HospitalInspections.org

Based on observation, document review and staff interview, it was determined the hospital failed to have an effective governing body as evidenced by failure to ensure:

1. the categories of practitioners were evaluated and eligible candidates were selected for appointment to the medical staff. Clinical records documented various categories of practitioners worked in the hospital. The governing body had not determined what privileges each category was granted.

2. each practitioner had documentation that privileges were granted. Various medical staff files had no documentation of appointment by the governing body. The files had no documentation of privileges granted. A practitioner who provided telemedicine behavioral health services had no documentation privileges were granted.

3. medical staff bylaws were current. The medical staff bylaws available for review were dated 2007.

4. medical staff bylaws and rules and regulations were revised as needed and were approved by the governing body. There were no governing body meeting minutes to show this had been done.

5. practitioners were working within their scope of practice. A certified registered nurse anesthetist (CRNA) performed surgical pain procedures and was also allowed to order, select or obtain drugs and devices to be used outside the perioperative/periobstetrical period. Respiratory therapists performed conscious sedation outside of their scope of practice and without supervision and oversight by a registered nurse.

6. all patients were under the care a qualified, licensed practitioner. Clinical records documented patients received care solely from a CRNA, outside the perioperative period, and without the supervision of a physician.

7. ARNPs, CRNAs and physicians without privileges were prohibited from admitting patients.

8. all contracted services were evaluated through the QAPI process. The governing body failed to ensure all contracted to services were identified. A partial list of contracted services was provided to the surveyors. The CEO stated the list was missing several contractors. The list did not include the scope and the nature of the services provided. There was no evidence any contracted services were evaluated for quality.

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

a. inform patients and/or their representatives of all patient rights. See Tag A 0117;

b. ensure patients were made aware of the hospital's grievance process. See Tag A 0118;

c. ensure the grievance process was approved by the governing body. See Tag A 0119;

d. include a mechanism for timely referral of patient concerns regarding quality of care or premature discharge to the Quality Improvement Organization. See Tag A 0120;

e. provide patients and/or their representatives with information on how to submit a grievance. See Tag A 0121;

f. respond to all grievances in writing. See Tag A 0123; and

g. the hospital failed to develop and implement a comprehensive policy for prohibition of patient abuse that included all the required components. See Tag A-0145.

Based on hospital document review and staff interview, it was determined the hospital failed to develop, implement and maintain an ongoing hospital wide Quality Assessment Performance Improvement (QAPI) program.
Findings:
1. On the morning of 12/02/2013 hospital administrative staff was asked to provide the current QAPI plan and meeting minutes. None was provided.
2. The Chief Executive Officer (CEO) stated the hospital had no current functioning QAPI program.

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

1. the medical staff conducted periodic conduct appraisals of its members. None of the documents provided had evidence this was done;

2. credentials of prospective medicals staff members were examined and recommendations made to the governing body. Not all medical staff files reviewed had documentation this was done;

3. each practitioner had documentation that privileges were recommended by the medical staff. A practitioner who provided telemedicine behavioral health services had no documentation privileges were recommended by the medical staff;

4. the medical staff bylaws were reviewed and approved by the medical staff. The bylaws provided were last approved in 2007;

5. a statement of duties and privileges for each category of medical staff was provided; and

6. the hospital failed to ensure a process for granting, withdrawing and modifying privileges was followed. The files for medical staff members had no documentation of privileges granted, withdrawn or modified. The majority of the medical staff files were incomplete or out of date.

Based on hospital document review and staff interview, it was determined the hospital failed to:
a. organize nursing services with a plan of administrative authority and clear delineation of responsibilities for patient care. See Tag A 0386;

b. provide a process to ensure all nursing personnel had valid and current licenses. See Tag A 0394;

c. ensure a registered nurse (RN) supervised and evaluated the nursing care for each patient and ensure adequate assessments were provided. See Tag A 0395;

d. ensure a registered nurse assigned care to other nursing personnel according to their qualifications and level of competence. See Tag A 0397;

e. specify who was authorized to administer medications; prohibit administration of medications by staff not authorized to do so; ensure only approved standing orders were used; ensure medication orders were written with all the required elements; ensure medications were administered and documented according to recognized standards of practice; and ensure the medical staff reviewed and approved medication administration policies and procedures. See Tag A 0405;

f. prohibit a CRNA from ordering, selecting or obtaining drugs and devices for use in a pain management clinic conducted at the hospital. See Tag A 0406; and

g. the hospital failed to provide an organized nursing service and failed to integrate the nursing service into the Quality Assessment Performance Improvement (QAPI) program.
Findings:
1. On the morning of 12/02/2013, hospital administrative staff was asked to provide a nursing organizational chart for all locations where the hospital provided nursing services. No nursing organizational chart was provided.
2. The Chief Executive Officer stated he was the director of nursing but since he had assumed the role of CEO, there was not another identified director of nursing.
3. The surveyors were told none of the nursing departments had a designated nurse manager. Later, the OR manager was identified as the nursing manager for surgery, recovery, pre-operative care, emergency room, obstetrical services, and medical-surgical nursing. She stated she was also the employee health nurse.
4. The hospital had no current QAPI program. The QI Coordinator stated nursing services were not reviewed for quality.

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

1. Document in writing the scope and complexity of radiology services offered by the hospital.

On 12/02/13, the chief executive officer (CEO) and radiology manager were asked to provide a written scope of services for radiology services offered. None was provided. The radiology manager stated there was no written scope of services.

2. Ensure the medical staff and the governing body approved the scope and complexity of the radiology services offered. There were no meeting minutes that documented the medical staff and governing body approved the scope of radiology services.

3. Develop comprehensive policies and procedures for the radiology department based on nationally recognized standards of practice. The radiology policies and procedures reviewed were outdated, not relevant to the current radiology services provided, and did not have references to national standards of practice.

4. Include radiology services in the hospital-wide QAPI process. On the morning of 12/03/13, the radiology manager told the surveyors she did not know what QAPI was. The CEO told the surveyors the hospital does not have a QAPI program at this time.

5. Implement radiology policies, procedures and practices that ensured safety for patients and personnel.

The radiology did not have documentation of policies and procedures that described how radiation hazards were prevented in the department.

The radiology department did not have policies and procedures related to safety and emergency procedures specific to the radiology department.

On the morning of 12/03/13, the radiology manager stated there was no training or practice drills for emergencies in the radiology department.

6. Ensure radiology personnel had documented evidence of specialized training, education, qualifications, and certification necessary for work in the radiology department.

Staff V stated she was qualified to take plain x-rays films but was also performing CT scans and limited MRI diagnostic exams.

On the morning of 12/03/13, the radiology manager verified staff in the radiology department were operating equipment they were not qualified to run.

The medical staff had not designated qualified staff to operate the radiological equipment and to administer procedures in the radiology department.

7. Ensure a qualified radiologist supervised all radiology services. The radiology manager and the CEO stated the hospital had not appointed a supervising radiologist.

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

1. provide evidence of routine and preventive maintenance and testing of medical equipment in all areas of the hospital. The surgery department, radiology and nuclear medicine departments among others, had no documentation of this requirement. The plant manager did not provide documentation of a biomedical equipment program as requested by the surveyors.

2. perform emergency preparedness drills specific to each area of the hospital. Staff in surgery, radiology, OB, nuclear medicine and emergency department among others, stated they had no department-specific drills.

3. maintain the condition of the hospital. Surveyed areas of the hospital were in disrepair, were cluttered, and were not cleaned routinely or adequately. Specifically the surgical areas, recovery and the emergency department lacked adequate routine, terminal and deep cleaning.

4. collect and dispose of trash and biohazardous waste appropriately. Open, industrial-sized trash cans were placed in hallways and in surgical areas and within access to patients and visitors. These cans were uncovered and were allowed to remain in place, collecting waste over a matter of days, until full. There were no identified biohazard waste collection rooms in the emergency department, endoscopy, surgery or recovery.

5. maintain facilities to reflect the scope of services provided. The endoscopy suite was a large combination room within the emergency department. It was not a separate area of the hospital and was not a part of the surgery department.

There was no separation between the endoscopy procedure room and the scope decontamination room. The decontamination room was not laid out to maintain adequate infection control. The endoscopy suite was used to store excess equipment.

Emergency department examination rooms were used as pre-op and post-op rooms. Examination rooms that did not meet the requirements for recovery rooms were used to recover patients from moderate or deep sedation.

The recovery room had been used also as an instrument sterilization area, an office, a tissue bank freezer area, emergency equipment area and general storage area. The room was not laid out to function appropriately as a recovery room.

The tissue bank freezer was not located in an appropriate area within the surgery department and had no evidence of routine calibrations.

A patient room was used to store sterile surgical supplies. The characteristics of the room did not meet the requirements for a sterile supply storage room and did not ensure integrity of the packaging. This room was also used for general storage.

Surgical pain procedures were performed in a non-surgical area.

6. store hazardous chemicals appropriately in the operating room. Formalin was observed dripping out of an overturned specimen container on a shelf in an enclosed OR supply cabinet where sterile supplies were kept.

7. ensure the line isolation monitors were operational in the OR. The staff stated this had been broken for an extended period of time.

Based on observation, staff interviews and review of hospital documentation it was determined 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 hospital did not have a person identified as the infection control officer to develop and implement infection control policies that addressed the roles and responsibilities for infection control within the hospital to include all hospital departments. (Refer to 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 to and provide follow-up to ensure corrective actions were appropriate. (Refer to Tag A-0749).

3. The hospital did not ensure the infection control program had a current tracking mechanism for patients and staff infections and possible transmission of infections and communicable diseases. Surveillance data provided only documented reportable diseases that were reported to the Oklahoma State Department of Health. The hospital did not monitor and track surgical site infections.

4. The disinfectants used throughout the hospital were not 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. Hospital infection control policies and procedures were not current.

6. 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. (Refer to Tag A-0756).

Based on record review and staff interview, it was determined the hospital failed to develop and implement a discharge planning process.

Findings:

On 12/02/13, the administrative staff was asked to provide discharge planning policies and procedures. None were provided.

A review of 26 clinical records had no documentation of discharge planning activities.

Throughout the survey, nursing staff were asked about the discharge planning process. They stated they had no information on that and did not know who was responsible for it.

The administrative staff stated there was no formal discharge planning process.

Based on document review and staff interview, it was determine the hospital failed to meet the Condition of Participation for Organ, Tissue and Eye Procurement.

On 12/03/13, the CEO stated the hospital did not have
an Organ Procurement Organization (OPO) agreement and did not have a hospital program for it.

He stated there were no hospital policies and procedures for organ procurement.

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

a. prohibit CRNAs from performing surgical procedures;

b. provide an organizational chart for surgical services. No physician had been appointed as the chief of surgical services;

c. ensure outpatient surgical services were provided in a manner consistent with the hospital's inpatient surgical services;

d. ensure a qualified registered nurse performed circulating duties in the operating room (OR) and that these duties were carried out according to recognized standards of practice. See Tag A-0944;

e. maintain a current roster that included each practitioner's surgical privileges. See Tag A-0945;

f. ensure current policies, based on nationally recognized standards, were available to the surgical services department. See Tag A-0951;

g. ensure properly executed informed consents were provided prior to surgery. See Tag A-0955;

h. ensure post-operative care was provided according to acceptable standards of practice. See Tag A-0957;

i. provide an operating room register with all the required elements. See Tag A-0958;

j. prohibit the performance of surgical pain procedures in a non-surgical area;

k. follow nationally recognized standards of practice for tissue banking; and

k. the hospital failed to integrate surgical services into the hospital's QAPI program.

Findings:

1. On 12/03/12, the OR staff and the administrative staff stated a CRNA performed pain management procedures in the hospital.

The clinical records for four (#14, 15, 16 and #17) of four pain management patients reviewed documented the CRNA performed these procedures independently without physician involvement.

The procedures the CRNA performed involved injection of therapeutic substances into joints and/or the central nervous system.

Some clinical records for pain management patients documented the CRNA was identified as the "admitting physician."

2. No organizational chart was available for surgical services. No physician was identified as the chief of surgical services.

3. Outpatient surgical services were not provided in a manner consistent with inpatient surgery. Not all outpatients were provided a complete assessment pre-operatively. The intraoperative records for outpatients did not document they were afforded the same level of care and monitoring as inpatient surgery cases. The outpatients were not provided the same level of recovery phase care as inpatients.

Outpatient surgical patients were admitted to and shared a waiting room with potentially sick emergency department patients and other outpatients waiting for testing or other services.

Outpatient surgical patients had pre- and post-operative care provided in the emergency department examination rooms.

4. Surgical pain management procedures were performed in a non-surgical area within the radiology department. This area did not meet the standards for surgery and did not have oversight by the surgery department staff.

5. The surgery department had a tissue banking freezer. There were no policies and procedures governing this practice. There was no indication any administrative staff had oversight and authority over this practice.

6. The OR manager stated surgical services were not included in the QAPI program. The CEO confirmed the hospital did not have a functioning QAPI program.

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

a. a qualified physician was appointed as the director of anesthesia services. The hospital had no organizational chart for anesthesia services and the CEO stated no physician had been appointed as the director of anesthesia;

b. anesthesia services provided throughout the hospital were organized into one anesthesia service. There was no formal description of where and what type, of anesthesia services were provided in various areas of the hospital;

c. anesthesia services policies and procedures were developed and implemented to address the minimum qualifications and supervision requirements for each category of practitioner who was permitted to provide moderate sedation;

d. a system and process was in place to evaluate adverse events, medication errors, and other quality indicators related to anesthesia;

e. CRNAs who provided general anesthesia, regional anesthesia, monitored anesthesia and deep sedation/analgesia were supervised by the operating practitioner or an anesthesiologist. See Tag A-1001;

f. comprehensive anesthesia policies and procedures were developed, approved and implemented. See Tag A-1102; and

g. the hospital failed to integrate anesthesia services into the QAPI program.

Based on observation, clinical record review and staff interview, it was determined outpatient services were not provided in a manner consistent with in-patient services.

Findings:

1. Surgical outpatients were treated differently depending on the type of procedure performed. They were not consistently processed as surgical patients. Non-surgical outpatients who received conscious sedation were not recovered as other patients who received conscious sedation.

2. Surgery outpatients were not provided post-operative care in the identified recovery room, but were recovered in the emergency department examination rooms.

3. Endoscopy surgical procedures were provided in the emergency department in an area that does not meet the requirements for surgery.

4. Outpatient surgical pain procedures were provided in the radiology department. The area did not meet the requirements for surgery and was not integrated into and overseen by the surgery department.

5. Outpatient services was not included in the hospital's organizational chart. There was no single person identified as responsible for outpatient services.

6. Outpatient services were not integrated into the hospital's QAPI program.

7. Hospital leadership verified these findings.

Based on clinical record review, policy and procedure review, personnel record review and staff interview, it was determined the hospital failed to ensure:

a. emergency services were provided under the direction of a qualified member of the hospital's medical staff. See Tag A-1102;

b. emergency department policies and procedures were reviewed and approved by the medical staff. See Tag A-1104;

c. emergency services personnel requirements were met. See Tag A-1110; and

d. failure to ensure staff working in the emergency department had demonstrated skills competencies. See Tag A-1112.

Based on hospital document review and staff interview, it was determined the hospital failed to ensure respiratory therapy services were integrated into a Quality Assessment Performance Improvement (QAPI) program.

Findings:

1. On the morning of 12/02/2013, administrative staff was asked to provide the hospital's current QAPI plan and meeting minutes. No QAPI plan or meeting minutes was provided.
2. Hospital administrative staff verified that there was no current QAPI plan.
3. On the morning of 12/04/2013, the respiratory therapy director was asked if respiratory therapy services were reported to QAPI. She stated no.

Based on observation, interview and document review, it was determined the hospital failed to notify patients and/or their representatives of their rights.

Findings:

On the morning of 12/03/13, the Quality Improvement/Compliance Manager stated patients and/or their representatives were not given a written copy of their rights.

When asked how patients were notified of their rights, the Quality Improvement/Compliance Manager stated patient rights information was located in folders placed in the patient rooms and in other waiting areas. The information provided in the folder did not contain all the patient rights components as required.

The hospital did not have a policy that addressed how patients were notified of their rights.

Based on document review and staff interview, it was determined the hospital failed to inform patients on how to file a grievance.

Findings:

On 12/03/13, the compliance manager was asked how patients were informed on how to file a grievance. She stated, "The staff will tell them to contact me."

She stated that there was no written information given to patients about how to file a grievance with the hospital, the state agency or the QIO.

The hospital did not have a policy related to notifying patients about how to file a grievance. There was no policy that instructed staff on how to identify and report a patient grievance.

Based on document review, policy and procedure review and staff interview, it was determined the hospital failed to ensure the governing body approved and maintained oversight of the grievance process.

Findings:

On 12/03/13, the hospital was asked to provide the policy on the grievance process and to provide a list of grievances received by the hospital for the previous 12 months.

The policy did not document the governing body's review and approval of the grievance process. The policy did not describe the governing body's oversight of the grievance process.

The policy documented the Quality Council reviewed complaints and grievances quarterly and a medical staff committee reviewed physician complaints.

The list of grievances documented various complaints, including complaints about physicians.

There was no documentation the Quality Council and/or a medical staff committee reviewed any complaints or grievances.

The QI coordinator/Risk Manager confirmed complaints and grievances had not been reviewed in those meetings.

Based on document review, policy and procedure review and staff interview, it was determined the hospital failed to ensure patient concerns regarding quality of care or premature discharge were referred to the Quality Improvement Organization (QIO).

Findings:

On 12/03/13, the hospital's grievance policy was reviewed. The policy did not document a mechanism to refer complaints regarding quality of care or premature discharge to the QIO.

The policy documented, "... An issue concerning premature discharge will be forwarded for review to the Case Management staff..." The policy did not address complaints regarding quality of care.

Information provided to patients did not include reporting complaints to the QIO.

The QI Coordinator confirmed this finding.

Based on document review, policy and procedure review and staff interview, it was determined the hospital failed to establish a process to ensure patients were informed about how to submit a written or verbal grievance to the hospital.

Findings:

On 12/03/13, patient information materials were reviewed. There was no clearly established process for patients to submit a written or verbal grievance to the hospital.

Patient care staff were interviewed about how patients could submit a written or verbal grievance. They stated they were unsure of the process.

The QI Coordinator stated patients could call her regarding grievances. She further stated patient complaints and grievances were captured with a satisfaction survey.

Based on document review and staff interview, it was determined the hospital failed to respond to all grievances in writing. When grievances were responded to in writing, the notice did not include all the required information.

Findings:

On 12/03/13, the hospital's grievances were reviewed. Two of three grievances had no documentation the complainant was responded to in writing.

The third grievance was responded to in writing, but the notice failed to include steps taken to investigate the issue, the hospital's decision and the date of resolution.

The QI Coordinator confirmed these findings.

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.
Findings:
On the morning of 12/02/2013, hospital administrative staff was asked to provide the policy and procedure on patient abuse.
A policy titled, "Recognizing and Reporting Abuse" was not current and did not contain the necessary components including prevention, screening, identifying, training, protecting, investigating and reporting patient abuse.
Hospital administrative staff verified that this was the hospital's current policy on patient abuse.

Based on document review and staff interview, it was determined the hospital failed to organize nursing services with a plan of administrative authority and clear delineation of responsibilities for patient care.

Findings:

1. On 12/02/13, administrative staff were asked to provide an organizational chart for nursing services. None was provided.

The CEO stated he was also the director of nursing. He stated no one was designated as the assistant director of nursing. When asked who provided direct supervision of the various nursing units, he stated the OR manager had oversight of the nursing units.

It was later determined the OR manager also worked in surgery as a circulating nurse and also as the recovery room nurse. She stated she also took call for emergency surgery.

2. There were no registered nurses identified as shift supervisors or identified as unit charge nurses.

3. The nursing policies and procedures were not current and had no documentation they were reviewed and approved by the director of nursing. The OR manager stated she was working on nursing policies and procedures as time permitted.

Based on hospital document review, personnel record review, and staff interview, it was determined the hospital failed to provide a process to ensure all nursing personnel had valid and current licenses.

Findings:

On 12/02/13, the human resources manager was asked to provide the personnel records for various members of the nursing staff. He stated the records did not include documentation of current licenses. He stated he could print license verification from the nursing website for the surveyors to review.

The hospital did not have a policy that described how the hospital would ensure that all nurses working had current licenses.

Based on medical record review, and staff interview, the hospital failed to ensure a registered nurse (RN) supervised and evaluated the nursing care for each patient. The hospital failed to ensure adequate assessments were provided by registered nurses.

Findings:

1. All emergency room patients were not immediately assessed and triaged by a registered nurse.

On the morning of 12/02/13, the emergency department (ED)staff stated emergency patients were checked in at the outpatient registration area (an area outside the emergency department). They stated this area was also designated as the ED waiting room.

The CEO was asked how walk-in patients to the registration desk were assessed and triaged. He stated, "The registration clerks are trained to determine if patients are sick or not sick. Then they call a nurse for triage from the ED."

There was no documentation the clerks had any formal medical training to assess and triage emergency patients.

Staff P was asked who triaged emergency department patients. She stated any nurse (RN or LPN) could triage ED patients.

Staff O, an LPN, stated, "I triage patients all the time." Staff P verified Staff O triaged patients.

Thirteen ED patient records were reviewed. Nine of the records had no documentation vital signs were taken and nursing assessments were performed when patients were triaged. Some of the records had no documentation an RN was involved in the patients' care.

2. When an ED patient was cared for by someone other than an RN, there was no documentation an RN assessed and supervised the provision of care.

Patient #5 was admitted to the ED with a diagnosis of acute respiratory failure and exacerbation of asthma. The medical record documented the patient's vital signs were: pulse 141 beats per minute and respirations 30 breaths per minute. The patient's oxygen saturation was documented as 84%.

A respiratory therapist documented, "... Lung sounds: wheezing, right and left lobes... Respirations: labored..." An LPN documented, "... Respirations easy, nonlabored, clear to auscultation, right upper lobe, left upper lobe, right lower lobe, left lower lobe..."

There was no documentation a registered nurse assessed the patient and verified these findings.

3. Surgical patients had documentation of inadequate assessment and care by a registered nurse during the pre-operative period.

Clinical records reviewed for patient care in the pre-operative area had missing or incomplete assessments by a registered nurse. Pre-operative patient safety checklists were missing or incomplete. Routine pre-operative care was not documented.

Patient #26 was scheduled for non-emergent abdominal surgery. The clinical record had no documentation of assessment of the patient's abdomen, last bowel movement, last menstrual period, or a urine pregnancy test. There was no documentation of the nursing assessment of the patient's previous medical history. The pre-operative safety checklist was not completed.

The pre-procedure record for patient #17 documented the patient had a past medical history related to his heart. No further assessment or information was provided about this condition. The record did not document a baseline oxygen saturation level. There were no nurse's notes. There was no documentation of the time the patient left pre-op, how he left that area, where he went and with whom.

The RN documented patient #14 had a medical history that included problems with "hepatitis" and the "heart." There was no further details given about these conditions. There was no assessment of the patient's allergies. There were no nurse's notes.

4. Not all surgical patients had documentation of assessment and care by a registered nurse in the intraoperative or procedure areas.

Patients #14, 15, 16, and #17 had procedures. There was no documentation of nursing care during the procedure. It could not be determined a registered nurse provided or supervised the care of the patients during the procedure. The was no procedure nursing record.

Patient #18 had a surgical procedure. The intraoperative record had no signature for the person completing the record. It could not be determined a registered nurse provided or supervised the care of the patient during the surgical procedure.

5. Patients were administered conscious sedation by respiratory therapists without evidence an RN supervised and evaluated the care provided.

Patient #21 and #22 had procedures with conscious sedation provided by a respiratory therapist. The records had no documentation an RN or the respiratory therapist assessed the patients prior to conscious sedation according to all the requirements in the hospital's policy and procedure.

There was no documentation the RN supervised the care provided and reviewed the assessments and documentation written by the respiratory therapist.

6. Patients were administered conscious sedation without evidence an RN was present during the procedure.

The clinical records for patient's #14, 15, 16 and #17 had no documentation a registered nurse was involved in the conscious sedation and subsequent pain procedure administered to the patients.

Although orders were written for medications for conscious sedation, the patient records did not include a conscious sedation record. It could not be determined who administer the medications, when the medications were administered and the patient's response.

There was no documentation of monitoring of physical condition, cardiac rhythm, end tidal CO2, level of consciousness, skin color or temperature as required by policy and procedure.

There was no documentation by a supervising RN during the entire procedure period.

There was no documentation of pre and post procedure assessment by an RN.

7. The supervising RN did not prohibit the administration of conscious sedation medications when the physician was not present.

The clinical records for patients #21 and #22 had documentation the patients received an initial dose of IV versed and fentanyl given by the respiratory therapist before the physician was present in the room.

The record for patient #21 had documentation the IV medications were given before the physician was in the room. The respiratory therapist documented the first medications were given at 1:48 p.m. The nurse documented the physician arrived to the procedure at 1:50 p.m.

A physician's order for patient #22 documented, "... Give versed 2 mg. [and] fentanyl 100 mg IV, then call [doctor name deleted]."

The hospital's conscious sedation policy documented, "... The physician must be present during the initial and each subsequent administration of any sedation/analgesia medication given by an RN and/or RRT..."

8. RN assessments for post-operative patients were missing or incomplete.

Patient #26 had no documentation of an assessment of the patient's condition at the time of discharge from recovery.

Patient #17 had a drop in oxygen saturation and the record indicated oxygen at two liters per minute was administered. There was no documentation of standing orders for the administration of oxygen and no documentation the CRNA was notified to obtain orders. There was no documentation of assessment of the patient's respiratory status or response to the oxygen. There was no assessment of the patient at the time of discharge from recovery.

Patient #16 had no documentation of post-procedure recovery nursing care and RN assessment. There was no documentation the patient had a recovery period, although the patient received two doses of both fentanyl and versed (conscious sedation) during the procedure.

Patient #20 had a vaginal hysterectomy. There was no assessment of vaginal bleeding when admitted to recovery. When the patient was to be transferred to a room, the recovery room nurse did not perform an assessment and did not re-evaluate the Aldrete score. There was no documentation of the presence/absence of bleeding, pain, nausea or vomiting. There was no documentation of a head to toe assessment.

When the patient was transferred to a room, there was no head to toe assessment and no focused assessment of the patient's surgical condition, bleeding, pain, nausea or vomiting.

9. Patients were not assessed for the effectiveness of pain medication.

Six of six records reviewed for pain assessment did not include the assessment of the effectiveness of pain medication every time pain medication was given.

10. When the patient had a change in condition, the RN did not perform re-assessments.

Patient #20 developed uncontrolled pain after surgery. There was no description of the pain and no other assessment documented. When the patient's pain medication was changed, the patient developed facial itching. There was no corresponding patient assessment and response to treatment.

The patient's vital signs were taken every 15 minutes over a period of several hours. There was no documentation of who took the vital signs or that the RN reviewed them. There was no documentation of on-going assessment of the patient that described the patient's response to treatment and other interventions.

Based on record review and staff interview, it was determined the hospital failed to ensure a registered nurse assigned care to other nursing personnel according to their qualifications and level of competence.

Findings:

1. On 12/02/13, administrative staff was asked to provide an organizational chart for the nursing staff in the emergency department. None was provided.

The emergency department staff stated RNs, LPNs, paramedics, EMTs and nurse aides provided care in the department.

The staff was asked to provide policies and procedures that described what each category of nursing staff was allowed to do. None was provided.

There was no documentation the medical staff reviewed and approved the tasks each category of nursing staff were authorized to do.

A review of medical records had documentation LPNs performed patient assessments without oversight by a registered nurse. The emergency department staff stated LPNs also triaged emergency patients.

2. The hospital was asked to provide an organizational chart for the surgery department nursing staff. None was provided. Through staff interview, it was determined CRNAs, RNs, scrub techs, instrument techs and respiratory therapists worked in the department. There was no designation of lines of authority.

3. On 12/03/13, the respiratory therapy staff stated they were sometimes assigned to provide conscious sedation to patients during surgical and other procedures.

There was no documentation the medical staff authorized respiratory therapists to administer IV conscious sedation medications and to provide a comprehensive patient assessment before, during and after the procedure.

A review of medical records for patients who had conscious sedation indicated respiratory therapists administered the IV medications during the procedure. Some medical records had no documentation as to who administered IV conscious sedation medications.

On 12/04/13, the respiratory director stated the respiratory therapists were trained to provide conscious sedation "on the job."

On 12/17/13, interviews were conducted with three program directors for respiratory therapy education programs in the State of Oklahoma. Each program director stated IV therapy and the administration of intravenous drugs and controlled substances was not within the core curriculum for respiratory therapists. They stated assessment of pain and level of consciousness and adequate sedation was not included in the curriculum.

In addition, they stated conscious sedation was not considered within the scope of practice for respiratory therapists. They stated they had no knowledge of any respiratory therapists engaging in this practice, anywhere in the state.

According to the State of Oklahoma Respiratory Care Practice Act, Title 59 O.S., Section 2016-2045, "...Practice of respiratory care shall include, but not be limited to, the direct and indirect respiratory care services including but not limited to the administration of medical gases, pharmacological, diagnostic and therapeutic agents and services related to respiratory care procedures..."

4. The hospital did not have a policy that required an RN to make all patient care assignments based on level of education, experience, licensure, competence and specialized education.

Based on medical record review, document review and interview, it was determined the hospital failed to:

a. develop and implement a policy approved by the medical staff to specify who was authorized to administer medications;

b. prohibit administration of medications by staff not authorized to do so;

c. ensure only approved standing orders were used;

d. ensure medication orders were written with all the required elements;

e. ensure medications were administered and documented according to recognized standards of practice; and

f. the hospital failed to ensure the medical staff reviewed and approved medication administration policies and procedures.

Findings:

1. On 12/02/13, the hospital was asked to provide policies and procedures from various departments including pharmacy, nursing and administration. No policy was found that specified who was authorized by the medical staff and the governing body to administer medications.

On 12/03/13, it was determined that registered respiratory therapists provided conscious sedation with the administration of IV medications (including controlled substances) to patients during surgical procedures and during cardioversion procedures.

There were no medical staff or governing body meeting minutes that documented authorization of this practice.

On 12/04/13, the respiratory director stated the respiratory therapists were trained to provide conscious sedation "on the job."

On 12/17/13, interviews were conducted with three program directors for respiratory therapy education programs in the State of Oklahoma. Each program director stated IV therapy and the administration of intravenous drugs and controlled substances was not within the core curriculum for respiratory therapists.

In addition, they stated conscious sedation was not considered within the scope of practice for respiratory therapists. They stated they had no knowledge of any respiratory therapists engaging in this practice, anywhere in the state.

According to the State of Oklahoma Respiratory Care Practice Act, Title 59 O.S., Section 2016-2045, "...Practice of respiratory care shall include, but not be limited to, the direct and indirect respiratory care services including but not limited to the administration of medical gases, pharmacological, diagnostic and therapeutic agents and services related to respiratory care procedures..."

2. Inpatient and outpatient records reviewed during the survey had documentation of the use of standing orders. There was no documentation on the pre-printed standing orders of the date they were approved by the medical staff and governing body.

The hospital did not provide a policy for standing orders.

3. Twenty-six medical records were reviewed for medication orders. All 26 records failed to include one or more of the minimum requirements for medication orders, including:

date and time of the order
dose, frequency and route
quantity and/or duration
instructions for use
name of prescriber

Conscious sedation standing orders did not require the prescriber to provide a dosage, route and frequency for those medications.

The medical records had no documentation incomplete or unclear medication orders were clarified by the prescriber.

4. Some medical records documented medications on a medication administration form. However, there was no documentation of when the medications were administered and how much was administered. Some records had no documentation of who administered the medications.

Medications administered during pain procedures such as local anesthetics, steroids, radiopaque dye and others were not documented by nursing for time administered, route, amount and who administered it.

5. All 26 records documented medication orders that were not noted by the nurse attending to the order.

6. On 12/04/13, the pharmacist was asked if his department had any medication administration policies. He stated he did not. He stated those policies belonged to the nursing department.

The nursing department had limited medication administration policies. Those policies were outdated and had no documentation they were reviewed and approved by the medical staff.

None of the policies documented they were based on Federal and State law and accepted standards of practice.

Based on medical record review and staff interview, it was determined the hospital failed to prohibit a CRNA from ordering, selecting or obtaining drugs and devices for use in a pain management clinic conducted at the hospital.

Findings:

On 12/03/13 and 12/04/13, four medical records (#14, 15, 16 and
#17) were reviewed for patients who had pain management procedures. Hospital administrative staff stated a CRNA performed pain management procedures at a "pain clinic" conducted within the hospital's radiology department.

All four records documented a CRNA ordered medications and contrast media for use during a pain management procedure that she performed. The orders for the medications were documented on a standing order form titled, "Pain Management Clinic Order and Signature Pre-procedure orders."

The orders written by the CRNA included Versed, Fentanyl, Depomedrol, Bupivacaine, Lidocaine, Celestone, Biogel and Omnipaque. The medications and contrast media were also documented and initialed by the CRNA on the medication administration record.

The form had a pre-printed signature line that documented the CRNA as the ordering practitioner. The CRNA initialed and dated the orders. There was no documentation an authorized supervising physician ordered the medications and contrast media for the patients.

There was no documentation in the records of a physician's signature authenticating the orders.

According to the official Opinion of the Attorney General for the State of Oklahoma, "...Title 59 O.S. 567.3a (10) (b) limits the authority of CRNAs who have received authorization from the Board of Nursing to 'order, select, obtain and administer legend drugs' solely to the perioperative or periobstetrical period. A CRNA cannot exercise the authority granted in subsection 59 O.S. 567. 3a (10)(b) to select, order to obtain drugs and devices in a setting that does not involve the perioperative or periobstetrical period, such as a pain management clinic..."

The hospital had no policy and procedure that required an authorized supervising physician to order all medications and contrast media in the pain clinic.

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

a. the pharmacy department was administered according to accepted standards of practice. See Tag A-0491;

b. drugs and biologicals were controlled and distributed appropriately for patient safety. See Tag A-0500;

c. drugs and biologicals were kept in a secure, locked area. See Tag A-0502;
d. outdated and unusable drugs and biologicals were not available for patient use. See Tag A-0505; and

e. the hospital failed to ensure drug administration errors, adverse drug reactions and incompatibilities were identified, responded to, documented, investigated and reported to the physician and to the QAPI program. The hospital failed to develop and implement comprehensive pharmacy and medication administration policies, approved by the medical staff, to minimize drug errors and adverse drug events. See Tag A-0508.

The hospital failed to develop and implement comprehensive pharmacy and medication administration policies, approved by the medical staff to minimize drug errors and adverse drug events.

Based on observation, record review and staff interview, it was determined the hospital failed to ensure the pharmacy department was administered according to accepted standards of practice.

Findings:

1. On 12/02/13, pharmacy policies and procedures were requested and reviewed. The policies were very limited in scope and did not address pharmacy services and medication administration in a comprehensive manner.

The few policies provided did not have documentation they were based on national standards of practice. The policies and had not been reviewed by the medical staff and the governing body.

The nursing staff did not have access to current pharmacy and medication administration policies and procedures.

The pharmacist stated he was working on policies and procedures.

2. During tours of various areas of the hospital, observations were made of incorrect medication and biological product storage. The pharmacist stated his department personnel did not monitor for storage compliance in all areas where medications and biologicals were stored.

Based on observation, document review and staff interview, it was determined the hospital failed to ensure drugs and biologicals were controlled and distributed appropriately for patient safety.

Findings:

1. On 12/02/13, the pharmacy department policies and procedures were reviewed. There were no policies that addressed:

high risk medications and high risk patients
dose limits
special labeling requirements
double checks
limited access to concentrated solutions (potassium chloride, sodium chloride, heparin, among others)
written guidelines for staff

2. There was no evidence the pharmacist participated in decisions about emergency medication kits/carts.

3. There was no documentation the pharmacist evaluated the automated dispensing system.

4. The pharmacy did not provide a policy and procedure for reporting adverse drug reactions to the FDA MedWatch progra.

5. There was no policy and procedure that addressed the use of medications brought into the hospital by patients or their families.

6. The pharmacist stated he and his department did not conduct periodic inspection of areas where medications were kept to ensure proper storage.

Based on observation and staff interview, it was determined the hospital failed to ensure drugs and biologicals were kept in a secure, locked area.
Findings:
1. On the morning of 12/02/2013, the surveyors observed a crash cart located at the nurses' station on the obstetrical unit with two unlocked drawers (the first and the fourth drawers). The first drawer contained medications used in emergencies and the fourth drawer contained intravenous fluids.
Staff C was asked if she knew why the crash cart was unlocked. She stated she didn't know it was unlocked. She stated the nurses were supposed to check the crash cart every shift to make sure it was locked.
The nurses' station was open and accessible to unauthorized persons. Staff H stated there were times when the nurses' station was unattended by the nursing staff.
2. An unlocked anesthesia cart was also found on the obstetrical unit in an unlocked storage room. The anesthesia cart contained multiple medications. The staff didn't know why this cart was stored in an unsecured room unlocked.
3. Multiple unsecured medications and biologicals were found throughout the emergency department, including within the examination rooms. The items found were: single dose aspirin tablets, nitroglycerin tablets, bags of IV fluids, IV saline flushes and sterile irrigation solution bottles.

IV fluids were stored unsecured and vulnerable to tampering in cabinets or on countertops in patient exam rooms.

4. Unsecured medications were found in the operating rooms and in the endoscopy procedure room.

Based on observation and staff interview, the hospital failed to ensure outdated and unusable drugs and biologicals were not available for patient use.

Findings:

1. On the morning of 12/02/13, the following expired drugs and bilogicals were found in the emergency department and obstetrics department:

xylocaine 1% expired November 2013
rubbing alcohol expired June 2011
betasept expired March 2013
diprivan expired March 2013
buprivacaine expired July 2013
buprivacaine expired September 2013
lidocaine 1% expired August 2013
lidocaine 1% expired July 2012
bicitra expired July 2012
infant sodium bicarbonate expired January 2012
sodium chloride for injection expired July 2012

2. In the emergency department, obstetrics unit, endoscopy suite and in the surgery department, medications and biologicals were not dated when opened.

3. Single dose medication vials were being used for multiple patients in the emergency department and in surgery.

4. IV fluids and sterile irrigation solutions were placed in warmers for two weeks and then later returned to shelves for use.

A sign posted on the warmers documented, "Fluids can be placed into the warmer for two weeks and then must be removed. Fluids can be placed back on the shelf and used until expiration on bag/container..."

There was no posted information about temperature/time/product variances that affected the safety of these products once they had been warmed, then cooled. There was no instruction that previously warmed bags could not be re-warmed.

The hospital had no product information that documented how each product could be safely warmed, cooled, stored and used.

There was no hospital policy and procedure for warming/cooling/storing sterile solutions.

Staff stated the pharmacist put the signs up and said it was "okay" to return previously warmed sterile fluids back on the shelf for patient use.

In the emergency department and in surgery, IV fluids and irrigation solutions were found on shelves, ready for patient use, that had previously been warmed for two weeks. Hand-written dates in and out of the warmer were found on the packaging.

Staff P stated, "The in and out dates are when they were placed in the fluid warmer and then taken out. The pharmacist said we can use them until the expiration date on the bag."

The CEO verified the pharmacist approved fluids to be placed in the warmer for two weeks and if not used, returned to stock for patient use. He stated this was the common practice throughout the hospital.

5. On 12/04/13, the pharmacist stated his department did not check for expired medications and that it was "nursing's responsibility." Nursing staff in various areas did not know who was supposed to check for expired medications.

Based on policy and procedure review and staff interview, it was determined the hospital failed to establish a protocol, approved by the medical staff, automatic stop orders.

Findings:

The hospital's automatic stop policy was dated 2000. It did not reflect current practices and did not include information about the automated system currently used by the hospital.

There was no documentation this policy had been reviewed and approved by the medical staff.

On 12/04/13, the pharmacist stated he was working on updating policies and procedures.

Based on document review and staff interview, it was determined the hospital failed to ensure drug administration errors, adverse drug reactions and incompatibilities were identified, responded to, documented, investigated and reported to the physician and to the QAPI program.

Findings:

1. On 12/04/13, the pharmacist stated the hospital did not have a current policy that defined medication errors, adverse drug reactions and drug incompatibilities. There was no policy that addressed how staff should respond to these events.

He stated medication errors were captured through incident reports. There was no documentation that indicated any additional steps were taken to identify medication errors, such as observations of medication passes, and concurrent or retrospective clinical record review.

A review of the pharmacy and therapeutics committee meeting minutes had documentation of numbers of medication errors only. There was no analysis of the medication errors for root cause analysis or trends. There was no documentation of actions taken in response to the errors.

The pharmacist stated he did not investigate medication errors. He stated that was a nursing function.

A review of medical records related to medication errors showed the staff did not document all medication errors (specifically omissions) in the medical record when they were identified. When the medication errors were not documented in the record, there was also no documentation the physician was notified.

A review of selected medical records had documentation medications were given to treat allergic medication reactions and that reversal agents had been used when patients were in the recovery room.

Twelve of thirteen physician's medication orders had no documentation of the patient's allergies.

2. The pharmacist was asked to provide adverse drug reaction reports. He stated there had not been any adverse drug reactions reported in the past year. He stated adverse drug reactions were probably under-reported. He was asked if suspected adverse drug reactions information could be captured in any other way. He stated they could probably be identified when certain medications used to treat adverse drug reactions were ordered. He was asked if the use of reversal agents was reviewed. He stated this type of surveillance was not done.

3. The pharmacist stated he did not provide reports to the QAPI committee on medication errors, adverse drug reactions or incompatibilities. He stated there were no reports on any pharmacy quality indicators reported to the QAPI committee.

Based on observation and staff interview, it was determined the hospital failed to inspect, monitor and maintain medical equipment as required within the biomedical program.

Findings:

On the morning of 12/02/13, the surveyors toured the facility and observed the following medical equipment with expired inspections or no documentation of inspection:

reverse isolation unit in the ED
blanket warmers
fluid warmers
speculum lights
Lifepak 20 (multiple)
IV pumps
epidural pumps
portable suction machines on crash carts
DynaMap (vital sign monitors)
radiology equipment
otoscopes and ophthalmoscopes

Emergency department staff verified equipment in ED and elsewhere was not monitored, inspected, and or maintained.

On the morning of 12/04/13, Chief Executive Officer (CEO) provided a list of contracted services that did not include a biomedical engineer.

The plant manager was asked to provide documentation of the hospital's biomedical program. None was provided.

Based on hospital document review and interview it was determined the hospital failed to designate an infection control officer to be responsible to develop and implement infection control policy and procedures.
Findings:
1. On the morning of 12/02/2013 the Chief Executive Officer (CEO) was asked who the infection control practitioner was. The CEO stated that the infection control nurse left in March of 2013 and there was not someone in that position.
2. On the afternoon of 12/02/2013 the surveyors reviewed the infection control policies and procedures. All the infection control policies and procedures were not current.

Based on observation, review of infection control data, surveillance activities, meeting minutes, hospital documents, staff personnel files, staff interviews and observation, it was determined the hospital failed to develop and maintain an ongoing comprehensive system for reporting, analyzing and controlling infections and communicable diseases among patients and staff.
Findings:
1. On the morning of 12/02/2013, hospital administrative staff was asked to provide infection control meeting minutes, infection control policies and procedures, all infection control surveillance activities and the name of the infection control officer.
2. The Chief Executive Officer stated there was not an active infection control officer. The CEO stated the infection control nurse left in March 2013.
3. The hospital IC program had not developed a system to ensure appropriate infection control procedures were implemented and evaluated for each department in the hospital. Review of infection control policies and procedures, dietary policy and procedures, laundry policy and procedures and employee health policy and procedures showed the policies were outdated, did not reflect current standards of practice did not reference nationally accepted standards and were not approved by the IC committee or medical staff.
4. There was no documentation of any surveillance activities for infection control in the different hospital departments.
5. There was no documentation of regular environmental rounds.
6. There was no documentation all departments reported regular, ongoing infection control activities and surveillance to the infection control committee.
7. There was no documentation that chemicals used in the hospital for cleaning and disinfecting were approved by the infection control committee and the medical staff.
8. The CEO verified at time of document review that the chemicals used in the hospital had not been approved by the infection control committee.
9. The hospital did not have a current reportable disease list provided by the Oklahoma State Department of Health.
10. The hospital did not have a current bloodborne pathogen exposure control plan.
11. Surveyors reviewed personnel health files. Thirteen of fourteen files reviewed did not contain current influenza vaccines or vaccine refusal documentation and thirteen of fourteen did not contain current TB testing.
12. The hospital did not have a comprehensive respiratory protection program. An annual facility TB risk assessment was not conducted. On 12/03/13, the hospital provided a TB risk assessment performed on that day.
13. Surveyors reviewed physician personnel health files. Ten of ten files reviewed did not contain documentation of influenza vaccines or refusal and there was no documentation of TB testing.
14. Surveyors reviewed staff education files. Fourteen of fourteen files reviewed did not contain documentation of ongoing infection control training.
15. On the morning of 12/02/2013, surveyors observed the Emergency Room (ER). Surveyors observed biohazard bins stored in the main ER hallway.
16. The decontamination room in the ER contained clean wheelchair pads that were used for patient use. The decontamination room contained clean stuffed animals that were used to give to pediatric patients and the decontamination room contained clean pillows that were used for patients.
17. In the ER surveyors observed an open vial of medication that is intended for single patient use being used on multiple patients. Staff P verified that the medication was being used for multiple patients at time of observation.
18. On the morning of 12/02/2013, surveyors observed the obstetrical floor. Surveyors observed the storage room where linens were stored. The linens were stored uncovered.
19. The soiled utility room on the OB floor contained "clean" sequential compression device equipment (SCD) stored on the counter top. Staff H confirmed that the soiled utility room is where the SCD equipment was stored and was used on patients.
20. Sterile instruments/equipment on the OB floor was stored incorrectly. Sterile supplies were stored with non-sterile supplies. Several of the sterile instruments were out dated or contained no date. Surveyors asked staff H how they would know if the instruments were still sterile. Staff H stated "we don't really use these instruments."
21. Extra linens were stored in the LDRP (labor, delivery, recovery and postpartum) rooms in a bedside table. Staff H verified that if the linens are not used while one patient is in the room, the linens remain in the bedside table for the next patient.
22. There was a refrigerator in the patient nutrition room that contained food designated for the patients. The staff stored their personnel food in the patient refrigerator.
23. On the morning of 12/03/2013 surveyors observed the radiology department. Staff V could not verbalize what disinfectant would be used to clean equipment if a patient had diarrhea.
24. The head of the radiology department stated the technicians in the MRI, CT and nuclear medicine departments clean the department. Surveyors reviewed eight radiology employee personnel files. Eight of eight contained no documentation of training for cleaning the department.
25. On 12/02/13, surgery department observations were made to include the following:
a. Outpatient surgery patients shared the waiting room with sick emergency department (ED) patients. These patients had to share a public toilet while waiting.
b. The endoscopy surgical suite was a room within the ED and not a separate area of the hospital. This room was also used for equipment storage. The room was cluttered, disorganized and dirty. There was no evidence of routine terminally cleaning. There was no evidence the room had ever been deep cleaned.
Endoscopy patients were prepared pre-operatively and recovered post-operatively in ED examination rooms. (One room that was used for patient recovery was the ED airborne isolation room.) The patients had to share toilets with ED patients and visitors.
c. Endoscope decontamination/processing was not provided in an area consistent with infection control standards and practices. There was no separation between the dirty endoscopy processing room and the surgery procedure room. The processing room had no hand washing sink. The room had non-intact surfaces that could not be adequately disinfected between uses.
Because of the size and configuration of the scope processing room, it was not possible to avoid cross-contamination between clean and dirty steps. Scope decontamination/cleaning/rinsing was provided in a single sink. There was inadequate space for storage of necessary supplies and equipment.
d. Large, open industrial size trash cans with no lids were found in the endoscopy suite and in the surgery department. These cans were observed partially full with trash. The staff stated they were not emptied between cases, but were left open until they were full, even if that meant trash remained until the next day.
e. Biohazard waste containers/boxes were stored in the corridors in surgery and in the endoscopy suite. Neither area had an identified soiled utility or biohazard waste containment room.
f. In surgery, the janitor's closet had been equipped with a Neptune docking station. This took so much space in the closet that the mop bucket and mops were stored in the surgery corridor. Housekeeping supplies and chemicals were stored outside the janitor's closet.
g. Clean OR table linens, including sheets and blankets were stored with clean mop heads and housekeeping rags.
h. Cardboard shipping boxes were found in endoscopy and in the surgery department.
i. OR storage cabinets were rusted. The door tracks were so rusted, the doors could not open correctly.
j. Sterile supplies were stored with non-sterile supplies. Liquids were stored over sterile supplies. Specimen containers of formalin were dripping into a plastic bin in an Or sterile supply cabinet.
k. Sterile supplies were stored in an old patient room outside the surgery department. Supplies were found in the room's bathroom. Sterile supplies were stored in a manner vulnerable to beach of integrity and contamination. Equipment, such as wheelchairs, were stored in the sterile supply room. The room had vertical blinds on large picture windows that could not be terminally cleaned. There was evidence the room had never been terminally cleaned or maintained on a regular basis.
The sterile supply room did not maintain required temperature and humidity controls.
l. The recovery room was used as office space with printers, fax machines, books, file cabinets, desks and computers. The room housed the tissue bank freezer, a chemical sterilizer and the surgery department's emergency carts. The room was also used for general storage. The room could not be adequately cleaned. There was evidence the room was not regularly cleaned and never had terminal or deep cleaning.
m. Because a chemical sterilizer was housed within the recovery room, surgical equipment had to be walked through this room to be placed in the processor. Likewise, sterile equipment was brought out of the processor and walked through the recovery room to then be taken into surgery.
n. Sterile processing policies and procedures were last reviewed in 1997. There was no documentation they were based on current standards of practice.

Based on clinical record review and staff interview, it was determined the hospital failed to ensure a qualified registered nurse performed circulating duties in the operating room (OR) and that these duties were carried out according to recognized standards of practice.

Findings:

Clinical records were reviewed for evidence a registered nurse provided circulating duties in the OR.

1. Some clinical records had no documentation a circulating nurse was present during the surgical procedure.

2. Surgery records lacked documentation to support evidence of adequate care by the circulating nurse during surgery.

The surgery record for patient #26 had no documentation of:

the time the patient arrived in the OR
who administered a numbing medication at the beginning of the procedure
monitors applied to the patient
the patient's position for the procedure, padding and positioning supports
the patient's condition at the conclusion of the procedure
the time the patient left the OR.

3. The intraoperative records for outpatient procedures did not reflect the same care as inpatient surgery.

Based on document review and staff interview, it was determined the hospital failed to maintain a current roster that included each practitioner's surgical privileges.

Findings:

On 12/02/13, the hospital administrative staff provided information on practitioners who had surgical privileges.

Some practitioners who had performed surgery had no documentation they had been privileged for surgical procedures.

Other practitioners had temporary privileges that were expired.

One practitioner had expired surgery privileges from December 2012.

The surgery department did not have a current list of practitioners with expired, suspended or revoked privileges.

Based on document review and staff interview, it was determined the hospital failed to ensure current policies, based on nationally recognized standards, were available to the surgical services department.

Findings:

On 12/02/13 and 12/03/13, the policies and procedures for surgical services were reviewed. The policies were not current and lacked documentation they were based on nationally recognized standards.

The policies and procedures for the operating room did not include all the policies required by regulation.

There were no policies and procedures to govern the pre-operative and post-operative care areas.

There were no policies specific to the care of pediatric patients.

The OR manager stated work needed to be done on the policies.

Based on record review and staff interview, it was determined the hospital failed to ensure properly executed informed consents were provided prior to surgery.

Findings:

Staff was asked to provide a policy that governed informed consents for surgery or other procedures. They stated they did not have one.

Thirteen clinical records were reviewed for patients who had surgical or other procedures that required informed consent. 13 of 13 records had consent forms that were executed improperly.

1. Surgical consents were written in a manner the patient was not likely to understand.

Medical abbreviations were used to identify the procedure to be performed. For example, "EGD" rather than "esophagogastroduodenoscopy" or "Lap Chole" rather than "laparoscopic cholecystectomy" or "LESI" rather than Lumbar Epidural Steroid Injection."

The consent form for patient #17 documented the procedure as, "epidural-lumbar Transforaminal Right C-arm - contrast & IV sedation."

The consent form for patient #15 documented the procedure as, "LESI fluro contrast IV sedation and Bil S1 joint areas for Trigger points."

2. Some informed consent information written by staff was illegible to patients. Some consents had information that was scratched out and written over.

3. Persons other than the surgeon documented they explained the surgical procedure and the risks and benefits to the patient.

The record for patient #26 documented a respiratory therapist signed the consent form on the line indicating that he/she was the person who explained the risks and benefits of the surgical procedure to the patient, not the surgeon.

4. Surgical consents forms did not always document a witness signature, date and time.

5. The hospital had two different blood consent forms. One form had no line for a witness signature/date/time, and therefore was not witnessed. The other form had the witness line with a date, but it was not completed.

6. The informed consent was not written as ordered.

The record for patient #16 had an order for the informed consent to document, " LESI-fluro contrast." The consent documented, "LESI." The patient had fluoroscopy with contrast.

The record for patient #20 had an order for consent for a vaginal hysterectomy and cystoscopy. The consent form documented, "hysterectomy, vaginal/laparoscopic/abdominal."
Cystoscopy was not included on the consent. The surgery included cystoscopy.

7. Some informed consents had no signature by the physician or the practitioner who was to perform the procedure.

8. The hospital did not require patients to sign consent for conscious sedation, so this was not documented on the majority of records for patients who received conscious sedation.

Based on clinical record review and staff interview, it was determined post-operative care was not provided according to acceptable standards of practice for seven (#14, 15, 16, 17, 18, 20 and #26) of seven records reviewed for post-operative care.

Findings:

Clinical records were reviewed for post-operative care.

1. Patient #14 had a pain management surgical procedure. A dictated procedure note documented, "... He was returned to the outpatient area where he was monitored for approximately 15 minutes..."

The nurse's notes documented the patient was monitored for 13 minutes after the procedure. The post-operative nursing assessment documented, "... 11:25 a.m.... Alert and oriented. [Respirations] even, non-labored... 11:42 a.m.... [Patient] ambulating [without] difficulty..." No other assessment was documented. No vital signs were documented in the recovery period.

2. Patient #15 had a pain management surgical procedure. The only assessment of the patient's condition in the recovery period documented, "... Good leg strength [no] pain at this time. Alert/oriented..." No other assessment was documented. No vital signs were documented in the recovery period.

3. Patient #16 had a pain management surgical procedure. A dictated procedure note documented, "... He was returned to the outpatient area where he was monitored for approximately 30 minutes..."

There was no post-procedure care and monitoring documented by the nursing staff.

4. Patient #17 had a pain management surgical procedure. A dictated procedure note documented, "... He was returned to the outpatient area where he was monitored for approximately 20 minutes..."

The nurse's notes documented the patient was monitored for 5 minutes after the procedure. The post-operative nursing assessment documented, "... 11:45 a.m.... Alert and oriented. States pain is less... 11:50 a.m.... Discharge home..."

No other assessment was documented. No vital signs were documented in the recovery period.

5. Patient #18 had a surgical procedure with anesthesia that lasted one hour and 48 minutes. The patient was in the recovery room for only 17 minutes before transferring to an outpatient room.

6. Patient #20 was in the recovery room for only 42 minutes after general anesthesia and surgery that lasted 3 hours and 15 minutes. The recovery room record did not document a comprehensive assessment by the RN. There was no documentation of the presence or absence of bleeding.

7. The clinical record for patient #26 documented the patient was in the recovery room for only 31 minutes after a laparoscopic cholecystectomy with general anesthesia.

There was no documented comprehensive physical assessment performed in the recovery room, to include the presence or absence of bleeding, the condition of dressings, if any, and assessment of the surgical site.

8. None of the surgery patients had documentation of cardiac rhythm, the patient's airway status or breathing pattern.

9. There was no documentation of the patient's condition at the time of discharge from recovery and no documentation of where the patient went after recovery.

10. The staff stated the hospital had no policy and procedure to specify transfer requirements to and from the recovery room and no policy related to patient assessment and care during the post-anesthesia/analgesia period.

11. Inpatient and outpatient surgical patients were not afforded the same post-operative care. The staff did not utilize the same process for both types of patients, recovery forms were not used for outpatients, and the assessment parameters for both types were different.

Based on record review and staff interview, it was determined the hospital failed to provide an operating room register with all the required elements.

Findings:

On 12/02/13, the operating room register was reviewed. The following elements were missing:

1. The surgeon was not identified as an MD or DO.
2. Scrub techs and circulating nurses were not clearly identified with a title, i.e., CST, ST or RN.
3. The anesthesia provider was not clearly identified.
4. The register did not document the patient's age.
5. The register did not identify caesarean sections as "primary" or "repeat."

The OR manager stated she was not aware of the requirements for the OR register.

Based on document review and staff interview, it was determined the hospital failed to ensure CRNAs who provided general anesthesia, regional anesthesia, monitored anesthesia and deep sedation/analgesia were supervised by the operating practitioner or an anesthesiologist.

Findings;

On 12/03/13, the CEO stated the hospital had not established the requirement for supervision of CRNAs by the operating practitioners. He stated the hospital had no anesthesiologist on staff.

There were no hospital policies and procedures that required supervision of CRNAs.

Based on document review and staff interview, it was determined the hospital failed to develop anesthesia policies and procedures that:

1. delineated pre and post anesthesia responsibilities;
2. described how anesthesia needs within the hospital would be met;
3. instructed staff on requirements for informed consent for anesthesia. The hospital did not require and consistently execute informed consent for different types of anesthesia and analgesia;
4. outlined anesthesia infection control requirements;
5. identified what safety practices were required in all areas identified as anesthetizing locations;
6. documented emergency life support protocols;
7. detailed anesthesia reporting requirements;
8. detailed anesthesia documentation requirements; and
9. established equipment requirements and monitoring, inspection, testing and maintenance of anesthesia equipment.

The OR manager stated there were no current anesthesia policies. The few policies provided had no documentation they were based on nationally recognized standards of practice.

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

1. Define in writing the scope of nuclear medicine services provided. The CEO and the radiology manager stated there was no written scope of services.

2. Appoint a qualified MD/DO as the director of nuclear medicine services. The CEO and the radiology manager stated no physician had been appointed.

3. Verify 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 policies and procedures for the preparation, labeling, use, transportation, storage and disposal of radioactive materials.

5. Determine 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.

On the afternoon of 12/03/13, the radiology department manager stated she did not know who to contact if there were problems with nuclear medicine equipment. She stated the nuclear medicine technician took care of that.

The nuclear medicine technician stated if there were problems, she would call the manufacturer and talk with the engineers.

The hospital had no policies and procedures for this and no documentation the nuclear medicine equipment was included in the biomedical program.

7. Develop, approve and implement policies related to nuclear medicine reporting requirements and a requirement for nuclear medicine reports to be stored for at least five years.

8. Ensure nuclear medicine services were provided according to on nationally recognized standards.

The radiology manager stated no qualified physician was present when nuclear medicine examinations or tests were performed. She stated the physician assigned to the emergency department would come to the department if there was an emergency. The manager was asked if the emergency physician was credentialed for nuclear medicine privileges. She stated she did not know.

An emergency cart for the radiology and nuclear medicine department had expired equipment and supplies. The department manager was unfamiliar with its contents and who was responsible for the care and maintenance of it.

The department personnel were not trained and drilled on emergency procedures.

9. Include nuclear medicine services in the hospital's QAPI program. The CEO stated the hospital did not have a current, functioning QAPI program.

Based on document review and staff interview, it was determined the hospital failed to ensure emergency services were under the direction of a qualified member of the hospital's medical staff.

Findings:

1. On the morning of 12/02/13, the chief executive officer (CEO) stated the emergency department director was a contracted physician.

The physician's credentialing file had no documentation the physician had been appointed by the governing body as the ED director.

2. There was no documentation in the medical staff meeting minutes or the governing body meeting minutes that indicated any physician had been appointed director of the ED.

3. The hospital's organizational chart did not identify an ED director.

Based on policy and procedure review and staff interview, the hospital failed to ensure the emergency department policies and procedures were current and approved by the medical staff.

Findings:

1. The emergency department (ED) policies and procedures had documentation they were last reviewed in 2010. The hospital's ED policy documented they were to be reviewed, revised, and updated every two years.

2. The ED manager stated the policies and procedures were not current.

3. Medical staff meeting minutes for 2013 had no documentation the medical staff reviewed and approved the emergency department policies and procedures.

Based on personnel record review and staff interview, it was determined the hospital failed to ensure the emergency services personnel requirements were met.

Findings:

1. Three (Staff N, O, and P) of three staff files reviewed had no documentation of current nursing licenses, basic life support, advanced cardiac life support, and pediatric advanced life support certifications.

2. None of the files had documentation of emergency department skills competencies.

3. The HR Director verified that all personnel files were complete.

Based on personnel record review and staff interview, the hospital failed to ensure staff working in the emergency department had demonstrated skills competencies.

Findings:

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

~Triage Assessment
~Intravenous (IV) insertion, accessing/de-accessing implanted central venous devices
~Venous blood draws 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.

2. On the afternoon of 12/02/13, Staff O and Staff P stated the hospital had not provided skills competency training and had not performed competency testing for nursing staff that worked in the ED. The staff verified the above skills were required in the ED.

3. Non-nursing staff were working in the ED, such as EMTs and paramedics. The medical staff had not designated what categories of staff could work in the ED and what tasks they could perform.

Based on review of respiratory policies and procedures and staff interview, it was determined the hospital's medical staff failed to develop and approve current respiratory therapy polices for all respiratory services provided.

Findings:

1. On the morning of 12/02/201,3 surveyors requested respiratory therapy policies and procedures to include the scope of respiratory services. A respiratory therapy policy and procedure binder was provided. The first page in the binder documented, "all policies in this manual have been reviewed, revised or added as new of 06/02/2010, and must be completed every two (2) years."

The staff stated there had been no current review.

Based on review of personnel files and staff interview, it was determined the hospital failed to ensure respiratory services/procedures were administered by trained staff.

Findings:

1. On the morning of 12/02/2013, staff O and staff P stated the emergency department staff provided nebulizer breathing treatments when the respiratory therapists were busy or not available.

2. Personnel files for emergency department staff O and staff P were reviewed. The personnel files contained no documentation of respiratory therapy training and competency evaluation.

3. The respiratory therapy director stated she was unaware emergency department staff did this.

Based on hospital document review and staff interview it was determined the hospital leadership failed to ensure infection control problems were addressed through the QAPI committee.
Findings:
1. On the morning of 12/02/2013 hospital administrative staff was asked to provide the current QAPI plan and meeting minutes. No QAPI plan or meeting minutes was provided.
2. Hospital administrative staff verified that there was no current QAPI plan.