HospitalInspections.org

Based on review of policy, observation, and staff interview the Critical Access Hospital (CAH) failed to ensure staff maintained 6 of 15 oxygen tanks in a safe operating condition.

Failure to ensure staff secured all oxygen tanks in the CAH could potentially result in an oxygen tank being dropped to the floor resulting in a high pressure gas escaping from the broken valve opening and could potentially result in the cylinder moving about in a destructing uncontrollable manner resulting in injuries and harm.

Findings include:

1. Review of the policy titled, Safety dated 4/27/10, reads in part ...to ensure that compressed gas cylinders used within the CAH are maintained in a safe manner to protect staff, patients and visitors this policy will be enacted. All compressed gas cylinders must be maintained in an upright position and firmly secured in a stand whenever moved or used. Safe handling will be maintained at all times.

2. Observation on 9/15/15 at 8:15 AM, with Staff H, Maintenance Manager, showed a locked storage room that held 6 of 15 unsecured oxygen tanks. Staff H agreed staff failed to secure 6 of the oxygen tanks in a safe manner.

Based on observation, review of policy, manufacturer's instructions, and staff interview the Critical Access Hospital (CAH) failed to date the control solutions upon opening for use in the medical/surgical unit, emergency department (ED), infusion clinic and same day units. The CAH administrative staff reported a census of 2 current medical surgical patients, an average monthly census of 150 ED patients, 11 same day surgery patients and 33 infusion clinic patients.

Failure to ensure staff documented the opened date on the glucose control solution bottle could result in the use of glucose control solution beyond the 3 months after the glucose control solution was opened. The use of expired glucose control solution could potentially alter the performance of the Accu-Chek Aviva monitor and patient glucose test results.

Findings include:

1. Review of the policy titled, "Quality Control Testing" dated 2/9/12 included in part, "...Glucose control solutions are stable for 3 months after opening...The date the container is opened...should be written on the container..."

2. Review of the manufacturer's information titled, "Accu-Chek Aviva Blood Glucose Meter Owner's Booklet" included in part, "...Control Solutions...Write the date the bottle you open the bottle on the bottle label. The control solutions must be discarded 3 months from the date the bottle was opened or the "Use by" date on the bottle label, whichever comes first..."

3. Observations in the following areas showed staff failed to document an open date on glucose control solution bottles:

a. On 9/14/15 at 10:30 AM, in the medical/surgical unit,with Staff A; Chief Clinical Officer.

b. On 9/14/15 at 1:10 PM, with Staff B, Registered Nurse (RN) in the ED.

c. On 9/15/15 at 1:00 PM, with Staff C, RN for Infusion Clinic.

d. On 9/15/15 at 2:45 PM, with Staff G, RN in the same day surgery unit.

4. During an interview on 9/15/15 at 1:00 PM Staff I acknowledged the glucose control solution bottles in the infusion clinic did not show an opened date.

During an interview on 9/15/15 at 1:15 PM, with Staff D acknowledged the glucose control solution bottles in the medical/surgical unit did not show an opened date.

During an interview on 9/15/15 at 2:45 PM, with Staff F, RN in the ED acknowledged the glucose control solution bottles in the ED did not show an opened date.

During an interview on 9/15/15 at 1:15 PM, with Staff G acknowledged the glucose control solution bottles in the same day surgery unit did not show an opened date.

Based on review of policy, observation, and staff interview the Critical Access Hospital (CAH) Administrative staff failed to have a system in place to ensure all patient's confidential information contained in patient's medical records and on patient's x-ray films is limited to those individuals authorized as having a need to know.

Failure to have a system in place to ensure all patients confidential information contained in patient's medical records and on patient's x-ray films is limited to those individuals authorized as having a need to know could potentially result in unauthorized use of patient's personal information.

Findings include:

1. Review of policy titled, "Protected Health Information-Minimum Necessary Requirement" dated 3/19/15 stated in part, "...Need to Know Information Only- that information required by the employee in order to perform the duties assigned which may include portions of the medical record..."

2. During an interview and observation on 9/15/15 at 8:15 AM, with Staff H, Maintenance Manager, revealed 2 locked storage rooms in the basement. Observation showed one storage room contained approximately 100 boxes of patient records. Review of the patient medical records revealed patient names, their date of birth, and the patient addresses. The second storage room contained approximately 1500 binders of patient x-ray films. Review of the patient x-ray films revealed patient names, their date of birth, and the patient's addresses. The Maintenance Manager reported an electrical panel is located in the storage rooms that required the Maintenance Manager and 2 maintenance staff to have keys to access the 2 storage rooms. The Maintenance Manager verified both storage rooms contained patient medical records and patient x-ray films.

I. Based on review of policies, documents, manufacturer's information, personal files, AORN (Association of periOperating Room Nurses) guidelines, and staff interviews, the CAH Administrative staff failed to ensure:

1. The OR staff failed provide documentation of the Cidex OPA test results before the cleaning of each endoscope in accordance with the manufacturer's instructions.

3. The OR staff failed to mix Skylar Instr-Guard One Step enzymatic disinfectant solution in accordance with the manufacturer's information.

4. The OR staff failed to follow the Bowie Dick (A test used during sterilization of surgical instruments.) manufacturer's information to ensure the surgical instruments were properly sterilized.

5. The OR staff failed to manufacturer's information when using the Biological Indicator (used to monitor steam sterilization for the autoclave), a process used for sterilization of surgical instruments.

6. Administrative staff failed to ensure staff received training to clean and disinfect endoscopes, surgical instruments, and the sterilization process of surgical instruments in accordance with policies, manufacturer's instructions, and AORN guidelines.

The cumulative effect of these system failures and deficient practices resulted in an immediate jeopardy situation placing patients at risk of infection in the operating room. This resulted in the condition level deficiencies for Surgical Services.

II. During the recertification survey, the surveyors identified an Immediate Jeopardy (IJ) situation, a situation that placed the patients at risk for harm, related to Condition of Participation, Surgical Services.

The Administrative staff took action and put a corrective action plan in place and abated the Immediate Jeopardy prior to the exit date of the recertification survey. Condition level deficiencies remained for the Condition of Participation Surgical Services.

The corrective action plan abated the IJ and included in summary:

1. The Purchasing Manager purchased a new Biological system, Assure Accufast Biological Test that included Accufast test strips and an incubator to ensure staff performed accurate sterilization of the surgical instruments.

2. Staff will maintain documentation of all sterilization tests including the Bowie-Dick, the cleaning of endoscopes, testing and usage of Cidex OPA solution.

3. Manufacturer of the Assure Accufast Biological system, Bowie Dick, provided education for the Central Processing staff, Surgery Staff, and OR Manager to include proper technique, reading and documentation of the test result, and to ensure staff had an understanding of the procedures to follow if a Biological indicator fails.

4. Infection Control Practitioner provided education for the Central Processing staff, Surgery Staff, and OR Manager for the proper mixing of the Cidex OPA solution and use of the Cidex solution test strips before each disinfection of the endoscope and proper documentation of each test result to ensure staff were competent in the use of Cidex OPA solution and Cidex solution test strips.

5. Infection Control Practitioner provided education for the Central Processing staff, Surgery Staff, and OR Manager for the proper mixing procedures of the Skylar Instr-Guard One Step solution.

6. Manufacturer of the Olympus endoscopes provided education on the cleaning and disinfection of the endoscopes for the Central Processing staff, Surgery Staff, and OR Manager to ensure all staff understood and performed the proper techniques, documented and tracked the cleaning and disinfection of each endoscope.

7. The OR Manager removed all previously sterilized instruments and all endoscopes from use. The OR Manager cleaned and disinfected all endoscopes and re-sterilized all surgical instruments in accordance with the policies and manufacturer's information.

III. Based on observation, review of policies, documents, and staff interview the Critical Access Hospital (CAH) failed to ensure staff performed and documented the testing of the Cidex OPA before each use of the Cidex OPA solution to disinfect endoscopes.

Failure to ensure staff performed the Cidex Solution test and documented the results of the Cidex Solution test strips before each use of the Cidex OPA solution could potentially result in the use of inefficient Cidex OPA solution to disinfect "dirty" endoscopes. The use of inefficient Cidex OPA solution could potentially result in microorganisms remaining on the endoscopes and result in cross contamination between patients causing severe illness or death. The CAH performed more than 1 patient's colonoscopy procedure on 6 of 21 days from 6/15/15 through 9/16/15. (6/15/15, 7/16/15, 7/23/15, 8/6/15, 8/17/15, and 9/3/15)

Findings include:

1. Review of the CAH policy titled, "Cleaning, Storage and Disinfection of Colonoscopy", Reviewed 7/2015, failed to provide guidance for staff to perform and document the results of the Cidex Solution test before each use of the Cidex OPA solution.

2. Review of the manufacturer's information titled, "How to use Cidex OPA Solution " dated 2009 stated in part, "...4. Test: It is recommended that Cidex OPA Solution be test before each usage with Cidex OPA test strips to verify that the appropriate concentration is present..."

Review of the manufacturer's information titled, "Cidex Solution Test Strips", undated stated in part, "...Why should you test your CIDEX solution? To ensure each CIDEX solution efficiently destroys 100% of Mycobacterium tuberculosis, the minimum effective concentration (MEC) required for high level disinfection should be tested with the appropriate CIDEX solution test strip prior to each use..."

3. Review of the AORN (Association of periOperative Registered Nurses) guidelines, titled, Guideline for Cleaning and Processing Flexible Endoscopes and Endoscopes Accessories" 2015 Guidelines for periOperative Practice AORN, stated in part, "...endoscopes, by virtue of the body cavities in which they are used, acquire high levels of microbial contamination during each use. Failure to completely follow the cleaning process, beginning with pre-cleaning, has shown to cause inadequate decontamination leading to patients exposed to infectious agents...The presence of organic materials (blood and body fluids)...pre-cleaning reduces the likelihood of the formation of biofilms, which contain...microorganisms..."

4. Review of the OR Log Report dated 6/15/15 through 9/16/15 showed on some of the days the OR staff performed more than one patient's colonoscopy procedure. Review of patient medical records revealed the following:

Patient #9 and #18 colonoscopy performed on 6/15/15

Patient #8 and #9 colonoscopy performed on 7/16/15.

Patient #10 and #11 colonoscopy performed on 7/23/15.

Patient #12 and #13 colonoscopy performed on 8/6/15.

Patient #14 and #15 colonoscopy performed on 8/17/15.

Patient #16 and #17 colonoscopy performed on 9/3/15.

5. During an interview on 9/15/15 at 11:10 AM, Central Processing Technician reported she documented the testing of the Cidex OP solution. Review of the document showed one "P" for each day the test was performed. Central Processing Technician reported the "P" indicated the Cidex OPA solution efficiently passed the Cidex OPA test. The document lacked documented evidence to show staff performed the Cidex Solution test between each endoscope cleaned and disinfected on 6/15/15, 7/16/15, 7/23/15, 8/6/15, 8/17/15, and/or 9/3/15 when staff cleaned and disinfected more than one endoscope after the patient's colonoscopy procedures on those dates.

During an interview on 9/16/15 at 9:05 AM, the Operating Room Manager reported the CAH OR staff followed the AORN Guidelines.

During an interview on 9/17/15 at 2:30 PM the Operating Room Manager agreed documentation failed to show staff performed the Cidex Solution test for the Cidex OPA solution before staff cleaned and disinfected a "dirty" endoscope to determine if the Cidex OPA solution was effective on the days when more than one colonoscopy procedure is performed.

IV. Based on observation, review of policies, procedures, manufacturer's information, and staff interviews, the CAH failed to ensure OR staff mixed Skylar Instr-Guard One Step enzymatic disinfectant solution in accordance with the manufacturer's information.

Failure to ensure OR staff mixed the Skylar Instr-Guard One Step enzymatic disinfectant solution in accordance with the manufacturer's information could potentially result in bacteria remaining on surgical instruments and could potentially result in cross contamination between patients, severe illness, and/or death.

Findings include:

1. Review of policy titled, "Solutions Used for Cleaning and Disinfection Mixing and Dilution Instruction" undated, Lacked documented instructions for staff to mix Skylar Instr-Guard One Step to obtain an efficient final concentration.


2. Review of manufacturer's information titled, "Sklyar Instr-Guard One Step" stated in part, "...Manual Cleaning: One ounce of Skylar Instr-Guard One Step to one gallon of warm water..."

3. During an interview on 9/15/15 at 11:10 AM, the Central Processing Technician reported she did not measure the Skylar Instr-Guard One Step enzymatic disinfectant solution or water to ensure the final concentration is correct in accordance with the policies and manufacturer's information.

V. Based on observation policies, manufacturer's information, and staff interviews the OR staff failed to follow the manufacturer's instructions to perform the Bowie Dick (This test verifies that the sterilizer's vacuum phase is removing a sufficient amount of air prior to the introduction of steam into the chamber.) The CAH preformed 183 surgical procedures from 9/1/14 to 9/15/15.
Failure to ensure OR staff followed the manufacturer's instructions to perform the Bowie Dick test could potentially result in ineffective vacuum system of a pre-vacuum sterilizer.

Findings include:

1. Review of policy titled Steam Sterilizer Test Record (Bowie Dick Test), with a review date of 8/15 reads in part ...7. The completed tests will be placed on spindle next to autoclave.

2. Review of manufacturer's document titled, "Getinge Assure SMART Test Pack (Bowie Dick Test)/Getinge Infection Control" dated 9/15/15, stated in part "... various uneven distribution of color and various color tests that labeled test failed..."

3. Review of the AORN Guidelines, 2015 Edition stated in part, "...For sterilizer qualification testing (Dynamic air-removal sterilizers only), should be run within a test pack after sterilizer installation, relocation, malfunction, major repair or sterilization process failure; test should be run three times consecutively in an empty chamber after biological indicator (BI) tests..."

4. Observation on 9/15/15 at 11:10 AM, in the sterilization room in the OR showed a Bowie Dick Test processed on 9/15/15. Observation showed an uneven color distribution on the test.

5. During an interview on 9/15/15 at 2:07 PM, when asked why the Bowie Dick test result showed an uneven color distribution after the test was processed, the Central Processing Technician reported the discolored test was because the autoclave procedure ran on the flash cycle. The Central Processing Technician reported that was the wrong cycle, however, it was acceptable due to the center of the test area showed it was pink in color. The Central Processing Technician reported she accepted this same result in the past. The Central Processing Technician reported she placed the Bowie Dick test on the bottom rack over the drain at the start of each day. When asked if the Bowie Dick test results were maintained the Central Processing Technician reported she discarded the Bowie Dick test results and no record is kept.

During an interview on 9/16/15 at 9:05 AM, the OR Manager acknowledged the staff failed to save the Bowie Dick test results, and agreed the first Bowie Dick test performed on 9/15/15 failed because of the uneven color distribution test result. The OR Manager reported the CAH followed AORN guidelines.

During an interview on 9/16/15 at 3:05 PM, the Operating Room Manager, reported in accordance to the manufacturer's representative e-mail an uneven distribution of color from the 1st Bowie Dick run on 9/15/15 would be a failed test.

VI. Based on observation, review of policies, manufacturer's instructions, and staff interviews, the OR staff failed follow manufacturer's information to perform the Biological Indicator test. The CAH preformed 183 surgical procedures from 9/1/14 to 9/15/15.

Failure to ensure OR staff followed the manufacturer's instructions for the proper preparation and placement of the Biological Indicator test in the autoclave could potentially result in the inability to ensure autoclave temperatures were adequate for the sterilization procedure to ensure surgical instruments/equipment were effectively processed to kill microorganisms and bacterial spores, resulting in severe illness and/or death.

Findings include:

1. Review of policy titled, "Biological Monitoring of Steam Sterilization" dated 7/2015 stated in part, "...3. Test pack-on of the following: a. Indicator placed in linen pack..."

2. Review of the manufacturer's information titled, "Professional Education and Training" dated February 2011 stated in part, "...Components: One or more BI (Biological Indicators), Sixteen clean, preconditioned, reusable or absorbent surgical towels, in good condition, each approximately 16 in x 26 in. Preparation: Fold each towel lengthwise into thirds and then fold widthwise in the middle. Stack towels one on top of another, with folds opposite each other, to form a stack that is approximately 9 in wide 9 in long and 6 in high. Place BI between the eighth and ninth towels in the approximate geometric center of the pack..."

3. During an interview on 9/15/15 at 11:10 AM, the Central Processing Technician reported a biological indicator is in each load of the autoclave and is placed under some layers of gowns and drapes in a wrapped package on the bottom rack of the autoclave above the drain.

4. During an interview on 9/16/15 at 3:45 PM, the OR Manager, reported the biological indicator is put into a pack containing 6 towels, 2 cloth drapes 54 x 54, and doubled wrapped with cloth wrappers. The OR Manager stated, "I do not know exactly where indicator is placed in the pack." The OR Manager acknowledged the Central Processing Technician failed to prepare the Biological Indicator for the procedure in accordance with the policy and/or manufacturer's information.

VII. Based on review of personal file and staff interview the Administrative staff failed to ensure the OR staff received training to perform the sterilization of surgical instruments/equipment and cleaning and disinfection of the endoscopes. The CAH preformed 226 endoscope procedures and 183 surgical procedures from 9/1/14 to 9/15/15.

Failure to provide training for the OR staff responsible to perform the sterilization of surgical instruments/equipment and the cleaning and disinfection of endoscopes could potentially result in the lack of knowledge to perform all the procedures in accordance with polices, manufacturer's information, and AORN guidelines.

Findings include:

1. Review of Staff I's personal file lacked documented evidence of training for the sterilization of surgical instruments/equipment and cleaning and disinfection of endoscopes procedures

2. During an interview on 9/16/15 at 9:05 AM, the OR Manager reported Staff I lacked documentation of training. The OR Manager reported Staff I was trained on the job approximately 15 years ago. The OR Manager stated, "I am confident Staff I does a complete thorough job. I have failed to check on her practices, this is something I just did not think to do."

Based on review of documents, medical record, and staff interviews, the Critical Access Hospital (CAH) failed to ensure patients, skilled inpatient and outpatients, were informed of patient rights information regarding visitation rights including the ability to receive designated visitors, but not limited to a spouse, a domestic partner (including same-sex domestic partner) and another family member or friend for 2 of 2 current swing bed patients (Patients # 1 and 2), 5 of 5 closed swing bed patients (Patients #3, 4, 5, 6, and 7) and all outpatients. The CAH administrative staff reported a current census of 2 swing bed patients and approximately 901 outpatients a month receiving services.
Failure to provide all inpatients, skilled patients and outpatients, with patient rights information for visitation could potentially result in limiting/restricting access of visitors to patients that infringed on their right to have a support person present when they are provided any type of care services or treatment modalities.

Findings include:

1. Review of the policy titled "Visitor Policy" revised 12/2013 revealed in part, "...Policy; Loring Hospital patient (or support person) will have the right, subject to his or her consent, to receive visitors, whom he or she designates, including, but not limited to, a spouse, a domestic partner (including a same sex domestic partner), another family member or friend..."

2. Review of a document titled, "Swing Bed Program- Patient Bill of Rights" undated, (provided to swing bed patients on admit to the CAH), revealed a lack of documentation regarding his or her consent to receive visitors whom he or she designates, including but not limited to, a spouse, a domestic partner (including a same sex domestic partner), another family member or friend.

Review of a document titled, "Patient Rights and Responsibilities" undated, (provided to acute care patients and outpatients on admit to the CAH), revealed a lack of documentation regarding his or her consent to receive visitors whom he or she designates, including but not limited to, a spouse, a domestic partner (including a same sex domestic partner), another family member or friend

3. Review of documentation in Patient #1 and 2's, current skilled patients medical records, lacked documented evidence staff provided both patients with a copy of the Swing Bed Program- Patient Bill of Rights.

Review of documentation in Patient #3, 4, 5, 6, and 7's discharged skilled patient medical records, lacked documented evidence staff provided each of the patients with a copy of the Swing Bed Program- Patient Bill of Rights.

4. During an interview on 9/14/15 at 1:15 PM, Staff E, Registered Nurse, Discharge Planning acknowledged the Patient Rights provided to the inpatients and outpatients lacked the verbiage that identified a domestic partner (including a same sex domestic partner) in accordance with the CAH policy.