HospitalInspections.org

Based on observation and interview, it was determined that the facility failed to provide care in a safe setting.

Findings were:

Facility document entitled "Patient Information Guide" stated in part "The patient has the right to expect reasonable safety insofar as the hospital practices and environment are concerned."

Tour of Foundation Surgical Hospital Outpatient Imaging on 6/4/18 revealed an electrical cord that led from the wall to the X-Ray machine. The cord was wrapped in black electrician tape. The Director of Radiology stated that she was unaware of this wrapped cord but probably the cord was frayed and "fixed" with the electrician tape. She acknowledged that this was a safety issue.

Tour of the outpatient rehab area on 6/4/18 revealed a patient restroom with no emergency pull cord. The need of an emergency call system in patient restrooms was acknowledged that same day by the Director of Outpatient Rehab Services.

Tour of Radiology Services on 6/5/18 revealed an emergency pull cord was wrapped around a safety "grab bar." If a patient fell, he would be unable to call for help. This was acknowledged by the Director of Radiology on 6/5/18.

Based on a review of documentation and interview, the facility failed to ensure their quality improvement program used the data collected to identify opportunities for improvement and implement changes that will lead to improvement. The hospital also failed to take actions aimed at performance improvement, and after implementing those actions, measure its success, and track performance to ensure that those improvements were sustained.

Findings included:

Facility based policy entitled, "Performance Improvement Plan" for the department/function of "Quality & Risk Management Performance Improvement Plan 'Surgical Services'" stated in part, "Further evaluation must be conducted whenever a threshold is reached, a pattern or trend that may negatively impact care/service is identified, or an opportunity to improve care is recognized. Additionally, further evaluation of any performance measure may be triggered by an associated customer complaint, departmental comparison of their performance with that of another institution (benchmarking) or when there is a desire by the department to reduce variation or improve mean performance.

Evaluation may consist of:

Consistent review of any single occurrence through the use of a "Secondary Screen"

Further study as described in written reports

Identification of specific processes involved

Flowcharting of processes involved

Referral for interdepartmental evaluation

All evaluation activities are reported in the quarterly report.

Take actions to improve care.

Actions taken, as well as follow-up planned, are included in the quarterly report. Team involvement in suggestion and implementation of actions is vital to the success of the program. Actions taken may reflect systems change, product change, educational intervention or human resource management. Emphasis is placed on the correction/improvement of systems/processes involved.

Assess the effectiveness of the actions taken and document the improvement in patient care/service.

Effectiveness of patient care improvement activities are assessed and documented through the ongoing performance improvement program.


Results are communicated.

Findings, conclusions, recommendations, actions taken and the results/effectiveness of actions taken are communicated through:

Reporting on a quarterly basis to the Performance Improvement Committee"


Facility based "Risk Management Program" stated in part,
"7. The responsibilities of the Risk Manager include, but are not limited to the following :

a. Review of all occurrences and investigation reports, trending of data, recommending corrective action, and continued monitoring to evaluate the effectiveness of actions taken...


PROCEDURES:

1. The Operational Linkages between Risk Management, Safety, Infection Control, Patient Representatives, Quality Improvement, Utilization Management, Care of the Patient, Infection Control, Employee Health, Employee/Patient Satisfaction, Administration and the Board of Trustees is a key component to the success of the Risk Management Program. These linkages are supported through the following mechanisms:

a. Referrals from concurrent review will be made to the appropriate department and/or committee.

b. Any identified occurrence(s) related to clinical aspects of patient care and safety will be referred to the appropriate committee or department for investigation, analysis and action.

c. Sentinel events and/or identified trends will be referred to the appropriate committee for evaluation and action.

d. If an opportunity to improve care is identified, the appropriate staff, department or committee will be notified and appropriate action developed, initiated and monitored for effectiveness....


2. Occurrence and/or incident reporting should occur based upon any happening out of the ordinary, which results in a potential for or actual injury to a patient or visitor or damage to facility property or reputation....

d. The Risk Manager will be responsible for regular and systematic review of all occurrence/incident reports, for the purpose of identifying exposures, trends, and/or patterns. If an exposure, trend or pattern is identified, the Risk Manager will develop
recommendations for corrective action or make a referral to the appropriate committee, department chairperson of the medical staff, or director/manager of a hospital department."


Facility based policy entitled, "Risk Management Plan" stated in part,

"H. Risk Manager...Specific duties of this positon include:...

10. Maintain the occurrence notification system, perosnally investigate serious accidents, receive and review supervisors' occurrence and investigate reports and check or follow up on corrective action to eliminate accident causes."


Review of facility based incident reports revealed two potentially serious incidents in the Operating Room Area during 2018:

* One incident involved an implant that was dropped on the sterile field, near the unsterile portion of the arm board, presenting a risk for potential contamination.

* Another incident involved a near miss with a cottoniod left inside an incision. The physician began closing the site before the count was complete. The missing cottonioid was identified prior to the last suture being placed.


The incident reports for the two incidents above indicated the corrective action taken was that involved employees were counseled. Review of personnel files revealed no documented counseling of the employees involved in the above incidents. There was also no documented continued monitoring to evaluate the effectiveness of the corrective actions. In an interview with staff #D7 on 06/06/18, at 5:00 PM, when asked for the corrective action or employee counseling documentation on staff #D11 and D20 regarding the incidents, staff #D7 stated they could not find any documented.


These incidents were not discussed in quality meetings for 2018. These incidents represent opportunities to improve care and prevent future occurrences per facility based performance improvement plan. These incident reports (data) had been reviewed by quality assurance (QA) and risk management. However, QA did not identify theses as opportunities for improvement and changes that would lead to improvement. Per an interview with staff member #D2 on 06/06/18, the identified corrective actions aimed at performance improvement for these incident were not effectively implemented, as no documented evidence was found of employee counseling. The facility also did not have documentation to track performance to ensure that improvements/corrective actions were sustained regarding the above incidents.


In an interview with staff #D2 on 06/06/18, at 3:00 PM, they verified that the facility collects data (tracks and trending) and implements performance improvement measures identified in their yearly performance improvement plan. However, the incidents in the OR had not been reviewed or addressed during meetings as an opportunity for improvement and/or changes that will lead to improvement. Along with tracking and trending data the facility needs to ensure that data and incident reports are used to create a meaningful quality assurance program with identified opportunities for improvement and take actions aimed at performance improvement and, after implementing those actions, measure its success, and track performance to ensure that improvements are sustained. Such QA program activities and identified opportunities for improvement will contribute to effective pateint care and an improved culture of safety at the facility.


The above findings were confirmed with staff members #D1 and D2 on 06/06/18.

Based on a tour of the facility, the facility failed to ensure that outdated, mislabeled, or otherwise unusable drugs and biologicals were removed from patient use.

Findings were:

During a tour of the emergency department on 6-6-18, the following observations were made in the trauma room crash cart:

*4 of 4 arterial blood gas collection syringes had expired 4-2018 but were still available for patient use.

*1 of 1 arterial line had expired 5-2018 but was still available for patient use.

*1 of 3 adult, colorimetric carbon dioxide detector had expired 11-2017 but was still available for patient use.

*1 of 1 adult, multi-lumen central venous catheter had expired 2-28-18 but was still available for patient use.


During a tour of the emergency department on 6-6-18, the following observations were made in the medical supply shelving unit:

*1 of 1 bag of dextrose 5% in normal saline intravenous solution had expired 11-2017 but was still available for patient use.

*3 of 3 bags of dextrose 5% in 0.45% normal saline solution had expired but were still available for patient use. 1 of 3 had expired 2-2017 and 2 of 3 had expired 5-2017.


Facility policy ED 1330.01 titled "Crash Carts" states, in part:

"I. Purpose: Crash carts will be ready for use at all times.


IV. Policy:
Crash carts will be checked daily:

*Open and check expiration on equipment/supply monthly."


The above was confirmed in an interview with staff #A-11 on 6-6-18.

Based on observation, a review of facility documentation, and staff interviews, the facility failed to maintain temperature and humidity levels as required by facility policy and professional standards in all anesthetizing locations and in the sterile processing department. Humidity levels outside accepted ranges have the potential to impact equipment integrity and functionality, promote microbial growth and can compromise the integrity of wrapped sterile instruments and supplies. Temperatures affect patient comfort and well-being. Thus, this deficient practice had the potential to affect the safety and well-being of any patient undergoing surgery in the hospital.

Findings were:

A January 2015 joint statement from the Ambulatory Surgery Center Association (ASCA), American College of Clinical Engineering (ACCE), American Hospital Association (AHA), American Society for Healthcare Engineering (ASHE), American Society of Anesthesiologists (ASA), American Society of Heating, Refrigeration and Air Conditioning Engineers (ASHRAE), Association for Healthcare Resource & Materials Management (AHRMM), Association for the Advancement of Medical Instrumentation (AAMI), Association of perioperative Registered Nurses (AORN), Association of Surgical Technologists (AST), Health Industry Distributors Association (HIDA), and the International Association of Healthcare Central Service Materials Management (IAHCSMM) included the following:

" ... In many locations across the country, cold weather or desert conditions create dry environmental conditions. In order to achieve higher levels of RH that are required in accordance with nationally recognized expert organizations whose guidelines have been incorporated into State or Federal regulatory standards, hospitals and ambulatory surgery centers have to add humidity into the building air, an activity that is expensive and creates its own unique challenges to patient safety.

Relative humidity can impact the shelf life and product integrity of sterile supplies. Some products, such as biological indicators and chemical indicators used for sterilization monitoring and EKG electrodes used for patient monitoring, are very sensitive to humidity ...

Relative humidity may affect the operation of some electro-medical equipment used in the OR, particularly with older model electro-medical equipment. This equipment may malfunction unexpectedly. Too low humidity levels may also impact calibration. Larger electrostatic discharge (ESD) pulses may create a risk of destruction of parts, premature failure, and erratic behavior of software that is "confusion" from ESD pulses. And, in an
environment where humidity is low, a person can more easily become "charged" and receive an electrostatic shock when coming in contact with medical equipment ...

...Healthcare facility leaders, clinicians, engineers and supply chain professionals must understand that the lower RH level can actually harm the integrity of the products they use, and they need to consider carefully the ramifications of low RH levels ..."


Facility policy SS.OR.5.24 entitled "Temperature and Humidity," last revised 3/18, included the following:

"I. PURPOSE
There will be maintenance of appropriate relative humidity in all Operating room suites to minimize the potential of pathogenic contamination.

II. SCOPE:
All Peri-operative suites, including operating rooms, endoscopy rooms, instrument processing areas and sterilization areas.

III. POLICY:
It is the policy of Foundation Surgical Hospital to maintain relative humidity in the peri-operative areas.

IV. PROCEDURE:
- Humidity and temperature will be monitored and record [sic] daily using a log based on HVAC (heating, ventilation, air conditioning) system parameters.

- Operating Room:

o Relative humidity will be maintained between 20% and 60% within the operating room suites.

o Temperature should be maintained between 68 F to 75 F within the operating room suites ...


- Decontamination Room:

o Temperature should be maintained between 60 F to 73 F within the decontamination room.


- Preparation and Packaging Room (Clean Work Room):

o Humidity won't exceed 60% within the preparation and packaging room.

o Temperature should be maintained between 68 F to 73 F within the preparation and packaging room.


- Sterile Storage:

o Temperature won't exceed 75 F within the sterile storage room ...

- If the HVAC system fails, the following steps must be taken: ...
o The event will be reported to the Director of Maintenance ..."


Facility policy #SS.CS.6.19 entitled "Sterilization," last revised 6/15, included the following:

"Providing a Control Environment

Control and monitor room temperature, humidity, and ventilation in accordance with local, state and federal [sic].

- Control room temperature, humidity, and ventilation in the decontamination areas to ensure that
o Temperature does not exceed 72 [degrees] F to 78 [degrees] F ..."


A review of the SPD (Sterile Processing Department) Room Temperature & Humidity Log for the clean work room (preparation and packaging room) for April and May 2018 revealed an expected humidity range of 30-60% and appropriate temperature range of 68 to 77 degrees F. There were 15 days in April 2018 when the facility was open, the temperature was below this range and the humidity was below the expected range for 22 open days. In May 2018, the temperature was below the expected range during 18 days when the facility was open. The temperature and humidity log form had been changed in May 2018 to read "Not to Exceed 60% Humidity."


In an interview with the Staff #12, Lead Sterile Processing Tech, and Staff #3, Surgical Services Manager, during a tour of the sterile processing department on the afternoon of 6/5/18, the temperature in the clean work room (preparation packaging room) was checked on the wall-mounted thermometer. It read 81.5 degrees. The temperature had been noted on the log earlier in the day at being in the appropriate range as noted above. When Staff #12 was asked about the temperature, he stated, "Yes, it can warm up in here in the afternoon." When asked what had been done about it, he stated, "I would contact plant ops." When asked if he had done that, Staff #12 stated, "That's what I would do."


A review of the temperature and humidity logs for the six operating rooms of the hospital included the following findings:

March 2018

OR #1 - temperature below 60 degrees F on 10 of 22 open days.

OR #2 - temperature below 60 degrees F on 17 of 22 open days.

OR #3 - temperature below 60 degrees F on 5 of 22 open days.

OR #4 - temperature below 60 degrees F on 6 of 22 open days.

OR #5 - temperature below 60 degrees F on 5 of 22 open days.

o Humidity - 11% on 3/5/18
o Humidity - 4% on 3/6/18
o Humidity - 18% on 3/7/18
o Humidity - 19% on 3/21/18
Maintenance had been notified of the decreased humidity on 3/5 and 3/6/18.

OR #6 - temperature below 60 degrees F on 4 of 22 open days.

o Humidity - 15% on 3/5/18
o Humidity - 19% on 3/6/18
Maintenance had been notified of the decreased humidity on 3/6/18.



April 2018

OR #1 - temperature below 60 degrees F on 8 of 22 open days.
Maintenance had been notified of the low temperature on 4/9/18

o Humidity - 19% on 3/2/18
o Humidity - 19% on 3/4/18
o Humidity - 13% on 3/16/18

Maintenance had been notified on decreased humidity on 4/6/18


OR #2 - temperature below 60 degrees F on 9 of 22 open days.

Maintenance had been notified of the low temperature on 4/9/18. Only the temperature on 3/2/18 was below 60 degrees.

The other dates all occurred after 4/9/18.
o Humidity - 19% on 4/18/18.


OR #3 - temperature below 60 degrees F on 7 of 22 open days.


OR #4 - temperature below 60 degrees F on 11 of 22 open days.


OR #5 - temperature below 60 degrees F on 7 of 22 open days.

o Humidity - 14% on 4/2/18
o Humidity - 14% on 4/3/18
o Humidity - 17% on 4/12/18
o Humidity - 7% on 4/16/18
o Humidity - 12% on 4/17/18
o Humidity - 14% on 4/18/18
o Humidity - 14% on 4/19/18

Maintenance had been notified of the decreased humidity on 4/2/18,

4/14/18, 4/16/18, 4/17/18, 4/18/18 and 4/19/18.


OR #6 - temperature below 60 degrees F on 4 of 22 open days.

o Humidity - 16% on 4/2/18
o Humidity - 19% on 4/6/18
o Humidity - 19% on 4/18/18

Maintenance had been notified of the decreased humidity on 4/2/18.



May 2018

OR #1 - temperature below 60 degrees F on 19 of 22 open days.

o Humidity - 71% on 5/21/18
o Humidity - 74% on 5/22/18
o Humidity - 67% on 5/24/18
o Humidity - 63% on 5/25/18

Maintenance had been notified of the increased humidity on 5/22/18.


OR #2 - temperature below 60 degrees F on 18 of 22 open days.

o Humidity - 70% on 5/22/18
o Humidity - 70% on 5/23/18
o Humidity - 75% on 5/24/18
o Humidity - 67% on 5/25/18

Maintenance was notified of the increased humidity on an unspecified date.


OR #3 - temperature below 60 degrees F on 2 of 22 open days; however, the temperature range listed as acceptable on the log was 68 degrees F to 75 degrees F. Taking this range, the temperature was below the accepted range 22 of 22 open days in May.


OR #4 - temperature below 60 degrees F on 14 of 22 open days; it was below 68 degrees F 22 of 22 open days.


OR #5 - temperature below 60 degrees F on 11 of 22 open days; it was below 68 degrees F 22 of 22 open days.

o Humidity - 16% on 5/2/18
o Humidity - 17% on 5/10/18
o Humidity - 19% on 5/15/18
o Humidity - 12% on 5/17/18
o Humidity - 67% on 5/21/18

No notification of maintenance was documented.


OR #6 - temperature below 60 degrees F on 6 of 22 open days; it was below 68 degrees F on 22 of 22 open days.

o Humidity - 64% on 5/30/18
o Humidity - 64% on 5/31/18

No notification of maintenance was documented.


In an interview with Staff #2, Plant Ops & Safety Manager, on the afternoon of 6/6/18 in an administrative office, he was asked about the temperatures and humidity levels in the ORs and sterile processing department. He stated, "We had some issues with some of the equipment back there."

Based on review of facility policies, review of facility documents, and staff interview, the facility failed to provide a sanitary environment and have an effective program for the prevention, control, and investigation of infections and communicable diseases as evidenced by:

A. Failure to keep the facility clean and orderly

B. Failure to ensure its policy regarding immediate use steam sterilization (IUSS) was congruent with nationally recognized infection control guidelines

C. Failure to effectively monitor surgical site infections

D. Failure to monitor implants

E. Failure to follow up on incidents regarding infection control issues

(Cross refer A0749)

Based on observation and interview, it was determined that the hospital failed to maintain and provide a clean and orderly environment to its patients and staff. This deficient practice had the potential to affect all hospital patients.

Findings were:

Tour of Foundation Surgical Hospital Outpatient Imaging on 6/4/18 revealed the following infection control concerns:

* A dirty sheet, covered with flecks of debris covered the imaging table. The technician accompanying the surveyors said the room was ready for patient use.

* All horizontal surfaces in the room were covered with a thick layer of dust.

* Dirt/hairballs were noted on the floor.

* The merchant board (used to stabilize knees/legs during x-ray) was dirty.

* 2 holes were observed in the ceiling tile. These holes could allow entry of bugs into the imaging room.

* 2 stained ceiling files were observed. These stains could indicate water leaks in the ceiling.


The above infection control concerns were confirmed by the Director of Radiology on 6/4/18.



Tour of the kitchen on 6/6/18 revealed the following:

Facility policy entitled "Food Storage" stated in part "Ready to eat foods shall be marked with a discard date at the time of opening or preparation:

* The discard date shall be 7 days after the food has been opened if the food has been refrigerated at 40 degrees F or less.

* The discard date shall be 4 days after opening these foods refrigerated at 45 degrees F."


Metal warming pans were stacked while wet. When these pans were separated, water dripped onto the floor. When dishes and pans are not air dried, there is potential for bacterial growth. According to FDA Food Code 2009: Annex 3 - Public Health Reasons / Administrative Guidelines - Chapter 4, Equipment, Utensils, and Linens, "4-901.11 Equipment and Utensils, Air-Drying Required: Items must be allowed to drain and to air-dry before being stacked or stored. Stacking wet items such as pans prevents them from drying and may allow an environment where microorganisms can begin to grow. Cloth drying of equipment and utensils is prohibited to prevent the possible transfer of microorganisms to equipment or utensils."

When the oven was opened, there was a grease buildup inside. The oven doors had grease and debris on the handles. This indicated improper cleaning of the oven.


A bucket was found in the kitchen with cleaning solution and cleaning rags inside. Employee # 13 (Cook) was asked how often chemical testing should be done for cleaning solutions and he replied, "The cleaning solution is changed out twice daily. This bucket was prepared this morning." The surveyors asked the employee to test the water with the Hydrion QT-10 test strips. After dipping the test strips into the solution for 10 seconds, there was no notable change in color on the strip. This indicated no cleaning solution was evident in the water. According to FDA Food Code 2009: Annex 3 - Public Health Reasons / Administrative Guidelines - Chapter 4, Equipment, Utensils, and Linens, "Testing devices to measure the concentration of sanitizing solutions are required for 2 reasons: (1) The use of chemical sanitizers requires minimum concentrations of the sanitizer during the final rinse step to ensure sanitization; and (2) Too much sanitizer in the final rinse water could be toxic."


The walk in refrigerator had unlabeled fresh vegetables. A box of romaine lettuce was discovered that had several brown/decaying heads of lettuce within. Employee # 13 claimed that the vegetables were delivered yesterday. The refrigerator also contained a covered pan of sugar free jello. According to the label, the jello was made on 5/24/18 and could not be eaten after 5/31/18. The Kitchen Manager agreed that the jello should have been disposed of over a week ago.


The above findings were confirmed by the Kitchen Manager on 6/6/18.


32870



The facility aslo failed to ensure that its policy regarding immediate use steam sterilization (IUSS) was congruent with nationally accepted infection control guidelines and professionally acceptable standards of practice, and that IUSS was used by the facility only in cases of emergency. This deficient practice lead to an increased risk of a post-procedural surgical site infection for any patient undergoing surgery at the hospital.


Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008, published by the CDC, includes the following: "Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time ..."


AORN (Association of perioperative Registered Nurses) 2015 Guidelines for Perioperative Practice includes the following:

"Immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner ...Immediate use steam sterilization may be associated with increased risk of infection to patients ...
VII.a. Immediate use steam sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Immediate use steam sterilization should not be used as a substitute for sufficient instrument inventory ..."

Use of IUSS, even when all steps are performed properly, should be limited to situations in which there is an urgent need and insufficient time to process an instrument by using terminal sterilization (AORN, 2014 and Association for the Advancement of Medical Instrumentation (AAMI), 2013). Thus, IUSS should be reserved for immediate use needs (e.g., used only emergently), when a needed instrument has been contaminated and there is no sterile replacement available, or for a patient care item that cannot be packaged, sterilized and stored before use. Monitoring test results (including results of chemical and biological indicators) must be evaluated by trained personnel at the conclusion of the IUSS process before use of the instrument(s)/device(s) (AORN, 2014 and AAMI, 2013).



Facility policy #SS.OR.5.11 entitled "Immediate Use Steam Sterilization," last reviewed 8/16, included the following:

"I. PURPOSE:

To provide guidance to perioperative personnel for immediate use steam sterilization (IUSS) of items to be used in the perioperative setting. The expected outcome is that the patient is free from signs and symptoms of infection ...

IV. PROCEDURE:

General Principles

1. Although the wrapped method is preferred, correctly performed IUSS is a safe and effective process for the sterilization of critical medical devices. IUSS is considered appropriate in special clinical situations: ...When there is insufficient time to sterilize an individual item by the preferred packaged method ...

PROCEDURE ...

In the event that instruments have been used on a patient and sterilization indicators are positive, a recall procedure will be instituted utilizing the policy in the Sterile Processing Department manual. At minimum, the Surgical Services Director or Operating Room manager will be notified and, together with the Infection Control Practitioner, notify the surgeon immediately ..."



Facility policy #SS.CS.6.27 entitled "Loaned Instruments - Cleaning and Care," effective date 8/16, included the following:

"It is the policy of Foundation Surgical Hospital that:

o Loaned instruments will be requested when the surgery is schedule [sic] and delivered to the facility in sufficient time to allow inhouse inventory, disassembly, cleaning, inspection, packaging, and terminal sterilization in accordance with the manufacturer's written instructions (IFU).

o Before use, all loaned instruments and devices will be cleaned, decontaminated, inspected, packaged, and sterilized ...

o Loaned instruments will be considered contaminated and delivered directly to the sterile processing area ..."


Immediate use steam sterilization logs of the facility for sterilizers #3 and #4 for April through May 2018 included the following (NOT a complete listing of all items):

Autoclave #3
4/3/18 - x 2 Phaco Trays, x 2 Phaco knob covers
4/4/18 - Biotmet Cement Gun
4/4/18 - Knee ACL Lap Tray #1
4/5/18 - Lap Chole Tray #5
4/9/18 - [physician's name] [illegible]
4/9/18 - Met-One inst.
4/9/18 - Met-One inst.
4/9/18 - EEA Sizers, Lighted Abd Retr., clamps, Bowel Grasper
4/10/18 - x 2 Phaco Trays, x 2 Phaco knob covers
4/10/18 - Sys 7
4/10/18 - knee ACL #1, Lambotte Osteos
4/10/18 - Biomet Post, Lambotte Osteos
4/10/18 - Sys 7
4/12/18 - Biomet [Physician name] patella clamp
4/17/18 - Phaco [illegible]
4/17/18 - x 2 Phaco Trays, x 2 Phaco knob covers
4/17/18 - Stryker 2.0/3.5 Fixos Screw, Biomet post
4/17/18 - Biomet [illegible]
4/18/18 - [physician name] inst.
4/18/18 - EEA Sizers & Lighted [illegible]
4/18/18 - Lap Tray #3
4/21/18 - Biomet Screw Driver
4/23/18 - x 4 [illegible] Handles
4/23/18 - Styker(?) Easy Clip
4/24/18 - Master Drill
4/24/18 - x 2 Phaco Trays, x 2 Phaco Knob Covers
4/24/18 - x 2 Phaco Trays, x 2 Phaco Knob Covers
4/24/18 - Phaco Trays x 2, Phaco Know Covers x 2, Phaco Instruments
4/25/18 - ENT Tray & Stryker Asnis Micro
4/25/18 - Lap Chole card
4/26/18 - x 2 Minor Tray #1,3
4/26/18 - [illegible] Uni Base Tray, [illegible] Cement Gun
4/26/18 - [physician's name] patella clamp
4/26/18 - UniPatella, Oval Patella, Cement Gun
4/26/18 - Uni Patiella & Inst.
4/26/18 - Uni Patella
4/30/18 - Bio Met x 3 ...cable ready TK Extras
5/8/18 - Arthroscopy #2
5/8/18 - Arthroscopy #4, Phaco Tray #6, Phaco Knob Covers
5/8/18 - Biomet Post
5/10/18 - Biomet Patella Clamp
5/10/18 - x 2 Bowel Graspers
5/10/18 - Sys 7, Precision Saw
5/10/18 - System 7, Drill Set
5/10/18 - Precision Saw
5/10/18 - Precision Saw
5/10/18 - Flash - [illegible] Inst. [physician's name]
5/16/18 - ENT Tray
5/16/18 - ENT Tray
5/21/18 - Foot Tray #2
5/21/18 - Master Drill Attachments
5/23/18 - 5MR Tray #2
5/24/18 - Lap Chole #1


Autoclave #4
4/2/18 - ENT
4/2/18 - Black Triangle (Loaner)
4/10/18 - Biomet TKA Post
4/10/18 - x 2 Phoco Trays, x 2 Phoco Knob Cover Sets
4/10/18 - Biomet post
4/17/18 - x 2 Phaco Markers
4/17/18 - Biotmet [illegible] & Post
4/25/18 - [physician's name] Trays
5/8/18 - x 2 Phaco Trays, x 2 Phaco Knob Cover Sets
5/8/18 - x 2 Phaco Trays #2,5, x 2 Phaco Knob Cover Sets
5/8/18 - Phaco Tray #4, Phaco Knob Covers, Arthroscopy #1, [illegible]
5/8/18 - Phaco Tray #3, Phaco Knob Covers, Arthroscopy #5
5/10/18 - Precision Saw
5/10/18 - X-tra key & chuck
5/10/18 - Knee ACL #2
5/15/18 - Biomet [illegible] tabular [illegible]
5/16/18 - K-Stroz Sinus, Diego Elite
5/25/18 - 5MR (Loaner)
5/25/18 - Stryker Anchorage
5/29/18 - Phaco Tray #5, Phaco Knob Cover Sets, x 2 mallets
5/31/18 - Frenulectomy Tray

None of the above items included a documented reason for using the method of IUSS for sterilization.


In an interview with Staff #12, Lead Sterile Processing Tech, and Staff #3, Surgical Services Manager, on the afternoon of 6/5/18, Staff #12 identified hallway sterilizers #3 and #4 as those used for immediate use steam sterilization. Both individuals agreed the facility continued the use of IUSS, but that it was "less than in the past."



Based on observation, review of facility documentation and staff interview, the facility failed to maintain a sanitary hospital environment. This deficient practice had the potential to affect all hospital patients.

Findings were:

Facility policy #SS.CS.4.1 entitled "Infection Control," last revised 7/15, included the following:

"IV. PROCEDURE

RESPONSIBILITIES:

Central Service Supervisor: ...
o Reports potential infection hazards to the Infection Control Practitioner ...

Infection Control Practitioner:
o Reviews all infection control practices and processes in Central Service ...

Personal Hygiene: ...
o Frequent and thorough hand washing is mandatory ...
Proper storage and handling of sterile supplies shall be maintained to prevent contamination ..."



Facility policy #SS.CS.6.19 entitled "Sterilization," last revised 6/15, included the following:

"Packaging ...
- Monitor that the weight of each instrument set does not exceed 25 lb ..."


Facility policy #IC.2.23 entitled "Care of Refrigerators, Freezers, and Microwaves," last reviewed 8/17, included the following:

"I. PURPOSE

To set standards to ensure the cleanliness of refrigerators, freezers, and microwaves throughout the hospital ...

III. POLICY...

B. Refrigerator temperature readings are recorded daily on temperature log and gauges should be adjusted accordingly to reach appropriate temperature ...

F. Freezers are defrosted when there is an ice build up on the freezing surface. Freezers are defrosted as needed when the refrigerator is cleaned ..."


During a tour of the sterile processing department with Staff #12, Lead Sterile Processing Tech, and Staff #3, Surgical Services Manager, on the afternoon of 6/5/18, the following items were noted:


In the clean sterile instrument packaging room:

o Thick dust on horizontal surfaces

o A cabinet with an unhinged door with stains on the inside cabinet bottom

o There was no scale to weigh the instrument sets. Weight and tray-loading techniques are both important in the effective sterilization and drying of surgical instruments. Staff #12 stated that he knew how much the sets generally weighed.


In the dirty sterile processing room:
o There was no handwashing sink. Thus, staff could not wash hands after handling contaminated surgical instruments.

o The concentration of the enzymatic cleaner solution in which to soak dirty instruments could not be ascertained. Staff #12 stated, they sometimes used a small cup to measure how much cleaner they used but was unable to locate the cup. Thus, it was thus unclear whether an effective concentration was being used to clean contaminated surgical instruments.



During a tour of the OR sterile suite on the morning of 6/6/18 with Staff #1, Director of Quality, the following items were noted:

o Chips in the plaster on the walls of OR #3, making thorough cleaning impossible

o The OR medication room had thick dust on horizontal surfaces and a wooden side table with a sink in it. The top of the table had laminate which was broken in several locations. The side of the wooden table was exposed, permeable wood. The broken laminate and wood surfaces made thorough cleaning impossible.

o The water of the OR scrub sinks near the external exit door was run for several minutes. The water temperature reached, at best, a tepid level. Staff #1 stated the water temperature was "probably never tested," and agreed the water did not appear to be heating.



During a tour of the endoscopy recovery area on the morning of 6/6/18 with Staff #1, Director of Quality, the following items were noted:

o There was a thick layer of ice in the patient nourishment refrigerator. The refrigerator also had no temperature log. Food items were stored in the refrigerator and were available for patient use. The items had no date as to when they were placed in the refrigerator.

o There was a thick layer of dust on several horizontal surfaces.


All these findings were confirmed with the above individuals during the tours. No additional evidence of compliance was offered or received.






36594



The facility also failed to have an effective system for identifying, reporting, investigating, and controlling infections and communicable disease of patients and personnel by:

A. Failing to effectively monitor surgical site infections

B. Failing to monitor implants

C. Failing to follow up on incidents regarding infection control issues


A. CDC procedure-associated module titled "Surgical Site Infection (SSI) Event," dated January 2018 stated in part, "Surgical Site Infection Criteria:

*Superficial incisional SSI must meet the following criteria:

Date of event for infection occurs within 30 days after any NHSN [National Healthcare Safety Network] operative procedure (where day 1 = the procedure date) ...


*Deep incisional SSI must meet the following criteria:

The date of event for infection occurs within 30 or 90 days after ...


*Organ/Space SSI must meet the following criteria:

Date of event for infection occurs within 30 to 90 days after ..."



Facility policy titled "Detection of post-op surgical/invasive produre [sic] site infections" stated in part, "IV. Procedure: ...B. The OR manager/Director will send surveillances reports to the physicians every (60) days. This report will be completed and returned to the Infection Control Nurse if any SSI/infections are reported.

...F. Patients who have had surgery and/or invasive procedures will be followed for thirty (30) days."



The facility sent a letter dated 4/4/18 to 31 physicians that stated in part, "Attached is a list of surgeries/procedures that you performed for the months of January, February, and March 2018. We are following certain procedures for post-operative infections. Please check if the patient has returned to your office with signs and symptoms of a post-operative infection ..."


The following physicians returned the letter:

*On an unknown date, staff #D8 indicated 25 patients (with surgery dates 3/14-28/18) had no post-op infections within 30 days after surgery

*On 4/27/18, staff #D9 indicated 5 patients (with a surgery date of 3/29/18) had no post-op infections within 30 days after surgery

*On an unknown date, staff #D10 indicated 23 patients (with surgery dates 3/10-24/18) had no post-op infections within 30 days after surgery

*On 4/4/18, staff #D11 indicated 8 patients (with surgery dates 3/15-22/18) had no post-op infections within 30 days after surgery

*On 4/4/18, staff D12 indicated 5 patients (with surgery dates 3/13-23/18) had no post-op infections within 30 days after surgery

*On an unknown date, staff #D13 indicated 12 patients (with surgery dates 3/5-28/18) had no post-op infections within 30 days after surgery

*On 4/24/18, staff #D14 indicated 7 patients (with a surgery date of 3/26-28/18) had no post-op infections within 30 days after surgery

*On an unknown date, staff #D15 indicated 7 patients (with surgery dates 3/14-28/18) had no post-op infections within 30 days after surgery

*On 4/6/18, staff #D16 indicated 2 patients (with surgery date 3/9/18) had no post-op infections within 30 days after surgery

*On 4/10/18, staff #D17 indicated 2 patients (with surgery dates 3/30/18) had no post-op infections within 30 days after surgery

*On 4/4/18, staff #D18 indicated 10 patients (with surgery dates 3/7-21/18) had no post-op infections within 30 days after surgery

*On 4/6/18, staff #D19 indicated 4 patients (with surgery dates 3/14-28/18) had no post-op infections within 30 days after surgery

*On an unknown date, staff #D20 indicated 13 patients (with surgery dates 3/5-13/18) had no post-op infections within 30 days after surgery

*On 4/4/18, staff #D21 indicated 3 patients (with surgery dates 3/14-28/18) had no post-op infections within 30 days after surgery

*On 4/6/18, staff #D22 indicated 32 patients (with surgery dates 3/6-27/18) had no post-op infections within 30 days after surgery

*On an unknown date, staff #D23 indicated 23 patients (with surgery dates 3/6-27/18) had no post-op infections within 30 days after surgery

*On 4/10/18, staff #D24 indicated 14 patients (with surgery dates 3/10-30/18) had no post-op infections within 30 days after surgery


The above surveillance reports provided revealed that physicians were signing and returning surveillance reports prior to the 30-day minimum time frame for reporting surgical site infections according to facility policy and CDC guidelines. There was no documented evidence provided of nosocomial or surgical site infection surveillance conducted after 30 days. For the first quarter of 2018, 1,003 patients had procedures at the facility; only 560 of those patients were tracked correctly, according to facility policy.



B. In an interview with staff #D4, Infection Control Director, on 06/06/18 at 9:50 AM, she was asked how implants are tracked at the facility. She replied, "We track them for a year out ... The log should be here for the implant and the tissues. They have the log these patients came in and received these implants. They don't pull them out [the log] unless the patient comes back in."

She was asked how the facility monitors for potential infections. She replied, "The implants what she was saying is they have the log all these patients and the type of implant they receive. If patient doesn't go to the doctor with an infection here is no way of finding out." She was again asked if the facility monitors for infections or if the physician notifies infection control of any potential infections. She replied, "No they don't. If they have an infection they will got to the doctor for an I&D [incision and drainage]."

She was asked to clarify if they only track implants that have a reported problem and she replied, "correct." She was asked what if the patient presents to another facility, she replied, "We don't know that."


C. Facility policy titled "2017 Infection Prevention and Control Plan" stated in part, "7. Statement of Authority and Responsibilities.

...d. The Infection Control Nurse (ICN) will: ...(6) Assist in developing and maintaining an effective hospital environmental control program to include sanitation inspections, environmental monitoring, surveys and assistance in preparation of procedures related to environmental control (i.e. ... disinfection/sterilization procedures, etc.)

...f. Department directors/Managers will:
(1) Ensure compliance of their staff with all infection prevention and control practices as outlined in the Infection Control Policy and Procedures."



Facility policy titled "Standard of Care Policy" stated in part, " ...3. Care of equipment. This involves ... the cleaning, sterilization and disinfection of equipment, instruments and devices. All staff should follow manufacturer and facility protocols in all instances."

Event/Complaint Log dated 1/2018 stated in part, "During Right Total Knee Arthroplasty the implant fell on the blue sterile area very close to the unsterile area. Surgeon took implant soaked in betadine solution, alcohol solution then rinsed in Normal Saline. Surgeon then implanted the insert."


In an interview with staff #D4, Infection Control Director, on 06/06/18 at 9:50 AM she was asked about the dropped implant during a total knee procedure. She replied, "I did go talk to them [in the surgery department] on this. They don't have a policy. Some patients have them custom made. They are supposed to do autoclaving and all that. If not custom made, the reps bring in a couple more and then they can replace it. I was asking if there's not a policy is there a process? They were telling me 'we just know' to autoclave them." She was asked how the surgery employees know what can be sterilized or flashed if an implant is dropped. She replied "there needs to be something in writing".

Staff #D4 also confirmed she was not immediately notified of the incident involving a staff member cutting their finger in the operating room. She stated, "If person gets cut they get orders to get labs and go to be seen. That, I wasn't notified of until after the fact."



In an interview with staff #D2, the Director of Quality and Risk Management, on the afternoon of 6/6/18, when discussed the IC director did not know about the incidents of the employee cut finger and dropped implant, staff #D2 stated, "They did, I talked to the director of surgery because when she brought it to me, I asked what did you guys do. She said the tech did not tell us and the doctor sutured her up. I said, 'What are you guys talking about?' I said, 'I know that can't be done.' So yes we talked about that and I told them they need to bring me the stuff sooner. I already told them about it ... In that situation, they told me that nothing got contaminated because the doctor was there. Nothing got contaminated. When she cut her finger, they took everything out and didn't use anything. They said nothing touched the patient. I asked about that. I can only go by what they tell me. I told them I need those reports sooner." Regarding the dropped implant, staff #D2 stated, "The doctor did that. Yes [shaking her head]." When asked if the patient got notified the implant was dropped, staff #D2 stated, "I don't know."

The above was verified in an interview with the CNO and Director of Quality on the afternoon of 6/6/18.