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Based on observation, record review, and interview, the hospital failed to meet the Condition of Participation for Governing Body as evidence by:


A. Failed to provide documentation of currently approved patient care policies from January 2015 through the end of 2017 and failed to follow and enforce it's approved policies for Quality Assessment and Process Improvement from January 2017 through December 2017.


Refer to Tag A 0063 for additional information.




B. Failed to meet the Condition of Participation for care in a safe setting for Acute End Stage Renal Disease patients as evidence by:

1.) ensure the powdered potassium chloride additive which was for altering concentration of the dialysate was approved to be used by the dialysis staff working in the hospital. Also, the dialysis policy titled, "Adding Electrolytes to Dialysate" had not been approved by the Governing Body. Also, that the hospital Pharmacist had not approved the use of powered potassium chloride additive and that it could be stored outside the pharmacy in a non-secure storage area.

2.) ensure the security of the dialysis supplies and products in the acute dialysis unit.

3.) ensure the safety of the dialysis patients in the acute unit if an emergency occurred.

4.) ensure the pick-up tubes (wands) were fitting securely to the acid and bicarbonate jugs that were being used to dialyze the patients during a dialysis treatment to prevent nonbacterial contamination and evaporation.

5.) ensure that 2 (#32 and #33) of 3 dialysis machines were disinfected every 7 days and bleach clearance checked prior to the next patient use.

6.) ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.

7.) ensure the dialysis patient treatment log was current and up to date, so that patients in the facility would not miss their dialysis treatment.

8.) ensure the pump pressures for the portable (RO) (reverse osmosis water system) machines #1, #2, and #4 for the months of October, November, and December 2017 were maintained at a pressure of greater than 150.

9.) ensure 1(#53) of 5 dialysis staff had hemodialysis nurse skills checklist completed annually.

10.) ensure the dialysis Quality Assurance Performance Improvement (QAPI) program was developed, implemented, maintained and evaluated with focus indicators to improve the outcomes of the acute dialysis unit.

11.) ensure that an incident report for a "Near Miss" event was completed for the dialysis nurse that was dialyzing with the wrong dialyzer and wrong acid concentrate on Patient #24.

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.


Refer to Tag A 0144 for additional information.





C. Failed to meet the Condition of Participation for Patient Rights "Use of Restraint and Seclusion" as evidence by:

The facility failed to ensure the patients were free from corporal punishment in the Emergency Department(ED).The facility used the local police to restrain, seclude, and handcuff patients when not detained or documented as a forensic patient from staff interviews and 2 (35 and 36) of 2 patient charts reviewed.

The facility failed to follow its own policy and procedure to prevent patient restraints or seclusion to ever be used as a means of coercion, discipline, or convenience. Patient chart reviews and staff interviews revealed that less restrictive restraints were not applied before administering a psychoactive drug (chemical restraint), due to the excessive paperwork required for seclusion or physical restraints in 2(35 and 36) of 2 patient charts reviewed.

The facility failed to ensure patients safety while handcuffed to a stretcher. Nursing failed to assess patient #36 for injuries after flipping a stretcher over while still handcuffed.

The facility failed to have any Quality Assessment Performance Improvement (QAPI) data or monitors in place for any restraints in the ED. QAPI failed to properly log, track, analyze, and implement a productive plan to ensure the patients were safe in restraints.

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.


Refer to Tag A 0154 for additional information.




D. Failed to meet the Condition of Participation for Patient Rights "Use of Restraint and Seclusion" as evidence by:

Staff failed to recognize a psychoactive medication given as a restriction to manage a patients behavior as a chemical restraint in 2(35 and 36) of 2 patient charts reviewed.

The facility failed to follow its own policy and procedure to prevent patient restraints or seclusion to never be used as a means of coercion, discipline, or convenience. Patient chart reviews and staff interviews revealed that de-escalation techniques or less restrictive restraints were not applied before administering a psychoactive drug (chemical restraint), due to the excessive paperwork required for seclusion or physical restraints in 2(35 and 36) of 2 patient charts reviewed.

There was no documentation of a nursing assessment after chemical restraints were given. There was no documentation of patient behavior, effectiveness of the medication, or patient's physical status after the administration of the chemical restraint. Failed to ensure the physician did a face to face for a restraint and documented that assessment in 2(35 and 36) of 2 patient charts reviewed.

The facility failed to have any Quality Assessment Performance Improvement (QAPI) data or monitors in place for any restraints in the ED. QAPI failed to properly log, track, analyze, and implement a productive plan to ensure the patients were safe in restraints.

The facility failed to ensure that an order for a stat chemical restraint was administered in a timely manner. Nursing delayed the stat order for two hours without documentation for delay in 1(36) of 2(35 and 36) patient charts.

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

Refer to Tag A 0160 for additional information.





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E. Failed to meet the Condition of Participation for Quality Assurance and Performance Improvement (QAPI) as evidence by:

1.) The Governing Board Bylaws failed to specify the frequency and detail of Quality Assessment Performance Improvement (QAPI) data collection.

Refer to Tag A0273 for additional information



2.) QAPI failed to gather data, track for adverse patient events, and implement preventative actions for restraints used in the Emergency Department in 2 of 2 (35 and 36) charts reviewed.

QAPI failed to have clear expectations for safety established from adverse patient events and no preventative actions implemented. Patient #36 did not have a sentinel event documented for turning a stretcher over while handcuffed to the bed and receiving a chemical restraint. A technologist not familiar with our PET/CT Policies allowed a patient to use a public hospital restroom with no incident reports or follow through from QAPI.

Refer to Tag A0286



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F. Based on observation, review of record, and interview, the facility failed to the Condition of Participation for nursing services as evidenced by the failure to ensure nursing staff:

1. administered intravenous (IV) medications using aseptic (free from contamination) technique in 1 (Patient #43) of 3 IV medication administrations observed.

2. followed policy for ensuring informed consent for blood transfusions were present prior to administering blood products in 7 out of 7 patients reviewed (Patient #'s 9, 10, 11, 12, 13, 17, and 18).

3. followed policy for assessing vital signs during blood transfusion in 2 patients (Patient #9 and #12) out of 7 reviewed.

4. verified complete orders for titrating medications were present for 1 patient (Patient #18) out 3 reviewed.

IV medications and blood products were not administered and/or monitored in a safe manner and/or consistent with hospital policy.

See Tag A0409




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G. Failed to meet the Condition of Participation for Infection Control as evidence by:

The facility failed to:

1. follow the policy, INFECTION RISK ASSESSMENT. There was no evidence of input from medical staff, nursing and leadership, in developing a risk assessment to identify infection risks for this organization.
The risk assessment provided by the facility failed to use the required criteria set in the policy.
There was no evidence of analysis of surveillance activities and other infection prevention and control data required to develop a risk assessment.

Refer to tag A 0748


2. provide a sanitary environment and have an active program for preventing infections.

This deficient practice was found in 12 of the hospital departments and 1 outside storage/containment area. Dialysis, Surgery, Respiratory, Laboratory, Gastrointestinal Department (endoscope reprocessing room), Labor and Delivery, Intensive Care Unit, Kitchen, Emergency, Pharmacy, Physical Therapy, Rehabilitation, and Biohazard containment/storage area.

Refer to tag 749

Based on observation, interview and document review, the facilities Governing Body failed to provide A) documentation of currently approved patient care policies from January 2015 through the end of 2017 and B) failed to follow and enforce it's approved policies for Quality Assessment and Process Improvement from January 2017 through December 2017.


This deficient practice had the likelihood to effect all patients of the hospital.


Findings included:

A.
On 12/27/2017 in the conference room the Governing Board meeting minutes were reviewed from December 2017 back through the year 2015. No patient care policies were found documented in the meeting minutes of presentation, discussion or approval during that three year period.


On 12/28/2017 in the conference room an interview with the Chief Nursing Officer, staff #1, confirmed policies were being reviewed and revised. She confirmed that patient care policies had not been presented to the Governing Body for review and revision. The facility did not have current policies and procedures.

Examples of Policies which were no longer adequate:

Physical Therapy Department and Rehabilitation Department policies for the Hydroculator (Warm water containment system for moist heat packs) indicated the water should be changed once a month. However, the manufacturer's recommendation was to change the water every 2 weeks, and to keep the packs completely submerge in the hot water between cleanings to insure sanitation.

On 12/29/2017 in the morning an interview with the manager of the Physical Therapy Department confirmed the documentation provided by both departments indicated the warm water was changed once a month in the Hydroculator. The manufacturer's instruction were read together and she confirmed the instruction indicated changing the water every two weeks. Her department and the Rehabilitation department had been following the hospitals' policy which no longer complied with the manufacturer's recommendations for sanitation.


B.
On 12/28/2017 in the conference room and interview with the CNO, staff #1, revealed the Governing Body had created a "Board Quality Improvement Committee" that was given the responsibility to oversee and improve the quality and safety of patient care. A request to review the policy for the created committee was reviewed. The policy identified as,

"Organizational Performance Improvement, reference #1002, effective date 10/20/2016. Approved by staff #1 the Chief Nursing Officer.

Organization/Responsibility:

To achieve fulfillment of the objectives, goals, and scope of the organizational Performance Improvement Plan, the organizational structure of the program shall be designed to facilitate an effective system of monitoring, assessment and evaluation of the care and services provided throughout the hospital.

The Governing Body has the ultimate responsibility for stabling (sic) an Organizational Improvement Process , monitoring and implementing, supplying the resources and evaluating its effectiveness and efficiency.

The Governing Body had instituted a Board QI (Quality Improvement) Committee that is given the responsibility to oversee and improve the quality and safety of the patient care. The Board QI Committee consists of three Board members appointed by the Board of Directors Chair, the Administrator/CEO (chief executive officer) and administrative staff. The committee will also determine the frequency and detail of data collection that is to be reported.

Each department is responsible for establishing and implementing a performance improvement plan/project. The plan shall integrate quality assessment/improvement, continuous quality improvement (CQI) and quality control activities into a system that will foster improvement in patient care. Each department also shall delegate responsibilities for monitoring, action, evaluation and reporting.

Performance improvement activities will be reported to the committee where they will be evaluated and analyzed and dispersed to the appropriate entities.

Methodology:

The PLAN, DO, CHECK, ACT (PDCA) methodology shall be utilized to plan, design, measure, assess and improve functions and processes related to patient care and safety throughout the organization.

Annual Evaluation and Approval:

The PIPS/PCS (Performance Improvement Patient Safety/ Patient Care Services) committe will fulfill this responsibility and evluattion shall be documented and dorwarded through the approapriate reporting structure to the medical staff and Governing Body".


On 12/28/2017 in the afternoon a review of the documentation submitted as evidence of the Governing Board meeting minutes revealed, the Board QI Committee findings, were not reflected on the agenda for the year 2017. The Governing Board meeting minutes did not reflect knowledge or review of the Quality process within the facility.

Further review of the Governing Body rules and regulations failed to identify the frequency of meetings for the Quality Assessment Process Improvement Review.

Based on observation, record review, and interview, the hospital failed to meet the Condition of Participation for care in a safe setting for Acute End Stage Renal Disease patients as evidence by:

A.) Failing to ensure the powered potassium chloride additive which was for altering concentration of the dialysate was approved to be used by the dialysis staff working in the hospital. Also, the dialysis policy titled, "Adding Electrolytes to Dialysate" had not been approved by the Governing Body. Also, that the hospital Pharmacist had not approved the use of powered potassium chloride additive and that it could be stored outside the pharmacy in a non-secure storage area.

B.) Failing to ensure the security of the dialysis supplies and products in the acute dialysis unit.

C.) Failing to ensure the safety of the dialysis patients in the acute unit if an emergency occurred.

D.) Failing to ensure the pick-up tubes (wands) were fitting securely to the acid and bicarbonate jugs that were being used to dialyze the patients during a dialysis treatment to prevent nonbacterial contamination and evaporation.

E.) Failing to ensure that 2 (#32 and #33) of 3 dialysis machines were disinfected every 7 days and bleach clearance checked prior to the next patient use.

F.) Failing to ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.

G.) Failing to ensure the dialysis patient treatment log was current and up to date, so that patients in the facility would not miss their dialysis treatment.

H.) Failing to ensure the pump pressures for the portable (RO) (reverse osmosis water system) machines #1, #2, and #4 for the months of October, November, and December 2017 were maintained at a pressure of greater than 150.

I.) Failing to ensure 1(#53) of 5 dialysis staff had hemodialysis nurse skills checklist completed annually.

J.) Failing to ensure the dialysis Quality Assurance Performance Improvement (QAPI) developed, implemented, maintained, and evaluated with focus indicators to improve the outcomes of the acute dialysis unit.

K.) Failing to ensure that an incident report for a "Near Miss" event was completed for the dialysis nurse that was dialyzing with the wrong dialyzer and wrong acid concentrate on Patient #24.


It was determined that the deficient practices at the following Conditions of Participation for Patient's Rights for care in a safe setting in an Acute End-Stage Renal Disease unit posed an Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, impairment and/or subsequent death.


Refer to Tag A 0144 for additional information.



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2.) Based on observation, interview, and record review the facility failed to meet the Condition of Participation for Patient Rights "Use of Restraint and Seclusion" as evidence by;

The facility failed to ensure the patients were free from corporal punishment in the Emergency Department(ED).The facility used the local police to restrain, seclude, and handcuff patients when not detained or documented as a forensic patient from staff interviews and 2 (35 and 36) of 2 patient charts reviewed.

The facility failed to follow its own policy and procedure to prevent patient restraints or seclusion to ever be used as a means of coercion, discipline, or convenience. Patient chart reviews and staff interviews revealed that less restrictive restraints were not applied before administering a psychoactive drug (chemical restraint), due to the excessive paperwork required for seclusion or physical restraints in 2(35 and 36) of 2 patient charts reviewed.

The facility failed to ensure patients safety while handcuffed to a stretcher. Nursing failed to assess patient #36 for injuries after flipping a stretcher over while still handcuffed.

The facility failed to have any Quality Assessment Performance Improvement (QAPI) data or monitors in place for any restraints in the ED. QAPI failed to properly log, track, analyze, and implement a productive plan to ensure the patients were safe in restraints.

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

Refer to Tag A 0154 for additional information.


3.) Based on observation, interview, and record review the facility failed to meet the Condition of Participation for Patient Rights "Use of Restraint and Seclusion" as evidence by;

Staff failed to recognize a psychoactive medication given as a restriction to manage a patients behavior as a chemical restraint in 2 (#35 and #36) of 2 patient charts reviewed.

The facility failed to follow its own policy and procedure to prevent patient restraints or seclusion to never be used as a means of coercion, discipline, or convenience. Patient chart reviews and staff interviews revealed that de-escalation techniques or less restrictive restraints were not applied before administering a psychoactive drug (chemical restraint), due to the excessive paperwork required for seclusion or physical restraints in 2(35 and 36) of 2 patient charts reviewed.

There was no documentation of a nursing assessment after chemical restraints were given. There was no documentation of patient behavior, effectiveness of the medication, or patient's physical status after the administration of the chemical restraint. Failed to ensure the physician did a face to face for a restraint and documented that assessment in 2(35 and 36) of 2 patient charts reviewed.

The facility failed to have any Quality Assessment Performance Improvement (QAPI) data or monitors in place for any restraints in the ED. QAPI failed to properly log, track, analyze, and implement a productive plan to ensure the patients were safe in restraints.

The facility failed to ensure that an order for a stat chemical restraint was administered in a timely manner. Nursing delayed the stat order for two hours without documentation for delay in 1(36) of 2(35 and 36) patient charts.

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

Refer to Tag A 0160 for additional information.

4.) Based on review of records and interview, the facility failed to ensure that patients or their representatives were provided with risks and benefits as related to the patient's diagnosis and prognosis prior to procedures or treatments in 8 out of 8 charts reviewed (Patient #'s 9, 10, 11, 12, 13, 17, 18, and 36). Consents were not properly documented by the physicians prior to blood transfusions and central line placements [intra-venous (IV) access into a large vein for medication and blood administration]. Also, the facility failed to follow their own medical staff rules and regulations for obtaining informed consent.

The facility failed to allow patient #36 to make an informed decision on receiving a psychotropic medication and its side effects when pregnant or if attempting to conceive when not being administered during an Emergency Behavioral Restraint.

Refer to Tag A0131

Based on review of records and interview, the facility failed to ensure that patients or their representatives were provided with risks and benefits as related to the patient's diagnosis and prognosis prior to procedures or treatments in 8 out of 8 charts reviewed (Patient #'s 9, 10, 11, 12, 13, 17, 18, and 36). Consents were not properly documented by the physicians prior to blood transfusions and central line placements [intra-venous (IV) access into a large vein for medication and blood administration]. Also, the facility failed to follow their own medical staff rules and regulations for obtaining informed consent.

The facility failed to allow pregnant patient #36 to make an informed decision on receiving a psychotropic medication and its side effects when not being administered during an Emergency Behavioral Restraint.


Patient #9

Patient #9 was a 48 year old male with Stage IV multiple myeloma (cancer that has spread to other areas of the body). He was sent to the emergency department by his physician on 12-12-2017 due to a high temperature. During the emergency department work-up, he was also found to have a low hemoglobin (hgb) of 5.3 (part of the red blood cell that carries oxygen to the body). The patient was admitted for intravenous antibiotics and blood transfusion.

On 12-12-17 at 10:25 pm, the patient signed a consent for blood transfusion. The consent for blood transfusion was located on the chart. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed by the physician prior to the transfusion.

Patient #10

Patient #10 was a 90 year old male brought to the emergency department from the nursing home with severe shortness of breath. He was admitted to the hospital on 12-11-2017. During the course of his stay, he required a blood transfusion.

On 12-15-2017 the patient's grand-daughter signed a consent for blood transfusion. The consent for blood transfusion was located on the chart. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed by the physician prior to the transfusion.

Patient #11

Patient #11 was a 48 year old female with a history of multiple medical conditions who went to the emergency department with chest pain. She was found to have pneumonia and sepsis. She was admitted on 12-20-2017 to the Intensive Care Unit.

Review of her chart showed that the patient needed a central line [intra-venous (IV) access into a large vein for medication and blood administration].

A consent for central line placement was located on the chart. The patient signed the consent on 12-22-2017 at 7:45 a.m. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed by the physician prior to the procedure.

Review of the chart showed that the patient received a blood transfusion on 12-21-2017. A consent for blood transfusion was located on the chart. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed by the physician prior to the transfusion.

Patient #12

Patient #12 was a 22 year old female who had a normal spontaneous vaginal delivery on 12-21-2017. "The patient experienced normal blood loss at delivery, but hgb dropped to 5.6 and patient became symptomatic." On 12-22-2017, the physician ordered two units of blood.

A consent for blood transfusion was located on the chart. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed by the physician prior to the transfusion.

Patient #13

Patient #13 was a 68 year old male with multiple medical conditions to include gastro-intestinal (GI) bleeding, low blood sugar, myocardial infarction (MI - heart attack), and wound infections. Patient #13 required blood transfusions on three separate dates. Consents were found for each occurrence.

Consents for 12/19/2017, 12/23/2017 and 12/28/2017 were blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed by the physician prior to the transfusion on consents for 12/23/2017 and 12/28/2017.

Patient #17

Patient #17 was an 88 year old male. He was sent from the nursing home due to abnormal lab results requiring blood transfusion on 11-24-2017.

A consent for blood transfusion was located on the chart. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed prior to the transfusion. The consent had been electronically signed by the physician on 11-30-2017 at 7:57 pm, six days after the blood transfusion was completed.


Patient #18

Patient #18 was an 88 year old male from an assisted living center. He was admitted due to an altered mental status and suspected urinary tract infection. He was found to have rectal bleeding requiring further testing and blood transfusion. During his stay, he started having breathing difficulty, requiring intubation (a tube placed in his airway) and ventilation (a machine to support breathing). He was transferred to the Intensive Care Unit (ICU).

Review of his chart showed that the patient needed a central line [intra-venous (IV) access into a large vein for medication and blood administration].

A consent for central line placement was located on the chart. The patient's son had signed the consent on 12-23-2017 at 12:10 p.m. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed prior to the procedure.

Review of the chart showed that the patient received a blood transfusion on 12-25-2017. A consent for blood transfusion was located on the chart. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed prior to the transfusion. No similar statement was found in the physician progress notes prior to the procedure.



Review of the Medical Staff Rules and Regulations, Article V, Patient Rights, Section 5.2 Informed Consent, was as follows:

"It is the responsibility of the practitioner performing the procedure, or his/her partner, to perform the informed consent process and obtain informed consent from the patient according to hospital policy."



Review of hospital policy Reference #1026, Subject: Blood/Blood Components-Transfusion, Effective: July 1, 2017, Page: 2, Item II. Obtaining or Confirming Informed Consent, was as follows:

"a. Confirm that a signed and witnessed informed consent is in the patient chart.
b. If informed consent is unavailable, contact the provider to obtain consent before proceeding."



Review of hospital policy Number: 1:10, Title: Blood Transfusion Clinical Guidelines, Dated 3/9/2010, Page 1 of 5, Purpose, was as follows:

" ...While the risks of transfusion-transmitted disease have been greatly reduced, transfusion continues to carry significant risk. Established risks include hemolytic reactions, febrile reactions, allergic reactions, transfusion-related lung injury, hypotensive reactions, bacterial contamination, volume overload and iron overload. Transfusion has also been associated with adverse clinical outcomes including wound infection, pneumonia, prolonged ventilator support, acute coronary events, prolonged length of stay and in-hospital mortality."



Review of the form titled Disclosure of Risk for Medical and Surgical Procedures was made. Patients or their representatives were asked to initial the appropriate box. The box for blood transfusions did not disclose the known risks as outlined in the policy titled Blood Transfusion Clinical Guidelines. The form disclosed the following risks:

"This form is designed to meet and exceed requirements promulgated by the Texas Medical Disclosure Panel.

The appropriate procedure(s) should be highlighted and initialed by the patient.

...

9. Hematic and lymphatic system.
A. Transfusion of blood and blood components
1. Fever
2. Transfusion reaction which may include kidney failure or anemia
3. Heart failure
4. Hepatitis
5. A.I.D.S. (acquired immune deficiency syndrome)
6. Other infections"


This placed the burden on the patient or patient's representative to know how the risks would impact the patient's potential outcome without a physician present to explain the risks and the benefits based on the patient's diagnosis and prognosis. This list also did not include the established risks listed in the blood policy, preventing the patient from fulling understanding the scope of risks possible as related to the patient's diagnosis.

Review of the Texas Board of Nursing's position on the Nurse Practice Act (NPA) was as follows:

"In relation to nurses, the NPA section 301.002 "definition of professional nursing" states that professional nursing does not include "medical diagnosis or prescription of therapeutic or corrective measures." (i.e.: the RN may not engage in activities that require the use of independent medical judgement)." http://www.bon.texas.gov/index.asp

An interview was conducted with the Laboratory (Lab) Director on 12-28-2017 in the conference room. The Laboratory Director confirmed that the signed consent does not have to be presented at the lab when the blood is being picked up by nursing. Per the Lab Director, "We rely on nursing to ensure consent is obtained."

An interview was conducted with Staff #1 on 12-28-2017 in the conference room. Staff #1 confirmed that it is the physician's responsibility for obtaining informed consent and that informed consent should be documented by the physician prior to the procedure.



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Patient #36

Review of patient #39's medical record revealed she was in the ER on 12/10/17 at 8:25AM.

Review of the nurses triage note dated 12/10/17 at 8:34AM stated,

"Primary Treating Complaint: Bloodwork

Primary Complaint Details: Patient states she found out here that she was pregnant four days ago and was told to follow up here for bloodwork today to determine how far along she is via HCG levels.

Current Pain Level: 0
Orientation: Person, Place, and Time
Level of Consciousness: Alert
Pregnant: YES
Pregnant Details: Trimester: 1st, Confirmed By: Urine HCG, Urine HCG Details: When: 12/7/17
Prenatal care: Provider/Provider Name: Dr._____MD (01610) - Obstetrics and Gynecology."

Review of the ED Nursing Initial Assessment Note dated 12/10/17 at 9:31AM revealed she was seen by the nurse at 8:47AM. The primary complaint details were the same as the Triage Notes that were documented at 8:34AM. The note stated, "Behavioral/Emotional: PSYCH: Appropriate, Cooperative."
There was no assessment for pain found in the initial Nurses Notes.

Review of the Physician Notes dated 12/10/17 at 11:48 Patient #39 was seen by a mid-level nurse practitioner (staff #73) on 12/10/17 at 9:10AM. The patient had symptoms of cramping for 4 days and was currently in pain of "Severe (7-10) Cramping and Sharp. In first Trimester of pregnancy confirmed by HCG."

The patient had an ultrasound done on 12/10/17 at 11:27AM. The ultrasound revealed a small cystic structure is again present within the endometrium without definite well-developed decidual reaction. No fetal pole or yolk sac is seen. Ectopic pregnancy cannot be occluded."

Review of the physician orders dated 12-10-17 at 9:39AM revealed the patient was ordered,
"Hydromorphone 1MG Intramuscular ONE TIME for 1 doses." (Hydromorphone Hydrochloride Tablets, USP an opioid analgesic.)
And
"PROMETHAZINE (Phenergan) 50MG Intramuscular ONE TIME for 1 doses." (Phenergan is first-generation antihistamine sometimes given to relieve nausea.) The nurse documented in the vital signs that the patient #39's pain was at a "6" at 9:47AM. Both medications were administered by the nurse on 12-10-2017 at 9:47AM.

There was no documentation if the medication was effective, a nursing reassessment, or vital signs were conducted after the medication administration.

The nurse documented in the vital sign pain score and location at 11:27AM "Pain Location; Abdomen, MAK pain score 10." No other reassessment or vital signs found.

Review of the physician orders dated 12-10-17 at 10:57AM revealed the patient was ordered,
"Hydromorphone 1MG Intramuscular ONE TIME for 1 doses." (Hydromorphone Hydrochloride Tablets, USP an opioid analgesic.)
And
ZIPRASIDONE (GEODON) 20MG Intramuscular ONE TIME STAT for 1 Doses."

According to the "U.S. Department of Health and Human Services FDA Food and Drug Administration" the insert information from the manufacture of Geodon revealed the following;

"Ziprasidone is an antipsychotic medication.

Pregnancy - Pregnancy Category C - There are no adequate and well-controlled studies in pregnant women. Ziprasidone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In animal studies ziprasidone demonstrated developmental toxicity, including possible teratogenic effects at doses similar to human therapeutic doses.

(2) Given the primary CNS effects of ziprasidone, caution should be used when it is taken in combination with other centrally acting drugs."

Review of the Provider Note dated 12-10-17 at 11:51am the Nurse Practitioner stated, "Clinical status; Improving Diagnostic Impression; Ectopic Pregnancy discharge to home. Stable."

There was no further documentation of patient pain or pain level. There was no documentation of assessment other than a set of vital sins at 12:25PM at patient 39's discharge. There was no documentation found of medications that were administered in the ED. The only discharge information found in the chart was on Ectopic Pregnancy.

Patient #39 was given Geodon IM without any written documentation of a psychiatric event. There was no documentation of why the medication was administered and why it was ordered stat. There was no education to the patient concerning the psychotropic medication administration to make an informed decision of her health care. She was not informed of the side effects when pregnant or if attempting to conceive.

Patient #39 was not warned of the possibility of CNS effects such as Antipsychotic drugs (GEODON) may cause drowsiness, dizziness, or lightheadedness upon standing which could lead to falls, fractures, or other injuries.

Interview with staff #1, CNO, on 12-5-17 revealed she was unaware of a patient recieving Geodon for pain. Staff #1 stated, " I have no idea why that patient would have recieved Geodon for pain. That doesn't make sense."

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

A.) ensure the powdered potassium chloride additive which was for altering concentration of the dialysate was approved to be used by the dialysis staff working in the hospital. Also, the dialysis policy titled, "Adding Electrolytes to Dialysate" had not been approved by the Governing Body. Also, that the hospital Pharmacist had not approved the use of powered potassium chloride additive and that it could be stored outside the pharmacy in a non-secure storage area.

B.) ensure the security of the dialysis supplies and products in the acute dialysis unit.

C.) ensure the safety of the dialysis patients in the acute unit if an emergency occurred.

D.) ensure the pick-up tubes (wands) were fitting securely to the acid and bicarbonate jugs that were being used to dialyze the patients during a dialysis treatment to prevent nonbacterial contamination and evaporation.

E.) ensure that 2 (#32 and #33) of 3 dialysis machines were disinfected every 7 days and bleach clearance checked prior to the next patient use.

F.) ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.

G.) ensure the dialysis patient treatment log was current and up to date, so that patients in the facility would not miss their dialysis treatment.

H.) ensure the pump pressures for the portable (RO) (reverse osmosis water system) machines #1, #2, and #4 for the months of October, November, and December 2017 were maintained at a pressure of greater than 150.

I.) ensure 1(#53) of 5 dialysis staff had hemodialysis nurse skills checklist completed annually.

J.) ensure the dialysis Quality Assurance Performance Improvement (QAPI) program was developed, implemented, maintained and evaluated with focus indicators to improve the outcomes of the acute dialysis unit.

K.) ensure that an incident report for a "Near Miss" event was completed for the dialysis nurse that was dialyzing with the wrong dialyzer and wrong acid concentrate on Patient #24.


It was determined that the deficient practices at the following Conditions of Participation for Patient's Rights for care in a safe setting for an Acute End-Stage Renal Disease unit posed an Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, impairment and/or subsequent death.


Findings include:

A. During a tour of the facility on 12/27/17 at 9:00 AM, it was observed that in the cabinets of the acute dialysis unit were twenty-eight (28) 12.7 grams of powered potassium chloride additive packages. The cabinets had no locking mechanism. This allowed all employees to have access to the potassium chloride. This product was being used to spike the acid concentrate in the acid jugs. Also, it was observed that if the solution was not completely used by the nursing staff, the solution was saved for the next patient. The next patient's treatment could be the next day. Furthermore, a review of the schedule revealed it was not always the same nurse. There was no continuity of care for the dialysis patients. The dialysis nurses were using the additive electrolyte concentrate from another nurse that had spiked the jug the day before. When the surveyor asked for the policy on adding electrolyte to dialysate; the chronic dialysis unit had to fax the policy to the hospital. So there was no additive policy on-site at the facility. A further review of the acute dialysis policies revealed the policies had never been approved by the hospital Governing Body.

An interview with hospital pharmacist #19 on 12/29/17 at 10:00 AM confirmed that the pharmacist had no knowledge that the powdered potassium chloride was available in the hospital. Staff #19 was asked does the hospital allow potassium chloride to be available to nursing staff for mixing higher concentrates. Staff#19 stated, "No, and I did not know the potassium was even in the hospital."

An interview with Staff #4 on 12/29/17 at 10:00 AM confirmed that potassium chloride should not be available for the nursing staff to change the electrolyte concentrate.

The manufacture of the liquid acid concentrate "RenalPure" was from Rockwell Medical. A phone interview with the company representative from Rockwell informed the surveyor that the company does not allow additives to their products, because they make all 4 types of concentrates in acid. The additive potassium chloride being used in the acute dialysis unit was from a company called "Edlaw EP pharmaceuticals." The Rockwell medical company will not stand by their product if additives are added per the company representative.


B. During a tour of the facility on 12/27/17 at 9:00 AM, observed the acute dialysis unit had a keypad entry for security. The nursing staff from the floor and housekeeping had access to the dialysis supplies and products. Observed different nursing staff entering and leaving the unit. Staff #35 was asked when does housekeeping enter the unit. Staff#35 stated, "At night when we are gone." Observed in the cabinets were twenty-eight (28) 12.7 grams of powdered potassium chloride additive. The cabinets had no locking mechanism. This allowed employees access to the potassium chloride. Also, the dialysis staff were saving open acid and bicarbonate jugs that had solution left in them for the next patient on the next day. This deficient practice allowed access to the open jugs and allowing potassium chloride additives to be added to the open jugs or tapering with the open jugs.

An interview with Staff #4 and Hospital Pharmacist on 12/29/17 at 10:00 AM confirmed that potassium chloride should not be available for the nursing staff without approval from the pharmacy.


C. During a tour of the Acute dialysis unit on 12/29/17 at 9:00 AM, observed there was no emergency call system at the patient's bedside. The staffing for the acute dialysis unit was 1-2 patients per 1 dialysis nurse. The dialysis nurse was the only nurse in the unit. Staff #35 was asked was there an emergency call system. Staff #35 stated, "I guess not, I thought it was at the bedside." The surveyor observed a white button behind the nurse's station that said emergency, but when turned on nothing happened. On 12/27/17 at 2:00 PM the surveyor had observed 2 dialysis patients in the unit with 1 nurse.

An interview with Staff #4 on 12/29/17 on the morning of the tour, it was confirmed there was no working emergency call system in the acute dialysis unit and the staffing in the acute dialysis unit was 1 nurse per 1-2 patients.


D. During a tour of the facility on 12/27/17 at 2:00 PM, observed a patient receiving a dialysis treatment. The pick-up tubes (wands) were hanging out of the acid and bicarbonate jugs. There was no secure connection from the pick-up tube to the opening of the acid or bicarbonate jug. This deficient practice allowed for cross contamination, acid spills, and bacteria growth in the bicarbonate jug. Acid concentrate is not susceptible to bacteria contamination, but every effort should be made to keep the system closed to prevent nonbacterial contamination and evaporation per the ANSI/AAMI standards.


E. A review of the disinfection logs for dialysis machines #32, 33, and 34 for the months of October, November, and December 2017 revealed the following:

1. Machine #32 in the month of October was not checked for bleach clearance prior to use on 10/23/17 and 10/30/17. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.

2. Machine #32 in the month of December was not bleached within the 7-day period. The bleaching should have been performed on 12/11/17, but was performed on 12/12/17 which was a day late. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.

3. Machine #33 in the month of October was not checked for bleach clearance prior to use on 10/23/17. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.

An interview with the Staff #35 on 12/29/17 at 10:00 AM confirmed the above findings.


F. During a tour of the acute dialysis unit on 12/27/17 in the morning and afternoon observed the following infection control issues:

1. The dialysis machine was used on a nursing unit at the patient's bedside. The machine was brought back to the unit before it was disinfected. A patient was receiving a dialysis treatment in the unit. On the back of the machine was an open plastic container with extra dialysis supplies. The container had been in the patient's room. Also, noted that there was a splash of blood on the back of the machine beside the plastic container of supplies. The supplies had the likelihood to be contaminated from the splash marks and the supplies had been exposed to the contaminants in the patient's room.

2. On a cart in the acute unit, observed several cardboard boxes broken down near the patient receiving a dialysis treatment. The cart was dirty with rust spots.

"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." (AAM1 ST46-Section 5.2 Receiving items).

3. The shelf holding the dialysis supplies was covered in dust particles.

4. The cabinet door hinge was broken and door was falling off the cabinet that was storing the packages of potassium chloride and sterile dialysis supplies.

5. Observed 5 plastic bags of trash piled on the floor of the acute unit.

6. Observed staff #34 treating a patient with a central line catheter. The nurse wore her mask during the dressing change and then pulled the mask down under her chin. When staff #34 was ready to treat the next patient she pulled the mask up and used on the second patient. Staff #34 never changed her mask.

7. Staff #34 took the "pHoenix meter" in the storage area and rinsed the meter, but never disinfected the meter.

8. Staff #34 had long hair and while changing the central line dressing observed her hair falling into the dressing site area and her hair was touching the sheets of the bed. The deficient practice had the likelihood to contaminate the sterile dressing site.

9. Staff #34 ask the Bio-med Technician to help her get a safe site cap off the central line port. The bio-med Technician put gloves on without washing his hands and loosed the cap. The bio-med technician never washed his hands prior to putting on gloves or taking off gloves.

10. Observed that the dialyzers 180 were placed in the 160 dialyzer's plastic container. This deficient practice had the likelihood to cause a wrong dialyzer to be placed on a dialysis patient.

11. There was an acid jug of concentrate that had been spiked with additives left from the day before by Staff #53. The normal routine of the nursing staff was if the acid solution was not completely used, leave the solution for the next day to be used. This deficient practice had the likelihood for a nurse to give an additive that another nurse had spiked not knowing if the procedure had been spiked per the policy.

An interview with Staff #4 on 12/27/17 in morning and afternoon confirmed the above findings during the tour of the facility.

G. A review of the dialysis "Hospital Services" log revealed a patient was placed on the treatment log that had been dialyzed on 12/28/17.

Upon entering the dialysis unit on 12/28/17 at 8:00am, Staff #53 was asked what patients were going to be dialyzed. Staff #53 stated, "I don't know. I have to call the floor to see what patients need to be dialyzed. We have a log, but someone had written a patient that needs CCPD (continuous cycler peritoneal dialysis) and I don't do peritoneal dialysis." Surveyor asked Staff #53 where was dialysis patient #24 and #25 and again Staff #53 stated, "I don't know." The surveyor questioned Staff #53 doesn't there need to be a process in place to know what patients need to be dialyzed so treatments are not missed. Staff #53 stated, "I don't know."

An interview with the Staff #4 (Clinical Outcomes Director) on 12/28/17 at 8:30 AM confirmed there was no process in place to know what patients in the facility need to be dialyzed. Staff #4 agreed that the dialysis unit needs to have a process in place to know which patients in the facility need to dialyzed and don't miss their dialysis treatments.

H. A review of the "Service Daily Portable (RO) Log" for RO machines #1, #2, and #4 for the months of October, November, and December 2017 revealed the following:


(RO) machine #1:

A review of the log indicated the pump pressure was to be maintained greater than 150.

In the month of October 2017 the pump pressure readings never reached greater than 150.

In the month of November 2017 the pump pressure readings never reached greater than 150.

In the month of December 2017 the pump pressure reading reached 150 on one of the days checked. On all the other days the pump pressure readings were below 150.


(RO) machine #2:

A review of the log indicated the pump pressure readings were to be maintained greater than 150.

In the month of October 2017 the pump pressure readings never reached greater than 150.

In the month of November 2017 the pump pressure readings never reached greater than 150.

In the month of December 2017 the pump pressure readings reached 150 on three of the days checked. On all the other days the pump pressure readings were below 150.


(RO) machine #4:

A review of the log indicated the pump pressure was to be maintained between 100 and 150.

In the month of October 2017 the pump pressure readings were greater than 150 for the month.

In the month of November 2017 the pump pressure readings were greater than 150 for the month.

In the month of December 2017 the pump pressure readings were greater than 150 for the month.


There was no consistency in the forms for which the dialysis nursing staff were to document the pump pressure readings. The facility was using 2 different forms. The forms had 2 different readings for pump pressures. One of the forms indicated the reading should be greater than 150. The other form indicated the pump pressure should be between 120 and 150.

There were numerous write overs and mark outs on the log readings.

Staff #35 was asked if the abnormal pump readings were reported to the Bio-Med Technician. Staff #35 stated, "Yes, but he told us as long as the readings were above 120 the machine was okay." On the form it was clearly written to "Notify the Technical dept. if readings are out of range. Enter work orders in Tech module." Staff #35 stated, "I was entering the out ranges and Bio-Med technician told me to stop."

On 12/28/17 at 8:30 AM the Bio-med technician #54 was asked why do the forms indicate greater than 150 and some indicate between 120 and 150. Staff #54 stated, "as long as the pressure was greater than 120 the machine was okay. I have redone the form and it was approved by the Medical Director to start in January 2018.

An interview with Staff #54 on 12/28/17 at 8:30 AM confirmed the pump pressures were out range and there was inconsistency with the forms; which made it difficult for the dialysis nurses to know what readings were out of range on the (RO) machines.

I. A review of 1 (#53) of 5 dialysis nurses revealed the hemodialysis nurse skills checklist had not been completed since January of 2016.

An interview with #15 on 12/29/17 at 10:30 AM confirmed the above findings.

J. A review of the QAPI meeting minutes February through October 2017 did not address the issues with the disinfection logs, R/O machine logs, the numerous write overs and mark outs on the logs. The QAPI meeting minutes discussed delays of treatments on each of the quarterly meetings, but there was no implementation to develop a plan to correct the delay issue. The Charge Nurse of the acute dialysis unit (Staff #35) was asked are you involved in the quality meetings. Staff #35 stated, "No".

An interview with Staff #33 on 12/29/17 at 10:00 AM confirmed the QAPI meetings did not address the above findings.

K. During an observation of Staff #34 setting up treatment for patient #24, surveyor observed that a wrong dialyzer and wrong concentration was connected to the patient. The patient was to have a 160 dialyzer and a 180 dialyzer was connected to the dialysis machine. Patient #24 was to receive a 3 K bathe (dialysate) and she was connected to a 2 K bathe (dialysate). Staff #34 caught the "Near Miss" prior to starting the machine. On 12/29/17 Staff #35 was asked was an incident report filled out for the "Near Miss." Staff #35 looked in computer system and there was no incident report filed. Staff #35 called Staff #34 to verify if she had filled out the incident and she said no, but she would fill out the form today.

An interview with Staff #35 on 12/29/17 at 10:00 AM confirmed the above findings.

Based on observation, interview, and record review the facility failed to meet the Condition of Participation for Patient Rights "Use of Restraint and Seclusion" as evidence by;

The facility failed to ensure the patients were free from corporal punishment in the Emergency Department(ED).The facility used the local police to restrain, seclude, and handcuff patients when not detained or documented as a forensic patient from staff interviews and 2 (35 and 36) of 2 patient charts reviewed.

The facility failed to follow its own policy and procedure to prevent patient restraints or seclusion to ever be used as a means of coercion, discipline, or convenience. Patient chart reviews and staff interviews revealed that less restrictive restraints were not applied before administering a psychoactive drug (chemical restraint), due to the excessive paperwork required for seclusion or physical restraints in 2(35 and 36) of 2 patient charts reviewed.

The facility failed to ensure patients safety while handcuffed to a stretcher. Nursing failed to assess patient #36 for injuries after flipping a stretcher over while still handcuffed.

The facility failed to have any Quality Assessment Performance Improvement (QAPI) data or monitors in place for any restraints in the ED. QAPI failed to properly log, track, analyze, and implement a productive plan to ensure the patients were safe in restraints.

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.



Review of patient #35's chart revealed she was a 48 year old that arrived in the ED on 12-15-17 at 21:52 (9:52PM). Review of the physician's chart revealed the patient was here for a complaint of hallucinations. The patient was brought to the facility by her daughter.

The physician documented, "Pt c/o weakness to L side since Tuesday, states she went to medical center for same symptoms and was d/c with a migraine. She states her symptoms have not gotten better and has fallen a few times at home. In triage, face is symmetrical, speech is clear, no drooping noted. Hand grips strong and equal, foot pushes weak and L slightly weaker. Pt was able to ambulate to room."

After blood test and a CT scan of the head was performed, the physician documented on 12-16-17 at 3:30AM, "Clinical Status: Getting Worse. Findings: This patient was initially felt to have alcohol intoxication delirium, and it was felt that she could be discharged to sleep off her intoxication. In fact, her chart was completed and discharged papers printed, but upon informing the patient and family of the plans of her care. It was blatantly obvious that the patient had gotten much more confused and delusional. She is now having hallucinations also, and she is talking about things that make no sense even to her family. It is very possible that she is having an adverse effect from the alcohol and benzodiazepines in addition to the opioid pain medication and Promethazine she was given earlier. Regardless, it is felt at this point, that she needs to have a psych evaluation, but at the moment, she is so confused, delusional, and agitated that she will be given Geodon and Ativan in an attempt to settle her down. In the morning, we will have her alcohol level rechecked and get the Burke Center to evaluate her.

Diagnostic Impression: Hypokalemia, Acute Urinary Infection, Dehydration, Headache, Delirium, Acute Psychosis, Hallucinations and Delusions."

Review of patient #35's chart revealed the patient had an order for "ZIPRASIDONE (GEODON) 20MG Intramuscular ONE TIME STAT for 1 Doses." At 2:40AM and 8:49AM on 12-16-17.
Lorazepam (ATIVAN) 2 MG Intramuscular ONE TIME STAT for 1 Doses on 12-16-17 at 6:10AM."

Review of the Nurses Notes revealed the following documentation for Patient #35;

"12/16/17 12:32AM- pt has been increasingly more confused, she is rambling and talking about different things, disorganized words and sentences, trying to get out of bed and walking around. MD made aware.

12/16/17 2:05AM- Dr. ____ (ER Doctor) spoke with daughter and boyfriend, they want pt to stay overnight and not be discharged. They said she has been acting crazy for the past 4 nights, rambling, and not making sense, also trying to burn plastic containers on the stove. They are scared to take her home and want her to stay overnight for observation. New orders from Dr. ____ (ER Doctor) to call Burke for evaluator.

12/16/17 2:05AM- Spoke with Kim at Burke center at 2:15, states she will send an evaluator out ASAP, unable to give me a time when. Updated her daughter and boyfriend and notified ERP. Pt given Geodon IM d/t pt walking around and going into other people's rooms and will not stay in bed."

There was no nursing documentation found of any de-escalation techniques used to assist the patient in controlling the behavior before a chemical restraint was applied. There was no documentation that other less restrictive restraints were applied before administering a chemical restraint.

Review of the Nurses Notes dated 12-15-17 revealed the patient was seen by the mental health authority and had slept for a few hours. On 12-16-17 patient #35 continued to wait in the ED for placement to a psychiatric facility. Review of the Nurses Notes on 12-16 17 revealed the following;

"7:29AM- pt walked up to the nurse's station and stated that we were talking about her as well as that she was going to leave because we were talking about her family. Pt then proceeded to walk over to the computer and asked me to help her get to the car.

7:32AM- pt is walking around at this time previously asked to stay in her room also tried to call the burke center no answer.

7:49AM- tried to call the burke center no answer trying to call the other number, pt wandering all over the ER and is going out to the lobby, the nurse is reviewing the chart at this time.

8:01AM Patient talking to self and attempting to "clean" objects in the room. Patient alert but noted to continue having visual hallucinations. No distress noted. Patient remains in view of the nurse's station.

8:25AM- Called police dept. and they stated that they are not sending anyone out and they will not do a warrant ____( House Supervisor) aware pt still wandering all over and MD states this pt is not safe to leave.

8:35AM- called NPD and asked who the JP on call was _____RN will call to get a warrant for this pt.

8:47AM- Pt given Geodon and gave blanket and turned lights off to try to redirect and help relax."

Review of the chart revealed the patient was not offered any redirection or de-escalation before being administered another chemical restraint. There was no evidence found of a sitter or family present to help with redirection. There was no evidence of a MD face to face to evaluate the patients need for another administration of a chemical restraint. The ED has a seclusion room with a locked door to assist with patients in crisis that need seclusion. There was no evidence of a less restrictive restraint applied such as seclusion or physical restraint attempted.

"10:19AM- Patient continues to leave room and try to wonder the unit when redirecting patient to room she is becoming slightly agitated.

10:32AM- Patient found in another patients room and was returned to her room.

10:34AM- Patient walked outside ambulance exit and got all the way outside with me following. Patient refused to come inside for a few minutes but then agreed to come in.

10:51AM- Patient rushed into another patient's room and tried to take the patient which was a child from the mother's hands, pt had to physically removed by myself and EMS. Pt placed back in room and Nacogdoches PD called.
11:02AM- NPD at bedside."

There was no documentation that indicated why the police officer was asked to physically assist with a patient that was not detained. There was no found documentation on why the police officer was sitting with the patient and who authorized the officer to detain a patient that was not documented as "under arrest" or a forensic patient.

"12:23AM-Faxed application for warrant to Judge____.

12:30AM- Received warrant from judge via fax. Called dispatch and request an officer for the monitoring of their patient under a warrant. Dispatch is sending their Sargent to look over the warrant and go from there. Nacogdoches police officer arrived and patient placed in psy/obs room for patient and other's safety."

During a tour of the ED on 12-28-17 review of the psy/obs room is also a seclusion room. The room locks from the outside.

Review of patient 35's chart revealed a Mental Health Warrant for Emergency Detention (EDW) was found dated by the judge on 12/16/17. There was no time on the warrant. The RN had filled out the application for detention but it was not notarized or witnessed. The warrant does not state the patient is under arrest only to transport the person to a safe location and or to the mental health authority for the purpose of a preliminary examination. The patient was already in a "safe place" and had been medically cleared for a transfer to a psychiatric facility for further evaluation and care. The patient had no documentation of being in police custody or under arrest at this time.

During an interview with staff#23 RN in the ED on 12/28/17 at 2:40PM, Staff #23 was asked if a patient was in the ED for a psychiatric issue and became violent what would be the first course of action. Staff #23 stated that he would try to talk to them and calm them down. Staff #23 stated that most of the time he feels just speaking with them and giving them space works. Staff #23 was asked about chemical restraints. Staff #23 stated that they don't use any restraints in the ED. Stated, "we are trying to be restraint free here." Staff #23 confirmed if the patient becomes violent, the ED staff call the local police department and let them handle the patient. Staff #23 stated, "I'm not going to do all that paperwork for a physical restraint. I'll just give them a shot. If that doesn't work the police can handle it or they can just hit the street." Staff #23 confirmed the local police assist with restraining patients and seclusion. Staff #23 confirmed there was no place to document if a patient was under arrest or not. Staff #23 stated, "I'm not gonna get myself hurt. The cops can handle these patients if they become a problem."

During an interview with staff#62, RN ED Director, in the ED on 12/28/17 at 2:48PM, Staff #62 confirmed he had only been the ER Director for a few months and that staff #23 was the ED Director and had stepped down into a floor RN position in the ED. Staff #62 was questioned on the use of Geodon in the ER and what direction the staff were following for chemical restraint use. Staff #62 was not aware that chemical restraints were being used in the ED and was not aware that Geodon was a psychotropic medication until today. Staff #62 did not have a restraint log available for chemical restraints. Staff #62 confirmed that the police are called to assist the staff with patients that are difficult to control or need to be held for psychiatric care until transferred or discharged to home. Staff #62 confirmed there was no documentation by the staff, to determine, if a patient is being watched by police for the hospital or under arrest and/or is a forensic patient. Staff #62 was unable to explain why the patients were not being monitored or reassessed after giving a chemical restraint, and why the facility policy and procedure were not followed in documentation of a chemical restraint. Staff #62 stated, "I can see we need to relook at all of this and do some education." Staff #62 confirmed they had taken a coarse online for de-escalation but was not aware of any chemical restraint training. Staff #62 confirmed at the yearly education fair they are trained on physical restraints.

An interview with staff #61 Security Guard on 12/29/17 revealed she was one of 3 fulltime security guards. Staff #61 stated that there is also 3 part time guards to help with the schedule. Staff #61 stated that she was told by the hospitals consultant management company that the guards are not to touch a patient. Staff #61 stated, "We can go to the ED and talk to the patient but we are not allowed to assist the staff. We have to call the police to come handle that." Staff #61 confirmed that the City PD or Sheriff Department gets called if a patient become out of control or violent. The police can then come in and put the patient in handcuffs or in the seclusion room. Staff #61 confirmed that she was not aware if a patient was under arrest or not when a police officer uses cuffs. Staff #61 stated, "I know they come often and we try to talk to the patients but sometimes they are acting out so bad they have to be restrained." Staff #61 confirmed the police department officers are not employees of the hospital.

An interview with staff #7, Quality Assurance Performance Improvement (QAPI) Director, and #1, CNO, was conducted on 12-29-17. Staff #7 confirmed that she was not logging chemical restraints and had not been monitoring them. Staff #7 offered a restraint log that had 3 inpatients on it from October-December of 2017 for physical restraints. Staff #7 confirmed that there had been more than 3 inpatient physical restraints when we went over the auditing sheets. Staff #7 had not been gathering data or monitoring any restraints in the ED. Staff #7 stated, "We have been looking over the materials like the policy and procedures we had when we had a geri psych unit, trying to see if it would help us with restraints. Restraints just have not been covered for the ED at all. No one has monitored these pts for safety. That's something I have to fix." Staff #1 stated, "Yes, we have to fix that."


Review of patient #36's chart revealed the patient was a 29 year old male brought to the ED on 12-13-17 by EMS and the Nacogdoches County Sheriff Department (SO). The patient was registered as a "Self Pay" patient and not as a forensic patient.

The EMS report dated 12-13-17 reported the Sheriff Deputy was with the patient when they arrived. "The patient had been found running around naked in someone's back yard. Pt is AAOx4 but has times of what appears to be drug induced psychosis. Pt was saying that he sprayed a chemical that he uses to cook meth, into his milk. Pt show's signs of aggressiveness at times. Pts cuffs moved to the front and left in place for crew safety." The patient refused to allow any treatment just vital signs. The NSO followed the patient to the hospital with a police officer's warrant for treatment and detainment at the hospital. EMS documented that the patient has a history of "traumatic brain trauma, drug abuse."

Review of the Nurses Initial Assessment Note on 12-13-17 at 10:58AM stated, "Psychiatric complaint. Associated symptoms: mania, Delusion, Agitation, and pt is speaking to no one but it is hard to tell who? Pt states he has done Meth and believes someone has given him a lot of drugs, but states he doesn't know exactly what he was given, believes he "Is on a lot of meth right now" states " I am speeding like you would not believe right now.

Behavior Details;
Delusion and Hallucinating
Naked
Uncooperative and Suspicious
Agitated, Inappropriate, Interfering with Medical Treatment or Device and Verbally Abusive.
Insight poor
Judgment Impaired."

Review of the Nurses Notes dated 12-13-17 revealed the following;

"10:30AM- Pt refused xray and is demanding water.

10:32AM- Pt ripping monitors at this time, NSO at bedside at this time.

10:42AM- Pt refused lab draw, NSO at bedside witnessed.

10:44AM 2 cups of water given to this pt and he is still refusing blood draw at this time."

Food and water was given to the patient and he gave a urine sample. There was no documentation if the patient was still handcuffed or if the patient was given any clothes.

"11:28AM- Pt is moved to the psych room per ___RN and ___RN at this time

11:40AM- Tray given to pt, pt is also being very aggressive at this time both physically and verbally towards staff members and police.

1:38PM- Pt is up on bed and is jumping on the bed slamming against the window punching and kicking, Geodon administered via staff #62 and pt is screaming" Give me the dope ohh yea" when the Geodon was being administered pt was very aggressive towards staff and possibility for injuring himself."

There was no documentation of an assessment after the chemical restraint was given. There was no documentation of the incident, need for a chemical restraint, or if the physician did a face to face for a restraint. There was no found documentation of the event in the Physician Notes. There was no documentation found if the patient was still in handcuffs or what action the officer took. There was no documentation of de-escalation techniques used or other forms of restraint before going to a chemical restraint.

Review of the Physician Orders revealed a verbal order for "ZIPRASIDONE (GEODON) 20MG Intramuscular ONE TIME STAT for 1 Doses." Dated 12-13-17 at 11:34AM. However, the medication was not administered until 1:38PM. There is no documentation on why a stat order for a chemical restraint was delayed for 2 hours.

Review of patient #36's chart revealed the mental health authority had interviewed the patient and was recommending psychiatric inpatient care. The patient's chest xray was obtained. The pt was offered a food tray and was eating at 5:40PM. At 6:53 report was given to another nurse and he resumed pt care.

"7:10PM- Pt combative, insisting that one of the staff members wanted him to go home with her. Flips stretcher in room while still handcuffed. Extremely violent. Geodon ordered and administered. Pt is finally compliant with blood draw. Cont. to monitor."

There was no prior documentation of the patient in handcuffs. There was no documentation if the patient was assessed for injuries after flipping a stretcher over while still handcuffed. There was no found documentation in the physician notes of this incident and if he evaluated the patient for injuries.

The order for Geodon was a verbal order and was not ordered until 7:23PM, 13 minutes after the administration. It was not signed by the physician until 8:32PM, 1 hour and 22 minutes after administration. There was no further documentation found on any physical restraints used or assessment of administration of a chemical restraint.

The patient had vital signs documented on 12-13-17 at 2:30PM, 6:30PM, 11:00PM. On 12-14-17 at 2:00AM, 7:04AM, 11:15AM, and 1:50PM. The patient was transported to an inpatient facility on 12-14-17 at 2:02PM.

Review of the incident report log revealed there was no incident report logged for patient #36. There was no found documentation that an incident report was completed but not logged. Staff #7 confirmed there was no incident report filed for patient #36.



Review of the Facility's policy and procedures titled "RESTRAINTS" stated, "All patients have the right to be free from restraint or seclusion of any form, and Nacogdoches Memorial Hospital strives to be restraint free. Restraints will be used only if needed to improve the patient's well- being when less restrictive interventions have been determined to be ineffective. All efforts will be undertaken to calm or redirect the patient before the use of restraints, or seclusion and the minimum amount of restraint necessary to address the problem will be applied. Restraints or Seclusion will never be used as a means of coercion, discipline, convenience, or staff retaliation. Seclusion will be used only as a last resort for management of violent or self-destructive behavior that immediately jeopardizes the physical safety of the patient, staff, or others. All restraints and seclusion, regardless of type or reason for application, will be discontinued at the earliest possible time.

Methods of Restraint;
Chemical Restraint- A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition.
Types of Restraint;
a. Non-Violent/Non-Self-Destructive Restraint
i. Can be either a physical or a chemical restraint.
b. Violent/Self Destructive restraint
i. Can be either a physical or a chemical restraint.
c. Forensic Restraint
i. Any restraint applied to a patient who is in the custody of law enforcement officers is the responsibility of that law enforcement agency and is not the responsibility of Nacogdoches Memorial Hospital. In those cases, an officer will be in constant attendance with the patient.
ii. Unless the patient is in law enforcement custody (under arrest), he or she is the responsibility of Nacogdoches Memorial, and law enforcement personnel will not be permitted to restrain or seclude the patient."

Based on observation, interview, and record review, the facility failed to meet the Condition of Participation for Patient Rights "Use of Restraint and Seclusion" as evidence by;

Staff failed to recognize a psychoactive medication given as a restriction to manage a patients behavior as a chemical restraint in 2(35 and 36) of 2 patient charts reviewed.

The facility failed to follow its own policy and procedure to prevent patient restraints or seclusion to never be used as a means of coercion, discipline, or convenience. Patient chart reviews and staff interviews revealed that de-escalation techniques or less restrictive restraints were not applied before administering a psychoactive drug (chemical restraint), due to the excessive paperwork required for seclusion or physical restraints in 2(35 and 36) of 2 patient charts reviewed.

There was no documentation of a nursing assessment after chemical restraints were given. There was no documentation of patient behavior, effectiveness of the medication, or patient's physical status after the administration of the chemical restraint. Failed to ensure the physician did a face to face for a restraint and documented that assessment in 2(35 and 36) of 2 patient charts reviewed.

The facility failed to have any Quality Assessment Performance Improvement (QAPI) data or monitors in place for any restraints in the ED. QAPI failed to properly log, track, analyze, and implement a productive plan to ensure the patients were safe in restraints.

The facility failed to ensure that an order for a stat chemical restraint was administered in a timely manner. Nursing delayed the stat order for two hours without documentation for delay in 1(36) of 2(35 and 36) patient charts.

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.


Review of patient #35's chart revealed she was a 48 year old that arrived in the ED on 12-15-17 at 21:52 (9:52PM). Review of the physician's chart revealed the patient was here for a complaint of hallucinations. The patient was brought to the facility by her daughter.

The physician documented, "Pt c/o weakness to L side since Tuesday, states she went to medical center for same symptoms and was d/c with a migraine. She states her symptoms have not gotten better and has fallen a few times at home. In triage, face is symmetrical, speech is clear, no drooping noted. Hand grips strong and equal, foot pushes weak and L slightly weaker. Pt was able to ambulate to room."

After blood test and a CT scan of the head was performed, the physician documented on 12-16-17 at 3:30AM, "Clinical Status: Getting Worse. Findings: This patient was initially felt to have alcohol intoxication delirium, and it was felt that she could be discharged to sleep off her intoxication. In fact, her chart was completed and discharged papers printed, but upon informing the patient and family of the plans of her care. It was blatantly obvious that the patient had gotten much more confused and delusional. She is now having hallucinations also, and she is talking about things that make no sense even to her family. It is very possible that she is having an adverse effect from the alcohol and benzodiazepines in addition to the opioid pain medication and Promethazine she was given earlier. Regardless, it is felt at this point, that she needs to have a psych evaluation, but at the moment, she is so confused, delusional, and agitated that she will be given Geodon and Ativan in an attempt to settle her down. In the morning, we will have her alcohol level rechecked and get the Burke Center to evaluate her.

Diagnostic Impression: Hypokalemia, Acute Urinary Infection, Dehydration, Headache, Delirium, Acute Psychosis, Hallucinations and Delusions."

Review of patient #35's chart revealed the patient had an order for "ZIPRASIDONE (GEODON) 20MG Intramuscular ONE TIME STAT for 1 Doses." At 2:40AM and 8:49AM on 12-16-17.
Lorazepam (ATIVAN) 2 MG Intramuscular ONE TIME STAT for 1 Doses on 12-16-17 at 6:10AM."

Review of the Nurses Notes revealed the following documentation for Patient #35;

"12/16/17 12:32AM- pt has been increasingly more confused, she is rambling and talking about different things, disorganized words and sentences, trying to get out of bed and walking around. MD made aware.

12/16/17 2:05AM- Dr. ____ (ER Doctor) spoke with daughter and boyfriend, they want pt to stay overnight and not be discharged. They said she has been acting crazy for the past 4 nights, rambling, and not making sense, also trying to burn plastic containers on the stove. They are scared to take her home and want her to stay overnight for observation. New orders from Dr. ____ (ER Doctor) to call Burke for evaluator.

12/16/17 2:05AM- Spoke with Kim at Burke center at 2:15, states she will send an evaluator out ASAP, unable to give me a time when. Updated her daughter and boyfriend and notified ERP. Pt given Geodon IM d/t pt walking around and going into other people's rooms and will not stay in bed."

There was no nursing documentation found of any de-escalation techniques used to assist the patient in controlling the behavior before a chemical restraint was applied. There was no documentation that other less restrictive restraints were applied before administering a chemical restraint.

Review of the Nurses Notes dated 12-15-17 revealed the patient was seen by the mental health authority and had slept for a few hours. On 12-16-17 patient #35 continued to wait in the ED for placement to a psychiatric facility. Review of the Nurses Notes on 12-16 17 revealed the following;

"7:29AM- pt walked up to the nurse's station and stated that we were talking about her as well as that she was going to leave because we were talking about her family. Pt then proceeded to walk over to the computer and asked me to help her get to the car.

7:32AM- pt is walking around at this time previously asked to stay in her room also tried to call the burke center no answer.

7:49AM- tried to call the burke center no answer trying to call the other number, pt wandering all over the ER and is going out to the lobby, the nurse is reviewing the chart at this time.

8:01AM Patient talking to self and attempting to "clean" objects in the room. Patient alert but noted to continue having visual hallucinations. No distress noted. Patient remains in view of the nurse's station.

8:25AM- Called police dept. and they stated that they are not sending anyone out and they will not do a warrant ____( House Supervisor) aware pt still wandering all over and MD states this pt is not safe to leave.

8:35AM- called NPD and asked who the JP on call was _____RN will call to get a warrant for this pt.

8:47AM- Pt given Geodon and gave blanket and turned lights off to try to redirect and help relax."

Review of the chart revealed the patient was not offered any redirection or de-escalation before being administered another chemical restraint. There was no evidence found of a sitter or family present to help with redirection. There was no evidence of a MD face to face to evaluate the patients need for another administration of a chemical restraint. The ED has a seclusion room with a locked door to assist with patients in crisis that need seclusion. There was no evidence of a less restrictive restraint applied such as seclusion or physical restraint attempted.

"10:19AM- Patient continues to leave room and try to wonder the unit when redirecting patient to room she is becoming slightly agitated.

10:32AM- Patient found in another patients room and was returned to her room.

10:34AM- Patient walked outside ambulance exit and got all the way outside with me following. Patient refused to come inside for a few minutes but then agreed to come in.

10:51AM- Patient rushed into another patient's room and tried to take the patient which was a child from the mother's hands, pt had to physically removed by myself and EMS. Pt placed back in room and Nacogdoches PD called.
11:02AM- NPD at bedside."

There was no documentation that indicated why the police officer was asked to physically assist with a patient that was not detained. There was no found documentation on why the police officer was sitting with the patient and who authorized the officer to detain a patient that was not documented as "under arrest" or a forensic patient.

"12:23AM-Faxed application for warrant to Judge____.

12:30AM- Received warrant from judge via fax. Called dispatch and request an officer for the monitoring of their patient under a warrant. Dispatch is sending their Sargent to look over the warrant and go from there. Nacogdoches police officer arrived and patient placed in psy/obs room for patient and other's safety."

During a tour of the ED on 12-28-17 review of the psy/obs room is also a seclusion room. The room locks from the outside.

Review of patient 35's chart revealed a Mental Health Warrant for Emergency Detention (EDW) was found dated by the judge on 12/16/17. There was no time on the warrant. The RN had filled out the application for detention but it was not notarized or witnessed. The warrant does not state the patient is under arrest only to transport the person to a safe location and or to the mental health authority for the purpose of a preliminary examination. The patient was already in a "safe place" and had been medically cleared for a transfer to a psychiatric facility for further evaluation and care. The patient had no documentation of being in police custody or under arrest at this time.

During an interview with staff#23 RN in the ED on 12/28/17 at 2:40PM, Staff #23 was asked if a patient was in the ED for a psychiatric issue and became violent what would be the first course of action. Staff #23 stated that he would try to talk to them and calm them down. Staff #23 stated that most of the time he feels just speaking with them and giving them space works. Staff #23 was asked about chemical restraints. Staff #23 stated that they don't use any restraints in the ED. Stated, "we are trying to be restraint free here." Staff #23 confirmed if the patient becomes violent, the ED staff call the local police department and let them handle the patient. Staff #23 stated, "I'm not going to do all that paperwork for a physical restraint. I'll just give them a shot. If that doesn't work the police can handle it or they can just hit the street." Staff #23 confirmed the local police assist with restraining patients and seclusion. Staff #23 confirmed there was no place to document if a patient was under arrest or not. Staff #23 stated, "I'm not gonna get myself hurt. The cops can handle these patients if they become a problem."

During an interview with staff#62, RN ED Director, in the ED on 12/28/17 at 2:48PM, Staff #62 confirmed he had only been the ER Director for a few months and that staff #23 was the ED Director and had stepped down into a floor RN position in the ED. Staff #62 was questioned on the use of Geodon in the ER and what direction the staff were following for chemical restraint use. Staff #62 was not aware that chemical restraints were being used in the ED and was not aware that Geodon was a psychotropic medication until today. Staff #62 did not have a restraint log available for chemical restraints. Staff #62 confirmed that the police are called to assist the staff with patients that are difficult to control or need to be held for psychiatric care until transferred or discharged to home. Staff #62 confirmed there was no documentation by the staff, to determine, if a patient is being watched by police for the hospital or under arrest and/or is a forensic patient. Staff #62 was unable to explain why the patients were not being monitored or reassessed after giving a chemical restraint, and why the facility policy and procedure were not followed in documentation of a chemical restraint. Staff #62 stated, "I can see we need to relook at all of this and do some education." Staff #62 confirmed they had taken a coarse online for de-escalation but was not aware of any chemical restraint training. Staff #62 confirmed at the yearly education fair they are trained on physical restraints.

An interview with staff #61 Security Guard on 12/29/17 revealed she was one of 3 fulltime security guards. Staff #61 stated that there is also 3 part time guards to help with the schedule. Staff #61 stated that she was told by the hospitals consultant management company that the guards are not to touch a patient. Staff #61 stated, "We can go to the ED and talk to the patient but we are not allowed to assist the staff. We have to call the police to come handle that." Staff #61 confirmed that the City PD or Sheriff Department gets called if a patient become out of control or violent. The police can then come in and put the patient in handcuffs or in the seclusion room. Staff #61 confirmed that she was not aware if a patient was under arrest or not when a police officer uses cuffs. Staff #61 stated, "I know they come often and we try to talk to the patients but sometimes they are acting out so bad they have to be restrained." Staff #61 confirmed the police department officers are not employees of the hospital.

An interview with staff #7, Quality Assurance Performance Improvement (QAPI) Director, and #1, CNO, was conducted on 12-29-17. Staff #7 confirmed that she was not logging chemical restraints and had not been monitoring them. Staff #7 offered a restraint log that had 3 inpatients on it from October-December of 2017 for physical restraints. Staff #7 confirmed that there had been more than 3 inpatient physical restraints when we went over the auditing sheets. Staff #7 had not been gathering data or monitoring any restraints in the ED. Staff #7 stated, "We have been looking over the materials like the policy and procedures we had when we had a geri psych unit, trying to see if it would help us with restraints. Restraints just have not been covered for the ED at all. No one has monitored these pts for safety. That's something I have to fix." Staff #1 stated, "Yes, we have to fix that."



Review of patient #36's chart revealed the patient was a 29 year old male brought to the ED on 12-13-17 by EMS and the Nacogdoches County Sheriff Department (SO). The patient was registered as a "Self Pay" patient and not as a forensic patient.

The EMS report dated 12-13-17 reported the Sheriff Deputy was with the patient when they arrived. "The patient had been found running around naked in someone's back yard. Pt is AAOx4 but has times of what appears to be drug induced psychosis. Pt was saying that he sprayed a chemical that he uses to cook meth, into his milk. Pt show's signs of aggressiveness at times. Pts cuffs moved to the front and left in place for crew safety." The patient refused to allow any treatment just vital signs. The NSO followed the patient to the hospital with a police officer's warrant for treatment and detainment at the hospital. EMS documented that the patient has a history of "traumatic brain trauma, drug abuse."

Review of the Nurses Initial Assessment Note on 12-13-17 at 10:58AM stated, "Psychiatric complaint. Associated symptoms: mania, Delusion, Agitation, and pt is speaking to no one but it is hard to tell who? Pt states he has done Meth and believes someone has given him a lot of drugs, but states he doesn't know exactly what he was given, believes he "Is on a lot of meth right now" states " I am speeding like you would not believe right now.

Behavior Details;
Delusion and Hallucinating
Naked
Uncooperative and Suspicious
Agitated, Inappropriate, Interfering with Medical Treatment or Device and Verbally Abusive.
Insight poor
Judgment Impaired."

Review of the Nurses Notes dated 12-13-17 revealed the following;

"10:30AM- Pt refused xray and is demanding water.

10:32AM- Pt ripping monitors at this time, NSO at bedside at this time.

10:42AM- Pt refused lab draw, NSO at bedside witnessed.

10:44AM 2 cups of water given to this pt and he is still refusing blood draw at this time."

Food and water was given to the patient and he gave a urine sample. There was no documentation if the patient was still handcuffed or if the patient was given any clothes.

"11:28AM- Pt is moved to the psych room per ___RN and ___RN at this time

11:40AM- Tray given to pt, pt is also being very aggressive at this time both physically and verbally towards staff members and police.

1:38PM- Pt is up on bed and is jumping on the bed slamming against the window punching and kicking, Geodon administered via staff #62 and pt is screaming" Give me the dope ohh yea" when the Geodon was being administered pt was very aggressive towards staff and possibility for injuring himself."

There was no documentation of an assessment after the chemical restraint was given. There was no documentation of the incident, need for a chemical restraint, or if the physician did a face to face for a restraint. There was no found documentation of the event in the Physician Notes. There was no documentation found if the patient was still in handcuffs or what action the officer took. There was no documentation of de-escalation techniques used or other forms of restraint before going to a chemical restraint.

Review of the Physician Orders revealed a verbal order for "ZIPRASIDONE (GEODON) 20MG Intramuscular ONE TIME STAT for 1 Doses." Dated 12-13-17 at 11:34AM. However, the medication was not administered until 1:38PM. There is no documentation on why a stat order for a chemical restraint was delayed for 2 hours.

Review of patient #36's chart revealed the mental health authority had interviewed the patient and was recommending psychiatric inpatient care. The patient's chest xray was obtained. The pt was offered a food tray and was eating at 5:40PM. At 6:53 report was given to another nurse and he resumed pt care.

"7:10PM- Pt combative, insisting that one of the staff members wanted him to go home with her. Flips stretcher in room while still handcuffed. Extremely violent. Geodon ordered and administered. Pt is finally compliant with blood draw. Cont. to monitor."

There was no prior documentation of the patient in handcuffs. There was no documentation if the patient was assessed for injuries after flipping a stretcher over while still handcuffed. There was no found documentation in the physician notes of this incident and if he evaluated the patient for injuries.

The order for Geodon was a verbal order and was not ordered until 7:23PM, 13 minutes after the administration. It was not signed by the physician until 8:32PM, 1 hour and 22 minutes after administration. There was no further documentation found on any physical restraints used or assessment of administration of a chemical restraint.

The patient had vital signs documented on 12-13-17 at 2:30PM, 6:30PM, 11:00PM. On 12-14-17 at 2:00AM, 7:04AM, 11:15AM, and 1:50PM. The patient was transported to an inpatient facility on 12-14-17 at 2:02PM.

Review of the incident report log revealed there was no incident report logged for patient #36. There was no found documentation that an incident report was completed but not logged. Staff #7 confirmed there was no incident report filed for patient #36.



Review of the Facility's policy and procedures titled "RESTRAINTS" stated, "All patients have the right to be free from restraint or seclusion of any form, and Nacogdoches Memorial Hospital strives to be restraint free. Restraints will be used only if needed to improve the patient's well- being when less restrictive interventions have been determined to be ineffective. All efforts will be undertaken to calm or redirect the patient before the use of restraints, or seclusion and the minimum amount of restraint necessary to address the problem will be applied. Restraints or Seclusion will never be used as a means of coercion, discipline, convenience, or staff retaliation. Seclusion will be used only as a last resort for management of violent or self-destructive behavior that immediately jeopardizes the physical safety of the patient, staff, or others. All restraints and seclusion, regardless of type or reason for application, will be discontinued at the earliest possible time.

Methods of Restraint;
Chemical Restraint- A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition.
Types of Restraint;
a. Non-Violent/Non-Self-Destructive Restraint
i. Can be either a physical or a chemical restraint.
b. Violent/Self Destructive restraint
i. Can be either a physical or a chemical restraint.
c. Forensic Restraint
i. Any restraint applied to a patient who is in the custody of law enforcement officers is the responsibility of that law enforcement agency and is not the responsibility of Nacogdoches Memorial Hospital. In those cases, an officer will be in constant attendance with the patient.
ii. Unless the patient is in law enforcement custody (under arrest), he or she is the responsibility of Nacogdoches Memorial, and law enforcement personnel will not be permitted to restrain or seclude the patient."

Based on observation,interviews, and record reviews, the facility failed to meet the Condition of Participation for Quality Assurance and Performance Improvement (QAPI) as evidence by:

The Governing Board Bylaws failed to specify the frequency and detail of Quality Assessment Performance Improvement (QAPI) data collection.

Refer to Tag A0273



QAPI failed to gather data, track for adverse patient events, and implement preventative actions for restraints used in the Emergency Department in 2 of 2 (35 and 36) charts reviewed.

QAPI failed to have clear expectations for safety established from adverse patient events and no preventative actions implemented. Patient #36 did not have a sentinel event documented for turning a stretcher over while handcuffed to the bed and receiving a chemical restraint. A technologist failed to follow Positron Emission Tomography/Computed Tomography (PET/CT) policies and allowed a patient who had received nuclear isotopes, to use a public hospital restroom with no incident reports or follow through from QAPI.

Refer to Tag A0286

Based on record review and interview, the Governing Body failed to specify the frequency and detail of Quality Assessment Performance Improvement (QAPI) data collection.

Review of the Board of Directors Bylaws revealed there was no mention of QAPI or the expectations of the program scope or data collection.

Interview with staff #7 on 12-29-17 reveled there was a sub-committee looking at the QAPI data. However, the facility did not have any Governing Board Minutes that approved a sub committee for QAPI oversight and failed to offer any policies that specified the expectations of the program scope or data collection.

Based on observation,interviews, and record reviews, the Quality Assessment Performance Improvement (QAPI) failed to:

QAPI failed to gather data, track for adverse patient events, and implement preventative actions for restraints used in the Emergency Department in 2 of 2(35 and 36) charts reviewed.

QAPI failed to have clear expectations for safety established from adverse patient events and no preventative actions implemented. Patient #36 did not have a sentinel event documented for turning a stretcher over while handcuffed to the bed and receiving a chemical restraint. A technologist not familiar with our PET/CT Policies allowed a patient to use a public hospital restroom with no incident reports or follow through from QAPI.

Review of the "Performance Improvement Patient Safety/Patient Care Services Committee Meeting Minutes" for September 12th, October 10th, November 14th, and December 12th, 2017 revealed there was no data for Emergency Department (ED) patient restraints. Meeting minutes from September- December 2017 stated, "ER Restraints will be added." There was no ER restraint data found.

Review or patient #36 Physician Orders revealed a verbal order for "ZIPRASIDONE (GEODON) 20MG Intramuscular ONE TIME STAT for 1 Doses." Dated 12-13-17 at 11:34AM. However, the medication was not administered until 1:38PM. There is no documentation on why a stat order for a chemical restraint was delayed for 2 hours. Nursing failed to follow facility policy and procedures and document on the administration of the drug as a restraint.

There was no documentation of an assessment after the chemical restraint was given. There was no documentation of the incident or need for a chemical restraint or if the physician did a face to face for a restraint. There was no found documentation of the event in the Physician Notes. There was no documentation of de-escalation techniques used or other forms of restraint before going to a chemical restraint.

Review of patient #35's chart revealed on "12-13-17 at 7:10PM- Pt combative, insisting that one of the staff members wanted him to go home with her. Flips stretcher in room while still handcuffed. Extremely violent. Geodon ordered and administered. Pt is finally compliant with blood draw. Cont. to monitor." There was no prior documentation of the patient in handcuffs. There was no documentation if the patient was assessed after flipping a stretcher over while still handcuffed. There was no found documentation in the physician notes of this incident and if he evaluated the patient for injuries. There was no found incident report. Staff #1 nor #7 had any knowledge of the incident.

Review of the "Performance Improvement Patient Safety/Patient Care Service Committee Meeting" minutes From September 12, 2017- December 2017. Review of each monthly meeting minutes under "follow up" stated, "ER restraints will be added."

An interview with staff #7 Quality Assurance Performance Improvement (QAPI) Director and #1 CNO was conducted on 12-29-17. Staff #7 confirmed that she was not logging chemical restraints and had not been monitoring them. Staff #7 offered a restraint log that had 3 inpatients on it from October-December, 2017 for physical restraints. Staff #7 confirmed that there had been more than 3 inpatient physical restraints when we went over the auditing sheets. Staff #7 had not been gathering data or monitoring any restraints in the ED. Staff #7 stated, "We have been looking over the materials like the policy and procedures we had when we had a geri psych unit, trying to see if it would help us with restraints. Restraints just have not been covered for the ED at all. No one has monitored these pts for safety. That's something I have to fix." Staff #1 stated, "Yes, we have to fix that."


29762


A review of a document titled Radiation Safety Officer Monthly Audit revealed on 2/9/2017 a back-up PET technologist not familiar with PET/CT Policies allowed a patient to use a public hospital restroom. Survey and wipe test performed. The PET company (a contracted service) was notified.

Positron emission tomography (PET) is a test that uses small amounts of radioactive materials. In addition to the radioactive decay, the remaining radiopharmaceutical is eliminated from the body through urine.
No further follow-up was provided by the facility. No incident report was presented by the facility after multiple requests.

A review of the document titled PATIENT SAFETY & RISK MANAGEMENT
PROGRAM revealed:
AUTHORITY, ACCOUNTABILITY AND STRUCTURE OVERVIEW:

The Board of Directors:
The governing body sets expectations and provides oversight for development of patient safety and risk management activities across the system. Oversight is carried out by delegating to the Performance Improvement & Patient Safety/Patient Care Services (PIPS/PCS) Committee and
Environment of Care (E0C) Committee the authority to receive reports related to patient care delivery, patient safety and risk management activities.

...each relevant program, service, site, or department (including contract services) participate collaboratively in patient safety and risk management activities.

Scope of Patient Safety/Risk Management Service:
Identification of Safety Concerns:
Concerns identified through Incident reporting ...

An interview with staff #74 revealed an incident report was not completed regarding the above incident.

Based on observation, review of record, and interview, the facility failed to the Condition of Participation for nursing services as evidenced by the failure to ensure nursing staff:

A. administered intravenous (IV) medications using aseptic (free from contamination) technique in 1 (Patient #43) of 3 IV medication administrations observed.

B. followed policy for ensuring informed consent for blood transfusions were present prior to administering blood products in 7 out of 7 patients reviewed (Patient #'s 9, 10, 11, 12, 13, 17, and 18).

C. followed policy for assessing vital signs during blood transfusion in 2 patients (Patient #9 and #12) out of 7 reviewed.

D. verified complete orders for titrating medications were present for 1 patient (Patient #18) out 3 reviewed.

IV medications and blood products were not administered and/or monitored in a safe manner and/or consistent with hospital policy.

See Tag A0409

Based on observation, review of records, and interview, the facility failed to ensure nursing staff:

A. administered intravenous (IV) medications using aseptic (free from contamination) technique in 1 (Patient #43) of 3 IV medication administrations observed.

B. followed policy for ensuring informed consent for blood transfusions were present prior to administering blood products in 7 out of 7 patients reviewed (Patient #'s 9, 10, 11, 12, 13, 17, and 18).

C. followed policy for assessing vital signs during blood transfusion in 2 patients (Patient #9 and #12) out of 7 reviewed.

D. verified complete orders for titrating medications were present for 1 patient (Patient #18) out 3 reviewed.

Findings were as follows:

A. On the morning of 12-28-2017 Staff #23 was observed during the administration of IV medication to Patient #43. Staff #23 was observed to remove the plastic cover of the medication vial, wipe the vial top with an alcohol wipe, and then hold the cleaned vial in his closed fist while placing the needle tip on the syringe. He then took the medication vial from his closed fist and accessed the medication vial with the syringe without cleaning the top again.

Staff #23 confirmed that he held the vial in his closed fist. Staff #23 responded, "But I didn't touch the top".

Review of the Association for Professionals in Infection Control and Epidemiology (APIC) Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Healthcare from July 30, 2009 was as follows:

"The transmission of bloodborne (sic) viruses and other microbial pathogens to patients during routine healthcare procedures continues to occur due to unsafe and improper injection, infusion and medication vial practices being used by healthcare professionals within various clinical settings throughout the United States.

Breaches in safe injection, infusion and medication vial handling practices continue to result in unacceptable and devastating events for patients.
...

APIC strongly supports adherence to the following safe injection, infusion and medication vial practices.

Aseptic Technique
Perform hand hygiene prior to accessing supplies, handling vials and IV solutions, and preparing or administering medications.

Use aseptic technique in all aspects of parenteral medication administration, medication vial use, injections and glucose monitoring procedures.

Store and prepare medications and supplies in a clean area on a clean surface."

http://www.ascquality.org/Library/safeinjectionpracticestoolkit/Safe%20Injection%20Infusion%20and%20Medication%20Vial%20Practices%20in%20Healthcare%20(APIC).pdf

B. Review of charts for blood administration revealed the following:

Patient #9

Patient #9 was a 48 year old male with Stage IV multiple myeloma (cancer that has spread to other areas of the body). He was sent to the emergency department by his physician on 12-12-2017 due to a high temperature. During the emergency department work-up, he was also found to have a low hemoglobin (hgb) of 5.3 (part of the red blood cell that carries oxygen to the body). The patient was admitted for intravenous antibiotics and blood transfusion.

On 12-12-17 at 10:25 pm, the patient signed a consent for blood transfusion. The consent for blood transfusion was located on the chart. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed by the physician prior to the transfusion.

Patient #10

Patient #10 was a 90 year old male brought to the emergency department from the nursing home with severe shortness of breath. He was admitted to the hospital on 12-11-2017. During the course of his stay, he required a blood transfusion.

On 12-15-2017 the patient's grand-daughter signed a consent for blood transfusion. The consent for blood transfusion was located on the chart. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed by the physician prior to the transfusion.



Patient #11

Patient #11 was a 48 year old female with a history of multiple medical conditions who went to the emergency department with chest pain. She was found to have pneumonia and sepsis. She was admitted on 12-20-2017 to the Intensive Care Unit.

Review of the chart showed that the patient received a blood transfusion on 12-21-2017. A consent for blood transfusion was located on the chart. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed by the physician prior to the transfusion.

Patient #12

Patient #12 was a 22 year old female who had a normal spontaneous vaginal delivery on 12-21-2017. "The patient experienced normal blood loss at delivery, but hgb dropped to 5.6 and patient became symptomatic." On 12-22-2017, the physician ordered two units of blood.

A consent for blood transfusion was located on the chart. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed by the physician prior to the transfusion.

Patient #13

Patient #13 was a 68 year old male with multiple medical conditions to include gastro-intestinal (GI) bleeding, low blood sugar, myocardial infarction (MI - heart attack), and wound infections. Patient #13 required blood transfusions on three separate dates. Consents were found for each occurrence.

Consents for 12/19/2017, 12/23/2017 and 12/28/2017 were blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed by the physician prior to the transfusion on consents for 12/23/2017 and 12/28/2017.

Patient #17

Patient #17 was an 88 year old male. He was sent from the nursing home due to abnormal lab results requiring blood transfusion on 11-24-2017.

A consent for blood transfusion was located on the chart. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed prior to the transfusion. The consent had been electronically signed by the physician on 11-30-2017 at 7:57 pm, six days after the blood transfusion was completed.

Patient #18

Patient #18 was an 88 year old male from an assisted living center. He was admitted due to an altered mental status and suspected urinary tract infection. He was found to have rectal bleeding requiring further testing and blood transfusion. During his stay, he started having breathing difficulty, requiring intubation (a tube placed in his airway) and ventilation (a machine to support breathing). He was transferred to the Intensive Care Unit (ICU).


Review of the chart showed that the patient received a blood transfusion on 12-25-2017. A consent for blood transfusion was located on the chart. The consent was blank under the section "Risks as discussed by physician."

The statement "I have explained the risks, benefits, and potential complications associated with procedures to the patient and/or guardian. Alternative options have been considered." had a signature block for the physician's signature. The statement had not been signed prior to the transfusion.

Review of the Medical Staff Rules and Regulations, Article V, Patient Rights, Section 5.2 Informed Consent, was as follows:

"It is the responsibility of the practitioner performing the procedure, or his/her partner, to perform the informed consent process and obtain informed consent from the patient according to hospital policy."

Review of hospital policy Reference #1026, Subject: Blood/Blood Components-Transfusion, Effective: July 1, 2017, Page: 2, Item II. Obtaining or Confirming Informed Consent, was as follows:

"a. Confirm that a signed and witnessed informed consent is in the patient chart.
b. If informed consent is unavailable, contact the provider to obtain consent before proceeding."


C. Review of charts for blood administration revealed the following:

Patient #9

Patient #9 was a 48 year old male with Stage IV multiple myeloma (cancer that has spread to other areas of the body). He was sent to the emergency department by his physician on 12-12-2017 due to a high temperature. During the emergency department work-up, he was also found to have a low hemoglobin of 5.3 (part of the red blood cell that carries oxygen to the body). The patient was admitted for intravenous antibiotics and blood transfusion.

Patient vital signs were documented on the transfusion record and in the chart prior to the transfusion. The transfusion began at 05:55 a.m. Vital signs due at 7:55 a.m. were not documented. The transfusion ended at 08:00 a.m.

Patient #17

88 year old male from nursing home. Was sent from NH with HGB 6.9 for blood transfusion on 11-24-2017.

Chart review was completed.

Patient vital signs were documented on the transfusion record and in the chart prior to the transfusion. The transfusion began at 12:50 p.m. Vital signs were again documented at 1:05 p.m., 1:20 p.m., 2:50 p.m., and 3:50 p.m.

Vitals signs were not found for 4:50 p.m. The transfusion ended at 4:55 p.m. Vital signs for 1 hour post-transfusion were missing. Patient discharged from the emergency room at 5:50. Discharge vital signs were not documented.

Review of policy Subject: Blood/Blood Components - Transfusion, Reference #1026, Effective: July 1, 2017, Page 5 of 12, was as follows:

"VII. Administering the blood:

....

i. Monitor and record vital signs (T, P, R and BP), and assess signs and symptoms of transfusion reaction:
i. (sic) Adult patient should be monitored using the following:
1. Prior to transfusion
2. 15 minutes from the transfusion start time
3. 30 minutes from the transfusion start time
4. 1 hour from the transfusion start time
5. Every hour thereafter until transfusion is complete
6. 1 hour after transfusion end time (last set of vital signs)"



D. Review of Patient #18 revealed that the patient was mechanically ventilated in the Intensive Care Unit. The patient was sedated with Diprivan, and required Levophed to support his low blood pressure. Review of the orders for titrating (adjusting the medication up or down based on set criteria and clinical outcome endpoints) these medications revealed the physician had not included the clinical outcome endpoints that were desired to be achieved with the titrations.

Interview was conducted with Staff #4 on 12-28-2017. Staff #4 confirmed that the desired clinical outcome endpoints were not present in the order.

Interview was conducted with Staff #68 on 12-28-2017, the nurse caring for the patient. Staff #68 was asked to explain how the Diprivan was being titrated for sedation since it wasn't included in the order. Staff #68 explained that Richmond Agitation Sedation Scale (RASS) was used to determine how sedated a patient was. Staff #68 stated that as long as patients weren't pulling lines and the endotracheal tube (ET tube is placed in patient airway and connected to ventilator), nurses used their nursing judgement as to what level of sedation the patient needed to be.

Review of the policy Title: Titrate and Taper Medication Orders, Policy Number: 4.05, Effective Date: August 2017, Page 1 of 2 and attachments were as follows:

"Procedure
Titration Orders
Medication order for titratable drips/infusions need to follow the guidelines as outlined in the Standard Drips and Titration table. This table includes the following elements:
Starting dose
Maximum dose (if appropriate)
Dosing increment by which to adjust
Clinical outcome endpoint(s)/parameter(s) used to determine dosage adjustment needs (e.g. blood pressure, blood glucose, etc.)

Orders for titrating medications that do not contain the components listed above are clarified with the prescriber."

"Standard Drips: Titration and Taper Guidelines
These guidelines are to be used for titration and/or taper of standard drips commonly used in our critical care population"

Diprivan was not listed on this table.
Levophed was listed with the Titration/Monitoring Parameters of "Titrate to maintain SBP (systolic blood pressure)>90mmHg (millimeters of mercury) or SBP ___ mmHg"

Based on review of records and interview, pharmacy staff failed to ensure incomplete medication orders for titrated medications were clarified with the physician prior to dispensing medication for 1 patient (Patient #18) of 3 reviewed.

Review of Patient #18 revealed that the patient was mechanically ventilated in the Intensive Care Unit. The patient was sedated with Diprivan, and required Levophed to support his low blood pressure. Review of the orders for titrating (adjusting the medication up or down based on set criteria and clinical outcome endpoints) these medications revealed the physician had not included the clinical outcome endpoints that were desired to be achieved with the titrations.

Interview was conducted with Staff #4 on 12-28-2017. Staff #4 confirmed that the desired clinical outcome endpoints were not present in the order.

Interview with the Pharmacy Director was conducted. The Pharmacy Director stated that the pharmacists do not review for the desired clinical outcome endpoints when reviewing orders for completeness.

Review of the policy Title: Titrate and Taper Medication Orders, Policy Number: 4.05, Effective Date: August 2017, Page 1 of 2 and attachments were as follows:

"Procedure
Titration Orders
Medication order for titratable drips/infusions need to follow the guidelines as outlined in the Standard Drips and Titration table. This table includes the following elements:
Starting dose
Maximum dose (if appropriate)
Dosing increment by which to adjust
Clinical outcome endpoint(s)/parameter(s) used to determine dosage adjustment needs (e.g. blood pressure, blood glucose, etc.)

Orders for titrating medications that do not contain the components listed above are clarified with the prescriber."

"Standard Drips: Titration and Taper Guidelines
These guidelines are to be used for titration and/or taper of standard drips commonly used in our critical care population"

Diprivan was not listed on this table.
Levophed was listed with the Titration/Monitoring Parameters of "Titrate to maintain SBP (systolic blood pressure)>90mmHg (millimeters of mercury) or SBP ___ mmHg"

Based on observation, record review, and interview, the hospital failed to meet the Condition of Participation for Infection Control as evidence by:

The facility failed to:

A. follow the policy, INFECTION RISK ASSESSMENT. There was no evidence of input from medical staff, nursing and leadership, in developing a risk assessment to identify infection risks for this organization.
The risk assessment provided by the facility failed to use the required criteria set in the policy.
There was no evidence of analysis of surveillance activities and other infection prevention and control data required to develop a risk assessment.

Refer to tag A 0748


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B. provide a sanitary environment and have an active program for preventing infections.

This deficient practice was found in 12 of the hospital departments and 1 outside storage/containment area. Dialysis, Surgery, Respiratory, Laboratory, Gastrointestinal Department (endoscope reprocessing room), Labor and Delivery, Intensive Care Unit, Kitchen, Emergency, Pharmacy, Physical Therapy, Rehabilitation, and Biohazard containment/storage area.


1.) Failing to ensure the acute dialysis unit was clean and sanitary by not allowing cardboard boxes in patient care areas, dust on the shelves, cleaning of dialysis equipment, staff following good handwashing technique, and following standard infection control guideline when caring for a central line catheter.


2.) Failing to keep the Steris machine clean of the slime water that was used to wash scopes in the surgical department.


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3.) Failing to ensure a surgical hinged instrument (hemostat) was sterilized in an open position in the Respiratory department. The facility failed to ensure ultrasound gel was refilled in containers and dated according to manufacturer guidelines in the respiratory department.


4.) Failing to ensure Cidex OPA test strips were dated with the open for use date and the discard date according to manufacturer's guidelines in the Endoscopic processing room. Staff used the testing strips 27 days past the date they were supposed to be discarded. The facility failed to ensure the Transesophageal Echo (TEE) scope was washed in a clean and sanitized basin.


5.) Failing to ensure supplies were removed from cardboard boxes prior to being stored in the laboratory department.



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6.) Failing to ensure the outside Biohazard room was kept secured from employee cross contamination within the hospital and scavenger cross contamination in the surrounding community.


7.) Failed to ensure the Rehabilitation and Physical Therapy departments followed the manufacturer's recommendation for every two week cleaning of the warm water in the Hydroculator, used to warm the moist heat packs, for patient use in rehabilitation and therapy services.


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8.) Failed to ensure the Dietary department maintained sanitary conditions in food preparation areas and dated food appropriately.

9.) Failed to ensure Pharmacy maintained sanitary conditions by allowing food preparation and consumption in a drug storage/preparation area and maintain sanitary conditions in the compounding hood area. Also, the cleanliness in the medication storage units of the Emergency Department (ED) and Intensive Care Unit (ICU).

10.) Failed to ensure the Out Patient Rehabilitation Unit maintained a sanitary environment in patient rooms, for patient equipment, and the gym area.



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11.) Failing to ensure that equipment, beds, and instruments were in good repair and/or stored in a manner that ensured they were sanitary for use in the ICU and L&D.

12.) Failing to ensure that patient rooms were clean and free of heavy buildup of dirt and dust in the ICU.


Refer to tag A 0749 for additional information.

Based on document review and interview the facility failed to follow the policy, INFECTION RISK ASSESSMENT. There was no evidence of input from medical staff, nursing and leadership, in developing a risk assessment to identify infection risks for this organization.
The risk assessment provided by the facility failed to use the required criteria set in the policy.
There was no evidence of analysis of surveillance activities and other infection prevention and control data required to develop a risk assessment.

A review of the document titled Infection Prevention / Control Department Plan / Risk Assessment / Appraisal revealed the year 2017 marked out and 2018 hand written in. The document did not include the required elements set forth in the policy:
Hospital care, treatment and services offered, including demographics, such as:
Number of beds
Number of physicians
Number of employees
Occupancy rates
Number of Emergency Department visits annually
Number of inpatient admissions annually
Number of outpatient visits annually
Hospital location, noting geographical locations that may contribute to infection
prevention and control issues.
Community served
Population served (age, high-risk populations, etc.)
There was no evidence the required analysis of surveillance activities and other infection prevention and control data, such as the following (not all inclusive):
Number of gram negative infections
Number of gram positive infections
Number of fungal infections
Number of urinary tract infections
Number of device related infections
Number of central-line associated bloodstream infections
Number of surgical site infections
Occurrences of ventilator-associated pneumonia
Occurrences of MRSA
Occurrences of VRE
Occurrences of Clostridium difficile
Employee health data
Monitoring of infection control processes, i.e., hand hygiene compliance,
central line bundle compliance.


A review of the policy titled INFECTION RISK ASSESSMENT revealed:
Infection risk assessment shall be conducted annually and whenever significant changes in
the organization occur,
The Infection Prevention and Control Committee and the Infection Prevention and Control
Nurse, with input from medical staff, nursing and leadership, shall perform a risk
assessment to identify infection risks for this organization.
The risk assessment shall include:
Hospital care, treatment and services offered, including demographics, such as:
Number of beds
Number of physicians
Number of employees
Occupancy rates
Number of Emergency Department visits annually
Number of inpatient admissions annually
Number of outpatient visits annually
Hospital location, noting geographical locations that may contribute to infection
prevention and control issues.
Community served
Population served (age, high-risk populations, etc.)
Analysis of surveillance activities and other infection prevention and control data,
such as the following (not all inclusive):
Number of gram negative infections
Number of gram positive infections
Number of fungal infections
Number of urinary tract infections
Number of device related infections
Number of central-line associated bloodstream infections
Number of surgical site infections
Occurrences of ventilator-associated pneumonia
Occurrences of MRSA
Occurrences of VRE
Occurrences of Clostridium difficile
Employee health data
Monitoring of infection control processes, i.e., hand hygiene compliance,
central line bundle compliance.

The organization's surveillance data shall be compared to existing data-bases, such
as the NHSN.

An interview on 12/29/2017 at approximately 10:00am with staff #7 revealed the facility had been without an Infection Prevention and Control Nurse. The interview confirmed the above findings.

Based on observation, record review, and interview, the facility failed to provide a sanitary environment to avoid transmission of infections and communicable diseases and the facility failed to have a program that included all departments in order to prevent the spread of infections. This deficient practice was found in 12 of the hospital departments and 1 outside storage/containment area. Dialysis, Surgery, Respiratory, Laboratory, Gastrointestinal Department (endoscope reprocessing room), Labor and Delivery, Intensive Care Unit, Kitchen, Pharmacy, Physical Therapy, Emergency, Rehabilitation, and Biohazard containment/storage area.

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


Findings include:


Dialysis:

During a tour of the acute dialysis unit on 12/27/17 in the morning and afternoon observed the following infection control issues:

1. The dialysis machine was used on a nursing unit at the patient's bedside. The machine was brought back to the unit before it was disinfected. A patient was receiving a dialysis treatment in the unit. On the back of the machine was an open plastic container with extra dialysis supplies. The container had been in the patient's room. Also, noted that there was a splash of blood on the back of the machine beside the plastic container of supplies. The supplies had the likelihood to be contaminated from the splash marks and the supplies had been exposed the contaminants in the patient's room.

2. On a cart in the acute unit observed several cardboard boxes broken down near the patient receiving a dialysis treatment. The cart was dirty with rust spots.

"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." (AAM1 ST46-Section 5.2 Receiving items).

3. The shelf holding the dialysis supplies was covered in dust particles.

4. The cabinet door hinge was broken and door was falling off the cabinet that was storing the packages of potassium chloride and sterile dialysis supplies.

5. Observed 5 plastic bags of trash piled on the floor of the acute unit.

6. Observed staff #34 treating a patient with a central line catheter. The nurse wore her mask during the dressing change and then pulled the mask down under her chin. When staff #34 was ready to treat the next patient she pulled the mask up and used on the second patient. Staff #34 never changed her mask.

7. Staff #34 took the "pHoenix meter" in the storage area and rinsed the meter, but never disinfected the meter.

8. Staff #34 has long hair and while changing the central line dressing observed her hair falling into the dressing site area and her hair was touching the sheets of the bed. The deficient practice had the likelihood to contaminate the sterile dressing site.

9. Staff #34 ask the Bio-med Technician to help her get a safe site cap off the central line port. The bio-med Technician put gloves on without washing his hands and loosed the cap. The bio-med technician never washed his hands prior to putting on gloves or taking off gloves.

10. Observed that the dialyzers 180 were placed in the 160 dialyzer's 160 plastic container. This deficient practice had the likelihood to cause a wrong dialyzer to place on a patient.

11. There was an acid jug of concentrate that had been spiked with additives left from the day before by Staff #53. The normal routine of the nursing staff was if the acid solution was not completely used leave the solution for the next day to be used. This deficient practice had the likelihood for a nurse to give an additive that another nurse had spiked not knowing if the procedure had been done by per the policy.

An interview with Staff #4 on 12/27/17 in morning and afternoon confirmed the above findings during the tour of the facility.

Surgery:

During a tour of the surgical department on 12/28/17 at 11:15 observed the following infection control issue:

While on tour observed a Steris machine in the sterilization room. Surveyor lifted the wash basin that holds the scopes during wash time and observed about 3 inches of slime water beneath the basin. The anesthesia technician was not aware that the Steris basin does not drain properly and water will stay beneath the basin unless manually dried out.

A hemostat was found in the bottom drawer of the crash cart located in the recovery department. There was no date on the peel pack to determine when the hemostat had been sterilized. Staff #69 confirmed the observation.


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Respiratory department:

During an observation on 12/27/2017 after 2:20 p.m. the following was found:

A closed hemostat was found in the bottom drawer of the crash cart located in the respiratory department. The hemostat had been sterilized closed. Staff #29 confirmed the observation.

According to the The Centers for Disease Control and Prevention (CDC) article, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, by William A. Rutala. Ph.D... M.P.H... David J. Weber. M.D...M.P.I-I., and the Healthcare Infection Control Practices Advisory Committee (HICPAC), found at: http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_ Nov_ 2008.pdf, states on page 74 that hinged instruments and instruments that close should be opened during the process of sterilization.


A bulk container of ultrasound gel was found in the procedure room and had no open date. There were three syringes in a zip lock bag that were not labeled with the product name on the syringe and were not dated with a fill date. Staff #29 confirmed the finding.

Review of Hospital policy dated 11/29/2017 "Use of Ultrasound Gel Products" revealed the following:

"PROCEDURE:
Once a container of sterile or nonsterile gel is opened, it is no longer sterile and contamination during ongoing use is possible.

Nonsterile Gel
"Fill bottles by using a dispensing device on the large bulk container, not by inserting the tip of the refillable bottles into the bulk container to aspirate the contents.
"Refill bottles as close as possible to the time of use.."

An interview with Staff #29 revealed that the Respiratory Department was refilling syringes with Medline Ultrasound Gel to carry to the patient's bedside for procedures. Staff #29 confirmed the department did not label the syringe or log open date on syringes.

Review of the product manufacturer's "CERTIFICATE OF SHELF LIFE" dated September 11, 2017 revealed:

"If the bottle has been refilled, it should be marked with a shelf life of 30 days. Preservative efficacy testing per USP <51> has been performed on this product to confirm that after refilling, there is no bacterial growth for 30 days. "

Interview with manufacturer representative #72 confirmed the shelf-life of ultrasound gel was 30 days.


Gastrointestinal Lab (endoscope processing room)


During an observation on 12/27/2017 after 2:45 p.m., Cidex test strips were found in a drawer underneath the Transesophageal Echo (TEE) scope decontamination container. The test strips had an open date recorded of 8-30-2017. There was no discard date recorded on the test strip bottle. The bottle of strips expired on November 30, 2017 (27 days ago). An interview with Staff #29 confirmed the respiratory department uses the expiration date on the bottle per manufacturer.

Review of the manufactures guidelines "Cidex OPA IFU, Ethicon US,LLC 2014" revealed the following:

"Discard any unused test strips Ninety (90) days after the bottle is originally opened."


During an observation on 12/28/2017 after 3:00 p.m., in the Scope decontamination room a basin used to process TEE probes was found with a build-up of yellow debris in the bottom and sides of the basin. There was dirt and dust in crevices of the container. Staff #70 confirmed the observation.

Review of the Cidex OPA log showed the Cidex solution had been changed 12/27/2017. Staff changed the solution and failed to clean the basin.


Laboratory:

During an observation in laboratory on 12/28/2017 after 8:00 a.m., cardboard boxes supplies found in two areas.

In the chute room a cardboard box was found on top of the cabinet. The box contained Intravenous catheters (IV).

In the supply room cardboard boxes of syringes and injection needles were found stored on the shelves with other laboratory supplies.

"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." (AAM1 ST46-Section 5.2 Receiving items).

Staff #71 confirmed the finding.


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Biohazard storage:

On 12/28/2017 in the afternoon during a tour of the outside plant operations areas, the biohazard containment room was observed to be unlocked. Upon entrance into the biohazard room a strong smell of cigarette smoke was present. The Director of Plant Operations was present and asked to step into the room. He confirmed the strong smell of cigarette smoke which indicated a staff member had recently used the biohazard room to smoke. Multiple boxes of biohazard material, awaiting pick up by the contracted biohazard disposal company, was present in the room. The biohazard material was accessible to any staff member or scavenger as the door was not securely closed or locked.

This represented a potential for cross contamination of staff who were using the biohazard room for smoking as well as provided a potential for scavenger to come in contact with the biohazard material and spread the contaminants to the community.


Rehabilitation /Physical Therapy:

On 12/29/2017 a tour of the Physical Therapy Department and the Rehabilitation Department revealed the department policies for the cleaning the Hydroculator (Warm water containment system for moist heat packs) indicated the water should be changed once a month. However, the manufacturer's recommendation was to change the water every 2 weeks, and to keep the packs completely submerge in the warm water between cleanings to insure sanitation.

On 12/29/2017 in the morning an interview with the manager of the Physical Therapy Department confirmed the documentation provided by both departments indicated the warm water was changed once a month in the Hydroculator. The manufacturer's instruction was read together and she confirmed the instruction indicated changing the water every two weeks. Her department and the Rehabilitation department had been following the hospitals' policy which no longer complied with the manufacturers recommendations. See below.

https://www.rehabmart.com/pdfs/22180e.pdf, Regularly clean and drain the tank (every two weeks). Failure to properly maintain the unit will cause premature wear and will void the warranty.


The Infection Control program failed to identify the potential risk to patients related to the use of the outdated sanitation policy which no longer adhered to the manufactures recommendations to insure sanitation.



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Dietary (Kitchen)

The kitchen floors are heavily soiled and buildup has made the light gray grout black in color. The door frame next to the hand washing sink is rusted and missing paint.

Under the sink area, on the kitchen floor, rodent traps were found in the food work area with no service dates, or when it was last checked.

The kitchen walls behind the sink's and food preparation areas were heavily stained and soiled with dried liquids and food particles.

8 stacked baking sheets were heavily soiled with carbon build up and greasy substance.

16 pans were found stacked on the clean shelf heavily wet with water. The pans had not been properly air dried before they were stacked on the shelf.

11 baking sheets were found on the dry, ready to use shelf. The sheets were stacked wet.

The rubber mat under the clean and ready to use stacked pots and pans was found with a pool of water underneath.

The hydrant to the dish washing sink was rusted and unable to be cleaned properly.

The dirty floor mat was rolled up and laying on top of the clean pots and pans.

The door frame and threshold to the pot and pan storage was heavily soiled with dirt and unidentifiable spills. The paint was missing and the floor was heavily soiled.

In the clean pots and pan storage room a heavily soiled crock pot was found on the shelf. The pot was soiled with dried food and liquids.

3 trash can barrels, with lids, were found sitting on plastic stands with castors. The barrels were made to roll around in the kitchen. The barrels had rice, flour, and dried beans in them. The outside of the cans were soiled with dust, food particles, and spilled liquids. The castors were heavily soiled with food particles and dried liquids. There was no schedule provided for cleaning.

A soiled stainless, three tiered cart was found in the clean pots and pan room. The cart was found broken and soiled with dust, dirt, and food particles.

A drawer, in the food preparation work table, was found to have cooking utensils, 2 cans of PAM spray, salt, post notes, a plastic bag from the store wadded up, and a newspaper with Dec. 27th 2017 date on it. The staff confirmed this was supposed to be a clean utensils drawer and not for garbage or newspapers.

The industrial stand up mixer was found to have paint missing from the legs and body of the unit. Those exposed areas were rusted.

Below the industrial can opener the floor was heavily spoiled with spilled food particles, liquid, grease, and dirt.

Plastic covered food trays were found being used to put pre-prepped food dishes on for storage. The trays were worn, broken, and missing plastic on the ends.

A three tiered cart was found in the kitchen next to a food prep area. The cart was found to be heavily soiled with dried food particles, spilled liquids, and dust.

On the food preparation line the refrigerated drawer was found to have four sections. The first section had an open bag of broccoli and one piece of breaded meat laying unwrapped. The second section had an opened bag of breaded chicken. The third section had a bag of open fries. The fourth section had an open bag of fajita type beef. There was no dates on the packages when they were opened or how long they had been in the drawer. The drawer below the top drawer was filled with 13 small bags of vegetables with no dates. The staff was unable to identify the date when the contents were placed in the refrigerated drawers.

The refrigerated drawers under the preparation line were found heavily soiled with carbon build up, dried food particles and dried liquid spills. The gaskets around the drawer did not seal properly and were soiled.

The condiments on the salad line were not in the original bottles. The condiments were in plastic bottles with no dates. There was no way to show how long the condiments had been in the plastic bottles.

The dried seasoning condiments on the salad line were not in the original bottles. The condiments were in plastic shakers with no dates. There was no way to show how long the condiments had been in the shakers.

The fire pull box and pipe, on the wall, next to the fryer, was covered in dirt, dust and grease.


Pharmacy:

In the Pharmacy the staff coffee maker was found sitting on the counter. Three shelves of medications were found above the coffee maker.

A staff refrigerator, with food inside, was found in the medication storage and preparation area.

A staff microwave was found in the medication storage and preparation area. Staff #19 confirmed the staff of the Pharmacy did not have a break room and used this area to prepare coffee and meals.

The air conditioning vent cover, on the ceiling, over the Pharmacy compounding hood, was found to be rusted and dirty.

Inside the pharmacy compounding room, the compounding hood has two sections, negative, and positive. The glass ceiling of the units, inside the hood, was soiled with dust and dirt on the outside part of the glass. The glass is contained inside the unit and requires maintenance to clean it.


Emergency Department

The bottom drawer of the medication storage unit in the Emergency Department was holding IV solutions. When the basket was pulled out, the bottom of the drawer was found to be heavily soiled with dust, dirt, and spilled dried liquids.

The medication storage unit refrigerator in the Emergency Department was found sitting on the floor of the ED. When the refrigerator was opened the bottom of the unit and door of the refrigerator was found soiled with dust and hair.


Out Patient Rehabilitation Unit

Patient files were being stored in the medication preparation room. The medication preparation room was also used as an office and storage.

The "clean room" held clean equipment ready for patient use. Next to the clean equipment was a laundry cart used to transport clean laundry from the other hospital. This cart was taken out of the hospital and transported in a van and brought back to the unit. The cart was parked in the clean room without being cleaned.

Patient Room #1- Out Patient Rehabilitation Unit

Patient room #1 was terminally cleaned and ready for a patient. The following issues were found in patient room #1;

The floor was found soiled with dried liquids. The surveyor was able to wipe up the spill with a wet towel.

The vinyl couch was found to be soiled with dried food particles under the cushions.

The fitted bed sheet was torn in two different spots.

The headboard was found soiled with dust and hair.

The biohazard trash can was soiled on the outside.

The bedside table was found with exposed particle board. The wall O2 cover was covered in a dried crusty substance.

The wardrobe drawers were raw wood with no sealant.

The air-conditioning unit was dusty and the filters were covered in lint and dust.

The window had a cloth valance over the top of the window. The valance was dusty and dirty.

The reclining chair was found to be soiled underneath with condiment packages, used napkins, trash. The rails on the inside of the chair were heavily soiled in food particles, dust and hair.

Under the bed, trash and soiled floor was found.

The floor was soiled under the couch. Candy wrappers and dust was found.

A bedside commode chair was found covered in plastic. The chair was soiled with dust. When the chair was turned to its side to look underneath a brown liquid dripped out of the legs onto the floor.

The bathroom door frame was missing paint and rusted. The threshold was soiled with dirt and dust.

The shower chair was rusted on the bottom and dripping rusted water down the wheels onto the floor.

The shower curtain was soiled on the inside with a white substance.

The soap holder in the shower was caked with a dusty lint like substance. The substance was so thick the surveyor could roll it up.

The shower wall and floor was soiled with mildew, soap scum, and residue.

The toilet base was soiled with dust, hair, and dried yellow substance. The floor behind the toilet was soiled with dried debris, dust, and dirt.

The toilet seat was soiled with dried feces and hair. Top of the base behind the seat was covered in a green substance.

Patient Room #5-Out Patient Rehabilitation Unit

Patient room #5 was terminally cleaned and ready for a patient. The following issues were found in patient room #5;

The door was soiled with multiple tape residue that had collected dust.

The sheet rock in the ceiling was cracked and unsealed.

The floor under the bedside table was soiled with debris and dust.

The wooden chairs was worn on the arms allowing the porous wood to be exposed.

The patient bedside table was broken and missing laminate on the top and edge. The particle board material was exposed.

The bed headboard was soiled with dust, dirt, hair and paper.

The couch had a broken wooden arm exposing the porous wood.

Patient Equipment Room-Out Patient Rehabilitation Unit

The following issues were found in the clean patient equipment room of the outpatient rehabilitation unit;

Bedside commode was found to be soiled and had rusted underneath and down the legs.

Inside the clean equipment room a stretcher was found to be soiled with dust and dirt. The base of the stretcher was soiled and covered in green paint from oxygen bottles. The cushion was soiled in the back with dust and dried unidentifiable materials. Staff confirmed the equipment was supposed to be clean and ready for patient use.

Patient Gym/Exercise Room-Out Patient Rehabilitation Unit

The following issues were found in the patient gym area of the outpatient rehabilitation unit;

Cool packs were stored in a small freezer. There was frost build up on the sides. The door to the freezer was mildewed all around the gasket. The outside of the freezer was rusted and dirty.

A wooden block, on the floor, was used by the patients to stand on. The block was not sealed and exposed wood was soiled with dirt and debris.

A table used by patients had the laminate strips hanging off the sides exposing particle board.


Intensive Care Unit

The bottom drawer of the medication storage unit in the Intensive Care Unit (ICU) was holding IV solutions. When the basket was pulled out the bottom of the drawer was found to be heavily soiled with dust, dirt and spilled dried liquids.

The medication storage unit in the ICU was soiled with dried liquids down the front glass doors.

The medication refrigerator in the Intensive care Unit was soiled on the inside with dust and hair.


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Intensive Care Unit:

A tour of the Intensive Care Unit (ICU) was made on 12-28-2017 with Staff #4. The following observations were made:


ICU clean storage room at entrance of ICU was observed to have a wheelchair available for patient use. The seat of the wheelchair had torn covering on each side. The metal bar that held the cover to the frame had pulled loose exposing the protected padding. The leg/heal pad on the right had a torn piece of covering missing, exposing the foam padding inside. These conditions prevented the wheelchair from being properly sanitized and allowed bacterial growth. Clean equipment for neurological patient monitor to include oximetry was also located in the room. The oximetry monitor connector was visibly soiled.

ICU2 (room #602) had patient monitoring equipment mounted to the wall at the head of the bed, as well as a fluorescent light. A clear plastic u-shaped holder was attached to monitoring equipment at head of patient bed. Dried red-brown matter was observed between the plastic holder and equipment. The inside bottom of holder heavily soiled with dust particles. The wall bracket attached to monitoring equipment was observed to be heavily soiled with dust particles. The fluorescent light fixture was also observed to be heavily soiled with dust particles. The backsplash caulking behind the sink was cracked, deteriorated, and visibly soiled. The backsplash behind sink was soiled with a heavy build-up of unknown material in the corner. The backsplash beside the sink was soiled with a heavy build-up of unknown material in the corner.

Labor and Delivery

A tour of the Labor and Delivery (L&D) unit was made on 12-29-2017 with Staff #65. The following observations were made:

The beds in L&D rooms 2506 and 2507, both had torn rubber boots meant to protect bed mechanisms, potentially allowing blood and bodily fluids to collect inside. L&D room 2506 bed mattress had worn protective covering meant to protect wiring bundles, potentially allowing blood and bodily fluids to collect inside. These conditions prevented the bed from being properly sanitized.

A tour of the clean supply storage room found that L&D sterile instruments were stored in a manner that allowed sharp instruments to puncture sterile wrappers. A sterile package containing a towel clamp was found to have a small puncture in the clear portion of the wrapper. A package containing multiple instruments had multiple punctures in the white paper portion of the wrapper.

Based on record review and interview, the surgeon and anesthesia provider failed to sign, date, and time the Disclosure and Consent form on 4 (#25, #27, #28, and #31) of 10 surgical records reviewed. Also, the facility failed to follow their own medical staff rules and regulations.


A review of Patient #25's record revealed the Disclosure and Consent form was not timed by the surgeon. There was no way to determine if the patient was seen by the surgeon prior to surgery.

A review of Patient #27's record revealed the Disclosure and Consent form was not timed by the surgeon. There was no way to determine if the patient was seen by the surgeon prior to surgery.


A review of Patient #28's record revealed that there was no Disclosure and Consent form by the anesthesia provider.

A review of Patient #31's record revealed the Disclosure and Consent form was not timed by the surgeon. There was no way to determine if the patient was seen by the surgeon prior to surgery. Also, there was not a witness signature or a time listed that the patient signed the consent form for the surgical procedure and the consent form was not labeled with a sticker of the patient's name. There was no way to determine who the consent form belonged to, except for the unwitnessed patient's signature on the informed consent.


A review of the facility's medical staff rules and regulations titled, "5.2 Informed Consent" revealed the following:

"5.2 Informed consent

It is the responsibility of the practitioner performing the procedure, or his or her partner, to perform the informed consent process and obtain informed consent from the patient according to the hospital policy."

An interview with Staff #69 on 12/28/2017 at 1:00 PM confirmed the above findings and that the facility's medical staff rules and regulations were not followed.

Based on record review and interview, the facility failed to ensure the patient's surgical record had an operative report that was dated and timed on the chart immediately following the surgical procedure on 4(#27, #28, #29, and #30) of 10 surgical records. Also, the facility failed to follow their own medical staff rules and regulations.

A review of Patient #28's record revealed the patient had an "amputation of the 1st metatarsal and 1st toe on left foot" on 11/08/2017. There was no documented date or time of the surgeon's signature to know when the operative report was completed. There was an electronic signature time and date, but the date was 3 days after the surgical procedure.

A review of Patient #27's record revealed the patient had an "Exploratory Laparotomy/Appendectomy" on 12/05/2017. There was no documented time of the surgeon's signature to know when the operative report was completed. There was an electronic signature time and date, but the date was 27 days after the surgical procedure.

A review of Patient #29's record revealed the patient had a "General Dentistry" on 10/18/2017. There was no documented date or time of the surgeon's signature to know when the operative report was completed.

A review of Patient #30's record revealed the patient had an "attempted Laparoscopic Appendectomy, Open Appendectomy" on 08/25/2017. There was no documented time of the surgeon's signature to know when the operative report was completed.

A review of the facility's medical staff rules and regulations titled, "3.9 Operative Reports and Notes" revealed the following:

"3.9 Operative reports and Notes

Operative reports should be written or dictated immediately after surgery and the report promptly signed by the surgeon and made a part of the patient's current medical record. It should include all items noted on the operative note and include a detailed report of the procedure."

An interview with Staff #69 on 12/28/2017 at 1:00 PM confirmed the above findings and that the facility's medical staff rules and regulations were not followed.

Based on record review and interview, the anesthesia provider failed to enter the time on the Pre Anesthesia Evaluation Assessment form on 1 (#31) of 10 surgical records reviewed. There was no documented evidence to know if the patient had been evaluated for anesthesia risks prior to the surgical procedure. Also, the facility failed to follow their own medical staff rules and regulations.

A review of Patient #31's record revealed the Pre Anesthesia Evaluation Assessment form did not have the time entered by the anesthesia provider.

There was no documented evidence to know if the patient had been evaluated for pre anesthesia complications related to respiratory function, cardiovascular function, temperature, pain control, nausea and vomiting, and hydration before the surgical procedure was performed.

A review of the facility's medical staff rules and regulations titled, "Article VI Surgical Care 6.2 Anesthesia" revealed the following:

"6.2 Anesthesia

The anesthesia care provider will maintain complete anesthesia record (to include evidence of the pre-anesthetic evaluation and post-anesthetic follow -up) of the patient's condition for each patient receiving deep sedation and anesthesia."

An interview with Staff #69 on 12/28/2017 at 1:00 PM confirmed the above findings and that the facility's Medical Staff Rules and Regulations were not followed.

Based on record review and interview, the anesthesia provider failed to conduct a post anesthesia evaluation and enter the time on the Post-Operative Anesthesia Evaluation Note on 2 (#27 and #28) of 10 surgical records reviewed. The Anesthesia Provider failed to evaluate the patient within the 48-hour timeframe from when the surgical procedure was performed. Also, the facility failed to follow their own medical staff rules and regulations.

A review of Patient #27's record revealed no documentation on the "Post Anesthesia Evaluation" form. The form was left blank by the anesthesia provider.

A review of Patient #28's record revealed the "Post Anesthesia Evaluation" form did not have the time entered by the anesthesia provider.

There was no documented evidence to know if the patient had been evaluated for post anesthesia complication related to respiratory function, cardiovascular function, temperature, pain control, nausea and vomiting, and hydration after the surgical procedure.

A review of the facility's Medical Staff Rules and Regulations titled, "Article VI Surgical Care 6.2 Anesthesia" revealed the following:

"6.2 Anesthesia

The anesthesia care provider will maintain complete anesthesia record (to include evidence of the pre-anesthetic evaluation and post-anesthetic follow -up) of the patient's condition for each patient receiving deep sedation and anesthesia."

An interview with Staff #69 on 12/28/2017 at 1:00 PM confirmed the above findings and that the facility's Medical Staff Rules and Regulations were not followed.