The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

WAGONER COMMUNITY HOSPITAL 1200 WEST CHEROKEE STREET WAGONER, OK 74467 Feb. 8, 2018
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
Based on record review, interview and observation, the hospital failed to ensure:
A. Six of six (Staff #DD,E,EE,F,G and N) nursing staff had demonstrated competence or received education related to the care of pediatric patients.

This failed practice had the potential for three of three pediatric patients (#17, 21, and 22) admitted from the emergency department to the med-surg unit from 10/01/17 to 02/08/18 to have an increased risk of inappropriate care provided and adverse outcomes.


B. Six of six (Staff #DD,E,EE,F,G and N)nursing staff provided a safe environment appropriate for pediatric patients.

This failed practice had the potential for three of three pediatric patients (#17, 21 and 22) admitted from the
emergency department to the med-surg unit from 10/01/17 to 02/08/18 to have an in-
creased risk for harm.



Findings:
A. Competency and Education
Review of a hospital document titled "emergency room Log" showed three of three (#17, 21, and 22) pediatric patients were admitted to the medical-surgical unit from 10/01/17 to 02/08/18.

Review of three of three (#17, 21 and 22) pediatric patient medical records showed no documentation of the use of a buretrol (intravenous volume control chamber). Despite the use of an infusion pump, the lack of a buretrol had the potential for accidental bolus of fluid or medication and resulted in increased risk of serious adverse health outcomes for the three (#17, 21 and 22) pediatric patients who received intravenous infusions.

Review of a hospital policy titled "Ages of Population Served in Nursing Departments" showed pediatric patients under the age of 12 years to less than 12 months were a major population of patients admitted to the Med-Surg unit and seen in the Emergency Department.

Review of six of six(staff #DD, E, EE, F, G and N) nursing personnel files showed no pediatric competencies or
education.

On 02/06/18 at 12:00 pm, in the emergency department, Staff DD stated he/she had cared for pediatric patients regularly, had not received education from or demonstrated competencies to the hospital and was not aware of pediatric policies at the hospital.

On 02/07/18 at 10:45 am, in the nurse's station, Staff E stated he/she had cared for pediatric patients in the hospital, was currently caring for patient #21(three year old), and had not received education from or demonstrated competencies in the care of pediatric patients to the hospital. Staff E further stated he/she did not know hospital policy regarding pediatric IV (intravenous) therapy and that he/she would use a buretrol (intravenous volume control chamber) with patients less than ten years of age.

On 02/08/18 at 9:15 am, in the nurses' station, Staff E stated although she did not have prior experience with a buretrol (intravenous volume control chamber) she was currently using one for patient #21.

On 02/08/18 at 9:30 am, in the nurses' station, Staff A stated education for nursing was done by Staff G, but it was workload dependent and had not been done. Staff A further stated nursing staff did not have pediatric competencies or education.

On 02/08/18 at 9:30 am, in the nurses' station, Staff G stated he/she had not been able to educate nursing staff due to workload.


B. Safe pediatric environment

Review of hospital nursing policy "Pediatric Physical and Social Environment" showed children under the age of six would have electrical outlet protectors or tape over the outlets and tape over the bed controls.

On 02/06/18 at 12:00 pm, in the emergency department, Staff DD stated he/she cared for pediatric patients regularly, had not received education from or demonstrated competencies in the care of pediatric patients to the hospital and was not aware of pediatric policies at the hospital.

On 02/07/18 at 9:15 am, surveyors observed no electrical outlet protectors or tape over the electrical outlets or patient #21's bed control.

On 02/07/18 at 10:45 am, in the nurses' station, Staff E stated he/she had not received education from or demonstrated competencies in the care of pediatric patients at the hospital.

On 02/08/18 at 9:30 am, Staff A stated education for nursing was done by Staff G, but it was workload dependent and had not been done. Staff A further stated nursing staff did not have pediatric competencies or education.

On 02/08/18 at 9:30 am, Staff G stated he/she had not been able to educate nursing staff due to workload.
VIOLATION: SUPERVISION OF CONTRACT STAFF Tag No: A0398
Based on record review and interview the hospital failed to ensure:

A. One (Staff HH) of two agency (non-employed) nursing staff were oriented to hospital policies and procedures before providing patient care.

B. The Director of Nursing oriented and evaluated the competency before one (Staff HH) of two agency nursing staff before they provided care.

These failed practices increased the risk to patient safety provided by agency staff who were not oriented to practices and procedures and could lead to adverse patient outcomes.

Findings:

Review of hospital policy titled "Agency Nurses" showed agency nursing staff should have evidence of a "checklist of skills competencies" and documentation of current clinical competencies for the assigned patient care area. Each agency nurse should be provided a packet of orientation information that includes a hospital policy and procedure manual.

Review of one (Staff #HH) of two agency staff files reviewed showed he/she had no evidence of completion and acknowledgment for review of the hospital's policies and procedures (manual) and a checklist and documentation of his/her clinical competencies provided by the agency per hospital policy.

On 02/08/18 at 11:46 am, Staff A stated agency staff are required to read and complete and acknowledgement form. Staff A stated the hospital provided a packet of information that includes the hospital's policies and procedures that contract staff should review and sign an acknowledgment form of completion. Staff A stated the acknowledgement form would be provided by the agency prior to agency staff providing patient care.
VIOLATION: CONTENT OF RECORD Tag No: A0449
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on records review and interview the hospital failed to ensure the EMR reflected sufficient documentation of the interventions, assessments, treatments and patient's responses to demonstrate the patient's progress and any changes in condition for three (Patient #4, 10, and 11) of 23 medical records reviewed.

This failed practice resulted in the delay in patient care decisions for one patient (Patient #11) of 23 patients being admitted to the mental health unit prior to medical stabilization and potential risk to all patients due to the unavailability of pertinent information to make timely medical and nursing decisions.

Findings:

Review of hospital document titled "Medical Staff Rules and Regulations" showed documentation in progress notes were to be completed at time of observation, be sufficient to support continuity of care, identify clinical problems correlated with specific orders (when possible).

Review of hospital policy titled "Chart Documentation" showed the patient's EMR were a method of communication utilized among health care providers regarding the status of a patient and documentation for continuity of care using the nursing process.

Review of hospital policy titled "Charting" showed the patient's EMR provided documentation of the patient's care and treatment during their stay. The EMR reflected all observations, complaints and/or subjective symptoms identified. Notification of physician were documented in the EMR including the abnormal findings or pertinent events.

Patient #4 a [AGE] year old female admitted to the hospital for complaints of abdominal pain, nausea and diarrhea. Electrolyte abnormalities of potassium (K+) of 2.9mEq/L (normal 3.5 to 5.0mEq/Liter) and acute renal injury were noted on admission. A consult note dated 10/06/17 and progress note dated 10/07/17 by the nephrologist did not include identification of clinical problems and specific treatment or orders under "Assessment & Plan".

Patient #10 a [AGE] year old female admitted to the hospital for an elevated INR (international normalized ratio - standardized measure used to determine how long it takes a patient's blood to clot and determines the effectiveness of anticoagulants [blood-thinners] on blood clotting), complaints of weight loss and fatigue. Electrolyte abnormalities of low K+, calcium and magnesium levels, and ECG (electrocardiogram - test showing the electrical activity of the heart) showing [DIAGNOSES REDACTED]were noted on admission. On 09/30/ 17 progress note by primary physician did not include an objective assessment, identification of clinical problems and specific treatment or orders under "Assessment & Plan".

Patient # 11 a [AGE] year old female who arrived in the ED for suicide attempt by overdose with 110 Oxycodone, and an unknown amount of Tylenol and Aspirin. Patient was admitted to the medical-surgical unit from the ED for treatment of hypokalemia secondary to a serum K+ level of 2.9. Patient had a urine drug screen positive for opioids, benzodiazepines and marijuana. On admission to medical-surgical unit the patient was lethargic and hypoxic (inadequate oxygen in the blood). The patient subsequently transferred to the mental health unit and remained lethargic and hypoxic requiring transfer back to the ED and transfer to an outside facility offering a higher level of care. The patient's electronic medical record showed no evidence of documentation for:

A. Patient's initial respiratory rate, oxygen saturation and to what level both decreased warranting the need for oxygen after the patient's oxygen saturation decreased to 88% and patient became lethargic and observed stumbling from the bathroom.

B. Interventions taken, including notification of the ED physician, after the placement of the non-rebreather mask in an attempt to increase the patient's oxygen saturation.

C. Vital signs including respiratory rate and oxygen saturation after receiving a dose of Narcan (medication used to block the effects of opioids, especially in an overdose)


D. Monitoring of the patient's medical status after receiving Narcan to determine stability of the patient's neurological and respiratory status.

E. After movement of the patient to the medical surgical unit for continued treatment of electrolyte imbalance, interventions taken for the patient's respiratory rate of six, decreased oxygen saturation of 64%, and periods of apnea. The medical record showed the charge nurse notified and a respirator obtained and a mask placed.

F. Stabilization of the patient's respiratory status prior to transfer to the mental health unit for treatment for suicidal ideation.

G. Notification of physician and interventions taken when patient had changes in neurological and respiratory status included: slow to respond to questions, increased lethargy, pupillary changes, vital signs, and oxygen saturation.

H. Hematoma to head, bruising to head, continuing severe headache and/or altercation that occurred in the ED on first night with police officers as noted by second ED physician.


On 02/08/18 at 9:16 am, Staff H stated Patient #11 initially admitted to the medical-surgical unit where he/she were assigned as the patient's nurse. Staff H stated the hospital had trouble with the EMR program Athena dropping or losing documentation and did not capture his/her documentation of Patient #11's condition including vital signs, assessment and oxygen saturation changes. Staff H reported he/she had trouble maintaining Patient #11 oxygen saturations initially because the oxygen not hooked up to the wall. Staff H stated once Patient #11's oxygen hooked up, he/she began to stabilize and were stable prior to transfer to the mental health unit. Staff H stated he/she reported the lost documentation on Patient #11 to the charge nurse on duty and Staff A.

On 02/08/18 at 11:46 am, Staff A stated leadership had reviewed why Athena (EMR program) lost or "dropped" nursing and physician documentation in a patient's electronic medical record. Staff A stated there had not been an identified pattern and had been random. Staff A stated hospital staff had reported they had charted and then the documentation would just randomly drop or be lost from the patient's chart. Staff A reported the issue had not been identified to a time of day or specific person. Staff A stated the hospital had identified the lost documentation in the EMR as an ongoing issue since implementation of the new EMR in August of 2017 but had not completed incident reports for each of these events.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
Based on record review and interview the hospital failed to ensure entries into the patient's electronic medical record (EMR) contained date and time, and they were signed or authenticated by the Registered Nurse (RN) responsible for supervising and evaluating the care provided by the Licensed Practical Nurse (LPN) for 11 (Patient #1, 2, 3, 4, 7, 8, 9, 10, 11, 12, and 13) of 23 EMR charts reviewed.

This failed practice resulted in the increased risk for inadequate assessment, delay in recognition and patient change in condition reported to health care providers for one patient (Patient #11) who transferred from ED to medical surgical unit and then the mental health unit while unstable, and the potential increased risk of inadequate assessment and delayed recognition of patient change in condition for all patients.

Findings:

Review of hospital policy titled "Charting" showed entries should be complete and accurate. Documentation should include treatments and activities performed and patient responses. An RN is responsible for the completion and documentation of a patient's initial admission assessment and documentation within four hours of admit. Changes in patient condition should be documented and physician notified.

The "Oklahoma Nursing Practice Act" defines the scope of practice for an LPN includes:
A. Contributing to assessment of health status of individuals and groups.
B. Participating in the evaluation of responses to interventions.

Eleven (Patient #1, 2, 3, 4, 7, 8, 9, 10, 11, 12, and 13) of 23 medical records reviewed showed no evidence the RN signed or authenticated the assessments completed by the LPN to ensure the RN responsible for the care of the patient were in concurrence with the LPN.

Seven (Patient #1, 2, 3, 4, 7, 8, and 9) of 23 medical records reviewed showed the case manager discharge planning visit were titled as a "nursing assessment" and completed by an LPN with no evidence of the RN signature or authentication of the assessments.

Six (Patient #3, 7, 8, 9, 10, and 11) of 23 medical records reviewed showed the RN had not perform and documented the patient's initial admission assessment per hospital policy.

On 02/08/18 at 10:02 am, Staff G stated the charge nurse were responsible for supervising the LPN during their shift and the charge nurse generally reviewed the LPN's assessments and shift notes as they were done unless it was busy, then he/she would do it at the end of shift and discuss any differences with the LPN. Staff G stated the current EMR program Athena does not have a place for the RN to co-sign or authenticate the LPN's assessments. Staff G stated the RNs were responsible for the admission assessment of the patient.

On 02/08/18 at 12:17 pm, Staff B stated the EMR does not have a co-sign the RN to sign after the LPN's assessment. Staff B stated the hospital had made requests to the company support for Athena regarding the inability of RN to authenticate or co-sign for the LPN for assessments. Staff B stated he/she had discussed with support personnel for Athena regarding adding an electronic signature similar to the electronic signature for physicians when co-signing for mid-level providers and students and had not received a "fix" yet.
VIOLATION: CONTENT OF RECORD - OTHER INFORMATION Tag No: A0467
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review and interview the hospital failed to ensure healthcare providers completed documented information into the patient's EMR necessary for patient safety, quality of care and continuity of care among providers for three (Patient #4, 7, and 9) of 23 medical records reviewed .

This failed practice had the potential for an increased risk of unavailability of pertinent information to make timely medical and nursing decisions among health care providers and adverse health outcomes for three (Patient #4, 7, and 9) of 23 patients.

Findings:

A review of hospital policy titled "Charting" showed all medications and treatments rendered must be documented. The policy showed no evidence regarding how medications were documented including documentation of medications at the time they were administered, IV medication start and stop times to identify the run time and when medications were not given to document a reason for why the medication not given and notification of the physician if indicated.

A review of hospital protocol titled "Adult Electrolyte Replacement Protocols" showed intravenous (IV) replacement of potassium (K+) through peripheral line were as follows:
A. K+ level - 3.6 to 3.9mEq/L - administer 10mEq IV over one hour x two - no additional monitoring needed
B. K+ level - 3.4 to 3.5mEq/L - administer 10mEq IV over one hour x three - no additional monitoring needed
C. K+ level - 3.1 to 3.3mEq/L - administer 10mEq IV over one hour x four - recheck serum K+ level two hours after infusion complete
D. K+ level - 2.6 to 3.0 mEq/L - administer 10mEq IV over one hour x five - recheck serum K+ level two hours after infusion complete
E. K+ level - 2.3 to 2.5mEq/L - administer 10mEq IV over one hour x six - recheck serum K+ level two hours after infusion complete
F. K+ level - less than 2.3mEq/L - call physician AND 10mEq IV over one hour x six - recheck serum K+ level two hours after infusion complete

A review of hospital policy "Potassium I.V. Administration" showed normal serum K+ were 3.5-5mEq/Liter. IV administration were indicated when oral therapy were not feasible. Cardiac arrhythmias and death can result from administration of K+. IV K+ could be administered on the medical-surgical unit with telemetry monitoring when serum K+ levels were greater than 2.0mEq/L. Dosage should not exceed 10mEq/100mL and given at a rate not to exceed 10mEq/hour. Prepared IV K+ solutions are not available anywhere except the pharmacy and only dispensed one at a time.

Patient #4 a [AGE] year old female admitted for complaints of abdominal pain, nausea and diarrhea. Electrolyte abnormalities with a K+ of 2.9 mEq/L and acute renal injury were noted on admission. There were six individual orders for "Potassium Chloride IV 10mEq once" at 10:13 am. No evidence in the EMR of the following:
A. K+ were ordered to be given in an IV solution.
B. Given at a controlled rate not to exceed 10 mEq/L per hour.
C. Use of telemetry per hospital policy.
D. Administered at a minimum of one hour intervals per hospital policy and protocol.

Patient #7 a [AGE] year old female admitted for altered mental status, dehydration and rhabdomyolysis. During admission the patient's K+ decreased to 2.9 and a series of six orders for K+ was placed (K+ 10mEq in 100mL NS IV 0.9% 100mL for 1/hour once). Last dose were documented as "not administered". No evidence in the EMR of the following:
A. Reason for why last dose of K+ were not administered.
B. Notifying physician patient had not received last dose of K+, or
C. Order from physician not to give last dose of K+.
D. Use of telemetry per hospital policy.

Patient #9 a [AGE] year old female admitted with complaints of chest pain, abdominal pain and diarrhea. Patient had a low K+ of 3.0 and a two series of four orders K+ were ordered over two days (K+ IV 10mEq in 100mL NS IV 0.9% 100mL/hr for 1 hour) on admission. The last series of four only the first dose were administered and the last three doses were documented as "not given". No evidence in the EMR for the following:
A. Reason for why last three doses of K+ were not administered.
B. Notifying physician patient had not received last dose of K+, or
C. Order from physician not to give last dose of K+.

On 02/08/18 at 9:30 am, Staff C stated K+ only comes from the pharmacy in a pre-mixed 100mL bag NS. Staff C stated administration of K+ were usually based on the patient and what their K+ level were. Staff C stated a critical level would be considered below 2.8. Staff C reported his/her practice would be to generally give three to four "bags" of K+ and then recheck the patient's labs in six to eight hours to see what their K+ level were. Staff C stated if the hospital had telemetry available he/she would order for the patient. Staff C stated the use of telemetry for a patient who received K+ would be individualized but it would be nice to have it. Staff C stated he/she were not aware of the hospital's Electrolyte Replacement Protocol. Staff C stated for Patient #4 it may look it were ordered as an injection, but K+ only comes in a pre-mixed 100mL bag and he/she knows and pharmacy would not prepare K+ as an injection.

On 02/08/18 at 9:55 am, Staff G stated K+ only comes as 10mEq in 100mL NS and nursing staff gives it over one hours. Staff C stated at times he/she may had to reduce the rate because K+ can burn the vein and a patient cannot tolerate it. Staff C stated for Patient #11 the staff nurse may had documented all doses at the same time when he/she pulled the medications from the Omnicell. Staff C stated when medications were not given there should be a reason documented.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on record review, interview, and observation, the infection control preventionist failed to implement and maintain an infection control action plan that ensured:

I. two (Staff Y and Staff FF) of two surgical staff were qualified to perform proper endoscope disinfection and reprocessing according to manufacturer's guidelines,

II. three (Staff R, Staff Y, and Staff FF) of three surgical staff were trained in the use of high level disinfectant and documentation requirements according to manufacturers' guidelines and policy,
.
III. adherence of proper personal protective equipment for one (Staff Y) of one surgical staff reprocessing endoscopes,

IV. Four of 22 surgical instruments were processed by immediate use steam sterilization (IUSS) from 10/25/18- 01/30/18 due to lack of instruments for number and the timing of the procedures scheduled.

V. endoscopic auxillary tubing (MAJ- 855) was used according to manufacturer's instructions when used in conjuction with automatic flushing pump during colonoscopy procedures as evidence in one of one observation,

These failed practices had the potential to increase the infectious risk for the approximately 131 endoscopic and 1111 surgical patients per year by failing to adhere to accepted standards of practice.

VI. proper environmental sanitation practices for two ( Room 40 and housekeeping closet by cafeteria) of two housekeeping rooms/closets and the one decontamination room observed.

These failed practices had the potential to increase the infectious risk for the approximately 1432 inpatients, 131 endoscopic, and 1111 surgical patients per year by failing to adhere to accepted standards of practice.

Findings:

On 02/06/18 at 8:46 am, during a tour of the decontamination room, the surveyor observed the following equipment in use: Olympus endoscopes 180 series, a Steris System IE [a liquid chemical sterilizer in which the endoscope was placed after pre-cleaning], and a small vat labeled Revital-ox [chemical used for high level disinfection].

I . Endoscope Reprocessing
A. Endoscopes- Leak Test
A review of the endoscope instructions for use manual titled, "Olympus GIF/CF Type- Reprocessing " showed the leak test should be performed in water only. (The purpose of the leak test is to ensure the endoscope had no holes and was waterproof. The endoscope is pressurized and an examination is performed looking for the presence of bubbles which would indicate a leak in the endoscope. The introduction of enzyme into the water during leak testing can foam and obscure leakage bubbles).

A review of the policy titled, "Fiberoptic Endoscopes: Care and Cleaning (date 06/20/14)" failed to address the leak test procedure.

A review of the personnel files for Staff Y and Staff FF showed the staff were determined to be competent to perform leak test, but the assessment did not include in what type of solution the endoscope should be submerged.

On 02/06/18 at 8:51 am, Staff Y stated he/she and other staff performed the leak test of endoscopes in enzymatic solution.

On 02/06/18 at 8:51 am, the surveyor observed Staff Y prepare to leak test an endoscope in enzymatic solution.

B. Endoscope Pre-cleaning

A review of the endoscope instructions for use manual titled, "Olympus GIF/CF Type- Reprocessing " showed the air/water cleaning adapter should be used immediately after the procedure at the bedside to flush water through the air/water channel channel.

On 02/06/18 at 9:53 am, Staff Y and Staff FF stated the air/water cleaning adapter was never used.

On 02/06/18 at 9:53 am, the surveyor observed new air/water cleaning adapters unused and wrapped in manufacturers' packaging in a tub under a shelf in the decontamination room.

A review of the endoscope instruction for use manual titled, "Olympus GIF/CF Type- Reprocessing " showed the adapters required for proper endoscopic pre-cleaning, to include, but not limited to the following 5 adapters: Air-Water Cleaning Adapter, Auxiliary Water Tube, Channel Plug, Injection Tube, and Suction Cleaning Adapter. The adapters are used to flush water and enzyme throughout all channels of the endoscope to remove bioburden during the pre-cleaning process.

A review of the policy titled, "Fiberoptic Endoscopes: Care and Cleaning (date 06/20/14)" failed to address the use of endoscope cleaning assessories including adapters.

A review of the personnel files for Staff Y and Staff FF showed the staff were determined to be competent to perform endoscope cleaning, which documented that cleaning adapters should be attached. Staff Y and Staff FF were determined competent in the ability to identify the components of the endoscope and accessories in the disinfection process.

On 02/06/18 at 8:51 am, Staff Y stated he/she and other staff did not use any cleaning adapter to flush the endoscope, but inserted the tip of a 60 ml syringe into the suction and air/water cylinders and flushed water and enzyme three times, and did not flush the auxillary channel.

On 02/06/18 at 9:53 am, Staff Y and Staff FF stated the Auxiliary Water Tube (MAJ-855) was not used.

On 02/06/18 at 8:51 am, the surveyor observed new adapters (the 5 listed) unused and wrapped in manufacturers' packaging in a tub under a shelf in the decontamination room.


C. Endoscope Brushes
A review of policy titled, "Disposable or Single Use Products (date 06/20/14)" documented disposible items were not to be reprocessed, resterilized, or reissued at any time.

On 02/06/18 at 8:51 am, Staff Y stated he/she and other staff used endoscopic cleaning brushes over and over, and randomly placed them in the Steris System 1E for chemical sterilization.

On 02/06/18 at 8:51 am, the surveyor observed the manufacturer's package for endoscope brushes which was labeled "single use".

D. Steris System 1E (SS1E)
A review of the sterilizer's instruction for use titled, "Steris System IE" documented failure to thoroughly clean devices and endoscopes may result in ineffective liquid chemical sterilization. (see A. Endoscope Cleaning). The instruction manual identified 4 filters in the SS1E (Pure membrane, Pre-filters A & B and the Air filter) and the intervals the filters must be changed. The manual documented the Pure membrane filter should be changed every 90 days.

A review of the instructions for use for SS1E chemical strips required a strip be placed in the chamber of the SS1E to verify that minimum effective concentration of disinfectant was achieved during each cycle.

A review of the policy titled, "Fiberoptic Endoscopes: Care and Cleaning (date 06/20/14)" failed to address the use of SS1E in endoscopic reprocessing and documentation requirements.

On 02/06/18 at 8:51 am, Staff Y stated the expired SS1E chemical strips were currently in use. Staff Y stated a chemical strip was placed in SS1E for cycle in which endoscopes were disinfected, but the result was not documented. Staff Y stated the lot number and expiration date for each bottle were not documented. Staff Y stated maintenance staff were responsible for all SS1E filter changes, and filter changes ocurred about every 4-6 months.

On 02/07/18 at 10:56 am, Staff L said maintenance changed the SS1E filters, but did not document the date the filters were changed.

On 02/06/18 at 8:51 am, the surveyor observed SS1E chemical strips identified as currently in use had an expiration date of 03/01/17. The surveyor found no log documenting SS1E chemical strips results per run cycle, lot number and expiration date, and no documentation of filter changes.

II. High Level Disinfection
A review of the instructions of use for Revital-Ox Resert documented quality control testing requirements for when a new bottle was opened. The instructions documented the requirements including verifying that three test strips were capable of passing the chemical concentration test of Revital-Ox solution and three test strips were capable of failing a diluted chemical concentration, and designated the method to perform this quality testing.

A review of the policy titled, "Revital-Ox Solution Tests Strips (date 06/20/14)" provided guidelines for performing quality control testing paralleled the manufacturer's instruction for use. The policy failed to address the documentation requirements for this process.

A review of table of contents for surgery and infection control did not contain a policy for the use of Revital-Ox.

A review of the personnel files of Staff Y and Staff FF showed the staff were determined to be competent for all components of "Resert XL" competency. ("Resert XL" was the policy name, but was the partial name for the actual disfectant used, which was named Revital-Ox Resert.). The competency check list included knowledge and skills demonstrated for the positive and negative quality control strip testing when new bottles were opened, and the proper solution temperature was 68F, and a 21 day timeframe for changing the solution. The competency checklist did not include verifying knowledge and skill for documenting lot numbers and expiration dates for testing strips and solutions.

A review of the hospital document titled, "Revital-Ox Log from 10/17/17- 12/01/17 showed eight entries in which masks and hoses were reprocessed. Eight of eight entries showed no lot numbers or expiration dates for chemical strips or solution and documented temperatures from 81.2 F to 83.6F.

A review of the hospital document titled, "Infection Control Clinic Survey Tool 05/09/17" which was completed by the infection control preventionist showed that standards for general Decontamination/HLD/Sterilization were met. (Despite the identified process deficiency findings).

02/06/18 at 8:51 am, Staff Y stated the expired Revital-Ox test strips were being used. Staff Y stated he/she and other staff never documented lot numbers and expiration dates for testing strips and solutions.

02/06/18 at 8:51 am, the surveyor observed the Revital-Ox test strips that were in use had expired 12/16/17.

III. Personal Protective Equipment (PPE)
A. Gowns during Endoscope Reprocessing

A review of the endoscope instructions for use manual titled, "Olympus GIF/CF Type- Reprocessing " instructed the person reprocessing the endoscope to wear PPE such as eye protection, moisture-resistant clothing, and chemical-resistant gloves.

A review of the sterilizer's instructions for use titled, "Steris System IE" documented the recommendation of wearing gloves, goggles and an apron with arm protection.

A review of the personnel files of Staff Y showed demonstrated competency regarding the use of PPE in the disinfection of endoscopes.

02/06/18 at 9:46 am, Staff Y stated he/she did not wear protective gowns during instrument and endoscopic reprocessing, because the gowns were too small.

B. Skull Caps
A review of policy titled, "Surgical Attire (date 07/13 "documented all head and facial hair were to be covered when in the restricted area of the surgical suite.

A review of AORN 2018 documented a requirement of a clean surgical head cover or hood that confined all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn.

A review of a position statement titled, "CMS Response to the American College of Surgeons (dated 09/16) documented "Net caps, caps or skullcaps that do not offer complete hair cover should not be worn in the surgical suite.

On 02/08/18 at 11:00am, Staff R acknowledged skull caps did not provide adequate coverage of staff's head.

On 02/06/18 at 09:53 am, Staff V and Staff Y were observed in the restricted operating room areas wearing skull caps.

IV Auxillary Tubing (MAJ-855)
A review of an Olympus document titled, "Important Safety Notice 02/11/09" showed the Auxiliary Water Tube (MAJ-855) is a one-way valve that prevents fluid from flowing backward through the tube used during patient exams to flush sterile water through the auxiliary water channel to wash the endoscopic field of view. When used with an automatic flushing pump, the instructions showed the flushing pump tubing was to be connected to the Auxiliary Water Tube (MAJ-855). The instructions document the Auxiliary Water Tube must be reprocessed each time it is used in an endoscopy procedure, regardless of whether the auxiliary water feeding function was used during the procedure or not.

A review of table of contents for surgery and infection control did not contain a policy for the use of Auxillary Water Tubes or automatic flushing pumps.

A review of the personnel files of Staff Y and Staff FF for endoscopic competencies failed to address Auxillary Water Tubes or automatic flushing pumps.

On 02/06/18 at 9:53 am, Staff Y and Staff FF stated the Auxiliary Water Tube (MAJ-855) was never used.

On 02/06/18 at 8:51 am, the surveyor observed Auxiliary Water Tube (MAJ-855) unused and wrapped in manufacturers' packaging in a tub under a shelf in the decontamination room.

V. Immediate Use Steam Sterilizaton (IUSS)
A review of policy titled, "Sterilization Immediate Use (06/20/14) " documented IUSS should only be performed for emergency situations during a procedure in which an instrument was contaminated and there was no replacement.

A review of CMS Survey and Certification Letter dated 08/29/17 regarding IUSS documented even when all steps are performed properly, IUSS should be limited to situations in which there is an urgent need and insufficient time to process an instrument by using terminal sterilization.

A review of the IUSS log from 10/26/17 -01/30/18 documented the following:
*10/26/17 Cycle # listed the instrument as Battery and System 6 Drill and the reason for performing IUSS was "Quick Turnover".
*12/05/17 Cycle # listed the instrument as Battery and System 6 Drill and the reason for performing IUSS was "Quick Turnover".
*12/05/17 Cycle # listed the instrument as Battery and System 6 Drill and the reason for performing IUSS was "Quick Turnover".
*12/05/17 Cycle # listed the instrument as Battery and System 6 Drill and the reason for performing IUSS was "Quick Turnover".

On 02/06/18 at 10:09 am, Staff R and Staff Y stated the hospital did not have enough System 6 Drill to accommodate the usage need.

VI. Environment Sanitation and Disinfection
A. Housekeeping Room/closets
A review of the hospital document titled, "Infection Control Clinic Survey Tool 05/09/17" which was completed by the infection control preventionist documented an inspection checklist for multiple areas of the hosptial, but failed to include the housekeeping room.

On 02/08/18 at 9:52 am, Staff J stated the housekeeping rooms and closets were not part of the infection control inspection list and inspections of those rooms had not occurred.

On 02/05/18 at 12:44 pm, the surveyor observed Staff Z place three cloth bags which were identified as dirty linen on the hallway floor awaiting a peer to unlock the door to housekeeping room 40. When the door was opened, Staff Z placed bags of dirty linens on a non-enclosed cart.

The surveyor observed the following within room 40:
* cluttered and disorganized room with no designation of the dirty and clean areas of the room,
* floors covered with grime, dirt, and large amount of brown lint and debris,
*dirty housekeeping carts with a partially filled bucket of brown liquid, and on top was an unlabeled secondary container of blue liquid,
*chemicals were on shelves amongst boxes, gloves, and other disorganized items. The chemicals included items that were not on the approved list of disinfectants to include, but not limited to: hydrogen peroxide, isopropyl alcohol, and Bravo- power foam,
*dirty mop handles in an open closet with a closet base of grime, dirt, and large amount of brown lint and debris,
*large bin of trash (in plastic bags),
* a sign reading "Soiled Linen Cart"
*two 32 ounce bottles in eyewash station which expired 01/03/18.

On 02/05/18 at 1:39 pm, the surveyor observed the housekeeping closet (near the cafeteria) to have the following:
*floor sink that was gray with dirt and grime and contained trash and debris,
*wall backsplash of the floor sink was not washable, and was grossly discolored and the covering was peeling off,
*floors were brown and covered with dirt and grime.

02/08/18 at 9:52 am, in accompaniment of the Staff J, ICP and Staff S, housekeeping supervisor, the surveyor observed dirty linen in cloth bags on floor room 40. Staff J and Staff S stated the room 40 was intended to be a "clean and dirty" storage area, to which they said primarily clean.

B. Decontamination Room

A review of policy titled, "Housekeeping of Processing-Decontamination Area (date 06/20/14) documented shelves were to be cleaned monthly.

A review of policy titled, "Environmental Cleaning of Central Processing (date 06/2014)" documented the policy included the decontamination room. The policy documented the work areas were to be kept clean and supply cart should be wiped daily with germicide solution.

On 02/06/18 at 8:51 am, the survey observed a cannister of PDI Gold disinfectant wipes on the counter of the decontamination room had expired 11/17. Staff Y stated he/she did not realize the wipes had expired.

02/06/18 at 8:51 am -the surveyor observed manufacturer's packaged single use brushes in a plastic uncovered basin on a shelf beneath the Steris System 1E. The packages and surrounding shelf were covered with crystalized-looking dried white powder. Staff Y stated he/she needed to clean the shelf under the Steris machine.
VIOLATION: WRITTEN POLICIES AND PROCEDURES Tag No: A0885
Based on document review and interview, the hospital failed to define their responsibilities according to the organ procurement agreement in its policy.

Findings:

A comparison review of the Lifeshare agreement titled, "Organ and Tissue Agreement (date 12/19/17) and the hospital policy titled, "Organ and Tissue Donation (date 02/18)" showed differences, which included, but not limited to three elements:
1. Imminent Death
The Agreement defined imminent death as follows:
A. Any patient on ventilator with Glascow Coma Score of five or less and no sedation or paralytic.
B. Any patient with brain death testing ordered.
C. Prior to decelerating care or withdrawal of support on any ventilator patient.
D. Any patient who experiences cardiac death.

The hospital policy defined " Brain death", but did not address imminent death. The policy instructed Lifeshare should be contacted for a Glascow Coma rating of four or less, which was not according to the agreement and the three other definitions of imminent death of the agreement were not addressed in the policy.

2. Tissue
The Agreement defined tissue to include bone, bone marrow, heart valves, skin, fascia, pericardium, nerve, tendon, cartlilage, cornea/eyes, blood vessels and other tissue.

The policy did not define tissue.

3. Timely Referral
The Agreement considered timely referrals to be within 60 minutes of a patient meeting the triggers for imminent death, or not meeting those triggers within 60 minutes, but had cardiac arrest.

The policy instructed Organ Sharing Network should be notified within 60 minutes of all deaths and did not consider imminent death.

On 02/07/18 at 12:45 pm, Staff A acknowledged difference in content between the organ procurement agreement and organ procurement policy.