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Based on record review, observation and interviews, the CAH (Critical Access Hospital) failed to ensure that personnel (surgery staff and physicians) were provided with a surgery changing area (room) to change from home attire and/or outside attire to hospital provided clean surgical attire for personnel working in the restricted and semi-restricted surgical areas of the hospital as evidenced by no surgical changing areas for staff and physicians being provided by the hospital.


Findings:


A review of the hospital floor plan revealed no designated area for surgery staff and/or physicians to change from home attire and/or outside attire to hospital provided clean surgical attire when working in the restricted and semi-restricted surgical areas of the hospital.


A tour of the hospital revealed no designated area for surgery staff and/or physicians to change from home attire and/or outside attire to hospital provided clean surgical attire.


In an interview on 01/11/16, at 11:45 a.m., with S3DON, she was asked for the designated area for the surveyor to change from home attire to surgical attire in order for the surveyor to tour the restricted and semi-restricted surgical areas. She indicated that the hospital did not have a designated changing area/room for surgery staff and/or physicians to change from home attire and/or outside attire to hospital provided clean surgical attire for personnel working in the restricted and semi-restricted surgical areas of the hospital. S3DON indicated that the surgery staff utilized the bathroom in the hallway or an office area in the hallway and that the surveyor could use one of those areas. S3DON further indicated that the physicians did not have a changing area/room at present.



In an interview on 01/11/16, at 1:30 p.m., with S21RN/OR, she indicated that after the Joint Commission Survey last month, the staff were instructed to start utilizing the bathroom in the hallway or an office area in the hallway to change from home attire and/or outside attire to hospital provided clean surgical attire. She further indicated that the physicians did not have a changing area and that she always remembered physicians wearing surgical scrubs from home and/or from other hospitals.

Based on observation and staff interview, the CAH (Critical Access Hospital) failed to ensure the hospital premises were kept clean and orderly as evidenced by:


1) Cardboard boxes of hospital supplies stored on the floor and in patient care areas of the radiology department, and;


2) Patient nutritional refrigerator in the medication room noted to have yellow tinged liquid pooled on the second shelf and rust colored wipe/drip marks on the exterior surface (on both freezer and refrigerator doors).


Findings:


1) Cardboard boxes of hospital supplies stored on the floor and in patient care areas of the radiology department:


On 01/12/16, at 10:45 a.m., an observation of the Radiology Department was made with S45Director of Ancillary Services. The storage room located inside the department was observed to have 2 cardboard boxes of Sani-cloths stored on the floor in the storage room. S45Director of Ancillary Services confirmed the boxes should not be stored on the floor.


Observation of the CT room at 10:45 a.m. with S45Director of Ancillary Services and S46RT revealed a cardboard box of disposable drapes was stored on the bench in the patient changing area. S45Director of Ancillary Services confirmed the box should be taken to a storage area and not left on the bench of the patient changing area.



2) Patient nutritional refrigerator in the medication room noted to have a yellow tinged liquid pooled on the second shelf and rust colored wipe/drip marks on the exterior surface (on both freezer and refrigerator doors).


On 1/11/16, from 9:45 a.m.-10:45 a.m., an observation was made of the patient medication room located on the main hall of the hospital. A yellow tinged liquid was noted to be pooled on the second shelf of the patient nutritional refrigerator. Further observation revealed the outer surface of the refrigerator was covered in a rust colored substance with wipe and drip marks noted on the exterior surface of both the freezer and refrigerator doors. The above referenced findings were confirmed by S3DON during the observation.


30984

Based on interview and record review, the CAH Governing Body failed to ensure policies governing the CAH's total operation were administered so as to provide quality health care in a safe environment. This deficient practice was evidenced by failure of the CAH to review/revise policies to maintain safety of PEC'd patients (being monitored by direct visual contact) attempting elopement/eloping from the Hospital's ED.


Findings:


Review of the hospital's policy titled, "Leaving Against Medical Advice; Elopement/Desertion, Paged No Answer," policy #: 01-03.10-0001, revealed the policy had last been reviewed in 1/15. Further review revealed no documented evidence that the policy had been revised since the last review in 1/15.


Review of the hospital's occurrence reports, presented by S2Director of PI/QA, revealed an incident report, dated 11/20/15, detailing Patient #9's elopement from the ED while PEC'd following a suicide attempt by driving his car into a pole. Further review revealed the patient had eloped while walking to the restroom, escorted by the RN. Patient #9 ran out back door of ED and ran out back door of the hospital leading to the back parking lot. Security was notified and the grounds searched. Patient #9 was not located on grounds. Additional review revealed the following abbreviated Root Cause Analysis (questions located on the incident report form): Unsafe act: pt. being monitored by staff member and not by security personnel; Unsafe condition: pt. being monitored by staff member and not by security personnel; Contributory factors: unknown; Why was act committed: unknown: Why did condition exist: unknown: Immediate action taken: have 2 staff members escort pt. to restroom; Long range action to be taken: Possibly have security personnel monitor PEC pt. 1:1. What additional assistance is needed to prevent recurrence: Possibly have security personnel monitor PEC pts.1:1.


On 1/11/16, at 3:50 p.m., another patient, Patient #8 (current PEC ED patient), eloped from the hospital by pretending to go to the bathroom and then walking out the ambulance bay doors to the front of the hospital, continuing out the door to the outside. Review of Patient #8's medical record revealed he had suicidal ideations and he heard voices telling him "to walk into traffic to kill himself".


In an interview on 1/12/16, at 10:50 a.m., with S2Director of PI/QA, she indicated an abbreviated question/answer root cause analysis had been performed on the back of the incident report after the above referenced elopement by Patient #9. She indicated no further in-depth root cause analysis regarding Patient #9's elopement had been conducted. She confirmed there had been no new policies/policy revisions instituted after the above referenced elopement of Patient #9. S2Director of PI/QA further indicated Patient #9's elopement had not been evaluated in the hospital's Quality Assurance Program as a high risk issue and no new interventions had been put into place.

Based on record reviews, observations, and interviews, the CAH (Critical Access Hospital) failed to meet the Conditions of Participation for Provision of Services as evidenced by:


I.

1) failing to ensure safe and effective care was provided to patients presenting to the hospital's ED who were a potential threat to themselves or others as set forth per hospital policy. This deficient practice was evidenced by:


a. failure to prevent elopement from the Emergency Department for 2 (1 current patient with suicidal ideations PEC in the ED (#8) and 1 closed actively suicidal patient (#9) that had been PEC in the ED and eloped on 11/20/15) of 2 patients reviewed for elopements out of a total sample of 21 patients; and


b. failure to maintain strict visual contact observation, during toileting, of patients at risk for suicide PEC in the ED. The physical environment in the ED bathroom presented potential opportunities for self harm of the psychiatric patients.


2) failing to ensure strict visual contact observation was maintained for PEC patients in the ED according to hospital policy for 1 of 1 (#8) current sampled PEC'd ED patients reviewed (SEE C-0271).



II.

failing to maintain a comprehensive and ongoing Infection Control Program designed to prevent, control, and investigate infection control practices that included: data collection, tracking, trending and analysis of infection control practices/breaches through monitoring and surveillance of all the services of the CAH, active surveillance of infection control practices to identify infection control breaches with implementation of corrective actions to prevent and control infections, monitoring of compliance with all infection control policies, procedures, protocols and other infection control program requirements that were implemented by the facility and the CAH failed to ensure that the designated Infection Control Officer was qualified through training and experience in infection control practice and/or procedures as an Infection Control Officer. (SEE C-0278)



III.

failing to ensure nursing services were provided to meet the needs of the patient as evidenced by:

1) failing to ensure nursing staff assigned to monitor telemetry patients were continuously monitoring the current inpatients on telemetry monitoring for 2 of 2 (#6, #21) current inpatients who had physician orders for telemetry (cardiac) monitoring, and;

2) Assigning ICU nursing staff to provide nursing care for ICU patients and monitor telemetry patients on the medical/surgical inpatient unit (SEE C-0294).


IV.
failing to ensure the registered nurse (RN) supervised and evaluated the nursing care for each patient as evidenced by:


1) Failure to ensure each patient was assessed at least every 24 hours by the RN as required by the Louisiana State Board of Nurse's Practice Act as evidenced by having patient care provided by LPNs without documented evidence of a RN assessment at a minimum of every 24 hours for 2 (#21) of 4 (#5, #6, #8, #21) sampled patient records reviewed and 2 of 2 (R1, R2) random patient records reviewed for RN assessments from a total sample of 21 patient records reviewed and 2 random patients;


2) Failure to ensure orders relative to the initiation and/or titration of continuous medication infusions were clarified prior to implementation by nursing staff as evidenced by failing to obtain dosing increments and intervals for initiation and/or titration for 2 of 2 (#1, #5) sampled patient records reviewed for continuous medication infusions out of a total sample of 21 patient records reviewed. Patient #5 was a current inpatient, and;


3) Failure to ensure orders relative to the use of sliding scale insulin administration were clarified prior to implementation by nursing staff as evidenced by failing to obtain the physician's order for the frequency of blood glucose accuchecks and insulin administration for 1 of 1 (#R2) random patient and 2 sampled patients (#1, #5) reviewed for sliding scale insulin administration out of a total sample of 21. (SEE C-0296)


V.
failing to ensure the assignment of nursing personnel for patient care services was done in accordance with nursing personnel competence by:


1) failing to ensure 3 out of 3 (S9RN, S42RN, S44RN) staff reviewed who monitored patients on moderate sedation had annual competencies in Propofol infusion administration, and failing to ensure that 4 of 4 RNs (S21RN/OR, S24RN/OR, S26RN/OR S27RN/OR) who administer Conscious Sedation/Analgesia in the O.R. had annual competencies in Conscious Sedation/Analgesia.


2) failing to ensure 2 of 2 (S9RN, S42RN) nursing staff who calculated and titrated insulin infusions according to a hospital protocol had documented competencies in the insulin infusion protocol. (SEE C-0297)

Based on record review, observations, and staff interviews, the CAH (Critical Access Hospital) failed to ensure health care services were furnished in accordance with written policies as evidenced by:


1) failing to ensure safe and effective care was provided to patients presenting to the hospital's ED who were a potential threat to themselves or others as set forth per hospital policy. This deficient practice was evidenced by:


a. failure to prevent elopement from the Emergency Department for 2 (1 current patient with suicidal ideations PEC in the ED (#8) and 1 closed actively suicidal patient (#9) that had been PEC in the ED and eloped on 11/20/15) of 2 patients reviewed for elopements out of a total sample of 21 patients; and


b. failure to maintain strict visual contact observation, during toileting, of patients at risk for suicide PEC in the ED. The physical environment in the ED bathroom presented potential opportunities for self harm of the psychiatric patients.


2) failing to ensure strict visual contact observation was maintained for PEC patients in the ED according to hospital policy for 1 of 1 (#8) current sampled PEC'd ED patients reviewed.


3) failing to follow the hospital policy for restraints for 1 out of 1 patients (Patient #1) reviewed for use of restraints over a 24 hour period.


Findings:


1) failing to ensure safe and effective care was provided to patients presenting to the hospital's ED who were a potential threat to themselves or others as set forth per hospital policy.


Review of the policy titled, "Mental Health patients: Assessment and treatment of, " policy #: 01-03.1-0014, effective date: 01/04, revealed in part:

Purpose: To provide assessment of patients and determine if an emergent or non-emergent medical condition related to mental health exists and to provide timely care to those identified patients.

Policy: This hospital shall provide safe and effective care to patients presenting to the hospital (inpatient or outpatient) who are a potential threat to themselves or others and patients presenting with alcohol, psychiatric, or drug related problems. Mental Health treatment services are not available at this hospital.

Definitions: Psychiatric or Behavioral Emergency: A Psychiatric or Behavioral Emergency occurs when " a patient, as a result of mental illness, substance abuse, or intoxication engages in behavior which in the clinical judgment of the physician places the patient or others at significant and imminent risk of damage to life or limb " .

Procedure for Emergent Psychiatric or behavioral Issue: 1. When staff member becomes aware that a patient may have a psychiatric or behavioral emergency: the nurse will perform triage and initial assessment; notify the physician immediately for an assessment and evaluation; place patient under direct observation.


2. Patients brought to the ED under police escort pursuant of involuntary admission/commitment status shall be placed under direct observation. A request will be made of the police authority bringing patient to assist in observation if needed.
Inpatient Setting: Once a Physician Emergency Certificate is issued on an inpatient, the nursing staff or social services shall attempt to find placement by contacting each treatment facility for acceptance.

Special Considerations: Strict visual contact by hospital security or nursing staff is to be implemented and continued until final disposition. In the event that additional security measures are needed hospital security personnel will follow appropriate security procedures in obtaining further assistance. If an emergency security issue arises, a Code White (security code) may be initiated.

Observation/Monitoring Guidelines: 1. Patients on strict visual contact shall be monitored by appropriately assigned personnel. 3. Patients may be placed on strict visual contact based on physician order or by RN assessment and evaluation. 4. Communicate patient ' s status to all other health care team members who may come in contact with the patient. 5. Nursing staff shall document the patient ' s status in the medical record. 9. Vigilance must be maintained during bath time, toileting, mealtime, early morning hours, during disturbances on the unit and after visitors leave. 10. Patient safety and personal rights must be considered at all times while on these precautions.

Review of the hospital's policy titled," Leaving Against Medical Advice; Elopement/Desertion, Paged No Answer", policy #: 01-03.10-0001, revealed the policy had last been reviewed in 1/15. Further review revealed no documented evidence that the policy had been revised since the last review in 1/15.

a. Elopements of PEC patients from the ED:


Patient #8 (current), Elopement: 1/11/16


Review of Patient #8's ED record revealed a date of service of 1/11/16, with a chief complaint of psychiatric evaluation for suicidal ideation. Further review revealed the patient's legal status was PEC (1/11/16 at 11:15 a.m.).


Review of the patient's ED History revealed the following, in part: To ED per ambulance with complaints of suicidal ideation, positive suicidal ideation and positive auditory hallucinations. Patient with history of depression , anxiety, homelessness presents with suicidal ideation, onset yesterday (1/10/16) after family disagreement, constant, severe, relieved by nothing. Feels like walking into traffic to kill himself and hearing voices that tell him to do so. No attempts.


Diagnosis: mood disorder and psychosis; Toxicology screen positive for cocaine and marijuana. Medically clear, Will seek inpatient psychiatric facility.


Review of the nurses note entries for Patient #8 revealed in part: legal status: PEC signed by MD: 1/11/16, 11:15 a.m. Further review revealed the patient had reported auditory hallucinations, " hearing voices telling me to hurt myself "; Judgment: impaired; Suicide check: Patient location: In room; Safety Precautions: Suicide; Interventions: Sitter: Visual checks, Continuous 1:1(CNA at bedside. Patient checked for contraband. Self injurious thoughts, actions, injuries: None observed.


On 1/11/16, at 3:50 p.m., a Code White (security code) was called in the ED. Upon arrival to the ED, staff indicated to the survey team that a code white (security code) had been called because Patient #8 had eloped to the front of the hospital from the emergency department through the ambulance bay doors. The patient was still outside at the time of the arrival of the surveyors to the ED.


On 1/11/16, at 4:00 p.m., an observation was made of the ED ambulance bay doors. The doors were noted to open to the outside of the hospital. A push button door release was located on the interior wall beside the bay doors. The hospital is located adjacent to a highway.


In an interview on 1/11/16, at 4:00 p.m., with S34CNA, she confirmed she was assigned to observe Patient #8. She indicated she had been assigned to "keep watch" of Patient #8 for his safety and to keep him in her sight. She reported the patient had left the room where she was observing him and had "acted like he was walking to the bathroom". She further reported she had been following the patient to the bathroom. S34CNA indicated the patient had just kept walking past the bathroom and walked out of the ambulance bay doors to the exterior of the hospital. S34CNA explained staff assigned to observe psychiatric patients in the ED routinely followed patients to the bathroom.

.
In interview on 1/11/16, at 4:00 p.m., with S3DON (acting ED nurse manager), she indicated PEC patients in the ED were held in 2 observation rooms with an anteroom located outside of the 2 rooms. She indicated patients PEC in the ED were placed on constant visual observation and were considered 1:1. S3DON reported staff was not expected to prevent patient elopement. She indicated the procedure for handling a patient elopement from the ED was to call a code white. S3DON indicated the hospital also alerted local law enforcement when a patient eloped to aid in the search for the patient. S3DON confirmed opening of the ambulance bay doors was controlled by a " push button " located at the side of the interior doors. S3DON indicated the second door of the ED that led into the hospital corridor had a push bar on the door that released from the inside. She confirmed both of the doors had been used as a means of elopement by PEC'd ED patients. She indicated the exit door in the anteroom located outside of the room where Patient #8 was being observed had remained open because the patient did not like "feeling closed in ".


In an interview on 1/12/16, at 8:35 a.m., with the S3DON, she indicated Patient #8 was still being held in the ED at this time awaiting placement at an inpatient psychiatric facility. She said the hospital usually initiated security for additional supervision after patients had attempted elopement. She said this pt. (#8) did not respond well to security. She confirmed no further actions had been initiated after the patient ' s elopement attempt.


Observations conducted on 1/12/16, at 8:57 a.m., 1/12/16, at 3:00 p.m., and 1/13/16, at 11:20 a.m., revealed no security staff was present, observing Patient #8, in the ED as back up staff to observe the patient after his elopement attempt on the afternoon of 1/11/16.


Patient #9 (discharged) -Elopement:11/20/15


Review of Patient #9's ED record revealed the patient presented with the chief complaint of suicidal ideation after attempting to hurt himself by running his car into a pole. Further review revealed the patient had a history of suicidal ideation (per psychiatric evaluation). Patient #9's diagnoses were documented as acute psychosis, depression, anxiety and suicidal intent.


Review of the Patient #9's ED history and physical revealed in part: Medical history including previous suicidal ideation and attempts. Presents in custody with suicidal ideation and attempt by deliberate motor vehicle collision. Pt. was brought by area ambulance service after being picked up on the scene of a motor vehicle accident. On arrival pt. stated he purposely tried to kill himself by running his car into a pole. He cites increasing stress at work as being reason for his current suicidal ideation and attempt. Further history reveals the pt. four years ago attempted to hang him-self and was subsequently hospitalized at an acute psychiatric facility.


Review of the hospital's occurrence report, dated 11/20/15, detailing Patient #9's elopement, revealed in part: Pt. walking to restroom, escorted by RN. Pt. ran out back door of ER and ran out back door leading to back parking lot. Security notified and grounds searched. Pt. not located on grounds. Additional review revealed the following abbreviated Root Cause Analysis (questions located on the incident report form): Unsafe act: pt. being monitored by staff member and not by security personnel; Unsafe condition: pt. being monitored by staff member and not by security personnel; Contributory factors: unknown; Why was act committed: unknown: Why did condition exist: unknown: Immediate action taken: have 2 staff members escort pt. to restroom; Long range action to be taken: Possibly have security personnel monitor PEC pt. 1:1. What additional assistance is needed to prevent recurrence: Possibly have security personnel monitor PEC pts.1:1.


In an interview on 1/11/16, at 10:30 a.m., with S3DON, she indicated patients PEC ' d in the ED were placed on strict visual contact. She also indicated staff assigned to monitor the above referenced patients included nursing staff, CNAs and security personnel.


In an interview on 1/12/16, at 10:50 a.m., with S2Director of PI/QA, she indicated an abbreviated root cause analysis had been performed on the back of the incident report after the above referenced elopement by Patient #9. She confirmed there had been no new policies instituted after the above referenced elopement. She also indicated the above referenced incident had not been evaluated in the hospital's Quality Assurance program and no new interventions had been put into place.



b. failure to maintain constant visual observation, during toileting, of suicidal patients PEC in the ED. The physical environment in the ED bathroom presented potential opportunities for self harm of the psychiatric patients.


Review of the policy titled, "Mental Health Patients: Assessment and Treatment of," policy #: 01-03.1-0014, effective date: 01/04, revealed in part:


Observation/Monitoring Guidelines: 1. Patients on strict visual contact shall be monitored by appropriately assigned personnel. 3. Patients may be placed on strict visual contact based on physician order or by RN assessment and evaluation. 9. Vigilance must be maintained during bath time, toileting, mealtime, early morning hours, during disturbances on the unit and after visitors leave. 10. Patient safety and personal rights must be considered at all times while on these precautions.


An observation on 1/11/16, at 10:30 a.m., of the ED bathroom used without strict visual contact by the PEC ' d ED patients revealed the following potential risks for self harm:

a. Exposed pipes under the sink-potential ligature anchor point;

b. Exposed ball valve plumbing for the toilet with a flanged handle-potential ligature anchor point;

c. Flanged sink handles and a gooseneck faucet-potential ligature anchor point;

d. 8 non-tamper resistant screws fastening the metal mirror to the wall;

e. interior door hinge with a protrusion on the top door hinge-potential ligature anchor point;

f. 2 plastic garbage bags in the trashcan.


In an interview during the observation, S3DON confirmed the above referenced findings and agreed they posed potential ligature/safety risks. She also confirmed the bathroom door could be locked from the inside. She indicated PEC'd patients in the ED were allowed to go to the bathroom without staff maintaining strict visual contact. S3DON further indicated staff stood outside the closed door in order to protect patient privacy.


In an interview on 1/11/16, at 4:00 p.m., with S34CNA, she explained staff assigned to observe psychiatric patients PEC'd in the ED routinely followed those patients to the bathroom. She said staff stood outside the closed door. She indicated if the patients were in the bathroom for a long time, "like 3 minutes," staff assigned to observe them checked on the patients through the door asking if they were okay.


2) failing to ensure strict visual contact observation was maintained for PEC'd patients in the ED according to hospital policy for 1 of 1 (#8) current sampled PEC ' d ED patients reviewed.


On 1/12/16, at 8:57 a.m., an observation was made of the Patient #8. He was in the ED observation room with the door closed and the lights were off. The door at the entry to the room had a small, elongated, rectangular shaped double paned clear glass window. Patient #8 could not be visualized by the surveyor through the window in the darkened room. S36CNA was seated at a bedside table in the anteroom located outside of the room where the patient was located. S36CNA could not visualize the patient through the window while seated because she was below the level of the window.


In an interview on 1/12/16, at 8:57 a.m., with S36CNA, she indicated she was assigned to observe Patient #8. She said she was to keep her eyes on the patient at all times. S36CNA further indicated that she checked on the patient every 30 minutes by looking through the window in the door if the patient was in the observation room with the door closed. She agreed she could not maintain strict visual contact with the patient at all times from where she was seated, with the door closed and the lights off in the room. S36CNA also agreed even if she had been standing, she could not visualize Patient #8 in the darkened room with the door closed.



3) failing to follow the hospital policy for restraints.

Review of the CAH policy for Restraint Usage: Violent and Non-Violent revealed in part,...E. A documented re-order, based on face-to-face examination of the patient by the Licensed Independent Practitioner is required every calendar day after the initiation of restraints under this section. F. The Licensed Independent Practitioner authorizes continued use of restraint beyond the first 24 hours by documented order in the medical record after face-to-face assessment of the patient and of the need for restraint.


Review of the EMR for Patient #1 revealed the patient was admitted on 10/30/15, with a diagnosis of Altered Mental Status and Diabetes. Further review of his EMR revealed he was ordered soft wrist restraints on 10/31/15 until 11/3/15, when he was transferred to another hospital. Additional review of the EMR revealed the physician did not document a face-to-face assessment for the continued usage of the restraints on 11/1/15 and 11/2/15.


An interview was conducted with S7Program Coordinator Quality on 1/11/16, at 2:15 p.m. With review of the EMR, she reported Patient#1 was in soft wrist restraints from 10/31/15 until 11/3/15. S7Program Coordinator Quality reported, with further review of the EMR, there was no face-to-face assessment conducted on the patient by the physician while the patient was in restraints for 11/1/15 and 11/2/15.


30984

Based on record review and interview, the CAH (Critical Access Hospital) failed to ensure identified medication errors were documented in the patient's medical record and the notification of the physician of the medication error was documented in the patient's medical record for 2 of 2 (Patient #R1 and Patient #R2) hospital identified medication errors reviewed.


Findings:


Review of the hospital's policy titled Medication Variance, Policy Number 01-04.0-0601, revealed in part, all medication variances will be reported online through the software program and the House Supervisor and the physician will be notified when a variance occurs.


Patient #R1

Review of the Medication Variance Reporting form for Patient #R1 revealed on 12/15/15, at 11:00 a.m., Patient #R1 did not received the 11:00 a.m. dose of insulin as ordered.


In an interview and electronic record review with S8RN on 01/12/16, at 2:00 p.m., the medical record of Patient #R1 revealed no documentation of the medication error or if the physician was notified of the medication error. S8RN confirmed there was no documentation of the medication variance or physician notification of the error in the patient's medical record.


Patient #R2

Review of the Medication Variance Reporting form for Patient #R2 revealed on 11/18/15, at 9:00 a.m., Patient #R2 did not received the 9:00 a.m. dose of Daptomycin (Intravenous antibiotic) as ordered (every 24 hours).


In an interview and electronic medical record review with S8RN on 01/12/16, at 1:35 p.m., the medical record of Patient #R2 revealed no documentation of the medication error or if the physician was notified of the medication error. S8RN confirmed there was no documentation of the medication variance or physician notification of the error in the patient's medical record.

Based on record reviews, observations, and interviews the CAH failed to maintain a comprehensive and ongoing Infection Control Program designed to prevent, control, and investigate infection control practices that included: data collection, tracking, trending and analysis of infection control practices/breaches through monitoring and surveillance of all the services of the CAH, active surveillance of infection control practices to identify infection control breaches with implementation of corrective actions to prevent and control infections, monitoring of compliance with all infection control policies, procedures, protocols and other infection control program requirements that were implemented by the facility and the CAH failed to ensure that the designated Infection Control Officer was qualified through training and experience in infection control practice and/or procedures as an Infection Control Officer.


Findings:


A review of the CAH policy titled "Infection Control Plan" provided by S3DON and S39RN/IC as the most current, revealed in part: To prevent infections throughout the organization and services by identifying opportunities through intense surveillance, monitoring, and control of infections. The Infection Control Officer will be responsible for coordinating data collection and the evaluation of data for the department, as well as measuring, assessing, and improving important care and transforming the data into information to be presented to the Infection Control Workgroup.


A review of the CAH policy titled "Infection Control Guidelines for the Surgery Department" provided by S3DON and S39RN/IC as the most current, revealed in part: To establish and maintain infection control guidelines involving O.R. environment, personnel, patient preparation and O.R. cleaning. Infection control in the O.R. will be a jointly shared responsibility of the O.R. surgical staff and the Infection Control nurse in compliance with the AORN (Association of periOperative Registered Nurses) guidelines.


In an interview on 01/13/16, at 10:50 a.m., with S39RN/IC, she indicated that she was the designated Infection Control Officer for the CAH. S39RN/IC indicated that the CAH followed the professional standards of practice of AORN (Association of periOperative Registered Nurses), CDC (Centers for Disease Control and Prevention), and APIC (Association for Professionals in Infection Control and Epidemiology). S39RN/IC further indicated that she was new in the position and had only been the Infection Control Officer for 2 months. She indicated that she was informally trained by the prior Infection Control Officer for the 2 months prior to her assuming the position and had no prior infection control training or experience prior to her assuming the position as the Infection Control Officer 2 months ago. S39RN/IC indicated that she did attend an infection control conference a couple of months ago and had recently become an APIC member, but had not completed any other infection control training, in-services or online training.


S39RN/IC was asked for the documented evidence of the CAH's active surveillance monitoring that included: data collection, tracking, trending and analysis of infection control practices/breaches with implementation of any corrective actions and evaluations. S39RN/IC indicated that she was not tracking, trending or analyzing the data she was collecting and had established no corrective actions for any of the identified infection control breaches/issues that she identified in her monthly environmental rounds. S39RN/IC indicated that she conducted the monthly environmental rounds each month in a different department. S39RN/IC further indicated that she also conducted informal "pass through's" of the departments, but she was not documenting anything. She indicated that she had no documentation of any data analysis, tracking, trending or follow-ups that she was currently reporting to the Department Manager (S2Director of PI/QA) or to QA (Quality Assurance).


S39RN/IC was made aware of the multiple infection control breaches/issues identified by the surveyor through observations in the surgical areas. S39RN/IC indicated that in September and October, she conducted environmental rounds in the surgical areas. She indicated that she made note of any infection control issues and informed the O.R. personnel to correct the infection issues. S39RN/IC was asked for the identified infection control breaches that were identified in the O.R. in September. In a review of the report with S39RN/IC, it revealed in part the following identified infection control breaches/issues:

-dust in some of the areas and on equipment,

-boxes on the floor,

-syringes opened and labeled and not monitored,

-lids off of sharps container,

-light bulbs out,

-O.R. door left open during a surgical procedure,

-linens uncovered,

-mask around necks,

-an area where dirty and clean were mixed and

-a personal scrub hat on an employee.


S39RN/IC indicated that she conducted another environmental round of the O.R. in October to see if corrections had been made, but had not implemented any data analysis with tracking or trending to identify any opportunities of improvements or to develop any corrective actions with evaluations to ensure that compliance was improved and/or maintained. S39RN/IC indicated that this was her process for all departments in the CAH.


S39RN/IC indicated that most of the infection control breaches/issues identified by the surveyor in the O.R. had not been identified by Infection Control. She indicated that she did not conduct any environmental rounds or follow-ups for December in any of the departments.


S39RN/IC was unable to provide any other surveillance monitoring other than environmental round data documentation and a report indicating the number of employees that were monitored for hand hygiene in each department each month (no other specific hand hygiene data analysis was evidenced or provided).


She further indicated that there were 5 (five) SSI (surgical site infections) identified in November and December, as MRSA wound infections and she had not started tracking or investigating the sources for possible links to the infections. S39RN/IC was asked about the prior Infection Control Officer's prior reports that identified tracking, trending, analysis, or any documented corrective actions with opportunities for improvement and/or evaluations that could demonstrate on ongoing Infection Control Program in the CAH. S39RN/IC was unable to provide any further documented evidence of an ongoing Infection Control Program. S39RN/IC indicated that she did not have any other available documentation to present to the surveyor that she maintained or that was maintained by the prior Infection Control Officer.


S39RN/IC was made aware of other department's functional and sanitary infection control issues/breaches that were identified by the other DHH surveyors to include:

a) On 1/11/16, at 10:15 a.m., an observation was made of a red biohazard waste receptacle in a bio-hazardous waste storage room located on a patient care hall (across the hall diagonally from room number 102). A crack was noted on the bottom of the left side of the can and a wet spot was noted on the floor beneath the cracked area. The above referenced finding was confirmed by S3DON during the observation. She indicated housekeeping needed to address the issue of the leaking biohazard waste receptacle.


b) During an observation on 01/11/16, at 9:45 a.m., with S3DON of the Med-Surg inpatient unit, 2 portable/rolling blood pressure machines and 1 portable/rolling thermometer were observed to have multiple pieces of transpore clear tape and tape residue. S3DON confirmed the patient care equipment did not have a smooth wipeable surface for disinfection due to the tape/tape residue.


c) During an observation on 01/11/16, at 10:20 a.m., with S3DON of the ICU, the radiology terminal was observed to have an accumulation of dust on the keyboard and the monitor screens. S3DON confirmed the observations. Also observed in the ICU was a mobile computer workstation with multiple pieces of transpore clear tape and tape residue. The tape was observed to secure a clear, plastic screen to the desk portion of the workstation. S3DON confirmed the observations and the workstation did not have a smooth wipeable surface for disinfection.


d) During an observation on 01/11/16,10:30 a.m., with S2Director of PI/QA, the infant scale was observed to have a strip of tape on the front of the scale. S2Director of PI/QA confirmed the presence of the tape and confirmed the scale did not have a smooth wipeable surface for disinfection. Also observed in the ED was tape residue on the crash cart. An accumulation of dust was observed on the pediatric crash cart and on the adult defibrillator. S2Director of PI/QA confirmed the observations.


e) During an observation on 01/12/16, at 11:00 a.m., with S45Dir of Ancillary Services of the CT scan room, the injection pole was observed to have an accumulation of a white substance on the base and a black substance in the bin attached to the pole. An overbed table was observed to have sticky tape residue on the sides of the table. A mobile computer workstation was observed on the right side of the CT scanner. The mobile computer workstation was observed to have tape residue on the desk area. S46RT also present for the observation stated the workstation was used by the physician during procedures. S45Dir of Ancillary Services confirmed the presence of the tape residue and confirmed the workstation did not have a smooth wipeable surface for disinfection.



S39RN/IC had no comment regarding the above infection control breaches identified by the other DHH surveyors.


In an interview on 01/13/16, at 12:00 p.m., with S2Director of PI/QA, she indicated that she was the supervisor for the Infection Control Officer, S39RN/IC. S2Director of PI/QA was made aware of the above interview with S39RN/IC. S2Director of PI/QA indicated that she had environmental round data sheets from the prior Infection Control Officer, but no analysis and tracking/trending information. S2Director of PI/QA did not present any other infection control documentation for the surveyor to review. S2Director of PI/QA further indicated that she (S2Director of PI/QA) had basic infection control knowledge as a nurse and would not consider herself qualified in infection control. She further indicated that S39RN/IC was new as the Infection Control Officer and only had about 2 months of experience.


30984




17091

Based on observations, interviews, and record reviews, the CAH failed to ensure nursing services were provided to meet the needs of the patient as evidenced by:

1) failing to ensure nursing staff assigned to monitor telemetry patients were continuously monitoring the current inpatients on telemetry monitoring for 2 of 2 (#6, #21) current inpatients who had physician orders for telemetry (cardiac) monitoring, and;

2) Assigning ICU nursing staff to provide nursing care for ICU patients and monitor telemetry patients on the medical/surgical inpatient unit.

Findings:

Review of the hospital's policy titled Telemetry/Cardiac Monitoring, policy number 01-03.3-0007 provided by S2Director of PI/QA as current, revealed implementation and discontinuance of telemetry were based on physician order. The policy revealed the ICU nurse was responsible for setting alarm limits, printing strips and documenting interpretation of the rhythm. There was no provision in the policy indicating who was responsible for continuous telemetry monitoring.

During an observation of the Med-Surg unit on 01/11/16, at 9:45 a.m., S47Mgr. of ICU/Med-Surg was observed on the Med-Surg unit.

During an observation of the ICU on 01/11/16, at 10:20 a.m., with S3DON, there was no staff observed to be monitoring the telemetry patients. Patient #5 was observed to be a current ICU patient. S47Mgr. of ICU/Med-Surg and S9RN were observed to be outside the nurse's station, conversing with a physician. S3DON stated S47Mgr. of ICU/Med-Surg was assigned to monitor telemetry. S3DON confirmed no staff were observing the telemetry monitor and stated they have alarms on. Observation of the cardiac monitor revealed Patients #6 and #21 were the telemetry patients from the Med-Surg unit.


Further observations made in the ICU on 01/11/16, revealed the following:

12:45 p.m. - S9RN was observed to be making entries in the electronic medical record for Patient #5. S47Mgr. of ICU/Med-Surg was observed to be seated at the telemetry monitor, but was reviewing the patient's medical record in an adjacent computer.

1:15 p.m. - No staff observing telemetry monitor. S9RN was reviewing electronic medical record with surveyor and S3DON and S47Mgr. of ICU/Med-Surg were standing away from the telemetry monitor, conversing.

2:05 p.m. - No staff observing telemetry monitor. S47Mgr. of ICU/Med-Surg and staff from information technology were at the adjacent computer.


In an interview on 01/11/16, at 2:30 p.m., S9RN and S48RN House Supervisor both confirmed the ICU nurse was responsible for monitoring the hospital's telemetry patients. S9RN stated if there are no ICU patients, the ICU RN monitors the telemetry from the Med-Surg unit and that was the nurse's only assignment. S9RN stated if there is an ICU patient, the RN is assigned the care of the patient and is responsible for monitoring the telemetry patients from the cardiac monitor in ICU. S9RN confirmed she could not maintain continuous observation of the telemetry monitor at all times when there are patients in ICU. S48RN House Supervisor confirmed the assignment procedure and stated she tried to stay in ICU as much as possible to assist with monitoring telemetry.


In an interview on 01/11/16, at 3:05 p.m. S8RN, who was assigned to the Med-Surg unit, stated Telemetry was monitored in ICU and stated the ICU staff was responsible for printing and documenting the rhythm strips. S8RN confirmed Patient #6 and Patient #21 were currently being monitored by telemetry.


Review of the medical record for Patient #6 revealed the patient was admitted to the hospital on 01/05/16, with diagnoses of Metastatic Neck and Lung Cancer, Health-Care Associated Pneumonia and Sepsis. Review of the physician orders revealed Telemetry was ordered on 01/05/16, at 6:19 p.m.


Review of the medical record for Patient #21 revealed the patient was admitted to the hospital on 01/06/16, with diagnoses of Congestive Heart Failure and Atrial Fibrillation (cardiac arrhythmia). Review of the physician orders revealed Telemetry was ordered on 01/06/16 at 8:47 p.m.


In an interview on 01/13/16, at 11:15 a.m., S44RN confirmed she was an ICU nurse, but was assigned to monitor telemetry on the Med-Surg unit today as there were no patients in ICU. S44RN confirmed when there are patients in the ICU, the ICU nurse was assigned the ICU patient care and the monitoring of the Med-Surg telemetry. S44RN stated when in a patient room in ICU, the ICU nurse can only see telemetry patient rhythms if that rhythm is alarming.

Based on record reviews and interview, the hospital failed to ensure the registered nurse (RN) supervised and evaluated the nursing care for each patient as evidenced by:


1) Failure to ensure each patient was assessed at least every 24 hours by the RN as required by the Louisiana State Board of Nurse's Practice Act as evidenced by having patient care provided by LPNs without documented evidence of a RN assessment at a minimum of every 24 hours for 2 (#21) of 4 (#5, #6, #8, #21) sampled patient records reviewed and 2 of 2 (R1, R2) random patient records reviewed for RN assessments from a total sample of 21 patient records reviewed and 2 random patients;


2) Failure to ensure orders relative to the initiation and/or titration of continuous medication infusions were clarified prior to implementation by nursing staff as evidenced by failing to obtain dosing increments and intervals for initiation and/or titration for 2 of 2 (#1, #5) sampled patient records reviewed for continuous medication infusions out of a total sample of 21 patient records reviewed. Patient #5 was a current inpatient, and;


3) Failure to ensure orders relative to the use of sliding scale insulin administration were clarified prior to implementation by nursing staff as evidenced by failing to obtain the physician's order for the frequency of blood glucose accuchecks and insulin administration for 1 of 1 (#R2) random patient and 2 sampled patients (#1, #5) reviewed for sliding scale insulin administration out of a total sample of 21.


Findings:


1) Failure to ensure each patient was assessed at least every 24 hours by the RN as required by the Louisiana State Board of Nurse's Practice Act:


Review of the LSBN's Practice Act revealed that RNs may delegate select nursing interventions to the LPN provided the patient is assessed by an RN every 24 hours.
Review of the Louisiana State Board of Nursing's "Administrative Rules Defining RN Practice LAC46:XLVII" revealed, in part,

"3703. Definition of Terms Applying to Nursing Practice ... Delegating Nursing Interventions - ... The registered nurse retains the accountability for the total nursing care of the individual. ... The registered nurse shall assess the patient care situation which encompasses the stability of the clinical environment and the clinical acuity of the patient, including the overall complexity of the patient's health care problems.

The assessment shall be utilized to assist in determining which tasks may be delegated and the amount of supervision which will be required.

a. Any situation where tasks are delegated should meet the following criteria: i. the person has been adequately trained for the task; ii. the person has demonstrated that the task has been learned; iii. the person can perform the task safely in the given nursing situation; iv. the patient's status is safe for the person to carry out the task; v. appropriate supervision is available during the task implementation; vi. the task is in an established policy of the nursing practice setting and the policy is written, recorded and available to all.

b. The registered nurse may delegate to licensed practical nurses the major part of the nursing care needed by individuals in stable nursing situations, i.e. (that is), when the following three conditions prevail at the same time in a given situation: i. nursing care ordered and directed by R.N./M.D. (medical doctor) requires abilities based on a relatively fixed and limited body of scientific fact and can be performed by following a defined nursing procedure with minimal alteration, and responses of the individual to the nursing care are predictable; and ii. change in the patient's clinical conditions is predictable; and iii. medical and nursing orders are not subject to continuous change or complex modification..."


Review of the hospital policy titled, Assessment of Patients and Family, policy number 01-03.1-0007, provided by S2Director PI/QA as the hospital's policy for RN assessments, revealed each discipline would identify the frequency of reassessment. There was no documented evidence of a provision for the RN to assess the patient at least every 24 hours.


Review of the hospital policy titled, Charting and Documentation, and Definition of Descriptors, policy number 01-03.2-0004, provided by S2Director PI/QA as the hospital's policy for RN assessments, revealed a full systems assessment on inpatients shall be completed on each patient at the beginning of each shift. There was no documented evidence of a provision for the RN to assess the patient at least every 24 hours.


Patient #8

Review of the EMR for Patient #9 revealed the patient was admitted to the hospital on 12/28/15, with a diagnosis of Chest Pain. Review of the ED record revealed the patient expressed suicidal ideations and was PEC'd on 12/28/15, at 10:48 a.m. Further review of the record revealed the patient was admitted to the hospital after the patient was unable to be cleared medically due to a heart rate of 41.


Review of the patient's nursing notes revealed the only nursing assessments documented were by the LPNs for the day shifts and the night shifts on 01/01/16, 01/03/16, and 01/04/16.

In an interview on 01/12/16, at 3:30 p.m., S8RN reviewed the electronic medical record and confirmed Patient #8 was not assessed by an RN on 01/01/16, 01/03/16, and 01/04/16. S8RN confirmed there was no current process in place for the RN to assess the inpatient at least once every 24 hours.


Patient #21

Review of the medical record for Patient #21 revealed the patient was admitted to the hospital on 01/06/16 with a diagnosis of Congestive Heart Failure. Review of the patient's nursing notes revealed on 01/07/16 and 01/08/16, the only nursing assessments documented were by the LPNs for the day shifts and the night shifts.

In an interview on 01/12/16, at 3:15 p.m., S8RN reviewed the electronic patient record and confirmed Patient #21 was not assessed by an RN on 01/07/16 and 01/08/16. S8RN confirmed there was no current process in place for the RN to assess the inpatient at least once every 24 hours.


Patient #R1

Review of the medical record for Patient #R1 revealed the patient was admitted to the hospital on 11/09/15, and discharged on 11/23/15, had a diagnosis of Peripheral Vascular Disease and Osteomyelitis. Review of the patient's nursing notes revealed the only nursing assessments documented were by the LPNs for the day shifts and the night shifts on 11/13/15, 11/14/15, 11/15/15, 11/17/15, 11/18/15, and 11/19/15.

In an interview on 01/12/16, at 1:35 p.m., S8RN reviewed the electronic medical record for Patient #R1 and confirmed there were no nursing assessments done by an RN on the above dates. S8RN confirmed there was no current process in place for the RN to assess the patient at least every 24 hours and stated the LPN assigned to the patient did the assessment of the patient.


Patient #R2

Review of the medical record for Patient #R2 revealed the patient was admitted to the hospital on 12/14/15, and discharged on 12/17/15, had a diagnosis of Diabetes Mellitus and Morbid Obesity. Review of the patient's nursing notes revealed on 12/16/15 the only nursing assessments documented were by the LPNs for the day shift and the night shift.

In an interview on 01/12/16, at 2:00 p.m., S8RN reviewed the electronic medical record for Patient #R2 and confirmed there was no assessment by the RN on 12/16/15.


2) Failure to ensure orders relative to the initiation and/or titration of continuous medication infusions were clarified prior to implementation by nursing staff:

Review of the hospital policy titled, Practitioners Orders: Acceptable Practices Relative to Orders, policy number 01-04.0-0311, revealed in part the following:

Orders should be clear and concise. Medication orders shall include: dose, route, frequency or rate of administration....Titrating Orders are orders in which the dose is either progressively increased or decreased in response to the patient's status may be utilized based on medical staff approved protocols or guidelines for that particular medication or class of medication.


Patient #1

Review of the EMR of Patient #1 revealed he was admitted to the hospital on 10/31/15, with Altered Mental Status and Diabetes. Further review of the EMR revealed a physician's order for Propofol infusion, initiate infusion at 5 mcg/kg/min (micrograms/kilogram/minute). May adjust rate by 50 mcg/kg/min every 30 minutes to achieve sedation goal. Do not exceed 50 mcg/kg/min. Continued review of the Propofol infusion orders revealed no orders/directions for the nursing staff as to the desired patient sedation goal. Review of the EMR revealed no clarification by the physician on the desired patient sedation goal.


An interview was conducted with S10QA (Quality Assurance) on 1/12/16, at 8:25 a.m., She reported the physician's order to titrate to sedation goal was too subjective and should have been clarified by the nursing staff. She further reported the hospital had no policy on Propofol administration.


Patient #5

Review of the EMR of Patient #5 with S9RN on 01/11/16, at 12:40 p.m., revealed Patient #5 was admitted to the ICU on 01/10/16 with a diagnosis of Diabetic Ketoacidosis (DKA). Review of the record revealed a continuous insulin infusion was administered to Patient #5 on 01/10/16, from 5:19 a.m. to 10:00 a.m.


Review of the physician's order for the insulin infusion revealed the following: Insulin Regular 100 units in Sodium Chloride 0.9% 100 ml infusion. There was no documented evidence in the record of a clarification order that directed the nurse to utilize an insulin infusion protocol, nor was there an order for directions on when to decrease the infusion or by what amount to decrease it by.


In an interview on 01/11/16, at 12:50 p.m., S9RN stated the nurses use a dosing chart to calculate and decrease the insulin infusion. S9RN provided the dosing chart for review and stated the rate changes were based on the amount the blood glucose changed. S9RN stated the changes were made after the calculations were checked by 2 nurses and the amount of rate change was according the the rate chart on the protocol. S9RN confirmed this protocol/dosing chart had been used to adjust Patient #5's insulin infusion. After reviewing the EMR physician orders, S9RN confirmed there was no order from the physician to use this protocol and there were no specific orders for how/when to decrease the insulin infusion.



In an interview on 01/11/16, at 4:15 p.m., S2Director of PI/QA provided a protocol for insulin infusions that was used by the hospital prior to the implementation of electronic medical records system (05/2013). S2Director of PI/QA stated the hospital did not have a policy and procedure for the use of the dosing chart and the current insulin infusion protocol being used in ICU.


In an interview on 01/12/16, at 9:05 a.m., S10QA stated she had reviewed the EMR for Patient #5 and confirmed there was no order to titrate the insulin infusion and stated the order was written incorrectly by the physician. S10QA confirmed the nurse should have contacted the physician and obtained a clarification order for the insulin infusion.




3) Failure to ensure orders relative to the use of sliding scale insulin administration were clarified prior to implementation by nursing staff as evidenced by failing to obtain the physician's order for the frequency of blood glucose accuchecks and insulin administration:


Patient #R2
Review of the medical record for Patient #R2 with S8RN on 01/12/16, at 2:00 p.m., revealed the patient was admitted to the hospital on 12/14/15, discharged on 12/17/15, had a diagnosis of Diabetes Mellitus and Morbid Obesity. Review of the physician orders dated 12/15/15, at 3:07 p.m. revealed an order for sliding scale insulin. The frequency of administration was documented as, "See Admin Instructions." There was no documented evidence of how often the blood glucose was to be checked and the insulin administered. There was no documented evidence of an order to clarify how often the blood glucose and sliding scale insulin was to be administered.


Review of the medication administration records revealed Patient #R2 received sliding scale insulin on 12/15/15, 12/16/15, and 12/17/15.


In an interview on 01/12/16, at 2:00 p.m., S8RN confirmed there was no physician's order for how often to administer sliding scale insulin. S8RN confirmed the accuchecks were done by the nurse. S8RN stated she thought the nurses knew the patient was diabetic and knew they needed to check the patient's blood glucose, but there was no physician's order to check the blood glucose. She confirmed there was no order for how often to check the blood glucose. S8RN confirmed the nurses should have clarified the physician's order for the sliding scale insulin to include a frequency of administration.


26351

Based on record reviews, observations, and interviews, the CAH (Critical Assess Hospital) failed to ensure the assignment of nursing personnel for patient care services was done in accordance with nursing personnel competence by:


1) failing to ensure 3 out of 3 (S9RN, S42RN, S44RN) staff reviewed who monitored patients on moderate sedation had annual competencies in Propofol infusion administration, and failing to ensure that 4 of 4 RNs (S21RN/OR, S24RN/OR, S26RN/OR S27RN/OR) who administer Conscious Sedation/Analgesia in the O.R. had annual competencies in Conscious Sedation/Analgesia.


2) failing to ensure 2 of 2 (S9RN, S42RN) nursing staff who calculated and titrated insulin infusions according to a hospital protocol had documented competencies in the insulin infusion protocol.



Findings:


1) failing to ensure 3 out of 3 (S9RN, S42RN, S44RN) staff reviewed who monitored patients on moderate sedation had annual competencies in Propofol infusion administration and failing to ensure that 4 of 4 RNs (S21RN/OR, S24RN/OR, S26RN/OR S27RN/OR) who administer Conscious Sedation/Analgesia in the O.R. had annual competencies in Conscious Sedation/Analgesia.


Review of the CAH's policy on Moderate Sedation revealed in part, Moderate Sedation shall only be administered by the Registered Nurse or LIP (Licensed Independent Practitioner) having documented completion of moderate sedation competencies. RN competencies will be measured initially and on an annual basis


Review of the personnel record for S44RN revealed her last competencies for Moderate Sedation Skills was 01/13/10. S44RN provided care to Patient #1, who was on a Propofol infusion during his hospital admission on 10/3/15 to 11/3/15.


An observation on 01/11/16, revealed that Patient #13 had an operative procedure with Conscious Sedation/Analgesia monitoring with S27RN/OR.


A review of the personnel files for S21RN/OR, S24RN/OR, S26RN/OR S27RN/OR revealed their last Conscious Sedation/Analgesia competency was dated 2010.


An interview was conducted with S3DON on 01/13/16, at 11:00 a.m. She reported the competencies for the registered nurses on moderate sedation had not been performed annually as set forth by the CAH's policy.


In an interview on 01/12/16, at 8:10 a.m., S9RN stated the ICU nurses administer Propofol infusions to patients on ventilators in the ICU.


Review of the personnel record for S9RN and S42RN revealed both RNs worked in the ICU. Review of the personnel record for S9RN revealed the last documented competency for Moderate Sedation was 01/11/10. Review of the personnel record for S42RN revealed the last documented competency for Moderate Sedation was dated 12/04/12.


In an interview on 01/13/16, at 11:20 p.m., S43EdDir confirmed the nursing competency for Moderate Sedation was only done upon hire and was not done annually.



2) failing to ensure 2 of 2 (S9RN, S42RN) nursing staff who calculated and titrated insulin infusions according to a hospital protocol had documented competencies in the insulin infusion protocol:


Review of the EMR of Patient #5 with S9RN on 01/11/16, at 12:40 p.m., revealed Patient #5 was admitted to the ICU on 01/10/16 with a diagnosis of Diabetic Ketoacidosis (DKA). Review of the record revealed a continuous insulin infusion was administered to Patient #5 on 01/10/16 from 5:19 a.m. to 10:00 a.m. The record revealed S42RN had administered the insulin infusion also.


In an interview on 01/11/16, at 12:50 p.m., S9RN stated the ICU nurses used a dosing chart to calculate and decrease the insulin infusion. S9RN provided the dosing chart for review and stated the rate changes were based on the amount the blood glucose changed. S9RN stated the changes were made after the calculations were checked by 2 nurses and the amount of rate change was according the the rate chart on the protocol. S9RN confirmed this protocol/dosing chart had been used to adjust Patient #5's insulin infusion. After reviewing the EMR physician orders, S9RN confirmed there was no order from the physician to use this protocol and there were no specific orders for how/when to decrease the insulin infusion.


In an interview on 01/11/16, at 4:15 p.m., S2Director of PI/QA provided a protocol for insulin infusions that was used by the hospital prior to the implementation of electronic medical records system (05/2013). The protocol revealed a developed date of 12/09/10. S2Director of PI/QA stated the hospital did not have a policy and procedure for the use of the dosing chart and the current insulin infusion protocol being used in ICU.


Review of the personnel records and training records for S9RN and S42RN revealed the following:


S9RN - Date of hire of 08/25/09. The training record revealed an Initial Skill/Competency Validation form that indicated demonstration of an insulin infusion on 12/28/09, prior to the development of the insulin infusion protocol. There was no documented evidence of any further competency evaluations for insulin infusions.


S42RN - Date of hire of 05/29/01. The training record revealed an Initial Skill/Competency Validation form that indicated verbal knowledge of an insulin infusion was documented 12/17/12. There was no documented evidence of competency assessment of the insulin protocol used by the ICU. There was no documented evidence of any further competency evaluations for insulin infusions.


In an interview on 01/13/16, at 11:20 a.m., S43EdDir confirmed the hospital had no other documentation of competency evaluations on insulin infusions for S9RN and S42RN other than the Initial Skill Competency Validation forms.


In an interview on 01/13/16, at 11:30 a.m., S2Director PI/QA confirmed the hospital did not do competency evaluations for administration of insulin infusions according to the current protocol. S2Director PI/QA also confirmed the hospital did not have a policy and procedure for the insulin infusion protocol.


26351




17091

Based on record review and interview, the hospital failed to ensure that the nursing staff developed and kept current a nursing care plan for each patient as evidenced by failing to individualize the patient's nursing care plan to include all of the patient's medical diagnoses for which the patient was being treated for 2 (#6, #10) of 8 (Patient #2, #3, #5, #6, #7, #10, #11, #21) sampled patients' medical records reviewed for a nursing care plan.


Findings:


Review of the hospital policy, Nursing Plan of Care, revealed in part, Procedure: 1. Problems/Nursing Diagnosis will be developed using information gathered from the patient assessment...3. The standard of Care Plan will be modified and adapted to meet the identified needs of each individual by adding and deleting interventions. 4. The Nursing Care Plan will be kept current and modified to meet the ongoing assessed needs of the patient as well as the patient's response to interventions.


Patient #6

Review of the EMR for Patient #6 with S8RN on 01/12/16, at 8:30 a.m., revealed the patient was a 60 year old admitted to the hospital on 01/05/16, and was currently an inpatient. The patient's diagnoses included Lung and Neck Cancer, Acute Kidney Injury, and Sepsis. Review of the EMR revealed the patient had elevated Calcium levels since admission and had received Aredia (Medication used to decrease Calcium) on 01/08/16, and 01/11/16.


Review of the plan of care for Patient #6 revealed no documented evidence that electrolyte imbalance or the patient's problem of elevated calcium had been included in the plan of care.


In an interview on 01/12/16, at 8:30 a.m., S8RN confirmed the patient was being treated for the elevated calcium levels and the problem was not included in the patients plan of care.


Patient #10

Review of Patient #10's EMR (Electronic Medical Record) revealed the patient was admitted on 11/6/15, for Pulmonary Embolism, COPD(Chronic Obstructive Pulmonary Disease) with exacerbation and Pain.


Further review of her EMR revealed during her hospital stay her pain was assessed as a 9 (on a scale from 1 -10) with sharp, back pain on 11/6/15, at 10:01 p.m.. On 11/7/15, at 7:31 a.m., Patient #10's pain was assessed at a 7, with the character of the pain being described as sharp and located in her shoulder. At 1:39 p.m. on 11/7/15, her pain was assessed at a 5. Review of the MAR (Medication Administration Record) revealed she received pain medication while in the hospital for her pain. The patient was discharged on 11/7/15.


Review of her EMR plan of care revealed Pain was not listed as problem for Patient #10 and no interventions were documented for her pain.


An interview was conducted with S8RN on 1/12/16, at 10:30 a.m., she reported pain was not listed as a problem on Patient #10's plan of care and the patient's pain should have been addressed in the care plan.


17091

Based on record reviews, observations, and interviews, the CAH (Critical Access Hospital) failed to meet the Conditions of Participation for Surgical Services by failing to ensure the CAH followed acceptable professional standards of practice governing surgical services and infection control as evidenced by:


1) failing to ensure that surgical instruments were available in a quantity that was commensurate with the CAH's expected daily procedure volume, as evidenced by the CAH's routine use of IUSS (Immediate Use Steam Sterilization) of surgical instruments for surgical procedures,


2) failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted and semi-restricted areas,


3) failing to ensure that the CAH maintained sterile equipment and clean supplies in a functional and sanitary environment and failing to ensure that acceptable workflow patterns, disinfecting practices and surgical protocols were adhered to,


4) failing to have properly executed informed consents that were complete and contained all of the required elements (proposed procedure, patient condition, indications, materials risks and benefits, treatment alternatives, the physician performing the procedure and the type of anesthesia) for 3 of 3 (#14, #19, #22) medical records reviewed for informed consents out of a total sample of 21 medical records, and

5) failing to ensure that personnel (surgery staff and physicians) were provided with a surgery changing area (room) to change from home attire and/or outside attire to the hospital provided clean surgical attire for personnel working in the restricted and semi-restricted surgical areas of the hospital.


Findings:

1) failing to ensure that surgical instruments were available in a quantity that was commensurate with the CAH's expected daily procedure volume, as evidenced by the CAH's routine use of IUSS (Immediate Use Steam Sterilization) of surgical instruments for surgical procedures.


A review of AORN (Association of periOperative Registered Nurses) Guidelines for Perioperative Practice, 2015 edition - Guideline for Sterilization: Recommendation VII revealed in part: Immediate Use Steam Sterilization (IUSS) should be kept to a minimum and should only be used in selected clinical situations. Immediate use is considered the shortest time possible between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field. IUSS should only be used when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. IUSS should not be used as a substitute for insufficient inventory.

A review of the CAH's IUSS log from 10/01/15, to present revealed over 28 pages of instruments that were IUSSed for a total of over 136 elective patient surgical procedures. The review further revealed that the most common items IUSSed was the endoscopy cameras, which were IUSSed over 88 times and the laparoscopy instruments which were IUSSed over 44 times for elective surgical procedures. Other surgical instruments with a high IUSS incidence from 10/01/15 to present included in part: cystoscopy instruments. A further review of the IUSS log book revealed no documented evidence indicating that the above items were IUSSed due to an urgent or emergent event or identified the clinical situation(s) present that required the item(s) to be IUSSed. The review further revealed that 8 patient procedures had no indication listed as to type of surgical instruments that were IUSSed with the item section identifying the instrument(s) that were IUSSed was blank.

In an interview on 01/11/16, at 3:00 p.m., with S21RN/OR, she indicated that she was the interim operating room supervisor. S2RN/OR was asked about the routine use of IUSS in the O.R. (operating room). She indicated that the O.R. had to IUSS instruments when scheduled elective cases were greater than their available supplies and there was not enough time for the O.R. to sterilize the instruments by the preferred method. S21RN/OR indicated that the O.R. had limited instruments to include in part: 1 (one) gynecological laparoscopic set and 2 (two) general laparoscopic sets, cystoscopy sets and endoscopic cameras. S21RN/OR indicated that she only kept track of the numbers of times IUSS was performed and not the specifics on each time IUSS was performed. S21RN/OR indicated that she reviewed the IUSS log informally and did not document with tracking, trending or analysis the IUSS use in the O.R. S21RN/OR further indicated that the O.R. did not have a present policy in place indicating the specific conditions and clinical situations that should be met and/or required before an item was IUSSed.

In an interview on 01/13/16, at 10:50 a.m., with S39RN/IC, she indicated that she was the designated Infection Control Officer for the CAH. S39RN/IC was asked about the monitoring of IUSS in the O.R. S39RN/IC indicated that she was not monitoring IUSS in the O.R. and was not aware of any prior monitoring of IUSS in the O.R. S39RN/IC indicated that the Infection Control Program had no documented evidence of a quality monitoring system in place with tracking/trending/analysis of IUSS use to determine opportunities for improvement or to determine problems, trends, or circumstances that addressed opportunities to prevent routine use of IUSS.

2) failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted and semi-restricted areas.

A review of the CAH policy titled "Attire for Surgical Services," provided by S3DON as the most current, revealed in part: Personnel entering the restricted areas of the O.R. are required to wear surgical attire; street clothes are not to be worn in the restricted areas and all persons entering this area will be required to wear clean surgical scrub clothing donned daily, warm-up jackets are required in the O.R., masks must be either on or off, cover all possible head and facial hair, cloths hats must be covered by a disposable bouffant hat, home laundering is not permitted.

A review of the CAH policy titled "Dress Code for Central Service Department," provided by S3DON as the most current, revealed in part: Autoclave and storage (yellow) area, limited and authorized access following specific dress code. Yellow areas (processing room for instruments and packs for sterilization and the sterilizer room where the autoclaves are located) are restricted to persons meeting attire requirements.

A review of the AORN (Association of periOperative Registered Nurses) Guidelines for Perioperative Practice, 2015 edition - Guideline for Surgical Attire- Recommendation I revealed in part: All individuals entering the restricted surgical area (O.R. suite) should wear a surgical mask when scrubbed personnel, sterile supplies and/or sterile equipment are present. A surgical mask protects the patient from transfer of microorganisms. The mask should cover the mouth and nose and be secured in a manner to prevent venting. A mask that is securely tied at the back of the head and behind the neck decreases the risk of staff transmitting nasopharyngeal and respiratory microorganisms to patients. Surgical masks are intended to contain and filter droplets from the nasopharynx. The filter portion of the surgical mask harbors bacteria collected from the nasopharyngeal airway. Surgical masks should be tied securely and discarded after each procedure or when soiled and should not be worn hanging from the neck. When in the semi-restricted or restricted surgical areas, all non-scrubbed personnel should wear a freshly laundered or single use long sleeved warm up jacket snapped closed with the cuffs down to the wrists. Wearing the warm up jacket snapped closed prevents the edges of the front of the jacket from contaminating a skin prep area or the surgical sterile field. Long sleeved attire helps contain skin squames shed from bare arms. All personal clothing should be completely covered by the surgical attire. Undergarments such as T-shirts with a V-neck, and shirts with sleeves which can be contained underneath the scrub top, may be worn; personal clothing that extends above the scrub top neckline or below the sleeve of the surgical attire should not be worn. Personnel clothing is not laundered by a health care-accredited laundry facility.

A review of the AORN Guidelines for Perioperative Practice, 2015 edition - Guideline for Surgical Attire - Recommendation II revealed in part: Only facility-approved, clean and freshly laundered surgical attire should be donned daily by all personnel entering or reentering the semi-restricted and restricted surgical areas to decrease the possibility of cross-contamination. Surgical attire should be laundered in a health care-accredited laundry facility either on-site or through a contracted service. Home laundering cannot be monitored for quality, consistency or safety, and laundering may not meet the specified measures necessary to achieve a reduction in microbial levels in soiled surgical attire with measures that involve mechanical, thermal, and chemical components.


A review of the AORN Guidelines for Perioperative Practice, 2015 edition - Guideline for Surgical Attire - Recommendation III revealed in part: All personnel should cover head and facial hair, including the sideburns, the ears and the nape of the neck, when in semi-restricted and restricted areas. Human hair can be a site of pathogenic bacteria such as MRSA. Hair acts as a filter when it is uncovered and collects bacteria. A clean, low-lint surgical head covering or hood that confines all hair and covers scalp skin and ears should be worn. The head covering or hood should be designed to minimize microbial dispersal. Skull caps (surgeon caps) fail to contain the side hair above and in front of the ears and hair at the nape of the neck and the ears and should not be worn. Reusable head coverings (cloth head coverings) should be laundered in a health care-accredited laundry facility.

A review of AORN Guidelines for Perioperative Practice, 2015 edition - Guideline for Surgical Attire: Recommendation IX revealed in part: Restricted areas in a surgical suite includes the OR (operating room) and procedure rooms, the clean core and the scrub sink areas. People in the restricted areas are required to wear full surgical attire (scrub attire, head coverings, masks, and shoe covers as applicable). The Semi-Restricted areas include the peripheral support areas of the surgical suite, the storage areas, the work areas, and corridors leading to the restricted areas of the surgical suite.

Observations on 01/11/16, from 11:45 a.m. to 3:30 p.m., and on 01/12/16, from 8:15 a.m. to 11:00 a.m., revealed the following surgical attire breaches in the restricted and semi-restricted surgical suite area:

-S15MD, S16MD wearing a skull cap that did not completely cover the hair and wearing a T-shirt that was not completely covered by the surgical attire,

-S11CRNA with facial hair that was not completely covered, and with the surgical mask worn hanging from the neck, and wearing a T-shirt that was not completely covered by the surgical attire,

-S25RN/OR, S27RN/OR with a cloth cap not completely covered by the disposable bouffant hat and no warm-up jacket while performing circulating tasks in a patient ' s surgical procedure,

-S22CNA wearing a cloth cap not covered by a disposable bouffant hat,

-S32PharmacyTech wearing street clothes while stocking the medication cart in the restricted area,

-S12CRNA wearing a home laundered warm-up jacket

In an interview on 01/11/16, at 12:50 p.m., with S2CRNA, she indicated that the warm-up jacket was her personnel warm-up jacket which she took home once a week to wash.

-S27RN/OR, S30ST with the surgical masks worn hanging from their necks and with a cloth cap not completely covered by the disposable bouffant hat

-S30ST opening up sterile supplies onto the sterile field without wearing a button down warm-up jacket,

-S34SRNA with facial hair that was not completely covered, and with the surgical mask worn hanging from the neck, and wearing a T-shirt that was not completely covered by the surgical attire,

-S11CRNA not wearing a warm-up jacket in the room during a surgical procedure

-S22CNA without a surgical mask, talking on the phone next to S28RN/OR when S28RN/OR was performing a surgical scrub at the scrub sink,

-S10QA with the surgical mask worn hanging from the neck,

-S14MD wearing surgical attire from another hospital and not changing into a clean surgical attire before performing a patient ' s surgical procedure, wearing a skull cap that did not completely cover the hair and wearing a T-shirt that was not completely covered by the surgical attire

In an interview on 01/12/16, at 9:50 a.m., with S21RN/OR she indicated that physicians did not have a changing area and she had not known of physicians to change to hospital scrubs on-site and always wore scrubs (surgical attire) from home or from other facilities.

In an interview on 01/12/16, at 10:45 a.m. with S14MD, before he scrubbed for his surgical procedure on Patient #14, he indicated that he was wearing surgical attire from another hospital and he placed a lab coat over them to travel to the CAH. He further indicated that he did not have to change his surgical attire from the other hospital since he covered them with a lab coat when he left the other hospital.

-S26RN/OR with the surgical mask worn hanging from the neck, and wearing a T-shirt that was not completely covered by the surgical attire,

-S29ST wearing a cloth cap not covered by a disposable bouffant hat, with the surgical mask worn hanging from the neck,

-S27RN/OR not wearing a buttoned down warm up jacket while performing circulating tasks during a patient procedure,

In an interview on 01/11/16, at 3:15 p.m., with S21RN/OR she indicated that the O.R. followed AORN Guidelines.

In an interview on 01/12/16, at 4:00 p.m., with S3DON she was made aware of the observations of the surgical attire infection control breaches. S3DON indicated that AORN Guidelines and acceptable infection control practices regarding O.R. surgical attire were not being followed by staff. S3DON indicated that the O.R. followed the professional standards of practice established by AORN Guidelines.

3) failing to ensure that the CAH maintained sterile equipment and clean supplies in a functional and sanitary environment and failing to ensure that acceptable workflow patterns, disinfecting practices and surgical protocols were adhered to.


A review of the CAH policy titled "HLD and Sterilization of Medical Equipment," provided by S3DON as the most current, revealed in part: Allow items to completely cool before removing items from the autoclave cart.

A review of the CAH policy titled "Storage of Sterile and Other Supplies," provided by S3DON as the most current, revealed in part: Storage of hospital sterilized and manufacturers sterile supplies and other patient care supplies shall be accomplished by the creation and maintenance of an environment to prevent contamination. Storage areas are to provide protection against dampness, dust, insects and vermin. Do not store under sinks or near splash areas. Supplies are to be positioned so that packaging is not crushed, bent, compressed or punctured.

A review of the CAH policy titled "Decontamination, Cleaning, Processing Instrument, Equipment, and Supplies Washer/Disinfector," provided by S3DON as the most current, revealed in part: Open instrument joints and immediately spray with enzymatic foam and transport to Central Sterile. Place instruments in appropriate baskets for washer/disinfector. One time use and/or disposable items are not reprocessed or reused. They are discarded.

A review of the MFU (manufacturer's instructions for use) on the enzymatic foam spray used by the O.R. revealed in part: Spray directly on soiled instruments immediately after use. Apply as needed to keep moist. Rinse after cleaning. If dries, reactivate to keep instruments moist until instruments are properly cleaned.

A review of the MFU on the surgical hand scrub used by the O.R. when performing a surgical hand scrub prior to aseptic gowning and gloving, prior to a patient's surgical procedure revealed in part: Dispense one pump into palm of hand. Dip fingers into the hand prep and work under the nails. Spread the remaining hand prep over the hand and up to just above the elbows covering all surfaces. Using a second pump, repeat for the other hand. Dispense a third pump into either hand and reapply to all aspects of both hands up to the wrist. Allow to dry before donning surgical attire.

A review of the AORN Guidelines for Perioperative Practice, 2015 edition- Guideline for Packaging Systems: Recommendation III revealed in part: Sterilized items should be considered sterile until an event occurs to compromise the sterility of the sterile item such as, moisture penetration or unacceptable storage conditions, exposure to airborne and other environmental contaminants. The sterility of sterile items is event related and not time related. The sterility of an item does not change with the passage of time, but may be affected by particular events (such as, amount of handling) or environmental conditions (such as humidity, dust).

A review of - AORN Guidelines for Perioperative Practice, 2015 edition - Guideline for Packaging Systems: Recommendation VII revealed in part: Paper-plastic pouch packages should be used according to manufacturer's written instructions. Paper-plastic pouch packages should be used only for small, lightweight, low-profile items. Double paper-plastic pouch packaging may be used to facilitate containment of multiple small items to be sterilized. Double paper-plastic pouch packages should be used in such a manner to avoid folding the inner package to fit into the outer package. Folding the edges of the inner peel packages may entrap air and inhibit the sterilization process. The plastic part of the outer package should not be written on, the points of pens and other writing devices may inadvertently puncture the package and compromise sterility.


A review of AORN Guidelines for Perioperative Practice, 2015 edition- Guideline for Sterilization- Recommendation III revealed in part: A controlled environment is intended to facilitate effective decontamination, assembly, sterilization and storage and to minimize environmental contamination and maintain sterility of sterilized items. Functional workflow patterns should be established to create and maintain physical separation between the decontamination and sterilization areas. Room temperature, humidity and ventilation must be controlled and monitored in accordance with regulation. Controlled conditions reduce the risk of contamination. Functional workflow patterns should be established in the following order: from potentially high contamination areas to clean areas to prevent recontamination. Attire, use of PPE (personnel protective equipment and limitations in personnel access and movement should be based on expected contamination levels.


A review of AORN Guidelines for Perioperative Practice, 2015 edition- Guideline for Sterilization- Recommendation VI revealed in part: After steam sterilization, the contents of the sterilizer should be removed from the chamber and left untouched until they are cooled. A period of 30 minutes to 2 hours may be necessary for the cool down. Warm or hot items should not be placed on cool or cold surfaces as moisture may condense from both inside and outside the package. Sterilized packages or containers that have formed condensate should be considered unsterile and the contents should not be used. Moisture can compromise the integrity of the barrier material and the sterility of the contents. Items should be allowed to cool on the sterilization rack.

A review of AORN Guidelines for Perioperative Practice, 2015 edition - Guideline for Sterilization: Recommendation XV revealed in part: Sterilized items should have limited exposure to moisture and humidity to decrease the potential contamination of the sterilized items. Factors that contribute to contamination include air movement, humidity, temperature, location of storage, presence of vermin, whether shelving is open or closed, and properties of the packaging material. Sterile packages should be stored under environmental controlled conditions. Sterile items should not be stored under sinks or in other locations where they can become wet. Open shelving may be used if they are located in a secure, environmental controlled clean area.

Observations on 01/11/16, from 11:45 a.m. to 3:30 p.m., and on 01/12/16, from 8:15 a.m. to 11:00 a.m., revealed the following functional and sanitary environment breaches in the restricted and semi-restricted surgical suite area:

-Sterile supply cabinet revealed multiple double peel-packed sterile packages with the inner peel pouch sealed and/or folded. The cabinet further revealed several bins containing multiple sterile peel-packed packages that were bunched together and being crushed by heavier sterile packages, some with their seals broken and many with the plastic outer part of the package being written on with pens and/or sharpies

-Equipment room with multiple instrument container sets (containing instruments) marked as unsterile and stored with sterile items

-Surgical step stool tops in the O.R. that were worn and bubbled up preventing adequate disinfection between surgical procedures

-Multiple observations of disposable blue surgical cloth towels (from single use surgical towel packs that were opened onto the surgical field for a patient's surgical procedure) that were laundered and reused in patient care areas (O.R.s, Sterile Central, decontamination rooms, and clean supply areas)

In an interview on 01/11/16, at 12:15 p.m., with S21RN/OR she indicated that the disposable blue surgical cloth towels (from single use surgical towel packs) were from towel packs that were opened onto the surgical field during a patient's surgical procedure and were not used during the patient ' s surgical procedure. S21RN/OR indicated that they send them to the laundry and reuse them for other patient care needs.

-Dirty Instrument Cart containing soiled instruments (from three surgical cases completed earlier that day) being stored in the clean area, that had not been transported to the Central Sterile area by staff for further cleaning and processing

In an interview on 01/11/16, at 12:30 p.m., with S21RN/OR she was asked about the Dirty Instrument Cart located in the clean area. S21RN/OR indicated that the O.R. washer broke a couple of months ago and they had to use the washer in the Central Sterile (located in an outside building), so they sprayed the soiled instruments with enzymatic foam after use and then stored the soiled instruments in the Dirty Instrument Cart located in the clean area until the end of the day when staff were able to bring them over to Central Sterile to use the other washer located there.

In an interview on 01/11/16, at 2:30 p.m., with S18CentralSupplyManager, she indicated that the O.R. staff decontaminated, washed, processed and packaged their own instruments and that her department was responsible for all the other departments. She indicated that her department was responsible for the sterilization of all hospital instruments from all the departments, including surgery. She further indicated that since the O.R. washer was broke, the O.R. staff brought their soiled surgical instruments in the Dirty Instrument Cart at the end of the surgery day to the Central Sterile decontamination area and used the washer there.

In an interview on 01/13/16, at 9:00 a.m., with S31Facility Director, he was asked about the Dirty Instrument Cart, containing soiled instruments from surgical cases, being stored in a clean area in the O.R. He indicated that he was not aware that a Dirty Instrument Cart was being stored in a clean area and further indicated that area was not being monitored as a decontamination room with recommended air exchanges and positive/negative air flow.

-Opened multiple dose medication vials been stored in O.R. #1 (Labetalol and Neostigmine), O.R. #2 (Labetalol) and the Endoscopy room (Labetalol) anesthesia carts which were located in patient care areas.

-A prepared 50ml bag Sodium Chloride with Phenylephrine 100mg, dated 12/08/15, and multiple 20ml syringes that were opened and pre-labeled being stored in a plastic ziploc bag in the Endoscopy anesthesia cart,

-S17CentralSupply with sterile surgical instruments on a rolling cart (12 large wrapped trays and 6 large metal instrument containers and 5 peel packed items) that were not cooled before being brought to the main O.R. from the outside Central Sterile building

-S17CentralSupply wearing a home laundered logo sweatshirt

-S14MD dispensed only one pump of the surgical hand scrub into his hands and rubbed over his hands and lower arms for less than 5 seconds and immediately proceeded to the O.R. where he immediately donned sterile surgical attire prior to a patient's surgical procedure

-S11CRNA bringing a soiled laryngoscope blade wrapped in a blue cloth towel to the sink in the clean area and leaving it in the sink to be decontaminated after the surgical procedure

In an interview on 01/12/16, at 11:15 a.m., with S12CRNA she indicated that when non-disposable laryngoscope blades were used by anesthesia, the soiled blades were placed in the sink in the clean room and decontaminated and processed at the end of the day

-S26RN/OR, S23ST and S29ST leaving the door open between the endoscopy procedure room and the endoscopy decontamination room during endoscopy procedures

-S26RN/OR, S23ST and S29ST in the endoscopy decontamination room going from dirty areas to cleans areas and back to dirty areas as they performed various tasks while decontaminating and sterilizing the endoscopes and not changing their soiled gloves or soiled plastic aprons each time

S23ST decontaminating endoscopes with the PPE gown (plastic apron) not tied in the back causing the plastic apron to shift during endoscope decontamination and having her surgical attire rubbing against the decontamination sink area

In an interview on 01/12/16, at 10:40 a.m., with S23ST she indicated that she never tied her PPE gown during endoscope decontamination. She indicated that she was never told by anyone that she had to tie the PPE gown and had always left it loose and untied.

In an interview on 01/13/16, at 9:00 a.m., with S31Facility Director he was asked about the air exchanges and positive/negative air flow in the endoscopy procedure room and the endoscopy decontamination room when the door between the endoscopy procedure room and decontamination room was left open during endoscopy procedures. He indicated the door should be closed at all times. S31Facility Director indicated that the proper air exchanges with proper positive/negative air flow in the endoscopy decontamination room had not been completed yet due to the room being recently designated as the new decontamination room for the endoscopy area and further indicated that his department was not monitoring this area yet.

-S22CNA while disinfecting the O.R. between surgical cases picked up sterile supplies (left in the O.R. after the surgical procedure was completed) with soiled gloves and brought them to the Sterile Supply Room to be returned to storage without removing her soiled gloves

-S22CNA placing clean sheets on the O.R. table (after disinfecting the O.R. room between surgical cases) while the O.R. floor was still visibly wet

-S20HK disinfecting an outpatient bed after use and not waiting the 2 minute contact time, as per the label on the EPA disinfectant solution, and wiped the bed dry and placed clean sheets on the bed

-Two large plastic bins containing sterile packaged instruments (more than 25 packs) in the Emergency Department being stored in a patient care area on the counter next to the sink

In an interview on 01/12/16, at 3:30 p.m., with S19ED ChargeRN, he was asked about the 2 bins of sterile instruments stored in a patient care area on the counter next to the sink. He indicated that they had been there for at least a week and he did not know where they were supposed to be stored.

In an interview on 01/12/16, at 4:00 p.m., with S3DON she was made aware of the above observations of the infection control breaches. S3DON indicated that acceptable infection control practices, hospital policy and AORN Guidelines were not being adhered to by staff. S3DON indicated that the CAH followed the professional standards of practice established by AORN Guidelines.

4) failing to have properly executed informed consents that were complete and contained all of the required elements (proposed procedure, patient condition, indications, materials risks and benefits, treatment alternatives, the physician performing the procedure and the type of anesthesia) for 3 of 3 (#14, #19, #22) medical records reviewed for informed consents out of a total sample of 20 medical records, and


Patient #14

The patient was admitted to the CAH on 01/12/16, for a scheduled General surgery procedure with S14MD with anesthesia. A review of the patient ' s informed consent for anesthesia revealed that the consent did not document (check off) the type of anesthesia that would be administered during the surgical procedure, the risks determined by the physician or the reasonable therapeutic alternates associated with the procedure ' s anesthesia.

Patient #19
The patient was admitted to the CAH on 01/12/16, for a scheduled endoscopy procedure with S13MD with anesthesia. A review of the patient's informed consents (procedure and anesthesia) revealed that the procedure consent under the "Patient's Condition," the "Risks and Additional Risks determined by the Physician" and the Physician Authorized to perform the Procedure" sections were not completed prior to the procedure and was blank. The anesthesia consent under the "Reasonable Therapeutic Alternatives and Risks" section was not completed prior to the procedure and was blank.


Patient #22
The patient was admitted to the CAH on 01/12/16, for a scheduled endoscopy procedure with S13MD with anesthesia. A review of the patient ' s informed consents (procedure and anesthesia) revealed that the procedure consent under the "Patient's Condition," the "Risks and Additional Risks determined by the Physician" and the Physician Authorized to perform the Procedure" sections were not completed prior to the procedure and was blank. The anesthesia consent under the "Reasonable Therapeutic Alternatives and Risks" section was not completed prior to the procedure and was blank.


In an interview on 01/12/16, at 10:45 a.m., with S10QA she indicated that she reviewed
consents for completeness as part of QA. The above consents were reviewed with S10QA.
She indicated that the above consents were signed, dated and timed by the physician and the
patient and were witnessed and that she would give these consents a 100% for
completeness. S10QA was asked if the consents should have all the blanks filled out.
S10QA indicated that they probably should, but she only QA consents for being signed,
dated and timed by the physician and patient and if they were witnessed.



5) failing to ensure that personnel (surgery staff and physicians) were provided with a surgery changing area (room) to change from home attire and/or outside attire to the hospital provided clean surgical attire for personnel working in the restricted and semi-restricted surgical areas of the hospital.


A review of the hospital floor plan revealed no designated area for surgery staff and/or physicians to change from home attire and/or outside attire to hospital provided clean surgical attire when working in the restricted and semi-restricted surgical areas of the hospital.


A tour of the hospital revealed no designated area for surgery staff and/or physicians to change from home attire and/or outside attire to hospital provided clean surgical attire.


In an interview on 01/11/16, at 11:45 a.m., with S3DON she was asked for the designated area for the surveyor to change from home attire to surgical attire in order for the surveyor to tour the restricted and semi-restricted surgical areas. She indicated that the hospital did not have a designated changing area/room for surgery staff and/or physicians to change from home attire and/or outside attire to hosp

Based on record review and staff interview, the CAH (Critical Access Hospital) failed to ensure the Quality Assurance program was effective as evidenced by the Quality Assurance program failed to include identified problems emergency service, infection control, and surgical services. The deficient practice was evidenced by:


1) failure of the CAH to include analysis, tracking and trending of PEC'd patient elopements from the ED in the hospital wide QAPI program;


2) failure of the CAH to identify problems in infection control failed to maintain a comprehensive and ongoing Infection Control Program designed to prevent, control, and investigate infection control practices that included: data collection, tracking, trending and analysis of infection control practices/breaches through monitoring and surveillance of all the services of the CAH, active surveillance of infection control practices to identify infection control breaches with implementation of corrective actions to prevent and control infections, monitoring of compliance with all infection control policies, procedures, protocols and other infection control program requirements that were implemented by the facility, and monitor these issues in the hospital wide QAPI Program.


3) failure to ensure the CAH to followed acceptable professional standards of practice governing surgical services and infection control and identify and monitor these problems in the hospital wide QAPI program


Findings:


Review of the hospital's policy titled Performance Improvement Plan, policy number 01-08.0-0100 revealed performance improvement priorities are based on high risk, low volume, and/or problem prone processes. The policy revealed aspects of care or processes that place or have potential to place a patient at risk for an adverse event or outcome would be included. The policy indicated data would be collected and measured for operative procedures, infection control practices, and safety and risk management activities.



I. failure of the CAH to include analysis, tracking and trending of PEC'd patient elopements from the ED in the hospital wide QAPI program:


Review of the hospital's occurrence reports, presented by S2Director of PI/QA, revealed an incident report, dated 11/20/15, detailing Patient #9's elopement from the ED while PEC'd following a suicide attempt by driving his car into a pole. Further review revealed the patient had eloped while walking to the restroom, escorted by the RN. Patient #9 ran out back door of ED and ran out back door of the hospital leading to the back parking lot. Security was notified and the grounds searched. Patient #9 was not located on grounds. Additional review revealed the following abbreviated Root Cause Analysis (questions located on the incident report form): Unsafe act: pt. being monitored by staff member and not by security personnel; Unsafe condition: pt. being monitored by staff member and not by security personnel; Contributory factors: unknown; Why was act committed: unknown: Why did condition exist: unknown: Immediate action taken: have 2 staff members escort pt. to restroom; Long range action to be taken: Possibly have security personnel monitor PEC pt. 1:1. What additional assistance is needed to prevent recurrence: Possibly have security personnel monitor PEC pts.1:1.


On 1/11/16, at 3:50 p.m., another patient, Patient #8 (current PEC ED patient), eloped from the hospital by pretending to go to the bathroom (followed by S34CNA) and then walking out the ambulance bay doors to the front of the hospital, continuing out the door to the outside. A code white (security code) was called and the patient was returned to the hospital ED. Review of Patient #8's medical record revealed he had suicidal ideations and he heard voices telling him "to walk into traffic to kill himself".


In an interview on 1/12/16, at 10:50 a.m., with S2Director of PI/QA, she indicated an abbreviated question/answer root cause analysis had been performed on the back of the incident report after the above referenced elopement by Patient #9. She indicated no further in-depth root cause analysis regarding Patient #9's elopement had been conducted. She confirmed there had been no new policies instituted after the above referenced elopement of Patient #9. S2Director of PI/QA further indicated Patient #9's elopement had not been evaluated in the hospital's Quality Assurance Program as a high risk issue and no new interventions had been put into place.



In an interview on 01/12/16, at 4:20 p.m., S2Director of PI/QA confirmed the QA program was not currently monitoring any aspects of care related to PEC'd patients in the ED. She confirmed there was no quality monitoring of the length of stay of PEC'd patients in the ED and there was no QI monitoring of PEC'd patient elopements.



II. failure of the CAH to identify problems in infection control failed to maintain a comprehensive and ongoing Infection Control Program designed to prevent, control, and investigate infection control practices that included: data collection, tracking, trending and analysis of infection control practices/breaches through monitoring and surveillance of all the services of the CAH, active surveillance of infection control practices to identify infection control breaches with implementation of corrective actions to prevent and control infections, monitoring of compliance with all infection control policies, procedures, protocols and other infection control program requirements that were implemented by the facility.


In an interview on 01/13/16, at 10:50 a.m., with S39RN/IC she indicated that she was the designated Infection Control Officer for the CAH. S39RN/IC indicated that the CAH followed the professional standards of practice of AORN (Association of periOperative Registered Nurses), CDC (Centers for Disease Control and Prevention), and APIC (Association for Professionals in Infection Control and Epidemiology). S39RN/IC further indicated that she was new in the position and had only been the Infection Control Officer for 2 months. She indicated that she was informally trained by the prior Infection Control Officer for the 2 months prior to her assuming the position and had no prior infection control training or experience prior to her assuming the position as the Infection Control Officer 2 months ago. S39RN/IC indicated that she did attend an infection control conference a couple of months ago and had recently become an APIC member, but had not completed any other infection control training, in-services or online training. S39RN/IC was asked for the documented evidence of the CAH's active surveillance monitoring that included: data collection, tracking, trending and analysis of infection control practices/breaches with implementation of any corrective actions and evaluations. S39RN/IC indicated that she was not tracking, trending or analyzing the data she was collecting and had established no corrective actions for any of the identified infection control breaches/issues that she identified in her monthly environmental rounds. S39RN/IC indicated that she conducted the monthly environmental rounds each month in a different department. S39RN/IC further indicated that she also conducted informal " pass through's " of the departments, but she was not documenting anything. She indicated that she had no documentation of any data analysis, tracking, trending or follow-ups that she was currently reporting to the Department Manager (S2Director of PI/QA) or to QA (Quality Assurance). S39RN/IC was made aware of the multiple infection control breaches/issues identified by the surveyor through observations in the surgical areas. S39RN/IC indicated that in September and October she conducted environmental rounds in the surgical areas. She indicated that she made note of any infection control issues and informed the O.R. personnel to correct the infection issues. S39RN/IC was asked for the identified infection control breaches that were identified in the O.R. in September. In a review of the report with S39RN/IC, it revealed in part the following identified infection control breaches/issues: dust in some of the areas and on equipment, boxes on the floor, syringes opened and labeled and not monitored, lids off of sharps container, light bulbs out, O.R. door left open during a surgical procedure, linens uncovered, mask around necks, an area where dirty and clean were mixed and a personal scrub hat on an employee. S39RN/IC indicated that she conducted another environmental round of the O.R. in October to see if corrections had been made, but had not implemented any data analysis with tracking or trending to identify any opportunities of improvements or to develop any corrective actions with evaluations to ensure that compliance was improved and/or maintained. S39RN/IC indicated that this was her process for all departments in the CAH. S39RN/IC indicated that most of the infection control breaches/issues identified by the surveyor in the O.R. had not been identified by Infection Control. She indicated that she did not conduct any environmental rounds or follow-ups for December in any of the departments. S39RN/IC was unable to provide any other surveillance monitoring other than environmental round data documentations and a report indicating the number of employees that were monitored for hand hygiene in each department each month (no other specific hand hygiene data analysis was evidenced or provided). She further indicated that there were 5 (five) SSI (surgical site infections) identified in November and December as MRSA wound infections and she had not started tracking or investigating the sources for possible links to the infections. S39RN/IC was asked about the prior Infection Control Officer ' s prior reports that identified tracking, trending, analysis, or any documented corrective actions with opportunities for improvement and/or evaluations that could demonstrate on ongoing Infection Control Program in the CAH. S39RN/IC was unable to provide any further documented evidence of an ongoing Infection Control Program. S39RN/IC indicated that she did not have any other available documentation to present to the surveyor that she maintained or that was maintained by the prior Infection Control Officer. S39RN/IC was made aware of other department's functional and sanitary infection control issues/breaches that were identified by the other DHH surveyors to include:
1.On 1/11/16 at 10:15 a.m. an observation was made of a red biohazard waste receptacle in a bio-hazardous waste storage room located on a patient care hall (across the hall diagonally from room number 102). A crack was noted on the bottom of the left side of the can and a wet spot was noted on the floor beneath the cracked area. The above referenced finding was confirmed by S3DON during the observation. She indicated housekeeping needed to address the issue of the leaking biohazard waste receptacle.


2. During an observation on 01/11/16, at 9:45 a.m., with S3DON of the Med-Surg inpatient unit, 2 portable/rolling blood pressure machines and 1 portable/rolling thermometer were observed to have multiple pieces of transpore clear tape and tape residue. S3DON confirmed the patient care equipment did not have a smooth wipeable surface for disinfection due to the tape/tape residue.


3. During an observation on 01/11/16, at 10:20 a.m., with S3DON of the ICU, the radiology terminal was observed to have an accumulation of dust on the keyboard and the monitor screens. S3DON confirmed the observations. Also observed in the ICU was a mobile computer workstation with multiple pieces of transpore clear tape and tape residue. The tape was observed to secure a clear, plastic screen to the desk portion of the workstation. S3DON confirmed the observations and the workstation did not have a smooth wipeable surface for disinfection.


4. During an observation on 01/11/16, at 10:30 a.m., with S2Director of PI/QA, the infant scale was observed to have a strip of tape on the front of the scale. S2Director of PI/QA confirmed the presence of the tape and confirmed the scale did not have a smooth wipeable surface for disinfection. Also observed in the ED was tape residue on the crash cart. An accumulation of dust was observed on the pediatric crash cart and on the adult defibrillator. S2Director of PI/QA confirmed the observations.


5. During an observation on 01/12/16, at 11:00 a.m., with S45Dir of Ancillary Services of the CT scan room, the injection pole was observed to have an accumulation of a white substance on the base and a black substance in the bin attached to the pole. An overbed table was observed to have sticky tape residue on the sides of the table. A mobile computer workstation was observed on the right side of the CT scanner. The mobile computer workstation was observed to have tape residue on the desk area. S46RT also present for the observation stated the workstation was used by the physician during procedures. S45Dir of Ancillary Services confirmed the presence of the tape residue and confirmed the workstation did not have a smooth wipeable surface for disinfection. S39RN/IC had no comment regarding the above infection control breaches identified by the other DHH surveyors.


In an interview on 01/13/16, at 12:00 p.m., with S2Director of PI/QA, she indicated that she was the supervisor for the Infection Control Officer, S39RN/IC. S2Director of PI/QA was made aware of the above interview with S39RN/IC. S2Director of PI/QA indicated that she had environmental round data sheets from the prior Infection Control Officer, but no analysis and tracking/trending information. S2Director of PI/QA did not present any other infection control documentation for the surveyor to review. S2Director of PI/QA further indicated that she (S2Director of PI/QA) had basic infection control knowledge as a nurse and would not consider herself qualified in infection control. She further indicated that S39RN/IC was new as the Infection Control Officer and only had about 2 months of experience.



III. failure to ensure the CAH followed acceptable professional standards of practice governing surgical services and infection control as evidenced by:


1) failing to ensure that surgical instruments were available in a quantity that was commensurate with the CAH's expected daily procedure volume, as evidenced by the CAH's routine use of IUSS (Immediate Use Steam Sterilization) of surgical instruments for surgical procedures,


2) failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted and semi-restricted areas as evidenced by multiple observations of surgical attire breaches,


3) failing to ensure that the CAH maintained equipment/supplies in a functional and sanitary environment as evidenced by failing to ensure that the sterility of sterile instruments and sterile supplies for patient use were not compromised, failing to ensure that equipment available for patient use was not torn or in disrepair so as to ensure effective cleaning/disinfecting, failing to ensure that opened multiple dose vials were not available in patient care areas, failing to ensure that single use items were not reused in patient care, failing to have a policy in place with the MFU (manufacturer's instructions for use) for sterilizing surgical items in plastic peel pouches, failing to ensure that staff adhered to acceptable decontamination protocols and workflow patterns for decontamination of soiled surgical instruments, failing to ensure that cleaning/disinfecting followed acceptable infection control practices, and failing to ensure that surgical hand scrubs followed MFU,


4) failing to have properly executed informed consents that were complete and contained all of the required elements (proposed procedure, patient condition, indications, materials risks and benefits, treatment alternatives, the physician performing the procedure and the type of anesthesia) for 3 of 3 (#14, #19, #22) medical records reviewed for informed consents out of a total sample of 21 medical records, and

5) failing to ensure that personnel (surgery staff and physicians) were provided with a surgery changing area (room) to change from home attire and/or outside attire to hospital provided clean surgical attire for personnel working in the restricted and semi-restricted surgical areas of the hospital as evidenced by no surgical changing areas for staff and physicians being provided by the hospital.

Based on record reviews and interviews, the CAH failed to ensure all patient care services and other services affecting patient health and safety were evaluated by the hospital's QA program as evidenced by failing to include organ procurement, swing bed services, and Infection Control in the QA program.


Findings:


Review of the Quality Assurance reports for 2015 revealed no documented evidence that quality indicators were developed, tracked and trended for organ procurement and swing bed services.


In an interview on 01/13/16, at 1:55 p.m., S2Director of PI/QA confirmed the QA program had no quality indicator monitoring of swing bed services and the contracted services of organ procurement.


In an interview on 01/13/16, at 10:50 a.m., with S39RN/IC she indicated that she was the designated Infection Control Officer for the CAH. S39RN/IC indicated that she had no documentation of any data analysis, tracking, trending, corrective actions or follow-ups reports that were currently being given to the Department Manager (S2Director of PI/QA) or to QA (Quality Assurance).


In an interview on 01/13/16, at 12:00 p.m., with S2Director of PI/QA, she indicated that she was the supervisor for the Infection Control Officer, S39RN/IC. She indicated that she had no reports that were currently being given to her by S39RN/IC for QA (Quality Assurance).




30172




30984

Based on record review and interview, the CAH (Critical Access Hospital) failed to ensure that mid-level practitioners had documentation of an evaluation by the medical staff of the hospital for 2 of 2 (S40APRN, S41APRN) mid-level practitioners' credentialing files reviewed.


Findings:


Review of the credentialing file for S40APRN revealed the APRN was currently credentialed with privileges in family medicine from 08/01/14 to 08/01/16. Review of the credentialing file revealed no documented evidence of any evaluations of the quality of care provided by S40APRN or the clinical performance of S40APRN.


Review of the credentialing file for S41APRN revealed the APRN was currently credentialed with privileges in emergency medicine from 04/01/14 to 04/01/16. Review of the credentialing file revealed no documented evidence of any evaluations of the quality of care provided by S41APRN or the clinical performance of S41APRN.


In an interview on 01/13/16, at 10:30 a.m., S2Director of PI/QA provided an email from S5MD that indicated the nurse practitioners were paired with physicians in the clinic and interact with each other daily. The email from S5MD indicated no routine chart review was performed.