HospitalInspections.org

Based on document review and interview, the facility failed to monitor the effectiveness and safety of services in 1 (Central Sterile Department) of 1 department reviewed:

Findings include:

1. Policy/procedure, Event Reporting, revised/reviewed 12/18 indicated:
A. page 1: "An event is defined as an injury, adverse outcome or undesired occurrence. Any individual who discovers, witnesses or otherwise becomes aware of information regarding an event or sentinel event is responsible to immediately notify his/her immediate supervisor...".
B. page 2: "Non-sentinel Events: Department managers or their designees are to review electronic event report investigation follow-up within five working days of the occurrence of the event. A root cause analysis will be conducted through the appropriate medical staff peer review committee as a result of any event deemed to have severe implication for patient care, even if the occurrence did not reach a sentinel event level. Aggregate data will be trended through Safety Committee and Quality Forum on a quarterly basis to seek organizational opportunities for improvement".

2. Infection Control and Prevention Plan FY 2019, revised/reviewed 4/3/19 indicated:
A. page 1: "The purpose of the plan is to outline the programs process for the identification and reduction of risks for acquiring and transmitting infections. The Infection Control and Prevention Committee has authority to...recommend actions to prevent or control infections based on surveillance reports and analysis".
B. page 2: "Infection Preventionist (IP) activities includes...E. Serves as content expert in the development and implementation of education programs related to infection control and prevention. F. Provide infection control and prevention education to...healthcare workers".
C. page 3: "O. Provide oversight for the sterilization and disinfection processes performed in the organization".

3. Review of Incident/Event Log dated 2/1/19 through 11/21/19 lacked evidence that an investigation of causative factors was documented related to patient 16, 17, 18, 19 and 20's Surgical Site Infection (SSI).

4. On 11/21/19 at approximately 1730 hours, staff N27 (RN Manager OR) was interviewed and confirmed the Incident/Event Log dated 2/1/19 through 11/21/19 lacked evidence that an investigation of causative factors was documented related to patient 16, 17, 18, 19 and 20's SSI.

Based on document review and interview, the facility failed to ensure staff followed processes for sterilization of surgical instruments in 1 (Central Sterile Department) of 1 department reviewed:

Findings include:

1 Infection Control and Prevention Plan FY 2019, revised/reviewed 4/3/19 indicated:
A. page 1: "The purpose of the plan is to outline the programs process for the identification and reduction of risks for acquiring and transmitting infections. The Infection Control and Prevention Committee has authority to...recommend actions to prevent or control infections based on surveillance reports and analysis".
B. page 2: "Infection Preventionist (IP) activities includes...E. Serves as content expert in the development and implementation of education programs related to infection control and prevention. F. Provide infection control and prevention education to...healthcare workers".
C. page 3: "O. Provide oversight for the sterilization and disinfection processes performed in the organization".

2. Policy/procedure, Pack Control - Steam Sterilizers and Sterrads, revised/reviewed 11/17 indicated: "An internal chemical indicator integrator strip will be placed in every sterile pack and instrument set container processed for pack control".

3. Review of Event Summary dated 10/11/19 at 1113 hours indicated: Occurred on: 10/11/19 0940 hours in Operating Room. Medtronic implant pan was opened when patient was already in room. The towels in the instrument/implant pan were wet. Central Sterile was notified. Staff N5 said we would need to use immediate use sterilization because we only have one set available. The tray was sterilized between room 1 and 3. The pan was dripping water when removed. The 2 inner trays were removed from the pan and were sterilized again. The indicators had turned each time. Biologicals were used with both loads. 10/11/19 Management Investigation - Assigned to staff N27. 10/21/19 staff N27, 'After re-running the loads, they were dry and optimal for use. Since this particular incident there have been no issues with the autoclave between OR's 1 and 3. We will continue to monitor. Staff have followed protocol as expected: no harm to patient'. 11/14/19 staff N24, 'as stated Central Sterile associates coached and track/trending'".
Review of facility documents related to the Incident/Event dated 10/11/19 lacked documentation of tracking/trending and staff coaching.

4. On 11/21/19 at approximately 1400 hours, staff N21 (RN Operating Room) was interviewed and confirmed he/she has seen tears in instrument wrapping, instrument sets that contained the wrong instruments, instrument sets that lacked internal chemical indicator integrator strips and mislabeled instrument packs.

5. On 11/21/19 at approximately 1430 hours, staff N23 (CST) was interviewed and confirmed on 11/4/19 approximately 5 to 7 orthopedic instrument sets lacked internal chemical indicator integrator strips ensuring the sterility of the instruments. Staff N23 confirmed on 10/11/19 a spinal instrument set was opened and found to have water/condensation in the tray. Staff N23 confirmed the spinal instrument set was returned to the Central Sterile department to undergo 'flash' sterilization prior to the start of the surgical procedure on 10/11/19. Staff N23 confirmed he/she has seen tears in surgical wrap. Staff N23 confirmed mislabeling of instrument sets is an on-going problem. Staff N23 confirmed staff lacked knowledge in the process for sterilizing the Trumpet Suction instrument.

6. On 11/21/19 at approximately 1500 hours, staff N25 (CST) was interviewed and confirmed he/she was hired to work in the OR setting-up surgical cases and passing instruments to surgeons during procedures. Staff N25 confirmed he/she has found instrument sets to be wrapped with paper/fabric containing tears. Staff N25 stated instrument set wrapping containing tears are potentially not sterile and should be returned to the Central Sterile department. Staff N25 confirmed he/she has opened instrument sets that were mislabeled. Staff N25 confirmed issues related to instrument sterilization has delayed surgical procedures in the OR.

7. On 11/21/19 at approximately 1515 hours, staff N26 (CST) was interviewed confirmed he/she has found tears in instrument wrapping, mislabeled instrument sets as well as orthopedic instrument sets that lacked internal chemical indicator integrator strips ensuring sterility of the set. Staff N26 confirmed the witnessing of the orthopedic instrument sets that lacked indicator strips occurred on 11/4/19.

8. On 11/21/19 at approximately 1730 hours, staff N27 (RN Manager OR) was interviewed and confirmed on 11/4/19, seven orthopedic instrument sets were opened by OR staff and discovered to have been processed without internal chemical indicator integrator strips. Staff N27 confirmed instrument sets processed without indicator strips cannot be assured of sterility and need to undergo reprocessing. Staff N27 confirmed staff involved in the processing of those seven instrument sets were reeducated but the reeducation was not documented. Staff N27 confirmed an Incident/Event Report was not documented. Staff N27 confirmed he/she was aware that OR staff have been documenting issues related to the sterile processing of instruments in a binder labeled 'Central Sterile Issues - Daily Log'. Staff N27 stated he/she does not routinely read the binder and/or track the issues documented related to sterile processing.

9. On 11/21/19 at approximately 1600 hours, staff N9 (Central Sterile Manager) was interviewed and confirmed he/she developed the 'Central Sterile Issues - Daily Log' to help track issues related to sterile processing. Staff N9 confirmed the 'Central Sterile Issues - Daily Log' contains entries documented by the OR staff indicating issues related to tears/nicks found in instrument wrapping, wrong instruments found in instrument sets and instruments found to contain debris (cement).

Based on document review and interview, the facility failed to ensure employees received department-specific orientation (Central Sterile Department) in 19 (Staff N1, N2, N3, N4, N5, N6, N7, N8, N9, N10, N11, N12, N14, N15, N16, N17, N18, N19 and N20) of 20 personnel files reviewed as well as 4 (N21, N23, N25, and N26) of 6 staff members interviewed and failed to ensure employees were evaluated for skills competency in 4 (N1, N8, N9 and N19) of 20 personnel files reviewed and 4 (N21, N23, N25, and N26) of 6 staff members interviewed.

Findings include:

1. Review of personnel files for staff N1 (Certified Surgical Technologist [CST]), N2 (CST), N3 (CST), N4 (CST), N5 (Instrument Technician), N6 (Certified Registered Central Service Technician [CRCST]), N7 (CRCST), N8 (CRCST), N9 (Central Sterile Manager), N10 (Instrument Technician), N11 (Instrument Technician), N12 (Instrument Technician), N14 (CRCST), N15 (Infection Preventionist [IP]), N16 (CRCST), N17 (CRCST), N18 (Registered Nurse [RN]), N19 (RN) and N20 (RN) each lacked documentation of department specific orientation.

2. Review of personnel files for staff N1, N8, N9, N19, N21, N23, N25 and N26 each lacked documentation of evaluation of skills competencies related to duties performed on the job.

3. Policy/procedure, Competency/Education Assessment of Hospital Associates, revised/reviewed 12/18 indicated: "Orientation to department-specific responsibilities is phased in over a period of time...Department managers are responsible for overseeing the orientation process of new associates within their department".

4. Policy/procedure, Competency Validations, revised/reviewed 5/19 indicated:
A. page 1: "At the time of employment, associates will complete designated validation tools. Performance validation will be documented on established forms and filed in individual's Human Resource files. Within an established time frame, area/unit specific skill functions and knowledge bases will be validated by set competency methods, criteria and critical elements".
B. page 2: "Competency assessments/validations include skill validation, written tests, case studies, exemplars, simulation lab, peer review, mock events, presentations, demonstrations, and/or chart documentation audit data. Identified skill/knowledge categories may be evaluated on both an annual and ongoing basis by a collaborative process...".

5. On 11/21/19 at approximately 1400 hours, staff N21 (RN Operating Room) was interviewed and confirmed he/she was hired as an Operating Room (OR) nurse performing duties that include circulating and scrubbing into surgical cases. Staff N21 confirmed he/she was asked to work in the Central Sterile Department by staff N22 (OR Charge Nurse). Staff N21 confirmed he/she has not completed an department-specific orientation or had an evaluation of his/her skills competency. Staff N21 confirmed he/she has worked in Central Sterile Department the last three months performing duties such as assembling surgical instrument sets and wrapping surgical instruments due to staff shortage.

6. On 11/21/19 at approximately 1430 hours, staff N23 (CST) was interviewed and confirmed he/she was asked to work in Central Sterile Department in mid-October 2019 by staff N24 (Director Surgical Services). Staff N23 confirmed he/she had not been through a skills competency check-off prior to performing duties that included washing and wrapping surgical instruments. Staff N23 confirmed he/she did not complete a department-specific orientation prior to working in the Central Sterile Department.

7. On 11/21/19 at approximately 1500 hours, staff N25 (CST) was interviewed and confirmed he/she was hired to work in the OR setting-up surgical cases and passing instruments to surgeons during procedures. Staff N25 confirmed about 2 months ago, he/she was asked to work in the Central Sterile Department. Staff N25 confirmed he/she performed duties such as wrapping instruments and assembling instrument sets. Staff N25 confirmed he/she had not been evaluated for skills competency and had not completed a department-specific orientation prior to performing the above-mentioned duties.

8. On 11/21/19 at approximately 1515 hours, staff N26 (CST) was interviewed and confirmed he/she was hired to work in the OR. Staff N26 confirmed he/she was asked to work in the Central Sterile Department about a month ago due to a staff shortage. Staff N26 confirmed he/she performed duties that included wrapping and assembling instrument sets and evaluating instruments for sterile integrity. Staff N26 confirmed he/she has not been evaluated for skills competency and has not completed a department-specific orientation.

9. On 11/21/19 at approximately 1730 hours, staff N27 (RN Manager OR) was interviewed and confirmed OR staff, including RN's, CST''s, CRCST's and Instrument Technicians have been asked to work in the department. Staff N27 confirmed the above-mentioned staff personnel files and staff N21, N23, N25 and N26 lacked documentation of department-specific orientation as well as evaluation of department-specific skills competencies. Staff N27 confirmed those staff that were asked to be cross-trained to work in Central Sterile Department, performed duties without to completing a skills competency check-off and department-specific orientation.

10. On 11/21/19 at approximately 1600 hours, staff N9 (Central Sterile Manager) was interviewed and confirmed OR staff are currently working in the Central Sterile Department without having been evaluated for department-specific orientation and skills competency.