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Based on record review and interview, the facility failed to ensure that 1 (#40) of 8 (#35-#42) staff members had the required certifications to work in the post-anesthesia care unit (PACU). Also, the facility failed to follow their own policy for staff working in the PACU area.


A review of #40's personnel file revealed no current certifications in ACLS (Advanced Cardiac Life Support), PALS (Pediatric Advanced Life Support), or BCLS (Basic Cardiac Life Support). Staff #40's certifications in Advanced Cardiac Life Support had expired September 2016, Pediatric Advanced Life Support had expired October 2016, and Basic Life Support had expired November 2016. The facility's policy requires surgical services staff members maintain current BCLS certification, with ACLS certification required for all PACU staff.


A review of the facility's policy titled, "Staffing for the O.R." Date of Origin: July 2005 and revised date November 2016 revealed the following:

"PURPOSE:
To establish staffing patterns for the Surgical Services Department that will ensure an adequate amount of nursing and surgical personnel is available to render intraoperative nursing care.

POLICY:
STAFFING:
The basic staffing plan for each Operating Room Suite is one RN, one scrub tech, and one assistant. The scrub tech position may be filled by a trained RN or a scrub technician or an LVN. Additional circulator and/or scrub techs are added to the case based on the patient's acuity, complexity of patients' care needs and instrumentation and staff skill mix. In cases where moderate sedation is administered, the policy, procedure and standards related to moderate sedation are followed. The Post Anesthesia Care Unit is staffed with RN(s) only.

QUALIFICATIONS OF STAFF:
Surgical Services staff members maintain current BCLS certification, with ACLS certification required for all PACU staff. All registered nurses maintain a current Texas state RN license. ACLS and PALS is recommended for all staff. Organizational memberships to the Association of perioperative Registered Nurses (AORN), the American Society of Paranesthesia Nurses (ASPAN) and Association of Surgical Technologists (AST) is encouraged. An on-going program of in-service education and periodic clinical skills evaluation for all staff members is maintained to ensure that the quality of care provided is kept current with the developments in the medical, nursing, anesthesia and infection control fields."


An interview with Staff #46 on 02/28/2017 at 3:00 PM confirmed the above findings in the personnel files that Staff #40's certifications had expired.

Based on observation, review of records and interview, the Governing Body failed to:

A. ensure that contracted services were identified and reviewed for quality and safety of services during the previous calendar year.

See Tag A0084



B. correctly identify 5 out of 10 patient complaints made in February 2017 as grievances.

See Tag A0118

C. act upon the abnormal range of the phoenix meters daily calibration results. Citing 6 months (September 2016 - February 2017) of 6 months (September 2016 - February 2017) of the phoenix meter logs reviewed. These deficient findings have the likelihood to cause harm to all patients receiving dialysis treatment at the facility.

D. 1.) follow its own policy and procedure for restraint and seclusion in 2(#20, #23) of 2 charts reviewed.

2.) have nursing assess the patient after the administration of psychoactive medications when used as a chemical restraint in 2(#20#23) of 2 charts reviewed.

3.) prevent PRN orders for chemical restraints in 1(#20) of 2(#20#23) patient charts reviewed.

4.) provide orders for psychotropic medication administration in 1(#20) of 2(#20#23) patient charts reviewed.

5.) perform a face to face with physician or qualified personnel within 1 hour of a chemical restraint in 2(#20#23) of 2 charts reviewed.

6.) ensure nursing interventions were performed and documented before administering psychotropic medications as a chemical restraint in 2(#20#23) of 2 charts reviewed.

7.) provide trained security to handle the patient population without the use of police force in 2(#20#23) of 2 charts reviewed.

See Tag A0144



E. ensure 1 service department (Respiratory Services) out of 17 services participated fully in the Quality Assessment / Performance Improvement (QAPI) program.

See Tag A0308




F. ensure nursing provided ongoing assessments on patients who had gastrointestinal, respiratory, cardiac problems, severe pain and complications in the area of dietary/fluid needs. This deficient practice was found in 4 of 42 sampled patients (Patient #'s 13, 35, 37, and 38).

G. ensure sufficient numbers of nursing staff were available on 3 of 3 units (Off-site Emergency department, K4 medical- surgical unit, and K5 medical-surgical unit).

See Tag A0392




H. ensure the compounding of drugs was supervised in a manner to ensure safe preparation of drugs in 1 of 2 pharmacies (Main Pharmacy).

See Tag A0501

I. ensure medications were stored securely in 1 of 2 pharmacies (Main campus pharmacy).

See Tag A0502

J. ensure outdated drugs were not available for patient use in 2 of 2 areas in the facility (Main pharmacy and K4 Medical-Surgical unit).

See Tag A0505

K. ensure there was a list of individuals who were designated as being able to remove medications from 1 of 2 pharmacies (Off-site Emergency Department (ED) Pharmacy).

See Tag A506




L. ensure that the person designated as infection control nurse (Staff #15) was qualified either through education, training, experience, and/or certification. Also, Staff #15 failed to follow the facility's job description for the Infection Control practitioner.

M. provide a sanitary environment to avoid sources and transmission of infectious and communicable diseases in 13 of 13 (#1 Surgery, #2 Main Pharmacy, #3 Offsite Emergency Department Pharmacy, #4 K4 Medical Surgical Unit, #5 Postpartum Unit, #6 Nursery, #7 Respiratory Therapy Arterial Blood Gas Room, #8 Inpatient Rehabilitation, #9 Central Supply, #10 Linen and Laundry, #11 Dietary, #12 Cardiac Rehabilitation, and #13 Waste Management) departments of the facility.

These deficient practices of infection control issues in the 13 departments of the hospital had the likelihood to cause serious harm or injury to the patients receiving care in the facility.

See Tag A0749

N. ensure hospital leadership identified problems and/or addressed problems identified by the infection control officer. They failed to implement successful corrective action plans in the affected problem areas.

See Tag A0756



O. ensure the surgical, sterilization, and Cath Lab departments provided a clean and sanitary environment.

P. ensure the surgical department sterilized implant trays and complete sets of instruments per the facility's sterilization policy or documented immediate use sterilization as an emergency. A review of the immediate use sterilization logs for the months of October, November, and December 2016 through January 2017 revealed unwrapped implant trays and full sets of instruments trays were being flashed in the flash sterilizers. Also, the facility failed to follow their own policy for in hospital sterilization, the AORN (Association of perioperative Registered Nurses) standards, and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards and the CDC guidelines.

Q. ensure the disinfection log documentation was completed for the transesophageal (TEE) echocardiogram ultrasound probes.

R. ensure the surgical staff were dating and timing irrigation and intravenous solutions in the warming devices in surgery. Also, the surgical staff failed to follow the facility's own policy on Warming Irrigation and Intravenous Solutions in Warming Devices.

S. provide 2 post anesthesia patient care areas per each operating room. The facility had 6 functional operating rooms, plus a Cysto room that were observed. In the postoperative care unit there were only 8 post anesthesia patient care areas. One of the patient care areas (pediatric room) was being used for storage of: respiratory supplies, seven (7) large cardboard boxes of gloves, a rocking chair, Christmas decorations, and other equipment.

See Tag A0940


T. ensure that the surgeon had completed a History and Physical examination form prior to the patient having a surgical procedure. The History and Physical form was completed before the patient arrived to the facility for 2 (#41 and #42) of 7 (#7, #8, #9, #10, #11, #41, and #42) surgical charts reviewed. Also, the surgeon failed to follow the facility's own Medical Staff Rules and Regulations on History and Physical examination note.

See Tag A0952

U. ensure that 1 (#40) of 8 (#35-#42) staff members had the required certifications to work in the post-anesthesia care unit (PACU). Also, the facility failed to follow their own policy for staff working in the PACU area.

See Tag A0957

Based on review of records and interview, Governing Body failed to ensure that contracted services were identified and reviewed for quality and safety of services during the previous calendar year.

On 2-27-2017, the hospital was requested to provide a list of services that were contracted. The hospital provided a list of 606 contracts. Staff #3 stated contracts were reviewed annually. On 3-1-2017, a review of annually reviewed contracts was completed with Staff #3. Staff #3 provided a list titled, "Contract Evaluation 2015". The list contained the names of 35 contracted services whose 2015 performance had been evaluated in January 2016. Only 21 of the contracts listed on the Contracts Evaluation 2015 list were on the main list that contained 606 contracts. No other evaluations had been completed since that time.

Staff #3 was asked why there were only 35 contracts listed since the hospital clearly had more contracts than that. Staff #3 stated that those 35 contracts were the contracts that had been identified by management as requiring evaluation. Staff #3 stated she had just been assigned the responsibility of coordinating the evaluation of contract services within the past two months and was in the process of having those identified services evaluated.

Staff #2 was interviewed. Staff #2 stated that not every contract is sent for review. When asked about the physician contracts for Medical Director Positions and other physician services, Staff #2 stated, "They should probably be evaluated annually. We missed those." Staff #2 was not able to provide an explanation of how a contract is identified and selected as requiring annual evaluation.

Based on record review and staff interview, the facility failed to


A. correctly identify 5 out of 10 patient complaints made in February 2017 as grievances.

See Tag A0118


B. act upon the abnormal range of the phoenix meters daily calibration results. Citing 6 months (September 2016 - February 2017) of 6 months (September 2016 - February 2017) of the phoenix meter logs reviewed. These deficient findings have the likelihood to cause harm to all patients receiving dialysis treatment at the facility.

C. 1.) follow its own policy and procedure for restraint and seclusion in 2(#20, #23) of 2 charts reviewed.

2.) have nursing assess the patient after the administration of psychoactive medications when used as a chemical restraint in 2(#20#23) of 2 charts reviewed.

3.) prevent PRN orders for chemical restraints in 1(#20) of 2(#20#23) patient charts reviewed.

4.) provide orders for psychotropic medication administration in 1(#20) of 2(#20#23) patient charts reviewed.

5.) perform a face to face with physician or qualified personnel within 1 hour of a chemical restraint in 2(#20#23) of 2 charts reviewed.

6.) ensure nursing interventions were performed and documented before administering psychotropic medications as a chemical restraint in 2(#20#23) of 2 charts reviewed.

7.) provide trained security to handle the patient population without the use of police force in 2(#20#23) of 2 charts reviewed.

See Tag A0144

Based on review of records and interview, the hospital failed to correctly identify 5 out of 10 patient complaints made in February 2017 as grievances.

Review of the complaints and grievance log for February was completed on 2-27-2017. The review showed the following grievances were logged and processed as complaints.

A complaint received on February 1, 2017 was referred to the Director of Medical Affairs for review and action.

A complaint received on February 17, 2017 was awaiting reply from investigation by the floor supervisor as of February 27, 2017.

A complaint received on February 20, 2017 was awaiting response from investigation by the supervisor as of February 27, 2017.

Two complaints received on February 23, 2017 were awaiting responses from supervisors as of February 27, 2017.

Review of the Policy Subject: Patient Complaint and Grievance - 1.099, page 2 of 4, revealed the following:

"When the patient care complaint cannot be resolved at the time of the complaint by staff present, is postponed for later resolution, is referred to another staff member for later resolution, requires investigation and/or further actions for resolution then the complaint is a grievance."

Interview was confirmed with Staff #70. Staff #70 was able to properly define a grievance per the policy above. When discussing the complaint received on February 17, 2017, Staff #70 confirmed that she processed this complaint. Staff #70 was unable to explain why she classified this as a complaint and not a grievance.

Based on observation, record review and staff interview, the facility failed to:

A. act upon the abnormal range of the phoenix meters daily calibration results. Citing 6 months (September 2016 - February 2017) of 6 months (September 2016 - February 2017) of the phoenix meter logs reviewed. These deficient findings have the likelihood to cause harm to all patients receiving dialysis treatment at the facility.



B. 1.) follow its own policy and procedure for restraint and seclusion in 2(#20, #23) of 2 charts reviewed.

2.) have nursing assess the patient after the administration of psychoactive medications when used as a chemical restraint in 2(#20#23) of 2 charts reviewed.

3.) prevent PRN orders for chemical restraints in 1(#20) of 2(#20#23) patient charts reviewed.

4.) provide orders for psychotropic medication administration in 1(#20) of 2(#20#23) patient charts reviewed.

5.) perform a face to face with physician or qualified personnel within 1 hour of a chemical restraint in 2(#20#23) of 2 charts reviewed.

6.) ensure nursing interventions were performed and documented before administering psychotropic medications as a chemical restraint in 2(#20#23) of 2 charts reviewed.

7.) provide trained security to handle the patient population without the use of police force in 2(#20#23) of 2 charts reviewed.


Findings.

A. Review of the facility policy titled "Phoenix Meter Level I Calibration" "If the meter fails (conductivity or PH) on initial should be conducted. If the level I calibration fails within specs for either conductivity or PH, do not use meter and contact Biomed for service. Document the completion of calibration on the log and contact biomed." sic

Review of "Phoenix Meter Calibration Logs" provided as logs for meter P26258, revealed the logs did not contain the meter serial number. Staff #7 on 02/27/2017 at 1:30 p.m., confirmed the serial number was missing from the logs.

Review of the "Phoenix Meter Calibration Logs" records revealed the acceptable range for the daily level one calibration of the phoenix meter conductivity is 14 +/- 0.1 and the PH range is 7.0 +/- 0.1.

Review of the Phoenix meter calibration log for September through February are as follows.

Phoenix Meter logs

September 2016

09/21/2016 - The PH was recorded as 7.2

October 2016

10/01/2016 the PH range was documented as 7.3
10/03/2016 the conductivity range was documented as 14.3

November 2016

11/04/2016 the conductivity was 13.3 and the PH was 6.8.
11/06/2016 the conductivity was 13.3.
11/08/2016 the conductivity was 13.3 and the PH was 6.8.
11/09/2016 the conductivity was 13.4 and the PH was 6.7.
11/10/2016 the conductivity was 13.4 and the PH was 6.7.
11/11/2016 the conductivity was 13.4.
11/14/2016 the conductivity was 13.4 and the PH was 6.8.
11/15/2016 the conductivity was 13.4 and the PH was 6.8.
11/16/2016 the conductivity was 13.4 and the PH was 6.8.
11/17/16 the conductivity was 13.4 and the PH was 6.6.
11/18/2016 the conductivity was 13.3 and the PH was 6.4.
11/19/2016 the conductivity was 13.6.
11/21/2016 the conductivity was 13.6.
11/22/2016 the conductivity was 13.5 and the PH was 6.8.
11/23/2016 the conductivity was 13.6 and the PH was 6.5.
11/24/2016 the conductivity was 13.5 and the PH was 6.6.
11/25/2016 the conductivity was 13.5 and the PH was 6.5.
11/27/2016 the conductivity was 13.7.
11/28/2016 the conductivity was 13.8.
11/29/2016 the conductivity was 13.8.

December 2016

12/02/2016 the conductivity was 13.7.
12/23/2016 the PH was 7.2.
12/13/2016 the PH was 6.8
12/24/2016 the PH was 7.2.
12/27/2016 the PH was 7.2.

January 2017

1/09/2016 the PH was 7.2.
1/13/2017-01/18/2017 the PH was 7.2
1/20/2017 the PH was 6.8

February 2017

02/21/2016 the PH was 6.8.
02/25/2016 the PH was 6.8.

There was no evidence the staff conducted a level one calibration for the abnormal conductivities and PH's, prior to using the meter to test the dialysate composition provided by the dialysis machine before each patient's treatment was started.

Review of the Quality Improvement minutes from September 2106 through January 2017 revealed the facility had failed to collect and review the technical audits of the phoenix meters.

Interview with Staff #6 on February 27, 2017 3:15 p.m. confirmed the above findings on the phoenix meter logs. Staff #6 also confirmed there was no evidence the facility reviewed the log findings through the quality improvement process.


These findings were considered an Immediate Jeopardy (IJ) by the failure to verify the accuracy of the phoenix meter prior to checking the dialysate reading of the dialysis machine before each patient's treatment.



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B. Review of patient #20's chart revealed the patient was brought into the Emergency Department (ED) on 12/31/16 at 22:45 (10:45PM) from a motorcycle accident. The patient was positive for alcohol at a .19 level. The patient had an open fracture to the left forearm.
The nurse documented patient #20 as alert, oriented and cooperative at 22:56 (10:56PM).
Patient #20 was documented as a 10/10 pain on a 1-10 pain scale. Morphine IV was administered for pain at 2307 (11:07PM).The nurse re-assessed the patient at 2309 (11:09PM). Patient #20 was found to be alert, oriented, agitated, and restless. The nurse documented, "Group Note: Repeated questions despite answers from staff." There was no nursing documentation found that physician was notified of patients change in condition.
The nurse documented on 12/31/16 at 23:35 (11:35PM) "Ketamine 100mg administered per Dr. XXX (staff #78). Left forearm reduced and splinted per Dr. XXX (staff #78). There was no nursing documentation found on patient #20 from 12/31/16 at 2345 (11:45PM) until 1/1/17 at 01:20 (1:20AM).

Patient #20 had a vital sign print out for the following times on 12/31/16-1/1/17 at 23:30, 23:45, 0:00, 0:15, 0:31, and 0:46. At 23:45 on the vital sign sheet the patient's oxygen saturation dropped down to 75. There was no nursing documentation on the patient's oxygen level and what interventions were taken.

The nurse documented on 1/1/17 at 1:20AM, "Expressed agitation and combativeness pulls own IV and screams and curses at staff." There was no neuro assessment or interventions documented.

The nurse documented on 1/1/17 at 1:26AM that Haldol 5mg was ordered and given IM in right gluteal. There was no documentation of medication effects, or if the patient was told what he was being given.

Review of the physician orders revealed there was no physician order found for the Haldol injection. There was no documentation from the ER physician concerning the patient's behavior or medications ordered.

The nurse documented on 1/1/17 at 2:38AM, "Refused CT of head." No further documentation of patient's behavior, neuro status, or effects of medication.
The nurse documented on 1/1/17 at 2:55AM, "Inpatient staff refuses patient due to violent outbursts and yelling. Plan of care includes holding patient in the ER until surgery." There was no documentation on what type of behavior, interventions attempted, or physician notification.

A physician order was found on 1/1/17 at 7:25AM, "Haldol 5mg IM Ativan 1 mg IM." There was no reason given for the order and no documentation found in the physician notes for the medication. There was no face to face or chemical restraint procedures conducted.
The nurse documented on 1/1/17 at 7:30AM that the Haldol and Ativan was administered. There was no documentation of what interventions were attempted before administration and no assessment done by the ER nurse. Patient #20 was documented as being accepted onto the floor at 7:40AM. A full nursing assessment was completed. The patient was documented as "resting quietly at present."

Review of the History and physical note done by staff #81 (MD) on 1/1/17 at 1:41AM stated, "54 year old male brought in after motor vehicle accident where he was a unrestrained driver of a motorcycle that went into a ditch. Currently the patient is in the emergency department he is intoxicated, combative, agitated and he is requiring local police intervention as well. He has been identified as having an open LEFT humeral fracture. There was no documentation found in the nurses notes of police intervention.
An inpatient physician order was found dated on 1/1/17 at 10:45AM, "Geodon 5 mg IM every two hours as needed. PRN agitation. Do not exceed 4 doses per 24 HRS. Consider restraint protocol. MD order. Face to Face."


Review of the facility's policy and procedure "Restraint or Seclusion" revealed "chemical restraints was a drug or medication used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not standard treatment or dosage for the patient's condition."

The policy and procedure of "Restraint and Seclusion" revealed the following:

"a. An order must be given by a credentialed physician or other LIP's who are responsible for the patient.

b. In emergency situations, the registered nurse will select the least restrictive means of restraint that will reestablish safety for the patient and others.

c.) PRN restraint orders will not be accepted.

d.) A physician must conduct a face to face evaluation of the patient within 1 hour of initiation of restraint. A physician may delegate the face to face with a trained Qualified Licensed Practitioner (QLP).

e.) during the face to face assessment the following are evaluated and addressed;
The patient's immediate situation
The patient's reaction to the intervention: and
The patient's medical and behavioral condition.
The face to face will be documented in the patient's record.

Review of the restraint log revealed there was no documented chemical restraints.

An interview was conducted with staff #59 on 3/1/17 revealed the ED facility has not been reporting chemical restraints to be listed on the restraint log. Staff #59 reported ER staff have not been using the Restraint Care Record when giving chemical restraints. Staff #59 reported they were using it but have not followed through. Staff #59 stated, "The staff will start back using it today." Staff #59 confirmed that the police department was called frequently to handle patients that were aggressive. The police are allowed to handle non-forensic patients and assist with putting them in restraints or holding for medication administration.

An interview with staff #75 (ER RN) reported when a patient gets violent or out of control he just calls security. Staff #75 reported that most of the time security calls the police department and has them watch the patient. Staff #75 confirmed the police department can put the non-forensic patient in hand cuffs but it should be a last resort. The police have helped us put the patients in soft restraints and hold them for injections.


Patient #23 brought to the ED by police for delusional behavior and attempting to choke his grandmother. Patient #23 had a diagnosis of bi-polar and schizophrenia. The nurse documented on 1/23/17 at 6:15AM that the patient was "Cooperative, restless, apprehensive and anxious." At 7:12AM the nurse documented, "heard pt.'s grandmother screaming, pt. grabbed her around the neck and was yelling at her. Security x3 into room while grandmother screaming, Called LPD for EPOW." (An EPOW is Emergency Police Officers Warrant)

The nurse documented on 1/23/17 at 7:22AM that patient #23 was given Geodon 20 mg IM in left deltoid. A verbal physician order was found on the chart that stated, "7:21 Geodon 20 mg IM." There was no reason given for the medication on the order. There was no documentation on the ED physician's notes concerning the psychoactive medications or patient behavior. There was no face to face done.

Review of the nursing notes revealed there was no documentation of interventions before the medication was given. There was no documentation of vital signs or nursing assessment after the psychoactive medication administration. The only vital signs found on the chart were the initial vitals upon presentation to the ED.

The nurse documented on 1/23/17 at 11:13AM (3 hours and 39 minutes later) that patient #23 was "resting well security at door grandmother at door also."
There was no further nursing assessment until 1/23/17 at 17:30 (5:30PM). The nurse documented Geodon 20 mg given in left deltoid. There was no reason why the patient was given an IM psychoactive medication. The physician order stated "1735 Geodon 20 mg IM now." There was no documentation concerning the patient's behavior or that another psychotropic medication was administered. There was no nursing assessment or interventions documented.

Review of the physicians progress note dated 1/23/17 at 8:00PM "re-examined. Patient became agitated, after awakening. Required IM Geodon, restraints." There was no nursing documentation found of patient assessment or toleration to chemical restraint. Patient #23 was transferred to a psychiatric facility on 1/23/17 at 23:24 (11:24PM).

Based on review of records and interview, the Governing Body failed to ensure 1 service department (Respiratory Services) out of 17 services participated fully in the Quality Assessment / Performance Improvement (QAPI) program.

Interview was conducted with Staff #3 on 2-28-2017. Review of 2016 Quality Council meeting minutes did not include a review of Respiratory Therapy Services. Review of the Quality Council Report Schedule for 2017 did not include Respiratory Therapy on the Quarterly Review schedule. Staff #3 was asked what QAPI projects were being completed by the Respiratory Therapy Department. Staff #3 stated that Respiratory Therapy attended the Quality Council but was not involved in their own QAPI project.

Staff #71 was interviewed. Staff #71 confirmed that Respiratory Therapy reported information to other departments for their QAPI projects, but did not have their own department project.

Based on interview and record review the facility failed to:


A. ensure nursing provided ongoing assessments on patients who had gastrointestinal, respiratory, cardiac problems, severe pain and complications in the area of dietary/fluid needs. This deficient practice was found in 4 of 42 sampled patients (Patient #'s 13, 35, 37, and 38).


B. ensure sufficient numbers of nursing staff were available on 3 of 3 units (Off-site Emergency department, K4 medical- surgical unit, and K5 medical-surgical unit).


Refer to tag A0392 for additional information.

Based on interview and record review the facility failed to:

A. ensure nursing provided ongoing assessments on patients who had gastrointestinal, respiratory, cardiac problems, severe pain and complications in the area of dietary/fluid needs. This deficient practice was found in 4 of 42 sampled patients (Patient #'s 13, 35, 37, and 38).


B. ensure sufficient numbers of nursing staff were available on 3 of 3 units (Off-site Emergency department, K4 medical- surgical unit, and K5 medical-surgical unit).


This deficient practice had the likelihood to cause harm to all patients.


Findings include:





A. Review of the Emergency Department (ED) triage nursing assessment on Patient #35 revealed he was a 22 year old male who presented to the ED on 03/01/2017 at 1:36 a.m..

At 1:49 a.m., Patient #35 was triaged and complained of dizzy, vomiting, shaky and a hard time breathing. Patient #35 was given an Emergency Severity Index level of 3.
The assessment included vital signs, oxygen saturation and Glasgow coma score(neuro
logical assessment).

During an interview on 03/02/2017 after 9:00 a.m., Staff #59 reported that Patient #35 was taken back to the waiting area after being triaged by a nurse. Patient #35 did not see a nurse practitioner in triage. Patient #35 left without being seen at 2:30 p.m. Staff #59 confirmed there was no other assessment performed on Patient #35.

Review of the facility's policy revised 2009 and named "EXTENDED TRIAGE PRIVILEDGES FOR MID LEVEL PROVIDERS" revealed the following:

"..The triage nurse will assess each patient and determine the acuity level based on chief complaint, history, mechanism of injury, and assessment. The patient should be treated in the area that is most appropriate.

The following guidelines from The Emergency Severity Index should be used to determine the priority with which persons seeking emergency care will be seen.
1. Level 1---Immediate life-saving intervention required.
2. Level 2---High risk situation, confused, lethargic, disoriented, or severe pain or distress.
3. Level 3--- Patients that are predicted to require two or more resources .....
Resource include: Labs, X-rays/Imaging studies, IV fluids, IV, IM, or Nebulized medications, specialty consults, simple procedure (laceration repair, foley), or complex procedures (Moderate Sedation)..."





Review of the ED clinical record revealed Patient #37 revealed she was a 29 year old female who presented on 02/26/2017 at 8:12 a.m. Patient #37 was triaged at 8:21 a.m. with complaints of legs, arms, and back pain. There was documentation that Patient #37 had a diagnosis of sickle cell and had a pain level of 10 ( 0 indicating no pain and 10 indicating severe pain). Patient #37 was given an Emergency Severity Index level of 3.

According to the facility's policy Patient #37 should have been assessed as a Severity level 2 (meaning high risk situation, confused, lethargic, disoriented, or severe pain or distress).


Review of the "EMERGENCY DEPARTMENT PHYSICIAN H&P" dated 02/26/2017 at 9:00 a.m., revealed orders were written for the following:

"Demerol 75 IV"
"NS 1 liter Bolus IV"

The orders were incomplete and did not indicate how many milligrams of the pain agent Demerol to give and how often to administer it. There was no indication of what strength of normal saline to administer to the patient.

There was documentation on the history and physical (H&P) that Patient #37 was in sickle cell crises.

There was no documentation of the orders being clarified before medication administration. One and a half hours after being written, nursing documented administration of the pain medicine and the normal saline bolus.

According to nursing notes, Patient #37 was discharged at 12:11 p.m... At this time there was documentation of the pain level being a 1 which is almost 4 hours after presenting with a pain level of 10. There was no documentation of the pain level throughout the visit by nursing.




Review of the ED record of Patient #38 revealed he was 77 year old male who presented on 02/24/2017 at. 11:35 a.m.. Patient #38 presented with complaints of chest pain at a level of 8. Patient #38 was given an Emergency Severity Index level of 3. An EKG was done and the physician was in to see the patient.
At 11:50 a.m., lab was drawn, heplock in and patient taken to x-ray.
At 12:10p.m., Patient given aspirin by mouth.
At 12:45 p.m. the doctor into the room to discuss plan of care.
At 1:45 p.m. repeat labs were drawn.

Review of "EMERGENCY DEPARTMENT PHYSICIAN H&P" dated 02/24/2017 revealed no physician orders documented on the form for all of the procedures and medication that was given during the visit.

At 3:00 p.m., emergency medical services arrived to transfer Patient #38 to a higher level of care. The transfer record revealed Patient #38 was being transferred for "CP, +Trop NSTEMI." Meaning chest pain, positive troponin (proteins released which indicate heart damage) elevation and non ST elevation myocardial infarction.

Review of the record revealed no continued assessment by nursing of the patient's condition which included vital signs and the level chest pain. An incorrect ESI level was assessed.


During an interview on 03/02/2017 after 9:00 a.m. Staff #59 confirmed the missing assessments.







Review of the ED record revealed Patient #13 was a 75 year old who presented on 02/24/2017 at 7:25 p.m., with complaints of discoloration of the lower extremities and a diagnosis of thrombus occlusion of the extremities.

Review of ED nurse's notes dated 02/24/2017 at 7:36 p.m. revealed Patient #13 had no respiratory distress and a pulse of 91 beats per minute.

Review of physician orders dated 02/24/2017 revealed staff were to "Notify MD for change in condition."

Review of a nursing assessment dated 02/25/2017 at 6:00 a.m., revealed Patient #13 had a heart rhythm of sinus tachycardia (rapid heart beat) and weak pulses were noted to both lower extremities. Breath sounds were diminished in all lobes and expiratory wheezing in right and left lower lobes. Patient #13 had a tracheostomy, gastrostomy tube, and was dependent on staff for assist with all ADLs. Patient #13 also had a necrotic pressure sore to the left heel.

According to the assessment the nurse documented no dietary consult was needed, even though Patient #13 had a tracheostomy, respiratory problems, cardiac problems, a gastrostomy tube and a necrotic pressure.

The following was documented on 02/25/2017:

At 7:00 a.m., PVCs (premature ventricular contractions) and heart beats were 74 per minute. Breath sounds were coarse in all lobes and respirations were shallow.
At 11:00 a.m., doctor ... was contacted about fluids at night. MD said to hold, but patient is getting nothing by mouth or g-tube or IV. He said to give fluids at 50cc per hour.
At 3:43 p.m., Patient #13 was moved to the medical surgical unit.
At 5:00 p.m., there was documentation of Patient #13 being in sinus tachycardia at a heart rate of 108 beats per minute.
At 5:30 p.m., Resume feeding of Jevity 1.5 at 60cc per hour with 35cc fluids every hour.
At 5:49 p.m., Patient #13 was on the tube feeding Jevity 1.5 calories at 60 cc per hour and 0.9 % Sodium chloride at 50 cc per hour intravenously.
There was documentation of Patient #13 also receiving intravenously fluids and being NPO (taking nothing by mouth).

There was still no dietary consultant's referral made for an assessment of Patient #13's calorie, fluid or protein needs or tolerance.

Some of the following was documented about the heart rate on 02/26/2017:
On 02/26/2017 at 7:50 a.m., Patient #13 was in sinus tach at a rate of 108.
On 02/26/2017 at 1:55 p.m., the heart rate was 73 and at 5:32 p.m. it was 93.

The following was documented on 02/27/2017:

At 1:28 a.m., the heart rate was 98 and at 5:07 a.m. it was 106.
At 5:00 a.m., there was documentation in the notes that there was brown secretions from tracheotomy, will notify doctor.
At 5:10 a.m. a new order for a sputum culture and notify hospitalist in the am was documented.
At 5:19 a.m., the doctor was notified of change of secretions and volume of secretions. There was no documentation of the elevated heart rates being a part of the notification.
At 7:00 a.m., there was documentation of Patient #13 being in sinus tachycardia with PVCs and the heart rate at 146.
At 7:09 a.m., a different doctor was notified about coffee ground sputum from the tracheotomy and no new orders were given.
At 7:15 a.m., dark brown liquid was coming from the tracheotomy. The respiratory therapist was notified and the attending doctor was paged. Which was a different physician from the other two physicians who were notified.
At 7:30 a.m., the tube feeding was stopped and there was documentation Patient #13 was vomiting ...Patient gagging and appears to be trying to vomit. Coffee ground emesis coming from out of trachea ....Patient #13 with sinus tachycardia with PVC and a heart rate of 146..
At 7:35 a.m., there was documentation that the staff were waiting for a return call from attending doctor.
At 7:45 a.m. the attending doctor paged for the second time regarding change in condition. Coffee ground emesis from trache..
At 7:50 a.m. Patient #13's breathing appeared to be more labored and heart rate was sustained in the 140's per telemetry. Oxygen saturation was at 93 percent. Crash cart at the bedside.
At 7:55 a.m., there was documentation that staff asked to be put through to the attending doctor's cell phone because he had been paged twice and they had gotten no response. Crash cart brought to the bedside ....Rapid response called due to vital sign change, patient running sinus tachycardia 140's with PVCs ....
At 8:05 a.m., the attending doctor arrived to the room. Ordered stat(meaning immediate) chest x-ray because he believes patient has aspirated ... ...
At 8:45 a.m. patient #13 was transferred to ICU (intensive care unit) ....

Review of a physician's progress notes dated 02/27/2017 revealed the following:
Assessment & Plan
"1. Acute hypoxic respiratory failure, questionable of aspiration pneumonitis. He will be transferred to ICU, placed on ventilator via tracheostomy ...
2. Significant sinus tachycardia ....We will give a liter of NS Bolus. This could be from dehydration from nausea and vomiting.
3. Acute renal failure ....
4. Bilateral feet ulcer & ischemic limb ...
5. Questionable of upper gastrointestinal bleeding ...."

During an interview on 02/28/2017 after 12:00 p.m. Staff #57 confirmed the documentation about physician notification of the heart rate in the chart and not being able to find an assessment from a dietitian. Staff #57 also confirmed that nursing staff could initiate Rapid response at any time they felt there was the need.




Review of the facility policy dated 02/2017 named "RAPID RESPONSE TEAM" revealed the following:

" ...The role of the Rapid Response Team will be to provide early and rapid intervention in order to promote better outcomes for patients whose condition may be deteriorating so as to reduce the number of hospital deaths ..."

" ...Any clinical staff member may call the Rapid Response Team if the patient meets the following criteria:
Rapid Response Team Activation Criteria)
1. Concern about patient's presentation or condition ...
3. Acute change in Heart Rate from patient's baseline ... (e.g. <40bpm or >130bpm) ...
8. Acute significant bleed ... ...


Review of the facility policy dated 07/25/2015 named "NUTRITIONAL SCREENING" revealed the following:

"POLICY:
All patients, will be screened or assessed within 24 hours of admission to identify the need for nutrition intervention.
PURPOSE:
To ensure timely and appropriate care of patients who need nutrition intervention or assessment by the Registered Dietitian.
PROCEDURE:
1. All patients are screened by nursing within 24 hours of admission to determine the need for nutrition intervention or assessment by the Registered Dietitian. Nursing will complete the Nutrition section of the Admission Assessment in the medical record using triggers that have been determined by a multi-disciplinary committee, A nutrition consult will be automatically generated for any positive screen identified .....
..b. Chewing/swallowing ...
...d. Enternal/parenteral feeding ...
...f. Skin breakdown (greater than Stage II) ..."




B. Offsite Emergency department

Review of staffing schedules, census and the matrix for the off-site Emergency department revealed the following:

February 2017

On the 7:00 p.m. to the 7:00 a.m. shift there was one Registered nurse (RN) scheduled for 19 out of 28 days.

During an interview on 02/28/2017 after 9:30 a.m., Staff #58 reported that she did not have enough RN's for sedation monitoring. Their policy was to have 2 RNs on duty when they have to administer sedation.

Review of a facility policy dated October 2013 and named "Moderate Sedate Policy" revealed the following:

"..Registered Nurses with documented competency may care for the patient receiving Moderate Sedation. The RN may have no other responsibility that would leave the patient unattended or compromise continuous monitoring throughout the procedure..'



Medical surgical unit (K4)

During an interview on 02/28/2017 after 10:45 a.m., Staff #57 reported they had a patient census of 13 on today. They had 4 registered nurses (RN) on the floor who were performing their duties and full activity of daily living care to patients. Staff #57 reported that the charge nurse was included in the total count of 4 RN's and was taking patients also. One of the RN's was a full time nurse on the floor and the other three RN's were from their internal staffing agency. There was also a licensed vocational nurse working who was in orientation.

There was one full-time nurse who was working the unit with 3 internal agency staff, 1 licensed vocational nurse orientee who had to be supervised, taking care of patients and having to perform charge nurse duties.


Review of the staffing schedules, census and matrix for the timeframe from 02/21-27/2017 revealed the following shortages:

The 7:00 a.m. -7:00 p.m. shift was short one RN on the 21st, 22nd and
24th. They were short by one 4 hour tech on the 23rd and 25th.


The 7:00 p.m. -7:00 a.m. shift was short one RN on the 21st, 22nd, 24th and the 26th. They were short by one 4 hour tech on the 23rd and 25th.

On the 23rd and 25th they were short by one 4 hour tech.

On the 24th they were short by one 8 hour tech.

On the 27th there was no tech on duty, but the staffing matrix called for one 12 hour tech.

During an interview on 02/28/2017 after 10:45 a.m., Staff #57 confirmed the staffing numbers. Staff #57 reported they did have a staffing need and that they were interviewing and hiring. Staff #57 reported needing 2 techs for days and nights.




Medical surgical unit (K5)

Review of the staffing schedules, census and matrix for the timeframe from 02/21-27/2017 revealed the following shortages:

The 7:00 a.m. -7:00 p.m. shift was short one RN on the 25th and 26th.

The 7:00 p.m. -7:00 a.m. shift was short one RN on the 22nd, 24th,25th, 26th and 27th.

During an interview on 02/28/2017 after 3:47 p.m., Staff #51 confirmed the staffing numbers. Staff #51 reported that she was substituting and adding an extra tech for that RN.

Review of the staffing matrix did not allow for the substitution of a RN for a tech.

Based on record review and interview, the facility failed to ensure the facility logs were legible. Citing 6 of 6 water logs and chlorine logs reviewed. These deficient findings have the likelihood to not be able to identify water problems or the level of the staff documenting in the record.

Findings:

Review of the medical record policy titled "Guidelines Patient Care Services Deleting or Inactivating your saved Charted Entries" p 8 of 8 " In the event you make a documentation error: strike or amend the data as appropriate, drawing a single line across the entry and writing the corrected entry. Write the entry as error in charting in charting include the time and date of incorrect charting". (sic)

Review of the facility water logs and chlorine logs for November, December and January revealed numerous write over of the numbers and obliteration of numerous entries. The staff failed to follow the facility's policy on corrections to the records. The December log also failed to note the serial number of the portable water system.

Interview with the #7 and # 9 02/28/2017 at 2:00 p.m., confirmed the incorrect changes to the water and chlorine logs. Staff #7 and #9 both confirmed the staff did not follow the medical record policy for changing incorrect notations.

Based on observation, interview and record review the facility failed to:


A. ensure the compounding of drugs was supervised in a manner to ensure safe preparation of drugs in 1 of 2 pharmacies (Main Pharmacy).

Refer to tag A0501 for additional information.


B. ensure medications were stored securely in 1 of 2 pharmacies (Main campus pharmacy).

Refer to tag A0502 for additional information.


C. ensure outdated drugs were not available for patient use in 2 of 2 areas in the facility (Main pharmacy and K4 Medical-Surgical unit).

Refer to tag A0505 for additional information.


D. ensure there was a list of individuals who were designated as being able to remove medications from 1 of 2 pharmacies (Off-site Emergency Department (ED) Pharmacy).


Refer to tag A0506 for additional information.

Based on observation, interview and record review the facility failed to ensure the compounding of drugs was supervised in a manner to ensure safe preparation of drugs in 1 of 2 pharmacies (Main Pharmacy).

This deficient practice had the likelihood to cause harm to all patients.


Findings include:


During an observation on 02/27/2017 after 10:30 a.m., the following was found in the medication compounding area in the main pharmacy:


The ante room had all PPE(personal protective equipment) stored in containers on the wall. Some of the containers were soiled with debris and spills.

There was a sink in the ante-room that contained bags of intravenous fluids. Some had already been mixed and contained patient labels.


An unidentified staff member was observed to enter the ante- room and breached the critical area to talk to Staff #62 without being in the proper protective covering on.

Staff #62 was observed during the compounding process to get supplies from a drawer that was attached to the laminar hood. The crevices on the outside of the drawers were soiled with a brown build-up. Staff#62 was observer to remove the tops off of five vials of medication that were to be used. She took an alcohol wipe and wiped all 5 bottles with the same alcohol pad.


Staff #63 confirmed the observations. Staff #63 identified the staff member talking to Staff #62 as a pharmacist. Staff #63 reported that the intravenous bags in the sink were from the patient care floors. Pharmacy staff would pick them up if they were not used and bring them back to the pharmacy.


Review of a facility policy dated 01/2016 and named "Sterile Products: General" revealed the following:

"AREAS FOR PREPARING STERILE PRODUCTS
Sterile products must be prepared in areas that will minimize opportunities for particulate and microbial contamination of the products."


Review of a facility policy dated 01/2016 and named "Sterile Products: Controlled /Buffer Area and Ante Area for Preparation of Parenteral and Sterile Products" revealed the following:

Ante Area
The ante area is defined as the area immediately near, but physically isolated from the buffer room areas and are intended to minimize the introduction of contaminants into the buffer area. A demarcation line or barrier identifies the separation of the buffer area from the ante area ...
The ante area is used for the:
*Introduction of supplies such as needles, syringes, ampules, bags, vials, and packages of transfer tubing. These supplies are uncartoned and disinfected.
*Hand sanitizing and gowning activities occur in the ante adjacent to the buffer area.
*Cleaning ... ... ...

Controlled area/Buffered area
The controlled area shall be defined as the area designated for the preparation of sterile products. The controlled area shall be functionally separate and constructed to minimize the opportunities for particulate and microbial contamination. The controlled area shall be used only for the compounding of sterile pharmaceuticals.
The buffer area shall:
...*Be clean and well lighted and only used for sterile product preparation ...

Personnel cleaning and Gowning
1 ....Personnel must don the following PPE and perform hand hygiene in an order that proceeds from the dirtest to the cleanest activities ....
3. After donning dedicated shoes or shoe covers, head and facial covers, and face masks, personnel shall perform a hand hygiene procedure ..."

Based on observation and interview, the facility failed to ensure medications were stored securely in 1 of 2 pharmacies (Main campus pharmacy).

This deficient practice had the likelihood to cause harm in all patients.

Findings include:


During an observation on 02/27/2017 after 10:30 a.m., medications were found stored on a shelf near an open window in the pharmacy. The medications were not stored in a secure manner. Anyone passing through could reach the medications. The medications stored were as follows:

Lidocaine/Epinephrine (anesthetic/adrenalin)
Bupivacaine (anesthetic)
Lexiscan (stress agent that works by increasing blood flow in the arteries of the heart)
Kenalog (corticosteroid)
Methylprednisolone (steroid)
Dexamethasone(steroid)
Regular Strength Tylenol (analgesic)

Staff #63 confirmed the observations.

Review of a facility policy dated 01/2016 and named"Storage:General" revealed the following:

"..Medications shall be safely and securely stored at all times ...Storage must be secure and not accessible to the public or nonauthorized access to medications ..."

Based on observation, interview and record review the facility failed to ensure outdated drugs were not available for patient use in 2 of 2 areas in the facility (Main pharmacy and K4 Medical-Surgical unit).


This deficient practice had the likelihood to affect all patients.

Findings include:


During an observation on 02/27/2017 after 10:30 a.m., the following was found in the main pharmacy:


A packet of medication was found on a bottom shelf not contained in a drawer or bin. The outside of the packet was soiled. The medication was the anti-coagulant Coumadin which expired 01/2017.

A bottle of anti-histamine was found stored on a shelf and it expired on 01/2017.

Four bags of intravenous fluids that had been pre-mixed and not in their overwraps were stored on a shelf with other intravenous fluids which were still in their overwraps. The following bags were stored on the shelf:
One bag had no preparation date, but expired 11/17/2016;
One bag was prepared 01/26/2017 and expired on 02/02/2017;
One bag was prepared 01/31/2017 and expired on 02/07/2017;
And another bag was prepared 02/16/2017 and expired on 02/23/2017.

The fluids were expired.



K4 (Medical-Surgical unit)

During an observation on 02/28/2017 after 1:00 p.m. of the emergency crash cart the following was found:

One 100 cc bag of 0.9% Sodium chloride and six boxes of the adrenalin Epinephrine which expired January 2017.

Review of the "CRASH CART INSPECTION FORM" dated February 2017 revealed the cart should be inspected each day. Nursing documented daily checks the entire month.

The following was also documented on the form"MONTHLY VERIFICATION OF INSPECTION OF ENTIRE CONTENTS BY PHARMACY." Underneath this was documentation that the contents were checked on 02/27/2017 at 9:30 a.m. There was no documentation of the expired fluid and medication being found in the emergency tray.

Staff #57 confirmed the observations.

Based on observation, interview and record review, the facility failed to have a list of individuals who were designated as being able to remove medications from 1 of 2 pharmacies (Off-site Emergency Department (ED) Pharmacy).

This deficient practice had the likelihood to cause harm to all patients who presented to the offsite ED.

Findings include:

During an observation of the Pharmacy room on 02/28/2017 after 8:30 a.m., there was no listing of designated staff who could enter the room.

Staff #58 confirmed the nursing staff had full access to the room after hours and reported they did not have list of designated staff. Staff #58 provided a list of staff with their names for the entire facility. The list included nurses, paramedics, radiation techs, and registrar staff. There was no documentation on the list of who was allowed in the pharmacy.

Based on observation, record review, and interview, the infection control program failed to:

A. ensure that the person designated as infection control nurse (Staff #15) was qualified either through education, training, experience, and/or certification. Also, Staff #15 failed to follow the facility's job description for the Infection Control practitioner.

See Tag: A 0748


B. provide a sanitary environment to avoid sources and transmission of infectious and communicable diseases in 13 of 13 ( Surgery, Main Pharmacy, Offsite Emergency Department Pharmacy, K4 Medical Surgical Unit, Postpartum Unit, Nursery, Respiratory Therapy Arterial Blood Gas Room, Inpatient Rehabilitation, Central Supply, Linen and Laundry, Dietary, Cardiac Rehabilitation, and Waste Management) departments of the facility.

These deficient practices of infection control issues in the 13 departments of the hospital had the likelihood to cause serious harm or injury to the patients receiving care in the facility.

See Tag: A 0749


C. ensure hospital leadership identified problems and/or addressed problems identified by the infection control officer. They failed to implement successful corrective action plans in the affected problem areas.

See Tag: A 0756

Based on record review and interview, the facility failed to ensure that the person designated as infection control nurse (Staff #15) was qualified either through education, training, experience, and/or certification. Also, Staff #15 failed to follow the facility's job description for the Infection Control practitioner.


A review of Staff #15's (Infection Control Practitioner) personnel file revealed the job description was not signed until 03/01/2017. The personnel file for Staff #15 revealed no documentation that she had taken the APIC (Association for Professionals in Infection Control and Epidemiology) certification. Staff #15 was hired into the position on April 1, 2015 and the System HR Manager wrote in the acceptance letter that Staff #15 had 1.5 years to complete the APIC certification. Staff #15 acknowledged the letter on April 2, 2015 knowing that she had to complete the APIC certification. There was a letter dated September 9, 2016 in the file from the System Quality Director extending the deadline for taking the APIC certification, but per the facility's policy, job description required to be Board Certified in Infection Control (APIC certification). Also, further review of Staff #15 file revealed no annual review of the job description to ensure the job description was current and that all revisions to the job description was to be coordinated with HR (Human resources).

A review of the job description titled, "Infection Control Practitioner" revealed the following requirements:

"Summary/Objective
Expert on infection prevention and control based on the principles of the APIC competency Model:
Leadership and Program Manager
Infection Prevention and Control
Performance Improvement and Implementation Science
Technical Skills
Utilizes Evidence base practice based on APIC, The Joint Commission (TJC) and NSHN standards

Competencies:
High level communication and negotiation skills, ability to influence through team and consensus building skills
Proficient in Excel. PowerPoint and other computer skills that support timely reports and presentations
Advanced level on the APIC Competency Assessment and professional development plan

Required Education and Experience

Bachelor's degree or 3-5 years of infection control experience required.
Current RN license
Board Certified in Infection Control (APIC certification)"

A review of the policy titled, "Job Descriptions" reveled the following:

"POLICY:
Job Descriptions shall be prepared for all staff positions. A draft job description must be submitted to Human
Resources (HA) for all new approved positions prior to the pre-employment process. Department Directors will review job descriptions at least annually to assure they remain current. Any revisions to job descriptions will be coordinated with HR. Revisions must be forwarded to HR. All official job descriptions will be published by HR."



An interview with Staff #3 on 03/01/2017 at 4:15 PM confirmed the Infection Control Practitioner had signed the job description, but the responsibilities of the job description were discussed. Also, Staff # 3 confirmed there was no documentation showing the extended deadline to Staff #15's job description was coordinated with HR.


An interview was conducted with Staff #15 on 03/02/2017 at 11:30 AM confirmed she did not have any APIC certification to oversee the infection control program for the facility.

Based on observation, record review, and interview, the infection control program failed to provide a sanitary environment to avoid sources and transmission of infectious and communicable diseases in 13 of 13 ( Surgery, Main Pharmacy, Offsite Emergency Department Pharmacy, K4 Medical Surgical Unit, Postpartum Unit, Nursery, Respiratory Therapy Arterial Blood Gas Room, Inpatient Rehabilitation, Central Supply, Linen and Laundry, Dietary, Cardiac Rehabilitation, and Waste Management) departments of the facility toured.

These deficient practices of infection control issues in the 13 departments of the hospital had the likelihood to cause serious harm or injury to the patients receiving care in the facility.


Surgery Department

During a tour of the sterilization department and Surgery supply storage area on 02/27/2017 from 10:30 AM to 12:00 PM with the Surgical Director and Sterilization Director, the following infection control issues and expired supplies were observed:

Sterilization and Surgery Supply Work Warehouse Area:

1. In the decontamination area, there was an Anteroom where the PPE (personnel protective equipment) supplies were kept in a cabinet drawer. Observed vacuum cleaning parts mixed with the PPE (personnel protective equipment).

2. In the surgical supply storage area, numerous wire carts on the bottom shelves were covered in dust. The bottom shelves in the surgical supply storage area on numerous wire carts were covered in dust. The dust was so thick you could write your name in the dust. Also, the plastic bins holding the open sterile surgical supplies were dirty with dust and trash particles. This storage area contained open sterile surgical supplies on open wire racks. The surgical supplies are then taken from the wire racks and placed on metal closed carts with the sterile instruments and taken to the operating rooms to be directly opened onto the surgical patients' table for their surgical procedures.

3. During the tour of the surgical storage area, a large cardboard box full of expired items was observed.. The box was not labeled that the supplies were expired and/or not available for use. The expired surgical supplies were available to anyone entering the supply storage area.

An interview with Staff #15, #44, and #47 on 02/27/2017 at 11:45 AM confirmed the above findings.



Cath Lab and Cardiovascular Operating Room:

During a tour of the Cath Lab department on 02/28/2017 from 8:30 AM through 10:00 AM with the Cath lab Director, and Staff #43 the following infection control issues were observed:

1. In the Anteroom, which was outside the isolation room and in the post recovery area for Cath lab patients, observed a cardboard box full of information pamphlets sitting on the counter. Staff #45 reported one the product vendors must have left the cardboard box on the shelf. Staff #45 was asked if this was a normal place for the cardboard box to be placed. Staff #45 stated, "No."

2. In two of the patients' bathrooms located in the Cath Lab area, the emergency pull cords were wrapped around the handicap rail. Emergency pull cords must be accessible even if the person is lying on the floor. The cord must hang freely and be within 6 inches from the floor.

3. The electrical room where the Cath Lab supplies were stored, it was observed that the floor was dirty with dark stains and trash.

4. The air flow vent located in the surgical Cardiovascular Room was covered in dust and lent particles. The Cardiovascular Room was located in the same area as the Cath Lab.

5. During the tour of the cardiovascular recovery room observed 3 light fixtures that were full of dead bugs.

6. The temperature and humidity was not being monitored where the sterile supplies and instruments were kept for the Cath Lab and Cardiovascular operating room. Staff #45 stated, The Environmental personnel monitor the temperature and humidity.

An interview with the environmental technician on 02/28/2017 at 10:00 AM stated, "We can adjust the temperature and humidity from a computer system for the Cath lab rooms and Cardiovascular operating room, but we do not have a daily print out of the temperature and humidity." There was no documentation showing the Cath Lab and Cardiovascular operating room was being monitored and the sterile supplies and instruments.

An interview with Staff #44 and #45 on 02/27/2017 at 10:00 AM confirmed the above findings.



Pre-operative Area, Surgery, and PACU:

During a tour of the Surgical areas on 02/28/2017 from 11:15 PM through 4:00 PM with the Surgical Director, Staff #43, and Staff #44 the following infection control issues and expired items were observed:


1. The floor had large chips of tile missing in several areas of the pre-operative area. Also, the counter in the pre-operative area had large pieces of Formica missing. These areas that had missing tiles and Formica which had the likelihood to harbor dirt and bacteria allowing for an unclean area for patient care.

2. Upon entering the surgery area which was where Operating room attire should be worn, an employee was only wearing the skullcap which did not totally cover the hair. The surgical team members are responsible for preventing SSI by properly donning and wearing the appropriate head cover or hood.


3. The soiled utility room walls and floor were dirty. The wall plaster had numerous holes where were the plaster was missing and the wall had a discolored appearance. The light was not working.


4. The linen cart for surgery was being stored in a storage room with the ice machine and there was no barrier on the bottom wire rack. There was a blanket wrapped around the drain area of the ice machine and it appeared that there was a leak with the ice machine. There was a large piece of tile missing from the floor. The floor behind the linen cart was dirty with dead bugs, dust, and trash particles. Also, there was linen that had fallen on the floor. The floor had a discolored appearance. The charge nurse of surgery reported he had placed 2 requests to the maintenance department for the ice machine and the floor to be fixed.

A review of the work orders from September 2016 to present showed 57 work orders had been placed and 16 were still active showing issues that needed to be completed in the surgery department.

5. In the storage room where patient's tissue specimen are stored there were endo-cervical swabs that had expired 09/30/2013 X 2. The wire rack in this area was filled different supplies and had a neglected or not properly maintained appearance. The Formica was cracked in several places. The shelf contained a plastic container full of screws, a sharps container full of Bio-hazard bags, papers, and an old tape dispenser.


6. In the surgical department in sub-sterile room #1, in the refrigerator there was a tray of solid ice in the freezer. There were surgical supplies requiring refrigeration, but not to be frozen that were stored in the refrigerator. Also, in sub-sterile #1, the autoclave drain was full of water and the floor was rusted.

7. The air flow vent located in the Surgical Room #2 was covered in dust and lent particles.

8. There was a large chip of flooring missing in the Cysto Room. These areas that had missing tile and flooring had the likelihood to harbor dirt and bacteria allowing for an unclean area for patient care. There were 4 surgical cases performed in the Cysto room on 02/25/2017.

9. While observing a patient having a procedure in the Cysto room, Staff #38 came into the room without wearing a mask while the procedure was being performed.

10. Observed in the sub-sterile #4, on the inside of a cabinet door there was tape stuck to the door where loads had been documented from a piece of equipment and the tape was dated back to 2-4-1999. Also, underneath the same cabinet was a water filter system that had been used for a piece of equipment. The filter inside the system was a dark rust color. There were numerous cracks on the Formica counter.

11. During the tour of the PACU area observed a clear plastic bag full of expired patients' supplies lying on the counter. The plastic bad was not labeled as expired supplies or labeled not for patient use. The plastic bad was full of expired items and available for any staff member. The expired items were in the same room with all the available patient supplies.

12. There was a Pediatric recovery bay area that was full of the following items: respiratory supplies, seven (7) large corrugated boxes of gloves, rocking chair, Christmas decorations in a large plastic container and a corrugated box of Christmas decorations, office supplies that consisted of 2 large boxes of printer cartridges, 6 bottles Enfamil that expired in January 2017, and other equipment. Only one person could enter the room it was so full of various items.

13. Throughout surgery, Pre-operative area, and PACU area the floors a numerous gaps in the tile and there were several places that large chips missing from the tile. The condition of the floors had the likelihood to harbor bacteria and dirt in the chips and gaps in the flooring which would lead to infection issues in caring for patients.

An interview with Staff #43, #44, and #47 on 02/28/2017 at 3:00 PM confirmed the above findings.




A review of the immediate use sterilization logs for the months of October, November, December 2016 and January 2017 revealed unwrapped implant trays and full sets of instruments trays were being flashed in the flash sterilizers. Also, the facility failed to follow their own policy for Immediate Use Stream Sterilization, the AORN (Association of perioperative Registered Nurses) standards, and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards.


A review of the IUSS (Immediate Use Stream Sterilization) sterilization log for the month of October 2016 for the flash sterilizers, there were 39 individual instruments and/or tray sets flashed. There were seven (7) instruments dropped or contaminated, twenty-six (26) not sterile/not ready, one (1) wet contents, one (1) not a facility instrument, and four (4) with a hole in the wrapper. Further, review showed of the IUSS sterilization log indicated PHACO instrument sets (eye instrument trays) were flashed 12 times. The IUSS system for the October log was used 14 times for single instruments and 25 times for sets of instruments.



A review of the IUSS sterilization log for the month of November 2016 for the flash sterilizers, there were 34 individual instruments and/or tray sets flashed. There were two (2) instruments dropped or contaminated, twenty-four (24) not sterile/not ready, two (2) not a facility instrument, two (2) with a hole in the wrapper, and one (1) one of a kind instrument. Further, review showed of the IUSS sterilization log indicated PHACO instrument sets (eye instrument trays) were flashed 9 times. The IUSS system for the November log was used 34 times for sets of instruments. There was no single instruments documented on the log as being flashed.


A review of the IUSS sterilization log for the month of December 2016 for the flash sterilizers, there were 34 individual instruments and/or tray sets flashed. There were three (3) instruments dropped or contaminated, twenty-three (23) not sterile/not ready, one (1) not a facility instrument, five (5) with a hole in the wrapper, one (1) vendor late with a set of instruments, and one (1) one of a kind instrument. Further, review showed of the IUSS sterilization log indicated PHACO instrument sets (eye instrument trays) were flashed 11 times. The IUSS system for the December log was used 16 times for sets of instruments and 18 times for single instruments.


A review of the IUSS sterilization log for the month of January 2017 for the flash sterilizers, there were 26 individual instruments and/or tray sets flashed. There were six (6) instruments dropped or contaminated, eleven (11) not sterile/not ready, and seven (7) with a hole in the wrapper. Further, review showed of the IUSS sterilization log indicated PHACO instrument sets (eye instrument trays) were flashed 10 times. The IUSS system for the January log was used 15 times for sets of instruments and 11 times for single instruments.

A review of the immediate use sterilization log indicated there were numerous times instruments were not ready and that immediate use sterilization was used due to hole in the wrappers.

A review of the of the Surgery Process Committee dated August 2016 and November 2016 revealed no documentation about the high usage of IUSS (immediate use stream sterilization) process. There was no drill down to track or analyze the issues causing the immediate use sterilization to have such a high usage in the facility. There was no written plan or process to address the high usage of immediate sterilization.

A review of the surgical clinical indicators that was reported to the quality department from the surgery department revealed no indication that the immediate use sterilizations was a quality issue that needed to be addressed.


A review of the facility's policy titled, "Immediate Use Steam Sterilization" revealed the following:

"PURPOSE: To decrease and eliminate the amount of Immediate Use Steam Sterilization in the operating suite, perform regular testing of the sterilizers, and meet local, state, and national regulatory requirements for testing and sterilizing items. To ensure appropriate steam sterilization guidelines and evidence-based practices are adhered to in the perioperative setting.

II. DEFINITIONS

Ill, POLICY: IUSS should only be completed when time it is an emergency. Steam sterilization in the OR will be accomplished by utilizing approved rigid containers designed for sterilization in immediate use. Open tray sterilization will be used only for those instruments or sets which cannot fit into the designated sterilization containers. IUSS should not be used as a substitute for insufficient instrument inventory. Implants will only be sterilized in the OR when absolutely no other option exists.

11. Immediate Use Sterilization should not be performed on:
a. Implants except in situations noted previously
b. Post-procedure decontamination of instruments used on patients who may have Crutzfeldt-Jakob Disease (CJD) or similar disorders.
c. Devices that have not been validated with the specific cycle employed.
U. Sterile devices sold as single use only."


A review of the perioperative standards and recommended practices "Association of Perioperative Registered Nurses" revealed the following:

"Recommendation VII

Immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner.

Immediate use steam sterilization may be associated with increased risk of infection to patients. Time constraints may result in pressure on personnel to eliminate or modify one or more steps in the cleaning and sterilization process. The term flash sterilization has historically been used to describe steam sterilization of unwrapped items intended to be used immediately. Flash sterilization cycles have traditionally been either 3 or 10 minutes of exposure, depending on the nature of the device being sterilized or the type of cycle indicated, minimal or no dry time, and no cooldown, thereby making the entire cycle time shorter than the cycle times for wrapped or terminally sterilized items. However, current manufacturers ' instructions for use may require a variety of cycle times and the use of single wrappers or flash containers as opposed to sterilizing unwrapped items. The term "flash sterilization" no longer serves to describe the various steam sterilization cycles and processes that are used to process items that are not intended to be stored for later use. For this reason, the more appropriate term is IUSS.

VII. a. Immediate use steam sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Immediate use steam sterilization should not be used as a substitute for sufficient instrument inventory."


An interview with Staff #44 and #47 on 02/28/2017 at 3:00 PM confirmed the facility's surgical department follows the AORN standards and ANSI/AAMI.


Upon a review of the 2011 "Association for the Advancement of Medical Instrumentation" ANSI/AAMI ST79:2010, the guidelines revealed the following:

"10.6.3 Release criteria for implants
As with all cycles, an experienced, knowledgeable person should review the sterilizer chart or printout at the end of the sterilization cycle, as well as the results of other indicators that have been used to monitor the sterilization process. The load should be quarantined until the results of the SI testing are available (CDC, 2008).
Releasing implants before the SI results are known is unacceptable and should be the exception, not the rule.
When documented medical exceptions dictate (e.g., the need for trauma-related orthopedic screw-plate sets), it could be necessary to release an implantable device before the SI results are known. In this case, the release of the device before the SI results are known should be documented; the SI result obtained later should also be documented. (See Annex L for examples of an implant log and an exception form.) It is critical that this documentation be fully traceable to the patient. Emergency situations should be defined in written guidance developed in consultation with infection prevention and control, the surgeon, and risk management. Steps should be taken to reduce the frequency of emergency release of implantable items. For example, ongoing periodic reviews of the exception forms and implant logs could reveal consistent patterns of events that are causing emergency release and that could be corrected.
NOTE-See Section 12 (New product evaluation) for general guidelines on how to assess the specific label claims of new products that become commercially available.
Rationale: Patient safety could be adversely affected by the implantation of a nonsterile device. The sterilization of implantables should be closely monitored and each load containing implants should be quarantined until it is verified that SI testing has yielded negative results. In defined emergency situations in which the quarantine of implants cannot be maintained, breaking of the quarantine is allowed for documented medical exceptions in accordance with facility policies and procedures. See also the rationale for 10.6.1."

An interview with Staff #44 and #47 on 02/28/2017 at 3:00 PM confirmed the surgical department was flashing instruments and instrument trays on a routine basis and not just for emergencies.




A review of the TEE probes disinfection log was completed during a tour of the decontamination room on 02/27/2017 at 11:00 AM. A review of the log dated from 02/01/2017 through 02/23/2017 revealed the probe serial number was left blank, so there was no way to know which TEE probe had been disinfected. The process was to document the serial number of the probe to indicate which probe was used on the patient in case there was an infection control issue the facility would be able to trace which probe had been used on the patient.

On 02/07/2017 the TEE probe serial number was left blank.
On 02/10/2017 the TEE probe serial number was left blank.
On 02/16/2017 the TEE probe serial number was left blank.
On 02/17/2017 the TEE probe serial number was left blank.


An interview with Staff #43, #44, and #47 on 02/28/2017 at 11:00 AM confirmed the above findings.




During a tour of the off-site emergency on 02/28/2017 at 9:00 AM observed the cold disinfectant solution was Revital OK (sic). The off-site emergency room was not following the facility's policy; which was to use Cidex OPA as the cold disinfectant solution. The Emergency room was using Revital OK, but there was no policy or guidance on how to use the Revital OK cold disinfectant solution.




During a tour of the radiology and ultrasound departments on 03/01/2017 at 3:00 PM there were transvaginal probes observed hanging on the wall with open clear plastic baggies covering them. Plastic baggies prevent air flow and any moisture on the vaginal probe covered with a plastic baggie will cause mold or bacteria to grow causing a risk of infection for a patient receiving a vaginal ultrasound procedure according to the CDC standard guidelines.





10135


Main Pharmacy

During an observation on 02/27/2017 after 10:30 a.m., the following was found in the main pharmacy:


Baseboards in the pharmacy had a build-up of dirt, spills and medication vials. The flooring underneath equipment had a build-up of spills and dust. The vinyl flooring in the room had ripped areas and buckled. The cement flooring underneath was exposed. There was no way the flooring could be sanitized.

The following vials of medication were on the floor underneath the shelves in the intravenous storage area:

Gastrointestinal agents Metoclopramide, Ondansetron, and Pantoprazole. The antibiotic Ampicillin.


Vials of the corticosteroid DepoMedrol were stored in a plastic bin which was soiled with spills.


A rusted shelf contained two pestles and a mortar, vase, cylinder, open bottle of alcohol and a half of gallon of distilled water. Another plastic container had a label on it that read distilled water. The open containers did not have open dates written on them. A spray bottle of 70% alcohol was stored on a shelf. It had no date written on it as to when it was poured into the container.


Five sharps containers which contained biohazards in them were stored next to shelves of patient medications.

Staff #63 reported the sharps containers were brought from the units and stored there.


A plastic cart used to transport medications to the nursing units was soiled with dirt and spills. A crash cart tray of medications was observed stored on the bottom shelf of the cart.


Open plastic bins on shelves had medication stored in them and they were soiled with a build-up of dust. Two portable medication storage bins which had individual drawers was found to be soiled and with a build-up of dust.


Two packet of medications were found on a bottom shelf and were not contained in a drawer or bin. The outside of both packets were soiled. One was the anti-coagulant Coumadin which expired 01/2017 and the other was the antibiotic Metronidazole.


A bottle of antacid and anti-histamine were found stored on a shelf and the outside of the bottles were soiled with a build-up of dried spills. The anti-histamine expired on 01/2017.


Bags of intravenous fluids were stored in plastic bins which had soiled tape on them and dust.


Four bags of intravenous fluids that had been pre-mixed and not in their overwraps were stored on a shelf with other intravenous fluids which were still in their overwraps. The following bags were stored on the shelf:

One bag had no preparation date, but expired 11/17/2016;
One bag was prepared 01/26/2017 and expired on 02/02/2017;
One bag was prepared 01/31/2017 and expired on 02/07/2017;
And another bag was prepared 02/16/2017 and expired on 02/23/2017.
The fluids were expired.

There was no separation of expired fluids and fluids currently in use.


A storage bin of packets of sterile intravenous tubing had a bottle of bleach stored directly on top of them.


A refrigerator which contained medications for cancer treatment, anemia treatment and pneumonia vaccines was found to be soiled with hair and a build-up of brown substance. The seal to the refrigerator door and lower inside of the refrigerator was soiled with a thick brown substance. The floor in front and on the side of the refrigerator was soiled with a brown substance. The front panel on the door of the refrigerator had dried spills.


A pharmacy storage room contained 90 plus shipping boxes which contained bags of intravenous fluids, antibiotics, anticoagulants and intravenous equipment. Some of the boxes were open.

According to the Association for the Advancement of Medical Instrumentation (AAMI ST46-Section 5.2 Receiving Items) the following was documented:

"External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust (AAMI ST46-Section 5.2 Receiving Items).

Staff #63 (Pharmacist) confirmed all of the observations.




During an observation of the compounding area in the pharmacy the following was found;

The ante room had all PPE (personal protective equipment) in containers on the wall. Some of the containers were soiled with debris and spills. There was a sink in the ante-room that contained bags of intravenous fluids. Some had already been mixed and contained patient labels.


An unidentified staff member was observed to enter the ante- room and breached the critical area to talk to Staff #62 without being in the proper protective covering on.

Staff #62 was observed during the compounding process to get supplies from a drawer that was attached to the laminar hood. The crevices on the outside of the drawers were soiled with a brown build-up. Staff #62 was observer to remove the tops off of five vials of medication that were to be used. She took an alcohol wipe and wiped all 5 bottles with the same alcohol pad.


Staff #63 confirmed the observations. Staff #63 identified the staff member talking to Staff #62 as a pharmacist. Staff #63 reported that the intravenous bags in the sink were from the patient care floors. Pharmacy staff would pick them up if they were not used and bring them back to the pharmacy.


Review of a facility policy dated 01/2016 and named "Sterile Products: General" revealed the following:

"AREAS FOR PREPARING STERILE PRODUCTS
Sterile products must be prepared in areas that will minimize opportunities for particulate and microbial contamination of the products."

Review of a facility policy dated 01/2016 and named "Sterile Products: Controlled /Buffer Area and Ante Area for Preparation of Parenteral and Sterile Products" revealed the following:

"Ante Area
The ante area is defined as the area immediately near, but physically isolated from the buffer room areas and are intended to minimize the introduction of contaminants into the buffer area. A demarcation line or barrier identifies the separation of the buffer area from the ante area ...

The ante area is used for the:

*Introduction of supplies such as needles, syringes, ampules, bags, vials, and packages of transfer tubing. These supplies are uncartoned and disinfected.
*Hand sanitizing and gowning activities occur in the ante adjacent to the buffer area.
*Cleaning ... ... ...

Controlled area/Buffered area

The controlled area shall be defined as the area designated for the preparation of sterile products. The controlled area shall be functionally separate and constructed to minimize the opportunities for particulate and microbial contamination. The controlled area shall be used only for the compounding of sterile pharmaceuticals.

The buffer area shall:
...*Be clean and well lighted and only used for sterile product preparation ...

Personnel cleaning and Gowning
1 ....Personnel must don the following PPE and perform hand hygiene in an order that proceeds from the dirtest to the cleanest activities ....
3. After donning dedicated shoes or shoe covers, head and facial covers, and face masks, personnel shall perform a hand hygiene procedure ..."


Review of a facility policy dated 01/2016 and named "Storage:General" revealed the following:

" ...ORDERLY STORAGE
-Drugs shall be stored in an orderly manner to facilitate inventory control and minimize errors.

CLEAN STORAGE
-Storage areas shall be kept clean, uncluttered and from trash, insects, rodents, and vermin. If lower shelves are not sealed to the floor, sufficient space shall be allowed underneath the shelves to permit access for cleaning..."

Off-site Emergency Department Pharmacy

During an observation of the pharmacy room on 02/28/2017 after 8:30 a.m. the following was found:

A bottle of Kayexalate (used to treat high potassium levels) was stored in the room and in use and had no expiration date on it.

An open multidose vial of the anesthetic agent Lidocaine was found stored on a shelf and staff failed to record an open date on it.

Staff #58 confirmed the observations.

According to the Association for Practitioners in Infection Control (APIC) article named"APIC Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Healthcare" dated 07/30/2009 revealed the following:

"If multidose vials must be used, it should be used for a single patient whenever possible. The risk of transmission posed by inappropriate handling of multi-dose vials has been clearly demonstrated and mandates a practice of one vial per one patient whenever possible. Infection transmission risk is reduced when multi-dose vials are dedicated to a single patient ...
Keep multidose vials away from the immediate patient environment..
Dispose of opened multidose medication vials 28 days after opening, unless specified otherwise by the manufacturer, or sooner if sterility is questioned or compromised."


K4 (Medical-Surgical unit)

During an observation on 02/28/2017 after 1:00 p.m. of the emergency crash cart the following was found:

One 100 cc bag of 0.9% Sodium chloride and six boxes of the adrenalin Epinephrine which expired January 2017.

The inside of the white emergency cart tray which had the medication stored in it was soiled with a dried brown substance.

Review of the "CRASH CART INSPECTION FORM" dated February 2017 revealed the cart should be inspected each day. Nursing documented daily checks the entire month.

The following was also documented on the form"MONTHLY VERIFICATION OF INSPECTION OF ENTIRE CONTENTS BY PHARMACY." Underneath this was documentation that the contents were checked on 02/27/2017 at 9:30 a.m. There was no documentation of the expired fluid and medication being found in the emergency tray.

Staff #57 confirmed the observations.


Postpartum and Nursery Unit

During an observation on 03/01/2017 after 9:30 a.m., the following was found:

Surgical bunny suits used by staff to cover their clothing during surgery was stored in a cabinet along with extension cords. The floor to the cabinet was soiled with dried spills and debris.

Seven metal baby cribs were stored in a room and they were rusted. There was no way the cribs could be sanitized the rust on them.

Three bottles of the lab testing media VersaTrek Redox was found in the nursery which had expired on 02/2016 ( one year ago).

A medication room in the postpartum area was found to have soiled linen on the floor in front of an ice machine which had the bottom front panel removed. The floor in the room was soiled from stains, dust and dead roaches.

Staff #60 confirmed the observations and reported the medication room had not been used for 3 ½ years.



36827


Respiratory Therapy Arterial Blood Gas (ABG) Room

On 3-1-2017 a tour of the Respiratory Therapy ABG (blood from a patient's artery is analyzed for the content of different gasses and compounds such as oxygen and carbon dioxide) room located on the ICU floor was conducted with Staff #71 present. Blood samples taken from ill patients were brought into the room to be analyzed in a machine for the purpose of assessing the patient's respiratory system. Patients' blood had the potential to transmit many dangerous infections. Also stored in the room were clean patient supplies used by respiratory therapists to care for ill patients. The clean supply were in close proximity and without protective barrier to blood samples that had the potential to contaminate clean supplies.

Staff #15 was interviewed. Staff #15 confirmed that the ABG rooms were included in the Infection Control surveillance rounds. When asked about blood being processed in a room with clean supplies, Staff #15 replied, "I never put it together."


Inpatient Rehabilitation

On the afternoon of 3-1-2017, a tour of the Inpatient Rehabilitation unit's gymnasium was conducted with Staff #72. A Hydrocollator was observed (a thermostatically controlled water bath for placing cloth heating pads. When the pads are removed from the bath, they are placed in covers and placed on the patient. The device is used during physical therapy). When the cover to the Hydrocollator was opened, the water appeared hazy. The inside walls and lid had a rust colored substance on them.

Based on observation, record review, and interview, the chief executive officer, medical staff, and director of nursing services failed to identify problems and/or addressed problems identified by the infection control officer. They failed to implement successful corrective action plans in the affected problem areas.


Findings included:

A review of emails from the Infection Control Preventionist revealed she had notified the Director of Surgery, the Manager of Sterilization, and the Manager of Central Supply of the infection control issues found in their departments. The email was dated December 5, 2016. The Quality Director was on the emails, because Infection Control Preventionist reports directly to the Quality Director.

A review of another email from the Infection Control Preventionist dated January 3, 2017 was sent to the Manager of Central Supply. The email read "What is the plan to clean dusty/dirty supply bins? I keep finding the same ones on rounds."

A review of the round sheets for the surgery 1st floor dated 07/22/2016 revealed numerous infection control and safety issues identified and report read; "spoke with manager, but there was no documented evidence that there was any follow up to the infection and safety issues addressed. Also, a review of the round sheets dated 12/15/2016 issues identified and spoke with manager, again no follow up to the infection and safety issues addressed on the clinical round sheets."

An interview with the Infection Control Preventionist on 03/01/2017 at 11:30 AM confirmed she identified infection control issues with the facility departments and reported it to her direct supervisor, but only in emails. A review of the Infection Control meeting minutes dated January 28, 2016, April 28, 2016, October 27, 2016 and January 26, 2017 did not address the infection control issues being identified in the departments, nor did the meeting minutes address the infection control issues that had been identified during the survey. The Infection Control meeting minutes report to the Quality Councilwere reviewed but the report did not address the infection control issues physically identified in the clinical rounds made by the Infection Control Preventionist and the EOC (Environment of Care) committee members. Also, the Infection Control Preventionist was asked have you addressed the deteriorating walls, dusty/dirty bins, and water leaks in the central supply area. Infection Control Preventionist stated, "Yes, I have reported it, but not in a writing or in the committee meetings." Also, she was asked you do realize the Infection Preventionist has authority to institute any surveillance, prevention, and/or control measures or studies when there is reason to believe that any patient or personnel may be in danger from a potential or actual outbreak of, or exposure to, infectious disease. Staff #15, "Yes, but no." There was no further comment for Staff #15.


An interview with the Safety/EOC Director and the Facility Director on 03/01/2017 at 9:00 AM revealed that they were aware of the condition of the deteriorating walls and water leaks in the central supply area, and both reported that a construction and plumbing bid had been placed and submitted to Administration approximately 4 months ago.

An interview with Staff #66 and #67 on 03/01/2017 at 9:00 AM confirmed that Administration was aware of the infection control issues that had been identified in central supply.

Based on observation, record review, and interview, the facility failed to:

A. ensure the surgical, sterilization, and Cath Lab departments provided a clean and sanitary environment.

B. ensure the surgical department sterilized implant trays and complete sets of instruments per the facility's sterilization policy or documented immediate use sterilization as an emergency. A review of the immediate use sterilization logs for the months of October, November, and December 2016 through January 2017 revealed unwrapped implant trays and full sets of instruments trays were being flashed in the flash sterilizers. Also, the facility failed to follow their own policy for in hospital sterilization, the AORN (Association of perioperative Registered Nurses) standards, and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards and the CDC guidelines.


C. ensure the disinfection log documentation was completed for the transesophageal (TEE) echocardiogram ultrasound probes.


D. ensure the surgical staff were dating and timing irrigation and intravenous solutions in the warming devices in surgery. Also, the surgical staff failed to follow the facility's own policy on Warming Irrigation and Intravenous Solutions in Warming Devices.


E. provide 2 post anesthesia patient care areas per each operating room. The facility had 6 functional operating rooms, plus a Cysto room that were observed. In the postoperative care unit there were only 8 post anesthesia patient care areas. One of the patient care areas (pediatric room) was being used for storage of: respiratory supplies, seven (7) large cardboard boxes of gloves, a rocking chair, Christmas decorations, and other equipment.


F. ensure that the surgeon had completed a History and Physical examination form prior to the patient having a surgical procedure. The History and Physical form was completed before the patient arrived to the facility for 2 (#41 and #42) of 7 (#7, #8, #9, #10, #11, #41, and #42) surgical charts reviewed. Also, the surgeon failed to follow the facility's own Medical Staff Rules and Regulations on History and Physical examination note.


G. ensure that 1 (#40) of 8 (#35-#42) staff members had the required certifications to work in the post-anesthesia care unit (PACU). Also, the facility failed to follow their own policy for staff working in the PACU area.



Findings included:

A. During a tour of the sterilization department and Surgery supply storage area on 02/27/2017 from 10:30 AM to 12:00 PM with the Surgical Director and Sterilization Director, the following infection control issues and expired supplies were observed:

Sterilization and Surgery Supply Work Warehouse Area:

1. In the decontamination area, there was an Anteroom where the PPE (personnel protective equipment) supplies were kept in a cabinet drawer. Observed vacuum cleaning parts mixed with the PPE (personnel protective equipment).

2. In the surgical supply storage area, numerous wire carts on the bottom shelves were covered in dust. The bottom shelves in the surgical supply storage area on numerous wire carts were covered in dust. The dust was so thick you could write your name in the dust. Also, the plastic bins holding the open sterile surgical supplies were dirty with dust and trash particles. This storage area contained open sterile surgical supplies on open wire racks. The surgical supplies are then taken from the wire racks and placed on metal closed carts with the sterile instruments and taken to the operating rooms to be directly opened onto the surgical patients' table for their surgical procedures.

3. During the tour of the surgical storage area, a large cardboard box full of expired items was observed.. The box was not labeled that the supplies were expired and/or not available for use. The expired surgical supplies were available to anyone entering the supply storage area.

An interview with Staff #15, #44, and #47 on 02/27/2017 at 11:45 AM confirmed the above findings.


Cath Lab and Cardiovascular Operating Room:

During a tour of the Cath Lab department on 02/28/2017 from 8:30 AM through 10:00 AM with the Cath lab Director and Staff #43, the following infection control issues were observed:

1. In the Anteroom, which was outside the isolation room and in the post recovery area for Cath lab patients, observed a cardboard box full of information pamphlets sitting on the counter. Staff #45 reported one of the product vendors must have left the cardboard box on the shelf. Staff #45 was asked if this was a normal place for the cardboard box to be placed. Staff #45 stated, "No."

2. In two of the patients' bathrooms located in the Cath Lab area, the emergency pull cords were wrapped around the handicap rail. Emergency pull cords must be accessible even if the person is lying on the floor. The cord must hang freely and be within 6 inches from the floor.

3. In the electrical room where the Cath Lab supplies were stored, the floor was observed to be dirty with dark strains and trash.

4. The air flow vent located in the surgical Cardiovascular Room was covered in dust and lent particles. The Cardiovascular Room was located in the same area as the Cath Lab.

5. During the tour of the cardiovascular recovery room, 3 light fixtures were observed full of dead bugs.

6. The temperature and humidity was not being monitored where the sterile supplies and instruments were kept for the Cath Lab and Cardiovascular operating room. Staff #45 stated, The Environmental personnel monitor the temperature and humidity.

An interview with the environmental technician on 02/28/2017 at 10:00 AM stated, "We can adjust the temperature and humidity from a computer system for the Cath lab rooms and Cardiovascular operating room, but we do not have a daily print out of the temperature and humidity." There was no documentation showing the Cath Lab and Cardiovascular operating room and the sterile supplies and instruments were being monitored. An interview with Staff #44 and #45 on 02/27/2017 at 10:00 AM confirmed the above findings.

Pre-operative Area, Surgery, and PACU:

During a tour of the Surgical areas on 02/28/2017 from 11:15 PM through 4:00 PM with the Surgical Director, Staff #43 and Staff #44, the following infection control issues and expired items were observed:


1. The floor had large chips of tile missing in several areas of the pre-operative area. Also, the counter in the pre-operative area had large pieces of Formica missing. These areas that had missing tiles and Formica which had the likelihood to harbor dirt and bacteria allowing for an unclean area for patient care.

2. Upon entering the surgery area which was where Operating room attire should be worn, an employee was only wearing the skullcap which did not totally cover the hair. The surgical team members are responsible for preventing SSI by properly donning and wearing the appropriate head cover or hood.


3. The soiled utility room walls and floor were dirty. The wall plaster had numerous holes where the plaster was missing and the wall had a discolored appearance. The light was not working.


4. The linen cart for surgery was being stored in a storage room with the ice machine and there was no barrier on the bottom wire rack. There was a blanket wrapped around the drain area of the ice machine and it appeared that there was a leak with the ice machine. There was a large piece of tile missing from the floor. The floor behind the linen cart was dirty with dead bugs, dust, and trash particles. Also, there was linen that had fallen on the floor. The floor had a discolored appearance. The charge nurse of surgery reported he had placed 2 requests to the maintenance department for the ice machine and the floor to be fixed.

A review of the work orders from September 2016 to present showed 57 work orders had been placed and 16 were still active showing issues that needed to be completed in the surgery department.

5. In the storage room where patient's tissue specimen were stored, there were endo-cervical swabs that had expired 09/30/2013 X 2. The wire rack in this area was filled with different supplies and had a neglected or not properly maintained appearance. The Formica was cracked in several places. The shelf contained a plastic container full of screws, a sharps container full of Bio-hazard bags, papers, and an old tape dispenser.


6. In the surgical department in sub-sterile room #1, there was a tray of solid ice in the freezer of the refrigerator. There were surgical supplies requiring refrigeration, but not to be frozen that were stored in the refrigerator. Also, in sub-sterile room #1, the autoclave drain was full of water and the floor was rusted.

7. The air flow vent located in the Surgical Room #2 was covered in dust and lent particles.

8. There was a large chip of flooring missing in the Cysto Room. These areas that had missing tile and flooring had the likelihood to harbor dirt and bacteria allowing for an unclean area for patient care. There were 4 surgical cases performed in the Cysto room on 02/25/2017.

9. While observing a patient having a procedure in the Cysto room, Staff #38 came into the room without wearing a mask while the procedure was being performed.

10. Observed in the sub-sterile #4, on the inside of a cabinet door there was tape stuck to the door where loads had been documented from a piece of equipment and the tape was dated back to 2-4-1999. Also, underneath the same cabinet was a water filter system that had been used for a piece of equipment. The filter inside the system was a dark rust color. There were numerous cracks on the Formica counter.

11. During the tour of the PACU area, a clear plastic bag full of expired patients' supplies was observed lying on the counter. The plastic bag was not labeled as expired supplies or labeled not for patient use. The plastic bag was full of expired items and available for any staff member. The expired items were in the same room with all the available patient supplies.

12. There was a Pediatric recovery bay area that was full of the following items: respiratory supplies, seven (7) large corrugated boxes of gloves, rocking chair, Christmas decorations in a large plastic container and a corrugated box of Christmas decorations, office supplies that consisted of 2 large boxes of printer cartridges, 6 bottles Enfamil that expired in January 2017, and other equipment. Only one person could enter the room it was so full of various items.

13. Throughout surgery, Pre-operative area, and PACU area, the floors had numerous gaps in the tile and there were several places that large chips were missing from the tile. The condition of the floors had the likelihood to harbor bacteria and dirt in the chips and gaps in the flooring which would lead to infection issues in caring for patients.


An interview with Staff #43, #44, and #47 on 02/28/2017 at 3:00 PM confirmed the above findings.



B. A review of the immediate use sterilization logs for the months of October, November, December 2016 and January 2017 revealed unwrapped implant trays and full sets of instruments trays were being flashed in the flash sterilizers. Also, the facility failed to follow their own policy for Immediate Use Stream Sterilization, the AORN (Association of perioperative Registered Nurses) standards, and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards.


A review of the IUSS (Immediate Use Stream Sterilization) sterilization log for the month of October 2016 for the flash sterilizers, there were 39 individual instruments and/or tray sets flashed. There were seven (7) instruments dropped or contaminated, twenty-six (26) not sterile/not ready, one (1) wet contents, one (1) not a facility instrument, and four (4) with a hole in the wrapper. Further, review showed of the IUSS sterilization log indicated PHACO instrument sets (eye instrument trays) were flashed 12 times. The IUSS system for the October log was used 14 times for single instruments and 25 times for sets of instruments.



A review of the IUSS sterilization log for the month of November 2016 for the flash sterilizers, there were 34 individual instruments and/or tray sets flashed. There were two (2) instruments dropped or contaminated, twenty-four (24) not sterile/not ready, two (2) not a facility instrument, two (2) with a hole in the wrapper, and one (1) one of a kind instrument. Further, review showed of the IUSS sterilization log indicated PHACO instrument sets (eye instrument trays) were flashed 9 times. The IUSS system for the November log was used 34 times for sets of instruments. There was no single instruments documented on the log as being flashed.


A review of the IUSS sterilization log for the month of December 2016 for the flash sterilizers, there were 34 individual instruments and/or tray sets flashed. There were three (3) instruments dropped or contaminated, twenty-three (23) not sterile/not ready, one (1) not a facility instrument, five (5) with a hole in the wrapper, one (1) vendor late with a set of instruments, and one (1) one of a kind instrument. Further, review showed of the IUSS sterilization log indicated PHACO instrument sets (eye instrument trays) were flashed 11 times. The IUSS system for the December log was used 16 times for sets of instruments and 18 times for single instruments.


A review of the IUSS sterilization log for the month of January 2017 for the flash sterilizers, there were 26 individual instruments and/or tray sets flashed. There were six (6) instruments dropped or contaminated, eleven (11) not sterile/not ready, and seven (7) with a hole in the wrapper. Further, review showed of the IUSS sterilization log indicated PHACO instrument sets (eye instrument trays) were flashed 10 times. The IUSS system for the January log was used 15 times for sets of instruments and 11 times for single instruments.

A review of the immediate use sterilization log indicated there were numerous times instruments were not ready and that immediate use sterilization was used due to hole in the wrappers.

A review of the of the Surgery Process Committee dated August 2016 and November 2016 revealed no documentation about the high usage of IUSS (immediate use stream sterilization) process. There was no drill down to track or analyze the issues causing the immediate use sterilization to have such a high usage in the facility. There was no written plan or process to address the high usage of immediate sterilization.

A review of the surgical clinical indicators that was reported to the quality department from the surgery department revealed no indication that the immediate use sterilizations was a quality issue that needed to be addressed.


A review of the facility's policy titled, "Immediate use Stream Sterilization" revealed the following:

"PURPOSE: To decrease and eliminate the amount of Immediate Use Steam Sterilization in the operating suite, perform regular testing of the sterilizers, and meet local, state, and national regulatory requirements for testing and sterilizing items. To ensure appropriate steam sterilization guidelines and evidence-based practices are adhered to in the perioperative setting.

II. DEFINITIONS

Ill, POLICY: IUSS should only be completed when time it is an emergency. Steam sterilization in the OR will be accomplished by utilizing approved rigid containers designed for sterilization in immediate use. Open tray sterilization will be used only for those instruments or sets which cannot fit into the designated sterilization containers. IUSS should not be used as a substitute for insufficient instrument inventory. Implants will only be sterilized in the OR when absolutely no other option exists.

11. Immediate Use Sterilization should not be performed on:
a. Implants except in situations noted previously
b. Post-procedure decontamination of instruments used on patients who may have Crutzfeldt-Jakob Disease (CJD) or similar disorders.
c. Devices that have not been validated with the specific cycle employed.
U. Sterile devices sold as single use only."


A review of the perioperative standards and recommended practices "Association of perioperative Registered Nurses" revealed the following:

"Recommendation VII

Immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner.

Immediate use steam sterilization may be associated with increased risk of infection to patients. Time constraints may result in pressure on personnel to eliminate or modify one or more steps in the cleaning and sterilization process. The term flash sterilization has historically been used to describe steam sterilization of unwrapped items intended to be used immediately. Flash sterilization cycles have traditionally been either 3 or 10 minutes of exposure, depending on the nature of the device being sterilized or the type of cycle indicated, minimal or no dry time, and no cooldown, thereby making the entire cycle time shorter than the cycle times for wrapped or terminally sterilized items. However, current manufacturers ' instructions for use may require a variety of cycle times and the use of single wrappers or flash containers as opposed to sterilizing unwrapped items. The term "flash sterilization" no longer serves to describe the various steam sterilization cycles and processes that are used to process items that are not intended to be stored for later use. For this reason, the more appropriate term is IUSS.

VII. a. Immediate use steam sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Immediate use steam sterilization should not be used as a substitute for sufficient instrument inventory."


An interview with Staff #44 and #47 on 02/28/2017 at 3:00 PM confirmed the facility's surgical department follows the AORN standards and ANSI/AAMI.


Upon a review of the 2011 "Association for the Advancement of Medical Instrumentation" ANSI/AAMI ST79:2010, the guidelines revealed the following:

"10.6.3 Release criteria for implants
As with all cycles, an experienced, knowledgeable person should review the sterilizer chart or printout at the end of the sterilization cycle, as well as the results of other indicators that have been used to monitor the sterilization process. The load should be quarantined until the results of the SI testing are available (CDC, 2008).
Releasing implants before the SI results are known is unacceptable and should be the exception, not the rule.
When documented medical exceptions dictate (e.g., the need for trauma-related orthopedic screw-plate sets), it could be necessary to release an implantable device before the SI results are known. In this case, the release of the device before the SI results are known should be documented; the SI result obtained later should also be documented. (See Annex L for examples of an implant log and an exception form.) It is critical that this documentation be fully traceable to the patient. Emergency situations should be defined in written guidance developed in consultation with infection prevention and control, the surgeon, and risk management. Steps should be taken to reduce the frequency of emergency release of implantable items. For example, ongoing periodic reviews of the exception forms and implant logs could reveal consistent patterns of events that are causing emergency release and that could be corrected.
NOTE-See Section 12 (New product evaluation) for general guidelines on how to assess the specific label claims of new products that become commercially available.
Rationale: Patient safety could be adversely affected by the implantation of a nonsterile device. The sterilization of implantables should be closely monitored and each load containing implants should be quarantined until it is verified that SI testing has yielded negative results. In defined emergency situations in which the quarantine of implants cannot be maintained, breaking of the quarantine is allowed for documented medical exceptions in accordance with facility policies and procedures. See also the rationale for 10.6.1."

An interview with Staff #44 and #47 on 02/28/2017 at 3:00 PM confirmed the surgical department was flashing instruments and instrument trays on a routine basis and not just for emergencies.


C. ensure the disinfection log documentation was completed for the transesophageal (TEE) echocardiogram ultrasound probe for 4 of 24 uses. The log was reviewed from 02/01/2017 through 02/23/2017.


A review of the TEE probes disinfection log was completed during a tour of the decontamination room on 02/27/2017 at 11:00 AM. A review of the log dated from 02/01/2017 through 02/23/2017 revealed the probe serial number was left blank, so there was no way to know which TEE probe had been disinfected. The process was to document the serial number of the probe to indicate which probe was used on the patient in case there was an infection control issue the facility would be able to trace which probe had been used on the patient.

On 02/07/2017 the TEE probe serial number was left blank.
On 02/10/2017 the TEE probe serial number was left blank.
On 02/16/2017 the TEE probe serial number was left blank.
On 02/17/2017 the TEE probe serial number was left blank.


An interview with Staff #43, #44, and #47 on 02/28/2017 at 11:00 AM confirmed the above findings.



D. ensure the surgical staff were dating and timing irrigation and intravenous solutions in the warming devices in surgery. Also, the surgical staff failed to follow the facility's own policy on Warming Irrigation and Intravenous Solutions in Warming Devices.



The fluid warmers were kept in the sub-sterile utility rooms in the surgical area. During the tour, observed five (5) 3000 bags of saline dated to be removed on 03/14/2017. The date of the observation was 02/28/2017. The bags of fluid should have been dated 03/13/2017 and there was no time on the bags of solutions. Observed 3 of 3 warming devices and there was no time documented on the solutions.

A review of the facility's policy titled, "Warming Irrigation and Intravenous Solutions in Warming Devices" revealed the following:

"POLICY:
The hospital staff will ensure that any Irrigation solutions (Normal Saline, Sterile Water) or
Intravenous Solutions that are pre-warmed for patient use meet the requirements as defined by the manufacturer's recommendations or the USP/NF.

PROCEDURE:
All fluids that will be placed in a warming device will be labeled with the date and time that they are placed in the warmer.
Solutions 150 ml or greater can be warmed in their plastic overpouches to temperatures not exceeding 104 degrees for a period of no longer than 14 days.
After 14 days, the solutions shall be removed from the warmer,
Identified as having been warmed and not subsequently returned to the warmer.
These solutions may be used until the labeled expiration date provided they have not been
warmed more than ONCE.
Irrigation solutions (Arthromatic and Uromatic) can be warmed in their overpouches to temperatures not exceeding 113 degrees for a period of no longer than 14 days.
After 14 days, the solutions shall be removed from the warmer,
Identified as having been warmed and not subsequently returned to the warmer."


An interview with Staff #43, #44, and #47 on 02/28/2017 at 2:00 PM confirmed the above findings.




E. During a tour of the surgical area on 02/28/2017 at 3:00 PM observed 6 functional operating rooms, plus a Cysto room. In the postoperative care unit there were only 8 post anesthesia patient care areas. One of the patient care areas (pediatric room) was being used for storage of: respiratory supplies, seven (7) large cardboard boxes of gloves, a rocking chair, Christmas decorations, and other equipment.



The recommendations and standards of practice by the American Society of Anesthesiologist recommended the following:

"The appropriate number of PACU bed slots will vary with the surgical case mix, the length of the cases (e.g., will first cases likely be discharged from the PACU before second cases are finished?) and the usual turnover time of both the OR and PACU beds. A high turnover of outpatients or a significant number of long-stay ICU patients will create a need for more PACU bed slots. In the past, the suggested guideline was that the number of PACU bed slots should equal the number of rooms in the OR suite. This idea has been replaced by a newer algorithm that recommends there should be one and a half to two PACU slots for each room in the OR suite. The factors described above and any other unusual issues for that particular PACU could impact such calculations. The important point is to involve all relevant personnel and departments (including support services, such as respiratory therapy and housekeeping) very early in the decision-making process. Their input can impact the decision as to how many bed slots to build."
The recommendations and standards of practice by the Facility Guidelines Institute; September 15, 2014 revealed the following:

"Operating Room Requirements for 2014 and Beyond

The number of Phase I (PACU or post-anesthetic care unit) patient care stations required in both inpatient and outpatient settings has been defined as 1.5 per OR. If that calculation yields a fraction, the number of patient care stations provided is to be rounded up to the next whole number. As explained in the definition of patient care areas, a patient care station can be a single-patient room or a bay or cubicle in a room with spaces for multiple patients."


An interview with Staff #47 on 02/28/2017 at 3:00 PM confirmed the above findings.


F. ensure the surgeon had completed a History and Physical examination form prior to the patient having a surgical procedure. The Surgeon completed the History and Physical form before the patient had arrived to the facility for 2 (#41 and #42) of 7 (#7, #8, #9, #10, #11, #41, and #42) surgical charts reviewed. Also, the surgeon failed to follow the facility's own Medical Staff Rules and Regulations on History and Physical examination note.


Cross Refer to Tag: A 0952


G. ensure that 1 (#40) of 8 (#35-#42) staff members had the required certifications to work in the post-anesthesia care unit (PACU). Also, the facility failed to follow their own policy for staff working in the PACU area.


Cross Refer to Tag: A 0957

Based on record review and interview, the surgeon had completed a History and Physical examination form for the patient having a surgical procedure prior to the patient arriving to the facility for 2 (#41 and #42) of 7 (#7, #8, #9, #10, #11, #41, and #42) surgical charts reviewed. Also, the surgeon failed to follow the facility's own Medical Staff Rules and Regulations on History and Physical examination note.

This deficient practice had the likelihood to cause harm in all surgical patients.

Findings include:

A review of Patient #41's record revealed that the surgeon completed the History and Physical information for the patient's medical conditions. The History and Physical form was dated 02/28/2017, but the time was marked out and there was no way to know if the History and Physical was completed prior to the patient going to surgery.

A review of Patient #42's record revealed that the surgeon completed the History and Physical information for the patient's medical conditions prior to the patient arriving to the facility. The History and Physical form was dated 02/28/2017 at 0730. The patient did not arrive at to the hospital until 8:40 AM on 02/28/2017.


A review of the facility's Medical Staff Rules and Regulations titled, "Medical Records" revealed the following:

"Medical Staff Rules and Regulations:

2.2 Admission History and Physical Examination:

2.2-1 A patient's medical history and physical examination (H&P) are performed by a licensed independent practitioner, or can be delegated to a physician assistant or advanced nurse practitioner who has been credentialed to perform and dictate the H&P examinations.

Each patient admitted for inpatient care, or placed in a unit for 23 -hour observation, has a medical history taken and an appropriate physical examination performed and documented within 24 hours after admission to the unit. If a history and physical examination have been performed and documented within 30 days before admission, this H&P is still relevant provided that the patient condition has been reassessed and documented as the same or with relevant changes made within 24 hours of the inpatient admission or observation placement.

A history and physical examination is required for all patients who undergo invasive procedures or who will receive moderate sedation or anesthesia in any medical center location. The practitioner must complete and document the H&P prior to the procedure. If a H&P has been performed and documented within 30 days of the procedure, this H&P is still relevant provided that the patient condition has been reassessed as the same or with relevant changes noted prior to the procedure being performed."


An interview with Staff #43 on 02/28/2017 at 12:00 PM confirmed the above findings.

Based on record review and interview, the facility failed to ensure that 1 (#40) of 8 (#35-#42) staff members had the required certifications to work in the post-anesthesia care unit (PACU). Also, the facility failed to follow their own policy for staff working in the PACU area.


A review of #40's personnel file revealed no current certifications in ACLS (Advanced Cardiac Life Support), PALS (Pediatric Advanced Life Support), or BCLS (Basic Cardiac Life Support). Staff #40's certifications in Advanced Cardiac Life Support had expired September 2016, Pediatric Advanced Life Support had expired October 2016, and Basic Life Support had expired November 2016. The facility's policy requires surgical services staff members maintain current BCLS certification, with ACLS certification required for all PACU staff.


A review of the facility's policy titled, "Staffing for the O.R." Date of Origin: July 2005 and revised date November 2016 revealed the following:

"PURPOSE:
To establish staffing patterns for the Surgical Services Department that will ensure an adequate amount of nursing and surgical personnel is available to render intraoperative nursing care.

POLICY:
STAFFING:
The basic staffing plan for each Operating Room Suite is one RN, one scrub tech, and one assistant. The scrub tech position may be filled by a trained RN or a scrub technician or an LVN. Additional circulator and/or scrub techs are added to the case based on the patient's acuity, complexity of patients' care needs and instrumentation and staff skill mix. In cases where moderate sedation is administered, the policy, procedure and standards related to moderate sedation are followed. The Post Anesthesia Care Unit is staffed with RN(s) only.

QUALIFICATIONS OF STAFF:
Surgical Services staff members maintain current BCLS certification, with ACLS certification required for all PACU staff. All registered nurses maintain a current Texas state RN license. ACLS and PALS is recommended for all staff. Organizational memberships to the Association of perioperative Registered Nurses (AORN), the American Society of Paranesthesia Nurses (ASPAN) and Association of Surgical Technologists (AST) is encouraged. An on-going program of in-service education and periodic clinical skills evaluation for all staff members is maintained to ensure that the quality of care provided is kept current with the developments in the medical, nursing, anesthesia and infection control fields."


An interview with Staff #46 on 02/28/2017 at 3:00 PM confirmed the above findings in the personnel files that Staff #40's certifications had expired.