HospitalInspections.org

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Based on observations, interviews, and document reviews, the hospital failed to maintain effective systems that ensured that patients received high quality healthcare that met their needs in a safe environment.

Failure to meet infection control program requirements for quality assurance and oversight risks patient safety.

Findings Included:

The hospital failed to develop and implement an effective infection prevention and control program.

Due to these findings and the scope and severity of deficiencies detailed under 42 CFR 428.41 Infection Control, the Condition of Participation for Governing Body was NOT MET.

Cross Reference: A0747, A0749, A0756

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Based on observation, interview and review of the hospital's infection control program, the hospital failed to develop and implement an effective infection prevention and control program.

Failure to develop and implement an effective infection prevention and control program puts patients, staff and visitors at risk of illness from communicable diseases.

Findings included:

1. The hospital failed to implement and monitor an effective infection prevention program that included:

a. Ensuring the hospital's unit based subcommittees were integrated into an overall infection prevention and control program.

b. Ensuring the infection prevention and control goals approved by the organization were implemented, monitored for effectiveness, data was collected and analyzed and effectiveness of interventions were measured.

c. Ensuring oversight of the unit based committees to ensure accountability and compliance with the plan and goals established in the hospital's Infection Control Plan.

d. Ensuring that staff properly performed critical and semi-critical high level disinfection according to commonly recognized practice standards.

e. Ensuring the surgical staff members followed hospital policy regarding surgical attire

Due to the scope and severity of deficiencies cited under 42 CFR 482.42, the Condition of Participation for Infection Control was NOT MET.

Cross Reference: A0749, A0756

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ITEM #1 - Duodenoscope Reprocessing

Based on observation, interview, and document review, the hospital failed to ensure that staff members properly performed manual cleaning of endoscopes according to manufacturer's instructions for use.

Failure to properly clean endoscopes risks transmission of infection to patients.

Reference: American Society for Gastrointestinal Endoscopy "Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update." January 2017, Pg. 7: "Recommendations: 5. Before manual or automated HLD, meticulously clean the entire endoscope, including valves, channels, connectors, and all detachable parts using only model specific cleaning devices (such as brushes) designed for the endoscope model being cleaned. Manual cleaning should occur within the manufacturer's recommended time frame. When cleaning is delayed beyond this interval, the manufacturer's directions for delayed processing should be followed. Strict compliance with manufacturer's guidance must be maintained, particularly for endoscopes with movable mechanisms such as the distal tip elevator present on duodenoscopes and linear US endoscopes."

Findings included:

1. Review of a manufacturer document titled, "Urgent Safety Notification Important Updated Labeling Information: New Reprocessing Instructions for the Olympus TJF-180V Duodenoscope," dated 03/26/15, showed that new reprocessing requirements were developed and validated for the TJF-160F/VF duodenoscopes. These instructions require an additional brush for manual cleaning prior to high-level disinfection and additional flushing steps on the elevator mechanism.

Review of the manufacturer's instructions for use for the TJF-180V Duodenoscope showed the manual cleaning steps required prior to reprocessing. The instructions are found on pages 42-79. These instructions describe the new manual cleaning steps, including required brushing and flushing procedures for the elevator mechanism. The instructions for use were updated on 05/15.

Review of the hospital policy titled, Surveillance Protocol for Duodenoscope Reprocessing, 12106," revised 08/26/16, showed that staff are to reprocess duodenoscopes according to manufacturer's instructions for use.

Review of the procedure titled, "Duodenoscope Step-by-Step Cleaning Process," Procedure #90-019 REVA, revised 09/07/16, showed that it contained detailed instructions for the manufacturer's recommended cleaning process for the Olympus TJF-180V duodenoscope, including the requirements to use the Olympus brush MAJ-1888 and flushing steps for the elevator mechanism.

2. On 10/17/17 from 2:00 PM to 2:30 PM, Surveyor #1 observed a reprocessing procedure for a duodenoscope (Olympus TJF-180V). The sterile processing technician (Staff #5) performing the procedure did not perform the required flushing steps following cleaning of the elevator mechanism. The technician was also not using the specified brush type (MAJ-1888) as recommended by the manufacturer for cleaning the elevator mechanism.

3. During the cleaning procedure, Surveyor #1 asked the technician (Staff #5) if and when the flushing steps would be performed. The technician stated that the flushing step was performed following the leakage test, which would be prior to the elevator mechanism brushing steps.

4. On 10/20/17, Surveyor #1 and Surveyor #4 conducted a tour of the central processing department and the endoscope reprocessing area. During the tour, Surveyor #1 asked a central sterile supervisor (Staff #6) to provide brushes used for cleaning duodenoscopes. The supervisor provided a brush with a model number Olympus BW-411B and stated that all channeled endoscopes are cleaned with this brush but did not include the other required brush used to clean the elevator mechanism (MAJ-1888).

ITEM #2 - Video Laryngoscope Reprocessing

Based on observation, interview, and document review, the hospital failed to ensure that staff properly performed manual cleaning of a video laryngoscope according to manufacturer's instructions for use.

Failure to properly perform manual cleaning places patients at risk of infection.

Findings included:

1. Review of the manufacturer instructions for use for the GlideScope video laryngoscope showed that the video baton (probes) is to be cleaned with a detergent or enzymatic cleaner followed by a disinfectant.

2. On 10/17/17 at 3:50 PM, Surveyor #3 toured the sixth floor of the Forest building. While inspecting the clean utility room, the surveyor observed a video laryngoscope. The surveyor asked the Director of the pediatric intensive care unit (PICU) (Staff #7), a registered respiratory therapist (Staff #9), and a PICU manager (Staff #9) about the cleaning process of the video laryngoscope. The respiratory therapist stated that the respiratory therapy department did not perform any cleaning of the video laryngoscope. The director of the PICU stated that staff wiped down the probes with Super-Sani Cloths (a disinfectant cloth).

3. On 10/18/17 at 8:30 AM, Surveyor #1 performed a follow up interview with the PICU Director (Staff #7) regarding the cleaning procedure for the video batons. The director stated that probe covers are used prior to use and that staff wipe the baton down with Super-Sani Cloths immediately after use. The director was unaware if any cleaning with detergent or enzymatic cleaners was conducted prior to disinfection.

ITEM #3 - Medical Device Pre-Cleaning

Based on observation, interview, and document review, the hospital failed to ensure that staff pre-cleaned, or treated instruments with enzymatic cleaner prior to transport to sterile processing.

Failure to pre-clean or treat devices with enzymatic cleaner places patients at risk for infection from insufficiently cleaned medical instruments.

Reference: Centers for Disease Control and Prevention, "Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008" - "Clean medical devices as soon as practical after use (e.g., at the point of use) because soiled materials become dried onto the instruments. Dried or baked materials on the instrument make the removal process more difficult and the disinfection or sterilization process less effective or ineffective."

Findings included:

1. Record review of the hospital policy titled, "Instrument Handling, 11934," revised 04/19/17, showed that staff are to spray all instruments with enzymatic solution prior to being sent to central sterile for reprocessing.

2. On 10/17/17 at 9:15 AM, Surveyor #1 toured the emergency department. During the tour, the surveyor asked a charge nurse (Staff #10) how items are treated prior to being transported to central processing. The nurse stated items are placed in a bin prior to being sent to central sterile. The nurse was unaware of the use for the enzymatic foam spray present in the soiled utility room and did not state that it was used to pretreat items prior to being sent to central processing.

3. On 10/18/17 at 9:30 AM, Surveyor #1 toured the sixth floor surgical unit of the River building. During the tour, the surveyor inspected the soiled utility room. The surveyor observed a large number of medical devices stacked into a small bin. No enzymatic cleaner was observed in the soiled utility room and the items appeared to be dry.

4. Surveyor #1 interviewed the surgical nurse manager (Staff #11) regarding the process for preparing instruments to be returned to central processing. The manager stated that items are placed in the bin and central processing collects items on a schedule. The manager was unaware of items being pretreated prior to being returned to central processing.

ITEM #4 Housekeeping

Based on observation, interview, and record review, the hospital failed to ensure that staff members properly performed housekeeping functions.

Failure to properly perform housekeeping functions places staff and patients at risk of infection.

Reference: Guidelines for environmental infection control in health-care facilities. Recommendations from CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). 2004. Pg 134. "E. Recommendations - Environmental Services. I. Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas. G. Avoid large-surface cleaning methods that produce mists or aerosols or disperse dust in patient-care areas."

Findings included:

1. Record review of the hospital policy titled, "Environmental Services, 10408," revised 06/14/17 and the document titled, "Check List Patient Room Discharge Clean," do not direct staff to utilize large-surface cleaning methods or spray bottles during cleaning procedures.

2. On 10/17/17 from 11:15 AM to 12:10 PM, Surveyor #1 observed a discharge room cleaning of room FA.4.203. During the procedure, the housekeeper (Staff #12) sprayed Clorox bleach solution from a spray bottle onto a reclining chair in the patient room. The finding was confirmed by a Clinical Operations Manager (Staff #13).

ITEM #5 Expired Test strips

Based on observation and interview, the hospital failed to ensure that expired test strips and indicators for reprocessing equipment were not available for use.

Failure to ensure that effective test strips are available risks ineffective reprocessing of semi-critical devices which puts patients at risk for infections.

Findings included:

1. On 10/17/17 from 2:00 PM to 2:45 PM, Surveyor #1 inspected the endoscope reprocessing area of the central processing department. The surveyor observed the following regarding chemical test strips:

a. A container of ASP Cidex OPA (a high level disinfectant) test strips had an expiration date of 08/28/17. No open date was listed on the product.

b. A container of Medivator Rapicide (a high level disinfectant) test strips where not labelled with an open date. The label indicates that the test strips have a beyond use date of four months following opening and the open date should be written on the container.

2. A Central Sterile Supervisor (Staff #14) confirmed the findings at the time of observation.
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ITEM #6 Cross-Connection Controls
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Based on observation, interview, and review of manufacturer's instructions for use, the facility failed to properly install ice machine drain lines.

Failure to properly install ice machine drain lines could result in potential contamination of the water and ice supply.

Findings included:

1. Record review of the manufacturer's instructions for use for Follett Symphony Series ice machines showed that the drain line is to be installed with a quarter inch slope for every one foot of drain line.

2. On 10/18/17 from 8:47 AM to 9:15 AM, Surveyor #1 toured the patient care unit on the third floor of the River building. During the tour, the surveyor made the following observations regarding ice machine drain lines:

a. The ice machine in RA.3.204 had a dependent loop in the drain line.

b. The ice machine in RA.3.21 had a dependent loop in the drain line.

3. The findings were confirmed by a Clinical Operations Manager (Staff #13).
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ITEM #7 Expired Patient Care supplies
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Based on observation, interview, and review of policy and procedure the hospital failed to ensure patient care supplies were not stored or available for patient use beyond the manufacturer's expiration date.

Failure to ensure that patient care supplies are within expiration dates risks ineffective care and treatment and patient harm

Findings include:

1. Review of the hospital job aid titled, "Supply Chain Product Expiration Auditing," policy #30-013 REV C, revised 04/22/16, shows that supply chain managed storage locations are to have quarterly audits and remove items with a less-than-90-days shelf life with certain exceptions. All products are to be removed when expired.

2. On 10/17/17 at 9:30 AM during an inspection of the emergency department, Surveyor #2 found seven packages of forensic blue swabs with an expiration date of 08/15/17.

3. On 10/17/17 at 3:51 PM, Surveyor #3 inspected the "Difficult Intubation Bag" located in the Cedar Alcove on the Pediatric Intensive Care Unit (PICU). Surveyor #3 observed three Intravenous (IV) catheters with a manufacturers expiration dates of 04/16, 02/17 and 07/17. At the time of the observation the PICU Manager (Staff #6) confirmed the findings and removed the expired supplies.

4. On 10/18/17 at 9:15 AM, Surveyor #1 inspected a supply room RA.5.824 on the fifth floor of the River building. The surveyor found 4 bottles of Similac formula with an expiration date of 10/01/17. The finding was confirmed by the fifth floor charge nurse (Staff #15) who discarded the expired products.

5. On 10/18/17 from 11:35 AM until 12:00 PM, Surveyor #3 inspected the Neonatal Intensive Care Unit (NICU). Surveyor #3 observed eight 54mL bottles of liquid hydrolyzed protein with a manufacturer's expiration date of 06/01/17, one container of Chem Strip Reagent with a manufacturer's expiration date of 08/17, and one container of Multi Cap capillary tubes with a manufacturer's expiration date of 02/17. At the time of the observations the NICU Manager (Staff Member #40) confirmed the findings and removed the expired supplies.

6. On 10/18/17 at 1:15 PM during an inspection of the inpatient rehabilitation unit, Surveyor #2 found four packages of 23 gauge butterfly needles with an expiration date of 09/17.

ITEM #8 Hydrocollator Cleaning

Based on observation, interview, and record review the hospital failed to ensure that hydrocollator heating units (devices used to heat pads used in patient therapy) were maintained in accordance with manufacturer's instructions.

Failure to properly clean hydrocollators per manufacturer instructions places patients at risk for unsafe care and infection.

Findings included:

1. Document review of the manufacturer's instructions for use for the Chattanooga Hydrocollator (a device used to heat hot pads for patient use) shows that the device is to be cleaned at least every two weeks. No hospital policy regarding hydrocollator cleaning was provided.

2. On 10/17/17 between 2:35 PM and 3:00 PM, the Therapy Supervisor (Staff #44), the Director of Safety & Emergency Management Systems (Staff #20), and Surveyor 4 toured the inpatient rehabilitation unit. In the Rehab Gym, room RB - 5.416, the surveyor observed a Chattanooga hydrocollator. The surveyor asked Staff #44 about maintenance of the hydrocollator. Staff #44 stated that the maintenance was done by rehab aides (RA), and that one RA is assigned to each unit. The RA for the Rehab Gym was not present at the time of the interview and Staff #44 did not know of a policy that addresses hydrocollator maintenance.

3. On 10/17/17 at 2:50 PM in the Sports Therapy Gym, room OA.6, Surveyor #4 observed another Chattanooga hydrocollator and asked a physical therapist (Staff #45) about its maintenance. Staff #45 stated she was not aware of a policy and that an RA is responsible for recording temperatures and regular maintenance. The RA assigned to the unit was not present at the time of the survey.

4. On 10/17/17 at 3:45 PM, during a tour of the Outpatient Physical Therapy Department with the unit supervisor (Staff #46) and Staff #20, Surveyor #4 observed another Chattanooga hydrocollator. The unit RA (Staff #47) explained that she cleaned the hydrocollator weekly but it was not recorded.

5. On 10/18/17 at 11:20 AM, Surveyor #1 toured the physical therapy unit of the Bellevue Clinic and Surgery Center. The surveyor asked a physical therapist (Staff #16) if the unit had any hydrocollators and how often they were cleaned. The therapist showed the surveyor a hydrocollator unit and an accompanying laminated check sheet, which indicated when the device was cleaned. The check sheet indicated that the device was cleaned every three weeks rather than the manufacturer's specification of two weeks.

ITEM #9 Personal Protective Equipment
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Based on observation and review of policies and procedures, the hospital failed to ensure that hospital staff members used appropriate personal barrier and transmission precautions.

Failure to use transmission-based precautions appropriately risks transmission of infectious diseases to patients and caregivers.

Findings Included:

1. The hospital's policy and procedure titled "Bloodborne Pathogens (BBP) Exposure Control Plan" (Policy #12287 revised 6/6/2017) showed that masks, eye protection, and/or chin-length face shields must be worn when splashes, sprays, splatters or droplets of blood or OPIM (other potentially infectious materials) pose a hazard to the eye(s), nose, and mouth. Eyeglasses do not replace the use of eye protection or other PPE (Personal Protective Equipment) preventing eye exposure.

2. On 10/18/17 at 11:00 AM, Surveyor #6 and the Operating Room Manager (Staff #25) observed the dental extraction surgical case for Patient #7. The surveyor noted the surgeon (Staff #33) wore a head covering, mask and eye glasses but not the required eye protection per hospital policy during the procedure.

3. On 10/18/17 at 11:00 AM, Surveyor #6 interviewed the Operating Room Manager (Staff #25) about the observed practice by the surgeon. Staff #25 confirmed Staff #33 did not follow the hospital policy as required.

ITEM #10 Surgical Attire
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Based on observation, interview and review of the hospital's policies and procedures, the hospital failed to ensure the surgical staff members followed hospital policy regarding surgical attire.

Failure to follow hospital policy and practice standards for surgical attire increases the risk for patient infections.

Findings Included:

1. The hospital policy and procedure titled "Surgical Attire" (Policy #11000 revised 10/13/2016) showed that: long-sleeved scrub jackets will be worn and fastened down the front during patient preparation; personal clothing worn under scrubs must be completely covered by scrub attire; all personal cloth head covers shall be covered by a hospital provided, disposable, bouffant style cap; any facial hair or any visible stubble will be covered with either a hood or a beard cover; masks will cover the mouth and nose and be tied securely to prevent venting at the sides or bottom; fingernails shall be kept short and clean and artificial fingernails (acrylic, silk wrap, gels, overlays, extenders and tips), including shellac nail polish will not be worn by personnel who provide patient care.

2. On 10/17/17 between 11:25 AM and 12:00 PM in the operating room, Surveyor #6 observed the following:

a. A circulating nurse (Staff #24) removed their long-sleeved scrub jacket and proceeded to perform a surgical preparation for Patient #4.

b. A surgical technologist (Staff #25) exposed long blue/black T-shirt visible below their scrub shirt.

c. A circulating nurse (Staff #24) with long, dark polished fingernails had difficulty opening a sterile package onto the sterile field.

d. A surgical technologist (Staff #26) working on the sterile field wearing a cloth hat only partially covered by a bouffant with visible hair exposed.

e. A surgical technologist (Staff #27) working on the sterile field wearing a cloth hat covered by a bouffant with 1 inch of hair visible outside the perimeter of both hats.

f. A surgical fellow (surgeon in training) (Staff #28) entered an operating room balancing a mask on the bridge of his nose with none of the mask ties fastened or secured while placing paper in the printer drawer during Patient #5's surgical procedure.

3. On 10/18/17 at 12:00 PM, Surveyor #6 interviewed the Director of Perioperative Services (Staff #32) who confirmed the above observed practices did not follow the hospital policy for surgical attire as required.

4. On 10/19/17 at 9:50 AM, in the hospital's Interventional Radiology Procedure Room #2, Surveyor #3 observed the Interventional Radiology team prepare Patient #6 for a procedure to treat a lymphatic malformation (nonmalignant mass caused by abnormal development of the lymphatic system). Surveyor #3 observed a physician (Staff #29) did not cover his beard and sideburns as required by policy.

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Based on interview, review of infection control documents, and quality documents, the hospital failed to ensure that the Chief Executive Officer, Medical Staff, and Director of Nursing Services implemented and monitored activities and interventions identified in the Hospital's Infection Control Program Plan as part of the hospital's overall Quality Program.

Failure to have oversight for infection control activities and responsibility for implementation and monitoring of corrective actions to address infection control problems, puts patients, staff and visitors at risk of communicable disease and healthcare-acquired infections.

Findings included:

1. The hospital's policy titled "Quality Assessment and Performance Improvement Plan (QA/PI)" (revised 07/27/17) showed that the hospital's Quality Improvement Steering Committee (QISC) was responsible for "developing quality oversight programs to review services, both retrospectively and prospectively, in order to improve the quality and safety of care and to reduce the risk to patients, staff and providers". The plan showed that the hospital's infection prevention program reported to the QISC.

2. The hospital's Infection Control Plan titled "Infection Prevention Plan Fiscal 2017," approved 04/25/17, contained the hospitals infection surveillance plan plus nine specific goals for fiscal year 2017. The strategies listed to achieve the goals included education, auditing, interventions, compliance measures, and measurement of effectiveness of interventions. Two of these goals and interventions included:

a. "Infection Prevention Education Goal:" Interventions included providing role specific education across the organization with areas of focus including sterile processing and operative services, environmental services, nutrition services, and building and engineering. Interventions were to be measured by compliance rates with education.

b. "Operative Services Goal:" Interventions included performing annual and as needed process walks (informational tour of a work area) with focus areas in care and initial cleaning of surgical instruments at point of use prior to delivery to sterile processing, decontamination and sterilizations of surgical instruments in the sterile processing department, appropriate use of immediate use sterilizations, and appropriate surgical attire. Operating Room practice audits were to be reviewed quarterly and effectiveness of the interventions measured by analysis of the results of the audits and process walks.

3. On 10/18/17 at 11:00 AM, Surveyors #3, #4, and #6 conducted an Infection Control program review that included the Infection Control Director (Staff #16) and the Medical Director of Infection Prevention (Staff #17). Staff #16 and #17 told the surveyors that the infection control activities in the hospital were led by unit based sub-committees. Staff #16 told the surveyors that there was no single infection control meeting, but an Infection Preventionist attended each unit based meeting. Staff #16 and #17 told the surveyors there was no organizational chart for the Infection Control program.

4. Review of the infection control program showed meeting minutes from 5 infection control sub-committees. Review of the minutes showed that the sub-committees:

a. Failed to address the infection prevention and control goals approved by the organization.

b. Failed to implement and monitor for effectiveness, interventions/action plans based on the infection control program goals.

c. Failed to collect and analyze audit data as directed in the infection control plan.

d. Failed to measure effectiveness of interventions by means established in the hospitals infection control plan.

e. Failed to follow-up on significant infection prevention and control issues and objectives identified within the unit based subcommittee.

5. Surveyor #3 found no evidence the unit based subcommittees were integrated into an overall infection prevention and control program.

6. Surveyor #4 found no evidence of oversight of the unit based committees that ensured accountability and compliance with the plan and goals established in the hospital's Infection Control Plan.

7. On 10/20/17 at 11:00 AM, Surveyors #1, #2, #3, #4, #5 and #6 conducted a Quality Program review related to the Infection Control Program findings. The surveyors described the observations and deficiencies found and asked how the hospital provided oversight of the infection prevention and control activities. At the time of the review, the Senior Vice President/Chief Medical Officer (Staff #18) confirmed Surveyor #3's findings. Staff #18 discussed the methods the hospital provided oversight but acknowledged that the organization had insufficiently documented its infection control activities at the unit and sub-committee level.