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Tag No.: C0241
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Based on observation, record review, and interview, the governing body failed to ensure:
*There was a facility-wide system to identify, investigate, and control infections and communicable diseases for all patients and personnel.
*The staff member responsible for the infection control program received training and education prior to her designation as the infection control coordinator.
*Surgical services were reviewed and evaluated as part of the quality assurance improvement program (QAPI).
*Sterilization technicians received training and competency testing to operate sterilization equipment in the surgery department.
*The provider's policy and procedure manuals for surgical services, emergency services, and infection control were reviewed annually.
Findings include:
1. Interview on 6/23/10 at 7:50 a.m. with the administrator, director of patient care service, nurse manager, infection control coordinator (ICC), and the maintenance/housekeeping supervisor revealed the provider did not have an effective infection control program developed and implemented throughout the facility.
Refer to C278 finding 1, 2, 3, 4, 5, 6, 7, and 8; and C320.
2. Interview on 6/23/10 at 7:50 a.m. with the ICC confirmed she had not received formal or informal training prior to or after her designation as the ICC.
Refer to C278.
3. Review of the QAPI meeting minutes from 7/30/09 to 2/25/10 revealed surgical services had not been referenced in those reports. Interview on 6/23/10 at 4:20 p.m. with the QAPI coordinator confirmed surgical services had not been integrated into the provider's QAPI program.
Refer to C336.
4. Interview on 6/22/10 at 4:00 p.m. with the nurse manager and the administrator regarding surgical services revealed there were three staff members that performed sterilization. They were not sure what training or qualifications those three staff members had received.
Refer to C320.
5. Interview on 6/23/10 at 10:20 a.m. with the administrator, nurse manager, and ICC revealed the policies and procedures for the surgical department and emergency (ED) had not been updated annually.
Refer to C280 and C320.
Tag No.: C0278
Based on observation, record review, and interview, the provider failed to ensure there was a facility-wide system to identify, investigate, and control infections and communicable diseases for all patients and personnel.
Findings include:
1. a. Interview on 6/23/10 at 7:50 a.m. with the infection control coordinator (ICC) revealed:
*She had no formal training in infection control.
*She had attended several conferences for medical technicians but not any concerning infection control programs.
*She called the infection control nurse at a hospital within the corporation with any questions or concerns she had.
*She used the Association for Professionals in Infection Control and Epidemiology manual as a resource.
*She used specimen culture reports, nursing staff, and open patient charts to collect information regarding infections within the facility.
*She did not always get all of the antibiotic use, because she only worked part-time.
*A patient with an infection who required an antibiotic could have been admitted and discharged when she was not working.
*She gathered the information and reported to the monthly general staff meeting every three months, sooner if needed.
*The facility physicians attended the general staff meeting.
b. Interview on 6/23/10 at 7:50 a.m. with the ICC regarding cleaning and sanitizing patient rooms upon discharge revealed:
*She was aware regular household bleach should be used to sanitize areas possibly contaminated with certain microbes.
*The nurses were to inform the housekeeping staff of patients with certain infections so they could use bleach to clean the resident's room.
*She did not know if the nurses informed housekeeping of the rooms that required bleach when cleaned.
*When cleaning a room of a patient with Contact Precautions housekeeping was to clean all horizontal surfaces, bathrooms, doorknobs, beds, and frequently touched areas.
*When cleaning a room of a patient with Respiratory Precautions housekeeping was to clean everything as with Contact Precautions, but they did not do the walls or curtains.
*They cleaned the walls and curtains about every six months.
*She did not know what chemicals housekeeping used to clean a patient room during or after their stay.
c. Interview on 6/23/10 at 7:50 a.m. with the ICC regarding cleaning and disinfecting environmental surfaces in the physical therapy department revealed:
*She did not do any monitoring or cultures of any of the areas cleaned by staff.
*There was not a policy and procedure to monitor the disinfection and sanitizing of any items or areas in the facility.
*She was not aware physical therapy did not change the cleaning cloth used to sanitize patient equipment between patients thus creating the potential for cross-contamination.
d. Interview on 6/23/10 at 7:50 a.m. with the ICC regarding cleaning and disinfecting environmental surfaces in the laboratory department revealed:
*She knew the laboratory blood draw chairs were not sanitized between patients.
*She knew the chairs were only sanitized if they became soiled.
*She had not thought about the potential for cross-contamination of several patients using the chairs without sanitizing between each one.
*There was not a policy and procedure regarding the cleaning and sanitizing of the laboratory blood draw chairs.
e. Interview on 6/23/10 at 7:50 a.m. with the ICC regarding dietary services revealed:
*She knew used meal trays were transported through the halls uncovered and on an open cart.
*She was not aware of the potential for cross-contamination with that practice.
f. Interview on 6/23/10 at 7:50 a.m. with the ICC regarding laundry service revealed:
*Some swing bed patient laundry was done in the residential washer and dryer in the basement.
*She knew mops, kitchen aprons, and cleaning cloths were also washed in those machines.
*She did not know those items were not sanitized by chemicals or 160 degree water.
*All other linen and laundry were contracted out of the facility.
*She did not visit the contracted laundry to monitor if they were sanitizing the linens properly.
2. Interview on 6/23/10 at 12:10 p.m. with the director of environmental services revealed:
*He knew what chemicals housekeeping used to clean patient rooms and areas.
*He knew some microbes were not killed by some cleaning chemicals and bleach needed to be used.
*He stated the nurses were to inform housekeeping if a patient's room needed special cleaning with a bleach solution.
*The nurses did not inform housekeeping, because "They did not need to know."
*The housekeeping and maintenance staff were bound by the same confidentiality rules as the nurses.
*Housekeeping did not clean the operating room. He knew two patient care technicians cleaned it, but he did not know what chemicals were used.
3. Observation on 6/23/10 of the breakfast meal revealed:
*An enclosed metal cart was used to deliver meal trays to the patient rooms.
*Approximately 45 minutes later the uncovered used meal trays were removed from the patient rooms and placed on an open cart.
*The cart was then wheeled through the hallway to the elevator.
Interview on 6/23/10 at 12:35 p.m. with the director of dietary revealed:
*The nurses informed her if dietary needed to use disposable dishes for a patient.
*The used meal trays were transported uncovered on an open cart back to the kitchen.
*She was not aware of the potential of cross-contamination of transporting uncovered used patient equipment through the halls.
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4. Interview, record review, and policy review on 6/23/10 at 10:20 a.m. with the administrator, director of patient services, nurse manager, ICC, and maintenance/housekeeping supervisor regarding the surgical areas revealed:
*Infection control processes were not reviewed for the surgical area by the ICC, surgical staff, or administrative staff.
*All agreed they did not have current and adequate infection control, sterilization/disinfection, personnel, and housekeeping policies and procedures specific to the surgical and sterilization area.
*No infection rate data of any kind was being collected in the surgical area.
*The Tuttnauer autoclave had been purchased a year or more ago. Staff had received no training of any kind on that machine prior to it being put into use or since then.
*Maintenance and biomed only looked at the two autoclaves when they were broken. The provider had no maintenance records/logs for either of those machines.
*All agreed the autoclaves had not been maintained per the manufacturer's guidelines.
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5. Observation on 6/22/10 at 8:15 a.m. in the physical therapy (PT) department revealed a cloth towel was draped over a spray bottle of disinfectant.
Interview with the head of PT at the time of the above observation revealed:
*The cloth towel was used to wipe down the equipment between clients.
*The cloth was used multiple times on multiple pieces of equipment.
*The cloth towel would be changed when it became saturated.
*She was not aware of the infection control risk of using a soiled cloth on multiple pieces of equipment.
Interview on 6/22/10 at 12:30 p.m. with the director of patient care who oversaw the PT department revealed:
*There was no policy or procedure for the cleaning of common-use equipment.
*She agreed using a soiled cloth multiple times on multiple pieces of equipment was not a good infection control practice.
6. Interview on 6/22/10 at 9:00 a.m. with housekeeping staff employee 4 and employee 5 regarding isolation rooms revealed:
*The housekeeping staff were responsible for cleaning all isolation rooms.
*The housekeeping staff were not notified by the nursing staff as to what infectious agent the room was isolated for.
*The housekeeping staff were not notified by the nursing staff if any special cleaning procedures were necessary.
*All rooms were disinfected with a quaternary ammonia product.
*The housekeeping staff were not aware quaternary ammonia products were not acceptable to disinfect against clostridium difficile.
Interview on 6/22/10 at 11:40 a.m. with the nurse manager revealed:
*The housekeeping staff were not notified of the infectious agent in isolation rooms.
*The housekeeping staff were not notified by the nursing staff if any special cleaning procedures were necessary.
*She was not aware housekeeping was using a quaternary product to clean all rooms including all isolation rooms.
7. Interview on 6/22/10 at 10:15 a.m. with laboratory (lab) technician employee 3 revealed the blood draw chair:
*Was cleaned a "couple of times" in a day.
*Was not disinfected between clients.
Interview on 6/22/10 at 12:30 p.m. with the director of patient care who oversaw the lab department revealed:
*The chair should have been disinfected between clients.
*She agreed not disinfecting the chair between clients was not a good infection control practice.
*There was no policy or procedure for the disinfecting of the blood draw chair between clients.
8. Review of a product label for Triax, a chemical, used in the laundry to sanitize revealed:
*The label made no claim to sanitize or disinfect laundry.
*The active ingredient was 8 percent hydrogen peroxide.
Interview on 6/22/10 at 12:00 with the director of environmental services revealed:
*Triax was used as a sanitizer when laundering linens for the dietary department and the housekeeping department.
*Housekeeping mops and cleaning towels used for cleaning all areas of the hospital were laundered in the same wash machine as the towels and aprons from the dietary department.
*He was not aware Triax did not provide a sanitizing step when used in laundry.
Tag No.: C0280
Based on observation, interview, and record review, the provider failed to ensure surgical and emergency department (ED) policies and procedure manuals were updated on an annual basis. Findings include:
1. Interview on 6/23/10 at 10:20 a.m. with the administrator, nurse manager, and infection control coordinator (ICC) revealed the surgical policies and procedure manuals had not been annually updated and did not include polices relating to:
*Infection control.
*Sterilization/disinfection of instruments and equipment.
*Maintenance and housekeeping procedures specific to the surgical department.
Further interview with the above mentioned administrative staff confirmed there were three surgical policy and procedure manuals and one of those manuals last revised in 1977.
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2. Interview on 6/23/10 at 9:15 a.m. with the nurse manager revealed she was not aware of a policy and procedures manual specific to the ED. She stated all ED policies and procedures would be in the nursing services policy and procedure manual.
Review of the nursing services policy and procedures manual revealed no policies and procedures specific to the ED.
Observation on 6/23/10 at 9:45 a.m. of one of the two emergency treatment rooms revealed a binder with an ED policy and procedure manual dated 1985. That manual had last been reviewed in 2007.
Tag No.: C0304
Based on record review and interview, the provider failed to ensure an admission consent form for treatment was completed for 6 of 14 sampled medical patients (3, 7, 8, 9, 13, and 33) reviewed. Findings include:
1. Review of patient 3, 7, 8, 9, 13, and 33's medical records revealed all those patients had been admitted to the hospital without an admission consent for treatment completed.
Interview with the medical records director on 6/22/10 at 11:15 a.m. confirmed the above patients had been admitted without admission consent forms for treatment completed. She stated medical records had just been made aware of the problem recently when an audit had been completed. She stated when the admission process changed to an electronic process the admission consent had been overlooked. She confirmed their current admission policy did not address the completion of an admission consent form for treatment.
Tag No.: C0320
Based on interview, record review, and policy review, the provider fail to:
*Have infection control, sterilization/disinfection, personnel, and housekeeping policies and procedures specific to the surgical care area.
*Inspect and maintain two autoclaves per the manufacturer's guidelines.
*Have a quality assurance program specific to the surgical care area.
*Have current job descriptions for operating room and sterilization staff.
Findings include:
1. Initial tour on 6/21/10 at 4:30 p.m. of the surgical care area revealed:
*Currently gastrointestinal (GI) scopes and eye procedures were the only procedures performed in the operating room.
*Four to eight GI scopes were performed one day a month.
*Four to eight eye procedures were performed one day a month.
Interview on 6/22/10 at 2:20 p.m. with sterilization aide 1 revealed:
*She did the sterilization for the eye procedures and for some of the floor supply.
*She was normally a dietary staff person, but she did sterilization a few hours a month.
*The provider had two autoclaves. The older of the two was an M11 UltraClave, and the newer of the two was a Tuttnauer. Both were used by sterilization staff for processing surgical instruments and equipment.
*She was not aware if anyone monitored, inspected, or tested the autoclaves on a regular basis.
*She did the basic cleaning of the autoclaves but did not keep any records as to what she cleaned or how often.
*She did the biological testing of the autoclaves but was not sure what to do if the autoclaves tested out of the normal parameters.
*She was not aware of the term flash sterilization when asked about it. However, when asked more questions about it, she identified flash sterilization as uncovered sterilization.
*She stated she did uncovered/flash sterilization up to six times on an eye procedure day, as the physician only brought two sets of instruments with him on procedure days.
*She was not sure how many times it would be recommended for instruments to be flash sterilized during a procedure day.
*She was not aware of any provider policies and procedures related to sterilization or specific to flash sterilization.
*She was not aware of any provider policies and procedures related to infection control in the surgical or sterilization area.
*She cleaned the operating room one to three days prior to procedures and also between cases on the operating day, but she was not aware of any policies or procedures related to cleaning of the operating room.
Interview on 6/22/10 at 4:00 p.m. with the nurse manager (NM) and the administrator regarding surgical services revealed:
*The NM had oversight of the operating room.
*Three personnel did sterilization in the facility, and neither of them were sure of the qualifications of those three personnel.
*They were currently unsure if the infection control coordinator for the facility was involved in the surgical area infection control processes.
*They were currently unable to identify any policies and procedures related to infection control for the surgical area.
*They were currently unable to identify any policies and procedures related to the monitoring, surveillance, or maintenance of the sterilization equipment.
*They were currently not aware of records/logs being kept on cleaning or maintenance of the autoclaves.
*The NM was not familiar with the entire sterilization process.
*They were currently unable to identify any current housekeeping policies and procedures for the surgical area.
Interview and record review on 6/23/10 at 9:10 a.m. with the director of human resources regarding sterilization staff qualifications revealed:
*No current job descriptions existed for surgical and sterilization staff.
*All three of the staff currently performing sterilization duties had been trained by the provider with on-the-job training (OJT).
*The provider had no records of the OJT of the three sterilization staff.
*No sterilization training program existed.
*Competencies did not exist for the sterilization staff.
*No annual training was provided to sterilization staff.
*She estimated the three sterilization staff worked roughly three to four hours each per month in sterilization.
*The three sterilization staff were cross-trained, and they normally worked in dietary, laboratory, and the patient care floor areas. None of the three staff were licensed health care providers.
Interview on 6/23/10 at 9:30 a.m. with sterilization aide 2 revealed;
*She did the sterilization of floor supplies and GI scopes.
*She had received about 10 hours of OJT seven years ago and had not received any ongoing training in sterilization since that time.
*During her OJT she did not have to complete any competencies on what she had been taught.
*She did none of the cleaning or maintenance of the autoclaves. She stated that was the job of sterilization aide 1.
*She had not received any training on the newer Tuttnauer autoclave. She and the other sterilization staff had been just figuring it out as they went along.
*She was not aware if the provider had any surgical or sterilization policies or procedures.
Interview on 6/23/10 at 9:55 a.m. with sterilization aide 1 revealed:
*She had received about twenty six hours of OJT three years ago and had not received any ongoing training in sterilization since that time.
*During her OJT she did not have to complete any competencies on what she had been taught.
*She had not received any training on the newer Tuttnauer autoclave. She and the other sterilization staff had been just figuring it out as they went along.
*She agreed cleaning and maintenance of the newer Tuttnauer autoclave had not been completed as per the manufacturer's operations and maintenance manual. In fact she had just submitted the manual last week to the director of patient services for advice about care of the autoclave.
*She was unsure how long the new Tuttnauer autoclave had been in use without maintenance and testing.
Interview, record review, and policy review on 6/23/10 at 10:20 a.m. with the administrator, director of patient services, NM, infection control coordinator (ICC), and maintenance/housekeeping supervisor regarding the surgical area revealed:
*Infection control processes were not reviewed for the surgical area by the ICC, surgical staff, or administrative staff.
*All agreed they did not have current and adequate infection control, sterilization/disinfection, personnel, and housekeeping policies and procedures specific to the surgical care area.
*No infection rate data of any kind was being collected.
*The newer Tuttnauer autoclave had been purchased a year or more ago. Staff had received no training of any kind on that machine prior to it being put into use or since then.
*Maintenance and biomed only looked at the two autoclaves when they were broken, and the provider had no maintenance records/logs for either of them.
*All agreed all of the autoclaves had not been maintained per the manufacturers guidelines.
*No data of any kind was being collected for the purpose of quality assurance.
*No quality assurance existed for the surgery department despite the surgery departments mission statement calling for it.
*All agreed no annual surgery specific training or competencies for the surgical and sterilization staff were offered.
*All agreed the provider did not have adequate job descriptions for surgical and sterilization staff.
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2. Interview on 6/23/10 at 7:50 a.m. with the ICC revealed she did not:
*Go into the OR.
*Swab the equipment for culture or spore testing.
*Review the surgical policies and procedures regarding infection control.
*Know anything about autoclave use or flash/uncovered sterilization.
*Know how often the OR was sanitized.
*Know what chemicals were used to sanitize the OR walls, floors, and equipment.
*Know how the gastrointestinal scopes were cleaned and stored.
*Know if the OR was cleaned between patients.
*Know if the patient care technicians knew to use bleach after a patient infected with clostridium difficile.
*Know who taught the three sterilization aides how to clean the OR, use the autoclaves, clean the gastrointestinal scopes, or to flash/uncovered sterilize surgical instruments.
*Do any follow-up on surgical cases to determine if a patient had developed an infection after their surgery.
Tag No.: C0336
Based on record review and interview, the provider failed to ensure their quality assurance (QA) program integrated their surgical services into their QA program for all surgical patients. Findings include:
1. Review of the quality assurance minutes dated 7/30/09, 12/1/09, and 2/25/10 revealed no documentation of any QA for surgical services. The QA minutes revealed the quality assurance performance improvement (QAPI) coordinator was the "gatekeeper." The QA minutes revealed each department head was responsible for selecting and monitoring the areas chosen for QA for their department.
Interview with the QAPI coordinator on 6/21/10 at 4:20 p.m. revealed she was the gatekeeper or in charge of QA. She revealed each department head determined what areas they would review for QA. The department heads would collect their data and report the results to QA quarterly. She revealed the infection control director had been completing a QA on handwashing.
Interview with the QAPI coordinator by phone on 6/23/10 at 10:45 a.m. revealed surgical services had not been integrated into their QA process. She revealed the nurse manager was in charge of surgical services. The nurse manager would be in charge of selecting areas to QA with surgical services. She stated there had been no follow-up QA with the cataract surgical patients.
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2. Interview, record review, and policy review on 6/23/10 at 10:20 a.m. with the administrator, director of patient services, nurse manager, infection control coordinator, and maintenance/housekeeping supervisor regarding the surgical area revealed:
*No data of any kind was being collected for the purpose of quality assurance.
*No quality assurance existed at all for the surgery department despite the surgery departments mission statement calling for it.