HospitalInspections.org

Based on document review, interview and observation, it was determined that the governing body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The governing body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Condition of Participation:

Cross reference: CFR 482.42 Infection Control

Based on observation made during a tour of the Booker Behavioral Health outpatient facility conducted at approximately 9:45 AM on 6/8/12, in the presence of Staff #11, it was determined that the facility failed to ensure proper notice of rights.

Findings include:

1. The facility's posting of Patient Rights was not present in the Pediatric Waiting Room.

2. This finding was confirmed by Staff #11.

Based on document review and staff interview on 6/7/12, it was determined that the facility failed to ensure that medications are administered in accordance with physician's orders.

Findings include:

1. Review of the electronic Medication Administration Record (eMAR), in Medical Record #25, revealed that Lisinopril 20mg (milligrams) was held on 6/6/12 at 9:00 AM. The reason for not administering the medication was not documented.

a. Upon interview, Staff #30 stated that the medication was held because the patient had a hemodialysis treatment.

b. The physician's order stated to hold for systolic blood pressure less than 100. The patient's blood pressure was recorded as 110/53.

c. There was no order to hold the medication prior to hemodialysis treatments.

d. Upon request, Staff #15 was unable to provide a facility policy indicating that blood pressure medications are to be held prior to hemodialysis.

Based on observation and document review conducted on 6/7/12, it was determined that the facility failed to ensure the implementation of policies and procedures addressing the identification of each patient prior to drug administration and proper handwashing during medication administration.

Findings include:

Reference #1: Facility policy titled "Patient Identification" states, "Policy ... Two consistent identifiers will be used in all care areas prior to administering medications ... Definitions: Meridian's approved patient identifiers are defined as follows: 1. For Adult & Pediatric Patients: Use the patient's first and last name and date of birth..."

Reference #2: Facility policy titled "Hand Washing and Hand Hygiene" states, "C. Hand Washing/Hand Hygiene Indications: Indications for hand washing and hand hygiene include, but are not limited to the following: ... 4. before preparing or administering medications..."

1. Staff #29 was observed not washing his/her hands prior to administering medications to Patient #26 at 10:40 AM.

2. During a medication pass observation conducted at 10:40 AM, Staff #29 was observed administering medications to Patient #26 without using the two identifiers, as referenced above. He/she scanned the patient's identification bracelet after administering the oral medications.

Based on observation, document review and staff interview conducted on 6/7/12, it was determined that the facility failed to ensure implementation of policies and procedures addressing the distribution of medications obtained through the automated dispensing machines (ADM).

Findings include:

Reference #1: Facility policy titled "Security, Handling, Storage, and Disposition of Medications" states, "Procedure ... If not administered to a patient, the medication, if intact and unadulterated, may be returned to the ADM [automated dispensing machines] machine or wasted as per ADM policy."

Referenced #2: Facility policy titled "Security, Handling, Storage, and Disposition of Medications" states, "Procedure ... If the medication to be administered is located in an (ADM), the nurse will remove one patient's medications at a time for patient safety. The medication should be moved to an approved storage area such as the patient medication cart or computer on wheels and securely stored until the medication is administered. This storage period between the (ADM) and administration of the medication to the patient should not be longer than 60 minutes ..."

1. On 6/7/12, the contents of 5 medication cassette drawers were compared with the Medication Administration Record (MAR). The following discrepancies were found:

a. Two (2) unit-dose tablets of Gabapentin 600mg were found in the cassette drawer for Patient #24. This medication is available to the nurse from the ADM. The administration times listed on the electronic MAR (eMAR) was 600mg at 09:00 and 21:00. It was recorded on the eMAR that the medication had not been administered on 6/7/12 at 09:00 because the patient was lethargic. There is a charting omission for the 6/6/12 at 21:00 administration. Neither dosage of medication had been returned to the ADM.

i. Upon interview, Staff #15 confirmed the above finding and stated that any medications that remained in the cassette during the delivery of medications to the cassettes by pharmacy personnel, at about 15:00, would be removed by the pharmacy technician and returned to the pharmacy. He/she confirmed that the pharmacy would not know from which patient's cassette, the medication had been removed, after being returned to pharmacy by the technician.

b. One (1) unit-dose tablet of Lisinopril 20mg was found in the cassette drawer for Patient #25. This medication is available to the nurse from the ADM. It was recorded on the eMAR that the medication had been administered on 6/7/12 at 09:00. The medication had been held on 6/6/12 at 09:00 due to low blood pressure. The dose that had not been administered on 6/6/12 at 09:00 had not been returned to the ADM and had not been removed by the pharmacy technician. This finding was confirmed by Staff #15.

c. At 11:45AM three (3) tablets of Amlodipine 7.5mg and one syringe of Lovenox 40mg were found in the medication cassette for Patient #27. These medications are available to the nurse from the ADM. The ADM record indicated that the medications had been removed from the ADM at 10:20 AM. The medications had not been removed from the ADM within 60 minutes of administration as required by the facility policy referenced above.

d. At 11:50 one (1) tablet of Ranolazine 500mg was found in the cassette drawer for Patient #28. It was recorded on the eMAR that the medication had been held on 6/6/12 at 17:00. Additionally, one (1) tablet of Risperidone 0.25mg was found in the medication cassette drawer. It was recorded on the eMAR that the medication had be held on 6/6/12 at 09:00. The medications had not been returned to the ADM and had not been removed by the pharmacy technician.

2. These findings were confirmed by Staff #15.

A. Based on observation, it was determined that the facility failed to ensure the hospital environment was maintained for the safety of patients.

Findings include:

1. On 6/8/12 at 10:45 AM, in the presence of Staff #36, the battery light in Operating Room (OR) #3 would not light.


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B. Based on observation and staff interview, it was determined that facility failed to clean and maintain walls, floors and equipment, to ensure a clean, safe and sanitary environment in surgical suites and sterile storage rooms.
Findings include:
1. On 6/7/12, In OR #3, the wall bumper guards were detached from the wall perimeters.

2. The door that separates the construction area from the active OR corridor/hallway was not tightly sealed/closed along the bottom edge.

3. In the Cysto Work Room, cabinets had exposed, unfinished wooden surfaces.

4. The ENT Equipment Room was cluttered with equipment.

5. The ENT Equipment Room had dust accumulation on sterile storage shelves.

Based on observation, staff interview, review of facility policies and procedures and equipment manufacturer's recommendations, it was determined that the facility failed to ensure hat all equipment are maintained to an acceptable level of safety and quality.
Findings include:
Reference #1: AAMI ST 79 section 7.2.2 on 'Manufacturer's instructions' state, "The written recommendations of the device manufacturer should always be followed. "

1. On 6/712 at 11:00 AM, a total of 4 'Laryngeal Mask Company Limited' Laryngeal masks were stored in locked OR anesthesia carts identified as #2 and #4. The manufacturer of 'Laryngeal Mask Company Limited' recommends "the masks are to be used a maximum of 40 times before being discarded. Continued use beyond the maximum times is not recommended as degradation of the components may result in impaired performance or abrupt failure of the device. Steam autoclave is the only method for sterilization." Staff #9 stated that he/she does not keep track of the number of usages for all reusable laryngeal masks.

2. On 6/7/12 at 11:00 AM, over five (5) laryngoscope blades were observed being stored in locked OR anesthesia carts. They were unlabelled in open and unprocessed peel packages. The care and maintenance instructions for 'Rusch' laryngoscope blades state, "Immediately after use, blades should be rinsed in clean tap water to remove any residue. The blades should then be gently scrubbed in soapy water with a soft brush to provide a thorough physical cleaning. After cleaning, thoroughly rinse the blade and dry thoroughly using a soft towel." Upon request, Staff #4 and #31 were unable to provide evidence to confirm that the blades had undergone proper decontamination and sterilization.

A. Based on observation, staff interview and review of facility documentation on June 7, 2012, it was determined that the facility failed to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. The infection control and prevention program failed to adequately implement the Association for the Advancement of Medical Instrumentation(AAMI) standards, selected by the facility, as indicated by Staff #9.

The Condition of Participation for Infection Control is not met.

Findings include:

1. The facility failed to implement nationally recognized infection control guidelines.

2. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases. (Cross refer to A0701.)

B. Based on observation, it was determined that the facility failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases where methods for processing reusable medical devices conform with Association for the Advancement of Medical Instrumentation(AAMI)ST79:2006 Comprehensive guide to Steam Sterilization and sterility assurance in health care facilities(ST 79 replaces and supercedes ST46 by consolidating ST 46 with 4 other AAMI standards [ST33, ST37, ST42, and ST35] approved 7/10/2009.)

Reference #1: AAMI Standard 79, section 3.3.7.1, Decontamination area indicates the area in which instruments and other devices are decontaminated should be physically separate from all other processing areas and from areas in where clean and sterile patient care procedures are carried out. Functional work areas should be physically separated to control contaminants.

1. There is no separation between soiled and clean equipment processes in the Medical Same Day Stay/Endoscopy department.

2. The two rooms identified as Decontamination, #1 and #2, function as combination soiled and clean processing rooms, as indicated by Staff #28, and can be accessed from the ORs at either side.

3. Staff #28 stated that a soiled to clean flow pattern is followed. However, two breeches in procedure were observed by the surveyor on June 6, 2012.

a. Staff #30 stated that reusable irrigation tubing is cleaned in the employee hand wash sink.

b. Staff #27 brought a soiled Cardiac TEE scope into the designated clean side.

Reference #2: AAMI Standard 79, section 6.3, Care and handling of contaminated reusable items at the point of use indicates; to prevent the formation of biofilm, definitive cleaning should occur as soon as possible. Biofilm is a biomass of bacteria that cannot be removed easily and is especially problematic in devices with lumens.

4. Laparoscopic instruments containing lumens are not always cleaned in a timely manner, allowing the potential for biofilm formation and potential contamination. The instruments are owned by the "Specialty Care Company" and leased to the medical center. The instruments are cleaned by Specialty Care staff.

5. Staff #31 indicated that instruments are not always cleaned and processed on the same day of surgery. He/she stated that instruments received after working hours are placed in 3 plastic totes containing clear tap water. Staff #31 indicated that instruments are cleaned the following morning.

Reference #3: AAMI Standard 79, section 7.2.2, Manufacturer's instructions indicates the written instructions of the device manufacturer should always be followed. If there are no specific instructions then the manufacturer should be contacted directly to provide a documented method.

6. Staff #27 was observed on June 6, 2012 transporting a Cardiac TEE scope from the OR into the room designated as Decontamination #2. He/she was observed using a terry cloth towel to hold and transport and then to wipe the soiled scope. He/she then placed the scope directly into the Cidex OPA soaking bucket without properly cleaning the scope. This is contrary to the manufacturer's instructions.

7. The Cidex OPA manufacturer instructions, for the manual disinfection of equipment, requires that the temperature of the solution be maintained at or above 68° F and should be monitored for temperature adherence. The manufacturer's instructions are not followed by the facility.

Reference #4: AAMI Standard 79, section 8.9.2, storage facilities indicate that sterile items should be stored so packaging is not crushed, bent, compressed, or punctured and so that their sterility is not otherwise compromised.

8. In the main sterile storage, numerous sterile peel packs of instruments, in white plastic buckets, were cramped and compressed, therefore providing a potential to compromise sterility of instruments.

9. Large trays and containers of surgical instruments were stacked, at least 4 high, in the bulk storage area, therefore providing a potential for sterility to be compromised.

10. In the medical supply room of Materials Management, supply carts for the storage of clean and sterile supplies, were soiled and dusty.


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Reference #5: AAMI ST 79 section 4.5.3 on 'Sterilization area(flash sterilization)' states, "personnel working in areas where items are flash sterilized should wear a liquid resistant face mask. Other protective and/or sterile attire might also be necessary depending on the method by which items are transferred from the sterilizer to the point of use."

11. On 6/7/12, based on interview with Staff #4, it was determined that 'Flashpak' container systems are utilized during flash sterilization in the OR suites. OR policies and procedures have not been developed regarding attire requirements and the proper handling and transport for flash sterilized items, for immediate use.

Reference # 6: Facility policy and procedure titled, 'Biological Indicators SPD' states, "Biological indicators are run with the 2nd load of the day and with all implantables."

12. On 6/7/12 at 1:45 PM, four (4) packages containing 'Teflon Orbital Plate,' all reprocessed on June 02, 2010, were observed stored in the ENT storage room. Based on interview with Staff #32, these devices were identified as implantable devices used during ENT procedures. Staff #9 stated that these devices were not previously identified as implantable devices, therefore biological monitoring tests were not conducted. A request was made to Staff #9, for the facility policies and procedures on the proper labeling and identification of implantable devices. Policies and procedures were not made available to the surveyor.

13. On 6/7/12 at 2:30 PM, the facility was notified of an immediate jeopardy (IJ) situation regarding the reprocessing of 'Teflon Orbital Plate' implantable devices. By 4:15 PM, a corrective action plan was submitted by the facility and accepted by the Department of Health. The IJ was therefore abated prior to the surveyors exiting the facility.

Based on document review and staff interview on 6/7/12, it was determined that the facility failed to ensure that medications are administered in accordance with physician's orders.

Findings include:

1. Review of the electronic Medication Administration Record (eMAR), in Medical Record #25, revealed that Lisinopril 20mg (milligrams) was held on 6/6/12 at 9:00 AM. The reason for not administering the medication was not documented.

a. Upon interview, Staff #30 stated that the medication was held because the patient had a hemodialysis treatment.

b. The physician's order stated to hold for systolic blood pressure less than 100. The patient's blood pressure was recorded as 110/53.

c. There was no order to hold the medication prior to hemodialysis treatments.

d. Upon request, Staff #15 was unable to provide a facility policy indicating that blood pressure medications are to be held prior to hemodialysis.

A. Based on observation, it was determined that the facility failed to ensure the hospital environment was maintained for the safety of patients.

Findings include:

1. On 6/8/12 at 10:45 AM, in the presence of Staff #36, the battery light in Operating Room (OR) #3 would not light.


18165

B. Based on observation and staff interview, it was determined that facility failed to clean and maintain walls, floors and equipment, to ensure a clean, safe and sanitary environment in surgical suites and sterile storage rooms.
Findings include:
1. On 6/7/12, In OR #3, the wall bumper guards were detached from the wall perimeters.

2. The door that separates the construction area from the active OR corridor/hallway was not tightly sealed/closed along the bottom edge.

3. In the Cysto Work Room, cabinets had exposed, unfinished wooden surfaces.

4. The ENT Equipment Room was cluttered with equipment.

5. The ENT Equipment Room had dust accumulation on sterile storage shelves.

A. Based on observation, staff interview and review of facility documentation on June 7, 2012, it was determined that the facility failed to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. The infection control and prevention program failed to adequately implement the Association for the Advancement of Medical Instrumentation(AAMI) standards, selected by the facility, as indicated by Staff #9.

The Condition of Participation for Infection Control is not met.

Findings include:

1. The facility failed to implement nationally recognized infection control guidelines.

2. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases. (Cross refer to A0701.)

B. Based on observation, it was determined that the facility failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases where methods for processing reusable medical devices conform with Association for the Advancement of Medical Instrumentation(AAMI)ST79:2006 Comprehensive guide to Steam Sterilization and sterility assurance in health care facilities(ST 79 replaces and supercedes ST46 by consolidating ST 46 with 4 other AAMI standards [ST33, ST37, ST42, and ST35] approved 7/10/2009.)

Reference #1: AAMI Standard 79, section 3.3.7.1, Decontamination area indicates the area in which instruments and other devices are decontaminated should be physically separate from all other processing areas and from areas in where clean and sterile patient care procedures are carried out. Functional work areas should be physically separated to control contaminants.

1. There is no separation between soiled and clean equipment processes in the Medical Same Day Stay/Endoscopy department.

2. The two rooms identified as Decontamination, #1 and #2, function as combination soiled and clean processing rooms, as indicated by Staff #28, and can be accessed from the ORs at either side.

3. Staff #28 stated that a soiled to clean flow pattern is followed. However, two breeches in procedure were observed by the surveyor on June 6, 2012.

a. Staff #30 stated that reusable irrigation tubing is cleaned in the employee hand wash sink.

b. Staff #27 brought a soiled Cardiac TEE scope into the designated clean side.

Reference #2: AAMI Standard 79, section 6.3, Care and handling of contaminated reusable items at the point of use indicates; to prevent the formation of biofilm, definitive cleaning should occur as soon as possible. Biofilm is a biomass of bacteria that cannot be removed easily and is especially problematic in devices with lumens.

4. Laparoscopic instruments containing lumens are not always cleaned in a timely manner, allowing the potential for biofilm formation and potential contamination. The instruments are owned by the "Specialty Care Company" and leased to the medical center. The instruments are cleaned by Specialty Care staff.

5. Staff #31 indicated that instruments are not always cleaned and processed on the same day of surgery. He/she stated that instruments received after working hours are placed in 3 plastic totes containing clear tap water. Staff #31 indicated that instruments are cleaned the following morning.

Reference #3: AAMI Standard 79, section 7.2.2, Manufacturer's instructions indicates the written instructions of the device manufacturer should always be followed. If there are no specific instructions then the manufacturer should be contacted directly to provide a documented method.

6. Staff #27 was observed on June 6, 2012 transporting a Cardiac TEE scope from the OR into the room designated as Decontamination #2. He/she was observed using a terry cloth towel to hold and transport and then to wipe the soiled scope. He/she then placed the scope directly into the Cidex OPA soaking bucket without properly cleaning the scope. This is contrary to the manufacturer's instructions.

7. The Cidex OPA manufacturer instructions, for the manual disinfection of equipment, requires that the temperature of the solution be maintained at or above 68° F and should be monitored for temperature adherence. The manufacturer's instructions are not followed by the facility.

Reference #4: AAMI Standard 79, section 8.9.2, storage facilities indicate that sterile items should be stored so packaging is not crushed, bent, compressed, or punctured and so that their sterility is not otherwise compromised.

8. In the main sterile storage, numerous sterile peel packs of instruments, in white plastic buckets, were cramped and compressed, therefore providing a potential to compromise sterility of instruments.

9. Large trays and containers of surgical instruments were stacked, at least 4 high, in the bulk storage area, therefore providing a potential for sterility to be compromised.

10. In the medical supply room of Materials Management, supply carts for the storage of clean and sterile supplies, were soiled and dusty.


18165


Reference #5: AAMI ST 79 section 4.5.3 on 'Sterilization area(flash sterilization)' states, "personnel working in areas where items are flash sterilized should wear a liquid resistant face mask. Other protective and/or sterile attire might also be necessary depending on the method by which items are transferred from the sterilizer to the point of use."

11. On 6/7/12, based on interview with Staff #4, it was determined that 'Flashpak' container systems are utilized during flash sterilization in the OR suites. OR policies and procedures have not been developed regarding attire requirements and the proper handling and transport for flash sterilized items, for immediate use.

Reference # 6: Facility policy and procedure titled, 'Biological Indicators SPD' states, "Biological indicators are run with the 2nd load of the day and with all implantables."

12. On 6/7/12 at 1:45 PM, four (4) packages containing 'Teflon Orbital Plate,' all reprocessed on June 02, 2010, were observed stored in the ENT storage room. Based on interview with Staff #32, these devices were identified as implantable devices used during ENT procedures. Staff #9 stated that these devices were not previously identified as implantable devices, therefore biological monitoring tests were not conducted. A request was made to Staff #9, for the facility policies and procedures on the proper labeling and identification of implantable devices. Policies and procedures were not made available to the surveyor.

13. On 6/7/12 at 2:30 PM, the facility was notified of an immediate jeopardy (IJ) situation regarding the reprocessing of 'Teflon Orbital Plate' implantable devices. By 4:15 PM, a corrective action plan was submitted by the facility and accepted by the Department of Health. The IJ was therefore abated prior to the surveyors exiting the facility.