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Tag No.: C0204
Based on record review and interview the hospital failed to ensure supplies in the crash cart were not expired and intravenous (IV) fluids were maintained in their original packaging.
Findings:
Review of hospital policy titled "Emergency Crash Carts, dated 06/30/16" failed to identify when emergency supplies such as endotracheal tubes and intravenous therapy supplies were to be inspected for expiration dates, the responsible staff for conducting inspections and the frequency of inspections of the emergency crash carts.
On 05/01/18 at 9:47 am, surveyors toured the ED and observed two endotracheal tubes 7.5 expired on 03/18 and one IV start kit expired on 03/01/18. In ER room #1 surveyors observed three bags of Normal Saline IV fluid in an upper cabinet removed from their original packaging and warm to the touch. Staff D removed expired supplies and unpacked Normal Saline.
On 05/01/18 at 10:00 am, Staff D stated once a month ED nursing staff open the ED crash cart and examine all items including medications and supplies and remove any items that had expired. Staff D stated he/she did not know why the three bags of Normal Saline IV fluid had been removed from their original packaging.
Tag No.: C0276
Based on record review, interview, and observation, the hospital failed to:
I. report and correct controlled substance discrepancies in the Omnicell (automated medication dispensing machine) in a timely manner. This failed practice resulted in three observed control substance discrepancies from 05/1/18 to 05/08/18 and 160 documented discrepancies from 10/01/17 to 04/27/18, all of which had the likelihood to create circumstances conducive for controlled substance diversion.
Findings:
I. Controlled Substance Discrepancies:
A review of the Omnicell manual defined a discrepancy as the difference between the "expected amount" of a medication stocked in the machine and the "actual amount". The manual showed a discrepancy could be triggered during issue, return, restock, cycle counts or bin level changes.
A review of the "Pharmacy and Therapeutics Committee Minutes" from 10/11/17 to 04/09/18 showed the following:
* 04/09/18: 31 discrepancies with comment of "Clinical Coordinator will begin resolving all discrepancies by end of shift."
* 03/09/18: 14 discrepancies
* 02/09/18: 23 with comments 2 miss keys, 10 miscounts, 1 input error, 1 miss pull, 1 restock error, 9 miscounts carrying forward
* 01/05/18: 22 with comments 10 miscounts, 3 miss pulls, 1 restock error, 3 miscounts carrying forward, 5 timing of count
* 12/07/17: 21 with comments 7 miss key, 9 miscounts, 2 input errors, 3 timing of counts
* 11/07/17: 22 with comments 4 miss key, 16 miscounts, 1 input error
A review of the document titled, "Pharmacy Discrepancy Report" from 10/01/17 to 04/30/18 showed 160 discrepancies. Some examples of discrepancies and of resolutions not being performed within the 12 hour shift time frame on this report were as follows:
* On 04/01/18 at 9:38 am, a discrepancy involving Marinol 2.5mg capsule was created and nine more discrepancies followed until resolved on 04/06/18 at 6:29 pm. Staff documented reasons for the discrepancies as "carry over", "miscount", "correct count 11 per count sheet", "paper count correct".
* On 03/28/18 at 4:49 pm, a discrepancy involving Morphine Sulfate injection was created and resolved 04/02/18 at 6:56 am with documented reason "error in previous countback quantity".
* On 02/15/18 at 9:34 am, a discrepancy involving Dilaudid injection was created and resolved on 02/16/18 at 10:04 am with documented reason "destocked 2 x 2mg and replaced with 4 mg".
* On 01/07/18 at 9:17 am, a discrepancy involving Lyrica 75mg was created and resolved on 01/12/18 at 8:22 am with documented reason "previous miscount".
* On 12/16/17 at 8:03 pm, a discrepancy involving Norco tablets was created and resolved on 12/18/17 at 12:07 pm with documented reason "error in count back".
* On 11/02/17 at 12:35 pm, a discrepancy involving Duragesic patch was created and resolved on 11/09/17 at 9:17 am with documented reason "Count after med removed".
* On 10/28/17 at 6:35 pm, a discrepancy involving Norco tablets was created and resolved on 11/01/17 at 4:55 pm with documented reason "error in previous count".
A review of policy titled, "Automatic Dispensing Machines- Control Substances (date 06/17)" documented:
* controlled substances inventory count should be performed once a shift.
* if an inventory count was incorrect, the user should be prompted to perform a recount. If the recount remained incorrect, a discrepancy should be created and communicated to Pharmacy Service.
* controlled substances shall be reported to the Pharmacy and Therapeutic Committee immediately.
* controlled substances discrepancies must be resolved at the time of discovery or by the end of shift.
* resolution of each discrepancy must be documented in the automatic dispensing system and witnessed by a second nurse. The policy failed to instruct how the resolution "reason" should be described in a uniform manner.
On 05/01/18 at 11:58 am, Staff TTTT, the Pharmacist stated a discrepancy should be resolved at the time it occurred. Staff TTTT stated "too many" discrepancies were occurring.
On 05/01/18 at 11:22 am, Staff E stated when the Omnicell detected a discrepancy, a notification message would appear in the Omnicell's screen which queued the staff to reassess the count. The Omnicell allowed staff to bypass the message and obtain the medication; an icon would appear on the screen which indicated a discrepancy existed. Staff E stated when staff created a discrepancy, they should notify the Charge Nurse as soon as possible.
On 05/01/18 at 11:22 am, Staff XX, Charge Nurse stated he/she was not notified of the 05/01/18 Ultram discrepancies. Staff XX and Staff A stated the discrepancies must be resolved by end of each shift (within 12 hours).
On 05/01/18 at 11:22 am, surveyor observed two discrepancies in the Omnicell involving Ultram 50 milligram tablets. The Omnicell showed discrepancies occurred at 05/01/18 at 9:34 am by Staff V and another cascading discrepancy resulted at 10:21 am when Staff Y removed an Ultram for another patient.
On 05/01/18 at 3:15 pm, Staff E and Staff Y performed an Omnicell narcotic count. The surveyor observed the bin designated for Halcion 0.125mg vial was empty and the Omnicell count was one. Staff E called the pharmacy and was told the Halcion had expired, was removed, and the technician failed to select zero as correct count.
Tag No.: C0278
Based on record review, interview, and observation, the Infection Control Preventionist failed to implement and maintain an infection control action plan that minimized the occurrence of improper:
I. preventative maintenance and documentation for Medivators automatic endoscope reprocessor (AER) according to manufacturers' guidelines.
II. disinfection practices according to manufacturers' guidelines pertaining to instrument and equipment: Endoscope, Fujifilm Endoscope Irrigation Bottles, Reusable Endoscope Brushes reprocessing, and Steam Autoclave Policy.
III. use of skull caps, personal protective equipment, for the surgical staff.
IV. use of quality controls and documentation of chemical indicators associated with disinfection practices.
These failed practices had the likelihood to increase the infection control risk for the approximately 140 patients receiving endoscopic services each year.
Findings:
I. Medivators
On 05/01/18 at 10:30 am, survyors requested policies regarding endoscopic (and endoscopic accessory) reprocessing and were provided the manufacturer's instructions for use for the automatic endoscopic reprocessor (Medivator DSD- Edge).
A review of the document titled, "Medivators DSD Edge-Endoscope Reprocessing System In- service Guide" showed the system contained four filters (three water filters and an air filter) which must be changed at designated intervals to ensure proper disinfection of equipment.
On 05/01/18 at 1:56 pm, Staff TTT stated Medivators were purchased and installed 02/18 and Staff C would maintain the system.
05/07/18 at 10:10 am, Staff C stated he/she did not know the AER had filters and had no role in the maintenance of the AER filter change. (The first filter change was due at three months)
II. Instrument and Equipment Disinfection
A. Endoscope Reprocessing Policy
On 05/01/18 at 10:30 am, surveyors requested policies regarding endoscopic (and endoscopic accessory) reprocessing and were provided Surveyors requested the Endoscope Reprocessing Policy and was initially provided a document titled, "Supplemental Measures for Reprocessing Duodenoscopes".
On 05/01/18 at 3:00 pm, Staff M stated the hospital did not use duodenoscopes.
On 05/08/18, Staff TTT provided the policy titled, "Process for Cleaning Flexible Endoscopes (date 10/10/14)". The policy failed to designate the specific model of endoscope to which the policy applied, and cited use of a high level disinfectant which was no longer used.
B. Fuji Endoscope Irrigation Bottles
A review of the document titled, "Fujifilm Water Tank (WT-4) Operation Manual showed the bottle could be reprocessed by steam autoclave or high level disinfection. (The water tank is an irrigation bottle attached to an endoscope to provide water and air through the endoscope). The manual showed the bottle contained a channel tube which was a lumen to be disinfected.
A review of the document titled, "Medivator Product Bulletin (date 2010) showed "soak-only" devices could be reprocessed, if the device did not containing lumens or channels (tube) that require separate flushing.
On 05/01/18 at 1:56 pm, Staff M stated although the channel tube was disinfected separately, Fuji endoscope irrigation bottles were disinfected in the Medivator.
C. Reusable Endoscope Brushes
On 05/01/18 at 3:00 pm, surveyors requested the manufacturer's instructions for use for reusable endoscopic cleaning brushes (WB32118FW2), and none were provided.
On 05/01/18 at 1:56 pm, Staff M stated reusable endoscopic cleaning brushes were disinfected in the Medivator. (No evidence was provided that this was an acceptable practice).
D. Steam Autoclave Policy
A review of policy titled, "Steam Sterilization / Use of the Autoclave (date 03/29/12) showed only "emergency flash" autoclaving may be used in the operating suite. The policy failed to define "emergency" immediate use steam sterilization.
A review of the document titled, "CMS Survey and Certification Regarding Immediate Use Steam Sterilization (date 08/14).
On 05/01/18 at 1:56 pm, Staff M stated immediate use steam sterilization was only performed when an instrument was dropped and a replacement was unavailable.
III. Skull Caps
A review of AORN 2018 documented a clean surgical head cover or hood that confines 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 05/01/18 at 1:56 pm, skull caps were observed in the staff dressing room, and Staff TTT stated one physician wore them.
IV. Chemical Indicators
On 05/02/18 at 7:43 am, Staff TTT identified Staff M and Staff N's responsibilities to include endoscope and endoscopic accessory reprocessing.
A review of the document titled, "Direction for use for Use Test for Levels of Peracetic Acid in RAPICIDE PA reprocessing solution High-Level Disinfectant Test Strips Sterilant Test Strips" provided instructions requiring quality testing for efficacy when each new bottle of strips was opened.
On 05/01/18 at 1:56 pm, Staff M stated he/she used Rapidcide PA to disinfect endoscopes. Staff M stated he/she utilized the manufacturer's chemical testing strips, but did not maintain documentation of the date and lot number for the chemical indicator strips bottle. Staff M stated quality control testing for chemical indicators were not performed as per manufacturer's guidelines.
On 05/01/18 at 1:56 pm, in simulation, the surveyor observed Staff M reprocess handle an endoscope, reusable brushes, and irrigation bottles to include, but not limited to: pre-cleaning, leak testing (endoscope), cleaning, use of AER, and storage.
Tag No.: C0284
Based on record review and interview the hospital failed to ensure emergency department (ED) staff were appropriately trained and competent to triage high risk patients and manage patient flow when the ED was at capacity. This failed practice resulted in one obstetrical patient not receiving timely treatment (Patient #1) of a total sample of four obstetrical patients and subsequently leaving the ED without being seen, and the likelihood for delay in treatment for patients with high risk needs who arrive at the facility during periods of capacity.
Findings:
Review of hospital policy titled "Obstetrical Triage, dated 01/29/16" showed upon presentation to the hospital pregnant patients were to be provided immediate evaluation .
Review of hospital policy titled "Triage - Patient Assessment, dated 01/29/16" showed an RN was responsible for an initial evaluation including chief complaint, vital signs, nursing observations . Triage categorization of resuscitative, emergency, urgent, semi-urgent or routine was to be determined on arrival in the ED.
Patient #1 was a 23 year old patient who arrived at the ED at 7:42 pm, entered into the ED log as "OB" for a pregnancy related complaint. The patient left the ED at 8:12 pm, approximately 30 minutes after arrival without being triaged, seen by nursing or evaluated by medical staff to determine the urgency of the patient's complaint and per hospital policy.
On 05/03/18 at 10:12 am, Staff KK stated pregnant patients who arrive in the ED were immediately triaged and brought back to an ED room and assessed. Staff KK stated the patient would be evaluated by the provider, stabilized and transferred to another facility that provided obstetrical services.
Tag No.: C0294
Based on record review, interview, and observation, the hospital failed to ensure:
I. two (Staff M and Staff N) of two staff performing disinfection/ sterilization of endoscopes and endoscopic accessories had documented competencies according to manufacturers' instructions for use. This failed practice had the likelihood for instrument reprocessing steps to be performed incorrectly which would increase the infection control risk for the approximately 140 patients receiving endoscopic services each year. (Refer to Tag C-0278 for deficiencies identified).
II. past Oklahoma Board of Nursing's disciplinary actions were reviewed and terms of employment approved by the Governing Body for two (Staff III and Staff SSS) of two registered nurses. This failed practice had the likelihood for staff with past nursing discipline action to be employed without the Governing Body's knowldge and approval.
III. nursing staff were competent prior to being assigned patient care. This failed practice had the likelihood to increase the risk to patient safety and adverse health outcomes to all in-patients.
Findings:
I. Endoscope and Endoscopic Accessory Reprocessing
On 05/02/18 at 7:43 am, Staff TTT identified Staff M and Staff N's responsibilities to include endoscope and endoscopic accessory reprocessing.
A review of the personnel files for Staff M and Staff N showed demonstrated competency for "cleaning/dating flexible endoscopes (respectively dated 03/18 and 10/17)". The competency documentation failed to designate the model of endoscope, components of competency, or address endoscopic accessories.
A review of the document titled, "In-Service Participant sign-in sheet- DSD Edge (dated 02/26/18)" showed attendance to a vendor training session for automatic endoscope reprocessor which included Staff M in attendance. The training session failed to address the components of the training and did not show evidence of staff demonstrated competency.
On 05/01/18 at 1:56 pm, in simulation, the surveyor observed Staff M reprocess an endoscope, reusable brushes, and irrigation bottles to include, but not limited to: pre-cleaning, leak testing (endoscope), cleaning, use of AER, and storage. (Refer to Tag C-0278 for deficiencies identified).
II. Nursing Board Discipline
A review of the Oklahoma Nursing license for Staff III and Staff SSS showed past disciplinary actions.
On 05/03/18 at 3:50 pm, Staff A stated the hospital had no policy that addressed the process for managing nurses disciplined by the Board of Nursing, and Staff III and Staff SSS's disciplinary issues were not reviewed and terms of employment approved by the Governing Body.
III. Staff Competencies
Review of hospital document titled "Competency Validation Record, undated" showed physical assessments, observations, interventions, and skills nursing staff was required to be assessed upon hire to ensure competency to provide care to patients.
Review of hospital document titled "Critical Equipment Competency Validation Record Licensed Nursing - Ventilator undated" showed critical behaviors, assessments, interventions and skills nursing staff was required to be assessed upon hire to determine competency before providing care to ventilator patients.
On 05/04/18 at 12:09 pm, Staff J stated he/she had started at the hospital two weeks ago. Staff J stated he/she had started with one patient and had performed assessments, started intravenous (IV) lines and placed two foley catheters. Staff J stated the first week he/she followed his/her preceptor who assessed his/her competency on administering medications, which included reconstituting (mixing) medication, and performing patient assessments. Staff J stated he/she had the competency checklists and his/her preceptor would check off the assessment or skill once he/she had performed it. Staff J stated the competency checklists were in his/her locker on the nursing unit.
On 05/04/18 at 12:30 pm, surveyor accompanied Staff J to the nursing unit and Staff J provided his/her "Competency Validation Record" which was blank. Staff J provided his/her "Critical Equipment Competency Validation Record Licensed Nursing - Ventilator" which showed the skill "suctioning a patient" skill had been checked as "able to perform without assistance". The competency validation record failed to provide evidence of when the observation was made and the staff member who validated Staff J's competency.
Tag No.: C0296
Based on record review and interview the RN failed to evaluate the care provided by licensed practical nurse (LPN) for seven (Patient #8, 9, 10, 11, 17, 18 and 22) of a sample of 22 patient medical records reviewed. This failed practice had the likelihood for delayed recognition for a clinical change in patient condition to be reported to healthcare providers for seven (Patient #8, 9, 10, 11, 17, 18 and 22) of 22 patients.
Findings:
Review of an undated hospital job description titled "LPN Med Surg" showed the LPN "contributes to the assessment of the patient".
Review of an undated hospital job description titled "RN Med Surg" showed the RN was responsible for supervision of LPNs and certified nurse aides (C.N.A.s) ... "provides supervision of patient care and staff performance" ...
The "Oklahoma Nursing Practice Act" defines the scope of practice for an LPN includes:
* Contributing to assessment of health status of individuals and groups.
* Participating in the evaluation of responses to interventions.
Seven (Patient #8, 9, 10, 11, 17, 18 and 22) of a sample of 22 patient medical records reviewed showed no evidence the RN evaluated the assessments performed by the LPN and provided documentation of the evaluation in the patient's EMR.
On 05/07/18 at 1:59 pm, Staff XX stated the charge nurse would be responsible for supervising the LPN. Staff XX stated an RN assessment was required every 24 hours on each patient. Staff XX stated RNs were assigned to one side of the unit on days and the other side on evenings to ensure all patients receive an RN assessment every 24 hours.
On 05/08/18 at 9:40 am, Staff A (DON) stated he/she was not aware RN staff were responsible for evaluating and countersigning LPN assessments.
Tag No.: C0302
Based on record review and interview the hospital failed to ensure:
I. the EMR reflected accurate documentation for restraint observations including the nurse who assessed and completed each observation for one (Patient #11) of one restraint patients in a sample of 22 patients. This failed practice had the likelihood to affect the patient safety and health outcomes for one (Patient #11) of one patient in restraints and for all patients who may have restraints applied.
II. nursing staff documented assessment and monitoring to ensure patient safety for three (Patient #5, 7 and 14) of three suicidal patients in a sample of 22 medical records reviewed. This failed practice had the likelihood to affect patient safety for three (Patient #5, 7 and 14) of three suicidal patients who presented to the ED for treatment.
Findings:
I. Restraint Documentation
Review of hospital policy titled "Restraint Policy, dated 05/06/16" stated the RN was responsible for conducting an initial assessment and documentation of findings ...minimum every two hours and patient's condition reassessed ...documentation of observations and care provided.
Review of hospital policy titled "Documentation-Nursing, dated 06/30/16" showed documentation of data collected should be by the individual rendering the care to the patient..."all documentation in the medical record will contain date, time and authentication of the entry".
Review of hospital policy titled "Clinical Record Requirements, Standards and Content, dated 11/30/17" showed "All entries in the medical record must be authenticated."
Review of hospital for electronic medical record titled "Nursing 24 Hour Restraint" showed assessment and observation indicators to be assessed for patients in restraints for determined frequencies every two hours. Although the flowsheet provided a field for an electronic signature and date/time to be completed by nursing staff performing the two hour assessments, the field could be altered by other staff who accessed (modified) the patient's medical record.
Patient #11 was an 88 year old patient who was admitted to swing-bed secondary to respiratory failure from aspiration pneumonia for continued weaning from mechanical ventilation and rehabilitation. Review of the patient's medical record showed the following:
*soft wrist restraints were initiated on 03/19/2018 at 8:00 pm, and continued with 24 hour renewal orders until 03/27/18.
*The Nursing 24 Hour Restraint Flowsheet was consistently completed and documentation entered into the patient's EMR by nursing staff within the 24 hour assessment period except for 03/20/18 and 03/21/18.
*On 03/20/18 and 03/21/18 the Nursing 24 Hour Restraint Flowsheet showed the assessments were modified by Staff E on 03/23/18 at 7:38 am, and 7:12 am, respectively.
On 05/08/18 at 11:10 am, surveyors requested staffing schedules, timecards, and badge access records to show evidence Staff E was at the hospital on 03/20/18 and 03/21/18. None were provided.
On 05/08/18 at 11:13 am, Staff E stated he/she did not work nights and would not be on the staffing schedule. Staff E stated he/she may have stayed over on those days. Staff E stated he/she does not recall why Patient #11's flowsheet was modified on 03/23/18.
On 05/08/18 at 11:35 am, Staff A stated the EMR program had no way of identifying what was modified in the Nursing 24 Hour Restraint flowsheet.
On 05/0818 at 11:39 am, Staff F stated each time a staff member logged into the EMR and modified a flowsheet, the computer would erase the name, date and time of the previous entry. Staff F stated to his/her knowledge the EMR program did not have a history each time the flowsheet was modified including the name, date and time it was modified.
II. Suicidal/Homicidal Ideation
Review of hospital policy titled "Assessment for Suicidal Ideation, dated 01/29/16" showed an evaluation for suicidal ideation was performed upon admission to the facility ...Suicide precautions were ordered by the physician and nursing staff were to implement the precautions until the order was received. The policy failed to address the individual interventions taken for suicide precautions, including environmental precautions.
Review of hospital policy titled "Psychiatric Evaluation, dated 01/29/16" showed patients requiring psychiatric treatment were to be provided a safe location and monitored ...assessments and reassessments performed. The policy failed to identify the components of monitoring the patients, frequency of monitoring and assessments.
Three (Patient #5, 7 and 14) of three suicidal patient medical records reviewed showed no documentation of an environmental assessment, suicidal risk assessment or frequent monitoring to ensure the patient's safety until transfer or discharge.
On 05/03/18 at 10:12 am, Staff KK stated suicidal patients would be assessed to determine if they had anything that they could harm themselves with. Staff KK stated a staff nurse was required to stay with the patient until police arrived. Staff KK stated he/she would monitor the patient every 30 minutes and document in the patient's electronic medical record.
Tag No.: C0306
Based on record review and interview the hospital failed to ensure nursing staff documented accurately and completely in the patient's EMR necessary for continuity of care, patient safety and quality of care as evidenced by:
I. inconsistent documentation of an assessment by the registered nurse (RN) every 24 hours per hospital policy for two (Patient #11 and 18) out of a total sample of 22 patient medical records reviewed.
II. inconsistent documentation of a nursing shift assessments for four (Patient #11, 17, 18, and 22) out of a total sample of 22 patient medical records reviewed.
These failed practices had the likelihood for increased risk to patient safety due to unavailability of pertinent information to make timely medical and nursing decisions among health care providers and adverse health outcomes for four (Patient #11, 17, 18 and 22) of a total sample of 22 patients from 02/26/18 to 05/03/18.
Findings:
I. 24 Hour RN Assessment
Review of hospital policy titled "Assessment and Reassessment, dated 06/30/16" showed an RN was responsible for assessment every shift ...
Review of hospital policy titled "Documentation - Nursing, dated 06/30/16" showed the RN was responsible for documenting the initial assessment of the patient and "appropriate reassessments".
Two (Patient #11 and 18) out of a total sample of 22 patient medical records reviewed showed the RN had not documented in the patient's EMR the 24 hour RN assessment.
On 05/07/18 at 1:59 pm, Staff XX stated RNs assess patients every 24 hours. Staff XX stated an RN was assigned on one-side of the unit on days and the evening RN was assigned the other side on the evening shift. Staff XX stated with this rotation it ensured all patients received an assessment every 24 hours.
II. Nursing Shift Assessments
Review of hospital policy titled "Assessment and Reassessment, dated 06/30/16" showed an assessment of the patient was required every shift.
Review of hospital policy titled "Documentation - Nursing, dated 06/30/16" showed reassessments should be documented in the patient's EMR.
Four (Patient #11, 17, 18 and 22) out of a total sample of 22 patient medical records reviewed showed nursing shift assessments had not been documented by nursing staff into the patient's EMR per hospital policy.
On 05/07/18 at 1:59 pm, Staff XX stated a nursing assessment was required to be completed and documented in the patient's electronic medical record every shift.