HospitalInspections.org

Based on record review and interviews with hospital staff, the governing body failed to ensure quality of care and hospital operations are conducted in safe manner.

Findings:

1. The hospital's governing body failed to ensure each patient's rights are protected and promoted. See A Tags 0115, 0117, 0118, 0121, 0122, 0123, 0145, and 0162.

2. The hospital's governing body failed to implement and maintain a quality assessment and performance improvement program (QAPI) that reflected the complexity of the hospital's organization and services, involved all hospital departments and services including those provided by contract or arrangement and had indicators selected that led to improved health outcomes. See A Tag 0263, 0273,. 0283 and 0286.

3. The hospital's governing body failed to ensure pharmaceutical services are administered in accordance with accepted professional principles to ensure safe and appropriate use of medications. See A Tags 0490, 0491, 0500, 0501, 0502, and 0505.

4. The hospital's governing body failed to ensure radiological services provided by the hospital were provided in accordance with acceptable standards of practice and met professionally approved standards for safety and personnel qualifications. The scope and complexity of radiological services offered were not specified in writing and approved by the medical staff and governing body. See A Tags 0528, 0529, 0535, 0536, 0545, 0546 and 0547.

5. The hospital's governing body failed to ensure the hospital is constructed, arranged and maintained to ensure the safety of the patients. See A Tags 0700, 0701, 0702, 0714, 0722, 0724, 0725 and 0726.

6. The hospital's governing body failed to ensure an active ongoing program to prevent, control, and investigate infections and communicable diseases to minimize infections and communicable diseases in patients and staff is maintained. See A Tags 0747, 0748, 0749 and 0756.

7. The hospital's governing body failed to ensure surgical services provided are well organized and provided in accordance with acceptable standards of practice and are in compliance with all the requirements of this Condition of Participation for Surgical Services. See A Tags 0941, 0942, 0943, 0944, 0945, 0951, 0956, 0957 and 0958.

8. The hospital's governing body failed to ensure: a. all locations where anesthesia services may be provided were organized under one anesthesia service; b. were overseen by a qualified physician; c. there was an organizational chart for anesthesia services; d. a chief of anesthesia services was recommended and approved by the medical staff and the governing body; e. policies and procedures were established for anesthesia services in accordance with nationally recognized guidelines; f. nursing staff who may be called upon to assist with rapid sequence intubation and provide conscious sedation were trained and deemed competent to do so; g. adverse events related to the administration of anesthesia and analgesia were monitored; h. anesthesia services were included in the QAPI program; i. the scope of anesthesia services offered were defined and who was qualified to administer anesthesia and deep sedation; j. policies and procedures related to anesthesia practices were provided; and k. a comprehensive post-anesthesia evaluation was completed at an appropriate interval after surgery. See A Tags 1000, 1001, 1002, 1005, 1104, 1110, and
1112.

9. The hospital's governing body failed to ensure the scope of nuclear medicine services was provided to ensure quality care and patient safety. See Tag A-1026.

10. The hospital's governing body failed to ensure the Special Requirements for hospital providers of long-term care services ("swing beds") were met by the hospital. See A Tag 1500.

Based on record review and interviews with hospital staff, the governing body failed to ensure that contracted services or services provided by agreement are evaluated by the hospital's quality assessment and performance improvement (QAPI) program. Leadership did not ensure infection control concerns and issues were reviewed, analyzed and corrective actions were taken through the quality assessment and performance improvement process. See Tag A-0

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

a. ensure that patient or patient's representatives were informed of their rights before starting treatment. See Tag A-0117;

b. develop and implement a grievance process. See Tag A-0118;

c. ensure a process for patients to submit a complaint or grievance. See Tag A-0121;

d. notify patients of time frames for responding to grievances. See Tag A-0122; and

e. respond to patient grievances in writing. See Tag A-0123;

f. ensure staff were provided abuse training. See Tag A-0145; and
g. develop and implement a seclusion policy and procedure. See Tag A-0162.

Based on medical record review and staff interview, the hospital failed to ensure that each patient or patient's representative was informed of their patient rights before starting treatment. This occurred in 18 of 18 medical records reviewed.

Findings:

1. Review of 18 medical records showed no documentation of patient rights being given to patients prior to treatment.

2. On the morning of 11/06/13, the Chief Nursing Officer (CNO) was asked if patients were given their patient rights upon registration. She stated, "They are given an admission packet which prints from the electronic health record and should be on the chart."

3. On the afternoon of 11/06/13, Staff D stated all medical records reviewed were complete.

Based on policy and procedure review, document review, and staff interview, the hospital failed to develop and implement a grievance process according to CMS requirements.

Findings:

1. On the morning of 11/05/13, administrative staff was asked to provide a list of complaints and grievances for 2013.
The Chief Executive Officer (CEO) and Director of Quality (DOQ) stated the hospital only had documentation of grievances and did not record complaints.

The CEO confirmed there was no evidence of the steps taken to investigate the grievances and verified that no written response had been sent/provided to any of the complainants.

2. The policy did not distinguish between a complaint and a grievance.

3. The policy did not provide the patient or patient's representative with a phone number, address, email, and website for filing a complaint or grievance with the State agency.

4. The hospital's policy did not document patients could contact the QIO or State Agency directly to file a grievance.

5. The policy did not include information that informed the complainant of the right to seek review by the Quality Improvement Organization (QIO).

6. A review of patient rights handouts and admission packets had no documentation patients were given State Agency contact information (including the OSDH email and website, for lodging complaints and grievances).

7. There was no documentation the hospital reviewed grievances through the Quality Improvement Committee.

8. The surveyors verified these findings with CEO and DOQ at the time of review.

Based on a review of policies and procedures and staff interviews,the hospital failed to ensure the process for submitting a complaint or grievance was clearly defined for the patient. The hospital grievance policy did not clearly explain how the grievance process worked.

Findings:

1. The hospital admission packet given to patients on admission to the hospital did not clearly explain the grievance process in the patient rights information.

2. The Chief Nursing Officer (CNO) verified that this was the patient rights information given to patients.

Based on document review and staff interview, the hospital did not ensure grievances are reviewed within a specified and reasonable time frame established by the hospital. There was no documented evidence that the hospital grievance process had grievance response time frames and patients were notified of established time frames for a response to grievances.

Findings:

On 11/05/13, the Chief Executive Officer (CEO) was asked if patients were informed of the hospital's time frame for responding to grievances. He stated he wasn't aware of the time frame himself and would ask the Director of Quality (DoQ).
Surveyors asked the DoQ if patients were informed of the hospital's time frame for responding to grievances. She stated, "It doesn't appear so."

Based on record review, policy and procedure review and staff interview, the hospital failed to respond to patient grievances in writing including all the required elements; name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process and the date of completion.

Findings:

1. On the morning of 11/05/13, surveyors requested the facility's grievance log. There were no grievances reported for 2013.
2. The Chief Executive Officer (CEO) stated that he had investigated grievances and reported back to the complainant but had not documented anything.
3. None of the grievance reports had documentation of investigation, actions taken to resolve the grievance or a written response to the complainant that included the required elements.

Based on policy and procedure review, and staff interview it was determined that the hospital failed to ensure that an abuse policy was in place that contained all the necessary components, which included the following; a. prevention, b. screening, c. identification of events that may contribute to abuse, d. training of staff, e. protection of patients, f. investigation of allegations; and reports to the appropriate authorities if necessary. The hospital's policy did not provide the necessary component of staff training.
Findings:
1. On the morning of 11/05/2013 the hospital administrative staff was asked to provide the hospital's abuse policy. An abuse policy was provided.
2. On the morning of 11/05/2013 staff G was asked if the staff was provided with ongoing training regarding abuse. Staff G stated that all the training is online on a program called "Care Learning." Staff G was asked to provide documentation of the online training curriculum. An example of the computer printout of Care Learning was provided. Abuse was listed as one of the training items. Staff G stated that the Care Learning training is done upon hire and yearly.
4. There was no evidence on the Care Learning training form that the staff was trained on how to recognize abuse and what the staff should do if they witnessed abuse of a patient.

Based on document review and staff interview, it was determined the hospital failed to include seclusion in their patient's rights policies and procedures.

Findings:

1. On the morning of 11/05/2013, administrative staff was asked to provide the hospital's seclusion and restraint logs. No seclusion log was provided.

2. On the morning of 11/05/2013, Administrative Staff was asked to provide the hospital's policies and procedures on seclusion, none was provided.

3. On the afternoon of 11/05/2013, surveyors were provided a document titled, "Elkview General Hospital Restraints" that documented, "...Seclusion is defined: the involuntary confinement of a person in a room or area where the person is physically prevented from leaving..."

4. Surveyors asked the Chief Nursing Officer (CNO) to provide seclusion logs and policies and procedures. The CNO stated the hospital did not utilize seclusion and did not have a policy and procedure. The CNO told surveyors that she would need to create a policy and procedure stating the facility does not use seclusion and take it through the medical staff to be approved.

Based on record review and interviews with hospital staff, the hospital failed to implement and maintain a quality assessment and performance improvement program (QAPI) that reflected the complexity of the hospital's organization and services, involved all hospital departments and services including those provided by contract or arrangement and had indicators selected that led to improved health outcomes.

Findings:

1. The hospital failed to develop indicators that reflect the scope of services the hospital provides and measure, analyze and track the indicators selected to monitor the effectiveness and safety of services and quality of care. See Tag A 0273.

2. The hospital failed to collect QAPI data that would identify opportunities for improvement from its high-risk or problem-prone areas. The hospital does not collect data from high-risk areas such as surgery and radiology services or incident reports. See Tag A 0283.

3. The hospital failed to ensure the quality assessment and performance improvement (QAPI) program includes measurable indicators to identify and reduce medical errors and adverse patient events, analyze the errors and events and implement changes to improve outcomes. See Tag A 0286.

Based on record review and interviews with hospital staff, the hospital failed to develop indicators that reflect the scope of services the hospital provides and measure, analyze and track the indicators selected to monitor the effectiveness and safety of services and quality of care. Review of governing body minutes, medical staff minutes and quality assessment/performance improvement (QAPI) meeting minutes for 2013 did not have evidence of indicators for all departments providing care.

Findings:

1. QAPI meeting minutes provided for review were narrative notes, but not specific indicators with measurable parameters that could be analyzed and measured to determine quality of care.

2. The hospital does orthopedic surgery, including joint replacement, weekly. This is a high risk surgery. There were no indicators from the surgical department specifically looking at the quality and safety of these procedures.

3. The hospital does nuclear radiation procedures and the QAPI program did not have indicators that analyzed and measured the quality and safety of these procedures.

4. Leadership did not ensure infection control concerns and issues were reviewed, analyzed and corrective actions were taken through the quality assessment and performance improvement process.

5.

Based on record review and interviews with hospital staff, the hospital failed to collect quality assessment and performance improvement (QAPI) data that would identify opportunities for improvement from its high-risk or problem-prone areas. The hospital does not collect data from high-risk areas such as surgery, infection control and radiology services or from incident reports.

Findings:

1. The hospital performs orthopedic surgery which includes joint replacement. The QAPI program documentation provided to surveyors had no evidence surgical services was included in the quality assessment process.

2. Leadership did not ensure infection control concerns and issues were reviewed, analyzed and corrective actions were taken through the quality assessment and performance improvement process.

3. There was no evidence in QAPI documents provided for review that radiology services including nuclear radiology services provided in the hospital were included in the QAPI process and data collected to evaluate the services.

4. There was no evidence in QAPI, Medical Staff and Governing Body meeting minutes that data from incident reports were used to identify opportunities for improvement.

Based on record review and interviews with hospital staff, the hospital failed to ensure the quality assessment and performance improvement (QAPI) program includes measurable indicators to identify and reduce medical errors and adverse patient events, analyze the errors and events and implement changes to improve outcomes. Medication errors were not included as part of the QAPI program. There was no evidence in QAPI meeting minutes medication errors were analyzed and preventive measures implemented.

Findings:

1. Medication errors provided for review were in individual nursing personnel folders. They were not analyzed and categorized to determine the potential causes and measures implemented to reduce the errors.

2. Hospital staff F stated on 11/06/13 in the morning that all the medication error sheets filled out were not truly errors, but deviations. There was no explanations of what differentiated a deviation from a medication error. These were not separated out from the errors.

Based on record review, observation and interviews with hospital staff, the hospital does not ensure that pharmaceutical services meet the needs of patients by assuring all drug storage areas are under the supervision of the pharmacist and pharmaceutical service and all drugs and medications are usable and stored properly to assure safe medication use. See A Tags 0490, 0491, 0500, 0502, 0504, and 0505.

Based on record review, observation and interviews with hospital staff, the hospital failed to ensure all drugs and medications in the hospital are controlled and maintained by the pharmaceutical service to assure proper storage and outdated and unusable drugs are not available for patient use. The pharmacy does not inspect all drug storage areas for outdated or unusable drugs.

Findings:

1. Multiple outdated and unusable drugs and medications were observed in the operating area. See A Tag 0500, 0502, 0504, and 0505.

2. Outdated drugs were observed in the radiology area. See A Tag 0535.

3. There was no documentation of any inspection by pharmacy personnel of drugs and medications stored in areas in the hospital where medications are stored. This was verified by Staff F on 11/06/13 in the afternoon.

Based on observation and staff interview, it was determined the hospital failed to ensure:

a. drugs and biologicals were stored appropriately in the surgery department;

b. medication delivery in the surgery department was evaluated;
and

c. the hospital failed to ensure the pharmacist had input in decisions about emergency medication kits.

Findings:

On 11/06/13, a tour of the surgery department was conducted. The following observations were made:

1. In an unrestricted hallway outside of the surgery department, bags of 3000 cc normal saline for irrigation were found taken out of the protective wrapper and hanging on a pole. The staff stated these had been there for two days. When asked why they were there, the staff stated they were in preparation for surgeries later in the week.

2. In the same hallway, injectable epinephrine was found unsecured on a table top.

3. Inside the surgery department:

~Naropin was found unsecured on top of a cart in the surgery central core.

~Naloxone was found unsecured on top of an anesthesia cart in an operating room.

~Paralytic agents were found in a refrigerator with staff food and drinks.

~IV fluids and sterile irrigation fluids were stored in a warmer that had no thermometer. The staff could not verify the fluids did not exceed the required temperature. The staff had not dated the fluids as to when they were placed in the warmer and were not aware they expired within one to two weeks of placement in the warmer.

~An anesthesia closet that was open and accessible to anyone in the OR, contained biologicals and medications that were not stored in an aseptic manner. Hetastarch 500 ml bags of IV fluids were stored directly on the floor. Injectable medications were stored with dust on them. Open vials of injectable medications were found with non-injectable medications. Open boxes of medications were found with dust, human hair and crumbs in them. Medications were stored with books, papers, manuals, and other miscellaneous items. Emergency medications were found in this room among the clutter of other things. The staff stated the CRNA was the person in charge of this closet and they "didn't really know what was in it" and "had nothing to do with it."

4. The OR staff were asked about emergency medication carts for the department. They stated the CRNA made the decisions about the emergency medications needed in the department and where they were stored. The staff stated they did not know what emergency medications the CRNA stored in the anesthesia carts. The staff stated the CRNA had the only keys to the anesthesia carts.

5. The OR staff was asked to open the narcotic cabinet. They stated the CRNA had the only keys to the narcotic cabinet. The staff were asked how they accessed narcotics for recovering patients. They stated, "We don't have access to those."

6. The OR staff was asked if the department had a central location (cabinet, closet or room) for the storage of medications. They stated they did not. They stated medications were stored in various locations (drawers and cabinets) throughout the surgery department. The staff was asked if they had a drug formulary or an inventory of medications for the surgery department. They stated they did not.

7. The OR staff was asked if the pharmacist reviewed the storage of medications and biologicals in the surgery department. They stated, "No one ever comes in here."

8. Radiology staff was asked about the emergency medication kits in that department. They stated they were not familiar with the drugs in them. They stated they were unsure about who made decisions about what was in them.

Based on observation, document review and staff interview, it was determined the hospital failed to ensure medications were secured in the surgery department.

Findings:

On 11/06/13, observations were made of the surgery department. Medications and biologicals were found unsecured in a hallway outside the department, unsecured on top of carts in various areas, unsecured in an unlocked closet and in various drawers and cabinets. Paralytic agents were stored in an unsecured refrigerator with staff food and drinks.

The surgery department was not staffed everyday.

The OR staff was asked if they had a policy and procedure for the storage of medications and biologicals. They stated they did not. A review of the OR procedure manual confirmed there was no such policy.

The pharmacist stated she did not inspect the OR for proper storage of medications.

Based on observation and staff interview, it was determined the hospital failed to ensure medications and biologicals were stored in a locked area within the surgery department and that access to the locked area was given to authorized personnel only.

Findings:

On 11/06/13, medications and biologicals were observed unsecured in many places within the surgery department. Medications and sterile irrigation fluids were also found outside of the department in a public hallway.

The OR staff stated the department did not have a centralized, secure area for medication storage. The staff stated access to medications was not limited to certain members of the staff, i.e., licensed personnel.

Based on observation and staff interview, it was determined the hospital failed to ensure outdated and unusable drugs and biologicals were not available for patient use in the surgery department.

Findings:

On 11/06/13, the surveyors observed expired and unusable medications and biologicals in the surgery department including:

~expired injectable xylocaine, lidocaine and epinephrine

~open injectable vials that were not dated when opened or dated as to when they should expire

~a bottle of inhalation anesthetic agent was found in the anesthesia closet. The bottle was so old, the label was faded. There was no expiration date provided by the manufacturer.

~IV solutions and sterile irrigation solutions were taken out of the protective wrappers days ahead of their intended use. The staff did not know how long the fluids could be unwrapped before they had to be discarded.

~IV solutions and sterile irrigation solutions had been stored for unknown periods of time in the warming cabinets. The staff were not aware these fluids were expired within one to two weeks.

The staff stated they did not have policies and procedures to address this and the pharmacy had not been inside the OR. They stated the pharmacy had no oversight of the medications in the OR.

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

a. document in writing the scope and complexity of radiology services offered by the hospital;

b. ensure the medical staff and the governing body approved the scope and complexity of the radiology services offered;

c. develop policies and procedures for the radiology department that were based on nationally recognized standards of practice;

d. include radiology services in the hospital-wide QAPI process. See Tag A-0529;

e. implement radiology policies and procedures that provide safety for patients and personnel. See Tag A-0535;

f. have policies and procedures in place to prevent radiation hazards for patients, personnel, and facilities. See Tag A-0536;

g. to ensure radiology personnel requirements were met. See Tag A-0545;

h. ensure a radiologist supervised radiology services. See Tag A-0546; and

i. ensure radiology personnel were designated as qualified by the medical staff to use the radiological equipment and administer procedures. See Tag A-0547.

Based on document review and staff interview, the hospital failed to:

a. document in writing the scope and complexity of radiology services offered by the hospital;

b. ensure the medical staff and the governing body approved the scope and complexity of the radiology services offered;

c. develop policies and procedures for the radiology department that were based on nationally recognized standards of practice; and

d. include radiology services in the hospital-wide QAPI process.

Findings:

On the afternoon of 11/06/13, the radiology department policies and procedures were reviewed. There was no description of the scope and complexity of radiology services provided by the hospital.

The policies and procedures had no documentation they were developed based on nationally recognized standards of practice. There was no documentation the policies were approved by a supervising radiologist.

There was no documentation in the medical staff meeting minutes or in the governing body meeting minutes that stated the hospital's radiology services were approved by these groups.

There was no documentation in the QAPI meeting minutes that indicated radiology services were included in the quality assessment process.

On the afternoon of 11/06/13, the director of radiology told surveyors that he had not been reporting to quality assessment performance improvement (QAPI).

Based on document review, observation, and staff interview, the hospital failed to implement radiology policies and procedures that provide safety for patients and personnel.

Findings:

1. On the morning of 11/06/13, surveyors toured the radiology department with the director of radiology. Surveyors observed the X-ray rooms, CT room, and the MRI suite where patients of all ages are serviced.

2. Surveyors observed the emergency medicine boxes in the CT room and the MRI suite. The radiology director was uncertain what was in the small tackle boxes. Surveyors opened the tackle boxes; medications contained in the boxes were expired.

The MRI small tackle box contained:
Three Epinephrine 1 ampule, expiration June 2012
Three Benadryl 50mg/ml, expiration February 2013
One Solumedrol via, expiration September 2015
One Epinephrine 1:10,000, expiration February 2012
One Atropine 1 mg, expiration January 2012
One Albuterol Sulfate 8 grams, expiration July 2012

The CT small tackle box contained:
Three Epinephrine 1 ampule, expiration June 2012
Three Benadryl 50mg/ml, expiration February 2013
One Solumedrol via, expiration September 2015
One Epinephrine 1:10,000, expiration February 2012
One Atropine 1 mg, expiration January 2012
One Albuterol Sulfate 8 grams, expiration July 2012

The emergency medication boxes did not include items to start an IV, draw up medications, and properly administer medications. There were not supplies for patients of different age ranges.

There was no crash cart in the radiology department.

According to the American College of Radiology ACR, national practice guidelines documented, "...Appropriate emergency equipment and medications must be immediately available to treat adverse reactions associated with administered medications. The equipment and medications should be monitored for inventory and drug expiration dates on a regular basis. The equipment, medications, and other emergency support must also be appropriate for the range of ages and sizes in the patient population..."

3. On the afternoon of 11/06/13, surveyors asked the radiology director for all policies and procedures.

The radiology department had one four page policy and procedure for the department.

The policy documented, "...Emergency Drug Boxes: There are emergency drug boxes in CT, MRI, and in Nuclear Medicine. The radiology emergency drug cart is utilized for contrast reactions. Due to the close proximity of the emergency department, we do not have the need for a "crash cart " at this time. These boxes are to be maintained by the radiology department..."

There was no evidence that the medical staff approved the four page policy for the radiology department. There was no evidence that the medical staff approved the sharing of a crash cart.

4. Surveyors asked Staff W what she would do if a patient had an allergic contrast reaction. She said "Call a nurse for help."

Staff W told surveyors, "There is not a physician typically in the hospital, just the PA."

According to the ACR, "...A physician should be available on-site whenever intravenous or intrathecal contrast or intravenous sedation is administered ..."

5. There was no evidence of policies and procedures for CT contrast reactions.

6. There was no evidence of policies, procedures, and special precautions for MRI reactions and emergency situations.

7. These findings were verified with the Director of Radiology at the time of review.

Based on document review, observation, and staff interview, the hospital failed to have policies and procedures in place to prevent radiation hazards for patients, personnel, and facilities.

Findings:

1. Multiple documented reports in 2013 by the radiation Physicist documented two employees had higher dose badge readings and follow up was needed.

Surveyors asked the director of radiology what had been done about the high dose badge readings. He stated nothing had been done yet but would be looked into.

2. On the afternoon of 11/06/13, surveyors asked the Radiology Director for all policies and procedures. Surveyors received one document from the Director of Radiology that was four pages titled, "Radiology P&P."

The policy documented, "...Standard radiation safety procedures while operating X-ray machines or performing radiological procedures or handling radio-nucleotides will be observed at all times..."

Surveyors observed a black binder marked radiology that did not include facility specific policies and procedures.

3. There was no evidence of Radiology quality assessment performance improvement (QAPI) for 2013.

4. The Director of Radiology told surveyors that he had not been reporting to QAPI.

Based on hospital document review, personnel record review, and interview, the hospital failed to ensure radiology personnel requirements were met. This occurred for four (Staff R, W, X, and Y) of four radiology staff files reviewed.

Findings:

1. On the morning of 11/06/13, surveyors reviewed four of four radiology personnel records that showed no evidence of current radiology competencies and in-service trainings.

2. On the morning of 11/07/13, the director of radiology told surveyors, "All radiology techs have current licenses in their files. I don't have any documentation of in-services or their competencies."

3. These findings were verified with the director of radiology at the time of review. No other documentation was provided to surveyors.

Based on document review, personnel file review, and staff interview, the hospital failed to ensure a radiologist supervised radiology services.

Findings:
1. On the morning of 11/05/13, surveyors asked administrative staff for an organizational chart to include the Director of Radiology and an employee list for the radiology department.

Administrative staff provided surveyors with an organizational chart with the Director of Radiology's name. The Director of Radiology is not a radiologist; he is a registered radiologist assistant. The hospital employee list identified ten employees in the radiology department; nine radiology employees are technicians, one employee is a clerk, there is not a radiologist on the employee list.

2. On the morning of 11/06/13, surveyors asked administrative staff for the supervising radiologist of radiology services. None was provided.

3. The director of radiology told surveyors that there was not a supervising radiologist. He stated, "The hospital contracts with a Radiology group out of Tulsa, if the department needs anything, there is an 800 number we can call. Anyone there in the group oversees our department."

4. On the morning of 11/06/13, surveyors asked administrative staff for all contracted radiologists credentialing files. None were provided.

5. Surveyors verified findings with Chief Executive Officer (CEO) at the time of review.

Based on policy and procedure review, document review and staff interview, it was determined the hospital failed to ensure radiology personnel were designated as qualified by the medical staff to use the radiological equipment and administer procedures

Findings:

1. Hospital administrative staff was asked to provide radiology department policies and procedures.

A four page radiology department policy and procedure was provided to surveyors. The policy did not specify what qualifications were necessary for the staff using the radiology equipment. The policy also documented radiology staff could start IVs and administer IV contrast material. There was no documentation in the employee files that indicated the staff were evaluated for competency to perform these tasks.

2. A physician's assistant (PA) administering radiological procedure is not qualified and is not a licensed independent practitioner.

On the afternoon of 11/06/13, the Radiology Director told surveyors that there are no physicians in the facility when patients have, MRI and CT scans procedures with contrast. He also stated that the PA, radiology technician, and a registered nurse (RN) perform nuclear medicine procedures with patients that have procedures ordered without a physician in the hospital.

3. The PA's supervising physician is not qualified and credentialed by the Medical Staff.

Based on record review and interviews with hospital staff, the hospital failed to ensure the consultant dietitian supervises the nutritional aspects of patient care. Review of consultant reports for the previous 12 months and 8 patient records did not have evidence of planning and implementing of patient care strategies to meet the nutritional needs of patients.

Findings:

1. The consultant dietitian did not have evidence of monthly visits to the hospital as required by Hospital Licensure Standards. The consultant dietitian reports were only documented for 7 (2/7, 3/4, 4/29, 6/4, 8/6, 9/8 and 11/4) of 11 months ( January through November) of 2013. There were no reports for January, May, July or October of 2013.

2. The dietitian reports consisted of check marks and didn't describe individual patient needs or suggestions for nutritional therapy.

3. Eight ( #'s 7, 8, 9, 10, 11, 12, 13 & 14) of eight inpatient records reviewed had the same identical documentation by the dietitian "labs/meds noted", "regular diet", "should meet needs with adequate intake", " continue to monitor". The notes did not address the individual nutritional needs of each patient.

4. Patient # 7 was a post surgical patient with abnormal laboratory values and Patient # 8 was a chronic alcoholic with a post operative infection. Both patients had identical dietary notes by the dietitian.

Based on record review and interviews with hospital staff, the hospital failed to ensure the current diet manual had been approved by the dietitian and the medical staff.

Findings:

1. The diet manual and medical staff meeting minutes for 2010 through 2013 did not have evidence of approval by either the dietitian or the medical staff.

2. Staff B stated on 11/05/13 that she did not know if the current diet manual had been approved by the dietitian and the medical staff.

Based on observation, record review and staff interview, it was determined the hospital failed to:

a. develop, approve and implement a current emergency preparedness plan and failed to conduct internal and external disaster drills. See Tag A-0701 and Life Safety Code Survey Tag K-0050;

b. provide battery back-up lighting in the operating room and ensure the emergency department was supplied with critical care branch emergency power. See Tag A-0702 and Life Safety Code Survey Tag K-0147;

c. ensure operating room staff were knowledgeable about their responsibilities during a fire. See Tag A-0714 and Life Safety Code Survey Tag K-0078;

d. ensure the physical facilities were appropriately designed and equipped for the services provided in the surgery department. See Tag A-0725 and Life Safety Code Survey Tag K-0130;

f. store equipment and supplies in a manner to ensure safety and quality. See Tag A-0724;

g. ensure critical medical equipment was regularly inspected for patient safety. See Tag A-0724 and Life Safety Code Survey Tag K-0147;

h. ensure proper ventilation, lighting, temperature and humidity control. See Tag A-0726 and Life Safety Code Survey Tag K-0067 and K-0078; and

i. the hospital failed to incorporate the facility maintenance program into the QAPI program.

Based on document review and staff interview, it was determined the hospital failed to develop and implement adequate emergency preparedness plans.

Findings:

On 11/06/13, the hospital was asked to provide the emergency preparedness plan. The internal disaster plan addressed a fire emergency only. It did not include other types of internal disasters. The external disaster plan had not been approved for implementation.

The emergency preparedness plans did not document the hospital's emergency sources of power, water and gas. The plan did not consider an emergency related to the loss of internet, intranet electronic capabilities, including electronic documentation.

The hospital had no documentation of any internal or external disaster drills, including fire drills.

Staff interviewed stated they had not participated in any disaster drills.

Based on observation and staff interview, it was determined the hospital failed to provide battery back-up lighting in the surgery department and failed to provide critical care branch emergency power to the emergency department.

Findings:

On 11/06/13, the plant manager stated the surgery department did not have battery back-up lighting. The surveyors observed there also was no battery back-up lighting in the endoscopy suite.

The surveyors determined that critical care branch emergency power was not supplied to the area identified as the new emergency department.

Based on record review and staff interview, it was determined the hospital failed to ensure operating room staff were knowledgeable about their responsibilities during a fire.

Findings:

On 11/06/13, the OR staff were asked if they had participated in any departmental fire drills. They stated they had not. They were unable to articulate what actions to take, including patient evacuation, in the event of a fire.

The plant manager provided a calendar of fire drills. However, there was no documentation of who participated in the drills and no documentation of an evaluation of the drills.

Based on observation and staff interview, it was determined the hospital failed to maintain the design of the facilities in a manner to support the scope of services provided.

Findings:

On 11/06/13 and 11/07/13 tours of the hospital were conducted. The following observations were made:

1. A nurses station and the surrounding rooms were being used as a converted emergency department (ED). The ED was no longer a separate area of the hospital. The common nurses station was used to care for the ED patients, as well as inpatients and outpatients. An inpatient isolation room was converted into an ED exam room. The inpatient area of the hospital no longer had the use of an isolation room.

The converted ED did not meet the design requirements for an emergency department and was not included on the emergency power branch as required for critical care areas.

The new ED waiting room was not a negative airflow room as required.

The original ED entrance was not manned, but was still marked as the emergency department entrance. The staff were asked how they would know if an emergency patient was in the parking lot but unable to walk in. They stated they checked a video camera periodically.

2. An x-ray film storage room was converted into the endoscopy suite. This area was not designed as a surgical suite and the hospital had not adequately modified it to meet the requirements for surgery. The endoscope decontamination room did not meet the requirements for this process. The room had no distinction between clean and dirty areas.

The endoscopy area was not located in a restricted area of the hospital. The entrance to the suite was directly off a public hallway.

3. The surgery department's janitor's closet was being used for janitorial services as well as the surgical instrument decontamination room. The janitor's closet did not meet the design requirements for an instrument decontamination room.

The surgery department's original instrument decontamination room was being used for surplus storage of old equipment or supplies no longer used in the department. The original decontamination room could only be accessed from the public hallway or through the sterile processing room.

4. The surgery department had been structurally modified and did not support the normal workflow processes that required movement from dirty to clean. Staff had to walk through sterile processing to get supplies. Staff used sterile processing as a break area with a refrigerator and microwave.

5. The room being used as the surgery sterile supply room was previously a labor and delivery room. The room did not meet the requirements for a surgical sterile supply room.

6. The recovery room was located within the sterile core. It was not a separate area of the hospital, and in fact, was not even separated from the OR by a door. Airflow was shared between the recovery room and the OR.

7. The surgery department's semi-restricted corridor was no longer maintained to restrict traffic to the surgical department. The corridor was openly accessible to all traffic. The hospital placed the IT processor room off of this corridor, as well as the sleep lab and it's control room. An oxygen tank supply room was located off of the corridor. The semi- restricted corridor was used to store old equipment, outdated supplies, trash and biohazardous waste.

8. The surgery staff were asked about the modifications to the department. They stated changes had been made over time.

9. A patient room had been converted to the pharmacy.

Based on observation and staff interview, it was determined the hospital failed to:

a. store biologicals, medications and surgical supplies to protect from damage, contamination or deterioration;

b. store hazardous chemicals appropriately;

c. ensure items were not stored in a manner to block passageways; and

d. the hospital failed to ensure a preventive maintenance and biomedical engineering program.

Findings:

1. On 11/06/13, a tour was conducted of the hospital. In an unrestricted corridor outside the surgery department, 3000 cc bags of sterile irrigation fluid for surgery were hanging from a pole. The fluid was not protected from potential damage and contamination.

Injectable medications were found on top of a table. The staff said those medications were used as an additive to the irrigation fluid. The staff were asked how they could ensure the irrigation fluid and the medications were free from tampering. No reply was made.

In this same hallway, intraocular lenses were stored unprotected. Multiple pieces of unused equipment was found in the hallway, blocking passage to exits.

2. In the surgery department's janitor's closet, a large multi-gallon container of formalin (with a tap dispenser) was stored on a shelf above other supplies. The room did not allow for the required ventilation for large quantities of formalin. This room also stored multiple bottles of rubbing alcohol on open shelves. The staff did not have a spill kit for hazardous chemicals.

In addition to the formalin and the alcohol, the room contained other hazardous cleaning products. Hazardous chemicals were stored with surgical skin prep solutions.

3. The hospital did not have a preventive maintenance program and did not ensure periodic testing of medical devices.

Based on observation and staff interview, it was determined the hospital failed to ensure the physical facilities were appropriately designed and equipped for the services provided.

Findings:

On 11/06/13 and 11/07/13, the surveyors observed the endoscopy room, the endoscope decontamination room, the sterile supply room, and the instrument decontamination room were not designed and equipped to support those services.

When the staff were interviewed, they had no information on the changes made to these areas.

Based on observation, record review and staff interview, it was determined the hospital failed to ensure proper temperature, humidity control and airflow requirements for the surgery department and in the emergency department.

Findings:

1. On 11/06/13, the surveyors requested logs of temperature, humidity and airflow monitoring for the surgery department.

No records were provided. The staff stated they were not aware of the requirements for positive or negative airflow requirements for various areas within the surgery department.

2. The room currently used for the emergency waiting room did not have negative airflow.

The plant operations staff stated they did not have documentation the room designated as the isolation room for the emergency department had the required air exchanges per hour.

Based on observation, staff interviews and review of hospital documentation, the hospital failed to maintain a sanitary environment and maintain an active ongoing program to prevent, control and investigate infections and communicable diseases.

Findings:

1. The staff identified as the infection control officer did not develop and implement infection control policies that addressed the roles and responsibilities for infection control within the hospital to include all hospital departments. See Tag A-0748.

2. The hospital did not have an ongoing infection control program that reviewed hospital practices and infections/communicable diseases, analyzed data on these practices and infections, developed qualitative plans of actions, and failed to provide follow-up to ensure corrective actions were appropriate. See Tag A-0749.

3. The hospital did not ensure the infection control program had a current tracking mechanism for patients and staff to track infections and possible transmissions of infections and communicable diseases. The log of patient infections was based on positive cultures from the lab and did not identify if the infections were hospital acquired See Tag A-0749.

4. The disinfectant used throughout the hospital had not been reviewed and approved by the hospital's infection control committee.

5. The hospital did not ensure the infection control program was evaluated and revised when indicated.

6. The hospital did not maintain a sanitary physical environment.

7. The infection control officer did not oversee the infection control practices of the dietary or surgical department.

8. Leadership did not ensure infection control concerns and issues were reviewed, analyzed and corrective actions were taken through the quality assessment and performance improvement process. See Tag A-0756.

Based on staff interview, infection control meeting minutes and infection control policy and procedure review, the hospital failed to ensure the designated infection control officer developed and implemented policies and procedures for each department/area of the hospital according to current standards of practice.
1. Staff H was designated as the infection control officer.
2. A policy titled,"Infection Prevention and Control Program", documented ..."The Infection Control Professional shall: Develop, review, implement and evaluate policies and procedures governing infections and communicable diseases, Develop and maintain a system for identifying, reporting, investigating, and controlling infections and communicable diseases" The policy further documented..."The Infection Control Professional will work in collaboration with all staff regarding infection prevention and control processes."
3. On the morning of 11/07/2013 Staff H stated that he had not gone into the surgery department to monitor the cleaning and sterilizing process of the surgical instruments. Staff H stated that he had not gone into the dietary department to monitor processes. Staff H stated "I don't know what temperature food should be cooked at." Staff H stated he had attended infection control training in Texas but stated "I am training myself."
4. On the morning of 11/07/2013 Staff H was interviewed. Staff H stated that he had given the dietary department and surgery department infection control policies and procedures and the department heads were responsible for their own area.
5. On the morning of 11/06/2013 the operating room staff was asked if the infection control officer ever went into the operating room to observe the processes of cleaning and sterilizing surgical instruments. The operating room staff stated no.
6. The policy and procedure manual for infection control was reviewed. A policy titled, "Cleaning Supplies and Chemicals" documented..." The Environmental Service Director will review all products intended for any level of disinfection ..." There was no documentation that the disinfectants used were approved by the infection control committee.
7. On the morning of 11/07/2013 Staff H stated that he had not reviewed or approved the disinfectants used in the facility. Staff H stated that Aramark who is the contracted housekeeping service approves the disinfectants used. This was also confirmed with the Chief Nursing Officer and the Chief Executive Officer.

Based on observation, review of infection control (IC) data, surveillance activities, meeting minutes, hospital documents, and staff interviews, it was determined the hospital did not ensure the infection control professional (ICP) developed and maintained an ongoing, comprehensive hospital-wide system to identify, report, prevent and control infections and communicable diseases among patients and staff as evidenced by failure to:

a. ensure surgical instrument disinfection and sterilization processes were carried out in a manner consistent with nationally recognized standards and according to manufacturer's directions;

b. ensure surgical staff packaged, labeled and stored sterilized surgical instruments and supplies consistent with nationally recognized standards of practice;

c. evaluate staff practices for cleaning the OR between surgical cases, terminal cleaning at the end of the day, and the performance deep cleaning at regular intervals to maintain the clean/sterile environment required of the surgery department;

d. maintain clear distinctions between clean and dirty areas of the surgery department to prevent cross-contamination by staff movement between dirty and clean areas of the surgery department;

e. evaluate and maintain airflow separation from the contaminated surgical areas to the clean areas to ensure air contaminants were prevented from entering.

f. evaluate how hospital linen is processed, handled and stored to prevent the spread of infection;
g. identify and approve for use all disinfectant agents used in the hospital and ensure all hospital staff used them correctly;
h. ensure laryngoscope blades were disinfected/sterilized, packaged and stored to protect from contamination;
i. implement relevant and active surveillance activities for infection control practices in various departments of the hospital;
j. ensure adherence to the Occupational Health and Safety Administration's Bloodborne Pathogens regulation at 29 CFR 1910.1030;
k. ensure employees had current immunizations and TB skin testing as required;
l. ensure biohazardous waste was handled appropriately in the surgery department; and
m. the hospital failed to implement an employee respiratory protection program.
Findings:
1. The OR staff were asked to provide records of sterilization. The records of each sterilization load did not clearly document: the date processed, total cycle time, maximum temperature exposure time, dry time, load number, or biological tests run with implants.
Flash sterilization records did not document: sterilization cycle parameters, reason for flashing, load number, or date. The staff stated they flash sterilized "everyday surgery was open."
The hospital had one policy and procedure related to sterile processing. It referred to the performance of biological testing. The policy was not current. The staff had no manufacturer's instructions for the use of the steam sterilizers.
The hospital utilized an enzymatic cleaner for initial endoscope decontamination. The OR staff had no product information that guided them on the proper use of this chemical to ensure its effectiveness.
2. Surgical instruments in peel packages, that the staff said were sterilized, were found incorrectly double-packaged in manner that did not allow for effective steam/heat penetration. Sterilized surgical instruments, such as scissors, hemostats and others, were found processed in the closed position. Some sterile instruments were processed without a sterilization indicator. Some instruments were processed with an indicator but the indicator could not be seen without opening the package and emptying the contents.
3. The surveyors observed the operating rooms were not adequately terminally cleaned. One operating room had trash from a previous day's surgical case. The glide scope stored in this room was dusty and dirty. Various pieces of equipment in the room were not clean. The OR rooms were used to store surplus equipment and supplies. These items could not, and were not cleaned between cases or terminally cleaned at the end of the day.
The entire surgery department and all related areas had no evidence of daily cleaning, terminally cleaned at the end of the day and at the end of the week or periodic department-wide deep cleaning. At the time of the survey, bloody suture was observed on the floor of the janitor's closet/decontamination room. A dirty fly swatter was hanging on the wall.
OR equipment, including OR table parts, had tape on them that could not be disinfected between patients. Pieces of egg-crate material or foam padding were taped to patient positioning items. These could not be cleaned between patients.
The surgery staff stated they were responsible for cleaning the department.
4. A entrance into the surgical core was directly off of a public hallway. If staff entered through this door, there was no area for staff to remove protective garments covering their scrubs and shoe covers before they entered the department.
A semi-restricted corridor was not protected from unauthorized foot traffic. The staff used this corridor to store old equipment and surplus items. The semi-restricted corridor was dirty, cluttered and unkept.
The staff used the janitor's closet as an instrument decontamination room. The instrument cleaning countertop and sink were adjacent to a hopper. A janitor's sink was being used in this room to empty mop buckets.
The room was also used for janitorial supplies, a mop bucket, sterile skin preparation solutions, large quantities of formalin, OR table parts, open rolls of paper towels, among various other things. The door to this room remained open at all times and allowed air circulation between this dirty area and the clean surgery core.
The original decontamination room was not used. However, the only way to enter this area was through the sterile processing room or through the public hallway.
Staff travelled through the sterile processing room to enter the sterile supply room. The sterile processing room contained a staff refrigerator and a microwave. The sterile processing room was open to the sterile supply room, the original decontamination room, and an open hallway that led to central surgical core.
The room used for "recovery" was open to the surgical core.
5. None of the surgery department rooms maintained the required air exchanges and positive or negative airflow as required for infection control purposes.
6. The staff stated all hospital linens were processed at local company. The hospital had not evaluated the linen service to ensure the contractor processed linens as required for hospitals.
7. The hospital allowed a contracted environmental services company to determine what disinfection and cleaning agents were provided for all areas of the hospital. The hospital staff did not know what cleaners were used or how they should be used to achieve disinfection.
On 11/06/13, the manager for environmental services was asked what disinfectant agents were used in the operating room. He stated, "Aramark (the contracted service) determines what disinfectants are used in the hospital." The surgery manager stated she was uncertain what disinfection agents were used in the OR. The staff were unaware how long the agents needed to be on the surface to achieve disinfection.
Later, a list of three disinfection agents used in the OR was provided to the surveyors. One product was to be used on walls and floors. The hospital had no product information on its use. Another product used on OR equipment and the OR tables required a 5-10 minute contact time to achieve disinfection. The staff stated they were not aware of this.
8. Laryngoscope blades were found unprotected and exposed to potential contamination on top of an anesthesia cart and inside drawers.
9. The infection control committee did not require the surgery department and sterile processing to conduct infection control surveillance and provide reports to the committee. All hospital departments were not included in the infection control plan.
10. An open sharps container was found in the janitor's closet. Used large bore needles were sticking out of the box. The infection control program did not include surveillance of bloodborne pathogen exposure hazards within the hospital. A review of employee exposures to blood and body substances documented they were not managed according to OSHA requirements.
11. Employee health files did not have documentation of all required immunizations and/or immunity. The hospital had no documentation hepatitis B vaccine boosters were offered to staff. Not all employee health files had documentation of current TB testing.
12. The surgery department stored containers of biohazardous waste in an open corridor. The staff also moved industrial-size rolling trash cans in and out of the OR as needed. Empty cans were stored in an open corridor until they were brought into surgery.
13. Staff employee health files did not include annual respirator fit-testing. When staff were fit-tested, the records did not have an annual medical questionnaire. The records did not document the size and type of respirator that was fitted. The hospital did not provide a respiratory protection program.

Based on hospital document review, Quality Assessment Performance Improvement (QAPI) meeting minutes, and infection control meeting minutes, it was determined that the hospital failed to ensure that the hospital wide QAPI program addressed problems identified by the infection control officer.
Findings:
1. Infection control meeting minutes and QAPI meeting minutes were reviewed during the on-site survey. The meeting minutes did not contain evidence/demonstrate the hospital leadership:
a. Reviewed and analyzed infection control data or lack of.
b. Ensured that all departments/units of the hospital were included and monitored through the infection control program.
c. Ensured infection control/prevention policies and procedures were developed, implemented and followed to ensure a safe and sanitary environment and that staff were given an in-service on the policies.
d. Developed corrective plans of action to reduce and/or prevent transmission of organisms and improve patient care, ensure a safe and sanitary environment, and prevent or decrease infections and communicable diseases; and
e. Provide follow-up/monitoring to ensure corrective actions taken were effective and sustainable.
2. Meeting minutes did not contain evidence the hospital ' s leadership had ensured policies and procedures were developed for all areas of the hospital concerning current accepted standards of practice in infection control. The hospital disinfectants were approved through an off-site housekeeping contracted service, Aramark. There was no policy in place to assure disinfectants were used according to manufacturer requirements. There was no evidence that hospital leadership had reviewed and accepted the use of the disinfectants.
3. Laundry services were provided off-site. There was no policy and procedure in place to assure the off-site service was performed according to regulatory requirements and current standards of practice.

Based on record review, document review, and staff interview, the hospital failed to ensure collaboration with the designated Organ Procurement Organization (OPO), that the family of each potential donor is informed of its options to donate organs, tissues, or eyes, or to decline to donate. This occurred in two (#16, 18) of two medical records reviewed.

Findings:

1. Two of two medical records reviewed showed no documentation that the family of each potential donor was informed of their options to donate or decline to donate organs, tissues, or eyes.

2. On the afternoon of 11/05/13, the Chief Nursing Officer (CNO) told surveyors that the Organ and Tissue Donation company is called but that information is not documented in the medical record, it is documented in a log book.

3. Director of Quality (DoQ) verified these findings at the time of review.

Based on observation, document review and staff interview, it was determined the hospital failed to:

a. define the scope of surgical services and did not develop an organization chart for surgical services that indicated lines of authority and delegation of responsibility. See Tag A-0941;

b. ensure the operating rooms were supervised by an experienced registered nurse. See Tag A-0942;

c. ensure a qualified registered nurse performed circulating duties in the operating room. See Tag A-0944;

d. maintain a current roster of practitioners with surgical privileges, restricted privileges and suspended privileges. See Tag A-0945;

e. develop, approve and implement surgery policies and procedures based on nationally recognized standards. See Tag A-0951;

f. maintain emergency equipment in an organized manner for use in the operating suites. See Tag A-0956;

g. provide postoperative care in accordance with accepted standards of practice. See Tag A-0957; and

h. the hospital failed to maintain a complete operating room register. See Tag A-0958.

In addition, the hospital failed to ensure:

1. Traffic flow patterns between the different areas of the surgical department adhered to accepted standards of practice. Staff transported dirty items through the sterile processing room to get to the decontamination room.

The endoscopy suite was located off of a public hallway. Even though it was located directly across from the surgery department, it was not accessible to the OR staff unless they left the sterile core and travelled across the public hallway.

2. Surgical materials were stored in a manner to ensure sterility. The sterile supply room had holes in the wall that opened into the attic space. The room was dusty and had debris on the floor. Case carts were stored in this room that staff used to pull supplies for surgical cases. The shelves of the carts were dusty and dirty.

Sterile supplies (peel packaged items) stored in the operating rooms were not at risk for punctures and tears. The items were packed too tightly, folded and wrinkled in storage bins. Some items were incorrectly double peel-packed. Sterile supplies were stored inside the OR in their original shipping boxes. Some sterile supplies available for use were found with expired dates. Sterile supplies were stored in the janitor's closet where the hopper was located.

Excessive amounts of peel packaged items were found in the operating rooms. The items at the bottom of the storage bins had no expiration dates. The staff stated the supplies had been there so long, no one knew how old they were.

Non-surgical supplies were stored with surgical supplies throughout the surgery department. Sterile and non-sterile supplies were stored in the same cabinets and on the same shelves.

3. The surgery circulators did not maintain complete records of implanted devices. The implant log did not document the date the items were used.

4. Temperature, humidity and air exchanges were not monitored and maintained in the surgery department. Documentation of this was not provided to the surveyors. The OR staff stated they were not knowledgeable about this.

5. Surgical devices and equipment brought into the OR by an outside contractor were not checked for safety by the hospital's biomedical program.

6. The surgery staff did not ensure expired items were not used in surgery. On 11/06/13, the surveyors observed boxes of an expired absorbable hemostatic agent in a cabinet where surgical supplies were stored. The staff stated no one assigned to check for expired items.

7. The hospital failed to ensure surgical services were integrated into the QAPI program. The QAPI program documentation provided to surveyors had no evidence surgical services was included in the quality assessment process.

Based on document review and staff interview, it was determined the hospital failed to define the scope of surgical services and did not develop an organization chart for surgical services that indicated lines of authority and delegation of responsibility.

On 11/06/13, the surgery manager stated the surgery department did not have a scope of services document and did not have an organizational chart.

Based on observation and interview, it was determined the hospital failed to ensure the operating rooms were supervised by an experienced registered nurse.

Findings:

On 11/06/13, the surveyors observed all areas of the surgery department. None of the areas, including the operating rooms, the instrument decontamination room, the sterile processing room, the endoscopy suite and the recovery, functioned according to nationally recognized standards.

Emergency medications, supplies, and equipment were not available in an organized manner for cardiopulmonary resuscitation or for a malignant hyperthermia emergency.

The hospital was asked to provide the employment record for the surgery department manager. None was provided. The hospital did not have a current job description that included qualifications for the surgery manager.

The surgery manager stated her surgery training and experience was "on the job" at this hospital. She stated she had never worked in any other hospital's surgery department. She stated she had never been in another hospital's OR.

The surgery manager stated she did not have membership in any surgery-specific professional organization such as AORN. She stated she did not have access to professional guidelines or standards for the OR.

The surgery manager was the only full-time registered nurse working in the operating room. She stated she usually worked as the circulating nurse and in recovery and had little time for management responsibilities.

Based on document review and staff interview, it was determined the hospital failed to ensure a qualified registered nurse performed circulating duties in the operating room.

Findings:

On 11/06/13, the surgery manager stated another registered nurse (staff Z) took emergency surgery call and filled in occasionally during the week as a circulating nurse.

The surveyors reviewed the employment record for this nurse. The record had no documentation the nurse had previous experience as a circulating nurse at any other hospital. There was no documentation of orientation and training for the OR. There was no documentation of training for OR-related emergency situations.

There record had no job description for a circulating nurse and had not competency evaluation for the circulator position.

The surgery manager was asked how this nurse was experienced enough to take emergency surgery call for the department. She stated, "He can always call me for back-up if he needs it, or if he has a question."

Based on record review and staff interview, it was determined the hospital failed to maintain a current roster of practitioners with surgical privileges, restricted privileges and suspended privileges.

The hospital did not establish the criteria, qualifications and credentialing process for the non-hospital employee who performed surgical services tasks under the supervision of the MD/DO.

On 11/07/13, the surgery staff provided a roster of staff with surgical privileges. The staff did not maintain a roster of practitioners with restricted or suspended privileges.

The staff stated an operating room technician (non-employee) who came to hospital with a physician and assisted in surgery did not have designated privileges.

The hospital did not maintain an assessment of the OR technician's training, experience, health status and performance. A file provided for the OR technician
had no current TB skin test, no proof of hepatitis B immunization or declination and no documentation of orientation and training for the hospital's emergency procedures in the surgery department.

Based on document review and staff interview, it was determined the hospital failed to develop, approve and implement surgery policies and procedures based on nationally recognized standards.

Findings:

The operating room policies were last reviewed and approved in 1999. The policies did not reflect current practices at the hospital. There was no documentation the policies were based on nationally recognized standards.

There were no policies related to:

Fire in the operating room
Use of alcohol-based skin preparation in anesthetizing locations
Aseptic and sterile surveillance and practice
Preoperative work-up
Patient consents and releases
Clinical procedures
Patient safety practices
Duties of all surgery personnel
Staff safety practices
Surgical counts
Surgery scheduling
Personnel policies unique to the OR
Resuscitative techniques
DNR status
Care of surgical specimens
Protocols for all surgical procedures performed, including equipment and supplies needed
Surgical instrument processing and sterilization and disinfection procedures
Acceptable OR attire
Handling infectious waste
Pediatric-specific policies

Based on observation and staff interview, it was determined the hospital failed to maintain emergency equipment in an organized manner for use in the operating suites.

On 11/06/13, the OR staff was asked if the surgery department had an equipped crash cart. They stated they did not. They stated various pieces of emergency equipment and supplies were stored in different areas of the department.

The defibrillator was stored in the recovery room. The tracheotomy set was stored in the sterile supply room. The surgery manager stated the CRNA said the department did not need a crash cart because all the required items were found in parts of the OR. The manager was asked how all the items could be pulled together quickly in an emergency. No reply was made.

There department had no supplies of emergency medications for a CPR emergency. The surgery manager stated the CRNA told the department staff that all the necessary emergency medications were available in the anesthesia cart. (The staff did not have access to this cart.) There were no emergency medications located in the recovery room.

The surgery manager was asked if the medical staff approved a list of emergency medications and equipment required for the OR and recovery areas. She stated she didn't think so. She was asked if the OR nursing staff and/or the pharmacy had oversight of the emergency medications to review them for expiration dates and adequate quantities. She stated they did not.

Based on observation, record review and staff interview, it was determined the hospital failed to provide postoperative care in accordance with accepted standards of practice.

Findings:

The recovery room is not located in a separate area of the hospital. The recovery room is a single, one-bed room located in the center of the sterile core of the surgery department.

The hospital did not develop, approve and implement policies and procedures for the post-anesthesia care area. There were no policies related to the transfer of patients to and from the recovery room.

The clinical records for surgery patients had inadequate documentation of assessment and monitoring by a registered nurse in the recovery room.

On 11/06/13, the OR manager was asked to describe the actions to take when there was a cardiac or respiratory arrest in the recovery room. She was uncertain as to the protocol for this emergency.

Based on document review and staff interview, it was determined the hospital failed to maintain a complete operating room register.

Findings:

On 11/06/13, the surgery staff was asked to provide the operating room register. There were multiple gaps in the record. The circulating nurse and the scrub tech assigned to the surgical case were not always identified. At times, the circulator and the scrub tech were only identified with first and last initials.

The surgeon was only identified by last name. There was no first name or initial documented, and no title; such as MD or DO.

The staff stated they were not aware of the requirements for the operating room register.

Based on observation, document review and staff interview, it was determined the hospital failed to:

a. organize all locations where anesthesia services may be provided under one anesthesia service. Hospital staff stated rapid sequence intubation and conscious sedation was provided in the ER. Conscious sedation was provided in the surgery department and endoscopy suite.

There was no indication the locations where anesthesia services were provided was overseen by a qualified physician. The hospital had no organizational chart for anesthesia services;

b. ensure the medical staff recommended and the governing body approved a chief of anesthesia services. The hospital had not appointed a chief of anesthesia services;

c. establish policies and procedures for anesthesia services in accordance with nationally recognized guidelines. The hospital had no anesthesia related policies and procedures;

d. ensure nursing staff who may be called upon to assist with rapid sequence intubation and provide conscious sedation were trained and deemed competent to do so. None of the nurses working in the ER or the OR had documentation of training and competencies for these tasks; and

e. the hospital failed to monitor adverse events related to the administration of anesthesia and analgesia, including moderate sedation, and failed to include anesthesia services in the QAPI program.

In addition the hospital failed to:

f. define the scope of anesthesia services offered and who was qualified to administer anesthesia and deep sedation. See Tag A-1001;

g. provide policies and procedures related to anesthesia practices. See Tag A-1002; and

h. the hospital failed to ensure a comprehensive post-anesthesia evaluation was completed at an appropriate interval after surgery. See Tag A-1005.

Based on document review and staff interview, it was determined the hospital failed to define the scope of anesthesia services offered and who was qualified to administer anesthesia and deep sedation.

Findings:

The surgery staff stated they had no documentation of a written scope of services for the anesthesia department. There was no documentation of who was qualified to administer anesthesia and deep sedation. The hospital had no policies and procedures governing supervision of CRNAs.

Based on document review and staff interview, it was determined the hospital failed to provide policies and procedures related to anesthesia practices.

Findings:

On 11/06/13, the surgery staff was asked to provide anesthesia policies and procedures. None were provided.

The hospital did not have policies to address:

How anesthesia service needs would be met
Anesthesia patient consent
Infection control measures related to the administration of anesthesia
Safety practices in anesthetizing locations
Life support protocols and medical emergency procedures
Reporting requirements
Documentation requirements
Equipment requirements
Pre- and post-anesthesia staff responsibilities

There was documentation inhalation anesthetics were administered to patients, including pediatric patients. Inhalation anesthetics were observed in the surgery department.

The surgery staff was asked if the department had a malignant hyperthermia cart. They stated they did not because the CRNA said it wasn't necessary.

The surgery department had six vials of dantrolene for a malignant hyperthermia event. A minimum of 36 vials is recommended according to accepted standards of practice. No other supplies, equipment or medications for a malignant hyperthermia event were available in an organized and central location in the surgery department.

Based on document review and staff interview, it was determined the hospital failed to ensure a comprehensive post-anesthesia evaluation was completed at an appropriate interval after surgery.

Findings:

A review of clinical records for patients who had anesthesia had documentation of a very limited post-anesthesia evaluation. The evaluations did not include:

Mental status
Temperature
Pain level
Nausea and vomiting
Postoperative hydration

There was no documentation of the time the post-anesthesia evaluations were conducted.

The surgery staff stated there was no hospital policy to address post-anesthesia evaluations.

Based on observation, document review and staff interview, it was determined the hospital failed to:

1. Define the scope of nuclear medicine services provided.

On 11/07/13, the radiology manager and hospital leadership was asked to provide a written scope of services for nuclear medicine services. None was provided.

2. Appoint a qualified MD/DO as the director of nuclear medicine services. The radiology manager was not certain who was identified as the director of nuclear medicine.

3. Show the staff were qualified and trained on their specific job responsibilities related to nuclear medicine. The hospital had not determined what qualifications, specialized training, education, licensure or certification was necessary for the staff working in nuclear medicine.

4. Develop, approve and implement no policies and procedures for the preparation, labeling, use, transportation, storage and disposal of radioactive materials.

5. Determined in writing if in-house preparations of radio pharmaceuticals would be done and who was qualified to do it.

6. Include the nuclear medicine equipment in the preventive maintenance and biomedical engineering program.

7. Determine the policies related to nuclear medicine reporting requirements and a requirement for nuclear medicine reports to be stored for at least five years.

8. The hospital did not demonstrate nuclear medicine services were provided based on nationally recognized standards.

The radiology manager stated no physician was present when nuclear medicine examinations or tests were performed. He stated the physician's assistant (PA) assigned to the emergency department and a floor nurse came over to nuclear medicine during the procedures. The manager was asked if the PA's supervising physician was credentialed for nuclear medicine privileges. He stated he did not know.

The manager was asked if there was an emergency cart in the department. He stated there was not. He stated the radiology/nuclear medicine department planned to use the emergency department's crash cart if needed. He stated the radiology/nuclear medicine department had an emergency drug box.

The surveyors asked what was contained in that box. He stated he was not sure. The surveyors noted the box did not contain the supplies necessary to administer the medications in it.

There was no documentation the staff had training or drills on emergencies in that department.

9. Nuclear medicine services were not included in the hospital's QAPI program.

Based on document and staff interview, it was determined the hospital failed to ensure emergency department policies and procedures were approved by the medical staff.

Findings:

1. On the morning of 11/05/13, surveyors requested policies and procedures for the hospital's emergency services.

On the afternoon of 11/05/13, the chief nursing officer (CNO) brought emergency department (ED) policies and procedures to the surveyors. The ED policies did not contain evidence of review, revision and or approval by appropriate staff.

2. On the afternoon of 11/06/13, the CNO verified to surveyors that there were many issues with the facility's policies and procedures.

Based on hospital document review, personnel record review, and interview, the hospital failed to ensure emergency service personnel requirements were met. This occurred for five (Staff E, G, H, Q, and S) of five staff files reviewed.

Findings:

1. On the afternoon of 11/05/13, the chief Nursing Officer (CNO) told surveyors, "The medical/surgical registered nurse (RN) or licensed practical nurse (LPN) will be assigned to the emergency department (ED) as well as their floor patients."

2. Five of five staff files reviewed showed no evidence of current basic life support (BLS), advanced cardiac life support (ACLS), and pediatric advanced life support (PALS).

3. Five of five staff files reviewed showed no evidence of current ED qualifications and competencies.

Staff training and education files were reviewed for evidence of demonstrated skills competencies for specialized tasks performed in the emergency room:

-Triage Assessment
-Intravenous (IV) insertion, accessing/de-accessing implanted central venous devices
-Venous blood draw sampling, and blood glucose monitoring
-Respiratory treatments, assessing, performing, and documentation
-Accessing, assembling, and delivering oxygen cylinders with regulators
- Electrocardiogram (ECG) 12 lead cardiac monitoring and rhythm recognition
-Neurological assessment using Glasgow coma scale (GCS)
-IV conscious sedation
-Rapid sequence intubations (RSI) and airway management
-Calculating and managing critical IV drips
-Restraints: application, monitoring, assessment, and interventions

None of the records had documentation of verification of skills competencies related to specialized tasks in the ED.

4. On the afternoon of 11/06/13, the CNO told surveyors, "It has been difficult getting staff BLS, ACLS, and PALS classes for their employees as the instructor who use to do it no longer is available."

5. The CNO verified that all personnel files were complete.

Based on hospital document review, record review, and staff interview, it was determined the hospital failed to ensure nursing staff working in the emergency department (ED) demonstrated skills competencies. This occurred for five (Staff E, G, H, Q, S) of five staff files reviewed.

Findings:

1. Staff training and education files were reviewed for evidence of demonstrated skills competencies for specialized tasks performed in the emergency room:

-Triage Assessment using the emergency severity index (ESI) based on Emergency Nurses Association (ENA) and Agency for Healthcare Research and Quality (AHRQ) guidelines;

-Intravenous (IV) insertion, accessing/de-accessing implanted central venous devices, venous blood draw sampling, and blood glucose monitoring using the Association for Vascular Access (AVA) guidelines;

-Respiratory treatments, assessing and performing based on American Association for Respiratory Care (AARC) guidelines.

- Electrocardiogram (ECG) 12 lead cardiac monitoring and rhythm recognition based on the American Heart Association (AHA) guidelines;

-Neurological assessment using Glasgow coma scale (GCS) based on the ENA;

-IV conscious sedation, rapid sequence intubations (RSI), and airway management based on American Society of Anesthesiologists guidelines;

-Calculating and managing critical IV drips based on the ENA and AHA guidelines; and

-Cardiopulmonary Resuscitation (CPR), Advanced Cardiac Life Support (ACLS), and Pediatric Advanced Life Support (PALS) certified based on AHA guidelines.

2. On the afternoon of 11/06/13, Staff E was asked to demonstrate how to test defibrillator. Staff E was unable to articulate and demonstrate how to use defibrillator in the ED.

3. On the morning of 11/06/2013, the Chief Nursing Officer (CNO) told surveyors, "The hospital provides online skills training but not performed hands on competency training for nursing staff."

4. On the morning of 11/07/13, Staff E, H, and Q stated the hospital had not provided skills competency training and had not performed competency testing for nursing staff that worked in the ED.

5. The chief nursing officer (CNO) was asked if the hospital required ED skills competency training. She stated the hospital requires competency training.

6. On the afternoon of 11/07/13, the CNO verified that hospital personnel files were complete. Six (Staff E, G, H, Q, and S) of six personnel records did not have current CPR and PALS certification.

Based on review of patient records, review of personnel files and interview, the hospital failed to ensure that respiratory services/procedures were administered by trained staff with each respiratory therapy procedure performed by each employee designated in writing, including the amount of supervision required when performing each procedure. This occurred in 2 of 2records reviewed where nursing staff administered nebulizer treatments to patients.

Findings:

1. On the morning of 11/05/2013, Staff H was asked if nurses provide respiratory therapy procedures such as, nebulizer breathing treatments. Staff H stated that the nurses did perform nebulizer breathing treatments when the respiratory therapists were not available.

2. Staff H stated the respiratory therapy department hours were 7:00am - 5:00pm.

3. Staff H was asked if the respiratory therapist provided the nursing staff with training on respiratory therapy treatments. Staff H stated that the respiratory therapist did provide training on respiratory therapy treatments.

4. Six of Six nursing personnel files reviewed did not contain current respiratory competency training and verification completed by the respiratory therapist.

5. Review of patient records #7 and #15 showed that a nebulizer breathing treatment was performed by the nursing staff.

6. On the morning of 11/06/2013 Staff H, E and Q verified that the nursing staff provided nebulizer breathing treatments when the respiratory therapists were not available.

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

a. comply with skilled nursing facility requirements.

b. notify patients of all rights related to swing bed status.

c. notify swing bed patients of the right to refuse treatment and participate in experimental research.

d. inform swing bed patients of items and services that may or may not be charged to the patient.

e. inform swing bed patients of right to choose attending physician.

f. inform swing bed patients about care and treatment and any changes in care.

g. inform swing bed patients of right to participate in planning care and treatment.

h. notify swing bed patients of right to privacy and confidentiality.

i. notify swing bed patients of rights related to performing work for the facility.

j. notify swing bed patients of sending and receiving mail.

k. ensure swing bed patients had access to visitors.

l. inform swing bed patients of their rights related to personal possessions. See

m. notify swing bed patients of rights related to married couples.

n. develop and implement a comprehensive policy that correctly reflected swing bed patient rights related to transfer and discharge. ;

o. implement a policy to assess a patient's needs prior to transfer or discharge to determine if a new care plan would allow the hospital to meet the patient's needs.

p. develop and implement a comprehensive policy that correctly addresses swing bed transfers or discharge documentation.

q. inform swing bed patients, families and/or legal representative in writing of the reason for transfer or discharge.

r. develop policy and procedures to meet the requirements for the discharge and transfer of swing bed patients.

s. develop policy and procedures to meet the requirements for restraints, abuse, and treatment of swing bed patients.

t. prevent the employment of individuals convicted of abusing, neglecting or mistreating individuals in a health care related setting.

u. provide an activities program for swing bed patients.

v. provide medically-related social services to swing bed patients.

w. ensure swing bed patients had adequate discharge summaries that included sufficient information pertinent to continuing care and failed to ensure a discharge plan of care was developed with the participation of the patient and the family.

x. provide required services and qualifications to meet the needs of the swing bed patients.

y. meet the dental needs of swing bed patients.

Findings:

1. On the afternoon of 11/06/13, surveyors asked for the hospital's swing bed resident's rights. Administrative staff provided surveyors with a document titled, "Patient's Bill of Right's."

2. On the afternoon of 11/06/13, the Chief Executive Officer (CEO) verified that the hospital did not have swing bed rights but would be referring to Center for Medicare and Medicaid Services (CMS) Appendix T, regulations for swing beds in hospitals.