P&P to address the daily documentation of the need to continue a central catheter. The Director stated he had been made aware of the surveyor's findings and realized physician documentation was a problem. The Director stated the hospital did require the physician to document the daily necessity of a central catheter. He stated the Medical Executive Committee had agreed to do this in 2008. However, the Director stated he had not monitored the process to ensure it had been done.

2. Review of the AORN 2010, Perioperative Standards and Recommended Practices showed free-standing humidifiers should not be used because they can harbor microorganisms in the fluid reservoirs and aerosolize these microorganisms into the clean environment.

Following the tour of the OR rooms with the Director of Surgery on 1/26/11 at 0700 hours, a tour was done of the surgical supply storage room. In the room three small gray machines were observed. When asked what the machines were used for, the Director stated two of the machines were humidifiers. The Director stated they also had two de-humidifiers, one of which was observed in OR room 2. He stated the machines were used as needed to keep the humidity in the OR rooms within limits. In drier seasons the Director stated he needed to add humidity to the air and in the wetter seasons he needed to remove moisture from the rooms. When demonstrating how the machines worked, water was found in the reservoir of one of the humidifiers. When the de-humidifier used in Room 2 was checked, water was also found in that reservoir. When asked to see the disinfection policy for the machines, he stated there was no policy for disinfection. The Director stated he did not think the humidifiers and de humidifiers had been disinfected in the eight months he had been employed in the hospital.

3. The 2010, AORN Perioperative Standards and Recommended Practices showed the environment should be assessed for cleanliness. Cleanliness means the absence of visible dust, debris, soil or body substances. A clean lint-free cloth should be used to damp dust. This was not done as follows: observation of four of four OR rooms showed patient equipment that was rusted and mattresses that were ripped and torn; floors and walls were damaged so that disinfection could not be assured; and equipment in the OR rooms were covered in a layer of white lint dust. See A 724 #2.

4. On 2/1/11 at 1130 hours, a follow up tour of the OR rooms was conducted with the Corporate Consultant, ST 1, RN P and RN O. Review of the rooms showed a white debris on the equipment, on top of the sheets and on the pads under the sheets.

At 1200 hours, during a meeting with the Director of Housekeeping, he stated he was not sure the towels presently used for cleaning were lint-free and was going to order new lint-free towels

5. The contracted dialysis provider's policies, used by dialysis staff when giving care in the hospital, were reviewed on 1/26/11. The policies were kept in a binder on the Medical Surgical Unit's nursing station as a refernce for staff. Policy 7-03-08 for Isolation Patient Care During Dialysis, revised 9/09, showed materials, which included the patient chart, were to be stored outside the isolation area.

Policy 7-03-01 for Infection Control in the Hospital Dialysis Setting, revised 9/10, under the area for Hospital Dialysis Setting Hygiene, Item 26, showed hand washing sinks should be dedicated only for hand washing purposes and remain clean. To avoid placing, cleaning or draining used items in hand washing sinks. Used or contaminated items should be handled in designated utility sinks. Item 29 showed if a common supply cart was used to store clean supplies in the hospital dialysis setting, the cart was to remain in a designated area at a sufficient distance from patient stations to avoid being contaminated with blood. Items taken into the patient station during treatment would not be returned to the supply cart. Only teammates with clean hands may remove items from the supply cart.

a. At 1330 hours on 1/25/11, in the ICU, Dialysis Nurse B was observed caring for Patient 36. The patient was on contact isolation (precautions included the wearing of PPE, gowns, gloves and a mask, to prevent transmission of infectious agents which are spread by direct/indirect contact with the patient or his environment), The Nurse was preparing to start Patient 36's dialysis treatment. The dialysis machine had been placed in the isolation room next to the patient's bed. Coming out of the isolation room entrance were hoses from the the dialysis machine. The hoses went out the door of the patient's room and across the main hallway floor for approximately 13 feet. The hoses were attached to the water faucet in the clean hand washing sink in the hallway. The water was needed to operate the dialysis machine. The drain hose, for all the waste products removed from the patient's blood, had also been placed to drain into the clean hand washing sink. Towels had been wrapped around the hoses in several areas.

Attached to the back of the dialysis machine was a large gray plastic container in which extra supplies such as extra blood lines, dialyzers, packages of electrolytes and a clipboard containing treatment sheets were stored. A table had been positioned outside the patient's room near the entrance on one side, and on the other side of the entrance, was a chair. On the table the nurse had a pump bottle of hand sanitizer and a large backpack which contained extra treatment supplies.

At 1350 hours, Dialysis Nurse B was observed standing partially out of the isolation room entrance wearing a yellow gown and mask. The nurse, who had removed her gloves and washed her hands, was reaching into the backpack on the table. However, the sleeves of the gown made contact with the outside and the inside of the bag.

At 1400 hours, the nurse was again observed coming partially out of the isolation room entrance and reached into the backpack on the table. The nurse went back into the room, reached into the gray plastic container behind the dialysis machine and removed the clipboard containing the treatment sheets. Dialysis Nurse B stepped out of the isolation room entrance wearing her PPE with the clipboard in her hand. The nurse placed the clipboard in the chair and moved the chair over to the entrance of the isolation room. Dialysis Nurse B sat in the chair in the entrance of the patient's room.

b. On 1/26/11 at 1530 hours, Dialysis Nurse C was observed performing a dialysis treatment for Patient 32 on the Medical Surgical Unit. Two rolls of tape were attached to the IV pole of the dialysis machine and an open box of gloves was stored on top of the machine. During an interview with Dialysis Nurse C, he stated he was not aware the box of gloves and the rolls of tape should not be left on the machines and used for other patients.

During the dialysis treatment the doors to the dialysis patient's room and the patient room next to the dialysis patient's room were observed as open. The water supply hoses and the waste drain hose were coming out of the dialysis patient's room and going into the sink of the patient's room next door. There was a patient in the room. The clean hand washing sink for this room was inside the door to the left. The drain hose for the waste products removed from the dialysis patient during treatment had also been placed in the other patient's clean hand washing sink.

When asked, Dialysis Nurse C stated the right connectors for the dialysis water supply were not in place on the handwashing sink in the dialysis patient's room. The sink in the next room had the right connectors so the nurse stated he hooked up the water hoses there. When asked why the contaminated waste removed from the dialysis patient was draining into the other patient's sink, Dialysis Nurse C stated he had been told they could not drain the waste products down the toilet and had to use the clean hand washing sinks. The nurse added the dialysis patient used the bathroom so he had to leave the toilet free.

On 2/1/11 at 0825 hours, an interview was done with the Director of Infection Control. He stated he visually monitored the contracted dialysis staff for their infection control practices. When asked, the Director stated he had not been aware of the draining of dialysis waste into the clean hand washing sinks until he was informed of the surveyor's observations.

6. On 1/25/11 at 1155 hours, a family member of Patient 31 was observed in the patient's contact isolation room. The family member's yellow gown had not been tied at the neck and the gown was falling down over her shoulders exposing her clothing underneath. At 1352 hours, the family member removed the gown and gloves and left the room. The family member walked past the hand washing sink and was walking toward the exit. Staff members stopped the family member and reminded her to wash her hands before leaving the area.

At 1200 hours on 1/25/11, LVN C was asked how infection control education was provided for Patient 31's family member. No documentation could be provided to show the family member had received any infection control education.


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7. The hospital's policy and procedure for PPE, dated 10/20/10 showed when exiting an isolation room, gloves are to be removed first, then the cover gown and then the mask. The mask is to be removed by grasping the ties/elastic. The front of the mask is considered contaminated and should not be touched.

On 1/25/11 at 0930 hours, RN G was observed leaving the contact isolation room of Patient 32. The nurse first removed the gown, then gloves and then the masks. The mask was removed by pulling at the front of the mask.

8. The AORN's 2010 "Perioperative Standards and Recommended Practices, Surgical Attire" showed personnel should cover head and facial hair including sideburns and neckline. According to the AORN, hair acts as a filter when left uncovered and collects bacteria in proportion to its length, curliness, and oiliness. Shedding from hair has been shown to affect surgical wound infections, therefore complete coverage is necessary.

On 1/26/11 beginning at 0740 hours, a procedure was performed in OR 1. During the procedure, which involved making a small incision into the patient's abdomen, breaches in infection control were observed. MD T's mask did not cover his beard and strands of RN L's hair were outside her cap. On 1/26/11, after the procedure, these breaches were acknowledged by the Director of Surgery who was in the OR at the time of the observations and had not corrected the practices.

9. The hospital's policy and procedure for infection prevention, dated 10/20/10, showed PPE, which included cover gowns, gloves and masks, would be worn based on Standard and Transmission guidelines.

The CDC's transmission based guidelines "2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings" recommended Contact Precautions for multidrug resistant bacteria in acute care settings with increased risk for transmission. MRSA (Methicillin-resistant Staphylococcus aureus) was identified by the CDC as a multidrug resistant bacteria. The CDC recommendations included wearing a cover gown and gloves. A mask can be added if indicated.

On 1/26/11 in OR 1, after recovery from a procedure that began at 0740 hours, Patient 47 was prepared for transport back the nursing unit. RN L and RN P put their surgical masks back on, placed a mask on the patient, and joined CNA B to help transport the patient to the nursing unit. When asked why the masks were being reapplied, the Director of Surgery stated the patient was on isolation precautions. There was no explanation as to why the masks were removed after the procedure.

RN L, RN P and CNA B transported the patient back to the nursing unit. On the outside of Patient 47's room was a sign showing Contact Precautions. The room was a semi-private room with another patient in the bed next to the door. Patient 47 was placed in the bed next to the window. RN L, RN P or CNA B did not stop to put on cover gowns and gloves prior to entering the room. None of the staff was wearing a cover gown during the transport from the OR.

On 1/26/11 at 1045 hours, during interview, RN R, who was caring for both Patient 47 and the other patient in the room, stated both patients were in contact isolation for MRSA that had been cultured from the inside of their noses.

On 1/27/11 at 0930 hours, the concern regarding proper PPE for a surgical patient in isolation was being discussed with the Director of Surgery and OR staff. OR nurse, RN O, stated she was unsure whether to put on the cover gown or not in that situation, as the gowns were not stocked in the OR.

10. The AORN's 2010 "Perioperative Standards and Recommended Practices, Environmental Practices," showed if an item in an OR can not be cleaned it should be covered with a moisture proof protective covering product that can be cleaned.

On 1/26/11 at 0730 hours, inspection of OR 1 showed a large sheet of paper, an item that can not be cleaned, taped to the wall with time out instructions. When this was shown to the Director of OR, the paper was removed from the wall.


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11. On 1/25/11 at 0900 hours, and throughout the survey, the cleaning and sanitizing of the hospital's two ice machines, (one bin ice machine in the kitchen (Brand A), and one shoot ice machine (Brand B) on the medical surgical unit, were investigated.

During a meeting with the Director of Engineering on 1/26/11 at 0930 hours, the preventative maintenance (PM) of the hospital's ice machines was reviewed. The Director presented two work orders dated 1/25/11, for cleaning and sanitizing PM for the kitchen ice machine and the medical surgical unit's ice machine. The Director stated he was unable to provide documentation of prior cleaning and sanitizing of the two ice machines. The Director stated both brands of ice machines were scheduled to be cleaned semiannually. Review of the two work orders dated 1/25/11, showed the work order directions did not provide specific instructions to match the manufacturers' recommended cleaning and sanitizing schedule or the specified sanitizing steps outlined in the manufacturer's directions.

On 1/26/11 at 0930 hours, review of the manufacturer's directions for Brand A ice machine showed the maintenance and cleaning should be scheduled a minimum of twice per year. A sanitizing solution of one ounce of household bleach to two gallons of water was to be run through the ice machine water system and the bin. Review of the manufacturer's directions for Brand B showed the cleaning and sanitizing should be performed every 3 months. When asked, the Director of Engineering confirmed he was not aware of the manufacturers' scheduled cleaning recommendations.

On 1/27/11 at approximately 1030 hours, the ice machine in the medical surgical unit was observed with the Director of Infection Control. The Director stated the infection control program was to provide an effective hospital wide program for the surveillance, prevention and control of infections. The Director stated the oversight of the cleaning and sanitizing of the hospital's ice machines was not addressed in the hospital's infection control plan.

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

* The Surgical Services department was provided the resources to safely perform operations/procedures. A circuit breaker that supplied electricity to the OR rooms was overloaded during a surgical procedure and shut off. The surgeon could potentially be unable to complete the surgery and/or the anesthesiologist unable to maintain anesthesia;

* Ensure surfaces and equipment in four of four ORs were not ripped, rusted or damaged; blocking the disinfection process;

* Ensure a dust free environment in four of four ORs;

* Ensure humidifiers and de humidifiers were not used to correct humidity levels in four of four ORs in compliance with the accepted practices established by the 2010 AORN Perioperative Standards and Recommended Practices. This shource shows humidifiers and de humidifiers can harbor germs in the fluid reservoirs and aerosolize these germs into the clean environment.

Findings:

1. The AORN's Position Statement on Patient Safety, in the 2010 Perioperative Standards and Recommended Practices, showed the operative setting is one of the most potentially hazardous of all clinical environments. The patient is vulnerable with diminished/absent defense mechanisms and the complications that can occur include hemorrhage, burns, and injury.

On 1/26/11 at 0740 hours, an endoscopic procedure (a way of looking inside the body through the esophagus using a flexible tube with a small camera on the end of it) was being observed in Operating Room 1. At 0750 hours, the power to the room went out. The room lights and surgical equipment in the room, which included IV pumps, suction equipment, endoscopic equipment and the computer system, all stopped working and the room was dark. ST 1 told the Director of Surgery to go down the OR hallway to a circuit panel on the left hand side and reset the circuit. The Director of Surgery left the room and after approximately one minute the lights and equipment came back on. At that time ST 1 stated the amount of equipment being used in the OR room had overloaded the electrical capacity of the room.

The endoscopic procedure was the only procedure/surgery scheduled for that day. The Life Safety Surveyors were informed of the event. After a further interview of hospital's surgical staff members and plant operations the survey team called an immediate jeopardy.

On 1/26/11, a review of the surgical log showed the hospital had performed nine surgeries in December 2010 and eleven in January 2011. Surgeries performed in the hospital's OR included tracheostomies (a hole in the throat to help with breathing), spinal surgery, permanent pacemaker insertion, throat surgery and hernia surgery.

On 1/27/11 at 0820 hours, ST 1 was interviewed. The ST stated the power outages to the OR rooms had occurred 11 times over the past six years. The most recent one occurred seven or eight months ago. According to ST 1 the outages had occurred in various OR suites (there were five OR suites). The ST stated staff had notified a former Director of Quality (not currently employed at the facility) but nothing to correct the situation had been done.

On 1/27/11 at 0930 hours, RN O stated during an interview she was unaware of power outages. However, the RN stated the staff had to be careful and know which outlet to plug in equipment. The staff would check with the ST before plugging in equipment. RN O stated sometimes the OR equipment had to be plugged into outlets in the hallway outside the OR suite in use.

On 1/27/11 at 0935 hours, MD M, an anesthesiologist, confirmed during interview that power outages had previously occurred, especially in OR 3. MD M stated to the best of his recollection outages had occurred seven to ten times.


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2. The 2010, AORN Perioperative Standards and Recommended Practices showed the environment should be assessed for cleanliness. Cleanliness means the absence of visible dust, debris, soil or body substances. A clean lint-free cloth should be used to damp dust.

a. During observation of the hospital's operating rooms with the Director of Surgery on 1/26/11 at 0700 hours, the following was found :

* The outer moisture-resistant covering of the mattress pads on the OR tables in rooms 2, 3, and 4 had splits, tears and large missing areas on the corners of the pads. The porous material underneath was exposed, making it difficult to ensure disinfection of the pads.

* Small white pieces of debris were observed in all OR rooms, on the equipment, on top of the sheets on the operating tables and under the sheets on the mattress pads.

* There were areas on the walls that had been patched, but not painted (leaving the porous patched surfaces exposed) making it difficult to ensure disinfection.

* The bases of the metal supply storage cabinets had areas where the paint had chipped off and the metal underneath was exposed. Some of the exposed metal was getting rusty and; therefore, difficult to ensure disinfection.

* The wooden entry doors into the operating rooms and into the sub-sterile areas were observed to have areas where the paint had been chipped off exposing the wood underneath.

* There were penetrations in the dark brown floor tiles in all the rooms.

* In OR 4, the air vents near the ceiling, and the arms on the overhead lights, had areas of chipped paint exposing the metal underneath. In some areas the metal was becoming rusty.

* The sub-sterile room had entry doors leading from the main hall and from OR's 3 and 4. To the left of the main entry door was a long metal counter. The entire length of the counter, where the metal counter met the overhead cabinets, was rusty. The bottom of the steam sterilizer was rusty. There was an accumulation of dirt observed in the corners by the doors. An area of exposed porous cement was noted between the control panel and the warming cabinet above the floor. The metal plate on the floor under the door which opened to Room 3 to was rusty and dirty. The bottom of the wood cabinet underneath the sink was covered with small pieces of rusty metal that had flaked off the underside of the metal sink. There was an open hole in the wall at the back of the cabinet.

*OR 3 had a dirt build up in the corners of the floor by the entry door and along the top of the metal edge that covered the end of the tiles, where the tile had been extended up the wall 2-3 inches. The base on the operating table and the metal bar in the middle of the operating table were rusty. The stainless steel bars attached to the sides of the operating table were rusty and dirty. The arms of the large overhead light had missing areas of paint.

* In OR 2 the OR table had areas of chipped paint. There were penetrations in the OR wall. The patched areas on the walls in this room had rust showing through the patching material.

*The metal plate on the floor at the bottom of the door into the sub-sterile area between ORs1 and 2 was rusty. There was a dirt build up in the corners of the floor by the main entry door, and on the metal edge that covered the end of the tiles where the tile had been extended up the wall 2-3 inches. A de-humidifier was observed in the room.

* OR 1 had two large laminate covered storage cabinets in the back of the room. There were two large areas where the laminate had chipped off exposing the porous wood underneath. There was a piece of paper taped to the wall without a plastic covering, making it difficult to ensure disinfection between cases. The black laminate-covered cart holding the computer had missing laminate on the corners, exposing the porous wood underneath. The wheels on the cart marked "soiled linen" had rusty wheels.

3. On 2/1/11 at 1130 hours, a follow up tour of the ORs was conducted with the Corporate Consultant, ST 1, RN P and RN O. Review of the rooms showed a white debris on the equipment, on top of the sheets and on the pads under the sheets.

At 1200 hours, during a meeting with the Director of Housekeeping, he stated he was not sure the towels presently used for cleaning were lint-free and was going to order new lint-free towels.

4. Review of the AORN 2010, Perioperative Standards and Recommended Practices showed free-standing humidifiers should not be used because they can harbor microorganisms in the fluid reservoirs and aerosolize these microorganisms into the clean environment.

Following the tour of the OR rooms with the Director of Surgery on 1/26/11 at 0700 hours, a tour was done of the surgical supply storage room. In the room three small gray machines were observed. When asked what the machines were used for, the Director stated two of the machines were humidifiers. The Director stated they also had two de-humidifiers, one of which was observed in OR 2. He stated the machines were used as needed to keep the humidity in the OR rooms within limits. In drier seasons the Director stated he needed to add humidity to the air and in the wetter seasons he needed to remove moisture from the rooms. When demonstrating how the machines worked, water was found in the reservoir of one of the humidifiers. When the de-humidifier used in Room 2 was checked, water was also found in that reservoir. When asked to see the disinfection policy for the machines, he stated there was no policy for disinfection. The Director stated he did not think the humidifiers and de humidifiers had been disinfected in the eight months he had been employed in the hospital.

5. The AORN's 2010 "Perioperative Standards and Recommended Practices, Surgical Attire" showed personnel should cover head and facial hair including sideburns and neckline. According to the AORN, hair acts as a filter when left uncovered and collects bacteria in proportion to its length curliness and oiliness. Shedding from hair has been shown to affect surgical wound infections, therefore complete coverage is necessary.

On 1/26/11 beginning at 0740 hours, a procedure was performed in OR 1. During the procedure, which involved making a small incision into the patient's abdomen, breaches in infection control were observed. MD T's mask did not cover his beard and strands of RN L's hair were outside her cap. On 1/26/11, after the procedure, these breaches were acknowledged by the Director of Surgery who was in the OR at the time of the observations and failed to correct the staff practices.

Based on record review, the hospital failed to ensure an informed consent form was complete prior to a surgical procedure for one of 31 sampled patients (Patient 58). There was no documentation to show the consent had been translated for the non English speaking patient and no documentation which showed the name of the physician who provided the information . This resulted in the potential for patient misunderstanding of the proposed procedure.

Findings:

The review of patient medical records was initiated on 1/26/10.

Review of the medical record for Patient 58 showed the patient had been admitted to the hospital on 1/11/11 for a surgical procedure. The Multidisciplinary Admission Assessment showed Patient 58's primary language was not English. Review of an informed consent for the surgical procedure dated 1/12/11 at 1020 hours, showed the signature area had been initialed by the patient, but the translator area had been crossed out. It showed the consent had been signed by the physician and anesthesiologist on 1/12/11 at 1430 hours. In the area of the consent where the risks, benefits and alternatives had been explained to Patient 58, no physician name was documented on the form.

Based on interview and record review, the hospital failed to ensure the respiratory services policies and procedures addressed the complexity of the patient population and RP (Respiratory Practitioner) roles, responsibilities, and under what circumstances procedures, such as intubation, could be performed. Intubation involves putting a flexible tube through the mouth or nose into the trachea to secure an airway and is often used when a patient is having difficulty breathing. When performed by an inexperienced practitioner, this procedure could potentially result in patient injury/death.

Findings:

Intubation of patients can be difficult and there are major potential complications with intubation. Reintubation of previously intubated patients can often be more difficult than initial intubation. Complications of intubation can include putting the breathing tube into the esophagus, puncturing part of the respiratory system and allowing air into the chest, low blood pressure, low oxygen levels and even stopping the heart. The number of attempts to intubate the patient can affect the patient's outcome (Joffe, A., Lieu, EM, Matroc, A, and Willman, K., Unanticipated difficult intubation in the medical-surgical intensive care unit: its effect on outcome of critically-ill adults. The Internet Journal of Anesthesiology 2010: Volume 24).

Also of note, the occasional performance of intubation does not ensure skill maintenance (Bishop, M., Michalowski, P.,Hussey, J. Massesy, L. and Lakshiminarayan, S. Respiratory Care 2001, Recertification of respiratory therapists' intubation skills one year after initial training: An analysis of skill retention and retraining).

On 1/25/11 at 0850 hours, a tour of the hospital's ICU was conducted. There were seven patients, six of whom had significant respiratory medical conditions. Five of the patient's had mechanical support systems to assist with breathing and breathing tubes in their throats including tracheotomies (a tracheotomy consists of making an incision on the front of the neck and opening a direct airway through an incision in the breathing tube in the throat). Some of the patients on the Medical Surgical unit had breathing tubes in, or had a tracheotomy prior to transfer to the Medical Surgical Unit.

On 1/27/11 at 0945 hours, during an interview, the Director of Cardiopulmonary Services stated that on day shift (0730 to 1900 hours), if a physician was not available, the RPs intubated patients. The Director added RPs had intubated a total of five or six patients in the past year. The Director stated usually the Lead RP did the intubations.

Review of the hospital's P&P for intubation, dated 4/10, showed a physician or RP may insert the tube into a patient's trachea. The P&P did not specify what requirements the RP must have completed in order to intubate a patient or define any parameters for patient selection.

The P&P did not differentiate if RPs can only intubate only in emergency situations or at any time. The P&P showed an informed consent should be obtained if it is not an emergency situation, but only physicians are responsible for informed consents. The P&P also showed that sedation was to be given but did not specify what sedation, who was ordering the sedation, or who was to give it.

A review of the RP's job description did not show intubation as a component of the job.

Based on observation, interview and record review, the hospital failed to have an effective QAPI system for identifying problem areas as evidenced by:

* The failure to correct safety in the OR which resulted in a power outage during a surgical procedure, putting the patient at risk.

* Failure to identify issues with the physical environment and infection control in the OR.

* No documentation to show Code Blue outcomes were analyzed to identify areas for improvement regarding the intubation of patients by an RP (Respiratory Practitioner).

* Failure to ensure the QAPI program monitored and analyzed data regarding the process of daily physician documentation for the necessity of continuing the use of a central catheter. This resulted in the potential for increased infections relating to the use of central catheters.

Findings:

1. On 1/26/11 during an observation of a procedure in the operating room, the power to the lights and equipment went out. After the event, the OR Director stated he was unaware of the problem.

During interviews on 1/27/11, ST 1 and MD M stated there were multiple occurrences of the power going out to the OR over the past six years.

During subsequent interviews, on 2/1/11, the Director of Quality, the CEO and the COO/CNO stated they were unaware of the problem. The CEO stated in an interview at 1535 hours, he had never heard there were electrical problems in the OR until informed of them by the survey team. He stated there had been no incident reports filed.


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2. During an observation of the OR on 1/26/11 beginning at 0700 hours, multiple observations were made of patient equipment that was rusted, OR mattresses that were ripped and torn; floors and walls were damaged so that disinfection could not be assured; equipment in the OR rooms was covered in a layer of white dust; and humidifiers and de-humidifiers were being used to correct the humidity levels in the ORs contrary to accepted standards of practice.

The Director of Quality Management and Infection Control was interviewed on 2/1/11 at 0825 hours. When the observations of the OR were discussed, the Director stated he was aware the floors needed repair and this had been requested. The Director stated some of these observations of the OR had been noted on his physical environmental rounds. The Director was asked to provide documentation of the environmental rounds. At the time of the survey team exit on 2/2/11, no documentation had been provided.

3. Review of the CDC Central Line associated Bloodstream Infections in Non ICU Settings Toolkit, 2009, showed one of the core prevention strategies to avoid or reduce central catheter infections was to remove unnecessary central lines. A bloodstream infection can occur when bacteria or other germs travel down a central line and enter the blood. Intravascular catheter-related bloodstream infections are an important cause of illness and excess medical cost. In prospective studies, the relative risk for a catheter-related bloodstream infection is 2 to 855 times higher with central venous catheters than peripheral venous catheters. The CDC Toolkit recommended daily assessments for the need of a central line be performed and to promptly discontinue those that are no longer required. Nursing staff should be encouraged to notify physicians of central catheters that were unnecessary.

The minutes of the Medical Executive Committee dated 8/27/08, were received for review on 1/25/11. Documentation showed new business: Central Line Insertion Practice (CLIP) Reporting requirements: The Director of Infection Control informed the committee beginning 7/1/08, the State required hospitals to monitor certain infection control processes. The first process selected was central line insertion practices. In addition, the Director informed the committee the hospital was required to do daily assessments for the necessity of a central catheter. A stamp was selected by the committee to be used on physician's progress notes. On a daily basis the physician was to complete the information requested. The stamp allowed the physician to indicate if the central catheter was to be continued, and if so, the reason for it's continuance. This process was not currently being implemented as follows:

Review of the medical records for Patients 37, 40, and 43, showed physician documentation was inconsistent and incomplete regarding an assessment of the continuing necessity for the central catheters. See A 748 #1.

The Director of Infection Control was interviewed on 2/1/11 at 0825 hours. The Director stated the hospital had reviewed the rate of central catheter infections and had found no problems at the time of insertion. The Director stated they had found if there was an infection, it occurred at a later date. He stated consistent site care was thus being addressed. The observations regarding the inconsistent documentation by the physician of a daily necessity for continuing the central catheter were shared with the Director. The Director stated the hospital did not have a P&P to address the daily documentation of the need to continue a central catheter. The Director stated he had been made aware of the surveyor's findings and realized physician documentation was a problem. The Director stated the hospital did require the physician to document the daily necessity of a central catheter. He stated the Medical Executive Committee had agreed to do this in 2008. However, the Director stated he had not monitored the process to ensure it had been done.

4. On 1/27/11 at 0945 hours, during an interview, the Director of Cardiopulmonary Services stated that on day shift (0730 to 0700 hours), if a physician was not available, the RPs intubated patients (intubation involves putting a flexible tube down into someone's trachea to secure his or her airway and is often used in emergency medicine when a patient is having difficulty breathing). The Director added RPs had intubated a total of five or six patients in the past year. The Director stated usually the Lead RP did the intubatations. See A 1152.

During an interview with the Director of Quality Management on 2/1/11 at 1450 hours, the Director stated the hospital's QAPI program had an error reduction program to identify prevention of errors and adverse patient events. The Director stated they looked at the process first to look for a fall out in process. When asked if outcomes of Code Blues had been analyzed regarding the practice of RPs intubating patients during an emergency, the Director stated that had not been studied.

Based on interview and record review, the Governing Body, administration and medical staff, through the QAPI process, failed to ensure:

*The need for a physician to be on duty or on call at all times for patient safety was identified and a process to provide this coverage was put in place and maintained. This could potentially result in a delay or an absence of physician response to patient medical emergencies.

*Environmental safety issues in the OR were identified and corrected which resulted in a power outage during a surgical procedure, putting the patient at risk.

Findings:

1. During an interview on 1/25/11 at 0850 hours, the Nursing Director of ICU stated from 1900 hours to 0730 hours, there was an in-house physician on duty. From 0730 hours until 1900 hours, she stated the hospital relied on physicians who happened to be in the hospital at the time to respond to emergencies or staff called the patient's attending physician. The nurses from the ICU responded to patient emergencies (Code Blue - cardiac or respiratory arrest). The charge nurse was the nurse who usually responded to the emergency.

On 2/1/11 at 0905 hours during interview, MD O, the hospital's Medical Director, stated the hospital had teams of nurses to respond to medical emergencies. MD O stated the physicians who were in the hospital would respond and/or the patient's primary physician would be contacted and would come in within an hour from their office if needed. On weekends, when physician offices were closed, MD O stated he was always available. When asked how nurses would know who to call in an emergency if MD O was not available, MD O stated nurses knew the chain and after him there were several pulmonologists available (pulmonologists are physician specialists in the respiratory system).

Review of the medical staff by-laws and rules and regulations failed to show any defined expectation for physicians to respond to emergencies while in the hospital during the hours of 0730 until 1900 hours or for physicians to have ALS (Advanced Life Support) training. The hospital's Code Blue P&P showed any in-house physician with ALS was a Code Blue team member. See Tag A 67.

2. On 1/26/11 at 0740 hours, an endoscopic procedure (a way of looking inside the body through the esophagus using a flexible tube with a small camera on the end of it) was being observed in Operating Room 1. At 0750 hours, the power to the room went out. The room lights and surgical equipment in the room, which included IV pumps, suction equipment, endoscopic equipment and the computer system, all stopped working and the room was dark. ST 1 told the Director of Surgery to go down the OR hallway to a circuit panel on the left hand side and reset the circuit. The Director of Surgery left the room and after approximately one minute the lights and equipment came back on. At that time ST 1 stated the amount of equipment being used in the OR room had overloaded the electrical capacity of the room.

On 1/27/11 at 0820 hours, ST 1 was interviewed. The ST stated the power outages to the OR rooms had occurred 11 times over the past six years. The most recent one occurred seven or eight months ago. According to ST 1 the outages had occurred in various OR suites (there were five OR suites). The ST stated staff had notified a former Director of Quality but nothing to correct the situation had been done. See A 951 #1

Based on medical record review and interview, the hospital failed to ensure the following for two of two patients reviewed (Patient 37 and 42) for medications: two licensed nurses checked and initialed the concentration and rate of IV heparin (decreases clotting) prior to infusion; IV tubing was date labeled and initialed as required by P&P; and IV tubing was changed prior to the expiration date and time. These failures had the potential to allow the administration of a drug which could, if dosed incorrectly, cause severe bleeding; and potentially failed to prevent the use of contaminated secondary IV sets during administration of medications.

Findings:

1. The P&P for Administration of Medication, last revised 7/10, was reviewed on 1/26/11. Documentation showed "Two licensed nurses must verify accuracy of insulin (a drug for lowering blood sugar) and heparin (a drug to prevent blood clots) before administration. These two nurses will verify by initialing on the Medication Administration Record (MAR)."

The medical record for Patient 37 was reviewed on 1/26/11 at 1000 hours. The Medication Administration Record (MAR) indicated that on 1/26/11 at 0915 hours, Patient 37 received Heparin 25,000 units per 250 ml (milliliters) IV at a rate of 7 ml per hour. The MAR was initialed by only one nurse.

The Director of Medical Surgical and RN T were interviewed on 1/26/11 at 1005 hours. Both nurses reviewed the MAR and acknowledged only one nurse had initialed the MAR to verify the accuracy of the heparin dose.

2. The P&P for IV Therapy, last revised 11/10, showed "All IV sites and tubing are dated. All IV tubing shall be changed at least every 96 hours ..."

a. On 1/26/11 at 0810 hours, IV sets currently used for administration of medications for Patient 42 were observed. None of the IV tubing used for administering medications had been dated. Tags had been attached to the tubing and indicated, "Change on Wednesday," or "Change on Thursday."

b. On 1/26/11 at 0810 hours , IV sets currently used for administration of medications for Patient 37 were observed. One of the IV tags contained a change date which indicated the IV tubing should have been changed on the previous night shift at 0545 hours on 1/26/11.

At 1000 hours on 1/26/11, The Director of Medical Surgical and RN T were interviewed. Both nurses acknowledged the IV tubing for Patient 37 should have been changed during the previous night shift.