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Based on observations, interviews, and document review, the hospital failed to:

a. adhere to national standards of practice and manufacturers' guidelines for endoscopic instrument decontamination and high level disinfection, and ensure that staff were competent to perform endoscopes/accessories reprocessing,

b. adhere to national standards of practice and manufacturer's guidelines for the use of CPAP equipment,

c. adhere to environmental controls to minimize the risk of infection transmissions,

d. adhere to proper personal protection equipment and operating room attire,

e. ensure all staff providing clinical health had been properly immunized, and

f. failed to ensure infection control surveillance, reporting and corrective actions for endoscopic procedures.

Findings:

Endoscope and Accessories Reprocessing and Staff Competency
On 12/01/2016 at 11:31 am, the surveyor observed Staff AA reprocessing a gastrointestinal endoscope and endoscopic water bottle. Multiple failures were observed in the steps of reprocessing as defined by the manufacturer. The failures were as follows:

~ After the procedure was performed, at the bedside, the air/water cleaning adapter was not used to flush the air/water channel of the endoscope.
~The leak test was not performed as part of pre-cleaning. (The leak test will detect damage to the interior or exterior of the endoscope. Perforated channels of endoscopes are an infection control risk and damage may also occur to parts of the endoscope not designed for fluid exposure.)
~The air/water and suction cylinders and buttons were not brushed to remove bio-burden debris.
~The entire length of all internal channels were not brushed to remove debris.
~Prior to placing it into the automatic endoscopic reprocessor (AER), the endoscope was not rinsed internally and externally to remove debris and enzymatic detergent.
~The temperature of the high level disinfectant was not measured, which was a manufacturer's specification for proper use.
~70% alcohol was not flushed through suction and biopsy channels. (The alcohol assists the evaporation of any residual water, which can harbor microbes.)
~ The endoscopic water bottle was not disassembled to clean and disinfect all surfaces. The lid assembly's internal tubing was not cleaned or disinfected.

On 12/01/2016 at 11:31 am, during an interview, the Director of Nursing (DON) stated Staff AA was assigned as the primary endoscopic reprocessor for the facility, and also functioned as trainer for Staff U. Staff AA said he had been reprocessing endoscopes and accessories for approximately one year. Although the endoscope manufacturer's instructions for use were available on the counter of the decontamination room, Staff AA stated he had never read the instructions, and was taught reprocessing by a former employee.

On 12/01/2016 at 4:19 p.m., the surveyor reviewed Staff AA's personnel file. No documentation of endoscopic reprocessing training or measurement of competency was found in Staff AA's file. The DON validated this finding, and stated, "we knew he was not trained correctly on endoscopy."

On 12/01/2016 at 4:00 pm, the hospital document titled, "OPD [Outpatient Department]- Scope Room Duties 11/12" was reviewed. The policy documented, "Endoscopes are reprocessed per manufacturer's instructions."

CPAP

The hospital failed to use single-use CPAP equipment for individual use only.

On 11/30/2016 at 9:45 am, the DON stated Sleep Study services and personnel were contracted by the hospital. The DON stated the contracted sleep study technicians were responsible for disinfecting the CPAP equipment.

On 11/30/16 11:17 am, the surveyors toured the sleep study rooms 201 and 205. The surveyors observed four CPAP masks that were not in the manufacturer's package, a circuit hose draped over a shower rod, and a plastic container that was identified by the DON as a chemical agent, Control III.

On 12/01/2016 at 8:52 am, a phone interview was conducted with the owner of the sleep study services, who also was a respiratory technician (Staff BB) that performed the sleep procedures and managed the CPAP equipment. Staff BB clarified the type of mask that was observed unpackaged in the sleep study supply room. Staff BB stated the mask was a "home multi-use mask". Staff BB stated the CPAP masks and circuit tubing were disinfected using Control III and used for more than one patient.

The surveyors reviewed the manufacturer's insert for the type of masks that were unpackaged and reused for multiple patients. The manufacturer's only cleaning instructions documented, "Cleaning your mask in your home." The surveyors requested evidence the CPAP masks and circuits used during the hospital's studies were reusable, and no validation was provided.

Environmental Controls

The hospital failed to minimize traffic in a restricted area.
~On 11/30/2016 at 11: 50 am, the Outpatient Department was toured. The Director of Nursing stated gastrointestinal (GI) endoscopy and pain management procedures were performed in the department.
~Staff AA and the DON stated Exam Room 5/Recovery was used for the sterile procedures of pain management, and recovery for both pain management and GI endoscopy. Staff AA stated family members were allowed to enter the recovery room and remain at the bedside. Family members were observed in street attire in Exam 5.

On 12/01/2016 at 8:27 am, during the tour of the endoscopic procedure and recovery rooms, Staff R stated bleach wipes were used to disinfect surfaces with suspected C. Difficile contamination. The surveyors requested to see the wipes used, and no wipes were ever presented.

On 11/30/2016 at 11: 50 am and 12/01/2016 at 11:31 am, during tours of the Outpatient area, the door between the endoscopic decontamination area and endoscope storage area remained open. (In the endoscopic decontamination area, to maintain required air ventilation with negative pressure vented to the outside , the doors must remain closed.)

On 11/30/2016 at 11: 50 am, endoscopes were stored hanging vertically suspended from a hook on a peg board. (Peg board are not cleanable and trap dust. Endoscopes should be stored in a endoscope storage cabinet per manufacturer's guidelines.)

On the afternoon of 12/01/2016, the surveyor requested documentation of the automatic endoscopic reprocessor's one month and six month required filter changes. No documentation was provided.

On 11/30/2016 at 11: 50 am, an unpackaged dilation guidewire was observed hanging on the peg board in the scope storage area. Staff AA stated that the wire had not been used in over a year, and staff had not been trained as how to reprocess the guidewire per manufacturer's guidelines.

On the morning of 12/05/2016, during a tour of the medical surgical unit, the surveyors observed personal protective equipment (PPE) hanging on the door of room 118. Staff AA stated the patient was in contact isolation, but no isolation signage was posted.

PPE OR attire

On the morning of 12/05/2016, during a tour of the medical surgical unit, a contact isolation sign was posted on the door of room 121, the surveyors observed a visitor sitting in the room without PPE. Staff D stated the visitor should be wearing PPE.

On 12/01/2016 at 8: 25 am, during a tour of the Outpatient Department, the surveyors observed:
~ Staff V wearing a skull cap, and had hair exposed, having just completed a sterile procedure for pain management. ("09/16 CMS Response to the American College of Surgeons OR Attire Statement" documented, "Net caps, caps or skullcaps that do not offer complete hair cover should not be worn in the surgical suite.")
~the outpatient staff assisting with pain management procedure wearing scrub uniforms. The DON stated this staff was also assigned to assist with surgeries in the operating room. Staff R stated the surgical staff were allowed to wear scrubs from home into the Operating Room suite. Staff R stated the staff had not been provided instructions as how to properly launder their scrubs uniforms at home. The hospital did not provide surgical scrubs to employees.
~During a review of the table of contents for clinical policies, no policy for operating room attire was found.

On 12/02/2016 at 11:04 am, during a tour of the Operating Department in the semi-restricted and restricted areas, the surveyors observed maintenance staff and visitors wearing yellow gowns which did not fully cover street clothes.

Immunizations:

On 12/05/2016 at 3:14 pm, the Director of Nursing (DON) stated the credentialing documents had recently been decentralized by the parent organization, and were available within a computer program. The DON stated Staff C was receiving training how to retrieve information. With the assistance of Staff C, credentialling files were reviewed for five physician and mid-level providers (Staff V, W, X, JJ, and KK). Five of five providers reviewed had no documentation of influenza vaccination.

The hospital provided a policy titled, "Influenza Vaccination Policy 7/16", documented, "Mercy requires that all co-workers, physicians...be immunized against influenza on an annual basis.

Surveillance

On 12/05/2016 at 1:00 p.m., the hosptial's infection control surveillance information . No surveillance of endoscope reprocessing was found. No infection control surveillance for GI endoscopic procedures was found. During an interview, the DON stated such surveillance was not performed or reported as a part of the QAPI plan.

Based on personnel record review and staff interview the hospital failed to:

a. verify staff ' s professional licenses are valid and/or up to date for three of nine employee records (Staff B, S, and T) reviewed.

b. ensure all staff meet minimum qualifications; and training/education requirements for five of twenty personnel files (Staff R, S, T, U, and AA) reviewed.

Findings:

On 11/30/2016 at 9:30 AM, surveyors requested the hospital ' s personnel records. Three of twenty (Staff R, S, and T) personnel records were not provided.

On 12/01/16 at 10:25 AM, personnel records review presented the following:
~ three of nine personnel records (Staff B, S and T) did not contain current professional licenses.
~ five of twenty personnel records (Staff R, S, T, U, and AA) did not include qualifications and/or training/education requirements to ensure compliance.

On 12/01/16 at 10:55 AM, an interview was conducted with Staff B who reported the hospital does not possess personnel files for Staff R, S, and T containing professional license, qualifications and training/education competencies.

Based on interviews and documentation, the hospital failed to grant privileges to physicians and mid-level practioners to administer and/or supervise the administration of moderate sedation.

Findings:

On 11/30/2016 at 9:45 am, the Director of Nursing stated Staff V and W administered and supervised the administration of moderate sedation, and supervised the monitoring of patients who receive it.

On 11/30/2016 at 2:02 pm, Staff E stated providers in the Emergency Department (Staff X, JJ, and KK) administered and supervised the administration of moderate sedation, and they supervised the monitoring of patients who receive it.

On 12/05/2016 at 3:14 pm, credentialing files were reviewed for five physician and mid-level providers (Staff V, W, X, JJ, and KK). Five of five providers reviewed had no documentation that moderate sedation privileges had been granted by the Governing Body.

(The American Society of Anesthesiology position statement titled, "Statement of Granting Privileges for Administration of Moderate Sedation to Practitioners who are not Anesthesia Professionals, 2005" documented, " The intent of this statement is to suggest a framework for granting privileges that will help ensure competence of individuals who administer or supervise the administration of moderate sedation. Only physicians, dentists or podiatrists who are qualified by education, training and licensure to administer moderate sedation should supervise the administration of moderate sedation."

Based on observations, interviews, and document review, the hospital to ensure that all contracted services were provided according to acceptable standards of practice.

Findings:

On 11/30/2016 at 9:45 am, the Director of Nursing (DON) stated Sleep Study services and personnel were contracted by the hospital. The DON stated the contracted sleep study technicians were responsible for disinfecting the CPAP equipment.

On 11/30/2016 at 2:30 pm, the hospital's evaluation of contracted services was reviewed. The Director of Nursing validated the Governing Body had not completed an evaluation for Sleep Study Services.

On 11/30/16 11:17 am, the surveyors toured the sleep study rooms 201 and 205. The surveyors observed four CPAP masks that were not in the manufacturer's package, a circuit hose draped over a shower rod, and a plastic container that was identified by the DON as a chemical agent, Control III.

On 12/01/2016 at 8:52 am, a phone interview was conducted with the owner of the sleep study services, who also was a respiratory technician (Staff BB) that performed the sleep procedures and managed the CPAP equipment. Staff BB clarified the type of mask that was observed unpackaged in the sleep study supply room. Staff BB stated the mask was a "home multi-use mask". Staff BB stated the CPAP masks and circuit tubing were disinfected using Control III and used for more than one patient.

The surveyors reviewed the manufacturer's insert for the type of masks that were unpackaged and reused for multiple patients. The manufacturer's only cleaning instructions documented, "Cleaning your mask in your home." The surveyors requested evidence the CPAP masks and circuits used during the hospital's studies were reusable, and no validation was provided.

On 11/30/2016 at 10:00 am, the employee files for the Sleep Study staff were requested. The DON stated the hospital did not keep health files for these staff, and did not validate licensure, immunizations status, or competency.

Based on document review and staff interview the hospital failed to adhere to a current process or establish a policy and procedure for grievances.

Findings:

On 12/01/16 at 1:34 PM, surveyor requested current policies for complaints/grievances; none were provided.

On 12/01/16 at 2:26 PM, a staff interview was conducted. Staff B reported the current policy for complaint and grievance cannot be retrieved and the hospital does not have a current process in place for grievances. Staff B reported a new policy titled, " Patient Complaint and Grievance Policy " will be submitted to the governing body in January 2017.

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

a. establish and maintain a grievance process approved by the governing body.

b. ensure grievances are reviewed and resolved by governing body or delegated grievance committee.

Findings:

On 12/01/16 at 1:34 PM, surveyor requested a current policy for complaints/grievances; a current policy was not provided.

On 12/01/16 at 2:26 PM, Staff B reported the hospital does not have a current process in place for grievances.

Based on document review and staff interview the hospital failed to review, investigate, and resolve each patient ' s grievance within a reasonable time frame.

Findings:

On 12/01/16 at 1:34 PM, surveyor requested grievance logs; none were provided.

On 12/01/16 at 2:26 PM, a staff interview was conducted. Staff B verified no specific dates of grievances were monitored for investigations or resolution.

Based on document review and staff interview the hospital failed to provide written notice to each patient reporting the grievance resolution, steps taken in the investigation, results, and completion date.

Findings:

On 12/01/16 at 1:34 PM, surveyor requested evidence of written responses to patient ' s grievances; none were provided.

On 12/01/16 at 2:26 PM, Staff B was interviewed and reported all patients do not receive a written notice regarding their grievance.

Based on observations, interviews, and document review, the hospital failed to:

a. Adhere to national standards of practice and manufacturers' guidelines for endoscopic instrument decontamination and high level disinfection, and ensure that staff were competent to perform endoscopes/accessories reprocessing,

b. Grant privileges to practitioner within the hospital's scope of service in terms of equipment and staff competency.

Findings:

1. On 12/01/2016 at 11:31 am, the surveyor observed Staff AA reprocessing a gastrointestinal endoscope and endoscopic water bottle. Multiple failures were observed in the steps of reprocessing as defined by the manufacturer. The failures were as follows:

~ After the procedure was performed, at the bedside, the air/water cleaning adapter was not used to flush the air/water channel of the endoscope.
~The leak test was not performed as part of pre-cleaning. (The leak test will detect damage to the interior or exterior of the endoscope. Perforated channels of endoscopes are an infection control risk and damage may also occur to parts of the endoscope not designed for fluid exposure.)
~The air/water and suction cylinders and buttons were not brushed to remove bio-burden debris.
~The entire length of all internal channels were not brushed to remove debris.
~Prior to placing it into the automatic endoscopic reprocessor (AER), the endoscope was not rinsed internally and externally to remove debris and enzymatic detergent.
~The temperature of the high level disinfectant was not measured, which was a manufacturer's specification for proper use.
~70% alcohol was not flushed through suction and biopsy channels. (The alcohol assists the evaporation of any residual water, which can harbor microbes.)
~ The endoscopic water bottle was not disassembled to clean and disinfect all surfaces. The lid assembly's internal tubing was not cleaned or disinfected.

On 12/01/2016 at 11:31 am, during an interview, the Director of Nursing (DON) stated Staff AA was assigned as the primary endoscopic reprocessor for the facility, and also functioned as trainer for Staff U. Staff AA said he had been reprocessing endoscopes and accessories for approximately one year. Although the endoscope manufacturer's instructions for use were available on the counter of the decontamination room, Staff AA stated he had never read the instructions, and was taught reprocessing by a former employee.

On 12/01/2016 at 4:19 p.m., the surveyor reviewed Staff AA's personnel file. No documentation of endoscopic reprocessing training or measurement of competency was found in Staff AA's file. The DON validated this finding, and stated, "we knew he was not trained correctly on endoscopy."

On 12/01/2016 at 4:00 pm, the hospital document titled, "OPD [Outpatient Department]- Scope Room Duties 11/12" was reviewed. The policy documented, "Endoscopes are reprocessed per manufacturer's instructions."

2. On 12/05/2016 at 3:14 pm, the credentialing file for Staff V was reviewed. Seven pages of general surgery and obstetric and gynecology privileges were granted to Staff V by the Governing Body.

During an interview, the Director of Nurses stated the hospital was not equipped and staff did not have the competency to perform all of the surgeries/ procedures that were delineated on the privilege list.

Based on record review, staff interview, and policy review the hospital failed to ensure physician ' s orders were completed on four (Patient 11, 12, 18, and 19) of twenty medical records reviewed.

Findings:

On 12/06/16 at 9:51 AM, medical records were reviewed. Four patient records (Patient 11, 12, 18, and 19) documented written orders by a physician for laboratory testing. Surveyors requested documentation for laboratory results, none were provided.

On 12/06/16 at 1:55 PM, Staff D reported laboratory results are unavailable and unsure if the orders were completed on the four medical records (Patient 11, 12, 18, and 19).

On 12/06/16 at 1:56 PM, Staff G reported the hospital does not have a process to reconcile Staff V ' s laboratory urine drug screen orders.

On 12/06/16 at 2:35 PM, a hospital ' s policy titled, " Content of the Legal Medical Record " was reviewed. The policy stated, " ...the content of the legal medical record ...shall contain the following ...all diagnostic and therapeutic procedures, test, and results ... "

Based on observations and interview, the hospital failed to ensure outdated drugs and biologicals were not available for use.

Findings:

On 12/02/2016 at 11:04 am, during a tour of the Operating Room Department, expired drugs and biological were observed in the substerile area.

In the presence of the Director of Nursing, the surveyors observed in a cabinet, the following expired drugs/biologicals:
~Two bottles of Ultane- expired 2/15.
~Two bottles of Sterile H2O 1500 ml- expired 11/14.
~Strong Iodine (Lugols)- expired 7/16,
~70% alcohol -expired 9/14, and
~70% alcohol with sprayer- expired 12/12.

The Director of Nursing stated there was a misunderstanding between the pharmacy and central supply staff as who was responsible for inspections and disposed of expired drugs in the substerile area.

Based on interviews and document review, the hospital failed to define a process for:
a. quarantining infectious blood and blood components, and
b. notifying and counseling recipients of infectious blood and blood components.

Findings:

On 12/02/2016 at 12:18 pm, the hospital's policies titled, "Blood Bank HIV/HTLV Lookback" was reviewed. The policy failed to define a process for quarantining infectious blood and blood components, and notifying and counseling recipients of that blood.

During an interview, Staff F stated the hospital did not have a process or policy for the components listed in the FDA regulations.

Based of observations, interviews, and document review, the hospital failed to ensure the physical plant / hospital environment was maintained in a safe manner, as evidenced by the following:

a. The excess storage within surgical/ procedural areas increased the difficulty of disinfecting surfaces and floors. The combination of the use of staff from a separately licensed affiliate and the co-mingling of in-use and out-of-use supplies and equipment increased the risk to the patients.

b. Surgery crash cart was being checked by unqualified staff,

c. Decontamination/ disinfection of CPAP equipment in an area not designed to perform such activities, and

d. Preventive Maintenance not being perform on medical equipment to include:
CPAP machine in the sleep study patient room 203, a portable negative pressure ventilation machine in ER room #2, refrigerator in the pharmacy, Berchtold chromophare C-571 located in operating room #2, and Phillips machine PV0280. (See Tag K-0921)

Findings:

1. Surgical / Outpatient Surgery Department

On 11/30/2016 at 10:00 am, during an interview, the Director of Nursing (DON) stated since May of 2016, nursing staff from an affiliate hospital served as the staff for outpatient procedures and surgeries. This staff would come to the hospital once a week to provide patient care.

On 12/02/2016 at 11:04 am, the Operating Room was toured.

The accompanying DON stated the operating room had significantly reduced services over recent years. She stated a few surgeries, such as hernia repairs, incision and drainage, appendectomies, and cyst removal were performed monthly. The DON stated the "city owned the equipment, and the hospital wanted to remove unused/ obsolete supplies and equipment, but were having difficulty".

In the substerile/ clean storage areas, mutilple cabinets were full of items identified as in-use and items that Staff D stated were no longer used. OR#1 was used to store equipment. The DON stated the Sterrad sterilizer was out of commission, but the equipment was not tagged out.

The hospital policy titled, "Lock out-Tag-out 7/16" was reviewed. The policy's purpose was "to prevent accidental starting or activating...while they are being repaired, cleaned, and/or serviced."

On 12/01/2016 at 11:30 am, the Outpatient Procedure area was toured.

The surveyor observed a endoscopic printer on the counter of the decontamination room. Staff AA stated the equipment was not used.



2. Crash Carts

On 12/02/2016 at 11:04 am, during a tour of the Operating Room, the surgical crash cart was examined.

The hospital's form, "Crash Cart Tracking Log" from September 30, 2016 to December 6, 2016 was reviewed. The crash cart checks included "defibrillator plugged in and battery charging and unplugged and discharged." Staff D confirmed the logs were completed by Staff U, an unlicensed staff. Staff U's personnel file was reviewed. No competency for defibrillator testing was found the Staff U's file.

On 12/06/2016 at 10:00 am, the surveyors requested the policy "Emergency Crash Cart" from the policy's table of contents. No policy was provided.

3. Inappropriate Decontamination Conditions

On 11/30/2016 at 10:17 am, the Sleep Study Lab and office were toured.

The DON stated room 203, a former inpatient room, was currently used as the sleep lab staff's office. The surveyors observed a rectangular plastic container of liquid lying on a small countertop, which was overhanging the edge of a small sink. The DON identified the container's content as the disinfectant used to reprocessed CPAP masks and circuit hoses. There was no other sink in the room. There was a circuit hose draped over the shower curtain rod in the room's bathroom.

On 11/30/2016 at 10:17 am, during an interview, the DON stated the hospital did not monitor air quality in room 203.

Based on observations, interviews, and document review, the facility failed to ensure that a Registered Nurse (RN), functioning as a circulating nurse, was present during every gastrointestinal (GI) endoscopy procedures requiring moderate sedation.

Findings:

On 12/01/2016 at 8:45 am, the Outpatient Surgery Department was toured.

The Director of Nursing stated GI endoscopy procedures were being performed using moderate sedation. 12/01/2016 at 8:50 am, during an interview, Staff AA stated moderate sedation (Fentanyl and Versed) was administered, under the supervision of Physician W, to endoscopic patients. Staff AA stated for most procedures, the only other staff in attendance in the room was Staff U, a scrub technician. Staff AA said routinely there was no RN exclusively performing the responsibilities of a circulating RN.

On 12/01/2016 at 10:00 am, Staff R stated for the GI endoscopy procedures, there was one RN present during each procedure.

On 12/05/2016 at 3:00 pm, the hospital policy titled "OPD [Outpatient Department] Scope of Care 11/12" was reviewed. The policy documented, "procedures in Outpatient Department requiring IV [intravenous] sedation will be attended by at least one qualified RN and one additional nurse or a qualified technician unless additional staff is otherwise requested or if the patient's condition warrants additional staff."

On 12/05/2016 at 3:00 pm, the hospital policy titled, "Conscious Sedation for Procedures 11/12" documented, a minimum of two personnel must be involved in the care of patients undergoing conscious sedation during the entire procedure...the practitioner...the RN or Paramedic..."

On 12/06/2016 at 3:00 pm, during the exit conference, Staff D stated a RN, who were administering moderation sedation, could perform additional interruptible tasks.

On 12/06/2016 at 3:00 pm, the hospital policy titled, "Surgery- Role of the Circulator" was reviewed. The policy delineated thirty-two responsibilities expected of a RN who functions as the circulator.

(The Oklahoma Board of Nursing's position statement titled, "Moderate (Conscious) Sedation Guidelines for Registered Nurse Managing and Monitoring Patients 5/15" documented, "the Registered Nurse administering, managing and/or monitoring moderate (conscious) sedation shall have no other responsibilities during the procedure that would leave the patient unattended or compromise continuous monitoring."