HospitalInspections.org

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Based on observation, interview, and review of hospital policies and procedures, the hospital's governing body failed to provide oversight of the Quality Assessment and Performance Improvement program.

Failure to provide effective oversight for quality improvement puts patients at risk of harm from inconsistent and inadequate treatment.

Findings included:

1. Failure to ensure an effective system is in place to develop service contracts, and to track and evaluate the scope, nature, and quality of the services provided as part of a 3rd party service used by the hospital to repair Biomedical equipment deemed as end of life, beyond repair, or labelled do not use by the hospitals' primary biomedical equipment repair and maintenance contracted service.

Cross Reference: A 083

2. Failure to systematically collect and analyze hospital-wide performance data limited the hospital's ability to identify problems and formulate action plans. This reduced the likelihood of sustained improvements in clinical care and patient outcomes.

Cross Reference: A 263

3. Failure to provide oversight of the hospital's quality program in order to ensure the quality program reflected the complexity of the organization and services and included process improvement for systematic deficiencies identified by consulting and regulating agencies in the hospitals Central Sterile Department.

Cross Reference A 308

4.. Failure to implement infection prevention and control policies and procedures consistent with national guidelines places patients and staff at risk of illness from exposure to communicable disease.

Cross Reference A 749

5. Failure to provide surgical services to patients in a way that ensures appropriate sterilization of surgical instruments and informs patients of the risks and benefits of surgery and anesthesia puts patients at risk of serious harm from exposure to infectious organisms.

Cross Reference A 940

Due to the scope and severity of deficiencies detailed under 42 CFR 482.21 Condition of Participation for Quality Assessment and Performance Improvement, 42 CFR 482.42 the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship, and 42 CFR §482.51 the Condition of Participation for Surgical Services, the Condition of Participation for Governing Body was NOT MET.
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Based on observation, interview, and document review, the Governing Body failed to ensure that the hospital had an effective system in place to develop service contracts, and to track and evaluate the scope, nature, and quality of the services provided as part of a 3rd party service used by the hospital to repair Biomedical equipment deemed as end of life, beyond repair or labelled do not use by the hospitals' primary biomedical equipment repair and maintenance contracted service.

Failure to ensure that the scope, nature, and quality of the services provided were defined created a lack of oversight by the hospital.

Findings included:

1. Document review of the hospital's Board of Trustee document titled, "Board of Trustee Bylaws of Capital Medical Center," approved 04/08/15, showed that the Governing Body is responsible for establishing, maintaining and supporting, through the Chief Executive Officer, Medial Staff, and its designated committees a comprehensive, hospital wide program for quality assessment and improvement, receiving reports of quality improvement information, and assuring that all aspects of the program are performed appropriately.

The Chief Executives responsibility includes negotiating and finalizing professional, consultant, and service contracts in accordance with corporate policy.

2. On 06/08/20 at 2:00 PM, during interview with the Interim Surgical Services Director (Staff #502) related to Immediate Use Sterilization (IUSS) rates and reports from staff related to lack of surgical instruments, Staff #502 stated that the hospital is short on instruments and had in excess of 110 surgical pans labeled for nonuse related to missing instrumentation. She stated that the hospital was having surgical instruments reprocessed by a 3rd party vendor (QUANTUM) after the regular contracted service provider Integrated Medical Systems Inc. (IMS) returned the instruments with a tag attached that stated that the vendor is unable to repair, the instrument is at end of life, and do not use. She stated that the instruments returned from the 3rd party vendor were unlabeled untracked, and there was no way to track the instruments at all. Staff #502 provided Investigator #5 with 3 examples of tags that had been attached to instruments returned by IMS that stated the instruments were unable to be repaired and do not use. Staff #501 stated that the instruments were sent to the 3rd party vendor and she had no way to track what they were, when they came in, how they were reprocessed, or if or when they were used for patient care. Staff #502 stated that QUANTUM was owned by the prior Surgical Services Director's husband.

3. On 06/08/20 at 4:00 PM, Investigator asked the Chief Nursing Officer (Staff #505) and the Chief Quality Officer (Staff #501) how they monitored quality of instrument repair for the 3rd party company QUANTUM who was repairing instruments returned to the facility as non repairable, end of life, and do not use. The Chief Nursing Officer (Staff #505) stated that she was not aware that instruments were being sent to a 3rd party vendor until after a prior Surgical Services Director had left. She stated she was not aware if there was a contract for the 3rd party vendor.

4. At this same time, the Chief Financial Officer (Staff #524) stated that she signed off on the invoices, but was not aware the hospital did not have a contract for the services provided by this vendor.

5. On 06/09/20 at 2:00 PM, during interview with Investigator #5, the Board of Trustees Chairman (Staff #508) stated that he was aware that instruments were being repaired by a third party vendor. He stated there was no budget for new instrumentation so the prior Surgery Director had permission from administration to take them home to give to her husband who was the owner of the Quantum company to see what could be done.

6. On 06/11/20, Investigator #5 reviewed 4 Invoices received from Quantum Medical Group including:

a. Invoice #92915 service dated 12/04/19,

b. Invoice #93773 service dated 03/25/20,

c. Invoice #93774 service dated 03/25/20,

d. Invoice #93904 service dated 04/15/20.

Investigator #5 reviewed the Board of Trustee meeting minutes from 03/13/19 that showed a listing and review of clinical contracts. The contract list did not include Quantum Company.

7. On 06/11/20 at 11:50 AM, the Chief Quality Officer (Staff #501) verified that the hospital did not have a contract with the Quantum company to repair surgical instrumentation returned as unrepairable, beyond life or do not use and stated that the hospital needed to put a process in place to monitor instruments leaving and returning to the hospital.
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Based on observation, interview, and review of quality documents, the hospital failed to develop a hospital wide quality assessment and performance improvement program to monitor, evaluate, and improve quality of patient care services through systematic data collection, analysis, implementation of process improvement, and monitoring of those plans post implementation to ensure sustained improvements in clinical care with oversight of the hospital's Governing Body.

Failure to systematically collect and analyze hospital-wide performance data limited the hospital's ability to identify problems and formulate action plans. This reduced the likelihood of sustained improvements in clinical care and patient outcomes.

Findings included:

Interview, record review, and review of the hospital's quality documents showed the following:

1. Failure to collect, aggregate and analyze data to improve patient outcomes.

Cross Reference: A273

2. Failure to establish performance measures and identify action plans for identified Quality and Patient Safety concerns

Cross Reference: A283

3. Failure to ensure that data related to potential patient exposure events were aggregated and analyzed for patterns, trends, and common factors through the hospital's quality program.

Cross Reference: A286

4. Failure of the Governing Body to be responsible for the quality of care provided to patients across service lines including contracted services.

Cross Reference: A308

Due to the scope of the deficiencies cited under 42 CFR 482.21; the Condition of Participation for Quality Assurance Performance Improvement was NOT MET.
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Based on interview, document review, and review of the hospital's quality program, the hospital failed to develop, implement, and maintain a hospital-wide, integrated Quality Assessment Performance Improvement (QAPI) program that included measuring, analyzing, and tracking quality indicator data on the hospital's use of Immediate Use Steam Sterilization.

Failure to systematically measure, analyze, and track quality care indicator data limits the hospital's ability to formulate action plans for improvement and reduces the likelihood of sustained improvements in clinical care and patient outcomes.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Immediate-Use Steam Sterilization," policy number 757.018, effective 06/03/16, showed that Immediate Use Steam Sterilization (IUSS) will be used only in cases of defined emergency when no other option is available and there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Cycle information and monitoring results are documented to include the item processed, patient identification, type of cycle, cycle parameters, monitoring results, date and time of cycle, operator information, and the reason for the IUSS.

Document review of the hospital's policy titled, "Instrument Quality Assurance," policy number 757.022, effective 04/16, showed that the purpose of the policy is to provide a method of monitoring quality of instrument trays assembled and processed in the Central Sterile Unit. All instruments trays/sets should be cleaned, assembled, processed, and stored according to established policies and procedures. The Central Sterile Supervisor will compile data and report to the Director and the Chief Quality Officer monthly using the Department Specific Process Improvement Project form.

Document review of the hospital's Quality Plan titled, "Quality & Risk Management Plan," Policy number 4.0, revised 03/18, showed that the Quality and Risk Management Program at Capital Medial Center promotes and supports practices and policies providing quality patient care, promoting safety, and minimizing adverse outcomes. The program is intended to reduce/prevent risk exposures to the patients, employees, and visitors in the facility, maintain equipment, and conserve hospital property. The hospital makes every effort to obtain an optimum level of safety by demonstrating safe practices and maintaining a safe environment in order to eliminate or reduce hazards to patients, staff, and visitors. The policy does not address the hospitals quality indicators or goals.

2. Document review of a Sterile Processing Department Consultation report titled, "Capacity Limitation in SPD (Sterile Processing Department) Capital Medical Center," completed by Alpha Consulting Group Incorporated, 2017, showed the following evaluation of the hospital's Central Processing Department:

a. The report showed that the IUSS rate for January (2017) was approximately 5% and that the consultants were anecdotally told that there are times when entire trays are "flashed" because there are not enough trays and there is not enough time to turn them around.

b. The hospital should review the Immediate Use Steam Sterilization reports and report them to Infection Control Committee and purchase trays that require frequent IUSS in order to decrease IUSS.

3. Document review of a Sterile Processing Department Consultation Report titled, "Life Point Hospitals: Central Sterile Assessment Findings and Recommendations Capital Regional," performed on 11/20/18 and edited on 12/04/18 showed the following Central Sterile Processing evaluation:

a. Immediate Use Steam Sterilization (IUSS) practices are high and did not meet the Advancement of Medical Instruments (AAMI) and the Joint Commission (JC) standards for IUSS. They reported that this is a patient safety hazard as the IUSS process is inconsistent with the standard of processing of instruments.

b. The hospital should identify high volume/frequently used sets and purchase sufficient quantity of these sets to prevent needing to IUSS full sets. Monitor IUSS data and report through quality and surgical services committee with the goal to be less than 5%.

4. On 06/09/20 at 12:00 PM, Investigator #5 and Investigator #6, and the Chief Quality Officer (Staff #501), and the Chief Nursing Officer (Staff #505) reviewed the hospital's Quality Improvement Program, and Quality Improvement Committee meeting minutes.

Investigator #5 noted that the hospitals IUSS Rates consistently exceeded the hospitals goals from 01/19 through 10/19 with rates of IUSS during this time from 9% to 29%. Investigator #5 noted that the IUSS rate for 11/19 through 02/20 showed 0%. Investigator #5 found no evidence in the Quality Committee meeting minutes that the data was analyzed, or that action plans to address the high IUSS rates were developed, implemented, or reassessed for effectiveness.

5. At the time of the QualityImprovement Program review, the Chief Quality Officer (Staff #501) stated that the hospital had purchased a system called "ONE TRAY" and were told by the previous Central Sterile Manager that this system was not IUSS. The hospital stopped documenting trays processed using the ONE TRAY system. She stated when the hospital attempted to purchase the system in 02/20 they became aware of the Food and Drug Administration letter that showed that the "ONE TRAY" system is IUSS. Staff #501 provided Investigator #5 with a coy of the FDA letter. Investigator #5 found no further evidence of data collection for IUSS from 02/20-06/20.

6. Document review of the letter titled, "Warning Letter Innovative Sterilization Technologies LLC MARCS-CMS 524761," dated 03/20/19, showed that the firm Innovative Sterilization Technologies had been marketing the ONE TRAY sealed sterilization System outside of its original clearance including use as terminal sterile storage and terminal storage with retained moisture. The document showed that the ONE Tray System is intended to hold reusable medical devices while they are flash sterilized for immediate use, and the FDA noted concerns about use outside original clearance including the increase risk of microbial contamination that could result in patient illness, injury, or death.

7. On 06/05/20 at 9:20 AM, during interview with Investigator #5, the Central Sterile Manager (Staff #503) stated that the Central Sterile staff had not documented IUSS from October of 2019 to current and was unaware of the current rate of IUSS. Investigator #5 found no evidence in the Quality minutes that IUSS data was collected, analyzed, or monitored from 02/20-06/20.
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Based on interview, document review, and review of quality data, the hospital failed to develop and implement performance improvement activities based on patient safety and quality of care concerns identified in consultative evaluations of the hospital's Central Sterile Department (Item #1), and failed to complete performance improvement action plans and track performance to ensure that improvements were sustained for patient safety and quality care findings in the Central Sterile Department identified during a 2019 Joint Commission Accreditation Survey (Item #2).

Failure to develop projects and action plans based on results of data collection and aimed at improving patient outcomes puts patients at risk from harm from substandard care.

Findings included:

Item #1 Consultative Evaluations of Central Sterile Department

1. Document review of a Sterile Processing Department Consultation report titled, "Capacity Limitation in SPD (Sterile Processing Department) Capital Medical Center," completed by Alpha Consulting Group Incorporated, 2017, identified the following findings during an evaluation of the hospitals Central Processing Department:

a. The IUSS rate for January (2017) was approximately 5% and consultants were anecdotally told that there are times when entire trays are "flashed" because there are not enough trays and there is not enough time to turn them around.

b. The hospital should review the Immediate Use Steam Sterilization (IUSS) reports and report them to Infection Control Committee. The hospital should purchase trays that require frequent IUSS in order to decrease the rate of IUSS on frequently used instrumentation.

c. Access to the Sterile Processing department (SPD) was not restricted to staff wearing PPE.

d. Sales Representatives were used to transport dirty instruments through hallways covered by the back table cover used on a case, passing by sterile supplies and equipment.

e. Instruments are not consistently sprayed with enzymatic foam or gel and not until they get to the decontamination room.

f. Dirty instruments are placed in basins.

g. Water temperature is not monitored in washing sinks.

h. Instruments are placed flat in trays and are not organized prior to placing in the washer decontaminator. Instruments should be placed in expandable stringers and placed in an upright position to allow for adequate cleaning and lubrication of the box lock.

i. Trays are not labelled or tagged in any way to identify what type of tray or case.

j. Staff interviews showed that many of the instruments are in poor condition with pitting and that many trays are missing items.

k. Trays are sterilized for 6 minutes on a pre-vac cycle with a 35-minute dry time instead of the standard 4 minute/30 minute dry time. When asked about the variance the staff stated that the sterilization time "has always been that way, and the dry time was due to "wet steam" causing wet loads.

l. Once the cycle is complete, the door is cracked to start cool down.

m. There is no method utilized to monitor the cooling time.

n. Staff is not measuring the temperature of the cooling instruments before touching them.

2. Document review of a Sterile Processing Department Consultation Report titled, "Life Point Hospitals: Central Sterile Assessment Findings and Recommendations Capital Regional," performed on 11/20/18 and edited on 12/04/18 identified the following failures:

a. Immediate Use Steam Sterilization (IUSS) practices are high and did not meet the Advancement of Medical Instruments (AAMI) and the Joint Commission (JC) standards for IUSS. They reported that this is a patient safety hazard as the IUSS process is inconsistent with the standard of processing of instruments.

b. Currently wet instruments from the washers are located too close to cooling sets, which could cause contamination by inadvertent splashing or increased humidity causing strike through in the wrappers of the cooking sets.

c. High numbers of holes identified in sterilized wrappers and noted that this is a patient safety issue as it may pass undetected and allow for a contaminated set to be used during surgery

d. Not all staff are trained to perform all duties on all shifts. The Travelers especially do not receive adequate precepting on the late shifts.

e. Lumened instruments are not properly prepared.

f. Instruments lack regular scheduled maintenance to ensure proper functioning and sharpness.

g. Current sterilizer limited tray size to 17 pounds and 240 pounds overall loads. Some current sets may be in excess of the recommended weight and compromise sterilization effectiveness.

h. Peel packs have been noted to have watermarks, not properly sealed/exposed, and lack tip protectors calling into question the integrity of the items sterility.

i. Incomplete documentation of maintenance and Quality Assurance of equipment.

j. Lack of adequate hand sanitizer/hand wash noted throughout the department.

k. Venders are not held to loaner policy.

l. Instruments ae not properly exposed during washing process, as instruments are not placed on stringer, which allows for expanded exposer.

m. The current instrument-wrapping table does not meet the demands of the case volume and type and the height is not conducive to employee safety.

n. The current sterilizer limits tray sizes to 17 pounds and 240 pounds overall loads. Some current sets may be in excess of the recommended weight and compromise sterilization effectiveness.

o. Peel packs have been noted to have watermarks, not properly sealed/exposed, and lack tip protectors. This calls into question the integrity of the items sterilized

p. Loose wraps on instrument sets and wrapped sets stacked for storage.

q. Markers not approved for sterilization are used. This can produce a toxin that can be transferred to the patient. AAMI recommends non-toxic markers for labeling sets and peel packs.

r. Incomplete documentation of maintenance and Quality Assurance of equipment. Completion of documentation is the foundation of sterility assurance. Although the tests and repairs may be performed, the lack of proper documentation eliminates assurance.

s. There was a lack of adequate hand sanitizer/hand wash throughout the department.

t. The location of Personal Protective Equipment (PPE) is not convenient and observations of breaks in PPE were observed causing contamination of nearby restricted areas.

u. Current spray nozzles are stationary and may cause aerosolization of biohazard material.

v. Currently alcohol is used to disinfect instruments that cannot be placed in the washer/disinfector prolonging processing times.

w. Inadequate lighting exists at the ultrasonic workstation, which may cause improper inspection of instruments.

x. Instruments are not properly exposed during the washing process, as instruments are not placed on a stringer, which allow for expanded exposure.

3. Document review of a hospital document titled, "Sterile Process Department Proposal Sterile Processing Department Request 2020," showed the following:

a. Poor Condition of equipment (Rigid Containers) showing compromised seals and deterioration resulting in a pathway for bioburden.

b. Inability to examine inner cannulas on suctions, cystoscopes for bioburden.

c. Inability for autoclave to be programmed to increase temperatures to IFU, and 2 autoclaves that cannot provide enough cycle spots to meet IFU requirements.

The report addressed concerns for equipment and instruments quality and patient safety concerns.

4. Document review of a Capital Medical Center Central Sterile Department evaluation report titled, "Central Sterile Department," completed on 04/30/20 identified the following quality and safety issues:

a. Damaged instruments (pitting, taped instruments that tape chipping, no regular maintenance or inspection of equipment). Label maker tape applied to multiple instruments and used to mark the item number (not on instrument instructions for use (IFU's) and a high risk for bioburden.

b. No regular maintenance/inspection of instruments.

c. No testing prior to assembly of laparoscopic instruments.

d. Beyond repair instruments labeled by the contracted repair vendor as, "do NOT use-instrument beyond repair-could impact patient safety," given to a third party vendor to repair that are now back in service with no way to track.

e. Inexperienced Staff.

f. 40% of trays without count sheets.

g. Use of alcohol to clean instruments bypassing decontamination and wash process.

h. Genesis pans brought to clean side from the Operating Room and never processed through decontamination as staff were told they were technically clean.

i. Contaminated instruments found on the clean side.

j. Improper method of sterilization for single metal instruments: Single Metal instruments ran through STERRAD machine due to convenience of shorter cycle when the instrument is needed in the operating room-this is not an approved method of sterilization for metal instruments and should be considered unsterile.

k. Tray inventory, peel pack inventory insufficient and 100 trays unusable related to missing instruments.

l. Ortho and spine instruments and general surgery instruments being hand washed only and passed through to the clean side to quicken the process of getting instruments to the OR room for cases being turned over.

m. Unsterile instruments repeatedly found on sterile racks

n. Sterilization Workaround: Staff have been told to leave trays inside the sterilizer at the end of the cycle to dry the instruments. Staff indicated that if they took the load out it was a wet load so the work around was to leave in the sterilizer to dry and which is against all Instructions for Use (IFU's) for all the instruments and the manufacturer guidelines for the use of the sterilizer.

o. Staff not removing the biologic tester within the required 10 minute to process, but rather leave it behind in sterilizer until the instruments are deemed dry enough (approximately 1 hour)

p. No ability to track, assemble, and process loaner trays (previous system was removed and a new system was not built to preplace).

q. CensiTrac (a surgical instrument tracking system): No instrument locations built into system.

r. Staff unable or unaware of how to use ONE SOURCE (IFU information)

s. No reference Manuals in the department.

t. No education, IFU's, instruction manuals, or service contract for CUBE Sterilizer (2 loads caught running on wrong cycle).

u. Sterilization parameters have not been built into the system.

v. No competencies to use the sterilizers, washers, STERRAD machines etc.

w. Staff not aware of how to "test" the sterilizers i.e. Bowie dicks.

x. Staff unable to scan equipment on all levels.

y. Using expired STARRAD sterilization tape from January until found in April. Multiple trays were used between this time and unable to verify the trays were sterile for use, also due to no track built for STERRAD they are unable to track what may have been used with expired tape.

z. Nothing built to run items in STERRAD.

aa. No proper documentation for washer testing.

bb. No one knows how to use the attachments for lumens in ultrasonic cleaner.

cc. No one was using the ultrasonic cleaner on any kind of regular basis only if they had time or remembered to do so. Not following IFU for instrument cleaning.

dd. Staff taught when using sink to decontaminate something to use your judgement for example if the item is really dirty use 1 ounce of cleaning.

ee. Curtain rings used in washers to separate items.

ff. Inappropriate cleaning resulting in Damaged equipment for 3 ureteroscopes, 4 rigid scopes, 2 light cords, and a bone mill occurring all in 1 week time.

gg. Limited and new staffing and students not being appropriately precepted. No competency unit wide.

hh. No standard work practices.

ii. No policies and procedures updated or readily available.

jj. No reference manuals on equipment used daily.

kk. Staff allowed to eat and drink in the department.

ll. Culture: Staff not to ask questions related to previous leaders anger/retaliation.

mm. No regular staff able to take on-call by themselves, as they do not have the skill to work independently.

nn. CensiTrac-At this time no location built, no tracking ability into decontamination area, no tracking ability to track sterilizer, no tracking to shelf, no tracking to repair, no tracking to carts, no tracking to patient room.

oo. No tray weights were built into the system.

pp. The evaluation showed that the hospitals CensiTrac system was only 10%-20% complete and at the time of the report there was no location built, no ability to track into decontamination, no tracking ability to track to sterilizer, no tracking to shelf, no tracking to repair, no tracking to carts, and no tracking to patient room.

5. On 06/05/20 at 9:20 AM, during interview with Investigator #5, the Central Sterile Manager (Staff #503) stated that the hospital recently hired him in April 2020. Staff #503 verified that he and the Interim Director of Surgical Services (Staff #502) who was also recently hired by the hospital had completed the evaluation of the Central Sterile Department and documented their findings in the document titled, "Central Sterile Department." Staff #503 stated that the findings were reviewed in person with the Chief Nursing Officer (CNO) (Staff #505).

6. On 06/05/20 at 10:15 AM, during interview with Investigator #5, the Interim Director of Surgical Services (Staff #502) verified that she and the Staff #503 performed an evaluation of the Central Sterile Department, and detailed their findings in the document titled, "Central Sterile Department." Staff #503 stated that she had been meeting with the CNO (Staff #505) and discussing all the issues identified during the evaluation. She stated that Staff #505 was not taking the Safety and Quality concerns identified during the evaluation seriously and that after 3 weeks of discussion with the Staff #505 she needed to take additional steps. On 04/30/20, Staff #502 stated that she emailed the report to the CQO and called a meeting later that afternoon with the Chief Executive Officer (Staff #504) and the Chief of Surgery (Staff #507) where all parties were provided a copy of the Central Sterile Department evaluation.

7. On 06/08/20, Investigator #5 reviewed an email sent from Staff #502 to the CQO (Staff #501), dated 04/30/20 at 4:51 PM, which showed the document detailing Safety and Quality concerns in the Central Sterile Department.

8. On 06/08/20 at 2:19 PM, the Chief of Surgery (Staff #507) verified quality of care and patient safety concerns identified during the evaluation of the Central Sterile Department were discussed in the meeting with the CEO (Staff #504) on 04/30/20.

9. On 06/08/20 at 4:00 PM, during interview with Investigator #5, the Chief Executive Officer (CEO) (Staff #504) stated that the 2017 Alpha Consulting report was reported to him and that in 06/17 the responsibility for improvement was given to the Chief Operating Officer who was no longer employed by the hospital. Staff #504 stated that the hospital had significant turnover in staff including "6 or 7 Managers and 4 Surgical Services Directors" since 2017 and that, it was hard to get "traction" for process improvement as the reports went to individuals who did not share the information. The current CNO (Staff #505) was given responsibility for the Surgical Services Department including the Central Sterile Department in May 2019.

10. On 06/09/20 at 11:30 AM, during interview with Investigator #5, the Chief Quality Officer (Staff #501) stated that she was "not aware" of the 2018 consultation report titled, , "Life Point Hospitals: Central Sterile Assessment Findings and Recommendations Capital Regional." At this same time, Staff #501 stated that she had only become aware of the 2017 Alpha Consulting Group Inc. consultation report titled, "Capacity Limitation in SPD Capital Medical Center," about 2 weeks prior to the complaint investigation when she was going through a tracer activity in the Central Sterile Department. Staff #501 was employed in the role of Chief Quality Officer in 2017, 2018, 2019, and 2020.

11. On 06/09/20 at 12:00 PM, Investigator #5 and Investigator #6 reviewed the hospital's Quality Improvement Program, Quality Improvement Committee meeting minutes, and Quality documents. Investigator #5 found no evidence that the Quality Committee developed or implemented action plans related to the deficiencies identified in the Central Sterile Processing evaluations completed in 2017, 2018, or 2020.

12. On 06/09/20 at 1:30 PM, during interview with Investigator #5, the CQO (Staff #501) verified the Investigators findings and stated that at the request of the CEO (Staff #504) she had completed a tracer activity in the Central Sterile Department on 05/18/20. She stated that her findings were similar to the report submitted by the Interim Operating Room Director (Staff #502) on 04/30/20. Staff #501 stated that at the time of the interview, she would be meeting with the Chief Nursing Officer to develop action plans.

13. On 06/10/20 at 10:15 AM, during interview with Investigator #5, the Board of Directors Chairman (Staff #508), stated that the Hospital Board of Directors had not received or reviewed the 2017 or 2018 consultation reports.

14. On 06/09/20 at 12:00 PM, Investigator #5 and Investigator #6 reviewed the hospital's Quality Improvement Program and the Quality Improvement Committee meeting minutes. Investigator #5 found no evidence the hospital developed or implemented any process improvement plans addressing the Patient Safety and Quality issues identified in the external consultation reports dated 2017 and 2018. Investigator reviewed the Surgical Services Quality Improvement reports for 2017 and 2018 and found no evidence of any process improvement activities related to any of the deficiencies identified in the 2017 or 2018 consultation reports. The CQO (Staff #501) verified that the Quality Committee had not reviewed the consultation reports or developed or implemented Process Improvement activities based on the deficiencies identified in the consultation reports.

15. On 06/17/20 at 1:30 PM, during interview with Investigator #5 and Investigator #6, the Lifepoint Western Division President (Staff #509) stated that she had reviewed the Sterile Processing Department Consultation Report titled, "Life Point Hospitals: Central Sterile Assessment Findings and Recommendations Capital Regional," performed on 11/20/18. She stated she was aware of work around the deficiencies noted in the report. Investigator #5 requested documentation related to the work completed by the organization in response to the consultation report. Staff #509 did not provide Investigators any documentation.

16. At this same time, the Chief Executive Officer (CEO) (Staff #504) stated that he had reviewed the report titled, "Life Point Hospitals: Central Sterile Assessment Findings and Recommendations Capital Regional," performed on 11/20/18 and included the information provided by the report in a GAP analysis that he provided to the corporate staff in the 1st Quarter of 2019. Investigator #5 requested the GAP Analysis and action plans. Staff #504 stated that they were still looking for the action plans. The hospital did not provide the requested Gap Analysis or action plans.

17. Investigator #5 found no evidence that the hospital developed or implemented any process improvement related to the deficiencies identified in the Central Sterile Department evaluations in 2017, 2018, or 2020. The hospital continued to perform surgical and invasive procedures using instruments processed by the Central Sterile Department during this time.

Item #2 Action Plan Completion

1. Document review of the hospital's document titled, "Capital Medical Center Central Sterile Future State Decision Brief," dated 05/07/20 showed that in 2019, the hospital received 5 citations in the Central Sterile Department related to Environment of Care and Infection Control as a result of a Joint Commission Triennial Survey.

Document review of the hospital's Joint Commission Action Plan showed that the hospital developed action plans for citations received during its Triennial Survey in 2019 for the following:

a. Dried blood found in a case cart and instruments not properly sprayed resulting in dried blood.

b. Sterilization: Instrument tray weights exceeding AAMI guidelines.

c. Expired Supplies.

d. Sterile Packaging: Peel Packs without Indicators.

e. Failure to document testing of the instrument washers and lot numbers of test strips used for high-level disinfection.

2. Document review of a Capital Medical Center Central Sterile Department evaluation report titled, "Central Sterile Department," completed on 04/30/20 showed the following:

a. No proper documentation for washer testing.

b. No tray weights were built into the system.

c. No competencies to use the sterilizers, washers, STERRAD machines etc.

d. Using expired STARRAD sterilization tape from January until found in April. Multiple trays were used between this time and unable to verify the trays were sterile for use. Additionally, due to no track built for STERRAD they are unable to track what may have been used with expired tape.

e. Use of alcohol to clean instruments bypassing decontamination and wash process.

f. Genesis pans brought to clean side from the Operating Room and never processed through decontamination as staff were told they were technically clean.

g. Contaminated instruments found on the clean side.

h. Improper method of sterilization for single metal instruments

i. No competencies to use the sterilizers, washers, STERRAD machines etc.

j. Staff not aware of how to "test" the sterilizers i.e. Bowie dicks.

3. On 06/09/20 at 12:00 PM, Investigator #5 and Investigator #6, the Chief Quality Officer (Staff #501) and the Chief Nursing Officer (Staff #505) reviewed the hospital's Quality Improvement Program, Quality Improvement Committee meeting minutes, and the hospital's Board of Trustees Joint Commission Action Plan Report for September 2019.

Investigator #5 noted that the Board of Trustees Joint Commission Action Plan Report showed incomplete data collection and no analysis of data not meeting targets. The data for weighing of instruments was only collected for 2 months with no further follow-up (May and June 2019). The data for sterile packaging showed 83% compliance in May 2019 and 77% compliance in June 2019, and then no further data collection or analysis of the non-compliance or any further follow up.

Investigator #5 noted that the Quality and Safety concerns identified in the Central Sterile Processing Department in 2017, 2018 and 2020 had not been incorporated into the hospital's Quality Improvement Program, and that Quality Improvement plans developed in response to Quality and Safety findings identified by the Joint Commission in 2019 had been abandoned.

Investigator #5 noted that the findings by the Joint Commission in 2019 were similar to findings identified in the evaluation completed by the new Surgical Services Director in 04/20.

3. On 06/09/20 at 12:00 PM, during interview with Investigator #5, the Chief Quality Officer (Staff #501) verified the observations and stated that it was very difficult to get information from the prior Surgical Services Director and she had no further data. She stated that in 05/20, the hospital identified that the action plans developed in response to findings during the hospital's 2019 Joint Commission Accreditation Survey had been "abandoned."

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Based on interview and review of the hospital's quality improvement program and performance data. the hospital failed to set clear expectations for safety in the Central Sterile Department and the Operating Room related to the use of potentially contaminated surgical equipment and failed to ensure a system was in place for reporting, identifying, and investigating potential safety events as directed by its policy and procedure.

Failure to systematically collect, aggregate, and analyze data related to patient events and set clear expectations for safety, limits the hospital's ability to develop action plans to prevent medical errors and patient injuries.

References: Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP), "Factors Affecting the Efficacy of Disinfection and Sterilization: Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)," reviewed 09/18/16, showed that organic and inorganic contaminants protect microorganisms from attack by acting as a physical barrier during the sterilization process.

The Association for the Advancement of Medical Instrumentation® (AAMI), "Understanding Key Factors in Steam Sterilization," March/April 2014, showed that steam cannot reach all surfaces then sterilization of the device will fail. A wet pack refers to moisture remaining after completion of the sterilization and cooling cycles. Such packs may lose their barrier properties, which could allow bacteria to migrate to the inside of the package and contaminate the contents or shorten the shelf life of the package. A wet pack at the end of a cycle could result in recontamination

Findings included:

1. Document review of the hospital's policy titled, "Serious Safety Event/Adverse Health Events," policy number SE-1, approved 11/21/18, showed the following:

a. All possible adverse patient occurrences that may meet the definition of a serious safety event or adverse event are promptly reported to the Chief Quality Officer (CQO).

b. Occurrence reports will be completed online and the CQO will notify and consult with the Chairperson of the Quality Improvement Council (QIC) and/or the Chief of the Medical Staff and the Chief Executive Officer to determine if the event meets the definition of a serious safety event/adverse event including a "near miss."

c. If it is determined that the event meets the definition of a serious safety event/adverse event (including a near miss) the quality department completes an investigation and reports the results to the Quality Improvement Committee for review.

2. Document review of the hospital's policy titled, "Notification of Patient Unanticipated Outcomes," policy number RI 8.0, revised 01/17, showed the following:

a. In the course of providing medical care, unanticipated outcomes can occur that may or may not affect the health status or well-being of the patient.

b. An unanticipated outcome is defined as an unexpected result stemming from healthcare, such as a diagnostic test, medical judgement, a procedure, treatment, or surgical intervention. The unanticipated outcome may or may not be the result of a medical error.

c. If a Registered Nurse or other healthcare provider has identified what could possibly be an unanticipated outcome, they should seek advice from the attending physician and or the Unit Director/Supervisor.

d. Following submission of an incident report and upon gathering all facts related to the occurrence, the Risk Manger should be contacted so that a formal investigation can be completed before reaching a decision about whether an unanticipated outcome has been identified.

e. If the Attending Physician is unsure whether an unanticipated outcome has been identified he/she shall discuss further with the Risk Manager.

f. The facility Chief Executive Officer, in consultation with the Chief of the Medical staff or his/her designee has primary responsibility to determine whether an event meets the hospital defined level of significance for notification and results in the patient and/or family being informed of the event.

g. At minimum, the patient should be notified of the nature of the unanticipated outcome, and known repercussions the unanticipated outcome may have had on the patients care and on short and long term health, a point of contact for further questions and avenues of recourse.

The responsibility for patient and/or family notification is ultimately the CEO's responsibility in conjunction with the Chief of Staff.

Event #1

3. On 06/05/20 at 10:15 AM, during interview with Investigator #5, the Central Sterile Manager (Staff #503) discussed the ongoing issues with wet packs (visible moisture left in the interior or on the exterior of a package after sterilization and the proper cooling period) and wet loads (moisture present on or in 2 or more packages in the same load after sterilization and the proper cooling period). Staff #503 stated that on 05/18/20 the Central Sterile Department identified that 3 of the 5 sterilizers had wet loads that resulted in the utilization of surgical instruments that could not be verified as sterile for 16 patients on dates 04/29/20, 05/05/20, 05/08/20, 05/15/20, 05/18/20. He stated that the information was emailed to the Chief Nursing Officer (Staff #505) and the Chief Quality Officer (Staff #501) on 05/18/20. Investigator #5 requested the document howing the 16 patietns affected and requested the email.

4. On 06/10/20 at 10:30 AM, Staff #503 provided Investigator #5 with copies of the requested documents for review. Investigator #5 reviewed the documents confirming the wet trays and the wet loads and the 16 affected patients. The document showed the patient names, dates, procedures, and instruments utilized for the 16 patients affected by the wet loads and wet trays (Patient #501, Patient #502, Patient #503, Patient #504, Patient #505, Patient #506, Patient #507, Patient #508, Patient #509, Patient #510, Patient #511, Patient #512, Patient #513, Patient #514, Patient #515, and Patient #516).

5. On 06/11/20 at 11:33 AM, Investigator #5 reviewed the document detailing the patients affected by wet loads and wet packs where sterilization of instruments could not be confirmed with the Chief Quality Officer (Staff #501). Staff #501 stated that she was provided with a list in a different format, but that the list included the same patients. She stated she did not initially understand the impact of "wet loads" and that the Interim Director of Surgical Services (Staff #502) told her that that it meant there was a potential that patients were impacted by the use of non-sterile surgical instruments during their surgical procedure. Staff #501 stated that she did not know if any patients had been contacted. Staff #501verified that the hospital had not followed its policy and did not evaluate if the events met the hospital defined level of significance for notification as defined in its policy.

6. On 06/11/20, Investigator #5 reviewed the hospital's Incident Report list titled, "CS (Central Sterile) and OR (Operating Room) Incidents, date range 01/01/19 through 06/07/20. Investigator #5 found no evidence incident reports were filed for the wet trays utilized for surgical procedures for 16 patients (Patient #501 through #516).

7. Investigator #5 found no evidence the hospital initiated an incident report. Investigator #5 found no evidence the hospital followed it's policy and procedures to evaluate whether this event met criteria to be determined a serious safety event, adverse event or unintended outcome or met the hospital defined level of significance for patient notification.

Event #2

8. On 06/05/20 at 10:15 A.M, during interview with Investigator #5, the Interim Surgical Services Director (Staff #502) stated that the hospital stopped performing surgeries in the main operating rooms on 05/18/20, but continued to process instruments to perform vaginal deliveries, cesarean sections, and process procedural and emergency kit instruments in Sterilizer #6. Staff #502 stated that she informed hospital administration on 05/28/20 via text that Sterilizer #6 had not been previously checked and Central Sterile identified that the Sterilizer was having the same issues as the other sterilizers including markings (staining) and debris and that they could not verify sterility of the instruments processed in that sterilizer. She stated that there was no response from administration and the hospital continued performing deliveries and cesarean sections. On 06/02/20, during a Surgery Committee meeting, Staff #502 stated that she again informed the hospital including members of the Surgery Committee that the hospital was utilizing surgical equipment and instruments that they could not verify were sterile for vaginal deliveries and cesarean sections. Staff #502 stated that Sterilizer #6 had not been previously checked and she could not verify that the instruments were sterile. At this time, she stated the Surgical Services Committee determined to halt all surgeries until issues around instrument sterilization could be resolved. She stated that later that day, a Physician wanted to perform an elective cesarean section and the CNO (Staff #505) went up to the Women's Services Surgical Suite and had the Surgical Tech perform a visual inspection of the surgical trays. The Surgical Technician did not see visible staining or wet marks. The CNO (Staff #505) told the staff to go forward with the surgery (Patient #543). Staff #502 stated that because of the issues with the functioning of Sterilizer #6, she expressed that she could not confirm that the surgical instruments were sterile but the decision was overridden by the CNO.

9. On 06/08/20 at 10:30 AM, Staff #501 and Investigator #5 reviewed the hospitals list of deliveries and noted 20 vaginal deliveries and 6 cesarean sections from 05/18/20 to 06/02/20 (Patient #518, #519, #520, #521, #522, #523, #524, #525, #526, #527, #528, #529, #530, #531, #532, #533, #534, #535, #536, #537, #538, 539, #540, #541, #542, and #543). Staff #501 stated that she was not aware of issues with Sterilizer #6 until it was reported by the Interim Surgical Services Director (Staff #502) during a Surgery Committee meeting that we (the hospital) was not using sterilized equipment to perform cesarean sections. Staff #501stated that the hospital had not evaluated if the events met the hospital defined level of significance for notification as defined in its policy and she was not aware if physicians had contacted any patients.

10. On 06/09/20 from 11:00 AM until 12:23 PM, during an interview with Investigator #5, the Infectious Disease Practitioner (Staff #510) stated that she attended a phone meeting with the Interim Director of Surgical Services (Staff #502), the Central Sterile Manager (Staff #503), and the Chief Operating Officer (Staff #511). She stated that she was asked if the hospital should be performing cesarean sections. She stated she told the meeting attendees that the hospital should not be performing cesarean sections, as the hospital is unable to verify sterility of the instruments used during these surgical procedures.

11. On 06/11/20, Investigator #5 reviewed the hospital's Incident Report list titled, "CS (Central Sterile) and OR (Operating Room) Incidents, date range 01/01/19 through 06/07/20. Investigator #5 found no evidence incident reports were filed for the surgical procedures performed with instruments processed in Sterilizer #6 (Patients #518-#543). Investigator #5 found no evidence an incident report was filed for the cesarean section performed (Patient #543) after the decision was made by the Surgical Service Committee and administration to stop performing labor and delivery and cesarean sections with instruments that could not be confirmed sterile.

12. Investigator #5 found no evidence the hospital initiated an incident report. Investigator #5 found no evidence the hospital followed it's policy and procedures to evaluate whether this event met criteria to be determined a serious safety event, adverse event or unintended outcome or met the hospital defined level of significance for patient notification.

Event #3

13. On 06/05/20 at 10:15 AM, during interview with Investigator #5, the Interim Surgical Services Director (Staff #502) stated that on 05/18/20 when the hospital resumed surgical procedures 2 surgical cases (Patients #517 and #544) involving 2 Surgeons (Staff #514 and #515) had trays that showed signs of wetness/staining. One of the Surgeons cases (Staff #515) had two sets of instrument pans that appeared contaminated and showed black debris inside the surgical instrument pan. She stated she called and sent photos of the surgical instrument pans to the hospitals Infection Disease Practitioner (Staff #510) who agreed that they could not verify the sterility of the instruments and that the instruments should not be used for the surgical procedure. Staff #502 stated that the Chief Nursing Officer (Staff #505) overrode the decision and stated to go forward with the surgery using these instruments as the indicator had changed.

14. On 06/05/20 at 1:05 PM, during interview with Investigator #5, a Central Sterile Technician (Staff #513) stated that the day after the holiday (05/26/20) a surgeon (Staff #514) had performed a surgical case using instruments that showed signs of staining on the interior wraps. She stated that when the Operating Room was opening the case and observed the staining, she was asked if the instruments were sterile. She stated she told the Operating Room that they were not. The Operating Room Manager (Staff #516) then came into the room and told the staff that the instruments were "okay" to use. She stated at this time she got frustrated, left the room, and stated that she could not go against the Manager.

Staff #513 reported that the next day 05/27/20, a similar situation occurred when a surgeon (Staff #514) performed a surgical case using instruments that showed signs of staining on the interior wraps and showed black debris that looked like "soot" inside the pans. When the operating room staff opened the case, they asked Staff #513 if the instruments were sterile. She stated that she told them no. Staff #513 stated she was aware that photos were taken of the black debris in the pan, but that she did not have them. Staff #513 stated that the Operating Room Manager (Staff 516), the Surgical Services Director (Staff #502), and the Chief Nursing Officer (Staff #505) came down to the operating room and she (Staff #513) was asked to return to her department. She stated she did not recall the patient's name.

15. On 06/05/20, Investigator #5 was provided with the photos of the instrument pans containing the black debris for Patient #517.

16. On 06/08/20 at 4:00 PM, during interview with Investigator #5, the Chief Nursing Officer (CNO) (Staff #505) stated that she was aware of the surgical case involving Staff #515. She stated that there was a discussion and the Surgeon wanted to go forward with using the instrumentation and he did not see it as a major issue. Staff #505 stated that the issue was not reported (via incident report).

17. On 06/09/20 at 9:00 AM, during interview with Investigator #5, the Operating Room Manager (Staff #516) stated that around 05/27/20 the operating room staff informed the surgeon (Staff #515) that the 1st and 2nd surgical instrument pans/sets were stained and had debris and that we could not validate that the instruments were sterile. She stated that the Chief Nursing Officer (Staff #505) came into the Operating Room Department and talked with the hospital's Infections Disease Physician who advised her not to go forward with the surgery. The CNO (Staff #505) stated that the indicators had passed and so it met parameters for sterility and directed Staff #502 to proceed with the surgery using the instruments.

18. On 06/09/20 at 11:00 AM, during interview with Investigator #5, the hospital's Infections Disease Practitioner (Staff #510) stated that on 05/27/20 she was contacted by the CNO (Staff #505) and by the Interim Surgical Services Director (Staff #502) when the contaminated surgical trays were discovered. She stated she told both Staff #502 and #505 that the instrument trays should not be used, as sterility could not be verified. She states she told the CNO specifically that she knew that people would not be happy but that they should not use for patient safety.

19. On 06/09/20 from 11:00 AM until 12:23 PM, during an interview with Investigator #5, the Chief Quality Officer (Staff #501) stated that she had not notified the CEO (Staff #504) about the 2 surgical cases where instrument sets that showed signs of staining and contained debris were utilized on patients. She stated that she had not become aware of the issue until it was already done. She stated that after she became aware, she asked the surgeon to fill out a form (stating he wanted to go forward with surgery) but the form came back with only a signature and did not have the patient's name). She stated this was not standard of practice.

20. On 06/11/20 at 11:33 AM, during interview with Investigator #5, the Chief Executive Officer (Staff (504) stated that he had not previously heard about the 2 surgical cases performed by Surgeon #514 and #515 with instrument pans with stains or debris, but when he heard about it he stated that they needed to follow the hospital process.

21. On 06/11/20, Investigator #5 reviewed the hospital's Incident Report list titled, "CS (Central Sterile) and OR (Operating Room) Incidents, date range 01/01/19 through 06/07/20. Investigator #5 found no evidence incident reports were filed for the 2 surgical procedures performed with stained instrument sets or sets containing black debris. Investigator #5 found no evidence the hospital followed it's policy and procedure to determine whether an event met the hospital defined level of significance.

22. Investigator #5 found no evidence the hospital initiated an incident report. Investigator #5 found no evidence the hospital followed it's policy and procedures to evaluate whether this event met criteria to be determined a serious safety event, adverse event or unintended outcome or met the hospital defined level of significance for patient notification.
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Based on interview and document review, the hospital's Governing Body failed to provide oversight of the hospital's quality program in order to ensure the quality program reflected the complexity of the organization and services and included process improvement for systematic deficiencies identified by consulting and regulating agencies in the hospitals Central Sterile Department.

Failure to ensure that the hospital's Quality Program reflected the complexities of services provided, limits the hospital's ability to identify areas of concern related to quality and safety, and limits the hospital's ability to implement process improvement actions to improve care outcomes and patient safety for identified deficiencies.

Findings included:

1. Document review of the hospital's Board of Trustee document titled, "Board of Trustee Bylaws of Capital Medical Center," approved 04/08/15, showed that the Governing Body is responsible for establishing, maintaining and supporting, through the Chief Executive Officer, Medial Staff and its designated committees a comprehensive, hospital wide program for quality assessment and improvement, receiving reports of quality improvement information, and assuring that all aspects of the program are performed appropriately.
Document review of a Sterile Processing Department Consultation report titled, "Capacity Limitation in SPD (Sterile Processing Department) Capital Medical Center," completed by Alpha Consulting Group Incorporated, 2017, showed deficiencies in the hospital's Central Processing Department.

Document review of the Board of Trustee Report for the hospital's Joint Commission Action Plan showed that the hospital developed action plans for citations received during its Triennial Survey in 2019. The document showed that the data for weighing of instruments was only collected for 2 months with no further follow-up (May and June 2019). The data for sterile packaging showed 83% compliance in May 2019 and 77% compliance in June 2019, and then no further data collection or analysis of the non-compliance or any further follow up.

2. Document review of a Sterile Processing Department Consultation Report titled, "Life Point Hospitals: Central Sterile Assessment Findings and Recommendations Capital Regional," dated 11/20/18, showed deficiencies in the hospital's Central Processing Department.

3. Document review of the hospital's document titled, "Capital Medical Center Central Sterile Future State Decision Brief," dated 05/07/20, showed that in 2019, the hospital received 5 citations in the Central Sterile Department related to Environment of Care and Infection Control as a result of a Joint Commission Triennial Survey.

4. On 06/09/20 at 12:00 PM, Investigator #5 and Investigator #6 reviewed the hospital's Quality Improvement Program. During interview with Investigator #5, the Chief Quality Officer (Staff #501) verified the observations and stated that it was very difficult to get information from the prior Surgical Services Director and she had no further data. She stated that in 05/20, the hospital identified that the action plans developed in response to findings during the hospital's 2019 Joint Commission Accreditation Survey had been "abandoned."

At this time, Investigator #5 noted that the Quality and Safety concerns identified in the Central Sterile Processing Department in 2017, 2018 and 2020 had not been incorporated into the hospital's Quality Improvement Program, and that Quality Improvement plans developed in response to Quality and Safety findings identified by the Joint Commission in 2019 had been abandoned. Staff #501 confirmed the finding.

5. On 06/09/20, Investigator #5 reviewed the monthly Board of Trustee (BOT) meeting minutes dated 12/11/18 through 05/27/20. Investigator #5 found no evidence in the minutes that the BOT discussed or analyzed the consultation report findings in the Central Sterile Department from 2017 or 2018. Investigator #5 found no evidence that the Board of Trustees discussed or developed action plans related to the hospitals Quality Committee's failure to complete the Joint Commission Survey finding actions plans for the Central Sterile Department in 2019.

6. On 06/09/20, at 3:00 PM, Investigator #5 and #6 interviewed the hospital's Governing Body (Board of Trustees). At this time, a Board Member (Staff #544) stated that a significant amount of the Governing Body meeting time is spent on the hospitals Quality Initiatives, but that the information may not be reflected in the minutes. Staff #544 and the Board Chairman (Staff #508) stated that they were unaware of the Central Sterile Department consultation evaluations in 2017 and 2018. They stated because the reports had not been provided to the Governing Body the minutes would not reflect reporting of this data. They were unaware that the Joint Commission Quality Improvement projects related to the Central Sterile department had been abandoned by the Quality Committee.

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Based on interview and document review, the hospital failed to develop and implement an effective infection prevention and control program that ensured compliance with nationally recognized infection prevention and control precautions, failed to ensure that staff followed hospital policies and industry standards for cleaning, disinfecting, and sterilizing critical instruments, and failed to implement corrective actions developed from previously identified findings.

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

Findings included:

1. The hospital failed to ensure a hospital wide infection prevention and control program demonstrated adherence to nationally recognized guidelines and best practices.

Cross Reference: Tag A 749

2. The hospital failed to ensure that the infection control program collaborated with the Quality Assurance and Performance Improvement program on infection control issues and activities.

Cross Reference: Tag A 750

3. The hospital failed to ensure staff properly reprocessed instruments for patient care that required sterilization and/or high-level disinfection (HLD).

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

Cross Reference: Tag A 775
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Based on document review, and interview, the hospital failed to ensure that hospital staff maintained sterilization processes according to hospital procedure and accepted standards of practice (Item #1), failed to ensure that staff followed manufacturer instructions for use when reprocessing supplies, instruments, and equipment used for surgical procedures (Item #2), failed to adhere to national standards for Immediate Use Steam Sterilization (Item #3), failed to ensure loaner/consignment instrumentation and supplies were processed according to national standards (Item #4), failed to effectively mitigate the occurrence of sterilizer Wet Loads (Item #5), failed to maintain quality and quantity of surgical supplies according to hospital policy and accepted standards of practice (Item #6), and failed to ensure a process was in place to decontaminate and sterilize medical instruments used for invasive patient procedures contained in emergency and procedure kits (Item #7).

Failure to implement infection prevention and control policies and procedures consistent with national guidelines places patients and staff at risk of illness from exposure to communicable disease.

Findings included:

Item #1 - Sterilization processes

References: AAMI ST79: 2017 Standard 3. Design considerations recommends that sterilization processes flow from dirty to clean and/or left to right.


- AAMI ST79: 2017 Standard 7. Cleaning, disinfection (microbicidal processes), and other decontamination steps, Standard 7 recommendations include the staff having access to the manufacturer ' s Instructions For Use (IFU) to determine the type of decontamination required and whether the device was exposed to pathogens, such as the prion that causes Creutzfeldt-Jakob disease (CJD) that require specialized processing steps, and the requirements for equipment maintenance.


- AORN Guidelines for Perioperative Practice, 2020: Sterilization, Recommendation 1. Process Based on Intended Use, includes staff access to manufacturer IFUs, reconciling sterilization parameters to meet equipment and instrument IFUs, including cycle and load configuration; Recommendation 13. Education, includes staff receiving initial and ongoing education and competency verification of sterilization activities.

- AORN Guidelines for Perioperative Practice, 2020: Instrument Cleaning, Recommendation 5. Sterile Processing Area, includes stocking the reprocessing area with brushes or other devices to remove organic material and debris from lumens, with a diameter and length appropriate to the lumen to be cleaned

1. Document review of the hospital's "Central Sterile Processing Tracer," dated 05/18/20, showed that the hospital findings included:

a. AAMI standards are not readily available to staff. A selection of AAMI standards is available electronically, but is incomplete.

b. Central Sterile Department (CSD) staff did not properly test ultrasonic instrument cleaner equipment for both cavitation and chemistry.

c. CSD staff could not articulate "dirty to clean" or "left to right" instrument flow in the decontamination area.

2. On 06/04/20 between 2:00 PM and 4:00 PM, Investigator #6 interviewed the Interim Director of Perioperative Services (Staff #616) and a Central Sterile Technician (CST) (Staff #602) about the Central Sterile (CS) Department procedures with the following result:

a. CSD staff could not identify the proper use of wire brushes in the decontamination area.

b. CSD staff could not identify sterilizer weight requirement/restrictions for washer trays.

c. CSD staff could not consistently prepare hinged instruments for washing.

d. CSD staff could not discuss routine maintenance of sterilization equipment and could not locate maintenance logs.

3. On 06/05/20 between 9:20 AM and 10:45 AM, Investigator #6 interviewed the Central Sterile Department Manager (Staff #615), between 12:00 PM and 4:30 PM, Investigator #6 interviewed the Perioperative Manager (Staff #617) and 5 CSTs (Staff #601, #604, #608, #609, and #618) about the Central Sterile Department procedures with the following result:

a. Sterilizer drying temperature for orthopedic instruments was too low to be effective against the prion that causes Creutzfeldt-Jakob disease (CJD).

b.CS Department does not have an approved policy or procedure to recall loads suspected of ineffective sterilization.

c. Reprocessed loads frequently contain debris and staining.

d. CS Department does not have reference manuals available to staff.


Item #2 - Manufacturer Instructions for Use (IFU)

References: CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, updated 05/19. Recommendations 19. a. Quality Control 4. ... train staff members to review and follow reprocessing instructions to compliance with scientific literature and manufacturers' instructions.

- AAMI ST79: 2017 Standard 7. Cleaning, disinfection (microbicidal processes), and other decontamination steps. Standard 7 recommendations include the staff having access to the manufacturer's Instructions For Use (IFU) to determine the type of decontamination required, and the requirements for equipment maintenance. .; 8. Preparation and assembly of instruments; 9. Packaging; 10. Sterilization; 11. Storage and transportation; 12; Installation, care, and maintenance of sterilizers; 13. Process monitoring, testing, and quality control

- AORN Guidelines for Perioperative Practice 2020: Sterilization, Recommendations: 1. Process based on Intended Use, includes staff access to manufacturer IFUs, reconciling sterilization parameters to meet equipment and instrument IFUs, including cycle and load configuration; Recommendation 5. Steam Sterilization, includes following the manufacturer's IFU for operating sterilizers; Recommendation 10. Quality

- AORN Guidelines for Perioperative Practice, 2020: Instrument Cleaning, Recommendation 5. Sterile Processing Area, includes stocking the reprocessing area with manufacturers' written IFUs; Recommendation 8. Cleaning Products includes review of instrument, cleaning product, and cleaning equipment IFUs for compatibility; Recommendation 9. Processing includes cleaning and decontaminating surgical instruments and equipment according to the manufacturer's validated, written IFU

1. Document review of the hospital's policy, "Handling, Collection, and Transport of contaminated surgical instruments," policy #IC 5.2, approved 09/19, showed that staff are to follow the manufacturer's IFU at all times.

- Review of the hospital's policy, "Instrument Cleaning and Decontamination," policy #757.020, revised 10/15, showed that staff are to consult the manufacturer's instruction for use (IFU) to clean, disinfect, and safely process surgical instrumentation.

- Review of the hospital's policy, "Sterilization - All Methods," policy #757.021, revised 03/16, showed that staff are to process items according to the device manufacturer's IFU.

2. On 06/04/20 between 2:00 PM and 4:00 PM, Investigator #6 interviewed the Interim Director of Perioperative Services (Staff #616) and a Central Sterile Technician (CST) (Staff #602) about the Central Sterile (CS) Department procedures with the following result:

a. CSTs do not adhere to manufacturer IFUs for the CS Department's sterilizers.

b. CSD staff could not identify sterilizer weight requirement/restrictions for washer trays.

c. Automated washer adjusted settings are contrary to manufacturer IFUs.

3. On 06/05/20 between 9:20 AM and 10:45 AM, Investigator #6 interviewed the Central Sterile Department Manager (Staff #615), between 12:00 PM and 4:30 PM, Investigator #6 interviewed the Perioperative Manager (Staff #617) and 5 CSTs (Staff #601, #604, #608, #609, and #618) about the Central Sterile Department procedures with the following result:

a. Manufacturer IFUs are not available for all equipment, supplies, and instruments.

b. Sterilizer loads routinely exceed the weight limits set by the manufacturer's IFU.

Item #3 - Immediate Use Steam Sterilization (IUSS)

References: CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, updated 05/19. Sterilization records should be retained. Recommendations 13. Flash Sterilization b. Do not use flash sterilization for convenience, or as an alternative to purchasing additional instrument sets, or to save time.

- AAMI ST79: 2017 Standard 5. Receiving; 10. Sterilization; 13. Process monitoring, testing, and quality control; 14. Quality process improvement

- AORN Guidelines for Perioperative Practice, 2020: Sterilization, Recommendation: 5. Steam Sterilization

1. Review of the hospital's policy, "Immediate-Use Steam Sterilization," policy #757.018, reviewed 06/16, showed that competency credentialed staff are to follow device manufacturer's IFU, use only containment device validated for IUSS and cleared by the US Food & Drug Administration for IUSS, document cycle information and monitoring results.

2. On 06/04/20 between 2:00 PM and 4:00 PM, Investigator #6 interviewed the Interim Director of Perioperative Services (Staff #616) and a Central Sterile Technician (CST) (Staff #602) about the Central Sterile (CS) Department procedures with the following result:

a. CS Department/Surgery Department performs Immediate Use Steam Sterilization (IUSS) due to insufficient instrumentation to accommodate the hospital's surgery schedule.

b. CS Department performs IUSS without record keeping or documentation.

c. CSTs receive inconsistent messages from department management and hospital administration regarding wet loads, reprocessing instruments, IUSS.

3. On 06/05/20 between 9:20 AM and 10:45 AM, Investigator #6 interviewed the Central Sterile Department Manager (Staff #615), between 12:00 PM and 4:30 PM, Investigator #6 interviewed the Perioperative Manager (Staff #617) and 5 CSTs (Staff #601, #604, #608, #609, and #618) about the Central Sterile Department procedures with the following result:

a. CS Department does not have an adequate number of trained staff to accommodate the hospital's surgery schedule.

b. CS Department/Surgery Department does not have sufficient instrumentation to accommodate the hospital's surgery schedule.

c. CS Department performs Immediate Use Steam Sterilization (IUSS) without record keeping or documentation.

Item #4 - Loaner/Consignment Instrumentation and supplies

References: CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, updated 05/19. Recommendations 5. Receiving

- AAMI ST79: 2017 Standard 13. Process monitoring, testing, and quality control

- AORN Guidelines for Perioperative Practice, 2020: Instrument Cleaning, Recommendations: 2. Processing Before Use; 16. Policies and Procedures

1. Document review of the hospital's "Central Sterile Processing Tracer," dated 05/18/20, showed that the hospital findings included:

a. The hospital did not have a vendor process for dropping off and logging in loaner trays and had been cited on 05/09/19 by its accrediting organization.

1. On 06/04/20 between 2:00 PM and 4:00 PM, Investigator #6 interviewed the Interim Director of Perioperative Services (Staff #616) and a Central Sterile Technician (CST) (Staff #602) about the Central Sterile (CS) Department procedures. Staff #602 and Staff #616 stated that instrument vendors bypass decontamination and leave instruments and equipment at the automatic washers without notification to staff and do not follow national standards for processing surgical instrumentation.

2. On 06/05/20 between 9:20 AM and 10:45 AM, Investigator #6 interviewed the Central Sterile Department Manager (Staff #615), between 12:00 PM and 4:30 PM, Investigator #6 interviewed the Perioperative Manager (Staff #617) and 5 CSTs (Staff #601, #604, #608, #609, and #618) about the Central Sterile Department procedures with the following result:

a. CS Department does not have a system to process or track loaner/vendor/consignment instruments.

b. The hospital does not follow national standards for processing of surgical instrumentation brought to the hospital for use by an outside vendor.

Item #5 - Wet loads

References: CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, updated 05/19. Sterilizing Practices; Recommendation 18. Storage of Sterile Items.

- AAMI ST79: 2017 Standard 3. Design considerations; 7. Cleaning, disinfections (microbicidal processes), and other decontamination steps; 8. Preparation and assembly of instruments; 10. Sterilization

- AAMI ST79:2017 Annex O. Wet packs are a concern because the moisture on or within a package can create a pathway for microorganisms to migrate from outside to the inside of a package. Investigation should be conducted to discover and diagnose the problem. The occurrence of wet packs should be documented.

- AORN Guidelines for Perioperative Practice 2020, Sterilization, Recommendation: 5. Steam Sterilization

1. On 06/04/20 between 2:00 PM and 4:00 PM, Investigator #6 interviewed the Interim Director of Perioperative Services (Staff #616) and a Central Sterile Technician (CST) (Staff #602) about the Central Sterile (CS) Department procedures with the following result:

a. CS Department is frequently getting wet loads (moisture is present on or within several packages in a sterilized load after the load has dried and cooled). There is no documentation of tracking system in place for wet loads.

b. CSTs receive inconsistent messages from department management and hospital administration regarding wet loads, reprocessing instruments, IUSS.

2. On 06/05/20 between 9:20 AM and 10:45 AM, Investigator #6 interviewed the Central Sterile Department Manager (Staff #615), between 12:00 PM and 4:30 PM, Investigator #6 interviewed the Perioperative Manager (Staff #617) and 5 CSTs (Staff #601, #604, #608, #609, and #618) about the Central Sterile Department procedures with the following result:

a. CS Department does not have an approved policy or procedure to recall loads.

Item #6 Quality and quantity of surgical supplies

Reference: CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, updated 05/19. Recommendations 13. Flash Sterilization.

- AAMI ST79: 2017 Standard 3. Design considerations; 7. Cleaning, disinfection (microbicidal processes), and other decontamination steps; 11. Storage and transportation

1. Document review of the hospital's policy, "Instrument Quality Assurance," policy #757.022, reviewed 04/16, showed that CSTs are to audit instrument quality weekly; the CS Supervisor is to compile data & report monthly to hospital administrators.

2. On 06/05/20 between 9:20 AM and 10:45 AM, Investigator #6 interviewed the Central Sterile Department Manager (Staff #615), between 12:00 PM and 4:30 PM, Investigator #6 interviewed the Perioperative Manager (Staff #617) and 5 CSTs (Staff #601, #604, #608, #609, and #618) about the Central Sterile Department procedures. Staff reported that the CS Department/Surgery Department does not have sufficient instrumentation to accommodate the hospital's surgery schedule.
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Item #7 Decontamination and Sterilization of Instruments Contained in Emergency and Procedure Kits

1. On 06/05/20 at 10:15 AM, during interview with Investigator #5, the Interim Director of Surgical Services (Staff #502) shared a timeline of events including:

a. On 05/18/20, the hospital made a decision to process Cesarean Section and vaginal delivery instruments and pans in Sterilizer #6 located in the hospital's Cystoscopy anteroom.

b. On 05/28/20, the Central Sterile Department identified that Sterilizer #6 was having the same issues as the other hospital sterilizers with wet packs (staining) and debris in and on the processed instrument trays.

c. On 06/04/20, the hospital began having the Cesarean section and vaginal delivery instruments and pans transported to a contracted facility for sterilization.

At the time of the interview, Staff #502 confirmed that the hospital continued to provide vaginal delivery and Cesarean Section surgical procedures from 05/28/20-06/04/20 utilizing instruments processed in sterilizer #6 that could not be verified as sterile.

2. On 06/08/20 at 4:00 PM during interview with Investigator #5, the Chief Executive Officer (CEO) (Staff #504) shared a timeline of events related to issues with surgical instrument sterilization. Staff #504 stated that in March per the Governor's directive the hospital stopped performing elective surgeries but continued with emergent cases. On 05/18/20, after the Governor's order expired the hospital began performing elective cases. Upon resuming cases, the hospital identified problems with staining and wetness. On 05/19/20, the hospital stopped remaining elective surgeries and investigated the issue the remainder of the week. On 05/22/20, the hospital thought the issue had been resolved, but on 05/26/20, the Central Sterile Department identified that the trays were coming out of the sterilizers stained and a decision was made to stop all surgeries except cesarean sections.

3. On 06/10/20 at 2:45 PM, during interview with Investigator #5, the Central Sterile Manager (Staff #503) stated that the instruments utilized in labor and delivery (vaginal and cesarean section deliveries) and instruments sterilized for physician offices and emergency trays were processed in Sterilizer #6 in the Cystoscopy suite.

4. On 06/16/20 at 10:00 AM, during inspection of the Intensive Care Unit and the Medical/Surgical Unit, Investigator #5 observed the following:

a. Three emergency code carts (2 in the Intensive Care Unit and 1 in the Medical/Surgical Unit) that contained patient care equipment that had been either reprocessed by the hospital, not reprocessed, or staff was unable to determine the date of reprocessing due to improper packaging.

b. Crash Cart #1 contained 1 McGill intubation forceps in its original packaging. It had never been processed for cleaning.

c. Crash Cart #2 contained 1 large forceps reprocessed by the hospital on 01/16/04, and an unlabeled and undated McGill intubation forceps in a peel pack with no indicator.

d. Medical/Surgical crash cart contained a McGill intubation forceps that was in an unlabeled, undated plastic sack.

e. A chest tube insertion kit located in the Intensive Care Unit medication room that contained a chest tube insertion kit reprocessed by the hospital on 08/26/19. The kit contained 8 hemostats, 1 blade handle, and 2 tweezers.

5. On 06/16/20 at 10:32 AM, Investigator #5 inspected the hospital's Emergency Department. Inspector #5 observed the following:

a. The Obstetrical Delivery cart contained 7 reusable instruments and kits that were reprocessed by the hospital on 03/13, 03/18, 10/18, 01/19, 2/20, and 3/20. Additionally, 2 kits were undated, and one sponge clamp package was opened.

b. The Ear, Nose, and Throat Emergency Kit contained 22 pieces of reusable instruments and kits that were reprocessed by the hospital on 06/15, 06/17, 04/19, 6/19, 01/20, and 03/20.

6. On 06/16/20 at 10:55 AM, during inspection of the Materials Management Department, Investigator #5 observed the following:

a. A Materials Management staff person (Staff #522) was returning a new chest tube kit to the Intensive Care Unit (as a replacement for a kit opened by the Investigator). The kit contained a chest tube insertion tray that was reprocessed by the hospital on 11/25/19.

7. At the time of the findings, during interview with the Chief Quality Officer (Staff #501) it was determined that the hospital did not have a process in place to decontaminate and sterilize instruments, or replace instruments utilized in the emergency kits or procedural kits as the contracted facility would only process the Labor and Delivery surgical instruments. Staff #501 confirmed that the hospital could not verify integrity of decontamination and sterilization of current instruments contained in the emergency kits and that any Emergency Procedure that included use of a kit or replacement instruments, would require the use of the kits and replacement instruments currently located in the hospital.

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Based on document review, the hospital failed to develop, implement and maintain active surveillance to prevent exposure to infectious diseases.

Failure to implement an active and appropriate hospital surveillance program for infection prevention and control with policies and procedures consistent with national guidelines places patients and staff at risk of illness from exposure to communicable disease.

References: CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, updated 05/19

- ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities

- AORN Guidelines for Perioperative Practice: Instrument Cleaning, 2020; Sterilization, 2020; High-Level Disinfection, 2020

Findings included:

1. Document review of the hospital's policy, "Handling, Collection, and Transport of contaminated surgical instruments," policy #IC 5.2, approved 09/19, showed that contaminated instruments should be sprayed with enzymatic pre-treatment at the point of use (pou) and transported in designated, leak-proof covered containers.

- Document review of the hospital's policy, "Immediate Use Steam Sterilization," policy #757.018, showed that Immediate Use Steam Sterilization (IUSS) is used when no other option is available and when specific conditions are met, including following manufacturer's instructions for use (IFU) and all IUSS must be documented.

2. Document review of the hospital's report, "The Operating Room (Quality and Safety Perspective)," dated 02/22/19, showed that the report findings included:

a. The Sterile Processing Department (SPD) transported contaminated surgical instruments without use of designated carts, in unsealed containers, through areas in proximity to sterile supplies and equipment.

b. Instruments were not consistently pre-treated with enzymatic foam or gel at the pou.

c. Instrument trays go through the sterilizer cycles at settings inconsistent with instrument manufacturer's IFU.

d. Instrument trays were allowed to cool in the sterilizer chamber with the door ajar for approximately 20 minutes, no documentation or monitoring was used.

e. SPD occasionally used IUSS for trays because there are not enough trays and not enough time between surgical cases that require the same instruments.

3. Document review of the 03/20/19 Warning Letter CMS #524761 between the US FDA and Innovative Sterilization Technologies (IST) LLC, marketers of One Tray, showed that One Tray is intended to hold reusable medical devices while they are sterilized for immediate use, and not approved for terminal sterile storage and terminal sterile storage with retained moisture.

4. Document review of the hospital's Quality Improvement Council and Infection Prevention meeting minutes for 12/18/19 showed that a discussion of IUSS rates and practices included current IUSS rates, validation of sufficient equipment and reprocessing. The committee discussed a product, "One Tray," that the Sterile Processing Department was using on a trial basis and had resulted in zero IUSS cases for December. The minutes stated that IUSS rates would be monitored monthly.

5. Document review of the hospital's "Central Sterile Processing Tracer," dated 05/18/20, showed that the hospital findings included:

a. Contaminated surgical instruments were transported using a "regular patient cart" which was not run through the cart washer before it was returned to the unit.

b. The hospital did not have a vendor process for dropping off and logging in loaner trays and had been cited on 05/09/19 by its accrediting organization.

c. CSD staff did not accurately weigh surgical procedure trays before beginning sterilization. A 05/09/19 citation by the hospital's accrediting organization found multiple trays above the allowed weight limits.

d. CSD staff did not appropriately place chemical indicators in packaging for sterilization.

e. CSD staff did not maintain complete documentation of surgical equipment and supplies released to medical staff prior to reading of the biological indicator (Early Load Release).

6. Document review of the hospital's "Clinical Education Specialists Report for Capital Medical Center," by Steris Corp., dated 06/01/20, showed that the report findings included:

a. Contaminated surgical instruments are not consistently pre-treated at the point of use (POU) prior to being transported to the Central Sterilization Department (CSD) according to national standards.

b. CSD staff could not describe reprocessing of reusable brushes, no IFU available.

c. Sterilization equipment (3 sterilizers) were heavily stained. CSD staff could not provide maintenance documentation.

d. Sterilizer loads were released prior to cooling, contrary to national standards.

e. Sterile supplies stacked for storage, contrary to national standards.
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Based on interview and document review, the hospital failed to ensure that staff were qualified (Item #1) and received competency-based training for processing surgical supplies, instruments, and equipment (Item #2) as demonstrated in 14 of 22 human resources and training records reviewed (Staff #601, #602, #603, #604, #605, #606, #607, #608, #609, #610, #611, #612,# 613, and #614).

Failure to ensure that staff are qualified and competent to process surgical supplies, instruments, and equipment puts patients and staff at risk of illness from exposure to communicable disease.

Findings included:

Item #1 - Qualified Staff

Reference: ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Standard 4.3.1 Sterile processing personnel should receive a) an initial orientation covering all tasks performed in the sterile processing area; b) continuing education at regular intervals to review and update knowledge and skills and to maintain competency and certification; and c) in-service training on all new instrumentation, devices, and equipment.

1. Document review of the hospital's "Job Description/Performance Review Form," for Central Sterile Technician, revised 02/19, showed that a Central Sterile Technician (CST) must have vocational/technical education and CST Certification. A CST must ensure the Central Sterile department complies with recommended practices (AORN, AAMI).

2. On 06/05/20 between 9:30 AM and 10:45 AM, Investigator #6 interviewed the Central Sterile (CS) Department Manager (Staff #615) about the department staff and CST training program. Staff #615 stated that the CS department had hired 6 new CST staff in the past 6 months. The new CST staff were receiving training, and had enrolled in an accredited, on-line certification course.

3. On 06/08/20, Investigator #6 completed a document review of the personnel files for 16 CSTs. The review showed that 6 of 16 CST staff personnel files did not have documentation of current certification (Staff #601, #602, #604, #605, and #607).

Item #2 - Competent Staff

Reference: AORN Guidelines for Perioperative Practice: Instrument Cleaning, 2020. Recommendation 15 Education, 15.1 Perioperative team members with responsibilities for cleaning and care of instruments used in surgery should receive initial and ongoing education and complete competency verification activities related to cleaning and care of surgical instruments.

1. Document review of the hospital's "Job Description/Performance Review Form," for Central Sterile Technician, revised 02/19, showed that a Central Sterile Technician (CST) assumes responsibility for processing of supplies, instruments, and equipment through cleaning, packaging sterilizing, and storing procedures.

- Document review of the hospital's "Job Description/Performance Review Form," for OR Tech, effective date 02/16, showed that an OR Tech (ORT) assumes responsibility for processing of supplies, instruments, and equipment through cleaning, packaging, sterilizing, and storing procedures. An ORT must ensure the Central Sterile department complies with recommended practices (AORN, AAMI).

- Document review of the hospital's policy, "New Hire Process," policy #HR 3.12, reviewed 03/18, showed that each new staff member should receive an assessment for competency in assigned responsibilities at 90 days of employment.

2. On 06/05/20 between 9:30 AM and 10:45 AM, Investigator #6 interviewed the Central Sterile (CS) Department Manager (Staff #615) about competency evaluation of the department staff. Staff #615 stated that he was developing a training program that included annual competency evaluation but he did not know whether the Central Sterile Department (CSD) conducted regular competency evaluations prior to his appointment in April 2020.

3. On 06/08/20, Investigator #6 completed a document review of the personnel files for 16 CSTs and 7 ORTs. The review showed:

a. Seven of 16 CST staff personnel files did not have current competency evaluation (Staff #601, #602, #603, #604, #605, #606, and #607).

b. Four of 7 ORT staff personnel files did not have current competency evaluation (Staff #611, #612, #613, and #614).
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Based on observation, interview and document review, the hospital failed to deliver surgical services according to regulatory requirements and acceptable standards of practice that kept patients safe from serious harm caused by improper processing of surgical instruments, and provide patients an opportunity for informed consent to surgical procedures and anesthesia.

Failure to provide surgical services to patients in a way that ensures appropriate sterilization of surgical instruments and informs patients of the risks and benefits of surgery and anesthesia puts patients at risk of serious harm from exposure to infectious organisms.

Findings included:

1. Sterile processing staff failed to adhere to hospital policy, national standards, and manufacturer's instructions when reprocessing supplies, instruments, and equipment used for surgical procedures.

Cross Reference: Tag A 772

2. Failure to ensure that standard infection control and safety practices were delivered in the operating room in a way that kept patients safe from serious harm from exposure to infection caused by improper sterilization of surgical instruments.

Cross Reference: Tag A 951

3. The surgical staff failed to ensure that Informed Consent for patient surgery and anesthesia were completed in 2 of 12 patient charts reviewed (Patient #308 and #309).

Cross Reference: Tag A 955

Due to the scope and severity of deficiencies cited under §42 CFR §482.51 the Condition of Participation for Surgical Services was NOT MET.




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Based on interview and document review the hospital failed to ensure that standard infection control and safety practices were delivered in the operating room in a way that kept patients safe from serious harm from exposure to infection caused by improper sterilization of surgical instruments (Item #1), and failed to ensure that staff and surgeons followed hospital policy for release of implants prior to the results of biological monitoring only in emergency situations and failed to ensure that the early release documentation was completed per hospital protocol (Item #2).

Failure to provide surgical services to patients in a way that ensures appropriate sterilization of surgical instruments puts patients at risk of serious harm from exposure to infectious organisms.

References: Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP), "Factors Affecting the Efficacy of Disinfection and Sterilization: Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)," reviewed 09/18/16, showed that organic and inorganic contaminants protect microorganisms from attack by acting as a physical barrier during the sterilization process.

The Association for the Advancement of Medical Instrumentation®, "Understanding Key Factors in Steam Sterilization," March/April 2014, showed that if steam cannot reach all surfaces then sterilization of the device will fail. A wet pack refers to moisture remaining after completion of the sterilization and cooling cycles. Such packs may lose their barrier properties, which could allow bacteria to migrate to the inside of the package and contaminate the contents or shorten the shelf life of the package. A wet pack at the end of a cycle could result in recontamination.

Findings included:

Item #1 Utilization of Potentially Contaminated Instruments

1. Document review of the hospital's policy and procedure titled, "Sterilization-All Methods, " policy number 757.021, revised 03/16, showed that it is the policy of Capital Medical Center that:

a. Items that enter the sterile tissue or vascular system will be sterile when used.

b. Items to be sterilized will be cleaned, decontaminated, inspected, packaged, sterilized, and stored in a controlled environment and in accordance with the device manufacturer's written instructions for use.

c. Sterilized materials will be labeled and stored in a manner to ensure sterility, and each item will be marked with the sterilization date.

d. Sterilized materials are monitored to ensure packaging, labeling, and storage occurs in a manner that promotes sterility.

e. Events are identified that can adversely affect sterility (for example: multiple handling, seal breakage, loss of integrity, moisture penetration).

2. On 06/05/20 at 10:15 AM, during interview with Investigator #5, the Central Sterile Manager (Staff #503) discussed the ongoing issues with wet packs (visible moisture left in the interior or on the exterior of a package after sterilization and the proper cooling period) and wet loads (moisture present on or in 2 or more packages in the same load after sterilization and the proper cooling period). Staff #503 stated that on 05/18/20 the Central Sterile Department identified that 3 of the 5 sterilizers had wet loads that resulted in the utilization of surgical instruments that could not be verified as sterile for 16 patients on 04/29/20, 05/05/20, 05/08/20, 05/15/20, 05/18/20.

At this same time, during interview with Investigator #5, the Interim Surgical Services Director (Staff #502) stated that on 05/18/20 when the hospital resumed surgical procedures 2 surgical cases (Patients #517 and #544) involving 2 Surgeons (Staff #514 and #515) had trays that showed signs of wetness/staining. One of the Surgeons cases (Staff #515) had two sets of instrument pans that appeared contaminated showing black debris inside the surgical instrument pan. She stated she called and sent photos of the surgical instrument pans to the hospitals Infectious Disease Practitioner (Staff #510) who agreed that they could not verify the sterility of the instruments and that the instruments should not be used for the surgical procedure. Staff #502 stated that the Chief Nursing Officer (Staff #505) overrode the decision and stated to go forward with the surgery using these instruments as the indicator had changed.

3. On 06/05/20 at 1:05 PM, during interview with Investigator #5, a Central Sterile Technician (Staff #513) stated that the day after the holiday (05/26/20) a Surgeon (Staff #514) had performed a surgical case using instruments that showed signs of staining on the interior wraps. She stated that when the Operating Room was opening the case and observed the staining, she was asked if the instruments were sterile. She stated she told the Operating Room staff that they were not. The Operating Room Manager (Staff #516) then came into the room and told the staff that the instruments were "okay" to use.

Staff #513 reported that the next day, 05/27/20, a similar situation occurred when a surgeon (Staff #514) performed a surgical case using instruments that showed signs of staining on the interior wraps and showed black debris that looked like "soot" inside the pans. When the Operating Room Staff opened the case, they asked Staff #513 if the instruments were sterile. She stated that she told them no. Staff #513 stated she was aware that photos were taken of the black debris in the pan, but that she did not have them. Staff #513 stated that the Operating Room Manager (Staff 516), the Surgical Services Director (Staff #502), and the Chief Nursing Officer (Staff #505) came down to the operating room and she was asked to return to her department. She stated she did not recall the patient's name.

Staff #513 stated that when instruments are opened that are possibly contaminated, the policy is to tear down and turnover and clean the room. This process did not happen for either case and the surgical procedures were performed on the patients.

Staff #513 stated that the hospital had been having issues with the sterilizers for a long time. She stated that staff fequently complain about brown watermarks on the surgical instruments when they open up the sets. She stated she did not feel confident that the equipment is sterile and it "bothers (her) a lot."' She was told by the prior Central Sterile Manager (Staff #517) that the brown staining on the wraps and liners was "normal." She did not feel she could go against administration.

See Reference A 286

4. On 06/05/20 at 12:28 PM, during interview with Investigator #5, a Central Sterile Technician (Staff #512) stated that they processed a lot of overweight sets through the sterilizer. The hospital did not have a system to weigh instrument trays and that the weights were not entered into the computer system.

5. On 06/05/20 at 2:20 PM, during interview with Investigator #5, a Central Sterile Technician (Staff #518) stated that wet trays and wet loads were a problem that had increased over the last 9 months. Staff #518 stated that the stained pans had been used in the operating rooms and that she was told by the prior Central Sterile Manager (Staff #517) and the Operating Room Manager (Staff 516) that the staining was normal because the sterilizers were old. Staff #518 stated that she was also told to leave the instrument trays in the sterilizer to ensure they were dry because many of the trays were coming out wet.

6. On 06/08/20 at 11:36 AM, during interview with Investigator #5, an Operating Room Technician (Staff #519) stated that the hospital used surgical trays even if there was staining. She stated, "No one thought it was an issue so we didn't tell anyone, it was a common thing." She stated that if the staining was major, staff would "take it into consideration," but if the edges were tan, we would use. It was not until the new managers came that they stated this was abnormal.

7. On 06/08/20 at 11:47 AM, during interview with Investigator #5. An Operating Room Technician (Staff #520) stated that that staining and debris in the instrument trays has been a problem. Staff #520 stated that the trays were used for patient surgeries and that "we were under the impression that it was okay, we were told it was." Investigator #5 asked Staff #520 if this was what she learned in her Operating Room Technician education program. She stated it was not, but that when she came here (to the hospital) and saw it, it was the "culture."

8. On 06/08/20 at 11:55 AM, during interview with Surveyor #5, an Operating Room Technician (Staff #521) stated that he had not used stained surgical instrument packs, but stated, "When I started seeing the staining, I was told it was natural and normal here."

Item #2 Early Release of Implants

1. Document review of the hospital's policy and procedure titled, "Implantation of Medical Devices," policy number 701.051, reviewed 04/13, showed that whenever feasible, In-hospital sterilized implants are not implanted until such time that results of biological monitoring are known.

Document review of the hospitals form titled, "Exception form for Premature Release of Implantable Device/Tray," no form number, dated 2013, shows that implantable devices will be released from quarantine in Central Sterile without biological results only in documented emergency situations.

2. On 06/05/20 at 10:30 AM, during interview with Investigator #5, the Interim Surgical Service Director (Staff #502) stated that when she arrived to the hospital she found a stack of incomplete implant early release forms. She stated that staff should document on the form when in emergency situations an implant is released for use in a patient before the biological indicators are read. She stated that appeared to be part of the culture. Staff #502 pulled a couple of the documents off her desk for the Investigator to review.

Investigator #5 reviewed the "early Release Form" for Patient #545 and found that the section titled, "Operating room Report" was blank including the sections that listed the reason for premature release and what could have prevented the premature release. The attached "Implantable Device Load Record" contained only an unreadable signature and a patient label. The sections of the form titled date, description of implant, department, time sterilized, sterilizer #, load #, date/time of biological indicator, date, and time of biological indicator result, early release, date and time released were blank.

Investigator #5 reviewed the "early Release Form" for Patient #546 and found that the entire form was blank including the sections that listed the reason for premature release and what could have prevented the premature release. The attached "Implantable Device Load Record" contained only an unreadable signature and a patient label. The sections of the form titled date, description of implant, department, time sterilized, sterilizer #, load #, date/time of biological indicator, date, and time of biological indicator result, early release, date and time released were blank.

3. On 06/16/20 at 4:30 PM, the Chief Quality Officer (Staff #501) provided Investigator #5 with an example of two incomplete early release documents. On review, they were the same documents provided to the Investigator by Staff #502. At this time, Staff #501 stated that she had just become aware of the issue with the early release of implants, that she had investigated the signature and they appeared to be from one surgeon, and that staff should have completed the documentation.

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Based on interview, record review, and review of the hospital's policies and procedures, the hospital failed to ensure that Informed Consent for patient surgery and anesthesia were completed in 2 of 12 patient charts reviewed (Patient #308 and #309).

Failure to obtain patients signed consent for surgery and anesthesia risks patients having surgery or anesthesia without understanding the interventions, risks, and benefits.

Findings included:

1. Document review of the hospital's policy titled, "Informed Consent/Refusal to Consent," Policy #RI 2.0, revised 12/19, showed that patient consent and authorization for surgery and anesthesia, or refusal to accept treatment should be documented in the medical record.

2. On 06/17/20 at 2:20 PM, Investigator #3 and the Peri-operative Manager (Staff #301), reviewed the charts of 12 patients. Informed Consent/Refusal to Consent documents were not available for 2 of 12 patients (Patient #308 and Patient #309).

At the time of the review, Staff #301 stated that Informed Consent/Refusal to Consent forms should be in the patient charts of every patient who has or refuses surgery and anesthesia.

3. On 06/18/20 at 10:42 AM, Investigator #3 interviewed the Records Clerk of Health Information Management (Staff #302). Staff #302 stated that her department had not received surgical and anesthesia consent forms for Patients #308 and #309.

4. On 06/19/20 at 12:00 PM, Investigator #3 interviewed the Chief Quality Officer (Staff #303). Staff #303 stated that surgical and anesthesia consent forms for Patients #308 and #309 could not be found or produced.
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