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

a. medical staff and allied health staff privileges were clearly designated and granted. See Tag A-0046;

b. contracted services were provided according to all applicable conditions of participation. See Tags A-0083 and A-0084; and

c. the governing body failed to ensure the hospital met all the Conditions of Participation.

Based on record review and staff interview, it was determined the governing body failed to ensure medical staff and allied health staff privileges were clearly designated and granted.

Findings:

Medical staff credentialing files were reviewed. The files had a single document that indicated the staff member had been granted privileges by the governing body based on the recommendations made by the medical executive committee.

However, there was missing documentation in the credentialing files that clearly identified all the required information for privileges requested, approved and granted.

1. There was no documentation to show the what practitioner requested certain privileges. The forms in the credentialing files had a list of privileges with check marks on them. However, it could not be determined who made the check marks. Credentialing staff stated the practitioner made the check marks on the form to indicate the privileges requested. The form had no initials and signature by the requesting practitioner.

2. The list of privileges form had no date as to when the practitioner made the request.

3. A second row of check marks was documented on the form. The credentialing staff stated these marks were made by the medical staff person reviewing the list of requested privileges. There was no documentation of this person's initials and signature on the form. There was no date as to when the list of privileges was reviewed.

4. The privilege request form had blank spaces that allowed for it to be altered later. For example, if a certain privilege listed on the form was not checked, there was no documentation the item was "not applicable." The item was just left blank.

5. Some of the requested privileges were vague. For example, one file had a list of privileges that included the line item "cosmetic procedures." There were no specific cosmetic procedures identified. This form also had a procedure listed that someone had documented "not approved." However, it was not documented when the form originated, who requested the privileges on it and who denied approval of a certain procedure.

6. Some of the credentialing files did not have a list of requested privileges at all.

7. Some credentialing files did not have a privilege list that included all the procedures the medical staff was actually providing at the hospital. For example, the physician who provided wound care with the use of hyperbarics had no documentation of privileges related to hyperbarics. In fact, there were very few actual wound care procedures listed on the privilege list form.

8. None of the credentialing files had clear evidence an accurate, complete and comprehensive list of requested privileges was submitted by the practitioner to the medical executive committee that included a date submitted and the signature of the requestor. There was no clear evidence what list was reviewed by the medical executive committee and no documentation of the date of the review and by whom.

9. The recommendation and approval form for hospital privileges signed by the chief of staff and the governing body could not be definitively linked to any certain privilege request list.

10. For those practitioners who were not credentialed for all services required for proper care of the patient (for example, the performance and documentation of a patient's medical/surgical history and physical examination), there was no documentation in the credentialing file as to who on staff would assume this responsibility.

11. The credentialing staff person available at the time of survey was asked various questions about the credentialing process and the documentation found in the files. She stated she did not know what all the processes were. She stated, "I just do it like it always been done."

12. Dental assistants working in surgery had files that indicated privileges had been granted. However, there was no documentation as to what privileges had actually been granted. There was documentation in the clinical records that indicated the dental assistants were functioning as surgical scrub techs. None of the dental assistant files had documentation they were qualified by education and experience to work as surgical scrub techs in the hospital.

In addition, the credentialing files for the dental assistants had no records of current immunizations, no current TB skin tests, and no criminal background investigation.

Based on review of governing body meeting minutes and review of Quality Assessment Performance Improvement (QAPI) meeting minutes and staff interview, the governing body failed to ensure that services provided by contract were provided in a manner the same as if they were provided by hospital staff.

Findings:

1. Surveyors reviewed governing body meeting minutes and QAPI meeting minutes. There was no documentation that the governing body evaluated services provided through contract.

2. On the morning of 04/18/2014 the Chief Nursing Officer was asked if the governing body evaluates services provided through contract. She stated that the governing body does not evaluate contracted services.

Based on document review and staff interview, it was determined the hospital failed to evaluate the quality of services provided by contract.

Findings:

The hospital was asked to provide a list of contracted services. Various committee meeting minutes were reviewed for evidence contracted services were evaluated for safety and effectiveness.

There was no documentation by the governing body that indicated this group required contracted services to be provided in a safe and effective manner.

There was no documentation in the quality assessment and performance improvement (QAPI) plan that required all contracted services to be evaluated for compliance with the applicable conditions of participation.

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

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

b. develop a process to notify patients/patients' representatives of the right for referral to the Quality Improvement Organization (QIO) for concerns regarding care or early hospital discharge. See Tag A-0120;

c. the hospital failed to provide written notice to the patient grievances. See Tag A-0123.

Based on document review and staff interview, the hospital failed to inform patients and/or their representatives of all required patient's rights.

Findings:

1. On the morning of 4/16/14, surveyors toured the facility with the Chief Nursing Officer (CNO).

Outpatient waiting areas except the emergency department (ED) did not have patient rights posted. The posted signage in the ED waiting area did not include all patient rights as federal regulation requires.

2. On the morning of 4/16/14, hospital administrative staff were asked to provide patient rights information given to patients and/or their representative at the time of admission.

The staff provided a patient's bill of rights given to inpatients that did not include all patient rights as determined by federal regulation.

3. On the morning of 04/16/14 surveyors requested an admission packet that a patient would receive during a patient's hospital stay.

There was no hospital documents provided to surveyors throughout the survey that addressed the standardized notice, "An Important Message from Medicare."

4. Two (#6 and #9) of two medical records reviewed did not have documented evidence of "An Important Message from Medicare" as required within two (2) days of admission and in advance of the patient's discharge.

5. On the morning of 4/18/14, the CNO told surveyors that the patient rights were not current and going to be updated.

Based on review patient rights handouts, review of policies and procedures, and staff interviews, the hospital failed to develop a process to notify patients/patients' representatives of the right for referral to the Quality Improvement Organization (QIO) for Medical Quality and concerns regarding care or early hospital discharge.

Findings:

1. On the morning of 04/16/14, surveyors toured the facility with the Chief Nursing Officer (CNO).

Patient information handouts, forms, and posted signage in the emergency department (ED) area did not provide notification to the patient or patient's representative that they could ask for a QIO review if they had concerns regarding quality of care provided or premature discharge.

The CNO verified this at the time of the hospital facility tour.

2. There was no documented evidence of hospital policy/procedure for ensuring patients and/or their representatives have information necessary to lodge a complaint to the QIO regarding quality of care.

The CNO verified this at the time of document review.

Based on document review, policy and procedure review and staff interview, it was determined the hospital failed to provide the patient with a written notice regarding the results of the grievance process.

Findings:

The hospital was asked to provide a list of complaints and grievances for the previous six months. The hospital provided files that documented grievances. There was no documentation the hospital collected information about patient complaints.

None of the documented grievances had evidence the patient was provided written notice of the hospital's decision regarding the grievance, the hospital's contact person, the steps taken to investigate the grievance and the results of the grievance process.

There was no documentation of the date of completion.

The hospital administrator was asked to provide documentation of the hospital's written response to grievances. None was provided.

The hospital's grievance management policy documented the grievance committee would provide a written response to all grievances within seven business days.

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

a. require the Quality Assessment and Performance Improvement (QAPI) program to reflect the complexity and scope of hospital services provided;

b. involve all hospital departments and include all contracted services that impacted patient care in the QAPI program;

c. focus QAPI indicators on improving patient heath outcomes and the prevention and reduction of medical errors;

d. provide adequate documentation to demonstrate evidence the QAPI committee reviewed valid and relevant data;

e. ensure the QAPI committee reviewed and responded to adverse patient events;

f. ensure the QAPI committee identified opportunities for improvement and recommended changes that would lead to improvement;

g. set specific priorities for performance improvement; and

h. the governing body failed to provide adequate oversight of the QAPI program and failed to ensure the hospital's QAPI program conformed to the requirements for the Condition of Participation.

Findings:

1. There was no documentation the governing body required changes in the QAPI program to reflect changes in hospital services. For example, additional surgery specialties were added to the hospital's services. These included urology, cosmetic surgery, orthopedics and bariatric services, among others. The QAPI program did not include these service areas.

2. QAPI meeting minutes had no documentation all departments were included in the QAPI program.

3. There was no documentation all contracted services impacting patient care were evaluated through the QAPI program.

4. While there were some health outcome indicators included in the QAPI program, the indicators did not reflect all outcomes relevant to the services provided by the hospital. In addition, there was no documentation the QAPI committee reviewed and responded to information obtained through patient complaints and grievances.

5. There was no documentation the QAPI committee focused on the reduction and prevention of medical errors. There was no documentation medical errors were reported to the QAPI committee. The hospital provided no documentation to show the hospital identified and analyzed medical errors, including medication errors and "near misses."

6. There was no documentation the QAPI committee reviewed and responded to adverse patient events. The hospital had documentation of adverse patient events, but no documentation this information was provided to the QAPI committee. There was no documentation the QAPI committee acted in response to adverse patient events.

7. There was no documentation in the QAPI committee meeting minutes that indicated the committee identified opportunities for improvement and recommended changes to be made in response to any of the information presented to the committee. There was no clear documentation of actual actions taken by the committee.

8. There was no documentation the QAPI committee set priorities for improvement based on relevant data that identified high-risk, high-volume and problem-prone areas. There was no documentation the QAPI committee prioritized health outcomes, patient safety and quality of care.

For example, the surgery department reported to the QAPI committee on immediate use steam sterilization. However, this was a low volume practice. In addition, the data collected on this practice was not relevant and did not focus on the critical issues related to this practice.

The other indicator reported by the surgery department was related to the correct documentation in the surgery register. While this may be a problematic issue, it was not related to patient outcomes, patient safety or adverse events.

Based on record review and staff interview, it was determined the medical staff failed to ensure staff privileges were clearly designated and granted.

Findings:

Medical staff credentialing files were reviewed. The files had a single document that indicated the staff member had been granted privileges by the governing body based on the recommendations made by the medical executive committee.

However, there was missing documentation in the credentialing files that clearly identified all the required information for privileges requested, approved and granted.

1. There was no documentation to show the what practitioner requested certain privileges. The forms in the credentialing files had a list of privileges with check marks on them. However, it could not be determined who made the check marks. Credentialing staff stated the practitioner made the check marks on the form to indicate the privileges requested. The form had no initials and signature by the requesting practitioner.

2. The list of privileges form had no date as to when the practitioner made the request.

3. A second row of check marks was documented on the form. The credentialing staff stated these marks were made by the medical staff person reviewing the list of requested privileges. There was no documentation of this person's initials and signature on the form. There was no date as to when the list of privileges was reviewed.

4. The privilege request form had blank spaces that allowed for it to be altered later. For example, if a certain privilege listed on the form was not checked, there was no documentation the item was "not applicable." The item was just left blank.

5. Some of the requested privileges were vague. For example, one file had a list of privileges that included the line item "cosmetic procedures." There were no specific cosmetic procedures identified. This form also had a procedure listed that someone had documented "not approved." However, it was not documented when the form originated, who requested the privileges on it and who denied approval of a certain procedure.

6. Some of the credentialing files did not have a list of requested privileges at all.

7. Some credentialing files did not have a privilege list that included all the procedures the medical staff was actually providing at the hospital. For example, the physician who provided wound care with the use of hyperbarics had no documentation of privileges related to hyperbarics. In fact, there were very few actual wound care procedures listed on the privilege list form.

8. None of the credentialing files had clear evidence an accurate, complete and comprehensive list of requested privileges was submitted by the practitioner to the medical executive committee that included a date submitted and the signature of the requestor. There was no clear evidence what list was reviewed by the medical executive committee and no documentation of the date of the review and by whom.

9. The recommendation and approval form for hospital privileges signed by the chief of staff and the governing body could not be definitively linked to any certain privilege request list.

10. For those practitioners who were not credentialed for all services required for proper care of the patient (for example, the performance and documentation of a patient's medical/surgical history and physical examination), there was no documentation in the credentialing file as to who on staff would assume this responsibility.

11. The credentialing staff person available at the time of survey was asked various questions about the credentialing process and the documentation found in the files. She stated she did not know what all the processes were. She stated, "I just do it like it always been done."

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

a. a registered nurse supervised and evaluated the nursing care for each patient in the emergency department. See Tag A-0395;

b. nursing staff prepared and administered drugs and biologicals according to recognized standards of practice. See Tag A-0405;

c. verbal orders were used infrequently. See Tag A-0407;

d. blood products were administered in accordance with approved medical staff policies and procedures and according to Oklahoma State Board of Nursing guidelines. See Tag A-0409;

Based on hospital document review and staff interview, the hospital failed to ensure a registered nurse (RN) supervised and evaluated the nursing care for each patient in the emergency department (ED).

Findings:

1. On the morning of 04/16/14, surveyors asked administrative staff to provide the hospital's Medical Staff Bylaws, Medical Executive Committee (MEC) meeting minutes, and ED policies and procedures.

Administrative staff provided the hospital Medical Staff Bylaws, MEC meeting minutes, and ED policies and procedures. There was no evidence that the Medical Staff approved defined scope of practice, and role of paramedic members to provide direct patient care to patients in the ED.

2. On the afternoon of 04/18/14, the CNO and Emergency Department Manager told surveyors that paramedics will be working in the emergency department triaging patients and providing patient care within their scope of practice, which will free up our registered nurses.
3. On the afternoon of 04/17/14, the CNO told surveyors she was unaware of what paramedics scope of practice included but was learning.
4. Two (Staff O and GG) of two personnel records reviewed did not document defined scope of practice, role, and supervision when working in the emergency department.

Based on observation, document review and staff interview, it was determined the hospital failed to ensure nursing staff prepared and administered drugs and biologicals according to recognized standards of practice.

Findings:

During tours of the surgery department, the following observations were made:

1. Bags of intravenous and irrigation fluids had been removed from the overwrap and were stored in various areas. The hospital failed to develop and implement a policy and procedure that required staff to follow the manufacturer's recommendation to only remove the overwrap immediately prior to use.

2. Swollen bottles of sterile water were found in the operating room. The nursing staff verified these bottles may have been exposed to excessive heat. The bottles were available for patient use. The hospital failed to develop and implement a policy and procedure regarding warming of IV fluids and irrigation fluids. There was no policy on drug and biological storage requirements.

3. On 04/17/14, two 100 ml bags of intravenous solution were found in an anesthesia cart. Both bags had been pre-mixed with medication additives. One bag was dated 04/17/14. There was no time documented as to when the medication was added. The other bag was dated as mixed on 04/12/14, five days prior to the observation by the surveyor.

The hospital had no policy and procedure that directed staff to use admixtures within one hour of preparation.

4. Some multi-dose medications were found open in the anesthesia cart. Some of the vials had not been dated as to when they were opened. One open vial had a stopper that was covered with clear, plastic medical tape. The hospital did not have a comprehensive policy on the safe use of multi-dose medications.

5. A multi-dose bottle of Cetacaine spray was found on an anesthesia machine. The bottle had the applicator attached. The bottle remained open and in the operating room during multiple patient procedures, although Cetacaine spray was not used during any of those cases.

6. In the anesthesia cart, syringes and needles had been removed from the sterile packaging and were assembled in advance and ready for use. The syringes and needles were not used the day of the observation. The hospital did not have a policy and procedure that prohibited the removal and assembling of sterile syringes and needles prior to use.

Based on record review, policy and procedure review and staff interview, it was determined the hospital failed to ensure verbal orders were used infrequently.

Findings:

Ten of ten clinical records reviewed had documentation of multiple verbal orders from physicians.

Some records had no documentation of any written physician's orders.

The CNO stated some physicians were not proficient with the use of the electronic medical record.

The hospital administrative staff was asked to provide a policy and procedure for the use of verbal orders. None was provided.

Based on personnel file review, medical record review and policy and procedure review, the hospital failed to ensure blood products were administered in accordance with approved medical staff policies and procedures and according to Oklahoma State Board of Nursing guidelines.
Findings:
1. A hospital policy titled, "Blood Product Administration," had no documentation of the LPN's role in blood or blood product administration. The policy referenced only the role of the registered nurse.
2. The Oklahoma Board of Nursing Guidelines for the Role of LPNs in IV therapy/medication administration documents, "... Employer policies and procedures should address at least the following:... determine routes of administration... by which the LPN may infuse solutions, medications and if appropriate blood and blood products... The employer should have a mechanism for training and competency evaluation for these skills..."
3. Two of two LPN staff files reviewed (staff CC and staff DD) had no documentation of IV therapy or blood administration training and competency evaluation.

4. A transfusion reaction was documented on 12/15/13. A detail report about the adverse event documented an LPN (staff CC) was involved in the administration of the blood product. There was no documentation as to supervision by an RN during the blood product administration.

Based on document review, policy and procedure review and staff interview, it was determined the hospital failed to ensure appropriate actions and oversight was taken by the nursing sevices and pharmacy services departments in response to drug administration errors.

Findings:

1. The hospital had no policy and procedure that identified the types of events that must be reported immediately to the attending physician, as well as those to be reported to the QAPI program.

2. There was no documentation medication errors were reported to the QAPI program. The QAPI program did not require reporting of medication errors and did not evaluate "near misses."

3. The pharmacy and therapeutics committee meeting minutes had no documentation medication errors and near misses were reported.

4. Reported medication errors were not documented in the patients' medical records.

5. There was no documentation of any other method of medication error identification other than through incident reporting. There was no evidence the pharmacist or nursing leadership observed medication passes or performed concurrent and retrospective review of clinical records.

6. There was no documentation the pharmacy and nursing departments collaborated to review and analyze processes related to an adverse drug event or error.

7. The nursing staff stated the only information they knew about medication errors was to document them on an incident report form.

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

a. develop and implement comprehensive pharmacy services policies and procedures, including those to minimize drug errors;

b. provide meaningful participation by pharmacy in the QAPI program;

c. ensure drugs and biologicals were stored according to manufacturer's instructions. See Tag A-0491;

d. ensure the pharmacist was responsible for developing, supervising and coordinating all pharmacy services throughout the hospital. See Tag A-0492;

e. ensure pharmacy services participation in decisions about emergency medications in the surgery department. See Tag A-0500;

f. prohibit the preparation of intravenous admixtures outside the laminar airflow hood for medications that were not administered within the hour and failed to prohibit assembling sterile needles and syringes, other than immediately prior to use. See Tag A-0501;

g. ensure unusable medications were not available for patient use. See Tag A-0505; and

h. the hospital failed to ensure appropriate actions and oversight was taken by the pharmacy services department in response to drug administration errors. See Tag A-0508.

Findings:

1. The hospital was asked to provide pharmacy services policies and procedures. A policy and procedure manual, last reviewed in 2008, was provided. There was no organization to the manual. There was no accurate table of contents. The policy and procedure manual provided to the surveyors was not useable in its current state. The manual had no documentation the policies were reviewed and approved by the medical staff.

No comprehensive policies could be found that addressed drug administration errors, adverse drug reactions and drug incompatibilities.

2. A review of QAPI meeting minutes for January 2014 had no documentation of reporting of indicators by the pharmacy department. The pharmacy QAPI report for the October 2013 meeting was limited to formulary additions and back-ordered medications.

The August 2013 QAPI meeting minutes (a non-pharmacy department report) documented medication error reporting was not accurate and that investigation into medication errors should look at problems with processes. There was no documentation of action taken as a result of the report in August 2013.

The pharmacy services report for the August 2013 meeting was limited to the hospital formulary and back-ordered medications.

3. See also other tags cited within the pharmacy services Condition of Participation.

Based on observation, policy and procedure review and staff interview, it was determined the pharmacy services department failed to develop, approve and implement current policies and procedures and failed to ensure drugs and biologicals were stored appropriately in the surgery department.

Findings:

1. Throughout the survey, various nursing staff members were asked about specific pharmacy policies. They stated they were not familiar with those policies and did not have access to them. They were asked how they were made aware of correct medication practices. They stated they "followed along with what everyone else was doing."

2. The pharmacy policies provided to the surveyors were outdated and no longer current. There was no documentation the policies were ever reviewed and approved by the medical staff. There were missing policies.

3. Observations were made of drugs and biologicals stored incorrectly in the surgery department. Members of the nursing staff were observed mixing and storing medications outside of the standards of practice.

4. The surgery staff stated the pharmacist did not come into the OR and did not have oversight of the pharmaceuticals stored there.

Based on document review, observation and staff interview, it was determined the hospital failed to develop and implement a comprehensive job description for the hospital pharmacists and failed to ensure pharmacy services were provided according to accepted standards of practice.

Findings:

1. The personnel files for the pharmacists had no current and comprehensive job description. There was no documentation the pharmacists' job performance was evaluated.

2. Pharmacy and Therapeutics committee meeting minutes were reviewed. The content of the minutes was limited to information on changes to the formulary, drug alerts and shortages.

3. There was no documentation in any hospital meeting minutes that referred to medication errors, or adverse drug events. There were no reports of inspection of all drug/biological storage areas within the hospital.

4. There was no documentation the pharmacists evaluated the job performance of pharmacy staff.

5. There was no documentation of pharmacist participation in department-related QAPI activities.

The findings were reviewed with hospital leadership. They stated the regular pharmacist was on an extended medical leave.

Based on observation and interview, it was determined the hospital failed to ensure the pharmacist was involved in decisions about emergency medications for the surgery department.

Findings:

The surgery department emergency cart was observed. The staff was asked how decisions were made about the inventory of medications in the cart. They stated they were not sure.

They were asked about the medications for a malignant hyperthermia (MH) crisis. They stated the only medication that was supplied was Dantrolene and sterile water for mixing it. The staff stated there were no other medications provided for this emergency.

They staff stated they did not keep cold IV and irrigation fluids on hand for MH.

The staff was asked if the pharmacist was consulted about the required medications and biologicals for MH and other medical emergencies in the OR. They stated the pharmacist was not involved with any medications and biologicals kept in the OR.

Based on observation and interview, it was determined the hospital failed to prohibit the preparation of intravenous admixtures outside the laminar airflow hood for medications that were not administered within the hour. The hospital also failed to prohibit assembling sterile needles and syringes, other than immediately prior to use.

Findings:

During a tour of the operating rooms, small bags of intravenous fluids with medications added were found in the anesthesia cart. One bag was dated five days prior to the observation. Another bag was dated the day of the observation. There was no time of preparation documented on the label. The medication was not administered during the three hours of the observation.

The nursing staff in the OR stated the CRNA routinely premixed medications in IV bags "in case they were needed." She stated the CRNA prepared medications on top of the anesthesia cart. At the time of the observation, the top of the cart was cluttered and showed evidence of dust and debris. Non-medicinal chemicals were present on top of the cart.

In a lower drawer on the anesthesia cart, multiple syringes and needles had been removed from sterile packaging and assembled for use. it could not be determined (and the staff did not know) how long those syringes and needles had been there.

The nursing staff was asked if the pharmacist was aware of the practice. She stated she didn't know, but assumed not, since the pharmacist never inspected the OR medications.

There was no policy related to the preparation of admixtures by personnel outside of the pharmacy.

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

Findings:

During a tour of the surgery department, the following observations were made:

~Multi-dose injectable medication vials were found opened and undated in the anesthesia cart.

~Open, undated topical medication was found on the anesthesia machine.

~Medications were found outside of protected storage in the OR when patients were present. The medications were not used on those patients.

~Medications were not stored in a sanitary manner.

~Open bottles topical solutions such as betadine and alcohol were found open and undated.

~Swollen bottles of sterile water for irrigation were found in cabinets in the OR.

~IV fluids were stored without the protective overwrap.

~One vial of injectable medication had the protective cap over the stopper removed. The stopper was covered with plastic medical tape.

The staff stated they did not have any direction about storage of medications. They were not aware of any rules about the use of open medications and biologicals.

Based on document review, policy and procedure review and staff interview, it was determined the hospital failed to ensure appropriate actions and oversight was taken by the pharmacy services department in response to drug administration errors.

Findings:

1. The hospital had no policy and procedure that identified the types of events that must be reported immediately to the attending physician, as well as those to be reported to the QAPI program.

2. There was no documentation medication errors were reported to the QAPI program. The QAPI program did not require reporting of medication errors and did not evaluate "near misses."

3. The pharmacy and therapeutics committee meeting minutes had no documentation medication errors and near misses were reported.

4. Reported medication errors were not documented in the patients' medical records.

5. There was no documentation of any other method of medication error identification other than through incident reporting. There was no evidence the pharmacist observed medication passes or performed concurrent and retrospective review of clinical records.

6. There was no documentation the pharmacy and nursing departments collaborated to review and analyze processes related to an adverse drug event or error.

7. The nursing staff stated the only information they knew about medication errors was to document them on an incident report form.

Based on observation and staff interview, the hospital failed to provide radiological services in accordance with accepted standards of practice.

Findings:

1. On the morning of 04/16/14, surveyors toured the radiology department with the radiology department manager.

2. Surveyors observed two bags of Normal Saline (NS) 1 liter (L) hanging and spiked in the Computed Tomography (CT) suite.

-Both 1 L bags of NS were not dated, timed, or initialed.
-One of the two bags of NS had approximately 100 milliliters of NS left in the bag.

The radiology manager verified both 1 L bags of NS were not dated, timed, or initialed.

3. The radiology manager told surveyors that NS 1 L bags of IV fluids and tubing are used for multiple patients to check the patency of each patient's IV site, and discarded after it is used up.

The radiology manager told surveyors if the IV fluids are not used after seven (7) days, then the IV fluids and tubing will be discarded.

4. On the morning of 04/16/14, the radiology manager told surveyors that the radiology department will stop using NS 1 L bags of IV fluids and tubing for multiple patients.

On the afternoon of 04/16/14, the radiology manager stated, "There will be a new policy and procedure immediately put in place for IV fluids and tubing to be single patient use."

5. On the afternoon of 04/17/16, the Infection Control Practitioner (ICP) told surveyors she was not aware that normal saline and tubing were being used on multiple patients. The ICP also indicated that she was not aware that normal saline was not dated, timed, initialed and used for up to seven days.

6. On the afternoon of 04/16/14, these findings were discussed with the CEO and CNO.

Based on observation, document review and staff interview, it was determined the hospital failed to ensure the facility was constructed, arranged and maintained for patient safety and to appropriately provide for the needs of the patients.

Findings:

1. A review of the hospital's QAPI meeting minutes had no documentation facility maintenance participated in the program. There was no documentation in the meeting minutes that indicated any hospital department reported problems with the physical environment.

2. A tour of the surgery department was conducted. The department did not have adequate space for the scope of services provided. All the required features for the surgery department were not provided.

There were no clean and dirty utility rooms. There was no medication room. The department did not have an anesthesia workroom. The operating rooms shared a janitor's closet with the recovery room. There was no biohazard waste collection room within the surgery department. There were no rooms designated for clean and dirty linen storage. There was no storage areas for chemicals.

The department had no provision for maintaining cold fluids in preparation for a malignant hyperthermia emergency.

There was no sterile supply room. Sterile surgery supplies and instruments were stored in the surgery corridor in the middle of the department traffic pattern. The sterile supplies were on shelves that were rusted, dirty and dusty. Sterile supplies were stored within the splash zone of the scrub sinks. Sterile supplies were also stored immediately adjacent to a steam sterilizer and were repeatedly exposed to the heat and the steam from the sterilizer. According to AAMI, the sterile storage area should be in a separate, enclosed, limited-access area, the function of which is to store sterile and clean supplies.

The decontamination room did not have enough square footage to accommodate the scope of work required in this room. Because of space limitations and resulting modification of infection control practices by staff, obvious cross-contamination was observed during the survey.

The room did not have three functionally separate areas for different levels of decontamination as recommended by the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of periOperative Registered Nurses (AORN).

There was inadequate space for the storage of personal protective equipment (PPE), cleaning supplies, regulated waste and sharps. There was no soiled linen hamper. There was place to store accessories for the automated testing equipment and automated washer. Work surfaces were not made of non-porous material.

There was no provision for a separate hand washing station. Staff washed their hands at the instrument decontamination sink.

The room did not have daily terminal cleaning and did not receive periodic deep cleaning as required. There were non-intact surfaces throughout that could not be disinfected. Some equipment surfaces had evidence of rust and mineral deposits that prevented adequate disinfection.

The sterile processing room was not large enough for the scope of work required in this room. There was no provision for the storage of protective wear, supplies for cleaning, monitoring supplies, packaging materials and preparation supplies.

The room did not have a lighted magnifier and there was no separate hand washing station.

The room was not maintained and cleaned in a manner according to required standards of practice. There were many unfinished and non-intact surfaces. There was damaged and unfinished wood surfaces that could not be disinfected.

Equipment in this room was obviously dirty, dusty and grimy. Some equipment was rusted. Stainless steel surfaces were dirty and had soil and debris that could be found on fingertips after it was touched. Surgical instrument were found on a metal cart in the sterile processing room. The staff stated the instruments were clean and ready for packaging and sterilization. The shelves on the cart were so dirty that soil was visible on the hands when it was touched.

Instrument wrappers were stored immediately adjacent to the automated washers and were subject to splash contamination.

Multiple surgical instruments were hung unsterile on a peg board. The peg board had visible soil. The instruments were not processed, packaged and sterilized. Closer inspection showed the instruments had been hanging so long they had become dirty and contaminated again. When staff was asked why they stored the surgical instruments this way, they stated they just took them down and sterilized them as they needed them.

The sterile processing room was also used as an office. Books and binders were placed on surgical instrument wrappers that should remain clean. A computer on a stand was placed in the sterile processing room across from the steam sterilizer.

There was a corkboard bulletin board in the room. Papers were hung on the walls. Other supplies needed for sterile processing were not stored in enclosed cabinetry.

Other than in the staff changing rooms, there was no staff hand washing facilities in the department. Staff stated they washed their hands in the surgical scrub sinks.

A closet within the OR was re-purposed into an endoscope processing room. The room did not meet the physical requirements for this function. The door was removed so that the room opened up to the sterile core. There was a drain hole in the floor. It was not possible for staff to work in this room without multiple infection controls breaches. Countertops and the floor was not intact and could not be disinfected. Obvious dust, dirty and grime was found in this room. The room could not be terminally cleaned.

3. Traffic and workflow processes in and through the department did not minimize the potential for cross-contamination. There was no logical traffic flow from clean areas to dirty areas.

Staff was observed in and out of the surgery department without regard for required infection control practices. Surgical staff sometimes wore jackets to cover their surgical attire when leaving the OR, but did not remove the cover jacket when returning to the OR.

Staff entered and exited the sterile processing via a public hallway. There was no provision for staff to don and discard protective wear required to cover surgical attire when leaving the department.

4. Disrepair throughout the surgery department prohibited adequate disinfection and contributed to environmental contamination. A telephone in an operating room was placed on the floor because it had become unattached from the wall where it was originally installed.

Surfaces of walls, ceilings and floors were damaged. There was overall evidence of dust accumulation and other sources of contamination, including water damage and unknown stains. Dust and splashes were observed on light fixtures in the surgery department, even those found on high ceilings. There were many porous surfaces found throughout the surgery department that could not withstand frequent cleaning and wet conditions.

Many of the ceiling materials were constructed of particulate and fiber-shedding materials. Ceiling tiles in various areas of the surgery department were broken, stained, no longer intact or missing. Some had evidence of mold and mildew. Some were cracked and flaking.

Directly over an OR table, an air vent was hanging down out of position. The attic space was exposed to the OR environment and air circulation was shared between the OR and the attic.

Dirty adhesive tape was found on multiple pieces of surgical department equipment. This equipment required daily disinfection. Adhesive tape cannot be disinfected.

5. Appropriate temperatures, humidity levels and air exchanges were not maintained in any area of the surgery department. This was documented by staff for more than a year. Equipment to regulate these environmental conditions had not been repaired.

6. Documents reviewed and staff interviews conducted indicated the department experienced frequent equipment failures, including critical sterilizing and high-level disinfection equipment failure.

The department was filled with old, broken, rusted or discarded equipment from other areas. Circulating nurses in the OR used a broken, chipped and rusted over-bed table as a desk. Equipment that was broken and never repaired was not removed from the OR. Almost all pieces of equipment found in all the operating rooms was significantly rusted and could not be disinfected.

There were many pieces of equipment found in the OR with ripped upholstery that exposed the foam padding. None of this equipment could be disinfected.

7. The department had no process for daily terminal cleaning and had no schedule for periodic deep cleaning. The floors throughout the department were scuffed, dingy and stained. Tile surfaces were dusty and had evidence of splashes and build-up of mineral deposits. Sinks and fixtures had mineral deposits that could not be disinfected.

8. A large steam sterilizer in the sterile core was not sealed appropriately and air circulated under and around it. Air coming from the sterilizer mechanical room was shared with the OR. The mechanical room was extremely dirty and had many contaminants in it. The sterilizer was installed so that mechanical parts and plumbing was exposed to the surgical environment.

9. A medication room in the recovery room was dirty. Surfaces and walls were not intact and could not be disinfected. The room was used for general storage and was not maintained exclusively for medication preparation. There was no evidence the room was terminally cleaned or deep cleaned.

10. See also the Life Safety Code survey documentation for deficiencies related to the physical plant.

Based on observation, interviews with staff and review of hospital documentation, the hospital did not 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:
1. The hospital did not have an ongoing infection control program that reviewed hospital practices and infections/communicable diseases, analyzed data on these practices and infections, developed qualitative plans of actions to and provided follow-up to ensure corrective actions were appropriate. (Refer to Tag A-0749)

2. The hospital did not ensure the infection control program had a current tracking mechanism for patients and staff to track infections and possible transmissions of infections and communicable diseases. On the afternoon of 04/17/2014, the Infection Control Practitioner (ICP) was asked if the hospital had a mechanism in place to track patient and staff infections. The ICP stated that she did track staff and patient infections. The ICP was asked to provide documentation for tracking of infections. No documentation was provided. The ICP stated that she did not document it.

3. The disinfectants used throughout the hospital had not been reviewed and approved by the hospital's infection control committee. On the afternoon of 04/17/2014 the ICP was asked if she had reviewed and approved the disinfectants used in the hospital. She stated that she had not.

4. Leadership did not ensure infection control concerns and issues are reviewed, analyzed and corrective actions are taken through the quality assessment and performance improvement process. (Refer to Tag A-0756)

5. See also Tags A-0700 and A-0940 for failure to provide and maintain sanitary conditions in the surgery department.

6. On 04/17/14, observations were made of a circulating nurse who donned gloves before coming into the OR. She kept the same gloves on as she cared for the patient, prepared and administered medications and handled contaminated items in the room. She wore the same gloves throughout the entire surgical procedure. She touched various equipment surfaces, door knobs, drawer pulls, etc. with the same contaminated gloves. These surfaces were not disinfected between patients.

7. At the beginning of the survey, hot water was not available at the hand washing sink in the women's restroom in the OR changing room.

8. The OR did not maintain adequate records of sterilization.

9. Allied health staff files lacked documentation of immunizations and TB skin testing.

Based on observation, interviews with staff and review of hospital documents, the hospital did not develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.

Findings:

On the morning of 04/16/2014, hospital administrative staff was asked to provide infection control meeting minutes, infection control policies and procedures, all infection control surveillance activities and the name of the infection control officer.
1. A binder was provided that contained a monthly count of infectious diseases seen in all areas of the hospital but there was no documentation of any investigative actions taken. On the afternoon of 04/17/2014 the Infection Control Practitioner (ICP) was asked if she investigated any infectious/communicable diseases throughout the hospital. She stated that she did investigate but did not document investigations.
2. There was no documentation that any personnel infectious/communicable diseases had been investigated.
3. There was no documentation of regular environmental rounds for all areas of the hospital. On the afternoon of 04/17/2014, the ICP was asked if she made environmental rounds. She stated that she did but did not document it.
4. See Tag A 0529.
5. There was no documentation of active surveillance activities throughout the hospital. On the afternoon of 04/17/2014, the ICP was asked if she conducted surveillance of all areas of the hospital. She stated that she did but did not document it.
6. There was no documentation that the disinfectants used in the hospital had been reviewed and approved by the ICP, the infection control committee and the medical staff. On the afternoon of 04/17/2014, the ICP was asked if she had reviewed and approved the disinfectants used in the hospital. She stated no she had not reviewed and approved the disinfectants used.
7. On the morning of 04/18/2014, 18 employee files were reviewed. Eighteen of eighteen employee files contained no documentation of the employee being fit tested for respirator use. Respirators are used when employees are at risk for exposure from patients with a communicable respiratory illness to prevent the employee from contracting the illness.
According to the Occupational Safety and Health Administration (OSHA), "Fit testing of all negative or positive pressure tight-fitting facepiece respirators is required prior to initial use, whenever a different respirator facepiece is used, and at least annually thereafter. An additional fit test is required whenever there are changes in the user's physical condition that could affect respirator fit (e.g., facial scarring, dental changes, cosmetic surgery, or an obvious change in body weight). The employer must be fit tested with the same make, model, style, and size of respirator that will be used. "
8. On the afternoon of 04/18/2014, the ICP was asked if employees had been fit tested for respirator use. She stated that the hospital uses the disposable respirator and that nobody had been fit tested.

Based on Quality Assessment Performance Improvement (QAPI) review, infection control policies and procedures and infection control meeting minutes it was determined the hospital leadership failed to ensure infection control problems were addressed through the QAPI committee.
Findings:
1 Review of QAPI did not document evidence that the hospital leadership reviewed and analyzed infection control data.
2. There was no evidence that all departments of the hospital were included and monitored through the infection control/prevention program.
3. There was no documentation that the hospital developed a corrective plan of action to reduce and/or prevent transmission of organisms and improve patient care to ensure a safe and sanitary environment.
4 There was no documentation that the hospital leadership required ongoing infection control training and competency for all hospital staff.

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

a. define the scope of surgical services approved by the medical staff and failed to provide an organizational chart for surgical services. See Tag A-0941;

b. maintain an accurate roster of practitioners with surgical privileges. See Tag A-0945;

c. maintain current policies and procedures for the surgery department. See Tag A-0951;

d. ensure a medical history and physical (H&P) examination was completed prior to surgery or anesthesia. See Tag A-0952;

e. ensure all required equipment was provided for the operating room. See Tag A-0956;

f. provide post-operative care according to recognized standards of practice. See Tag A-0957;

g. maintain an operating room register according to the requirements. See Tag A-0958;

h. ensure operative reports were provided according to the requirements. See Tag A-0959;

i. maintain surgery department traffic flow patterns according to standards of practice. See Tag A-0700;

j. provide appropriate cleaning between surgical cases and provide appropriate terminal cleaning;

k. enforce the use of proper surgical attire for staff and patients;

l. sterilized materials were packaged, handled, labeled and stored to ensure sterility. The hospital did not keep adequate records of sterile processing; and

m. the hospital failed to ensure temperature, humidity and air exchanges were maintained within accepted standards of practice. See Tag A-0700 and Life Safety Code survey.

Findings:

1. On 04/17/14, observations were made of the operating rooms. One room had clean linen on the operating table. The staff stated the room had been terminally cleaned for the day. However, there was trash in the room, trash in a biohazard container in the room and old suture was found on the floor.

It was observed that all trash and soiled linen was not removed from the operating rooms between cases but was allowed to collect until the receptacles were full.

Sharps collection containers were overfilled. Blood contaminated suture was hanging out of one sharps collection container in an operating room.

During an observation of a surgical procedure, a nurse wore contaminated gloves throughout the procedure. All the surfaces touched with the contaminated gloves were not disinfected between patients. In addition, the equipment that touched the patient, such as a blood pressure cuff, EKG leads and a pulse oximeter were not disinfected between patients.

2. Because the OR did not have a biohazard collection room within the department, the OR staff placed large red biohazard containers (the type of container transported on a truck for disposal)in the operating rooms. The containers collected biohazard waste from multiple patients and were not emptied or removed from the room at the conclusion of the surgical case.

3. Soiled linen and trash receptacles used in the ORs had foot operated lids that popped open when items were deposited in them. This type of receptacle promoted air currents that could carry contaminants from the the trash and soiled linen throughout the operating room.

4. Because the surgery department lacked adequate storage space, unnecessary equipment was stored in the operating rooms and was not disinfected between patients or terminally cleaned at the end of the day.

5. Gallon bottles of high-level disinfection agents were stored in the operating room supply cabinets where sterile surgery supplies were stored.

6. Sterile and non-sterile supplies were stored together throughout the department. Laryngoscope blades were stored unprotected on top of the anesthesia cart and they remained there through multiple surgical cases. Laryngoscope blades were stored unprotected from contamination in the drawers of the anesthesia cart.

7. Cleaning agents, trash bags and other housekeeping supplies were stored in the operating room sterile supply cabinets with sterile surgical supplies.

8. OR staff did not adhere to standards of practice regarding surgical attire. Staff wore surgical attire out of the surgery department without first covering with a gown or labcoat.

When a cover garment was worn, it was not taken off before returning to the OR. Staff wore shoes without covers in and out of the OR.

Patients were brought into the operating room in street clothes. Some patients' clothing was obviously dirty. When the patients cam off of the OR table, visible soil was left on the linen.

Patients' dirty shoes (some that had mud and dried animal waste) were placed under the patient carrier and brought into the operating room.

9. Sterile peel packages were stored wrinkled and crammed into bins. Items were double peel-packed with the internal packaging folded. Sterile supplies were stored within the splash zone of sinks and nearby the steam and heat from sterilizers. Sterile packages were stored under containers of liquids. Sterile packages were stored on dusty, rusted shelves.

Peel packages were over-filled with too many instruments. Peel packages were processed with the internal sterilization indicator obscured from view. Heavy instruments were processed in peel packages.

10. There were inadequate records of steam sterilization loads. The hospital did not have a policy to guide this practice. The hospital did not document and maintain records of steam sterilization as required by national standards of practice.

There was inadequate documentation of immediate use steam sterilization (IUSS). The staff documented reasons for IUSS such as, "kept unsterile", "other item broken and needed for second case", and "item brought by rep unsterile." The OR manager agreed these were unacceptable reasons for IUSS.

11. The findings were reviewed with the surgery department manager and the infection control professional. They stated they were aware of some of the issues.

Based on document review and staff interview, it was determined the hospital failed to define the scope of surgical services approved by the medical staff. The hospital also failed to provide an organizational chart for surgical services.

The OR manager confirmed this finding.

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

Findings:

1. A review of medical staff files had incomplete or missing information about surgical privileges. One surgeon's file documented privileges for "cosmetic surgery" but the specifics about the types of cosmetic procedures was not documented.

2. A review of the medical records documented dental assistants worked as scrub techs in the OR. There was no documentation the medical staff determined the specific privileges for the dental assistants working in the OR.

3. On 04/17/14, the OR manager stated the department kept a roster of practitioners with surgical privileges. She was uncertain how often it was updated. She stated the roster included physicians only and did not include a list of those with suspended or restricted privileges.

4. The hospital did not provide a list of practitioners that must be supervised in the OR. One surgeon's file documented the surgeon was to be under direct supervision to perform gastrointestinal endoscopy. This information was not provided in writing to the surgery department.

Based on policy and procedure review and staff interview, it was determined the hospital failed to maintain current policies and procedures for the surgery department.

Findings:

On 04/16/14, the hospital was asked to provide the surgery department policies and procedures. A manual was provided with policies and procedures in the process of revision.

The majority of the policies were not current. There was no clear documentation as to when they were last reviewed, updated and approved by the medical staff.

There was no documentation the policies and procedures were based on nationally recognized standards of practice.

There was no organization to the policy and procedure manual and individual policies were difficult to find. However, it was determined the manual did not include all the policies required.

The surgery staff stated they did not have access to the policies and procedures.

Based on clinical record review and staff interview, it was determined the hospital failed to ensure a medical history and physical (H&P) examination was completed prior to surgery or anesthesia for six of ten records reviewed.

Findings:

Clinical records were reviewed for ten patients who had surgical procedures.

1. Patients #17, 20, 23, 24, and #26 had no H&P prior to surgery.

2. Patient # 25 had an incomplete H&P prior to surgery.

3. The medical records staff stated the clinical records given to the surveyors were complete medical records.

Based on observation, policy and procedure review and staff interview, it was determined the hospital failed to ensure all required equipment was provided for the operating room.

Findings:

On 04/17/14, the surgery department's equipment was observed. The OR manager stated the surgery department did not have a tracheotomy set as a part of the required emergency equipment.

The hospital did not have a policy and procedure approved by the medical staff that documented what emergency supplies and equipment were required for the operating room.

Based on clinical record review and staff interview, it was determined the hospital failed to provide post-operative care according to recognized standards of practice for 10 of 10 records reviewed.

Findings:

1. A review of surgery department policies and procedures had no documentation of admission and discharge criteria for the post-anesthesia care unit (PACU). There were no policies and procedures to govern the recovery room.

2. A review of personnel files for registered nurses who worked in PACU had no documentation of training and experience for this specialized area.

3. Patient #17, a pediatric patient, had inhalation anesthesia with intubation for 50 minutes. The post-anesthesia care record documented the patient's vital signs were recorded at the time of admission to PACU and again five minutes later. No other vital signs were recorded. Temperature was only documented one time.

There was no documentation of the patient's airway status at the time of admission to PACU. There was no documentation of assessment of the patient's surgical site, the presence or absence of bleeding, or of the presence of pain. There was no head to toe assessment of the patient.

The patient was discharged home 30 minutes after arrival to recovery.

4. Patient #18, a 71 year old, received general anesthesia for one hour and 18 minutes. The patient's IV was discontinued 12 minutes after arrival in PACU. The patient's vital signs were monitored for a period of 20 minutes. Temperature was only documented one time.

The patient's airway was not assessed. There was no documentation of assessment of the patient's surgical site, the presence or absence of bleeding, or of the presence of pain. There was no head to toe assessment of the patient.

The patient was discharge home 45 minutes after arrival to recovery.

5. Patient #19, a 74 year old, had two surgical procedures with sedation that lasted 50 minutes. The patient's vital signs were recorded three times over a period of ten minutes. There was no documentation of assessment of the patient's surgical sites, the presence or absence of bleeding, or of the presence of pain. There was no head to toe assessment of the patient.

The PACU record documented the patient was discharged home 30 minutes after admission to recovery.

This patient returned to the emergency room that evening with a complication that required additional surgery.

6. Patient #20 had a surgical procedure with sedation that lasted 40 minutes. The patient's vital signs were monitored once during a five minute period. There was no documentation of assessment of the patient's surgical site, the presence or absence of bleeding, or of the presence of pain. There was no head to toe assessment of the patient.

The patient was discharged home 20 minutes after admission to recovery.

7. Patient #21 had a surgical procedure with general anesthesia that lasted one hour and 45 minutes. The patient had vital signs recorded three times over 15 minutes. Temperature was recorded once. There was no documentation of assessment of the patient's surgical site, the presence or absence of bleeding, or of the presence of pain. There was no head to toe assessment of the patient.

The patient was discharged home 50 minutes after admission to recovery.

8. Patients #22-#26 had similar findings in the clinical records.

9. Patients who were administered reversal agents were not given additional recovery time. Those patients were discharged home or transferred to the inpatient unit within the same time frames as all other recovering patients. The hospital had no policy and procedure to direct care of patients who received a reversal agent.

10. None of the records reviewed had PACU discharge orders received from the physician.

11. The CNO was made aware of the findings. No comment was made.

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

Findings:

On 04/17/14, the operating room register was reviewed. The following deficiencies were noted:

1. Staff persons documented on the register were not identified with a first name or initial. Staff were identified by last name only.

2. No professional titles were documented i.e., RN, CST, MD, DO, CRNA, etc.

3. Circulating nurses were identified by first and last initials only. There was no documentation the circulating nurses were registered nurses as required.

4. A product representative present in a surgical case was identified by first name only.

5. A student was present in a surgical case but there was no documentation as to the type of student (RN, LPN, scrub tech, etc.). There was no documentation of the school represented.

6. The operating room register did not identify a pre and post-operative diagnosis.

7. Two patients (#19 and #25) had complications as a result of the surgical procedures. These complications were not documented on the register.

8. The register documented a CRNA performed epidural steroid injections in the OR. There was no documentation of the supervising physician present in the room.

9. When IV sedation was documented on the register, there was no documentation as to who provided it.

10. The hospital had no policy and procedure to govern the operating room register.

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

Based on record review, policy and procedure review and staff interview, it was determined the hospital failed to ensure operative reports were provided according to the requirements for ten of ten operative reports reviewed.

Findings:

1. The hospital had no policy and procedure that governed operative reports.

2. Ten of ten operative reports reviewed were missing one or more elements or were completely missing. Some operative reports were not signed by the physician. Some operative reports were dictated by someone other than the surgeon.

3. The medical records staff stated the medical records provided were complete.

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

a. develop, approve and implement current anesthesia services policies and procedures that are based on nationally recognized standards of practice;

b. develop, approve and implement a written scope of anesthesia services;

c. develop, approve and implement an organizational chart for anesthesia services;

d. implement a system to identify, track and respond to adverse events related to anesthesia services;

e. ensure adequate supplies and equipment were provided and readily available for a malignant hyperthermia emergency; and

f. anesthesia services was not integrated into the hospital's QAPI program.

Findings:

1. At the time of survey, the hospital did not have current policies and procedures for anesthesia services. Many policies were missing according to the requirements at 482.52 (b). There was no documentation any of the policies and procedures had been reviewed and approved by the chief of anesthesia and by the medical staff and governing body.

2. The hospital did not have a written scope of anesthesia services.

3. The hospital did not have an organizational chart for anesthesia services.

4. The hospital did not have a system to identify, track and respond to adverse events related to anesthesia services.

5. At the time of survey, the hospital was not adequately prepared with all the required supplies and equipment to respond to a malignant hyperthermia event.

6. There was no documentation in the anesthesia policies, the QAPI program description, or in QAPI meeting minutes that indicated anesthesia services were evaluated for safe patient care.

7. The findings were discussed with hospital leadership. No comment was made.

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 two (O and GG) of two personnel files reviewed.

Findings:

1. On the afternoon of 04/18/14, the CNO told surveyors that paramedics will be working in the emergency department triaging patients and providing patient care within their scope of practice, which will free up our registered nurses.
According to CMS requirements, a registered nurse must supervise and evaluate the nursing care for each patient.
2. On the afternoon of 04/17/14, the CNO told surveyors she was unaware of what paramedics scope of practice included but was learning.
3. On the morning of 04/17/14, the Emergency Department (ED) Manager told surveyors that paramedics will primarily triage patients and re-assess patients.
4. There was no evidence that the Medical Staff approved defined scope of practice, and role of paramedic members to provide direct patient care to patients in the ED.
5. Staff training and education files were reviewed for evidence of demonstrated skills competencies for specialized tasks performed in the emergency room.

Both records did not have documentation of verification of skills competencies related to specialized tasks in the ED.

Both records did not document defined scope of practice, role, and supervision when working in the emergency department.