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Based on staff interview and review of policies, meeting minutes, credentials files, and call schedules, it was determined the CAH failed to ensure its organizational structure was sufficient to direct patient care. This impeded the ability of the CAH to provide effective care. Findings include:

Refer to C-241 as it relates to the failure of the Governing Body to assume responsibility for determining implementing, and monitoring poklicies to provide uninterrupted services to the community it served.

These systemic negative practices seriously impeded the ability of the CAH to provide services to patients.

Based on staff interview and review of policies, meeting minutes, credentials files, and call schedules, it was determined the CAH's Governing Body failed to assume full responsibility for determining, implementing, and monitoring policies governing the CAH's services. This impeded the CAH's ability to effectively manage hospital functions. Findings include:

1. The CAH offered obstetrical services, including labor and delivery and postpartum care. The Governing Body failed to ensure these services were provided without interruption.

Obstetrical Call schedules were reviewed since July 1, 2017. The schedules showed the obstetrician was not available 5 days in July 2017 and 5 days in August 2017. He was scheduled to be unavailable 7 days in September 2017.

No policy or procedure was found that addressed how the CAH would provide services when the obstetrician was not available to the CAH.

The CNO was interviewed on 9/19/17, starting at 1:40 PM. She stated the CAH had 2 Family Practice physicians who delivered babies vaginally. She said the CAH also had an obstetrician who delivered babies and performed Caesarian section surgery. She stated, if the obstetrician was not available, the hospital closed its obstetrical services. She stated the CAH did not have a policy or procedure to direct staff as to what actions to take if the obstetrical service closed. She stated there was no process to notify the public or emergency services when the obstetrical services closed.

The CNO further stated the CAH did not keep a record of when the service was closed. She said the obstetrical service would have been closed on days when the obstetrician was not available.

Discussion of obstetrical service issues was not included in Board of Directors meeting minutes since at least 9/01/16.

The Chairman of the Board of Directors for the CAH was interviewed on 9/21/17 beginning at 9:35 AM. She stated she did not think the Board had formally addressed the interruption of obstetrical services in the past year. She stated there was no current plan to address the interruption of obstetrical services.

The Governing Body failed to implement policies and monitor the CAH's obstetrical service.

2. Credentials files were reviewed with the Medical Staff Coordinator on 9/21/17, beginning at 11:00 AM. The following problems were noted:

While the obstetrical service was closed on days when the obstetrician was not available, other physicians were designated as on-call for those days. If a pregnant woman came to the hospital seeking services, the designated physician assessed her to determine if she was in labor. If the woman was in labor, the physician arranged for transfer to another hospital.

a. Physician A was reappointed to the Medical Staff on 2/23/16. Physician A was listed as the on-call physician for obstetrics at least 1 day per month from 5/01/17 through 9/30/17. However, his credentials file did not include privileges to evaluate women for labor.

b. Physician Assistant B acted as the first assistant for the CAH's orthopedic surgeon. He operated under the direct supervision of the surgeon. Physician Assistant B was reappointed to the Medical Staff on 2/23/16. His credentials file did not include privileges to assist the surgeon. Instead, his privileges included core surgical privileges and privileges for minimally invasive total knee arthroscopy. Since he was not a surgeon, he was not qualified for these privileges.

c. Physician C was an ophthalmologist who performed cataract surgery at the CAH. He was reappointed to the Medical Staff on 2/23/16. His credentials file did not list any procedures he had privileges to perform at the CAH.

The Medical Staff Coordinator, interviewed on 9/21/17 beginning at 11:00 AM, stated the above practitioners did not have the specified privileges.

The Governing Body failed to ensure practitioners had appropriate privileges.

3. Refer to C320 as it relates to the failure of the Governing Body to ensure surgical services were provided in a safe and effective manner.

4. Refer to C331 as it relates to the failure of the Governing Body to ensure an evaluation of the CAH's total program was carried out.

5. Refer to C336 as it relates to the failure of the Governing Body to ensure an effective quality assurance program was developed and maintained, including a system to investigate events harmful to patients.

Based on observation, policy review, instrument processing logs review, and staff interview, it was determined the CAH failed to ensure surgical services were provided in a safe and effective manner. This placed 1 of 1 patient (#33), whose surgery was observed, and all other patients having surgery, at increased risk for infections and complications. Findings include:

1. Patient #33 was a 35 year old female admitted to the CAH as an outpatient for a gallbladder removal. Her hospitalization was observed from admission to the preoperative area to her exiting the OR suite after her surgery to her initial recovery from anesthesia.

The CAH's anesthesia policy "Infection Control Responsibilities" stated "anesthesia personnel are responsible for abiding by infection control policies and procedures of the OR and PACU. Strict handwashing will be observed at all times between different patient contacts ...Standard precautions will be observed at all times and there will not be any direct contact with a patient's blood, body Fluids and/or secretions."

Patient #33's care was observed in the preoperative area and then in the operating room, on 9/19/17 starting at 7:04 AM. Observations included:

- The CRNA did not perform hand hygiene for his entire encounter with Patient #33, from 7:26 AM to 9:58 AM.

- The CRNA did not perform hand hygiene or don gloves during two attempts to start IVs on Patient #33.

- The CRNA did not use alcohol to prep medications vials prior to withdrawing medication, or to prep IV ports prior to injecting Patient #33's medications.

- Also, the CRNA was observed placing two large syringes on the anesthesia cart. The syringes were not labeled with the name of the medication, dose, or the date and time of expiration.

The CRNA was interviewed on 9/19/17, starting at 11:00 AM. He was asked when he last performed hand hygiene. He stated he last performed hand hygiene prior to coming to the CAH that morning. He stated he "could improve in that area." He stated he was not aware new vials of medication had to be cleaned with alcohol prior to inserting a needle. He stated the syringes contained Diprivan, a sedative. He stated the syringes were for two patients who were having colonoscopies later in the day.

Following surgery on 9/19/17, Patient #33 was taken to the PACU. Patient #33 and an RN were observed, between 10:07 AM and 10:32 AM. The RN did not perform hand hygiene however during that time, he touched the patient several times, documented on a keyboard, touched her covers, touched equipment in the room, adjusted the monitor, and performed other duties.

The PACU RN was interviewed on 9/19/17 at 10:45 AM. He stated he did not perform hand hygiene for 25 minutes during the observation. He stated this was a "fairly standard" practice during recovery.

The CAH failed to ensure Infection control policies were followed by surgical personnel.

2. The CAH policy 140-008 "Attire in the Operating Room," stated "personal jewelry worn in the surgical suites shall consist of the following:

- Watch ...

- Necklace -one (1) small single chain

- Earrings- small studs. All other earrings worn are to be confined by a cap at all times."

The AORN 2015 EDITION "GUIDELINES FOR PERIOPERATIVE PRACTICE," stated, under the chapter "SURGICAL ATTIRE" Recommendation I.j. "Jewelry (eg, earrings, necklaces bracelets, rings) that cannot be contained or confined within the scrub attire should not be worn in the semi-restricted or restricted areas ... I.c.1. the perioperative team member should wear scrub attire that covers the arms while performing perioperative skin asepsis."

An observation of Patient #33's surgery was made on 9/19/17, starting 8:05 AM. When Patient #33 entered the OR suite, the following observations were made:

- The CST was observed wearing loop earrings outside of her head covering.

- The Manager of Surgical Services #1 was observed prepping Patient #33 wearing a short-sleeved scrub top.

The CAH failed to ensure surgical attire followed its policies and national guidelines.

3. The instruments used in Patient #33's surgery were followed through the manual cleaning process. Ffurther observations were made in the central processing area to determine the CAH's practice of processing instruments. The policy "Infection Prevention and Control Plan," dated 2/21/16, stated the CAH followed CDC and AORN guidelines and recommendations.

On 9/27/17, the CDC website was accessed. Under "Sterilizing Practices" it stated "The aim of central processing is the orderly processing of medical and surgical instruments to protect patients from infections while minimizing risks to staff and preserving the value of the items being reprocessed ... Insuring consistency of sterilization practices requires a comprehensive program that ensures operator competence and proper methods of cleaning and wrapping instruments, loading the sterilizer, operating the sterilizer, and monitoring of the entire process."

a. National guidelines ensuring proper methods of cleaning and wrapping instruments, performing instrument processing and monitoring of instrument processing where not adhered to as follows:

i. The AORN 2015 EDITION "GUIDELINES FOR PERIOPERATIVE PRACTICE," stated under the chapter "GUIDELINE FOR CLEANING AND CARE OF SURGICAL INSTRUMENTS," Recommendation VI.a. "Personal protective equipment consistent with exposure risks in the decontamination area must be worn, including:

¿- A fluid resistant gown with sleeves

¿- gloves, (ie, general purpose utility gloves with a cuff that extends beyond the cuff of the gown),

¿- a mask and eye protection or a full face shield, and

¿- shoe covers or boots designed for use as PPE"

The LPN/CST was observed manually cleaning instruments, prior to washing and sterilization, on 9/19/17, staring at 10:05 AM. She was observed wearing a blue apron leaving her arms and shoulders bare, and gloves covering her arm halfway to her elbow. She was observed wearing a mouth and nose mask with her own glasses. When asked why her arms and eyes were not protected she stated "we just got this apron after recommendation from the surveyor. I have issues with allergies to the face shields. We have talked about protective glasses, but do not have any yet."

The CAH failed to ensure the LPN/CST used proper PPE while manually cleaning instruments.

ii. The AORN 2015 EDITION "GUIDELINES FOR PERIOPERATIVE PRACTICE," Recommendation VIII.c. stated "The cleaning product manufacturers written IFU should be followed for...concentration and dilution"

The LPN/CST was observed manually cleaning instruments, prior to washing and sterilization, on 9/19/17, starting at 10:05 AM. The product used was Proclean by the company Stryker. The directions for the product stated "Range of use is concentrations from 0.25 to 2.0 oz. per gallon." There was no observable measure of how much water was used per pump of the enzymatic cleaner When she was mixing the detergent in the sink. The LPN/CST stated "we are getting markers with thermometers to measure mixtures, but they are not here yet."

The Hospital failed to ensure detergent for manual cleaning of instruments was prepared per the manufacturers IFU.

iii. The AORN 2015 EDITION "GUIDELINES FOR PERIOPERATIVE PRACTICE," Recommendation VIII.d.2. stated "Brushes used to clean ...should ... be either designed for single use or be reusable and cleaned at least daily or more frequently as needed."

The LPN/CST was observed manually cleaning instruments, prior to washing and sterilization, on 9/19/17, staring at 10:05 AM. The cleaning of the scrubbing brushes was discussed. She stated they were "run through the instrument washer once a week." She stated they were not cleaned daily, as recommended.

The CAH failed to ensure the brushes for manually cleaning instruments were washed per standard.

iv. The AORN 2015 EDITION "GUIDELINES FOR PERIOPERATIVE PRACTICE," Recommendation XVII.A.1. stated "Mechanical cleaners (eg, washers disinfecters/decontaminators) should be tested for correct function on installation, at least weekly (preferably daily) during routine use, after major repairs, and after significant changes in cleaning parameter (eg, changing cleaning solutions)."

The LPN/CST was observed manually cleaning instruments, prior to washing and sterilization, on 9/19/17, starting at 10:05 AM. she stated the instruments were then loaded into the instrument washer. She was asked how the CAH checked the instrument washer. She stated she was unaware of any process for checking the correct function of the washer.

During an observation of instrument processing services on 9/19/17, starting at 11:30 AM, the Operating Room Technician was interviewed. She was asked about the manufacturer's IFU for the instrument washer. She stated she was unable to locate the manual, and was unaware of a process for checking its function.

The CAH failed to ensure the instrument washer was checked for effectiveness.

v. The CAH policy #140-026 "Event Related Shelf-Life Storage," stated "Sterility of items will be event related rather than date related. The integrity of the package will be the determining factor in establishing sterility of the enclosed items. All items being sterilized by central service will be considered sterile unless the package/pack/tray/container is damaged or wet. Damage includes:

¿- Holes or torn wrappers

¿- Securing tapes or locks have been tampered with or removed

¿- Broken seals in peel pouches or sterility maintenance covers

¿- Items dropped that are wrapped or in peel pouches

¿- Exposure to a contaminated or unsafe environment

¿- Exposure to any type of moisture"

During an observation of instrument processing services on 9/19/17, starting at 11:30 AM, the Operating Room Technician was interviewed. She was asked how the CAH determined how long an item remained sterile in its packaging. She stated during a mock survey in July of 2017, the surveyor had her call the company that produced the packaging and the company had informed her it was 2 years. She stated they had started labeling the packages with the date of sterilization.

Stored sterile packaging was observed, and the following additional issues were noted with sterile packaging:

- A large peel pack, containing a retractor, had gaps in its seal. The CST in charge of Central Service stated she knew there were some packages stored with gaps, and they were not supposed to use those instruments, however they were still stored with items that were ready for use.

- Multiple peel pouches contained instruments with hinges in the closed position, with sharp ends uncovered.

- Packages were labeled with the date of sterilization and load number only.

The CAH failed to ensure instruments requiring sterilization were packaged, labeled, and stored per hospital policy.

vi. The CDC website was accessed on 9/26/17. It stated "Sterilization procedures should be monitored using biological, mechanical, and chemical indicators. Biological indicators, or spore tests, are the most accepted means of monitoring sterilization because they assess the sterilization process directly by killing known highly resistant microorganisms"

The AORN 2015 EDITION "GUIDELINES FOR PERIOPERATIVE PRACTICE" recommendation VI.c.5. and VI.c.6 stated "Biological indicators should be used to monitor sterilizer efficacy. Efficacy monitoring should be done at least weekly and preferably daily ...loads containing an implant (hardware that remains in a patient's body after surgery, such as screws and plates connected to bones) should be monitored with a biological indicator and not released for use until the result of the test is available."

On 9/19/17, at 3:15 PM, the CNO presented the "Quality Assurance Records Chemical and Biological Monitoring" logs for the Steris (steam sterilizing) machines #1 and #2. Log #1 contained documentation for the following dates:

7/07/17- (implants and weekly monitoring done 10 days late)

9/18/17- (weekly monitoring done 80 days late)

"Quality Assurance Records Chemical and Biological Monitoring" log for the CAH's Steris Machines #1 were cross checked with the CAH's "AUTOCLAVE (sterilizing machine) LOG," for the dates of 6/28/17 through 9/19/17, to determine the number of instrument loads run without verification of the sterilization process with biologicals.

78 loads of instruments were documented as run through Sterilizer #1 during the time frames when biological monitoring was not being recorded as required.

Additionally, 10 sterilizer loads that included implants had incomplete documentation that biological indicators were checked and loads were evaluated for sterilization.

Log #2 contained entries for the following dates:

7/07/17- (weekly monitoring done 10 days late)
8/01/17- (implants and weekly monitoring were done 7 days late)
9/18/17 - (weekly monitoring was done 49 days late)

"Quality Assurance Records Chemical and Biological Monitoring" log for the CAHs Steris Machine #2 were cross checked with the CAH's "AUTOCLAVE LOG," for the dates 6/28/17 through 9/18/17, to determine the number of instrument loads run without verification of the sterilization process with biologicals.

114 loads of instruments were documented as run through Sterilizer #2 during the time frames when biological monitoring was not being recorded as required.

Additionally, there was incomplete documentation of the 6 loads that included implants had biological indicators run with the loads.

During an observation of instrument processing services on 9/19/17, starting at 11:30 AM, the CST in charge of processing instruments was interviewed. She stated she knew they had not been documenting the biological testing consistently for the Steris machines. She stated they used a biological test that required 24 hours to show results and she knew it was supposed to be done weekly and with each load that included implants. She stated, because the test took 24 hours "sometimes they get missed."

The CAH failed to ensure surgical instruments were sterilized per national standards.

vii. The AORN 2015 EDITION "GUIDELINES FOR PERIOPERATIVE PRACTICE," Recommendation XX.e.1 stated "Information should be recorded from each sterilization cycle and should include the

¿- identification of the sterilizer (eg 'sterilizer #1')

¿- type of sterilizer and cycle used

¿- load control number

¿- load contents (eg, major set, Kelly clamps)

¿- critical parameters for the specific sterilization methodology (eg, exposure time, temperature for steam sterilization), operator's name, and

¿- results of the sterilization process monitoring (ie, biological, chemical, physical)."

The CAH's "AUTOCLAVE LOGs" were reviewed for Sterilizer #1 and #2 and "Flash" for the dates of 6/23/17 through 9/18/17. The following information was not contained in any logs:

¿- identification of the sterilizer (eg 'sterilizer #1')

¿- type of sterilizer and cycle used

¿- load control number

¿- critical parameters for the specific sterilization methodology (eg, exposure time, temperature for steam sterilization), operator's name, and

¿- results of the sterilization process monitoring

During an observation of instrument processing services on 9/19/17, starting at 11:30 AM, the Operating Room Technician was interviewed. She pointed out where they could look for the sterilizers' parameters, but she stated there were no other logs except the one presented to record the above information. It was unclear how they were able to track instruments to ensure sterility.

The CAH failed to ensure Information from each sterilized load was documented per national standards.

b. The Operating Room Technician's competency was not assessed.

The Surgical Services Manager Job Description, revised 8/2015 was reviewed. Under "Essential Duties and Responsibilities," it stated one of the Surgical Services Manager responsibilities was to perform " ...training employees; planning assigning, and directing work; appraising performance ..." and "Supervise care of OR suite and equipment to ensure cleanliness, sterility and operational ability of all items."

The Operating Room Technician job description, revised 8/2017, was reviewed. Under "Essential Duties and Responsibilities," it stated "Is fully responsible for care of instruments/equipment during intra/postoperative phase, including cleaning and processing of instruments. Follows written procedures for steam sterilization; knows responsibilities and the necessity for chemical and biological monitoring." It stated the Operating Room Technician reported to the Surgical Services Manager.

The CNO was interviewed on 9/18/17, starting at 3:30 PM. She stated the CAH had been working on hiring a new Manager of Surgical Services. She stated the previous Manager of Surgical Services had left the position in mid-June. She stated in the interim the position responsibilities were divided between 2 of the RNs working in the department.

RN E, the Interim Manager of Surgical Services #2, was interviewed on 9/20/17, starting at 9:45 AM. When asked, "who had followed up with the Operating Room Technician to see how she was functioning in her new role" he stated "We have been in charge about a month. As far as I knew they [the Operating Room Technician and the previous Manager], had everything put together." He stated the current Operating Room Technician had been "thrown into it" due to the previous Operating Room Technician "leaving abruptly." The Interim Manager of Surgical Services #2 stated he had not been aware any issues with the sterilization process since the current Operating Room Technician had acquired the role.

On 9/20/17, a starting at 2:30 PM, the previous Manager of Surgical Services, who was also the CAH's Infection Preventionist, was interviewed. When central processing and sterilization of instruments were discussed, he stated he had been unaware of any problems, but he stated the previous Operating Room Technician had "left unexpectedly."

During an observation of instrument processing services on 9/19/17, starting at 11:30 AM, the Operating Room Technician was interviewed. When asked what national guidelines the CAH followed for instrument processing, or what policies were available for her to refer to, she stated she was unaware of any. She discussed a mock survey that was done for the CAH in July of 2017, and indicated the surveyor had recommended a book by AAMI (Association for the Advancement of Medical Instrumentation), which was not yet available to her. She stated "I was trained by the previous person who had this job, but she left suddenly, so I did not know everything when I started. I am frustrated because I would find out things I don't know and that I am doing wrong."

Information regarding the Operating Room Technician competencies was requested from the CNO on 9/26/17 via phone. On 9/27/17, information stating the Operating Room Technician's CST certification was issued 7/26/12. Training and competencies for the Operating Room Technician received after being hired were again requested on 7/27/17 via email.

No competencies were received.

The CAH failed to ensure the Operating Room Technician was supervised and competent in her new role.

c. The CAH's policies were outdated, and did not contain information to guide staff in instrument processing and infection control.

The AORN 2015 EDITION "GUIDELINES FOR PERIOPERATIVE PRACTICE," the chapter "STERILIZATION AND DISINFECTION," was reviewed. It stated "Policies and procedures...should be developed, reviewed periodically, and readily available in the practice setting in which they are used."

The CAH's lists of policies for infection control and surgical services were reviewed. The following list of policies related to instrument processing. The policies referred to AORN 2004 standards. New AORN standards were published in 2015. The policies were outdated and had not been changed. Examples include:

140-006 Asepsis

140-126 Event-Related Shelf-Life Sterile Storage

140-129 Flash Sterilization.

The CAH's central processing contained 3 sterilizers, two by the company Steris (steam sterilizers), and one by the company Sterrad (a low temperature hydrogen peroxide gas sterilizer). The CAH had 5 policies related to the Sterrad machine. There were no policies regarding the processing instruments using the Steris machines and no policies related to central processing.

During an observation of instrument processing services on 9/19/17, starting at 11:30 AM, the CST in charge of instruments was interviewed. She was then asked what policies guided her work with instruments. She stated she was unfamiliar with any policies related to central processing.

The CAH did not develop central processing policies.

d. The AORN 2015 EDITION "GUIDELINES FOR PERIOPERATIVE PRACTICE," stated, under the chapter "FLEXIBLE ENDOSCOPES" Recommendation IX.A. "Flexible endoscopes will be stored in a closed cabinet with ...Adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet ...Sufficient space for storage of multiple scopes to hang without touching ..." Additionally, it stated under Recommendation IX.a.1. "Flexible endoscopes should be reprocessed before use if unused for more than 5 days."

The CAH's cleaning and processing area for flexible endoscopes was observed on 9/21/17 starting at 1:30 PM. The Operating Room Technician was present and interviewed during the observation. She stated the precleaning detergent "Intercept" directions indicated a water temperature of 68-95 degrees Fahrenheit to be effective. She stated they had ordered measuring devices with thermometers but they had not yet arrived, so they had not been monitoring the temperature.

The storage of the flexible endoscopes was observed. Three of the scopes had portions of the scope ends touching the floor, which was covered with a towel. When asked how the CAH determined the length of time scope could hang before being reprocessed before putting it in a patient, she was not sure.

The CAH failed to ensure its flexible endoscopes were reprocessed and stored per national guidelines.

g. "GUIDELINES FOR HIGH-LEVEL DISINFECTION" recommendation I.b. stated "Items that come in contact with nonintact skin or mucous membranes are considered semi-critical and should receive a minimum of high level disinfection."

On 9/20/17 at 9:00 AM, the PACU crash cart (a cart containing lifesaving equipment and medications), was observed with RN D, the Manager of Surgical Services #1. The laryngoscope blades, used to insert breathing tubes, were not contained in a wrap or peel pouch. It was unclear how they were processed or kept clean. Additionally, 2 airway packages expired on 6/2017 and 7/2017, respectively.

RN D stated they recently started placing laryngoscopes in the anesthesia carts in peel pouches to keep them clean. She stated no one had been in the PACU crash cart for a long time and someone else was responsible for keeping items in the crash cart in date She agreed the items were expired.

The CAH failed to ensure items in the crash cart were properly stored and within the expiration date.

The cumulative effect of these systemic problems increased the potential for surgical patients to experience complications.

Based on staff interview and review of policies, quality documents, and incident reports, it was determined the CAH failed to ensure a periodic evaluation and quality assurance program had been developed and implemented. This resulted in the inability of the CAH to assess its services, identify areas needing improvement, and take steps to improve and monitor quality. Findings include:

1. Refer to C-331 as it relates to the failure of the CAH to ensure an evaluation of its total program was performed.

2. Refer to C-333 as it relates to the failure of the CAH to ensure an evaluation of its total program, including a representative sample of both active and closed clinical records, was performed.

3. Refer to C-334 as it relates to the failure of the CAH to ensure an evaluation of its total program, including the CAH's health care policies, was performed.

4. Refer to C-335 as it relates to the failure of the CAH to ensure an evaluation of its total program that determined whether the utilization of services was appropriate, the established policies were followed, and what changes were needed, was performed.

5. Refer to C-336 as it relates to the failure of the CAH to ensure an effective quality assurance program was developed and maintained, including a system to investigate events harmful to patients.

The cumulative effect of these negative systemic omissions resulted in the inability of the CAH to evaluate the care and services it provided.

Based on staff interview and review of policies and quality documents, it was determined the CAH failed to ensure an evaluation of its total program was carried out. This prevented the CAH from analyzing its care and services. Findings include:

An evaluation of the CAH's total program was not documented.

The Quality Director was interviewed on 9/20/17 beginning at 9:45 AM. The surveyor requested documentation of the CAH's evaluation of its total program. The Quality Director stated the CAH had not conducted an evaluation since at least 1/01/16. She also stated the CAH did not have a policy directing staff how to conduct such an evaluation.

The CAH failed to carry out an evaluation of its total program.

Based on staff interview and review of quality documents, it was determined the CAH failed to ensure an evaluation of its total program, including a sample of active and closed clinical records, was carried out. This impeded the CAH's ability to analyze its care and services. Findings include:

The CAH had not conducted an evaluation of its total program, including a sample of active and closed clinical records, since at least 1/01/16.

The Quality Director was interviewed on 9/20/17 beginning at 9:45 AM. She stated the CAH had not conducted an evaluation of its total program, including a sample of active and closed clinical records.

The CAH failed to carry out an evaluation of its total program, including a clinical record review.

Based on staff interview and review of quality documents, it was determined the CAH failed to ensure an evaluation of its total program, including a review of its health care policies, was carried out. This impeded the CAH's ability to analyze its care and services. Findings include:

The CAH had not conducted an evaluation of its total program, including a review of its health care policies, since at least 1/01/16.

The Quality Director was interviewed on 9/20/17 beginning at 9:45 AM. She stated the CAH had not conducted an evaluation of its total program, including a review of its health care policies.

The CAH failed to carry out an evaluation of its total program, including a review of its health care policies.

Based on staff interview and review of quality documents, it was determined the CAH failed to ensure an evaluation of its total program, that determined whether the utilization of services was appropriate, the established policies were followed, and what changes were needed, was performed. This prevented the CAH from analyzing its program and taking action to improve care. Findings include:

The Quality Director was interviewed on 9/20/17 beginning at 9:45 AM. She stated the CAH did not complete an evaluation of its total program, since at least 1/01/16, that attempted to answer the above questions.

The surveyor requested documentation of the CAH's evaluation of its total program. The Director of Clinical Services stated an evaluation of the CAH's program, that included a determination of whether the utilization of services was appropriate, the established policies were followed, and what changes were needed, had not been performed since at least 1/01/16.

The CAH failed to perform an evaluation of its program that examined its appropriateness and effectiveness.

Based on staff interview and review of policies and incident reports, it was determined the CAH failed to ensure an effective quality assurance program was developed and maintained, including a system to investigate events harmful to patients. The CAH also failed to act to prevent future incidents. This impeded the CAH's ability to prevent situations with the potential to harm patients. Findings include:

1. The policy "Occurrence Report," dated 10/20/05, contained a list of events which should be documented in an occurrence/incident report. The policy stated a department manager, nursing supervisor, or charge nurse would investigate the event within 24-48 hours. The policy stated the reports would then be forwarded to the Risk Manager. The policy did not include direction regarding how the incidents would be investigated or how the CAH would ensure corrections to processes would be made to prevent further incidents. The policy did not state how these actions would be documented.

The Quality Director was interviewed on 9/20/17 beginning at 9:45 AM. She stated the policy did not describe a process to investigate and document complaints.

The occurrence reporting policy was not complete.

2. Reports of 22 incidents, occurring from 3/01/17 to 8/31/17, were reviewed. None of the reports documented that systems or processes were reviewed to determine the cause of the incidents. None of the reports documented that any system changes had been made to prevent future incidents. Examples include:

a. An untitled incident report stated, on 4/20/17, a patient suffered burns during a surgery. There was no documentation that the incident was investigated. There was no documentation action was taken to prevent similar events from occurring.

b. An untitled incident report stated, on 3/24/17, a patient suffered a burn during an MRI test. There was no documentation that the incident was investigated. There was no documentation action was taken to prevent similar events from occurring.

c. An untitled incident report stated, on 4/20/17, a patient was over sedated. The report stated the patient's oxygen saturation levels dropped too low and the patient required Narcan, an antidote for opioid toxicity. There was no documentation that the incident was investigated. There was no documentation action was taken to prevent similar events from occurring.

d. An untitled incident report stated, on 6/05/17, an intravenous drip was set at the wrong rate. There was no documentation that the incident was investigated. There was no documentation action was taken to prevent similar events from occurring.

e. An untitled incident report stated, on 8/10/17, a dressing was used for a surgical patient. It was later determined the dressing's expiration date was May, 2016. There was no documentation that the incident was investigated. There was no documentation action was taken to prevent similar events from occurring.

f. An untitled incident report stated, on 7/24/17, a patient was given the wrong narcotic medication. There was no documentation that the incident was investigated. There was no documentation action was taken to prevent similar events from occurring.

The Quality Director was interviewed on 9/20/17 beginning at 9:45 AM. She stated the above incidents were assigned to department managers to investigate. She stated many of the investigations were conducted but were not documented. For example, she stated the incident with the MRI burn had been investigated and action was taken. She stated this was not documented.

The Quality Director stated the CAH used a program from their insurance company to document investigations and actions taken. She stated the department managers refused to document in the program. She stated staff had not documented investigations and actions in the program for longer than 1 year.

The CAH did not investigate incidents or act to correct problems that were identified.