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Based on observations, interviews, and record review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital when:

1. The hospital did not ensure an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases. Two of two autoclaves (machines used to sterilize [render germ free] reusable patient surgical instruments) were not cleaned according to manufacturer's instructions for use (IFU). Two of two previously cleaned and sterilized surgical instrument tray sets contained multiple instruments with brown and red staining. Multiple instruments were not processed according to manufacturer's IFU and in accordance with the hospital's infection control standards. Manufacturer's recommendations for the use of enzymatic (compound produced by living organisms) solutions (used to clean reusable patient surgical instruments) were not followed. Bristle (stiff hair or feather) brushes (cleaning tools) used in sterile processing department (SPD-a department that performs sterilization and other actions on surgical instruments) ) were not cleaned and disinfected according to manufacturer's IFU. The hospital was unable to provide evidence to indicate the hospital performed active infection control surveillance in SPD to ensure the department and staff performed surgical services in accordance with acceptable standards (Refer to A-749, Findings 1 through 6).

The survey team identified significant concerns in the hospital's Sterile Processing Department (SPD) and an Immediate Jeopardy situation was called on 6/3/19 at 7:41 p.m. with the following hospital staff in attendance: Assistant Chief Nurse Officer (ACNO), Surgical Services Manager (SSM), Quality Director (QD), Infection Control Preventionist (ICP 4), and the Patient Safety Officer (PSO). The IJ was called under CFR 482.42(a) Tag A 749 Infection Control and was supported by the the following findings: previously sterilized surgical instruments were observed with brown and red staining, autoclaves were observed with red and brown staining and not cleaned according to manufacturer instructions, dirty surgical instruments were not processed, cleaned and sterilized according to hospital infection control standards and no system was in place to monitor the proper technique for cleaning surgical instruments by SPD staff. The potential serious harm of this IJ situation could negatively affect all patients having surgery in the hospital. On 6/04/19 at 12:50 p.m., hospital staff provided the survey team an acceptable Plan of Removal for the IJ situation. On 6/04/19 at 12:54 p.m., the immediate jeopardy was removed, after the team verified completion of components of the corrective action plan through observation, interview, and record review. The team validated the autoclaves were cleaned per manufacturer's IFU, in-services were performed and new competencies were created for SPD staff to follow, according to AAMI standards for cleaning instruments. The IJ was removed by the district office and communicated to the hospital Assistant Chief Nursing Officer.

2. The hospital did not provide surgical services in a well-organized manner, in accordance with acceptable standards of practice and in a manner to prevent the risk of cross contamination (transfer of germs from one surface, substance, or person to another) when multiple instances of staff not following acceptable standards of practice related to infection control practices were observed and there was no documented evidence to indicate the hospital performed active infection control surveillance in SPD to ensure the department and staff performed surgical services in accordance with acceptable standards. Reusable surgical instruments used to clamp tubing on a heart-lung machine (temporarily takes over the functions of the heart and lungs during heart surgery) were not cleaned according to hospital's infection control standards. The hospital's policy for cleaning surgical instruments did not contain clear guidance for staff to follow when cleaning reusable patient surgical instruments. (Refer to A-951, Findings 1 through 3).

3. The hospital did not identify opportunities aimed at performance improvement in high-risk and high-volume surgical areas that affected health outcomes, patient safety, and quality of care. The hospital had no documented evidence that indicated active surveillance was performed in the hospital's SPD through observations and validation of staff competencies to ensure SPD staff performed duties in accordance with acceptable standards and in a manner to minimize the risks of hospital acquired infections (HAIs). The hospital's quality assessment and performance improvement program did not identify opportunities for improvement in infection control. (Refer to A-283).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and sanitary environment.

Based on observations, interviews and record review, the hospital failed to implement and maintain an ongoing, hospital-wide, data-driven Quality Assessment and Performance Improvement (QAPI) program to improve quality and safety when the hospital failed to identify opportunities aimed at performance improvement in high-risk and high-volume areas that affected patient health outcomes, patient safety, and quality of care when there was no documented evidence that indicated active surveillance was performed in the hospital's Sterile Processing Department (SPD-a department that performs sterilization and other actions on surgical instruments) to ensure SPD staff performed duties in accordance with acceptable standards and in a manner to minimize the risks of hospital acquired infections (HAIs- infections that patients get while receiving treatment for medical or surgical conditions) (Refer to A-283, A-749 Finding 6, and A-951 Finding 1).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality patient care in a safe environment.

Based on interview and record review, the hospital failed to identify opportunities aimed at performance improvement in high-risk and high-volume areas that affected health outcomes, patient safety, and quality of care when there was no documented evidence that indicated active surveillance was performed in the hospital's Sterile Processing Department (SPD-a department that performs sterilization and other actions on surgical instruments) that ensured SPD staff performed duties in accordance with acceptable standards and in a manner to minimize the risks of hospital acquired infections (HAIs- infections that patients get while receiving treatment for medical or surgical conditions). (Cross reference A-749 Finding 6 and A-951 Finding 1).

These failures resulted in the potential for all patients undergoing surgical intervention to have surgical site and/or HAIs by cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) by not ensuring the sterility (free from bacteria) of surgical instruments used for patient services and the hospital to not recognize the severity of the problem.

Findings:

During an interview with the Risk Coordinator (RC), on 6/10/19, at 2:25 p.m., she stated the hospital did not have evidence of surveillance of the SPD's practices in cleaning and disinfection of surgical instruments.

During an interview with the Director of Quality (DQ), on 6/10/19, at 2:32 p.m., he stated the quality department did not recognize performance improvement activities in SPD because there was no data collected from SPD or the Infection Control Program that identified opportunities for performance improvement. The DQ stated his expectation was for the SPD subject matter expert to have identified the severity of the problems that were identified. (Cross reference A-749 findings 1 through 6 and A-951 Findings 1 through 3). The DQ stated, "...I was a little surprised..."

A review of the hospital document titled, "Financial Statistics" dated 4/18 through 4/19 indicated an average of 1,100 surgeries performed each month.

A review of the hospital document titled, "Performance Excellence Plan" dated 2019, indicated, "...(name of hospital) aims to deliver exceptional healthcare to our patients through a commitment to continuous improvement and performance excellence...Continuous improvement relies on...B. Establishing organizational quality and patient safety goals that are consistent with the needs of internal and external customers. C. Identification, development and adherence to best practices associated with clinical, managerial and leadership practices to minimize variation in patient service processes. D. Education and acceptance of performance improvement tools. E. Reliance on validated analytical metrics to monitor and direct quality and patient safety performance improvement endeavors...Each year (name of hospitals) will conduct a formal review of its quality performance improvement programs. Focuses of this review will include...C. (name of hospital) will be formed, as appropriate, to maintain the integrity of patient care among facilities. Each service line will use criteria (high volume, high costs and/or problem prone) to determine performance improvement projects to focus..."

Based on interview and record review, the hospital's staff failed to administer medications according to a physician's order for two of 30 sampled patients (Pts 74 and 82) when Registered Nurses (RNs) administered Acetaminophen (medication used as pain reliever or fever reducer) for purposes not indicated per the physician's order.

This failure had the potential for Pts 74 and Pt 82 to receive an unnecessary medication.

Findings:

During a concurrent interview and record review with Informatics Nurse (IRN) 1, on 6/5/19, at 2:12 p.m., she reviewed the clinical record titled, "Medication Administration," dated 5/24/19, and stated Pt 74 received Acetaminophen 650 mg (milligram-a form of measurement) intravenously (IV- in a vein) on 5/21/19 at 11:38 p.m. IRN 1 stated the physician's order dated 5/21/19, indicated Acetaminophen 650 mg IV was prescribed as needed for temperature greater than 38 degrees Celsius (C - the scale of temperature). IRN 1 reviewed the vital signs (clinical measurements, specifically pulse rate, temperature, respiration rate, and blood pressure, that indicate the state of a patient's essential body functions) flowsheet on 5/21/19, and stated no temperatures were documented. IRN 1 reviewed the nursing progress notes on 5/21/19, and stated Acetaminophen IV was given to Pt 74 for a headache and not for a temperature over 38 degrees C. IRN 1 stated the physician's order for Acetaminophen 650 mg IV was not followed.

During a concurrent interview and record review with IRN 2 and Clinical Supervisor (CS) 15, on 6/6/19 at 10:50 a.m., IRN 2 reviewed the clinical record titled, "Medication Administration," dated 5/24/19, and stated Pt 82 received Acetaminophen 650 mg by mouth on 5/24/19 at 5:55 p.m. IRN 2 stated the physician's order dated 5/23/19, indicated Acetaminophen 650 mg was prescribed as needed for temperature greater than 39 degrees C. IRN 2 reviewed the vital signs flowsheet on 5/24/19, and stated Pt 82's temperature was documented 36.5 degrees C at 5 p.m. CS 15 stated the physician's order for Acetaminophen 650 mg was not followed. CS 15 stated Acetaminophen 650 mg was administered for a temperature that was not indicated per the physician's order.

A review of the hospital policy and procedure titled, "Medications-Orders, Administration, Storage, Documentation" dated 8/19, indicated, "I. Purpose ... To provide guidelines for the safe and accurate ordering, transcribing, labeling, administration, storage and documentation of medications ... 3. A medication order must be clear, legible and include the following ... f. As needed [PRN] medications must indicate the frequency and indication [symptom] for use ..."

A review of the hospital policy and procedure titled, "Physician Orders" dated 10/9/19, indicated, " ... M. The RN acknowledgement of orders indicates they assume responsibility for ensuring implementation of the order ..."

Based on interview and record review, the hospital failed to ensure blood transfusions were administered per approved hospital policies and procedures for two of 30 sampled patients (Pts 76 and 77) when vital signs (measurements of blood pressure, temperature, respirations, and heart rate) monitoring was not performed.

This failure resulted in an incomplete medical record and had the potential for delay in treatment of adverse reactions to blood products.

Findings:

During a concurrent interview and record review with Informatics Registered Nurse (IRN) 1 and Registered Nurse (RN) 22, on 6/5/19, at 3:40 p.m., a review of Pt 76's clinical record titled, "Transfusion Record" dated 5/26/19 at 8:59 a.m., indicated Pt 76's blood transfusion was initiated on 5/26/19 at 9:15 a.m. The transfusion record indicated vital signs were documented in Pt 76's electronic health record (EHR- medical record in the computer) on 5/26/19 at 9:15 a.m., 10:15 a.m., and 11:15 a.m. IRN 1 stated the first vital signs documented were one hour after the transfusion was started. IRN 1 stated the hospital's policy was not followed. RN 22 stated the hospital policy required vital signs to be documented when blood transfusions were initiated, 15 minutes after, then every hour until the blood transfusion was completed.

During a concurrent interview and record review with IRN 1, on 6/5/19, at 3:55 p.m., a review of Pt 77's clinical record titled, "Transfusion Record" dated 5/30/19 at 4:46 p.m., indicated Pt 77's blood transfusion was initiated on 5/30/19 at 5 p.m. The transfusion record indicated vital signs were documented on Pt 77's transfusion record and in the EHR. IRN 1 stated Pt 77's vital signs were documented on 5/30/19 at 5:23 p.m., 6:19 p.m., 7:39 p.m., and 8:15 p.m. IRN 1 stated Pt 77's vital signs were documented late.

During a concurrent interview with the Oncology Department Manager (ODM) and record review of Pt 76 and Pt 77's blood transfusion records, on 6/10/19, at 3:15 p.m., the ODM confirmed the findings and stated nurses were required to monitor and document patients' vital signs at the start of a blood transfusion, 15 minutes after start, one hour after start, then every hour until the blood transfusion was completed. The ODM stated the purpose of monitoring vital signs during blood transfusions was to identify signs and symptoms of blood transfusion reaction (changes in blood pressure, respiratory rate, and skin, fever, chills, etc.) in patients. The ODM stated signs and symptoms of blood transfusion reactions could be missed if patients were not monitored and policies were not followed.

A review of the hospital policy and procedure titled, "Blood Products Transfusion" dated 12/8/16, indicated, "I. Purpose ...A ... to ensure safe transfusion through patient assessment and nursing intervention ... B. Document the following in the patient's EHR or on the Transfusion Record Chart ... vital signs at the onset of transfusion ... Vital signs: pre-transfusion baseline, then 15 minutes and 60 minutes after start of transfusion, then every hour and as needed [PRN] during transfusion, and then at end of transfusion ..."

Based on interview and record review, the hospital failed to ensure physician's telephone orders were authenticated (verified and cosigned) in patient's medical records within 48 hours in accordance with approved hospital policy and procedures for one of 30 sampled patients (Pt 83).

This failure resulted in unverified physician orders and had the potential for inappropriate treatment and/or care of Pt 83.

Findings:

During a concurrent interview and record review with Informatics Registered Nurse (IRN) 2, on 6/6/19, at 10:10 a.m., Pt 83's clinical record indicated Medical Doctor (MD) 7 placed a telephone order for a Basic Metabolic Panel (BMP- blood test that measures blood sugar, electrolytes, and kidney function) on 5/21/19 at 9:02 a.m. The telephone order was signed by MD 7 on 5/27/19 at 12:19 a.m. IRN 2 validated the findings and stated the order was signed late, six days later by the prescribing physician. IRN 2 stated telephone orders are supposed to be signed by the ordering physician within 48 hours.

During a review of the clinical record for Pt 83, the BMP order details indicated, " ...BMP ...Lab morning draw daily ... Duration three [3] days ... Lab collect ...Order date and time 5/21/19 0902 ... Ordering Mode ...Telephone with readback ... Signed on 5/27/19 0019 (12:19 a.m.) ..."

A review of the hospital policy and procedure titled, "Physician Order" dated 6/16, indicated, "I. Purpose ...C. To provide guidelines for the receipt, documentation, authentication and use of verbal or telephone orders ...G. Telephone Orders ...1. Telephone orders are to be used infrequently and limited to those situations in which it is impossible or impractical for the ordering provider to enter the order in the HER (electronic health record) ...I. All verbal and telephone orders must be cosigned by the ordering provider within 48 hours from the date and time the order was entered ..."

Based on observation, interview, and document review, the hospital failed to ensure they had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases when:

1. Two of two autoclaves (machines used to sterilize [render germ free] reusable patient surgical instruments) were not cleaned according to manufacturer's instructions for use (IFU) (Refer to A-0749, Finding 1).

2. Two of two previously cleaned and sterilized surgical instrument tray sets contained multiple instruments with brown and red staining. (Refer to A-749, Finding 2).

3. Multiple instruments were not processed according to manufacturer's IFU and in accordance with the hospital's infection control standards (Refer to A-749, Finding 3).

4. Manufacturer's recommendations for the use of enzymatic (compound produced by living organisms) solutions (used to clean reusable patient surgical instruments) were not followed (Refer to A-0749, Finding 4).

5. Bristle (stiff hair or feather) brushes (cleaning tools) used in SPD were not cleaned and disinfected according to manufacturer's IFU. (Refer to A-749, Finding 5).

6. There was no documented evidence to indicate the hospital performed active infection control surveillance in the sterile processing department (SPD) to ensure the department and staff performed surgical services in accordance with acceptable standards (Refer to A-0749, Finding 6 and A-951, Finding 1).

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in surgical services in a safe environment.


The survey team identified significant concerns in the hospital's Sterile Processing Department (SPD) and an Immediate Jeopardy situation was called on 6/3/19 at 7:41 p.m. with the following hospital staff in attendance: Assistant Chief Nurse Officer (ACNO), Surgical Services Manager (SSM), Quality Director (QD), Infection Control Preventionist (ICP 4), and the Patient Safety Officer (PSO). The IJ was called under CFR 482.42(a) Tag A 749 Infection Control and was supported by the following findings: previously sterilized surgical instruments were observed with brown and red staining, autoclaves were observed with red and brown staining and not cleaned according to manufacturer instructions, dirty surgical instruments were not processed, cleaned and sterilized according to hospital infection control standards and no system was in place to monitor the proper technique for cleaning surgical instruments by SPD staff. The potential serious harm of this IJ situation could negatively affect all patients having surgery in the hospital. On 6/04/19 at 12:50 p.m., the hospital leadership provided the survey team an acceptable corrective action plan to lift the immediacy of the IJ situation. On 6/04/19 at 12:54 p.m., the immediate jeopardy was removed, after the team verified completion of components of the corrective action plan through observation, interview, and record review. The team ensured the autoclaves were cleaned per manufacturer's IFU, in-services were performed and new competencies were created for SPD staff to follow, according to AAMI standards for cleaning instruments. The IJ was removed by the district office to the hospital Assistant Chief Nursing Officer.

Based on observation, interview, and record review, the infection control officers failed to ensure a system was in place for identifying, reporting, investigating, and controlling infections and communicable diseases when:

1. Two of two autoclaves (machines used to sterilize reusable patient surgical instruments) were not cleaned according to manufacturer's instructions for use (IFUs);

2. Two of two previously cleaned and sterilized surgical instrument tray sets, contained multiple instruments with brown and red staining;

3. Multiple instruments were not processed according to manufacturer's IFU and the hospital's infection control standards;

4. Manufacturer's IFU of enzymatic solutions (type of cleaning solution that uses biologic chemicals) used to clean reusable surgical instruments were not followed;

5. Bristle (stiff hair or feather) brushes (cleaning tools) used in Sterile Processing Department (SPD were not cleaned and disinfected according to manufacturer's IFU; and

6. There was no documented evidence to indicate the hospital performed active infection control surveillance in the sterile processing department (SPD) to ensure staff performed surgical instrument cleaning techniques in accordance with acceptable standards.

The survey team identified significant concerns in the hospital's Sterile Processing Department (SPD) and an Immediate Jeopardy situation was called on 6/3/19 at 7:41 p.m. with the following hospital staff in attendance: Assistant Chief Nurse Officer (ACNO), Surgical Services Manager (SSM), Quality Director (QD), Infection Control Preventionist (ICP 4), and the Patient Safety Officer (PSO). The IJ was called under CFR 482.42(a) Tag A 749 Infection Control and was supported by the the following findings: previously sterilized surgical instruments were observed with brown and red staining, autoclaves were observed with red and brown staining and not cleaned according to manufacturer instructions, dirty surgical instruments were not processed, cleaned and sterilized according to hospital infection control standards and no system was in place to monitor the proper technique for cleaning surgical instruments by SPD staff. The potential serious harm of this IJ situation could negatively affect all patients having surgery in the hospital. On 6/04/19, hospital staff provided the survey team an acceptable Plan of Removal for the IJ situation. On 6/04/19 at 12:54 p.m., the immediate jeopardy was removed, after the team verified completion of components of the corrective action plan through observation, interview, and record review. The team validated the autoclaves were cleaned per manufacturer's IFU, in-services were performed and new competencies were created for SPD staff to follow, according to AAMI standards for cleaning instruments. The IJ was removed by the district office and communicated to the hospital Assistant Chief Nursing Officer.

Findings:

1. During an interview on 06/03/19 at 9:50 a.m. , Infection Control Preventionist (ICP 2) stated the hospital followed nationally recognized guidelines from the Association for Professionals in Infection Control (APIC); the Association of PeriOperative Registered Nurses (AORN); the Association for the Advancement of Medical Instrumentation (AMMI); and the Centers for Disease Control and Prevention (CDC).

On 6/3/19 at 2:30 p.m., during a concurrent tour and interview with the SPD Supervisor in the SPD prep and assembly area (a clean area used to prepare, package and sterilize reusable surgical instruments), two of two autoclaves were noted to have brown, red, orange staining within the chambers and thick gray fuzzy matter around the outer surfaces, adjacent to the door hinges. The SPD Supervisor confirmed the findings and stated the interior chambers of the autoclaves were not cleaned; she stated she was not familiar with the manufacturer instructions for use (IFU) related to cleaning and maintaining the autoclaves. The SPD Supervisor also stated the vendor of the autoclaves cleaned the autoclaves on an annual basis; however, documentation of evidence indicating both autoclaves were cleaned and maintained according manufacturer IFU was requested but not provided.

On 6/5/19 during a record review with the Quality Risk Coordinator in attendance, the undated manufacturer's instructions on cleaning and maintaining the autoclaves were reviewed. The instructions indicated the following:

4.1 Daily - 1. Clean chambers ..." (specific details and instructions provided by manufacture).
4. 2 Weekly - 1. Flush chamber drain ..." (specific details and instructions provided by manufacture).
4.3 Monthly - 1. Place a few drops of heavy machine oil ..." (specific details and instructions provided by manufacture).
4.4 Quarterly - 1. Grease door post as follows: ..." (specific details and instructions provided by manufacture).

2. On 06/03/19, at 3:20 p.m., during a concurrent tour of Sterile Processing Department (SPD) and interview with the SPD Supervisor, SPD Technician (Tech) 1, and SPD Tech 2 in attendance, two sterilization containers (one major and one minor) filled with various cleaned and sterilized surgical instruments were inspected and the following observations were made:
47 of 70 instruments in the major container had brown and red staining
19 of 43 surgical instruments in the minor container had brown staining.

SPD Tech 1 stated the instruments should not have any brown staining and SPD Tech 2 stated the trays should be reprocessed.

On 6/3/19 at 8 p.m., the above findings were discussed with ICP 4 who stated, there should be no brown staining on the instruments after they are cleaned.

3. On 6/3/19 at 4:15 p.m., during a concurrent tour and interview with Sterile Processing Department (SPD) Technician (Tech 3) in attendance, the following observations were made in the decontamination room (a room used to clean and disinfect reusable soiled patient surgical instruments): a) One "heart cart set" (contains instruments used for heart surgery) contained instruments with dried red matter on the instruments; SPD Tech 3 stated the red matter was "dried blood" and he stated the facility is short staffed on Mondays and Tuesdays and "that was why the carts are backed up." b) SPD Technician 3 was observed brushing soiled instruments from a thyroid set (instruments used for a thyroid surgery) above the water level. c) SPD Tech 3 cleaned a Transesophageal echocardiograph Transducer (TEE - a scope/transducer used to assess how well the heart works), a Thyroid Scope, and a mini Lap Storz (a rigid scope used for various surgical procedures) in the sink using the same water and disinfectant. SPD Tech 3 did not change the enzymatic solution or refresh the water.
d) SPD Tech 3 used a single, worn, wired toothbrush-like brush to clean all of the instruments without replacing the brush. Red matter could be visualized in the water that was used to clean all scopes and instruments.

SPD Tech 3 stated, "I will replace the brushes if they're worn and if there are chunks of matter on them."

On 6/3/19 at 4:45 p.m., during a concurrent interview, the SPD Supervisor stated that "everyone" cleans the instruments differently. ICP 2 stated, "All instruments opened in the operating room need to be cleaned."

On 6/3/19 at 8 p.m., the above findings were discussed with ICP 4 who stated, all instruments opened in the operating room need to be cleaned.

4. On 6/3/19 at 4:15 p.m., during a concurrent interview and observation of the decontamination room (a room used to clean and disinfect reusable soiled patient surgical instruments) and interview, Sterile Processing (SPD) Technician (Tech) 3 did not soak every instrument in the Mini Lap Storz set (contains surgical instruments), specifically, 12 hinged instruments did not get brushed or soaked. There was no timer available for SPD 3 to measure the soak time (the time needed as required by the manufacturer for surgical instruments to be soaked in the enzymatic [compound produced by living organisms] solutions [used to clean reusable patient surgical instruments]) was maintained and there was no thermometer to obtain a water temperature. The label on the enzymatic solution indicated to use "warm water ...clean for a minimum of 1 to 5 minutes. Cleaning times may be longer with dried on proteinaceous [containing protein] materials. If lower temperatures are used, a longer cleaning time may be necessary. Do not exceed 130 degrees Fahrenheit ..." SPD Tech 3 stated, she did not check the temperature of the water and did not know what the manufacturer's recommendations were for the temperature or the soak time of the enzymatic solution. SPD Tech 3 also stated, "Not every instrument gets cleaned, only the dirty ones, not the clean ones," referring to the instruments that did not get used for the surgical procedure.

5. On 6/3/19 at 4:15 p.m., during a concurrent tour and interview in the decontamination room (used to clean and disinfect reusable, soiled patient surgical instruments), Sterile Processing Department (SPD) Technician (Tech) 3 was observed using a single, worn, wired toothbrush-like brush with worn bristles to clean three of three instrument sets (instruments from different patient surgeries) without replacing the brush. SPD Tech 3 stated they reuse the brushes without cleaning them until they are worn and then discard them. SPD Tech 3 stated, "I will replace the brushes if they're worn and if there are chunks of stuff on them."

A review of the manufacturer's undated instructions for use (IFU) for cleaning brushes indicated, "Brushes must be cleaned prior to reuse. Clean and disinfect brushes daily, at a minimum, prior to reuse ..."

6. On 6/4/19 at 11 a.m., during an interview, the following observations in the Sterile Processing Department (SPD) were discussed with Infection Control Preventionist (ICP) 4: a) Two of two autoclaves (machines used to sterilize [render germ free] reusable patient surgical instruments) were not cleaned according to the manufacturer's instructions for use (IFU); b) Two of two previously cleaned and sterilized surgical instrument tray sets contained multiple instruments with brown and red staining; c) Multiple instruments were not processed according to the manufacturer's IFU and the hospital's infection control standards; d) Manufacturer's IFU for enzymatic (compound produced by living organisms) solutions (used to clean reusable patient surgical instruments) were not followed; e) Bristle brushes used in SPD were not cleaned and disinfected according to manufacturer's IFU. ICP 4 stated she did not know SPD staff were not cleaning the wire brushes used to clean instruments. ICP 4 stated she thought the brushes they used were disposable. ICP 4 stated she was unfamiliar with the hospital policies regarding decontamination, cleaning or handling of surgical instruments.

During an interview on 6/4/19 at 11 a.m. with ICP 4, she stated there was no documented evidence to show active surveillance and oversight was performed of SPD staff. When requested to provide evidence of monitoring, ICP 4 stated there was none. ICP 4 stated she provided quarterly rounding in SPD but did not document the rounds. ICP 4 stated she should have provided oversight to ensure staff performed their tasks according to standards. ICP 4 also stated she was unfamiliar with the enzymatic solution SPD used to clean instruments and had not observed the condition of the autoclaves.

A review of AORN guideline related to cleaning of surgical instruments indicated, "Manual cleaning should be accomplished by submerging the instrument in warm water with an appropriate detergent followed by complete submersion of the instrument in rinse solution to minimize aerosolization ]the dispersion in air of a liquid material or a solution in the form of a fine mist] of contaminants. Aerosolization of contaminants, splashing of infectious material, and injury from sharp objects are possible when manual cleaning is performed under a stream of running tap water."

A review of AMMI document titled, "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC (Centers for Disease Control) Guidelines, and AORN documents all indicated instruments should undergo an inspection for proper function and cleanliness.

A review of AMMI reference related to the cleaning of surgical instruments titled, "Standards and Recommended Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non-Clinical Settings, ANSI/AAMI ST35:2003," indicated " ... keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization".

A review of the manufacturer's undated instructions for use (IFU) for cleaning brushes indicated, "Brushes must be cleaned prior to reuse. Clean and disinfect brushes daily, at a minimum, prior to reuse ..."

A review of AORN document indicated, "Manual cleaning should be accomplished by submerging the instrument in warm water with an appropriate detergent followed by complete submersion of the instrument in rinse solution to minimize aerosolization [the dispersion in air of a liquid material or a solution in the form of a fine mist] of contaminants. Aerosolization of contaminants [to make unfit for use by the addition of something harmful or undesirable], splashing of infectious [disease causing organism] material, and injury from sharp objects are possible when manual cleaning is performed under a stream of running tap water."

A review of AMMI reference titled, "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities," a CDC guideline, and an AORN reference all indicated instruments should undergo an inspection for proper function and cleanliness.

A review of AMMI document titled, "Standards and Recommended Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non-Clinical Settings, ANSI/AAMI ST35:2003" indicated, " ... keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization".

Based on observations, interviews, and record reviews, the hospital failed to provide surgical services in a safe, well organized manner when:

1. Multiple instances of staff not following acceptable standards of practice related to infection control practices were observed and there was no documented evidence to indicate the hospital performed active infection control surveillance in the sterile processing department (SPD) to ensure the department and staff performed surgical services in accordance with acceptable standards; (Refer to A 951 finding 1)

2. Five reusable surgical instruments used to clamp tubing on a heart-lung machine (temporarily takes over the functions of the heart and lungs during heart surgery) were not cleaned according to hospital's infection control standards; (Refer to A 951 finding 2)

3. A policy for cleaning surgical instruments did not contain clear guidance for staff to follow when cleaning reusable patient surgical instruments. (Refer to A 951 finding 3)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

Based on observation, interview, and record review, the hospital failed to provide surgical services in a well-organized manner, in accordance with acceptable standards of practice and in a manner to prevent the risk of cross contamination (transfer of germs from one surface, substance, or person to another) when:

1. Multiple instances of staff not following acceptable standards of practice related to infection control practices were observed and there was no documented evidence to indicate the hospital performed active infection control surveillance in the sterile processing department (SPD) to ensure the department and staff performed surgical services in accordance with acceptable standards;

2. Five reusable surgical instruments used to clamp tubing on a heart-lung machine (temporarily takes over the functions of the heart and lungs during heart surgery) were not cleaned according to hospital's infection control standards;

3. A policy for cleaning surgical instruments did not contain clear guidance for staff to follow when cleaning reusable patient surgical instruments.

These failures resulted in the potential harm to cause infections or cross contamination in all patients having surgery in the hospital.

Findings:

1. On 06/03/19 at 9:50 a.m., during an interview, Infection Control Preventionist (ICP) 2 stated the hospital followed nationally recognized guidelines from the Association for Professionals in Infection Control (APIC); the Association of PeriOperative Registered Nurses (AORN); the Association for the Advancement of Medical Instrumentation (AMMI); and the Centers for Disease Control (CDC).

On 6/3/19 at 2:30 p.m., during a concurrent tour and interview with the Sterile Processing Department (SPD) Supervisor in the SPD prep and assembly area (a clean area used to prepare, package and sterilize reusable surgical instruments), two of two autoclaves were noted to have brown, red, orange staining within the chambers and thick gray fuzzy matter around the outer surfaces, adjacent to the door hinges. The SPD Supervisor confirmed the findings and stated the interior chambers of the autoclaves were not cleaned; she stated she was not familiar with the manufacturer instructions for use (IFU) related to cleaning and maintaining the autoclaves. The SPD Supervisor also stated the vendor of the autoclaves cleaned the autoclaves on an annual basis; however, documentation of evidence indicating both autoclaves were cleaned and maintained according manufacturer IFU was requested but not provided.

On 6/3/19 at 4:15 p.m., during a concurrent tour and interview in the decontamination room (used to clean and disinfect reusable, soiled patient surgical instruments), Sterile Processing Department (SPD) Technician (Tech) 3 was in attendance. One sterilized (rendered germ free) "heart cart set" (contained surgical instruments specific for a type of heart surgery) was opened and it contained instruments with a dried red matter on the instruments; SPD Tech 3 stated the red matter was "dried blood ..." SPD Technician 3 was observed brushing soiled instruments from a thyroid set (instruments used for a thyroid surgery) above the water level. SPD Tech 3 was observed cleaning a a Transesophageal echocardiograph Transducer (TEE - ascope/transducer used to assess how well the heart works), a Thyroid Scope (instrument used to examine the thyroid for abnormalities), and a mini Lap Storz (a rigid tool used for various surgical procedures) in the sink using the same water and disinfectant. SPD Tech 3 did not change the enzymatic (compound produced by living organisms) solutions (used to clean reusable patient surgical instruments) or refresh the water. SPD Tech 3 was also observed using a single, worn, wired toothbrush-like brush to clean all of the instruments without replacing the brush. Red matter could be visualized in the water that was used to clean all scopes and instruments. SPD Tech 3 stated, "I will replace the brushes if they're worn and if there are chunks of matter on them." SPD Tech 3 stated they reuse the brushes without cleaning them until they are worn and then discard them.

The manufacturer's undated IFU for cleaning brushes were reviewed. They indicated, "Brushes must be cleaned prior to reuse. Clean and disinfect brushes daily, at a minimum, prior to reuse ..."

On 6/4/19 at 11 a.m., during an interview, observations in the SPD and the decontamination room were discussed with Infection Control Preventionist (ICP) 4. ICP 4 stated she did not know SPD staff were not cleaning the brushes used to clean instruments; she stated she thought the brushes they used were disposable. ICP 4 stated she was unfamiliar with the hospital policies regarding decontamination (process of removing, inactivating, or destroying harmful germs from a surface or item), cleaning or handling of surgical instruments.

A request was made for documented evidence that active surveillance to ensure compliance with the hospital's infection control program took place in the SPD. ICP 4 failed to provide documentation and stated there was no documented evidence to show active surveillance and oversight was performed of SPD staff. ICP 4 stated she provided quarterly rounding in SPD but did not document the rounds. ICP 4 stated she should have provided oversight to ensure staff performed their tasks according to standards.

On 6/5/19, during a record review with the Quality Risk Coordinator in attendance, the manufacturer's undated instructions on cleaning and maintaining the autoclaves were reviewed. The instructions indicated the following:
4.1 Daily - 1. Clean chambers ..." (specific details and instructions provided by manufacture).

4. 2 Weekly - 1. Flush chamber drain ..." (specific details and instructions provided by manufacture).

Monthly 4.3 - Monthly 1. Place a few drops of heavy machine oil ..." (specific details and instructions provided by manufacture).

4.4 Quarterly - 1. Grease door post as follows: ..." (specific details and instructions provided by manufacture).

2. On 6/4/19 at 2:10 p.m., during a concurrent tour in Operating Room (OR) 3 and interview with the Perfussionist Manager, five surgical clamps were observed hanging from the heart lung machine. The Perfussionist Manager stated facility staff do not clean and sterilize the surgical instruments because they are used to clamp tubing; he further stated the clamps are reused on the tubing and do not make contact with the patients during surgical procedures. The Perfussionist Manager was requested and failed to provide documented instructions for use (IFU) from the manufacturer describing cleaning instructions for the clamps when used for other than its intended use.

O 6/5/19 at 1:50 p.m., during a record review, the Quality Risk Coordinator provided the facility's policy related to clamps and it was reviewed. The document described steps for thoroughly cleaning, decontaminating and sterilizing the clamps. No instructions were provided for other methods of cleaning, if used for other than its intended purpose.

3. On 6/5/19 at 11:15 a.m., the hospital policy titled, "Decontamination" dated 11/15/18, was reviewed. The document referenced infection control standards the hospital followed, including the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of PeriOperative Registered Nurses (AORN). The policy did not provide clear instructions and steps to properly clean reusable surgical instruments and very often referred staff to follow the manufacturer's instructions for use (IFU). The general steps for properly cleaning instruments per AAMI/AORN guidelines were not described in the document.

On 6/6/19 at 10:30 a.m., during a concurrent interview and record review, the policy titled, "Decontamination" dated 11/15/18, was reviewed with the Director of Infection Control and Infection Control Preventionist (ICP) 3 in attendance. ICP 3 agreed with the findings and stated that the decontamination policy did not provide clear guidance to staff on how to properly clean and disinfect reusable surgical instruments. ICP 3 stated, "It refers to follow manufacture instructions often and we have a lot of manufacturers." ICP 3 stated they will be making changes to give clearer guidance to staff.