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

a. Define the scope of surgical services that would be provided in the hospital and the appropriate location of these services, according to accepted standards of practice (See Tag A-941);

b. Ensure that policies and procedures were developed and implemented according to nationally recognized standards of practice (See Tag A-951);

c. Ensure that all surgical procedures had adequate qualified staff present;

d. Ensure that for nurses administering conscious/moderate sedation, the administration of the anesthetic and monitoring of the patient's condition was the sole responsibility of that nurse;

e. Ensure that post-operative care was provided according to acceptable standards of practice (See Tag A-957);

f. Ensure that surgical procedures were performed only by physicians granted privileges for those procedures (See Tag A-363 and A-945);

g. Ensure that surgical care was provided according to accepted standards of practice.

Based on record review and interviews with hospital staff, the governing body failed to ensure that personnel providing services by contract are oriented, evaluated to ensure competence and meet the same health requirements as employees of the hospital.

Findings:

On the afternoon of 3/20/14, Staff D stated radiological procedures (ultrasounds) were a contracted service provided by Staff AA and Staff BB.

Review of the personnel file for Staff AA did not contain documentation of hospital health requirement.

Review of the personnel file for Staff BB did not contain documentation of hospital orientation and health requirements.

The above information was presented to the administrative staff during the exit interview.

Based on record review and interviews with hospital staff, the hospital does not ensure all services provided by contract or arrangement are evaluated through the hospital-wide quality assessment and performance improvement (QAPI) program. Contracted services that performed non-clinical services such as biomedical checks of equipment were not included in the QAPI evaluations of services provided by contract.

Based on record review and interviews with hospital staff, the hospital does not ensure physicians who provide care to patients have privileges granted for the procedures they are performing. One (J) of three ( J, K, L ) physicians' credential files reviewed did not have evidence of privileges granted for procedures the physician performed. One (K) of three ( J, K, L ) physicians' credential files reviewed did not have evidence of privileges granted by the present hospital's governing body.

Findings:

1. Staff J performed a tracheostomy and did not have privileges granted.

2. Staff K did not have privileges granted by the present hospital's governing body. The privileges in the physician's credential file were granted by the previous governing body.

3. These findings were verified by hospital personnel.

Based on review of medical record and hospital documents, and staff interviews, the hospital failed to ensure all medical records were accurately written, authenticated, and completed promptly. This occurred in 10 of 10 records (Records #1, 2, 3, 13, 16, 19, 20, 21, 22, and 23) reviewed.

Findings:

1. Patient #13 was transferred on 08/12/2013 to another medical facility. Review of the medical record did not contain a signed transfer consent by Patient #13. This was confirmed by Staff JJ during chart review on 03/20/14.

2. Interoperative documentation was not complete and accurate for Records #1, 2, 3, 16, 19, and 20. Examples:

a. Based on review of the medical records cited above, the same nurse identified as the circulator also administered the moderate/conscious sedation. On 03/23 and 24/2014, Staff D and HH told the surveyors that there was always two registered nurses present and the one administering the sedation was not the circulator.

b. Record #1 - for the procedure on 12/23/2013 of a bronchoscopy and a bronchoscopy assisted percutaneous tracheostomy:

i. The interoperative record recorded Dr.(doctor) J performed the first procedure and Dr. L performed the second. The interoperative record does not list what procedure was performed #1 or #2.

ii. The operative reports document Dr. L performed the bronchoscopy and Dr. J performed the percutaneous tracheostomy.

iii. This finding was reviewed with Staff D at the time of review. Review of credential file showed neither physician had privileges for perform a percutaneous tracheostomy.

c. Record #2, the patient had a colonoscopy on 11/13/2013. The interoperative did not show where this surgical procedure took place. On 03/24/2014, Staff D and HH told the surveyors that colonoscopies were always performed in the procedure room.

d. Record #3, only the initials, "RT" were written on the designation of the scrub tech. On 03/24/2014, Staff HH told the surveyor that this meant the respiratory therapist helped with the bronchoscopy.

e. Record #16, no surgical prep is documented for the procedure on 01/30/2014. Staff HH told the surveyors that the hospital's chosen surgical prep was chloroprep. The hospital did not have a surgical prep policy to confirm this.

f. All records listed in the initial statement did not contain documentation of who was present during the "Time Out".

i. Record #19 - only the nurse signed the time out.

ii. Record #20 - the "Time Out" for the procedure on 03/07/2014,contained the name of the scrub tech, but not his title for the time out called at 1100, but the physician did not sign until 1430. In another record, the physician signed the "Time Out" form before the "Time Out" was performed.

3. All dictated reports completed by Dr. L did not contain the date and time they were signed/authenticated by the physician.

4. Records #19 and 20, the dictated reports by Dr. LL did not contain the date and time they were signed/authenticated by the physician.

5. The initial nursing assessment on Record #22 did not contain the title of the nurse completing the assessment.

6. Record #23, the ultrasound tech's notes on 03/17/2014, only contain Staff AA's initials and not her full name and title.

7. The above information was presented to the administrative staff during the exit interview on 03/24/2014. No additional information was provided.

Based on review of hospital documents, personnel file review and staff interview, the facility failed to have only qualified personnel designated by the radiologist in charge and/or the medical staff determine who can use radiology equipment and administer procedures. There was no evidence in personnel files that the radiologist/medical staff had determined staff qualified to operate specific radiological equipment. This occurred in four of four ( AF, I, AA and BB) radiology staff personnel files reviewed.

Based on surveyors' observations, hospital document review and interviews with staff, the hospital's infection control preventionist (ICP) failed to ensure hospital wide infection control policies were implemented.

Findings:

1. The hospital's policy for reportable diseases documented the current State list of reportable diseases and health department telephone number would be attached. The infection control manual did not contain this document. This finding was reviewed and verified with Staff R on 03/20/2014.

2. The ICP had not developed infection control procedure regarding surgical procedure performed in the hospital to ensure they follow infection control standards of practice, including the cleaning and maintaining of scopes.

Based on review of infection control data, personal files, hospital documents, and interviews with hospital staff, the hospital failed to ensure that the infection control practitioner (ICP) developed and implement infection control measures related to:

a. Hospital personnel. This occurred in four (Staff G, I, AA and BB) of fourteen health files and three (J, K and L) of three physician files reviewed.

b. Safe and sanitary environment.

Findings:

1. Review of the health files for Staff G, I, J, K, L, AA and BB did not contain documentation of complete immunization histories, as recommended by the CDC and its Advisory Committee on Immunization Practices (ACIP).

2. On 03/24/2014, surveyors observed dirty respiratory equipment was being cleaned in the clean respiratory storage area.

3. Surveillance activity reports did not demonstrate the ICP had monitored surgical practices to ensure they were performed in a safe and sanitary environment and the equipment was cleaned according to manufacturer guidelines and accepted standards of practice.

4. The above information was presented the the administrative staff during the exit interview.

Based on review of hospital documents and interviews with staff, the hospital failed to define in writing the scope of surgical services performed in the hospital and the appropriate location where those services/procedures may be performed in accordance with acceptable standards of practice.

Findings:

1. The hospital's policy and procedures manuals did not contain a policy defining the surgical procedures that had been approved by the medical staff and governing body to be performed in the hospital.

2. At the time of the survey, surgical procedures included, but not limited to, colonoscopy, esophagogastroduodenoscopy (EGD), bronchoscopy, percutaneous tracheostomy, and percutaneous endoscopic gastrostomy (PEG) tube placement.

3. The above surgical procedures were performed at patient's bedside in the intensive care unit and in the hospital's procedure room.

4. The hospital's procedure room has positive air flow (air movement flows out of the room in relationship to adjacent areas). Accepted standards of practice, including Oklahoma State Hospital Standards, require ventilation for endoscopic procedures to be negative air flow (air movement into the room in relationship to adjacent areas), unless they are performed in a surgical suite. The hospital has no surgical suite.

5. These findings were reviewed with administrative staff during the exit interview.

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

a. Establish qualifications for personnel who may perform circulating duties and provide competency verification.

b. Ensure there was a registered nurse circulator solely dedicated to care for patients during surgical procedures.

Findings:

1. The hospital did not have a policy or job description for circulator nurses and the qualification to perform this task.

2. Three of three nurses (Staff P, O, and KK), identified as circulators in patient medical records, did not have job descriptions for the positions of circulator or competency verification.

3. According to Records #1, 2, 3, 19, and 20, the same nurse documented as the circulator, also provided the conscious sedation. There was no evidence that another qualified registered nurse was in the room and to fulfill the circulator duties.

According to the Association of periOperative Registered Nurses, (AORN) Perioperative Standards and Recommended Practices For Inpatient and Ambulatory Settings 2013 Edition, page 417,

"... Recommendation IV: The perioperative registered nurse monitoring the patient receiving moderate sedation/analgesia should have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure... A designated perioperative registered nurse should continually monitor the patient during administration of moderate sedation/analgesia... An additional perioperative nurse registered nurse should be assigned to the circulating role during the administration of moderate sedation..."

4. These findings were reviewed with administrative staff during the exit interview.

Based on review of hospital documents, medical records, and physician files, the hospital failed to:

a. Ensure physician's performing surgical procedures only perform those procedure for which they have been granted privileges.

b. Keep a roster of physician surgery privileges available for surgical services.

Findings:

1. No roster of surgical privileges for the surgery services was provided to the surveyors. The surgery privileging delineation was contained in the physician credential files.

2. Physician # J and L did not have surgical privileges for the percutaneous tracheostomy procedures they performed.

3. Findings were reviewed and verified with Staff #D and HH, at the time of review of the credential files.

Based on review of policies and procedures and medical records and staff interviews, the hospital failed to ensure the surgical services policies were developed according to national standards of practice and were enforced to ensure patient safety.

Findings:

1. The hospital's policy and procedure manual that contained "Surgical and Invasive Procedures" did not contain:

a. A scope of surgical procedures that could be performed at the hospital;

b. Where the procedures were allowed to be performed, using accepted standards of practice;

c. Reference for where the accepted standards of practice were obtained.

2. The hospital policy requiring a "Time Out" procedure did not identify documentation to show who was present at the time of the "Time Out" was performed and who is responsible for singing the "Time Out" document. Records #1, 2, 3, 16, 19 and 20 did not contain documentation of who was present during the "Time Out". Signature documentation on the form was inconsistent: some had only the nurse signature; one had the physician signing before the time out was performed; and one had the nurse signed at the time of the procedure and the physician signing in the afternoon.

3. The hospital did not have a policy and procedure to require the interoperative endoscope procedure records contained documentation of all staff present during the procedure.

a. For Record #3, a bronchoscopy assisted percutaneous tracheostomy on 03/06/2014, only contained "RT" for assist/scrub tech. Surveyors were told this meant respiratory therapy provided this position.

b. Staff D and HH told surveyors that the procedures always had two registered nurses present - one to administer anesthesia and one to provide moderate/conscious sedation. This was not evident by medical record review.

4. The hospital did not have a policy and procedure for endoscope cleaning and processing and the requirement that if the instruments are not used within 5 days, they will be reprocessed.

5. The policy and procedure manual did not contain job descriptions detailing the requirements for scrub and circulating staff, with the duties and responsibilities.

6. The policy and procedure manual did not contain housekeeping requirements/procedure for be follow before and after surgical procedures were performed.

7. The policy and procedure manual did not contain a policy/policies governing patient care requirements of: preoperative work-up; patient consents and releases; clinical procedures; safety practices; and patients identification procedures.

8. The policy and procedure manual did not contain a policy and procedure for the care of any surgical specimens.

9. The policy and procedure manual did not contain a policy detailing the acceptable operating room attire for the different procedures performed.

10. The policy and procedure manual did not contain a policy concerning surgical area preps, the solutions approved for use, application of this/these products, and documentation required.

Based on review of medical records and hospital documents, surveyor observations, and hospital staff interviews, the hospital failed to ensure adequate provisions for immediate post-operative care. This occurred for six of six (Records #1, 2, 3, 15, 19, and 20) patient medical records reviewed.

Findings:

1. The hospital does not have a designated area of the hospital specifically for post-operative recovery care.

2. Documentation, for the medical records listed above, indicated that patient care was turned back over to the unit nurse after the procedure. Documentation did not support that the patient was provided post-operative care as outlined in the hospital policy, Moderate Sedation, under the Post-Procedure Protocol, which requires:

a. "...A patient who has received Moderate Sedation will be continuously monitored by a competent Registered Nurse during the recovery phase. The nurse does not have to be competent to administer and monitor the patient for Moderate Sedation. The Registered Nurse must be competent in the recovery of the patient."

b. "The patient will be assigned an Aldrete score upon admission to the recovery area."

c. "Vital signs (Blood Pressure, Pulse, Respiratory Rate) will be monitored and recorded on admission to the recovery area and then at five minute intervals, or more frequently if indicated."

d. "Pulse oximetry saturation will be monitored and recorded on admission to the recovery area and then at five minute intervals, or more frequently, if indicated."

e. "If a patient has received reversal agents (Narcan, Romazicon), the patient must have a post procedure recovery of at least 90 minutes."

f. "Level of pain, intervention, and patient's response to intervention."

g. "Plan of care for discharge."

3. The policy also provides requirements for "Post-sedation and discharge procedure which medical record review did not provide evidence that it was being done. The policy requires:

"...2. For inpatients, the criteria are as follows; the patient has had a recovery period of a minimum of 30 minutes with an Aldrete score of 8 or greater for a non-ventilator patient and an Aldrete score of 4 or greater for a ventilator patient."

"The following must be documented:"

"discharge Aldrete score"

"If the discharge Aldrete score cannot be met, an explanation must be documented and the physician who performed the procedure must be contacted and informed of the patient's condition"

"Nurses notes that reflect any unusual events of post procedure complications and the management of those events or complications"

"Total amount of medication that was administered during the procedure and post procedure"

"Total amount and type of intake (IVF and blood products)"

"Total amount of output (urine, blood, gastric, or other)"

"Ventilator settings or method and amount of oxygen delivery"

"Monitor strip will be documented prior to patient transport."

"Location that patient was discharged to, mode of transport, and name(s) of transport personnel"

"Name of Registered Nurse that ensured that safety standards were met for discharge and name of nurse who received the patient to the nursing unit"

"Vital signs (TPR and BP) upon return to the patient's room"

"Continuum of vital signs per protocol."

3. Review of seven registered nurses's personnel files did not demonstrate they had been trained and received competency verification for post-procedure recovery. The personnel files did not contain job description that detailed responsibility for post-procedure recovery responsibilities.

4. These findings were reviewed with administrative staff during the exit interview.

Based on review of hospital documents and surgery/procedure logs and interview's with hospital staff, the hospital failed to ensure that the surgical procedure log contained all the required information.

Findings:

1. The hospital did not have a policy requiring a surgical procedure log' what the log would contain; who would be responsible for it's maintenance; and where it would be kept.

2. Surgical procedures are performed both at the bedside and in the procedure room.

3. Staff supplied the surveyors with two computer logs of procedures. The first log (Log #1) presented to the surveyors, not only contained surgical procedures, but also entries for other types of procedures, including, but not limited to, ultrasound and doppler. Staff HH stated that the second log (Log #2) presented was the one she kept.


4. Log #1 did not identify:

a. Type of anesthetic and the name of the person administering the anesthetic;

b. Name of the circulating nurse;

c. The name of the scrub staff;

d. If an other individuals, students, representatives, etc. were present, and if so, their names;

e. Inclusive time of the operation, or at least the time surgery began and ended;

f. Age of the patient;

g. Location of the surgical procedure.


5. Log #2 did not identify:

a. Name of the surgeon;

b. Type of anesthetic and the name of the person administering the anesthetic;

c. Name of the circulating nurse;

d. The name of the scrub staff;

e. If an other individuals, students, representatives, etc. were present, and if so, their names;

f. Inclusive time of the operation, or at least the time surgery began and ended;

g. Age of the patient;

h. Location of the surgical procedure.


6. The above findings were reviewed and confirmed with Staff D and HH on 01/24/2014.