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, 0119, 0121, 0123, 0145, 0162 and 0196.

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.

3. The hospital's governing body failed to ensure nursing services were organized, personnel were qualified and deemed competent and a registered nurse supervised and evaluated the care provided by employee nursing personnel and non-hospital employee personnel providing nursing care. Also governing body failed to ensure verbal orders were used infrequently. See A Tags 0385, 0395, 0397, 0398 and 0407.

4. 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 0491, 0500, 0501, 0502, and 0505.

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, 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 governing body failed to ensure specific organ, tissue and eye procurement requirements are met. See A Tags 0884, 0885, 0886, 0887, 0888, 0889, 0890, 0891, 0892, 0893, 0940, 0942, 0943, 0944, 0945, 0951, 0956, 0957 and 0958.

8. 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. See A Tags 0940, 0941, 0942, 0943, 0944, 0945, 0951, 0956, 0957 and 0958.

Based on document review, policy and procedure review and staff interview, the hospital failed to protect and promote each patient's rights.

Findings:

a. The hospital failed to ensure that each patient or patient's representative was informed of their patient rights before starting treatment. See Tag A-0117;

b. The hospital failed to provide an established and approved process for the management of patient complaints and grievances. See Tag A-0118;

c. The hospital failed to ensure the Governing Body approved the complaint and grievance process. See Tag A-0119;

d. The hospital failed to ensure the process for submitting a complaint or grievance was clearly defined for the patient. See Tag A-0121;

e. The hospital failed to ensure that the patient was given a written notice in response to a grievance to include the steps taken to investigate the issue and the results of the process. See Tag A-0123;

f. The hospital failed to develop and implement an effective policy to protect and prevent patient abuse by staff. See Tag A-0145;

g. The hospital failed to develop and implement a restraint policy and procedure that includes seclusion. See Tag A-0162;

h. The hospital failed to provide training to staff on the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion. See Tag A-0196;

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. Review of QAPI meeting minutes for 2012 and 2013 did not have evidence of review of services provided by contract or agreement ensure quality of care and safety for patients.

2. Review of QAPI meeting minutes for 2012 and 2013 did not have evidence of review of the hospital's grievance process to identify areas of improvement to patient care and satisfaction. See A Tag 0119.

3. The hospital did not have QAPI indicators to monitor high risk/low volume processes of care and identify opportunities for improvement. Problems identified during the survey in physical environment, surgical services and infection control were not identified and monitored through the hospital's QAPI program to assure quality patient care and safety. See Tags 0700, 0702, 0714, 0722, 0724, 0725, 0726, 0747, 0748, 0749, 0756, 0940, 0941, 0942, 0943, 0944, 0945, 0951, 0956, 0957, and 0958 .

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

a. integrate nursing service into the QAPI program;

b. provide a current organizational chart for nursing services that included all areas where nursing services were provided;

c. provide job descriptions for all nursing personnel, including the chief nursing officer, the director of nursing and the surgery manager;

d. ensure registered nurses assessed and evaluated patients' health status during a conscious sedation procedure and when there was a change in a patient's condition. See Tag A-0395;

e. ensure the personnel assigned to the peri-operative areas were qualified and deemed competent to work in these areas; See Tag A-0397;

f. ensure a registered nurse supervised and evaluated the nursing care provided by non-hospital employees. See Tag A-0398; and

g. the hospital failed to ensure verbal orders were used infrequently. See Tag A-0407.

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;

b. provide emergency power and lighting in the operating room. 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. utilize and maintain facilities as originally designed. See Tag A-0722 and Life Safety Code Survey Tag K-0130;

e. ensure the physical facilities were appropriately designed and equipped for the services provided in the surgery department. See tag A-0725;

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

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

Findings:

On 10/30/13, the hospital was asked to provide the emergency preparedness plan. The plan provided was not current, had not been updated and had not been approved by the governing body.

The plan contained an emergency phone list dated 2009. The hospital had no documentation of any internal or external disaster drills for any time period.

On 11/01/13, the plant operations manager stated the hospital did not have any disaster drills last year. He stated a tornado drill was planned for this month.

Based on observation, interviews with staff and review of hospital documentation, the hospital failed to maintain an active, ongoing program to prevent, control, and investigate infections and communicable diseases to minimize infections and communicable diseases in patients and staff.
Findings:
a. The staff person identified as the infection control professional did not have training in establishing and maintaining an effective ongoing infection control program. Refer to Tag A-0748;
b. The infection control professional did not ensure the infection control policies and procedures were developed for each unit/area of the hospital. Refer to Tag A-0748;
c. The hospital did not have an ongoing infection control program that reviewed hospital practices, infections and communicable diseases. The hospital did not analyze data on these practices and infections, did not develop qualitative plans of action and did not provide follow-up to ensure corrective actions were appropriate, working and sustained. Refer to Tag A- 0749;
d. The hospital did not maintain sanitary conditions and practices within all areas of the hospital. Refer to Tag A-0749;
e. The hospital did not adhere to the Occupational Health and Safety Administration's Bloodborne Pathogens regulation at 29 CFR 1910.1030. Refer to Tag A-0749;
f. The hospital did not have documentation of a comprehensive
respiratory protection program and did not have evidence all
employees covered by the respiratory protection program were
fitted for respirators annually. Refer to Tag A-0749; and

g. The hospital leadership did not ensure infection control concerns and issues were reviewed, analyzed and shown to be corrected or resolved through the quality assessment and performance improvement process. Refer to Tag A-0756.

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

a. have and implement written policies and procedures. See Tag A-0885;

b. incorporate an agreement with an Organ Procurement Organization (OPO). See Tag A-0886;

c. incorporate an agreement with at least one tissue bank and at least one eye bank. See Tag A-0887;
d. ensure collaboration with the designated Organ Procurement Organization (OPO). See Tag A-0888;
e. ensure the individual(s) must be an organ procurement representative or a designated requestor. See Tag A-0889;

f. ensure and implement an employee training program. See Tag A-0890;
g. educate staff on donation issues. See Tag A-0891;
h. reviewing death records to improve identification of potential donors. See Tag A-0892;
i. educate staff on maintaining potential donors. See Tag A-0893.

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

a. ensure endoscopes were disinfected appropriately between patients. See Tag A-0749;

b. ensure surgical instruments and supplies were adequately sterilized according to national standards of practice. The hospital also failed to ensure sterilized materials were packaged, handled, labeled and stored correctly. See Tag A-0749;

c. provide immediate use steam sterilization. The staff stated the autoclave for the surgery department could not "flash" sterilize. See Tag A-0749;

d. avoid reprocessing single use biopsy snares. See Tag A-0749;

e. perform appropriate cleaning between surgical cases and terminal cleaning daily and periodic deep cleaning of the department. See Tag A-0749;

f. provide oversight of the contractor who provided surgical staff working in the operating room. See Tag A-0943;

g. ensure operating room staff adhered to the requirements for OR attire. See Tag A-0749;

h. maintain proper temperature, humidity, ventilation and air exchanges as required in the various areas of the surgery department. See Tag A-0726 and see the Life Safety Code survey;

i. define the scope of surgical services in writing and failed to approve the scope of surgical services through the medical staff and failed to provide an organizational chart that indicated lines of authority and delegation of responsibility that included the medical staff. See Tag A-0941;

j. ensure the surgery department was supervised by an experienced registered nurse. See Tag A-0942;

k. ensure trained surgical technologists (operating room technicians or scrub techs) served as "scrub nurses." See Tag A-0943;

l. ensure experienced registered nurses were assigned as circulating nurses. See Tag A-0944;

m. maintain a roster of practitioners with surgery privileges. See Tag A-0945;

n. develop, implement and enforce surgical policies and procedures based on current nationally recognized standards. See Tag A-0951;

o. provide all the required emergency equipment for the operating room. See Tag A-0956 and Tag A-1002;

p. ensure recovery room nurses were trained and experienced in post-anesthesia care and failed to ensure patients were adequately assessed before discharge from recovery. The hospital did not have adequate policies and procedures related to post-anesthesia care. See Tag A-0957;

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

r. remove expired surgical mesh, intravenous fluids, irrigation fluids and medications from patient use in the surgery department. See also Tags A-0500, A-0502 and A-0505;

s. limit access to the preoperative, intraoperative and recovery areas. On 10/30/13 and 10/31/13, the surveyors observed double doors propped open that were designed to restrict public access to the corridor leading into the preoperative (pre-op), intraoperative (surgery) and recovery (post-op) areas.

During the survey, visitors and various staff members entered the restricted corridor. The inner doors to pre-op, surgery and post-op were propped open as well. The public and non-authorized hospital personnel had unrestricted access to these areas, including the sterile corridor to the operating rooms. During the survey, the surgery door connecting the surgery sterile corridor to the restricted corridor remained open and unsupervised by staff for over 50 minutes. Visitors were observed walking through the restricted corridor and had free access to the surgery suite; and

t. the hospital failed to ensure surgical services was integrated into the QAPI program.

Based on document review and staff interview, it was determined the hospital failed to provide anesthesia services under the direction of a qualified MD or DO.

Findings:

1. On 10/30/13, the OR staff was asked to name the chief of anesthesia services. They stated they did not know who was designated as chief of anesthesia.

The hospital did not have documentation a qualified MD or DO had been appointed to this position. The hospital did not have an organizational chart for anesthesia services.

2. The hospital was not prepared for a malignant hyperthermia emergency. The hospital had inadequate anesthesia-related policies and procedures. See Tag A-1002.

3. The hospital failed to ensure post-anesthesia evaluations were conducted according to current standards of practice. See Tag A-1105.

Based on medical record review and staff interview, it was determined the hospital failed to ensure that each patient or patient's representative was informed of their patient rights before starting treatment. This occurred in 13 of 31 medical records reviewed.
Findings:
1. Review of 31 medical records showed no documentation of patient rights being given to patients prior to treatment.
2. Staff W was asked if patients were given their patient rights upon registration. Staff W stated, "They should be on the chart."
3. Staff U stated all medical records reviewed were complete.

Based on clinical record review, policy and procedure review, observation, and staff interview, it was determined the hospital failed to establish a process for patients to lodge a grievance with the State Agency (Oklahoma State Department of Health-OSDH). This occurred in 31 (#1 through #31) of 31 clinical records reviewed.

Findings:

1. On the morning of 10/30/13, surveyors asked for all of the facility's policies and procedures including the Patient Rights policies and procedures. The hospital's Patient Rights policy and procedures did not address patients being able to contact the State Agency directly to lodge a grievance. The Patient's Rights policy and procedure did not correctly define complaints and grievances.

2. On the morning of 10/30/13, surveyors asked for the patient rights handouts and admission packet. There was no documented evidence in the Notice of Privacy Practices handouts that patients were given the State Agency contact information, including the Oklahoma State Department of Health (OSDH) website, for lodging complaints and grievances.

There was no documented evidence in the Rights and Responsibilities of Patients handouts that patients were given complete State Agency contact information for lodging complaints and grievances.

3. Surveyors observed on the morning of 10/30/13, a document titled, "Rights and Responsibilities of Patients" posted in the lobby which contained contact information for a State Agency for filing grievances, but the contact information was not for OSDH.

4. 11/01/13 at 11:40 a.m., Director of Quality (DoQ) informed surveyors that there is no system in place to track complaints; if staff does not inform her of issues, the facility doesn't know about it.

5. The surveyors verified these findings with the Chief Executive Officer (CEO) and DoQ at the time of review.

Based on observation, staff interview, and document review, there is no evidence that the hospital has an established process for prompt resolution of patient grievances. There is no evidence that the governing body and Quality Assessment Performance Improvement (QAPI) process reviewed, analyzed, and resolved grievances.
Findings:
1. On the morning of 10/30/13, hospital administrative staff was asked to provide evidence of governing body meeting minutes and Quality Assessment Performance Improvement (QAPI) grievance meeting minutes. Administrative staff did not produce any supporting governing body meeting minutes and QAPI meeting minutes containing evidence of review, analysis and resolution of grievances. Administrative staff was given multiple opportunities throughout the survey to provide supporting documents. None were provided.

2. On 11/01/13 at 11:40 a.m., the Director of Quality (DoQ) informed surveyors that there is no system in place to track complaints. She stated, "If staff does not inform her of issues the facility doesn't know about it." Staff V was asked if there was documentation of analysis and trending of grievances and reports of the findings to any other committee. She stated there was not.

3. A hospital policy, titled "Rights and Responsibilities of Patients" documented, "... When possible a grievance will be promptly remedied or if not, a written response will be sent to complainant within 30 business days of receipt of complaint ..."

Based on document review, observation, and staff interview, the hospital failed to ensure a clearly explained procedure for the submission of a patient's written or verbal grievance.

Findings:

1. Administrative staff was asked multiple times throughout the survey for a copy of the grievance policies and procedures, none were provided.

2. Surveyors asked staff to verbalize what a complaint and grievance are and how to submit grievances.

Six (N, O, P, R, V, and W) of six staff were unable to verbalize what a complaint and grievance are. None were able to verbalize how a patient would submit a grievance.

Based on record review, policy and procedure review and staff interview, it was determined the hospital failed to respond to patient grievances in writing to include all the required elements.

Findings:

1. Administrative staff was asked multiple times throughout the survey for a copy of the grievance policies and procedures, none were provided.

2. A hospital document titled, "Rights and Responsibilities of Patients" documented, "...When possible a grievance will be promptly remedied or if not, a written response will be sent to complainant within 30 business days of receipt of complaint..."

3. On 10/30/13, three grievances reports were reviewed for a period from January 2013 through October 2013. 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 interview it was determined the hospital failed to have methods in place to ensure patients are free from all forms of abuse, neglect, or harassment. The hospital did not have policies and procedures with the required components in place for an effective mechanism to protect patients from all forms of abuse, neglect or harassment from staff, other patients or visitors.
Findings:
1. On the morning of 10/30/2013 hospital administrative staff was asked to provide the policy and procedure on abuse. No abuse policy was provided.
2. Again on the morning of 10/31/2013, hospital administrative staff was asked to provide the policy and procedure on abuse. No abuse policy was provided. The Chief Executive Officer stated that the hospital has no policy on abuse but they are looking into implementing one.

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 10/30/13, administrative staff was asked to provide the hospital's seclusion and restraint logs. No seclusion log was provided.

2. On the morning of 10/30/13, Administrative Staff was asked to provide the hospital's policies and procedures on seclusion. None were provided.

3. On the afternoon of 10/30/13, surveyors were provided a document titled, "Pauls Valley General Hospital ...Rights and Responsibilities of Patients" that documented, "...The patient has the right to be free from seclusion..."

4. Surveyors asked the CEO to provide seclusion logs and policies and procedures. The Chief Executive Officer (CEO) stated the hospital did not utilize seclusion and did not have a policy and procedure. The CEO 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 policy and procedure review, personnel file review and staff interview, the hospital failed to provide training to staff on the application of restraints, implementation of seclusion and restraint and monitoring, assessing, and providing care for a patient in restraint or seclusion. Twenty of 20 personnel files reviewed contained no documentation of staff training or competencies on the use of restraints or seclusion.
Findings:
1. A policy obtained from the nursing policy and procedure manual titled "Restraints" documented, ..."All nursing staff that have direct patient contact must receive orientation, ongoing education/training and demonstrate competency in the proper and safe use of restraint application and techniques, seclusion and alternative methods for handling behavior..."
2. Staff O and staff R were asked if restraints were used in the Emergency Department and to identify the restraints used. Staff O and staff R stated that soft and leather wrist and ankle restraints were both used.
3. On the afternoon of 10/30/2013 staff P stated, "I have only been here three weeks and I have not completed my orientation and training. "
4. On the afternoon of 10/30/2013 staff O and staff R stated that the hospital had not provided any training or competencies on the use of restraints or seclusion.

Based on clinical record review and staff interview, it was determined the hospital failed to ensure registered nurses assessed and evaluated patients' health status during a conscious sedation procedure and when there was a change in a patient's condition. The hospital also failed to ensure nursing staff documented a patient assessment at the time of discharge.

Findings:

1. The clinical record for patient #26 documented the patient received conscious sedation by a registered nurse. The nurse did not document the patient's skin color, the patient's temperature, the status of the patient's EKG, the patient's pain level or the patient's level of consciousness at any time during conscious sedation.

2. The clinical record for patient #31 documented the patient had a sudden change in condition while in the pre-op area. There was no documentation of a thorough patient assessment. The nurse documented chest pain, but did not describe the pain or it's intensity. There was documentation of only one blood pressure reading before the patient was transferred to the emergency department. There was no documentation of any other vital signs taken or assessment of the patient's condition at the time of transfer.

3. The clinical record for patient #34 had no documentation of the patient's status, to include a physical assessment, at the time of discharge. There was no documentation the patient was discharged and where the patient went.

3. The CNO stated she could not explain why further assessment was not documented.

Based on record review and staff interview, it was determined the director of nursing and the chief nursing officer did not ensure the personnel assigned to the peri-operative areas were qualified and deemed competent to work in these areas.

Findings:

1. The employment file for the surgery department manager had no documentation the surgery manager was experienced and qualified for this position. There was no documentation of how much OR experience this RN had before she assumed the surgery manager position. There was no documentation of prior supervisory or management experience. The RN stated she got all of her surgery experience at this hospital.

The file had no documentation of previous performance evaluations when working as an OR circulator. There was no documentation of training, experience and evaluation as a scrub nurse. There was no documentation of training, experience and evaluation for sterile processing job functions.

The file had no documentation the RN had been trained and deemed qualified to provide conscious sedation or qualified to oversee the nurses who provided this.

The surgery manager stated she also had oversight of pre-operative and post-operative care. The file had no documentation of training and experience in these areas. The file had no documentation of surgery-specific annual training or continuing education related to surgery.

2. A registered nurse who provided conscious sedation to surgery patients had no documentation of specialized training, experience and competency evaluation for this task. The employment file had no documentation of training and orientation to the OR and the related policies and procedures.

The medical record for patient #26 documented the patient received conscious sedation by this RN. The record had inadequate documentation of this procedure. There was no documentation of the patient's skin color, EKG, pain or level of consciousness. The nurse did not sign the documentation.

3. The employment file for the RN identified as the full-time OR circulator had no documentation of surgery experience before coming to work at the hospital. The file had no documentation of orientation and training for the OR. There was no documentation of competency evaluation. There was no documentation of annual surgery-specific training or of any continuing education related to surgery.

4. The employment file for the person identified as the full-time scrub tech had no documentation of previous experience in the healthcare field. There was no documentation of formal training or certification as a scrub tech. The last performance evaluation was done in 2011.

This person was also responsible for surgical instrument processing. There was no documentation of training and previous experience for this position. There was no documentation of performance evaluation for this job. The surveyors observed the scrub tech had set up endoscope processing in the OR janitor's closet and that other sterilization practices were not performed correctly.

The file had no documentation of annual surgery-related training or of continuing education.

Based on hospital document review and staff interview, it was determined the hospital failed to ensure a registered nurse supervised and evaluated the nursing care provided by non-hospital employees.

Findings:

1. On the afternoon of 10/30/13, emergency department Staff O and Staff R told the surveyors when they were short staffed, needed help, or couldn't successfully complete a procedure, they called the ambulance crew to come to the ED and help.

Staff O and Staff R told the surveyors the ambulance crew assessed patients' vascular access and started IVs. They stated the ambulance crew also assessed patients' respiratory status before and after they gave breathing treatments.

The staff stated the ambulance crew at times provided the same nursing care tasks on the inpatient units. The staff did not say the ambulance crew was supervised by registered nurses.

2. The CEO stated contract scrub techs worked in surgery. They stated the techs scrubbed in on eye surgery cases and performed some eye instrument processing tasks. The OR staff stated they were uncertain about what these techs were allowed to do. The OR staff was asked who supervised the contract scrub techs. They stated they did not know.

3. The hospital did not have a policy and procedure that required a registered nurse to supervise and evaluate the care provided by non-hospital employees.

4. There was no evidence the medical staff defined and approved the role and the scope of practice for the ambulance crew who provided direct patient care. There was no documentation the medical staff defined and approved the role and scope of practice for the contract scrub techs.

5. There was no documentation the non-employees who provided direct patient care were oriented to the areas where they were assigned. There was no documentation their clinical activities were evaluated.

6. The hospital allowed non-employee scrub techs to work in the surgery department. There was no documentation the techs were trained and qualified for this work. There was no documentation of orientation to the OR and to the related policies and procedures.

7. The hospital allowed non-employee ambulance crew members to provide direct patient care. There was no documentation of their training and qualifications to do so. The staff could not identify their status to say they were EMTs, paramedics or simply an ambulance driver.

Based on record review, document review, and staff interview, the hospital failed to ensure verbal orders were used infrequently and documented and authenticated as required for 22 of 31 medical records reviewed.
Findings:
1. On the morning of 10/30/13, administrative staff was asked to provide the hospital's verbal orders policies and procedures. None were provided.

2. Medical records (#4, 7, 10, 11, and 16 through #25) reviewed had multiple documented frequent verbal orders entries. There was no documentation the nurses conducted a read-back verification for the verbal orders. There was no authentication by the physician.

Medical records (#16 and #17) reviewed had documented verbal physical therapy (PT) orders; occupational therapy (OT) orders; and speech therapy (ST) orders. There was no documentation the nurses conducted a read-back verification for the verbal orders. There was no authentication by the physician.

3. On the afternoon of 11/01/13, surveyors asked nursing staff how often verbal orders were used. Staff M stated, "We use verbal orders most of the time as physicians are not in the facility."

4. On the afternoon of 10/30/13, administrative staff provided a document titled, "Medical Staff Bylaws, Rules and Regulations" that documented, "...Orders dictated over the telephone shall be signed, timed and dated by the person to whom dictated with the name of the physician per his/her own name. The order shall be signed, timed and dated by the physician at his/her next visit, however not later than 48 hours..."
Two current swing bed records documented verbal admission orders did not have read-back verification. Both swing bed records documented admission dates of more than thirteen days past the initial verbal admission orders and had not been authenticated by the admitting physician .
5. Review of Medical Staff and Quality Assessment Performance Improvement meeting minutes did not include any review of medical records for appropriate use and frequency of verbal orders.
6. ???The Medical Records Director and Chief Executive Officer (CEO) verified findings at the time of review.

Based on review of medical records, hospital documents, and staff interviews, the facility failed to ensure all verbal orders were signed by the physician with the date and time of the signature. This occurred in 23 (#1 through 5, #7, and #9 through #25) of 31 medical records reviewed for order completeness. The hospital also failed to ensure the receiver of physician's orders dated, timed and signed the orders as noted and carried out for six
(#26 through #31) of six records reviewed for physician's orders.

Findings:

1. On the morning of 10/30/13, administrative staff was asked to provide the hospital's verbal orders policies and procedures. None were provided.

2. On the afternoon of 10/30/13, administrative staff provided a document titled, "Medical Staff Bylaws, Rules and Regulations" that documented, "...Orders dictated over the telephone shall be signed, timed and dated by the person to whom dictated with the name of the physician per his/her own name. The order shall be signed, timed and dated by the physician at his/her next visit, however not later than 48 hours..."
Two (#16 and 17) of two current swing bed records documented verbal admission orders that did not have read-back verification. Both swing bed records documented admission dates of more than thirteen days past the initial verbal admission orders and the orders were not dated, timed, and authenticated by the admitting physician.

3. Medical records (#1 through 5, 7, and 9 through 25) reviewed had multiple documented frequent verbal orders entries. There was no documentation the nurses conducted a read-back verification for the verbal orders. There was no documentation that verbal orders were dated and timed by the physician.

4. The clinical records for patients #26 through #31 had physicians' orders that were not signed, dated and timed when received by the nurse.

Based on clinical record review, policy and procedure review and staff interview, it was determined the hospital failed to ensure surgery patient records contained documentation when medications were administered, documentation of implants that were used and documentation of all healthcare workers who were present during surgery.

Findings:

1. Patient #27 had cataract surgery. Pre-operative eye drops were ordered to be given. There was no documentation these medications were administered. The intraoperative record had no documentation of the lens that was implanted to include the name, the type and the required identifying numbers.

2. Patient #30 had a hernia repair with a mesh graft. There was no documentation in the intraoperative record of this implanted item.

3. The OR staff stated they did not have a policy regarding documentation of implants. The OR staff was asked to provide the implant log. None was provided.

4. Patient #26 had a pain procedure with the use of a C-arm. The intraoperative record had no documentation of the radiology staff who operated the C-arm.

Based on record review, observation and interviews with hospital staff the hospital does not ensure that pharmaceutical services are administered in accordance with accepted professional principles to ensure safe and appropriate use of medications. The pharmacist does not ensure oversight of all pharmacy/drug room services such as procurement, distribution and control of all medication products used in the hospital.

Findings:

1. Drugs and medications stored in the operating room areas are not monitored for outdates and proper storage by the hospital's pharmaceutical service. Staff BB stated on October 31 in the morning that pharmacy/drug room staff do not go into the surgical department to inspect the drugs stored there. See Tags A 500 and 505.

2. Drugs and biologicals are not stored in a secure area. See Tag A 502.

3. Drugs provided for patients are not always compounded, labeled and dispensed by pharmacists or pharmacist-supervised personnel. See Tag A 0501.

4. Review of 2 (BB & CC) of 2 pharmacy/drug room personnel files did not have evidence of job descriptions.

5. One (BB) of two pharmacy/drug room personnel files did not have evidence of performance evaluation by the pharmacist.

Based on observation, policy and procedure review and staff interview, it was determined the hospital failed to periodically inspect all areas where medications and biologicals were stored in the surgery department.

Findings:

On 10/30/13 and 10/31/13, the following observations were made of the surgery department:

1. Medications were found in numerous places, cabinets, drawers, closets, shelves. The staff stated there was not an identified medication room or central location for medication storage in the surgery department.

2. Normal saline intravenous solution and normal saline irrigation solution was stored in a warming cabinet. The surgery staff did not monitor the temperature of this cabinet to ensure temperatures did not exceed an acceptable range. The OR staff were not aware fluids for intravenous use and surgical wound irrigation could not be stored in a warmer indefinitely and then used safely on patients.

3. In the operating rooms, internal and external medications were stored together.

4. A 10,000 unit dose of heparin was found on a shelf in one of the operating rooms.

5. The OR did not have a refrigerator for medications. Refrigerated anesthesia medications were stored in the recovery room.

6. The OR staff stated the pharmacy did not come into the OR to inspect or inventory medications.

7. The OR staff was asked who was responsible for medication storage in the department. They stated no one was assigned to do this.

8. The surgery department had no policies related to the storage of medications and biologicals. The department did not have a policy regarding safely warming IV solutions and irrigation fluids.

Based on record review and interviews with hospital staff, the hospital does not ensure all compounding, packaging and dispensing of drugs/medications are under the supervision of a pharmacist and performed consistent with State and Federal laws. Review of repackaging logs did not have evidence a pharmacist reviewed the drugs which had been repackaged by non-pharmacist personnel before distribution to patients. Some intravenous antibiotics are mixed by unlicensed personnel without the supervision of a pharmacist and dispensed to patients.

Findings:

1. Staff BB a non-licensed staff member stated on 10/31/13 in the morning she would mix intravenous antibiotics that are not available in a premixed piggyback and send them to the floor for a nurse to give. The hospital has a drug room and does not have a pharmacist available all the time.

2. The hospital has transitioned from a drug room with a full-time pharmacist to a drug room with a consultant pharmacist.

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

Findings:

On 10/30/13, an unlocked anesthesia cart that contained propofol and other medications was found unlocked when the surgery department was closed.

Surgery staff stated they did not know why it was unlocked and that the anesthesia staff were responsible for ensuring it was locked.

On 10/31/13, a CRNA was observed preparing intravenous medications for a surgical case. The CRNA placed the prepared medications on top of the anesthesia cart and then left the operating room. No other staff was present in the room to ensure the medications were secure.

The OR door was propped open. In addition, the adjacent door that exited to a semi-restricted corridor was propped open. Visitors and non-authorized staff were observed walking past this door. These persons potentially could have entered the OR unobserved.

No OR staff was present for over 30 minutes while the medications were unsecured.

An unsecured prescription pad was found lying on a desk in the OR sterile corridor.

The surgery department had no policies related to the security of medications in the OR.

Based on observation, policy review and staff interview, it was determined the hospital failed to ensure expired or unusable medications and biologicals were not available for patient use in the surgery department.

Findings:

On 10/30/13 and 10/31/13, the surveyors made the following observations in the surgery department:

1. Expired medications and biologicals were found in the operating rooms, in medication carts, in fluid warming cabinets and in the department's crash cart. The expired items included:

normal saline intravenous solutions and irrigation fluids
sodium bicarbonate for injection
saline flushes

2. Previously opened vials of medications were found in various locations, including the anesthesia carts. The vials were not dated when they were opened and/or not dated when they should be discarded.

3. Intravenous fluids and sterile irrigation fluids placed in the warming cabinets were not dated as to when they should be discarded. The staff stated they were not aware these items would expire when placed in a warmer. They did not know the acceptable length of time they could be stored in a warmer. The department did not have a policy to address this.

4. The circulating nurse was asked who was responsible for checking for expired medications and biologicals in the department. She stated, "No one person is assigned to do this, but I guess all the nurses should be doing this."

5. On 10/30/13, the surveyors found expired IV fluids in the department's crash cart. The surveyors notified the circulating nurse. On 10/31/13, the IV fluids had not been removed from the crash cart.

5. The surgery department did not have a policy regarding expired medications, use of previously opened medications and dating medications when opened or stored in a warming cabinet.

6. The OR staff stated the pharmacy staff did not enter the OR to check expiration dates of medications.

Based on record review, policies and procedures, and staff interview, it was determined the hospital failed to provide daily clinical oversight and supervision of nutritional services by a certified dietary manager (CDM).

Findings:

1. State Hospital Licensure Standards Chapter 667, subchapter 17 requires either a full time dietician or a certified dietary manager to supervise nutritional services.

2. On the morning of 10/30/13, surveyors asked administrative staff to provide the names, personnel files, and competencies of the facility's registered and licensed dietician (RD/LD) and certified dietary manager (CDM).

On the afternoon of 10/31/13, Staff N told surveyors the facility had a consultant dietician who came to the facility once a week and did not have a CDM. Staff N also stated that the chief executive officer (CEO) is currently overseeing the administrative functions of dietary.

The CEO verified that the facility does have a consultant dietician that comes to the facility once a week. She further told surveyors that the facility does not have a CDM. The CEO told surveyors she has had no qualifications in dietary but had been overseeing administrative functions of dietary.

3. Personnel records for dietary services personnel were reviewed for evidence of education, competencies, and food handler certification. None of the records had this documentation.

Based on observation and interview, it was determined the hospital failed to provide the operating room suites with two sources of power. The operating rooms had only one source of power.

The hospital did not provide battery back-up lighting for the operating rooms.

On 10/31/13, the plant operations manager confirmed these findings.

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

Findings:

On 10/30/13, staff member C was asked by the surveyor the purpose of the Line Isolation Monitor Remote Alarm located on the wall in the operating room. She did not know the purpose of the equipment. She stated she thought it was a medical gas alarm.

A review of training files for the operating room staff had no documentation of training on all aspects of fire safety preparedness including:

~ the location of zone valves of nonflammable medical gas systems and the station outlets controlled by each valve
~ the location of electrical service boxes and the areas they served
~the location and proper use of fire extinguishers
~the designated methods and routes for evacuating patients from the OR
~the location of fire alarm boxes, or knowledge of other methods for summoning the fire department

There was no documentation the OR staff had conducted a fire drill within the department to evaluate and train for the fire hazards that could be encountered during surgical procedures.

Based on observation and staff interview, it was determined the hospital failed to utilize and maintain the areas within the surgery department as they were originally designed.

Findings:

On 10/30/13 and 10/31/13, observations were made of the surgery department.

1. The instrument decontamination room was not located within the surgery department and was not accessible to staff working in surgery. The only connection was a pass-through window between the sterile core and the decontamination room. The door to the decontamination area was located off a public hallway and not in a semi-restricted hallway.

This configuration would function only when a staff person was assigned to work in decontamination and never had to travel in and out of this area, i.e., never go into surgery or into the sterile processing area.

As the surgery department was functioning at the time of survey, no staff was dedicated solely to the decontamination room. Instead, surgery staff were required to work in surgery and also work in the decontamination room. This meant staff traveled back and forth between the two areas frequently throughout the day. There was no process or a defined area where staff could cover their surgical attire with an impervious gown before exiting surgery so that they could enter decontamination without contaminating the surgical attire.

There was no defined area where staff who had been in decontamination could remove the cover gown, discard it, wash their hands and then replace their hair covering and shoe covers before returning to surgery. There was no dedicated handwashing sink provided in the decontamination room. The staff used the instrument washing sink (a very contaminated area) for handwashing.

Because no one was assigned to work exclusively in decontamination, the surgery staff would have to repeat this process several times during the day as instruments would need to be reprocessed between patients.

During the survey, surgery staff were observed moving in and out of decontamination and in and out of surgery without adherence to the requirements for attire changes and handwashing. The staff were not provided with adequate cover gowns that protected the surgical attire while the staff worked in decontamination.

2. The sterile processing area was not accessible to surgery. The only connection was via a pass-through window. The two entrances into this area were through the decontamination room (which is against infection control requirements) or through the sterile supply room door that is also located in a public hallway(also against infection control requirements).

This configuration could function only if another staff person was assigned exclusively to the sterile processing and sterile supply areas and never required to move between this area, decontamination and the OR.

At the time of survey, the staff assigned to surgery and decontamination was also assigned to the sterile processing area. Staff were observed leaving surgery, traveling through a public hallway, going through decontamination and into sterile processing.
(The door from the public hallway into the sterile supply room was locked and not accessible to the OR staff.)

Surgery staff were asked how they retrieved sterile supplies from an area not connected to the OR. They stated they went through decontamination then into sterile processing and then into the supply room. They stated they exited the same way, carrying sterile supplies through the decontamination room.

The staff were asked how this was possible when surgery was taking place and the circulator needed to leave the OR to travel outside the department to retrieve additional supplies. The staff stated they "tried to pull two of everything so they didn't have to leave surgery to go there." They were asked what they would do if the surgeon requested something the staff had not anticipated. No reply was made.

On 11/01/13, the CEO confirmed the surgery department was configured so that personnel were assigned each to decontamination and to sterile processing and not also assigned to any other parts of the surgical department.

Based on observation and staff interview, it was determined the hospital failed to ensure critical medical equipment was regularly inspected for patient safety. The hospital also failed to store surgical equipment and other supplies in a manner to ensure quality and safety.

Findings:

On 10/30/13 and 10/31/13, tours were conducted throughout various areas of the hospital. The following observations were made:

1. Throughout the emergency department, various medical equipment had no evidence it had been inspected and determined to be safe for patient use.

The surveyors asked three ED staff members (staff O, P and R) and the chief executive officer (CEO) how they could identify the equipment was safe and ready for patient use.

They stated they did not know how to verify this because there was no documentation of a safety inspection found on the equipment itself.

Staff O verified that patient monitoring equipment, such as the portable Dynamap used in patient exam rooms had not been checked for safety.

She also verified the electrocardiogram machine had not been inspected for safety and was available to staff to be used on patients.

2. A contractor provided ophthalmology equipment to the hospital for use during surgical cases. The hospital plant manager stated this equipment was not a part of the biomedical equipment program and was not inspected by the hospital for patient safety prior to use.

3. Sterile supplies were stored in various places within the OR in a manner that subjected the items to contamination through punctures or tears through the packaging.

4. Sterile supplies were subjected to excessive heat and humidity levels as observed during the survey and as documented on hospital records of temperature and humidity in the sterile supply storage areas.

5. Sterile supplies were stored on dusty and dirty shelves.

6. Surgical equipment was not cleaned appropriately between uses. This was observed during a surgical procedure on 10/31/13 when patient monitoring equipment was not thoroughly cleaned between patient uses.

7. Vents in the OR and in other areas of the surgery department were not cleaned and allowed for air contamination of surgery equipment and supplies.

8. The linen supply room area was dirty. Clean linen was stored on racks with open shelves that did not protect it from contamination. Dirty HVAC vents were located directly over the clean linen racks.

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 in the surgery department.

Findings:

1. In the operating room, a janitor's closet was being used for endoscope cleaning and disinfecting. On 10/30/13, the surveyors were taken on a tour of the surgery department by the RN circulator. She showed the surveyors the janitor's closet and stated the endoscopes were cleaned in this room. She stated the endoscopes were washed in the utility sink and then placed in a tub of high level disinfectant that was also kept in this room. The scopes were then rinsed in the utility sink. The room did not have sufficient space to hang scopes for drying, so the staff took wet scopes into an operating room and hung them on a pole to dry.

The surveyors observed supplies and equipment necessary for endoscope processing stored in this janitor's closet, as well as supplies of general housekeeping cleaning products and stockpiles of paper towels for handwashing sinks.

The room was still being used as a functioning janitor's closet. A mop bucket was overturned in the janitor's sink. A dirty mop was nearby, as well as a broom, dust pan and a nylon hand duster. Chemicals to clean other areas of the OR were also stored in this area.

2. On the second day of survey, the staff moved endoscope processing into the surgical instrument decontamination room. The decontamination room was not designed or equipped and did not have the needed space to manage endoscope decontamination and high-level disinfection without significant risk of cross-contamination. The room did not have space to hang clean scopes to dry before storage. The staff stated they took the disinfected scopes out of the decontamination area and hung them from a pole in an operating room to dry.

3. One large room within the hospital (with the finishes and features similar to a garage) was being used as an all-purpose room. The room contained clean linen storage, dirty linen storage and housekeeping carts and housekeeping chemicals and supplies. An industrial washer and dryer was located in the this room.
Miscellaneous items not related to linens or housekeeping were also stored in the room.

There was no designation between the clean and dirty areas of the room. Dirty housekeeping carts were pushed through the clean linen area for storage in another part of the room.

The room did not have the design features to appropriately and sanitarily store clean linen. Clean linens were stored on open shelves, uncovered and exposed to dust and contaminates from a variety of sources.

The room did not have the design features to appropriately handle and process soiled linen.

Based on observation, record review and staff interview, it was determined the hospital failed to ensure proper ventilation, light, temperature and humidity control in the surgery department and other areas of the hospital.

Findings:

1. Lighting
On a tour of the surgery department, the surveyors observed the level of light in the recovery room was not sufficient for the nursing staff to adequately assess a patient's skin color, an integral part of the post-anesthesia care nursing assessment to determine adequate ventilation and oxygenation.

The plant operations manager was asked if the lights could be made brighter. He stated they could not. He stated a previous manager requested low lighting in the recovery room for patient comfort.

2. Temperature and Humidity
The surveyors noted excessive room temperatures and humidity in all areas of the surgery suites, including the operating rooms and the sterile supply room.

Records indicated the staff noted frequent excessive temperature and humidity over a period of time in various areas of the OR.

The humidity logs were not generated until May 2013. However,
the logs documented humidity levels that chronically exceeded the 60% range. There was no corrective actions taken when the humidity levels were high.

It was noted the valve controlling the humidifiers had been turned off.

3. Ventilation
a. The sterile supply room did not have positive air flow as required.

b. The soiled utility and soiled linen storage did not have exhausted air as required.

c. Soiled work areas and decontamination rooms did not have negative airflow pressure with 10 air exchanges per hour as required. The air was not ventilated directly outdoors as required.

d. The surgery decontamination room had gaps and openings between it and the sterile processing room that prevent contaminated air from being exhausted properly.

e. Fresh air intakes for the surgery department were installed two and one half feet above ground (a minimum of 6 feet is required). The fresh air intake was blocked with grass clippings from a mower.

f. The hospital did not ensure contaminated work areas and soiled storage areas maintained negative airflow and clean work areas and clean storage areas maintained positive airflow.

Based on hospital policy and procedure review, personnel file review and staff interview, it was determined the hospital failed to designate an infection control professional who was qualified and properly trained in infection control. The hospital also failed to ensure the infection control professional developed and implemented current infection control policies and procedures.
Findings:
1. A hospital wide policy and procedure obtained from the general nursing policy and procedure manual documented, " ... Infection Control Nurse: A registered nurse with at least three years clinical experience in an acute care setting, who is currently licensed in the State of Oklahoma ...[and] has had training in infection control ... "
The hospital administrator stated a respiratory therapist was designated as the infection control practitioner. She stated he had been in the infection control position since August 2013.
2. The personnel file for the respiratory therapist had no documentation of any formal infection control training or certification as an infection control preventionist.
On the afternoon of 10/31/13, the respiratory therapist verified he did not have infection control practitioner training or did not have certification in infection control prevention. He stated he was scheduled to go for his first EPIC training the next day.
3. The hospital infection control policy and procedure manual did not contain current policies and procedures. There was no evidence the policies in the manual were based on nationally recognized standards of practice for infection control prevention.
The infection control policy and procedure manual had no documentation it was approved by the Infection Control Committee and the Medical Staff.
4. The surveyors reviewed various departmental policy and procedure manuals. None of the manuals contained current department-specific infection control policies.
The infection control practitioner stated he was working on policies and procedures.

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 the high level disinfection and sterilization processes were carried out in a manner consistent with nationally recognized standards and according to manufacturer's directions;

b. ensure the surgery department provided immediate use steam sterilization ("flash" sterilization) capabilities;

c. prohibit reprocessing of disposable biopsy snares;

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

e. 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;

f. ensure staff adhered to surgical attire protocols to prevent introduction of pathogens into the clean/sterile surgical environment;

g. ensure surgical staff had access to and utilized the appropriate personal protective equipment for tasks performed in the decontamination room;

h. ensure all personnel working in surgery had proof of immunizations and regular TB skin testing;

i. monitor access to the surgery department by unauthorized personnel and prevent cross-contamination by staff movement between dirty and clean areas of the department.;

j. evaluate airflow separation from the contaminated surgical areas to the clean areas to ensure air contaminants are prevented from entering.

k. evaluate how hospital linen is processed, handled and stored to prevent the spread of infection;
l. identify and approve for use all disinfectant agents used in the hospital and did not ensure hospital staff used them correctly;
m. ensure laryngoscope blades were disinfected/sterilized, packaged and stored to protect from contamination;
n. implement relevant and active surveillance activities for infection control practices in various departments of the hospital;
o. ensure adherence to the Occupational Health and Safety Administration's Bloodborne Pathogens regulation at 29 CFR 1910.1030; and
p. the hospital failed to implement an employee respiratory protection program.
Findings:
On 10/30/13, the hospital ICP was asked if he conducted surveillance activities in the surgery department. He stated he did not. The surveyors conducted observations of the surgery department and conducted interviews with OR staff on 10/30/13 and 10/31/13.
1. Endoscopes were not processed and disinfected appropriately between patients.

On 10/30/13, the surveyors asked the OR staff to show them the room where endoscopes were processed. The surveyors were taken into the surgery department janitor's closet. The room was still being used as a janitor's closet. It had a utility sink and a drain in the floor for the disposal of dirty mop bucket water. The room contained a dirty mop bucket, a dirty mop (the mop head had not been changed from the day before), a broom, dust pail, dusters and environmental cleaning products.

The room did not have a handwashing sink.

The room and the floor was dirty, cluttered and did not appear to be cleaned on a regular basis. "Clean" supplies (such as paper towels for the surgery department) were stored on open shelves over the utility sink and well within the splash zone that allowed contaminated water to come in contact with clean items and surfaces. Several items stored in the room appeared to have evidence of splashes on them. Clean items were not protected from contamination in this room.

Soiled towels were spread out on countertops. It did not appear the towels were removed between cases or at the end of the day so that the countertops could be disinfected as needed.

The OR staff stated contaminated endoscopes were washed and rinsed in the utility sink and then were placed in a tub of disinfectant solution that was stored in this room. The scopes were then taken out of the disinfectant and rinsed in the same utility sink.

The plastic tub containing the high level disinfectant (Revital-Ox Resert XL HLD) was dated to expire 28 days after it had last been changed. The staff verified the solution was changed every 28 days.

According to the manufacturer's directions for use, the solution should be changed at a "maximum of 21 days, provided the required conditions of... concentration and temperature exist based on monitoring..."

The manufacturer's directions did not include Clostridium difficile in the list of organisms killed by Revital-Ox.

The surveyors observed bottles of Revital-Ox that were not dated when opened as required by the manufacturer.

On 10/31/13, the surveyors observed the OR staff process an endoscope. On this day, the staff stated the scopes were now going to be processed in the surgical instrument processing room.

The staff initially washed the scope in an average-size single sink. The sink was not wide or deep enough to allow for adequate scope washing and to minimize splashing outside of the sink. The washing process took about five minutes. During this process, the surveyors observed the staff was also washing a disposable biopsy snare. The staff stated the department routinely reprocessed biopsy snares. She stated, "We were told we could do this."

The department had no policy and procedure for reprocessing biopsy snares. There was no documentation the medical staff had approved reprocessing disposable biopsy snares.

After washing, the staff drained the sink and filled it with rinse water. (The wash sink and the surrounding countertops, was not and could not, be cleaned/disinfected before adding rinse water, thus allowing for recontamination of the scope after washing.) The staff did not utilize the separate rinse sink that was located out of the splash zone from the washing sink and that should have been disinfected and ready for the clean rinsing process. In addition, the rinse sink was not wide enough and deep enough to process endoscopes and to minimize splashing.

After rinsing, and without drying the endoscope and ensuring all excess water was removed from the channels, the staff placed the scope in the high level disinfectant agent. (According to the manufacturer, failure to remove excess water from the channels and dry the outside of endoscope allows the disinfectant to become diluted, and therefore ineffective.)

The staff was asked if the disinfectant had been tested for adequate temperature and strength prior to immersing the scope for disinfection. She stated it had not. She stated she was not the person who normally processed endoscopes. She stated it had been a number of months since she performed this task and was just doing what she had been taught.

She was asked if the temperature of the solution was monitored throughout the immersion time. She stated she wasn't sure about that.

She was asked if this scope was to be used on the next patient. She stated it was.

At this point, the surveyors notified the physician for the next case that there could not be assurances the endoscopes were adequately disinfected. The physician asked if another staff person could assist with the scope processing. The circulating nurse then came to the decontamination room. The other staff person told the circulator they needed to test the disinfectant for adequate strength. The circulator was not familiar with how to do that.

The physician was informed the circulator did not appear to be proficient in scope processing. He elected to cancel the remaining endoscopy cases for the day.

The staff was asked to provide endoscope processing records for the previous six months. The only records provided were for October 2013.

The records failed to show evidence the scopes had been appropriately processed in the past.

The records did not contain the required documentation to substantiate adequate processing to include:

~the identification number of the scope that was processed
~testing of the disinfectant for correct strength (pass/fail) before each scope was processed
~length of time the scope was immersed in the disinfectant
~dates and times when the disinfectant was changed
~final alcohol rinse of the scope chambers to facilitate drying

In addition, the records documented the disinfectant temperature was always 70 - 71 degrees, although the room temperature varied widely from these numbers. The hospital had no mechanism, such as a warming device or other method, to ensure the solution stayed warm enough throughout the cycle to provide adequate disinfection.

The hospital did not have policies and procedures for endoscope processing that aligned with all manufacturers' recommendations.

2. Endoscopes were not stored in a manner to prevent recontamination.

On 10/30/13 at 9:30 a.m., the surveyors observed endoscopes hanging from a pole in the procedure room. The OR staff was asked why the endoscopes were hanging there. They stated, "The tech probably hung them there to dry." The staff was asked how long the scopes had been hanging there. The staff stated, "Since yesterday." The scopes were not stored in the designated enclosed cabinet that was designed to protect the scopes from contamination after they were cleaned.

The surgery department did not have a policy and procedure in place for reprocessing scopes that had not been used for five days or longer.

The scope cabinet had soiled towels in the bottom. "Clean" scope parts were stored in the bottom of the cabinet underneath the hanging scopes and were potentially exposed to draining water coming out of the scopes.

The hospital did not have a policy related to storage of endoscopes.

3. Laparoscopic instruments (classified as critical devices) were not processed appropriately prior to patient use.

On 10/30/13, the OR staff stated the hospital did not have an ethylene oxide or peroxide gas plasma sterilizer. They were asked how laparoscopic devices that could not be steam sterilized, but could be sterilized with ethylene oxide or peroxide gas plasma, were processed.

They stated the equipment was soaked in the high level disinfectant (Sklar-Cide 28 HLD 3% Glutaraldehyde) for at least 10 hours. The staff stated the disinfection process was carried out in the janitor's closet. A tub with the disinfectant was observed in this area.

The staff stated the device was then removed from the solution, taken into the OR and rinsed once in sterile water. They said the instrument was then ready for placement on the sterile field. The staff verified the equipment was rinsed only once in the OR under sterile conditions.

According to the manufacturer of the disinfectant, "... Contraindications... Sterilant Use: Routine biological testing is not feasible with Sklar-Cide 28 HDL 3% Glutaraldehyde and therefore should NOT be used to sterilize reusable medical devices that are compatible with other available methods of sterilization that can be biologically monitored, e.g.: heat, ethylene oxide or peroxide gas plasma..."

In addition, the manufacturer's instructions documented, "... 3% Glutaraldehyde is a liquid chemical sterilant when used or reused according to directions for use, at or above the Minimum Effective Concentration of 1.8% for a maximum of 28 days at 25 degrees Celsius (77 degrees Fahrenheit) with an immersion time of at least 10 hours..."

The staff could not produce documentation of records for this process to include the solution was monitored for temperature. The hospital had no mechanism to ensure the solution remained at 77 degrees F for the duration of the 10 hour immersion time.

The manufacturer's instructions further documented, "... Remove equipment from the solution using sterile techniques and rinse thoroughly with sterile water... immersing it completely in three separate copious volumes of water. Each rinse should be a minimum of 1 minute duration... use fresh portions of water for each rinse...."

There was no documentation the staff rinsed the laparoscopic instruments three times as directed.

In addition, the hospital failed to process the laparoscopic devices according to manufacturer's instructions because they used glutaraldehyde as a sterilant that was not recommended for these devices. In addition, the hospital failed to follow the instructions for the use of glutaraldehyde as a sterilant.

The hospital had not policies related to laparoscopic device processing.

4. The hospital could not demonstrate surgical instruments were appropriately cleaned and steam sterilized according to national standards of practice.

On 10/31/13, the surveyors observed a plastic tub containing a contaminated endoscope on the pass-through counter top between the OR and the instrument decontamination room. The pass-through area was not kept clear. It was used to store clerical supplies and other items that should not be located in the potentially contaminated pass-through area.

The surveyors observed the instrument decontamination room. The room was cluttered. Clean supplies and equipment were stored next to the decontamination sink and within the splash zone. A soiled towel was found on the counter top next to the sink. It appeared the towel was not changed between loads and was not removed at the end of the day so that the counter top could be terminally cleaned.

Clean supplies were stored on open shelves that did not allow for protection from contamination. Supplies were stored in their original shipping boxes.

The decontamination room had two sinks, one for washing and one for rinsing, but the staff stated the practice was to wash and then rinse in the same sink. The room did not have a handwashing sink.

The decontamination room and the sterile processing room had an open door between them and thus shared common airflow.

The sterile processing room had not been regularly cleaned. There was no evidence of deep cleaning. A large blue linen cloth was covering the stainless steel table where instruments were wrapped. It cloth appeared dirty. The room had an upholstered chair that could not be adequately cleaned. Surfaces were dusty. Clutter was found on surfaces. Cardboard shipping boxes were found in this area.

On 10/30/13 and 10/31/13, the surveyors requested records of steam sterilization for the previous six months. The records for each load did not document the type of cycle used, the steam exposure time, or the temperature and pressure achieved.

The staff provided records of biological testing and stated they "thought" these were sterilization records.

The biological testing records were incomplete. There was no documentation of incubation times, the indicator results, and the sterilizer tested (the hospital has two steam sterilizers). The staff did not follow the manufacturer's instructions for biological testing.

The hospital did not have adequate policies related to steam sterilization and biological testing.

5. The surgery staff was asked to provide immediate use steam sterilization records. The staff stated the autoclaves for the surgery department could not longer "flash" sterilize. The staff was asked what they would do if they needed to flash sterilize a dropped instrument. They stated, "We just hope we have another one."

6. On 10/31/13, the surveyors observed the OR staff process a biopsy snare that had been used that morning. The snare appeared to be similar to the multiple disposable biopsy snares found within the surgery department.

The staff was asked why they were reprocessing the snare. They stated, "We were told we could reprocess them." The staff were observed using the same incorrect process to disinfect the snares as was used on the endoscopes.

The hospital reprocessed single use biopsy snares without documentation the manufacturer allowed for reprocessing and without policies and procedures to govern this practice.

7. Numerous peel packages containing instruments processed by the hospital were observed stored throughout the surgery department. The majority of the instruments were stored stuffed into storage bins, piled on each other, wrinkled and folded in a manner to allow for potential tears or punctures.

Some peel packages contained too many instruments. Some peel packages were double bagged. The inner bags were folded to fit inside the outer bag. Some instruments (such as scissors and hemostats were not processed in the open position to allow steam to penetrate all surfaces of the instruments.

Peel packages and instrument sets were not labeled with the name/initials of the person who processed them. Multiple expired sterile instruments were found in the department.

Sterile instruments and supplies were also found stored with non-sterile supplies. Sterile and clean supplies in their original cardboard shipping boxes were found stored in all areas of the surgery department.

One operating room had a Foley catheter set that had been taken out of the sterile plastic wrapper. The set was in a glass cabinet with other sterile supplies ready for use during a surgical case.

Syringes taken out of the original sterile packages were found in drawers in the operating rooms.

The hospital did not have adequate policies related to all aspects of processing and storing surgical instruments and supplies.

8. On 10/30/13, an operating room identified by staff as "terminally cleaned" still contained patient care trash from a surgical case performed two days prior to the survey. In addition, two endoscopes were hanging from a pole in this "clean" operating room.

Another operating room, also identified by staff as terminally cleaned, had trash from a previous case. The OR table had no linens on it, which indicated it may not have been disinfected. There was also trash from a previous surgery still in the room.

The staff was asked if they could determine whether or not the rooms were ready for use. They stated they were "not sure."

On 10/31/13, the surveyors observed the staff clean the endoscope procedure room between patients. After the case was finished, the staff wiped the back table and parts of the anesthesia machine. The oximeter monitor, the blood pressure cuff and the EKG leads were not disinfected between patients. No other surfaces in the room were cleaned.

Trash was not removed from the anesthesia cart. The floor was not mopped. The CRNA working in this room set up medications and supplies for the next case before the room and equipment was disinfected by the staff.

The all parts of the surgery department received minimal cleaning. Because the overall department and the operating rooms themselves were cluttered with unnecessary and unused equipment and supplies, dust, dirt and debris was prevalent throughout.

Floors were dingy and had not been stripped and waxed. Corners of the floors and ceilings were dusty and dirty. Air vents were dusty and dirty. Rust was found on many pieces of equipment. Water spots and mineral stains were found of various things, including equipment and the surgical scrub sinks.

Non-intact surfaces were found in all areas. These surfaces could not be disinfected properly.

The staff stated they did all the cleaning within the department. The staff was not familiar with the cleaning products used within the department. They did not know how long surfaces should remain wet with the disinfectant agent. The staff used buckets and rags to clean the department. When a rag was used, it was tossed back into the bucket.

The staff stated they diluted a concentrated cleaner in the bucket, but the precise concentration requirements were not known. The staff did not know how often the solution was to be changed.

Later in the survey, the surgery staff stated they used Hepastat 256, a quaternary ammonia disinfectant agent to clean surfaces and floors in the department. The product information documented the agent was not effective against C. difficile.

The surgery department staff did not have adequate policies related to cleaning and disinfection of the surgical environment. There were no policies that described cleaning requirements between cases, terminal cleaning at the end of the day, weekly cleaning requirements and periodic department-wide deep cleaning.

9. Staff was observed in surgical scrub attire uncovered, outside the surgery department. Staff regularly left the department and returned without changing their scrubs. Staff were observed outside the surgery department wearing shoe covers that they did not change before re-entering surgery.

Non-hospital staff who donned coverall "bunny suits" to enter the operating room were allowed to wear them outside the OR and then return to the OR without changing them. Other times, staff entered the surgery suite in street clothes covered by a plastic "gown" that did not cover all their clothing.

OR staff was observed leaving the surgery department to go to various areas around the hospital. The staff did not change their shoe covers when they returned to the OR.

Staff working in the decontamination room wore plastic gowns that did not fully protect their OR attire from contamination. Staff wore surgical masks (or nothing) when processing contaminated instruments. The staff was asked how they protected their eyes from splashes. They stated the "sneeze guard" over the sink protected them from splashes. The staff who was observed washing and rinsing the contaminated endoscope was not tall enough for the sneeze guard to fully protect the eyes, nose and mouth. (A face shield should be worn when a splash hazard to the face is present.)

The staff wore non-sterile exam gloves that only covered the hands and wrist when washing and rinsing contaminated instruments. The gloves did not protect the arms up to the elbow as needed when working in a sink filled with water and chemicals. The staff did not use puncture resistant gloves as required when washing and rinsing sharp contaminated instruments.

There was no specialized personal protective equipment located in the decontamination room that was provided solely for staff use in this area.

There was no evidence the OR staff had a process for removing and discarding personal protective equipment (impervious gowns, hair covers, shoe covers and face shields) in a sanitary manner prior to moving from the decontamination area into the sterile processing area. The emergency eye washing station was located in the decontamination room beside the decontamination sink.

10. Contract scrub techs were provided to the OR. The hospital did not ensure these techs had appropriate immunizations and TB skin testing.

11. The hospital did not maintain semi-restricted and restricted access to the surgery department and related areas. During an observation of the surgery department on 10/30/13 and 10/31/13, the surveyors noted the following:

~The double doors that prevented/deterred access to the semi-restricted corridor (outside of pre-op, surgery and recovery) was propped open. Visitors and non-departmental staff had unrestricted access to the semi-restricted corridor.

~The only door into the surgery department was propped open for over 50 minutes when a patient was transferred from surgery to recovery. During the majority of this time, no hospital staff was in the sterile core of the OR to restrict access by unauthorized personnel. Visitors and non-surgery staff were observed walking past and looking into the OR. In addition, because the OR door was propped open, airflow was shared between the restricted surgery sterile corridor and the semi-restricted hallway.

~A "clean" operating room door was propped open to the restricted corridor. Clean supplies and equipment were set up in this room for use on the next patient. Because this door was open, airflow was shared between the operating room and the restricted corridor and also the semi-restricted corridor, because the main OR door was also open.

~Because the decontamination room was not accessible from the OR, the staff travelled out through the semi-restricted hallway and into the public hallway as the only means to enter decontamination. There was no evidence staff covered their OR attire when leaving the OR and did not cover their attire when leaving decontamination to return through the public hallway and back into the OR.

~The door to the decontamination room was located in a public hallway. This door remained unlocked and allowed access by unauthorized personnel. There was a small storage room located within the decontamination room that contained clean and sterile wound care supplies. Also stored in this area were bottles of cleaners and disinfectants.

~The door to the sterile supply room was located in a public hallway. OR staff travelled through the public hallway to enter the sterile supply room or travelled through the decontamination area to the sterile supply room. On 10/30/13, the door to the sterile supply room was locked, preventing access from the public hallway. Staff regularly entered the sterile supply room through the decontamination room. At the time of survey, the sterile supply room door (a split, "Dutch" door) was padded with towels to prevent airflow in and out of the room. The towels had visible amounts of dust and dirt on them.

~On 10/31/13, the surveyors observed the door to the sterile supply room (from the public corridor) unlocked allowing unrestricted access to this area. No hospital staff were present in the sterile supply area at the time.

12. The hospital did not maintain required airflow restrictions between clean and dirty areas of the surgery department.

~Airflow was shared between the decontamination room and the sterilization room. The door between the two areas remained open during the survey. In addition, the pass-through instrument washer in the decontamination room had gaps around it that allowed for airflow around it into the sterilization room.

~The door from the sterilization room to the sterile supply room was open during the survey. Airflow and humidity was allowed to travel from the steam sterilizers into the supply room.

~Airflow was shared between the OR sterile core and the decontamination area. A pass-through window was found between the two areas that could not be closed.

~Airflow was shared between the instrument processing room (sterilization room) and the OR sterile core. A pass-through window was found here that could not be closed.

13. On 10/31/13, observations were made of the housekeeping and laundry work areas.

~There was no clear distinction between clean and dirty parts of this area.

~Dirty linens and housekeeping carts were moved through the clean linen area for storage.

~Laundered housekeeping mopheads and rags were stored with clean patient linens.

~The majority of the patient linen inventory was stored unwrapped and stacked unprotected on open racks. The clean linens were exposed to dust and dirt from HVAC vents and were not protected from other environmental contaminants in the room. Dusty ceiling fans and light fixtures hung over the clean linen racks. The manager was asked if the surgery department linen came from this area. He stated it did.

~Some linens were stored wrapped in plastic. The manager was asked why some linen was wrapped and some was not. He stated the staff wrapped the clean linen in plastic after it arrived from the laundry service. He was asked if the linens arrived to the hospital from the linen service covered and in a protected and sanitary condition. He stated he had never seen the linen delivered so he wasn't sure. He was asked if the hospital had done an onsite evaluation of the linen service to ensure the linen was handled and processed effectively (for heat and disinfection) to prevent the spread of infection. He stated he did not know if that had ever been done.

~Linen was not transported covered and protected from contamination when distributed to various areas of the hospital.

~The hospital did not have current linen handling policies and procedures.

14. There was no documentation that all chemicals used in the hospital for cleaning and disinfecting were identified, evaluated and approved for use by the infection control committee and the medical staff. There was no documentation staff were trained on the use of various disinfectants within the hospital. There were no policies and procedures to guide staff on the use of disinfectants within various departments of the hospital.

When staff were interviewed, they could not answer questions about the disinfecting products used in their areas. Staff in various areas were not certain what disinfecting agents were used in their departments. They did not know how the agents should be used or how long the chemicals had to remain on a surface to adequately disinfect.

The surveyors observed housekeeping carts in the hospital. The carts contained a variety of household (non-hospital grade) cleaners and disinfectants. There was no evidence the hospital had a surface disinfectant that was effective against C. difficile. There were no housekeeping policies and procedures related to the use of disinfectants in the hospital.

The housekeeping manager stated he did not know who approved the purchase and use of these products. He also stated the housekeeping department was not involved in the infection control committee and related activities.

On the morning of 10/30/13, a circulating nurse working in the OR was asked what disinfectant was used to clean surfaces and floors in the surgery department. She stated, "The scrub tech uses Valsure on the surfaces. I think something different is used on the floors. I'm not sure."

The scrub tech was not available for interview. The circulating nurse was asked who cleaned the OR when the tech was not working. She stated, "We all do."

The surveyors observed the label on the Valsure product. It documented it was "an enzymatic cleaner used as a manual pre-cleaner to be used in ultrasonic cleaners or washers for surgical instruments prior to sterilization of the instruments."

Later, the nurse stated the OR staff used a diluted Hepastat 256 solution on surgery department surfaces and floors. The staff was asked to provide the product directions for use. A chemical description was provided. There were no instructions for use. The staff was asked how they used the disinfectant The staff stated they "put a couple of pumps in the bucket and added water." The surgery department did not have policies and procedures for the use of Valsure or Hepastat 256.

15. During the survey of the surgery department, laryngoscope blades were found stored without protective packaging in drawers, in cabinets and on top of anesthesia carts. Dusty laryngoscope blades were found in the surgery crash cart. The blades were not stored in a manner to protect them from contamination.

16. In addition to the issues related to the use of personal protective equipment in the surgical instrument decontamination room, the hospital did not implement a current and complete bloodborne pathogen exposure control plan as required by OSHA regulation.

When exposures did occur, there was not enough documentation to determine all the requirements for post-exposure protocol were followed.

Confidential documentation of the exposure event and post-exposure protocol was not maintained by the hospital.

The hospital did not have a complete and accurate exposure log.

17. Ten of thirteen employee records reviewed did not have documentation of current respirator fit-testing. The hospital did not have documentation of a comprehensive respiratory protection program.

18. The ICP provided no documentation of any infection control surveillance activities for various hospital departments and no documentation of regular environmental rounds. There was no documentation all department managers reported regular, ongoing infection control activities and surveillance to the infection control committee.

Based on document review and staff interview, the hospital failed to develop and implement written policies and procedures to address and reflect the facility's organ procurement responsibilities.
On the morning of October 30, 2013, surveyors asked for the hospital's Organ Procurement Organization (OPO) policies and procedures. Administrative staff provided a policy titled, "LifeShare (Organ and Tissue Donation)" and a policy titled, "Organ and Tissue Recovery." Staff (M and N) told surveyors that these policies were not current and did not have current policies.

Based on document review and staff interview, the hospital failed to incorporate an agreement with an Organ Procurement Organization (OPO).

Findings:

1. On the morning of October 30, 2013, surveyors requested the hospital's OPO agreement.

2. Administrative staff provided a document titled, "Organ and Tissue Recovery Agreement" which documented, "This AGREEMENT is made as of May 15, 2011..." and "...The obligations in these provisions shall survive the termination or expiration of this Agreement for a period of one (1) year..."

3. On the afternoon of October 31, 2013, the Chief Executive Officer (CEO) provided an OPO agreement that was expired.

4. The CEO told surveyors there is not a current OPO agreement.

Based on document review and staff interview, the hospital failed to incorporate an agreement with at least one tissue bank and at least one eye bank. The hospital does not have a current agreement with a tissue or eye bank or Organ Procurement Organization (OPO) who provides these services.
Findings:
1. On the morning of October 30, 2013, surveyors requested the hospital's tissue and eye bank agreement.
2. Administrative staff provided a hospital document titled, "Organ and Tissue Recovery Agreement." The Chief Executive Officer (CEO) provided an expired contract.
3. On the afternoon of October 31, 2013, the CEO told surveyors there is not a current agreement with a tissue bank or eye bank or OPO.

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 (#11, 12) of two medical records reviewed.

Findings:

1. Medical records (# 11 and 12) reviewed showed no documentation that the family of each potential donor was informed of its options to donate or decline to donate organs, tissues, or eyes.

2. A hospital document titled, "LifeShare (Organ and Tissue Donation)" documented, "...The reporting nurse will complete the Certificate of Request for Anatomical Gift form..." and "...the nurse staff should contact a designated requestor..."

3. The hospital document, "Certificate of Request for Anatomical Gift" was not filled out and not completed. This was verified at time of record review with the Director of Medical Records.

Based on document review, personnel file review, and staff interview, the hospital failed to ensure the individual(s) designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor. Hospital staff are not educated and trained as required in the hospital's policies and procedures to be designated requestors for initiation of organ/tissue donation.

Findings:

1. On the morning of 10/30/13, surveyors requested all Organ and Tissue policies and procedures.

Administrative staff provided a hospital document titled, "Organ and Tissue Recovery" that documented, "...educating staff on donations issues..." and "...Requestors should be re-certified every 2 years according to federal regulations on organ and tissue donation."

Administrative staff provided a hospital document titled, "LifeShare (Organ and Tissue Donation)" which documented, "...PVGH employees are designated requestors..."

Twenty-nine (Staff A through CC) of twenty-nine personnel records reviewed, there was no documentation that staff were educated and trained on anatomical gift donation.

2. The Human Resource (HR) Coordinator told surveyors that the designated requestors on the policy are not current and not correct.

3. On the morning of 10/30/13, surveyors requested the hospital's Organ and Tissue recovery agreement. Administrative staff provided a hospital document titled, "Organ and Tissue Recovery Agreement." The Chief Executive Officer (CEO) provided an expired contract.

Based on hospital document review and staff interview, the hospital failed to ensure and implement an employee training program to encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors. The hospital does not have an employee training programabout approaching familes of potential organ donation.

Findings:

1. Throughout the survey, surveyors requested the hospital's training program to encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors. None was provided.

2. On the afternoon of October 31, 2013, the Chief Executive Officer (CEO) and Staff V informed surveyors that the hospital does not have an employee training program about approaching families of potential organ donation.

Based on document review, personnel file record review, and staff interview, the hospital failed to ensure that the hospitals works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues.

1. Twenty-nine (Staff A through CC) of twenty-nine personnel records reviewed, there was no documentation that staff were educated and trained on anatomical gift donation.

2. Four (Staff M, O, P, and R) of four staff told surveyors they did not receive any organ donation education or training.

Based on document review, personnel file record review, and staff interview, the hospital failed to ensure that the hospital works cooperatively with the designated Organ Procurement Organization (OPO), tissue bank and eye bank in educating staff on reviewing death records to improve identification of potential donors.

1. On the morning of 10/30/13, surveyors requested the hospital's Organ and Tissue recovery policies, procedures, and protocols.

Administrative staff provided a policy titled, "Organ and Tissue Recovery" that documented, "...the hospital works cooperatively with the OPO in educating staff on donation issues..."

2. Four (Staff M, O, P, and R) of four staff told surveyors they did not review death charts and did not receive any organ donation education or training.

3. Twenty-nine (Staff A through CC) of twenty-nine personnel records reviewed, there was no documentation that staff were educated and trained on anatomical gift donation.

4. Two (#12 and 13) of two medical records reviewed showed no evidence that the hospital reviewed death records to improve identifications of potential donors.

Based on document review and staff interview, the hospital failed to ensure that the hospitals works cooperatively with the designated Organ Procurement Organization (OPO), tissue bank and eye bank in educating staff on maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place. No documentation was provided throughout the survey documenting staff education on maintenance of potential donors during testing and placement of donated organs, tissures and eyes take place.

Based on record review and staff interview, it was determined the hospital failed to define the scope of surgical services in writing, failed to approve the scope of surgical services through the medical staff and failed to provide an organizational chart that indicated lines of authority and delegation of responsibility to include anesthesia providers, allied health staff and the medical staff.

Findings:

1. The hospital's policies and procedures for surgical services had no documentation to define the scope of surgical services. There was no documentation the medical staff approved the scope of surgical services.

2. A partial organizational chart for the surgery department was provided to the surveyors. There was no documentation of lines of authority that included anesthesia providers, allied health staff and the medical staff. The operating room staff stated they did not have a current and complete surgery department organizational chart.

The staff were uncertain about who was designated as the chief of surgery and chief of anesthesia.

Based on document review, observation and staff interview, it was determined the hospital failed to ensure the surgery department was supervised by an experienced registered nurse.

Findings:

The hospital had no policy that defined the qualifications necessary for the surgery department manager.

The employment file for the registered nurse identified as the surgery department manager had no documentation of a job description for this position. The file did not contain enough information to verify the RN had sufficient surgery experience to qualify as the department manager. There was no documentation of previous supervisory experience in any other area.

There was no documentation of orientation to the surgery department or to the OR manager position. The file did not have documentation of annual training and skills competency assessment for surgery.

The file had no documentation of on-going continuing education, specialized training or certification for the position. There was no documentation of membership in any surgery-related professional organization.

On 10/31/13, the OR manager stated she was trained for surgery "on the job" at this hospital. She stated she had not worked in surgery at any other hospital. She was asked if she was a member of AORN or any other professional organization related to surgery. She stated she was not.

She stated the hospital purchased the 2013 AORN manual for recommended standards and practices within the previous month. She stated the surgery department did not have a manual for recommended standards and practices for surgical instrument processing and sterilization .

The OR manager was observed incorrectly processing an endoscope. She stated, "I haven't done this in eight or nine months, but this is the way I was taught to do it."

Based on observation, record review and staff interview, it was determined the hospital failed to ensure trained surgical technologists (operating room technicians or scrub techs) served as "scrub nurses."

Findings:

1. On 10/30/13, a tour was conducted of the surgery department and related areas. Based on observations of the instrument decontamination areas, sterile processing areas and sterile supply storage areas, many deficient practices were evident. The deficient practices were associated with tasks and job responsibilities normally performed by a scrub tech/instrument tech. These tasks were also overseen by the OR circulating nurses and by the OR manager. (See other tags related to surgery and infection control.)

2. At the time of survey, the staff verified the hospital utilized one full time scrub tech who also worked as the instrument processing tech. The staff stated sometimes the OR circulators worked as scrub techs.

The full-time scrub tech's personnel file had no documentation of prior training or experience as a scrub tech or as an instrument tech. There was no documentation of any previous experience in the medical field. The only previous job experience documented on the job application in the file was for work as a "rigger."

There was no documentation the tech obtained formal training as a scrub tech or instrument tech, although this was recommended by a former manager. The file had no documentation of annual hospital training specific to the OR.

The file documented the most recent skills evaluation for scrub tech duties was done in 2011. The file had no documentation of training and skills competency for surgical instrument processing.

3. The OR manager's file documented she had been trained on scrub tech skills by this scrub tech. There was no documentation the manager or any other OR staff (such as the circulating nurses) had been formally trained in scrub tech skills anywhere other than on the job at this hospital.

4. The OR register had multiple gaps in documentation as to who was assigned as the scrub tech on each surgical case. The OR circulating nurse was asked if the hospital utilized any non-hospital staff in surgery. She stated they did not.

The CEO stated the contractor who provided supplies and equipment for ophthalmology surgery also provided scrub techs to work on the eye cases. These techs were not hospital employees.

The hospital had no personnel files on the contracted scrub techs. The hospital was unable to show evidence these scrub techs were educated, trained and deemed skills competent to perform scrub tech tasks in the OR.

The contracted scrub techs had not been approved by the medical staff to provide direct patient care in the OR.

Based on record review and staff interview, it was determined the hospital failed to ensure experienced registered nurses were assigned as circulating nurses.

Findings:

1. On 10/30/13, the hospital had documentation of one full time registered nurse identified as the circulating nurse for the operating room (OR).

2. The file for the circulating nurse had no documentation of previous OR training or experience prior to employment with the hospital. The file did not indicate how much OR experience the nurse had while employed at the hospital.

3. There was no documentation of orientation and training for the OR. There was no verification of skills competencies for the OR. There was no documentation of annual surgery-specific training.

There was no documentation of training or any general nursing skills competency evaluation after 2010.

4. Although the registered nurses working in the OR were expected to know and perform competently all tasks performed by a scrub tech/instrument tech, there was no documentation in the file that verified this nurse or the OR manager had been trained and evaluated in these areas.

On 10/31/13, observations were made of registered nurses involved in scrub tech duties, i.e., OR room cleaning and turnover and endoscope processing. The tasks were not performed correctly and the nurses could not adequately explain what they were doing and why.

Because registered nurses in the OR are also charged with supervising scrub techs and instrument techs, there was insufficient evidence the registered nurses in the OR were adequately trained and ready to do so.

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

On 10/30/13, the circulating nurse was asked to provide the surveyors with the operating room (OR) department's roster of medical staff with surgery privileges.

She stated she did not know if the department had a current roster. She stated she would look for it. No roster was provided to the surveyors.

Based on policy and procedure review, observation and staff interview, it was determined the hospital failed to develop, implement, and enforce surgical policies and procedures based on current nationally recognized standards.

Findings:

1. On 10/30/13 and 10/31/13, surgery policies and procedures were reviewed. There was no documentation the policies were based on nationally recognized standards. None of the policies referenced State or Federal regulations.

2. Some of the policies were not applicable to the hospital and did not reflect current practices. The majority of the policies were not dated and did not have documentation they were reviewed and approved by the OR manager, the medical director or the governing body.

3. The hospital did not have current policies as required including:

current sterilization and disinfection procedures
aseptic and sterile surveillance and practice
pre-operative work-up
surgical procedures and specific protocols
safety practices unique to the OR
patient identification
staff duties and responsibilities, lines of authority
staff scheduling
emergency procedures unique to the OR
DNR status
handling and processing of surgical specimens
malignant hyperthermia
handling infectious waste
outpatient care planning, coordination and provision of follow-up care.

The surgery RN job description was not current and documented it was last reviewed in 1997.

The malignant hyperthermia policy and procedure was not current and did not reflect current practices and national standards of care.

The surgery case scheduling policy did not reflect current practices at the hospital.

4. There was no documentation the staff were trained on surgery policies and procedures.

5. Although there were some policies that were current and reflected appropriate standards of practice, they were not enforced and were not practiced by staff.

For example, on 10/31/13 the surveyors observed multiple breaches of policy related to OR attire associated with the OR manager, the circulator and a physician.

5. The surgery manager was asked about the OR department policies and procedures. She stated she was working on policy revisions but they were not complete.

Based on observation, policy and procedure review and staff interview, it was determined the hospital failed to provide all the required emergency equipment for the operating room (OR) and the related patient care areas.

Findings:

On 10/30/13, observations were made of the operating room's crash cart. The cart was not secured with a break-away lock to ensure the integrity of the contents.

The circulator stated the crash cart was to be used in an emergency for the OR, pre-op and recovery areas.

The OR circulator was asked if the department had a current list of the required contents for the emergency carts. She stated there was no list. There was no documentation found that indicated the medical staff had determined the requirements for the contents of the emergency carts.

The OR crash cart did not contain:

resuscitation medications
intravenous access equipment
intravenous fluids (two bags of expired normal saline were found on the cart)
complete endotracheal intubation equipment
mechanical positive bag-valve mask device (Ambu or other)
suction equipment

The crash cart had laryngoscope blades for emergency intubation but there was no battery-powered light handle for the blades.

The circulator stated she "thought" the department had a tracheotomy set but she was not certain where it was located.

The circulator was asked why the crash cart did not contain all the required supplies and equipment. She stated the items not on the cart could be found in various locations in the OR, pre-op and recovery. She was asked if this was the best practice in the interest of time during a resuscitation emergency. No comment was made.

The crash cart defibrillator was not tested consistently. There was no policy that required regular testing of the defibrillator. The circulator stated stated there was no defined protocol for this.

None of the surgery department personnel files had documentation the staff were trained on the contents and use of the resuscitative equipment and supplies on the crash cart. The department did not practice mock codes in preparation for an emergency.

On 10/31/13, a nurse assigned to the pre-op area stated she did not have the access code to unlock the door to the surgery department. She was asked how she would access the crash cart in the event of an emergency. She stated she would not use the OR crash cart. She stated she would "pull the crash cart from the ER."

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

a. limit access to the recovery room;

b. ensure the recovery room nurses assessed patients adequately upon admission to recovery and before transfer or discharge from recovery;

c. develop, approve and implement policies and procedures related to patient assessment and transfer requirements to and from the recovery room: and

d. the hospital failed to ensure trained and experienced staff provided post-anesthesia care.

Findings:

1. On 10/30/13 and 10/31/13, the surveyors observed double doors propped open to the semi-restricted corridor leading to the recovery room. Visitors and unauthorized staff persons were observed in this area. The door to the recovery room itself was propped open, even when staff was not present in this area.

2. A review of patient surgical records had inconsistent documentation of patient assessment in the recovery room. There was inadequate documentation of a comprehensive assessment upon admission to recovery and at the time of transfer or discharge from recovery.

3. The surveyors observed that only very low lighting was provided in the recovery room. A recovery nurse was asked how a patient's skin color could be assessed in these lighting conditions. She stated, "I don't know. It's always been this way."

The plant manager was asked if the lighting could be increased in this area. He stated it could not. He stated a former manager of the department requested low lighting because "patients recovered better in low light."

4. The hospital had very few policies and procedures related to recovery. The policies had no documentation they were based on nationally recognized standards. There were no policies relating to assessment of patients in recovery. There were no policies related to transfer requirements to and from the recovery room.

5. The hospital had no documentation the staff working in recovery were trained and experienced in post-anesthesia care. There was no documentation of annual training specific to post-anesthesia care.

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

Findings:

On 10/30/13, the operating room (OR) register was reviewed. The register did not document the scrub tech's name on each surgery case. The register did not document the first name or first initial and the title of anesthesia providers and of any surgical assistants present in the operating room. When the patient received conscious sedation, there was no documentation of the nurse who provided it.

The register was not always complete. There were multiple gaps in documentation. There were surgical cases documented where no operation was noted.

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

Based on observation, policy and procedure review and staff interview, it was determined the hospital failed to ensure the operating room was prepared for a malignant hyperthermia emergency. The hospital did not ensure anesthesia policies and procedures were developed, approved by the medical staff and implemented to meet the needs of the patients.

Findings:

1. On 10/30/13, the circulating nurse stated the anesthesia department provided general anesthesia to surgical patients. Inhalation anesthetics were found in the department during the survey.

The surveyors asked the OR circulator to direct them to the malignant hyperthermia (MH) emergency cart. The cart was not secured with a breakaway lock to ensure the integrity of the contents. The cart was dusty and dirty, both inside and outside.

On top of the cart, the staff stored items such as an alcohol spray to clean the dry erase marker board, dry erase markers and yellow plastic bags for linen hampers.

Inside the drawers of the cart, random items were stored that were not a part of the required supplies and equipment to respond to a malignant hyperthermia crisis. There was no organization to the cart.

The circulator was asked if the surgery department had an approved list of supplies and equipment required for this cart. She stated they did not. She was asked if the staff and pharmacy periodically checked the contents of this cart. She stated they did not.

Expired sodium bicarbonate was found on the cart. A layngoscope blade was found in one drawer, but there was no light handle for it. The cart did not contain all the necessary items to treat this emergency. According to current standards of practice, the cart should also contain:

Dantrolene 36 viles (20 mg. each)
Sterile water (preservative-free) for drug dilution
dextrose 50%
regular insulin
calcium chloride
furosemide
lidocaine
assorted IV cannulas
IV administration sets
60 ml. syringes to dilute dantrolene
syringes, assorted sizes
needless cannulas
central venous pressure kit
transducing pressure system for arterial and central venous pressure monitoring
blood collection tubes
arterial blood gas kit
nasogastric tubes
irrigation tray with piston syringe
indwelling urinary catheter tray
0.9% sodium chloride IV fluids and irrigation solution (refrigerated)
bucket and plastic bags for ice

None of these supplies were found in the MH cart. The circulator was asked if the department had a refrigerated stock of IV fluids and irrigation solution to respond to this emergency. She stated they did not.

The circulator stated the OR and recovery room staff did not conduct drills for a MH emergency.

The surgery department malignant hyperthermia policy and procedure was outdated and did not reflect the current standards of practice. The policy had not been approved by the medical staff.
The MH policy did not instruct staff on a plan of action, such as treat and transfer, when this emergency presented, as the hospital did not provide intensive care services.

There was no documentation the surgery and recovery room staff were trained on MH preparedness.

2. The hospital had few anesthesia-related policies and procedures. The policies were outdated and did not reflect current practices. There was no documentation the policies were developed with the consultation of an MD, DO or CRNA. The policies had not been approved by the medical staff.

There were no anesthesia policies that addressed:

patient consent
infection control measures
safety practices in anesthetizing locations
protocols for cardiac, respiratory and malignant hyperthermia emergencies
reporting requirements
documentation requirements
equipment requirements
pre- and post-anesthesia staff responsibilities

Based on clinical record review and policy and procedure review, it was determined the hospital failed to ensure post-anesthesia evaluations were conducted according to current standards of practice for five (#26, 27, 28, 29, and #30) of five records reviewed for post-anesthesia evaluations.

Findings:

On 10/30/13 and 10/31/13, records were reviewed for documentation of post-anesthesia evaluations. There was no documentation as to when the evaluations were conducted.

The evaluations did not address mental status, temperature, pain, nausea and vomiting and post-operative hydration. The evaluations were basically the same for all surgery patients and did not address any special monitoring or assessment that may be needed specific to the type of surgery or procedure performed, ie., swallowing capability after an EGD (esophagogastroduodenoscopy).

The hospital had no policy that addressed the requirements for post-anesthesia evaluations.

Based on hospital document review, personnel record review, and interview, the hospital failed to ensure emergency service personnel requirements were met. This occurred for four (Staff O, P, R, and Z) of four emergency department (ED) 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
-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.

2. On the afternoon of 10/30/13, Staff O and Staff R told surveyors the hospital had not provided skills competency training and had not performed competency testing for nursing staff that worked in the ED.

3. Hospital nursing policy titled, "Moderate Sedation" documented,"...Competency is evaluated and documented annually by successful completion of training..." None of the records had documentation of verification of educational in service training.

4. On the afternoon of 10/31/13, the CEO and Staff N verified that all personnel files were complete.

Based on hospital document review, record review, and staff interview, the hospital failed to ensure staff working in the emergency department (ED) had demonstrated skills competencies. This occurred for four (Staff O, P, R, and Z) of four ED 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, performing, and documentation based on American Association for Respiratory Care (AARC) guidelines;

-Accessing, assembling, and delivering oxygen cylinders with regulators for patient use based on American Association for Respiratory Care (AARC) guidelines;

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

-Restraints: application, monitoring, assessment, and interventions based on CMS guidelines.

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

2. On the afternoon of 10/30/13, Staff O and Staff R told surveyors the hospital had not provided skills competency training and had not performed competency testing for nursing staff that worked in the ED.

3. On the afternoon of 10/30/13, Staff P told hospital surveyors, "I have only been here 3 weeks and have not completed my orientation and training."

4. The Chief Executive Officer (CEO) was asked if the hospital required ED skills competency training. The CEO stated, "They should have received training at hospital orientation."

5. Hospital nursing policy titled, "Restraints" documented, "...All nursing staff that have direct patient contact must receive orientation, ongoing education/training and demonstrate competency...through the use of restraints or seclusion..." None of the records had documentation of verification of educational in service training.

6. Hospital nursing policy titled, "Moderate Sedation" documented, "...Competency is evaluated and documented annually by successful completion of training ..." None of the records had documentation of verification of educational in service training.

7. On the afternoon of 10/31/13, the CEO and Staff N verified that all personnel files were complete.

Based on observation, interviews with staff and review of hospital documentation, the hospital failed to ensure review, analysis and correction or resolution of hospital infection control concerns and issues through the quality assessment and performance improvement process.

Findings:

1. The hospital's Governing Body, Medical Staff and Quality Assessment Performance Improvement meeting minutes provided for review did not have evidence of review, analysis or action taken to identify, report, prevent and control infections among patients and staff.

2. The hospital's Governing Body, Chief Executive Officer and Chief Nursing Officer failed designate an infection control professional who was qualified and properly trained in infection control. The hospital also failed to ensure the infection control professional developed and implemented current infection control policies and procedures. See Tag A 0748.
3. The hospital failed to designate a qualified infection control professional (ICP) who had developed and maintained an ongoing, comprehensive hospital-wide system to identify, report, prevent and control infections and communicable diseases among patients and staff throughout the hospital. See Tag A 0479.