HospitalInspections.org

Based on record review and interviews with staff, the hospital failed to have an agreement with an outside source for credentialing and quality assurance to assure the quality and medical necessity of medical care at the hospital.

Findings:

1. Currently, the hospital has two physicians, only one of which has active staff category privileges, and two physician assistants that work at the hospital. The physician on active staff does not perform surgical procedures. The other physician works in the emergency department and performs endoscopy procedures.

2. Medical record review for the purpose of determination of the physician's delivery of quality care and medical necessity (peer review) was being conducted by a physician assistant.

3. Records provided did not contain evidence the hospital had an outside source to perform peer review functions and assist with the credentialing process for medical staff appointment.

4. The above findings were reviewed and verified with Staff A on the afternoon of 07/09/2014.

Based on surveyors' observations, review of hospital documents and interviews with hospital staff, the hospital failed to ensure the physical plant and environment is constructed, arranged, and maintained to ensure the safety of patients. The hospital failed to:

a. Appropriately modify rooms within the surgical areas according to nationally recognized requirements for these areas. Refer to Tag C-0221;

b. Provide housekeeping and preventive maintenance in the surgical areas to ensure the facilities, supplies and equipment were maintained for safety and quality. Refer to Tag C-0222;

c. Maintain proper ventilation, temperature and humidification in the surgical area according to accepted standards. Refer to Tag C-0226.


Refer also to LSC (Life Safety Code) Tags

Based on surveyors' observations, review of hospital documents, and interviews with staff, the hospital failed to ensure the surgical department was constructed, arranged and maintained in a condition to ensure the adequate care and safety of the patients and staff.

Findings:

Staff A stated on 07/01/14, the hospital remodeled the surgical area in 2007.

In OR #1 there is a double bowl sink, white metal cabinets that was rusting on the bottom which extended to the flooring. A non-manufactured wooden closet was used to enclose the back of the autoclave. There was also a box fan on the floor. Staff C said the fan was used by the housekeeping staff. The baseboards were separated from the walls.

There was no documentation positive airflow was maintained in the operating room (OR) and the sterile processing room.

There was no documentation negative airflow was maintained in the decontamination and endoscopy procedure area.

There is a single bowl sink in the decontamination room and no separate sink for handwashing.

No separate handwashing sink in the clean workroom.

The surgical area does not have all the required spaces, such as but not limited to, a post anesthesia care unit (PACU), storage space for sterile and clean equipment and a janitor's closet.

The ceiling tiles in the endoscopy procedure room are not washable.

Review of the Medical Staff Meeting Minutes for April 24, 2014 documented, "...We are also working on our scope room to meet the current requirements, We will begin scheduling scopes as soon as area is ready..."

Based on staff interview, review of hospital documents, and observation of hospital's clinical equipment, the hospital failed to have a preventative maintenance program to ensure the hospital's medical devices and equipment were maintained in safe operating condition.

Findings:

On 07/01/14, Staff D was asked for documentation of the preventative maintenance inspection for the the ultrasound and magnetic resonance imaging (MRI) equipment. None was provided.

The hospital performs surgical procedures and maintains an autoclave for cleaning instruments.

On 07/08/14, Staff C stated the hospital purchased a autoclave around 2012. Staff C was asked for the yearly inspection of the autoclave, none was provided. There was no evidence an initial and yearly inspections of the autoclave had been completed..

Based on observation, hospital document review and staff interview, it was determined the hospital failed to ensure temperature, humidity and ventilation was maintained within acceptable standards.

Findings:

On 07/01/14, a tour was conducted of the surgery department.

1. There was no documentation positive airflow was maintained in the operating room (OR) and the sterile processing room.

2. There was no documentation negative airflow was maintained in the decontamination and endoscopy procedure area.

3. During the tour of the OR, Staff C stated the hospital had identified a problem with the humidification system in the OR and the problem had recently been repaired.

4. Inspection by the Life Safety surveyor revealed the humidification system for the OR was non-functioning.

Based on review of governing body meeting minutes and hospital documents and interviews with hospital staff, the hospital does not ensure the organizational structure of the hospital is effective in providing quality health care in a safe environment. The governing body failed to monitor, evaluate and ensure the services of the hospital. Refer to Tag C- 241 for details and findings.

Based on record review and interviews with hospital staff, the governing body does not ensure that policies governing the hospital's total operation are implemented and ensure quality health care is provided in a safe environment.

Findings:

1. The governing body did not ensure the Medical Staff followed their bylaws. The governing body did not have evidence of appointment to the medical staff of the practitioners providing patient care in accordance with medical staff bylaws.
a. Physician's #DD's and GG's Appointment/Reappointment Flow Sheet listed the physicians as recommended for the Staff Category of "Locums". According to the Medical Staff bylaws, Article IV. Categories of Medical Staff, that category did not exist.
b. The Appointment/Reappointment Flow Sheet for Physician #DD, under the "Department Affiliation" section for #DD, only as "Medical". This physician, in addition to emergency department services, performed surgical endoscopy services and information provided documented the physician might start providing laparoscopic surgery services.

2. The governing body does not ensure that all practitioners providing patient care are qualified and have current privileges granted. Two (#DD and GG) of three ( #CC, DD and GG) physician's credential files reviewed, of physician's who were currently providing care at the hospital, did not have evidence of current privileges granted. The physician's had been granted temporary privileges in December 2013 and expired in March 2014. Physician #DD was still performing surgical endoscopy procedures and working in the emergency department on a routine basis.

3. The governing body does not show oversight of the Medical Staff to ensure quality of care is provided by the hospital's medical staff. Meeting minutes did not demonstrate the governing body reviewed, analyzed and provided corrective action if indicated of the Medical Staff's activities through its meeting minutes. Staff A confirmed, on the afternoon of 07/09/2014, that Medical Staff meeting minutes were not forwarded to the governing body for review and action if indicated.

4. The governing body did not have evidence of oversight of the maintenance of the physical environment. Surgical services areas were not monitored, constructed and maintained to meet the required standards. Refer to Tag C-0320.

5. The governing body did not ensure the hospital had developed an active ongoing infection control program led by a trained professional that reviewed and evaluated infection control and prevention practices in the hospital, including surgical services, with corrective actions taken when needed, to ensure a sanitary environment and avoid sources and transmission of infections for patients and personnel. Refer to Tag C- 0278.

6. The governing body does not ensure that the hospital has an effective Quality Assurance and Performance Improvement (QAPI - the hospital's Department Head Meeting minutes) program to evaluate the quality and appropriateness of the diagnosis and treatment furnished.
a. There was no evidence QAPI meeting minutes were forwarded to the governing body for review, analysis and corrective action when indicated.
b. On the afternoon of 07/09/2014, Staff A stated QAPI meeting minutes were not forwarded to the governing body for review and action.
c. QAPI meeting minutes failed to demonstrate evidence of the hospital collecting and analyzing data concerning the quality and appropriateness of all patient care furnished in the hospital. Refer to Tag C-0336.

7. The governing body does not ensure a complete periodic evaluation of the hospital's total program is conducted at least once a year and includes a review of the following:
a. A representative sample of both active and closed medical records;
b. A review of the hospital's health care policies; and
c. An evaluation of the utilization of services, if policies were followed, and what changes if any were needed and has an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished. Refer to Tag C- 0330.

8. The governing body did not ensure the hospital had an agreement with an outside source to provide adequate peer review and assistance with the credentialing process. Refer to Tag C-0195 for details.

Based on record review and interviews with hospital staff, the hospital does not ensure the physician reviews and signs the records of all inpatients cared for by the physician assistant. This occurred in three (Patients# 7, 12 and 21) of five medical records reviewed of patients that were admitted to allied health staff.

Findings:

Staff FF is a physician assistant with admitting privileges to the hospital.

On the morning of 07/09/14, medical records were reviewed with Staff N and Q.

Review of the medial records for Patients # 7, 12 and 21 did not contain evidence of review and authentication of care, provided by Staff FF, by the supervising physician. this was confirmed by Staff N during medical record review.

The above information was presented to the administrator during the exit interview on July 9, 2014. No additional information was provided.

Based on review of hospital documents and meeting minutes, surveyors' observations, and interviews with hospital staff, the hospital failed to develop and provide services according to standards and written policies, as evidenced by failure to:

1. Ensure that outdated, mislabeled or otherwise unusable drugs are not available for patient use and ensure drug room staff are adequately trained. Refer to Tag C-0276.

2. Develop and maintain an effective ongoing infection control program, directed by a qualified staff with training, that reviewed, analyzed and provided corrective actions to prevent and reduce spread of hospital acquired infections and communicable diseases. Refer to Tag C-0278.

3. Ensure radiology services are performed by trained and orientated staff to protect patients and staff from radiation hazards and ensure the radiology department has oversight by a Radiologist or qualified Medical Staff. Refer to Tag C-283.

Based on personnel file review, observations and interviews with hospital staff, the hospital does not ensure the consultant pharmacist evaluates the performance and competency of drug room personnel who provide pharmacy services when the consultant pharmacist is not on the premises and assures that all outdated, mislabeled or otherwise unusable drugs are not available for patient use.

Findings:

The surveyors toured the hospital on the morning of 07/01/14.

1. Observations in the medical clinic:

4- vials of Ancef expired in March 2014,
Multi-dose vial (MDV) of 2% Xylocaine did not contain the date and time the vial was opened, and
One opened Single-dose vial (SDV) of 1% Xylocaine.

The above observations were confirmed by Staff I during the tour.

2. Observations in the surgical department:

Review of a hospital policy titled, "Emergency Medications", documents..." The Pharmaceutical Service Department is responsible for the integrity and security of medications contained in the crash carts..."

On the morning of 07/01/14, Staff B was asked who monitored for outdated medications in the surgical department, Staff B stated the surgery staff.

During the tour of the surgical department on 07/01/14, Staff C was asked who monitored for outdated medications in the surgical department, Staff C stated the pharmacy department.

Three bottles of indicator strips for the high level disinfectant were all expired.

The following medications in the crash cart were outdated: Epinephrine, Lanoxin, Lasix, Apresoline, Verapamil, Calcium, Adrenaline, Dilantin, Dopamine, Sodium Bicarbonate, Adenosine, Nitropress, Nitroglycerin, Lidocaine injection, Magnesium Sulfate, Dextrose 50 (D5W) and Marcaine.

The following medications in the anesthesia cart in OR #1 were outdated: Verapamil, Dexamethasone, Atropine, Epinephrine, Amiodarone, Phenytoin, Protamine Sulfate, Digoxin, Dopamine, Lidocaine Injection, Nitrobid Paste, Sterile Water and Viscous Lidocaine.

Irrigation solutions in the fluid warmer in OR #1 were not dated as to when they were put in and when they were to expire. Some of the bottles were swollen, indicating they had been exposed to excessive temperatures or had been in the warmers too long. Four bottles of the irrigation solutions had expired in 2013.

The following outdated medications were contained in the medication refrigerator in the sterile corridor:
2-Normal Saline bottles 3/2013
Pitocin 1/2013
Neostigmine 10/2012
Xylocaine 8/2013
Epinephrine 1/2014.

The above observations were confirmed by Staff C during the tour.


3. In the afternoon of 07/8/14, Staff B, stated Staff C and N both work in the drug room on an as needed basis.

The personnel files reviewed for Staff C and N did not contain evidence of orientation and competencies to the drug room by the consulting pharmacist.

Based on review of hospital documents, policies and procedures and meeting minutes, surveyors' observations and interviews with staff, the hospital failed to:

a. Develop and maintain an active on-going infection control/infection prevention (IC) program for ensuring a sanitary environment, and identifying and preventing infections and communicable diseases among patients and staff to include Surgical Services;

b. Analyze infection preventionist (IP) surveillance data and concerns, develop corrective actions when needed and conduct follow-up to ensure corrective actions are appropriate and sustained to ensure a sanitary environment and avoid sources and transmission of infections for patients and personnel; and

c. Provide on-going education/training for the IP in the principles and methods of infection control in order to develop, establish and direct an ongoing/sustainable infection control program.

Findings:

Plan/Program:
1. The hospital has not conducted a hospital-wide IC risk assessment to identify the types of patients, risks/concerns, organisms, and diseases prevalent in the community and hospital.

2. The hospital has not conducted a tuberculosis risk assessment.

3. The hospital does not have a current infection control plan (Plan) that details the types and frequency of monitoring for all departments to ensure infection control policies and procedures are followed and a safe and sanitary environment is maintained according to current accepted standards of practice.

4. These findings were reviewed and confirmed with Staff M on the afternoon of 07/02/2014.


IP Training/Education:
1. On the morning of 07/01/2014, administrative staff told the surveyors that Staff M was the infection control preventionist (IP).

2. Review of Staff M's personnel files did not contain documentation of ongoing training in the principles and methods of infection control in order to develop, establish and direct an ongoing/sustainable infection control program.

3. On 07/09/2014, administrative staff confirmed Staff M had not received ongoing training in establishing and maintaining a comprehensive effective infection control program. The infection control training/learning Staff M had completed was general knowledge as required for all hospital staff.


Policies and Procedures:
1. Although the infection control manual documented current review and approval of the policies and procedures, the policies and procedures were not current and all the the policies did not reflect current standards of practice and information. They did not contain documentation of what nationally recognized source/organization from which they were referenced.

2. The IC policy and procedure manual did not contain specific IC policies and procedures for Surgical Services and Central Sterile Services, including:
a. Policies and procedures on how to process instruments and the requirements testing of the equipment, including processing of endoscopes;
b. Policies and procedures for autoclaving, including types used by the hospital with details of hospital and manufacture approved sterilization temperatures and times and dry/exhaust times for each approved cycled used by the hospital.
c. Policies and procedures with details for cleaning between patient cases and terminal clean at the end of the day.

3. Although the IC policy and procedure manual did contain a hand hygiene policy and procedure, the policy did not address all the occasions this should occur according to current standards of practice, with reference to what nationally recognized source was used.

4. The IC manual policy and procedure did not contain specific policies for respiratory isolation protection of specialized masks, N-95 respirator. The IC policies and procedures did not specify:
a. Detail on how this was to be accomplished and by whom; and
b. Based on the current standards of practice and requirements by OSHA (Occupational Safety and Health Administration), how often fit testing would be performed.

5. The IC manual did not contain a policy and procedures on how patients and staff with potential or confirmed influenza will be medically managed, including:
a. Screening;
b. Any required tests to confirm infection;
c. Any particular requirements according to current CDC guidelines.

6. The IC manual's policy and procedure for reporting State reportable infections and diseases was not current. It was dated 1987. The policy and procedure did not detail the procedure to follow to submit data to the proper authorities, with delineation of responsibilities, including the most current list of reportable infections and diseases. Types of isolation required and for what amount of time to keep the patient in the required isolation.

7. The IC manual did not contain policies on disinfectant approval and list of approved disinfectants with what area used and application requirements, including:
a. mixture;
b. wet time contact with surface to be effective; and
c. what organisms each approved disinfectant kill.


Surveillance:
1. The IC program has not monitored to ensure all departments followed infection control policies and current recognized infection control practices on a regular scheduled basis to ensure compliance. The monitoring forms supplied for review were environmental rounds which provide only a "snap shot" and do not contain observation of entire tasks to ensure compliance with recognized standards of practice.

2. The Centers for Disease Control (CDC) and the Association for Professionals in Infection Control and Epidemiology (APIC) have identified hand hygiene as the first avenue/most important tool in the prevention of spread of organisms and diseases. Meeting minutes did not reflect hand hygiene was reported.

On the afternoon of 07/01/2014, Staff M supplied the surveyors hand hygiene observations/surveillance. The observations were not consistently performed each month or contained enough observations to calculate compliance and whether hand hygiene was accomplished at all the required times. The documents did not contain observations of each department and each discipline working in the hospital. No analysis had been performed and no information was reported to the infection control portion of the Department Head Meeting (the committee where infection control and quality assessment and performance improvement were processed).

3. Documents provided and meeting minutes did not demonstrate that, other than identifying patient nosocomial infections, the IC program monitored and evaluated infections of patients and staff to ensure infections and communicable diseases were not transmitted between staff and between patients and staff.

4. Central sterile processing is not monitored, including, but not limited to:
a. Maintenance and monitoring to ensure safe and effective autoclave sterilization;
b. Appropriate cleaning and packaging of instruments occurs, including endoscopes;
c. Sterilization practices - correct temperature, correct sterilizing time and correct dry time;
d. High level disinfection practices - correct product at correct temperature for correct amount of time; and
e. Appropriate disinfection occurs - products used according to manufacture's guidelines.

5. No monitoring of disinfectant applications throughout the hospital departments and locations to ensure:
a. Appropriate disinfectants are selected and used; and
b. The disinfectants are applied and remain "wet" contact time according to the manufacturers guidelines.
c. With the exception of the housekeeper, staff interviewed did not know if the hospital's disinfectants, 3M Neutral Quat Disinfectant, was not effective against C-difficile and did not know the "wet" contact times in order for the disinfectants to be effective. Surveyors also found Virex 256 (which also is not effective against C-difficile).

6. Infection control did not monitor/conducts observation of the Surgical Services Department. Staff M stated on 07/02/2014 that she was told that was not her responsibility.

7. Isolation monitoring was not conducted to ensure:
a. Patients are placed in appropriate isolation according to current CDC guidelines;
b. Isolation materials/supplies are readily available (Although staff knew the locations,staff had to go from area to area to show the surveyor where they would obtain the needed supplies, including the isolation signs.);
c. Staff, physicians, volunteers, and visitor follow appropriate isolation requirements; and
d. Appropriate disinfection of the room occurs.


Observations:
Refer to Tag C-320 for detailed information about surgical services observations. Observations including, but not limited to:
1. The surgical suite did not have a decontamination room with all the required spaces and equipment to clean dirty instruments and scopes.

2. Staff were not using chemicals and disinfectants appropriately.

3. The surgical services area contained structures, equipment and supplies with surfaces that could not be adequately cleaned and disinfected, some of which had rust.

4. A table-top autoclave was located in an inappropriate area in the clinic outpatient department.

5. Instruments were being autoclaved/sterilized in a closed/locked position and did not contain a chemical indicator strip in the peel-packs.


Meeting Minutes:
Staff A and M told the surveyors that the infection control and quality assessment and performance improvement business was processed through the hospital's Department Head Meeting.

1. The meeting minutes did not contain review, evaluation and analysis of infections to ensure infections and communicable diseases were not transmitted between staff and between patients and staff. Although nosocomial/HAI (hospital acquired infections) were identified in the attached reports, there was not review and analysis to determine if process should be changed to improve patient care and outcomes.

2. The meeting minutes did not demonstrate central sterile services were monitored, reviewed and analyzed with corrective actions taken and follow-up to ensure compliance with accepted standards of practice.

3. The meeting minutes did not contain documentation and review of surveillance/monitoring to ensure IC policies and procedures and current standards of practice are followed. Staff A confirmed on 07/09/2014 that this did not occur.

4. Concerns identified in meeting minutes showed no review and analysis to determine if corrective actions need to be developed or if current policies and procedures were followed.

5. The meeting minutes did not contain evidence disinfectants used in the hospital had been reviewed annually for appropriateness and approved for use. Staff M confirmed disinfectants had not been reviewed as part of IC.

6. The meeting minutes did not reflect employee illnesses and immunizations were part of the program. Review of health files for physicians and allied health files did not show complete immunizations as recommended by CDC and its advisory committee (ACIP). Annual influenza was not documented on all the files. Meeting minutes did not show employee illnesses were reviewed and analyzed to ensure transmission between staff and staff and staff and patients did not occur.

7. The meeting minutes did not reflect isolation monitoring was reviewed and analyzed to ensure:
a. Patients are placed in appropriate isolation according to current CDC guidelines;
b. Isolation materials/supplies are readily available (Although staff knew the locations,staff had to go from area to area to show the surveyor where they would obtain the needed supplies, including the isolation signs.);
c. Staff, physicians, volunteers, and visitor follow appropriate isolation requirements; and
d. Appropriate disinfection of the room occurs.

Based on policy and procedure manual review and interview with the hospital staff, the hospital failed to ensure all patient care policies are reviewed at least annually.

Findings:

The following policies had no documentation of an annual review:
Housekeeping 03/02/06
Dietary - 09/01/11
Laundry - 05/18/13
Anesthesia - 01/31/12
Operating Room, Operating Room Infection Control and Pharmacy - did not have any evidence of any current review.
Swing Bed - 04/26/13
Radiology - 12/2012
Respiratory Therapy - 05/28/05

Although the infection control policy and procedure manual had a current review date, the policies and procedure did not reflect current standards of practice or give reference sources. Refer to Tag C-0278 for details.

These findings were presented to the administrator during the exit interview on 07/09/14. No additional information was provided.

Based on review of the radiology department documents and interviews with hospital staff, the hospital failed to to protect patients and staff from radiation hazards.

Findings:

The hospital's MRI and ultrasound services are provided through a contract.

There was no documentation the contract personnel providing the MRI and ultrasound services were oriented to the hospital, trained, and deemed competent by the supervising radiologist and/or medical staff. This was confirmed by Staff D on 07/01/14.

The hospital did not have a health file for the contract staff providing the ultrasound services. This was confirmed by Staff A during the exit interview on 07/09/14.

On 07/01/14, Staff D was asked for documentation of the preventative maintenance for the the ultrasound and magnetic resonance imaging (MRI) equipment. None was provided.

There was no evidence the hospital has reviewed and approved policies and procedures for the MRI and ultrasound services.

The above information was presented to the administrator during the exit interview on the afternoon of 07/9/14. No additional information was provided.

Based on record review and interviews with hospital staff, the hospital failed to ensure that a list of all services provided through arrangements, contracts or agreements is maintained describing the nature and scope of the services provided.

Findings:

1. On 07/01/14, the surveyors was provided a list that contained the above information.

2. The list provided by the hospital was not complete.
Findings include, but not limited to:
a. The list supplied did not contain all the radiology contracts, including radiology badge readers and the physicist.
b. The list did not contain the organ procurement contract.

Based on review of hospital documents and medical record review and staff interview, the hospital failed to:

Findings:

a. Provide timely retrieval and policies and procedures for the electronic medical records
(EMR). Refer to Tag C-0301;

b. Maintain complete electronic medical records (EMR). Refer to Tag C-0304;

c. Ensure medical records contain pertinent orders and information. Refer to Tag C-0306.

Based on review of medical records and hospital meeting minutes and interviews with staff, the hospital failed to provide timely retrieval and policies and procedures for the electronic medical records.
Findings:
The hospital converted to an Electronic Medical Record (EMR) system in February of 2014. This was confirmed by Staff N. The hospital did not have policies and procedure for EMR.
During record review on 07/02/2014 Staff C, the staff assigned by the hospital as being able to locate all information in the EMR needed for review, was unable to locate patient information in the EMR requested by surveyors. Staff C received assistance from hospital staff in order to locate the requested information.
On July 9, 2014 surveyors reviewed EMR with Staff N and Q, also staff that were assigned by the hospital to help the surveyors with EMR review. Both Staff N and Q were unable to locate information in the EMR. The EMR helpline was called by the staff for assistance in locating patient information.
Review of medical staff minutes documented the physicians were unable to locate patient intake and output via EMR.
During the exit interview the administrator was asked if the hospital had policies and procedures for EMR. The administrator explained the hospital was in the process of developing policies and procedures for the EMR.

Based on interview with staff, review of the medical records and hospital documents, the hospital failed to maintain complete electronic medical records (EMR).

Findings:

The hospital implemented a new electronic medical record (EMR) system in February 2014

Review of the electronic surgical medical record for Patients #1, 2, 3, 4 and 5, did not contain pre-operative physician orders. This was confirmed by Staff N and Q during medical record review on the morning of 07/09/14.

Review of the medical staff meeting minutes, documented the physicians are unable to locate the patients' intake and output information via the EMR.

On 07/09/2014, the surveyors requested two (Patient Records #6 and 7) EMR be submitted as printed copies of the complete record to ensure the hospital was able to produce complete medical records when requested. The chart was not complete. The scanned documents were not submitted with the printed copies.

The above information was presented to the administrator during the exit conference. No additional information was provided.

Based on review of medical records and interviews with hospital staff, the hospital failed to ensure medical records contain pertinent orders and information. Documentation pertinent to the continued care of the patient was missing or not completed. This occurred in five (Patients #1, 2, 3,4 and 5) five surgery medical records reviewed.

Findings:

The hospital implemented a new electronic medical record (EMR) system in February 2014.

Patients # 1, 2, 3, 4 and 5 had surgical procedures performed at the hospital.

The medical records for Patients 1, 2, 3, 4 and 5 were reviewed on the morning of 07/09/14 with Staff N and Q.

Review of the medical records for Patients #1, 2, 3, 4 and 5, did not contain any pre-operative physician orders. Staff N and Q were both unable to locate the pre-operative physician orders for the patients. Telephone calls were made to the EMR's help-line by Staff N and Q for assistance in locating the orders. After consultation with the EMR help-line, staff were still unable to locate the orders in the EMR.

Based on observation, staff interviews, and a review of policies and procedures, medical records and hospital documents, the hospital failed to ensure that surgical procedures are performed in a safe manner.

Findings:

Surgery
On 07/01/14, a tour was conducted of the surgery department.

The anesthesia cart in operating room (OR#1) and the crash cart in the surgical department both contained outdated medications. This was confirmed by Staff C during the tour. Refer to Tag C-0276 for detailed information.

OR #1 contained contained a double sink, white metal cabinets that were rusting on the bottom which extended to the flooring. A non-manufactured wooden closet was used to enclose the back of the autoclave. There was also a box fan on the floor of this room. Staff C said the fan was used by the housekeeping staff. The baseboards were separated from the walls.

On 07/08/14, Staff C stated the hospital purchased a autoclave around 2012. Staff C was asked for the yearly inspection of the autoclave, none was provided. There was no evidence an initial or yearly inspection of the autoclave had been completed.

The medication refrigerator in the surgery department contained outdated medications. This was confirmed by Staff C during the tour. Refer to Tag C-0276 for detailed information.

The following items were located on the countertop in the sterile corridor:
supplies for wrapping instruments, wrapped and unwrapped surgical instruments, a half-empty container of bottled water, a label machine, and medical books.

Hypodermic needles were used to secure unprotected paper documents on the corkboards in the sterile corridor.

There was a fabric chair in the sterile corridor.

A home-use washing machine is being operated in the decontamination room with no written procedures for use of the washing machine.

There was no evidence the surgical department policies and procedures had been reviewed on an annual basis. They did not contain documentation of what nationally recognized source/organization from which they were referenced.

There was no documentation positive airflow was maintained to the operating room and the sterile processing room.

There was no documentation negative airflow was maintained to the decontamination and endoscopy procedure area.

Instruments in peel packs were sterilized in the closed/locked position and no chemical indicator was placed in the peel pack prior to sterilization.

On the morning of 07/01/14 Staff F stated she did not perform daily testing of the autoclave using a chemical indicator, such as Bowie-Dick or Dart Test.

Review of the electronic surgical medical record for Patients #1, 2, 3, 4 and 5, did not contain pre-operative physician orders. This was confirmed by Staff N and Q during medical record review on the morning of 07/09/14. Refer to Tag C-0306 for detailed information.

Endoscope

Endoscope procedures are performed in a procedure room outside the surgical department.

On 07/01/14, Staff C was asked what type of disinfectant was used to clean the room in-between patients. She stated 3M Quat. The disinfectant 3M Quat, is not effective against killing Clostridium Difficile (C-Diff). C-Diff is the most prevalent organism with endoscopic procedures.

The scopes are cleaned in room adjacent to the procedure room. Once the scopes are cleaned, they are placed on a wall inside the procedure room to dry.

The scopes are processed using Metricide OPA for high level disinfecting(HLD).
Review of the Metricide OPA instructions, documented, "...Metricide may be reused up to 14 days, assuming the minimum effective concentration (MEC) of glutaraldehyde, as measured by a chemical indicator..."
In an interview with Staff H on the afternoon of 07/01/14, she stated the Metricide is changed every 28 days. Staff H was asked if she documented the temperature of the Metricide and if the Metricide was tested with the appropriate indicator strip, she stated no.

Staff H was observed cleaning the endoscopes on the afternoon of 07/01/14, without the appropriate personal protective attire.

The ceiling tiles in the procedure room are not washable.

Outpatient Clinic

On 07/01/14, a tour was conducted of the outpatient medical clinic.

The outpatient clinic did not have a decontamination room to clean dirty instruments. They were being cleaned on a countertop, in a non-enclosed room, in a public area.

A table top autoclave was observed in use on a countertop, in the same non-enclosed area mentioned above. Staff F stated she sterilized the clinic's instruments using the autoclave.

Staff F stated the instruments are washed in a biohazard room in the clinic, after the instruments are washed, they are taken to the countertop, where they are wrapped and placed in the sterilizer.

Review of the autoclave logs for the clinic did not contain documentation of temperature, sterilizing time and dry time. This was confirmed by Staff F during the tour.

Based on review of medical records and staff interviews, the hospital failed to ensure all clinicians performing procedures are credentialed and privileged.

Findings:

1. On the morning of 07/01/14, surveyors reviewed the operating room log. Staff DD was listed as the physician performing the endoscopic procedures.

2. Review of the credential file for Staff DD documented Staff DD privileges expired February 26, 2014. This was confirmed by Staff A on the afternoon of 07/9/14.

Based on record review and interviews with hospital staff, the hospital does not ensure that the critical access hospital (CAH) performs a periodic evaluation and quality assurance review as required. The hospital has not conducted an annual periodic evaluation with all the required elements and does not have an effective and ongoing quality assurance program.

1. The hospital does not ensure a yearly program evaluation reviewing the utilization of CAH services, including the volume of services that are furnished. Refer to Tag C-0332.

2. The hospital does not ensure the complete periodic evaluation of the hospital's total program includes a review of a representative sample of both active and closed medical records. Refer to Tag C-0333.

3. The hospital does not ensure that the periodic evaluation of its total program is conducted at least once a year and includes a review of all (each department/service) of the CAH's health care policies to ensure they reflected current standards of practice. Refer to Tag C-0334.

5. The hospital does not ensure that a periodic evaluation of its total program is conducted at least once a year and includes an evaluation of the utilization of services, if policies were followed and what changes if any were needed. Refer to Tag C-0335.

6. The hospital does not have an effective quality assessment and performance improvement (QAPI) program that is implemented to evaluate the quality and appropriateness of the diagnosis and treatment of patients in the hospital through a functioning effective QAPI program. Refer to Tag C-0336.

7. The hospital does not have an effective QAPI program implemented to evaluate nosocomial infections and medication therapy. Refer to Tag C-0338.

8. The hospital does not have an effective QAPI program to ensure an appropriate outside source provided peer review to evaluate the quality and appropriateness of the diagnosis and treatment furnished by the physicians. Refer to Tag C-0340.

The hospital does not have a functioning effective QAPI system implemented so that remedial/corrective action can address deficiencies found through the QAPI program. Refer to Tag C-0342.

Based on review of quality/performance improvement (QAPI - the hospital's Department Head Meeting) meeting minutes and interviews with hospital staff, the hospital failed to perform at least an annual evaluation of its total program with the volume/type of services provided and determination if the services were appropriate; policies followed; and if any changes were needed.

Findings:

The surveyors were told the document, Annual Report/Evaluation of Total Critical Access Hospital Program, dated 09/16/2013, was the hospital's total annual evaluation of services. The evaluation did not contain evidence of a complete review of:

1. An evaluation of the utilization of services, if policies were followed, and what changes if any were needed and has an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished. Statistics provided included the number of admissions, swingbed admissions, and surgeries- including inpatient, outpatient and endoscopies. No analysis of these services was documented. The hospital also provides the following services that volumes of the services were not mentioned, including the volume of services utilized:
a. Emergency services;
b. Physical therapy;
c. Outpatient psychiatric services; and
d. Clinic services.

The annual evaluation did not demonstrate analysis of all hospital patient care services to determine if the services provided followed established policies and procedures and standards of practice and any service changes were needed.

2. A representative sample of both active and closed medical record. The document did not contain evidence medical record review for the annual evaluation.

3. A review of the hospital's health care policies for each department/service provided to patients in the hospital.

Based on review of hospital documents and interviews with hospital staff, the hospital does not ensure that a yearly periodic evaluation was conducted which included a representative sample of active and closed medical records.

Findings:

The surveyors were told the document, Annual Report/Evaluation of Total Critical Access Hospital Program, dated 09/16/2013, was the hospital's total annual evaluation of services.

1. The document did not contain evidence medical record review was completed for the annual evaluation.

2. Review of Department Head Meeting (the hospital's quality assessment and performance improvement - QAPI) and Medical Staff meeting minutes did not demonstrate medical record review was conducted.

3. These findings were reviewed and verified with Staff A on 07/09/2014.

Based on record review and interviews with hospital staff, the hospital does not ensure the hospital had an annual program evaluation which included a review of the hospital's health care policies. The hospital did not have an annual program evaluation that had evidence of review of the hospital's policies for each department/service furnished in the hospital.

Findings:
The following policies had no documentation of an annual review:
Housekeeping 03/02/06
Dietary - 09/01/11
Laundry - 05/18/13
Anesthesia - 01/31/12
Operating Room, Operating Room Infection Control and Pharmacy - did not have any evidence of any current review.
Swing Bed - 04/26/13
Radiology - 12/2012
Respiratory Therapy - 05/28/05

Although the infection control policy and procedure manual had a current review date, the policies and procedure did not reflect current standards of practice or give reference sources. Refer to Tag C-0278 for details.

These findings were presented to the administrator during the exit interview on 07/09/14. No additional information was provided.

Based on record review and interviews with hospital staff, the hospital does not ensure the annual program evaluation had determined whether the utilization of services were appropriate, established policies were followed and any changes were needed. The program evaluation did not have evidence that any changes to hospital services or policies were added or revised because of information from the annual program evaluation.

Findings:

The surveyors were told the document, Annual Report/Evaluation of Total Critical Access Hospital Program, dated 09/16/2013, was the hospital's total annual evaluation of services.

The evaluation did not contain evidence of a complete review of the utilization of services, if policies were followed, and what changes if any were needed and has an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished. Statistics provided included the number of admissions, swingbed admissions, and surgeries- including inpatient, outpatient and endoscopies. No analysis of these services was documented. The hospital also provides the following services that volumes of the services were not mentioned, including the volume of services utilized:
1. Emergency services;
2. Physical therapy;
3. Outpatient psychiatric services; and
4. Clinic services.

The annual evaluation did not demonstrate analysis of all hospital patient care services to determine if the services provided followed established policies and procedures and standards of practice and any service changes were needed.

This was verified by hospital staff during the survey.

Based on record review and interviews with hospital staff, the hospital does not ensure the hospital has an effective quality assessment and performance improvement (QAPI) program that collects relevant data, includes all analyzes the data and implements corrective action to ensure the quality and appropriateness of all patient care was furnished. The quality assurance meeting minutes for 2013 and 2014 provided for review did not have relevant indicators to identify potential problems and opportunities to improve quality of care. There was no analysis of any data that was collected and no evidence of the implementation of any corrective action taken.

Findings:

1. There were no indicators for the surgery anesthesia and central sterile departments. Other than numbers, no tracking of surgical cases was performed. No tracking of the environment occurred.

2. The minutes documented a nosocomial occurred, but no analysis of the occurrence occurred with determination if any procedures needed to be changed to effect better patient care outcome.

3. The minutes provided statical information, but no analysis of the information to look at processes for possible corrective action or any changes that needed to occur to improve patient outcome was demonstrated.

4. Not all departments were reviewed as part of the QAPI program.

5. These findings were reviewed with administrative staff on 07/09/2014.

Based on record review and interviews with hospital staff, the hospital does not ensure that the quality assessment and performance improvement (QAPI) program evaluates the hospital's patient care services to ensure patient health and safety.

Findings:

1. Services provided by contract were not evaluated by the QAPI program

2. Medication errors reported to QAPI were not analyzed and trended to evaluate and formulate an action plan to decrease medication errors.

3. There were no indicators in dietary to evaluate if the nutritional needs of patients were met.

4. Infection control data reported to QAPI did not analyze and trend infections and medication therapy to protect patients and ensure their safety.

Based on record review and interviews with hospital staff, the hospital does not ensure nosocomial infections and medication therapy are evaluated as part of a Quality Assurance and Performance Improvement (QAPI) program. Review of medical staff, governing body and QAPI meeting minutes for 2013 and 2014 did not have evidence of evaluation of nosocomial infections or medication therapy. This was verified with hospital staff on 07/09/14.

Based on record review and interviews with staff, the hospital failed to have an agreement with an outside source as part of the quality assessment and performance improvement (QAPI) program to assure the quality and medical necessity of medical care at the hospital.

Findings:

1. Currently, the hospital has two physicians, only one of which has active staff category privileges, and two physician assistants that work at the hospital. The physician on active staff does not perform surgical procedures. The other physician works in the emergency department and performs endoscopy procedures.

2. Medical record review for the purpose of determination of the physician's delivery of quality care and medical necessity (peer review) was being conducted by a physician assistant.

3. Records provided did not contain evidence the hospital had an outside source to perform peer review functions to determine if appropriate diagnosis and treatment occurred.

4. The above findings were reviewed and verified with Staff A on the afternoon of 07/09/2014.

Based on record review and interviews with hospital staff, the hospital does not ensure that appropriate remedial action is taken to address deficiencies identified through the quality assessment and performance improvement (QAPI) program. Medication errors and nosocomial infections identified were not analyzed and an remedial action plan implemented to correct the identified deficiencies. This was verified by hospital staff on 07/09/2014.

Based on review of hospital documents and interviews with hospital staff, the hospital does not have a process to protect the patients during abuse investigations. The hospitals' abuse policy was reviewed on 07/01/14, the policy did not describe how the hospital would protect the patient's during an abuse investigation. This was confirmed by Staff A at the time of review.