HospitalInspections.org

Based on chart reviews the facility failed to give Emergency Department (ED) patients their Patient Rights in 8(#43-50) of 8 charts reviewed.

Review of the patient ED charts revealed there was no patient rights information in the charts. There was no documentary evidence that the patients were provided with a written or verbal information.

Interview with staff #12 and #14 on 12/14/16 revealed the patient charts that were copied did not have documentary evidence that the patients were provided information on patient rights or patient consents for treatment were obtained. Staff #12 and #14 were instructed three times by the surveyor to make sure a completed chart was given to the surveyor. Three different copies were provided with no patient rights attached. Staff #12 and #14 confirmed they were complete charts.

Based on record reviews the facility failed to allow the patient to refuse treatment and be involved in the treatment process in 1(#45) of 3(#43-45) charts reviewed.

Review of patient #45's chart revealed the patient presented at the ED on 10/24/16 at 15:23 (3:23PM) Review of the physician notes stated, "15:43 Unable to obtain HPI due to ACUTE AGITATION . Physician's Note: 35 YO FEMALE WITH HX OF CROHN'S DISEASE AND SEIZURES WAS BROUGHT TO THE ED VIA POLICE ESCORT FOR PSYCHPROBLEMS TODAY. POLICE ESCORT STATES THAT PT HAS HI TOWARDS HER MOTHER AND HAS BEEN PARANOID WITH REPORTED METH USE. PT STATES SHE HAS BEEN GETTING TEXT MESSAGES FROM JAIL PEOPLE SHE KNOWS THREATENING TO KILL HER BY BURNING HER BODY. PT PRESENTED PHONE TO DR. STEWART AND SEEMS LIKE PT IS SENDING PAGES OF MESSAGES TO HER COUSIN ABOUT GOING TO HEAVEN TO MEET HER FATHER ETC. SHE IS ALLERGIC TO FLAGYL AND UNABLE TO OBTAIN ROS OR HPI DUE TO PT BEING ACUTELY AGGITATED.

Review of the nurse's notes dated 10/24/16 stated, "15:15 Nurse Notes: BH techs to pt's room to have her change into blue scrubs or green gown and to have her belongings removed. Pt refuses to change and release belongings. Pt yelling "Y'all are trying to take away my rights! "Staff assisted pt with removal of clothing and personal belongings and given to security. Pt placed in green gown. Informed pt that blood for labs and urine sample is needed. Pt yells "You not getting it. I will through my pee in your face." Pt refusing to provide urine and blood for labs. Advised pt that if she is unwilling to provide urine sample then an in and out catheter may be used. Pt continues to yell and demanding to leave. Pt with increased agitation and anxiety.

15:16 Special handling status: Psych.

16:04 Nurse Notes: Pt in bed with eyes closed, resp even/unlabored. Pt no longer with increased agitation/anxiety. Pt no longer yelling at staff. Med effective.

17:20 Labs drawn by ED staff using 23 gauge butterfly from the right hand. Labs sent per order to lab."

Review of the patient #45's physician orders revealed the patient was ordered the following medications;

10/24/16 at 15:20 Ativan 2mg IM once. Clinical Indications for Ativan: Agitation. The nurse documented at 16:03 "Follow Up: Response: No adverse reaction; Patient tolerated well; Patient no longer yelling at staff. Pt no longer with increased agitation and anxiety. Med effective."

10/24/16 at 15:20 Haldol 5mg IM once. Indications for Haldol: Disruptive Behavior. The nurse documented at 16:03 "Follow Up: Response: No adverse reaction; Patient tolerated well; Patient no longer yelling at staff. Pt no longer with increased agitation and anxiety. Med effective."

10/24/16 at 15:21 Benadryl 25mg IM once. There was no documented clinical indication for the medication. The nurse documented at 16:03 "Follow Up: Response: No adverse reaction; Patient tolerated well; Patient no longer yelling at staff. Pt no longer with increased agitation and anxiety. Med effective."

There was no documentation found where patient #45 was given time to adjust to the situation, deescalation techniques were used, or other SAMA techniques were used, to calm and reassure the patient, before threating to get blood and urine forcefully. The psychotropic medications were ordered immediately.

Based on reviews and interviews the facility failed to:

A. recognize the patient's rights to refuse treatment and keep the patient safe from staff abuse in 1(#45) of 2 (#44, and 45) charts reviewed.

B. have an order for a restraint chair in 1(#44) of 2(44, and 45) charts reviewed.

C. ensure the staff compared the dialysis machine conductivity to the independent device conductivity prior to beginning treatment on 1 (#5HD) of 5 (#1HD-#5HD) patients reviewed.


A. Review of patient #45's chart revealed the patient presented at the ED on 10/24/16 at 15:23 (3:23 PM) Review of the physician notes stated,"15:43 Unable to obtain HPI due to ACUTE AGITATION . Physician's Note: 35 YO FEMALE WITH HX OF CROHN'S DISEASE AND SEIZURES WAS BROUGHT TO THE ED VIA POLICE ESCORT FOR PSYCHPROBLEMS TODAY. POLICE ESCORT STATES THAT PT HAS HI TOWARDS HER MOTHER AND HAS BEEN PARANOID WITH REPORTED METH USE. PT STATES SHE HAS BEEN GETTING TEXT MESSAGES FROM JAIL PEOPLE SHE KNOWS THREATENING TO KILL HER BY BURNING HER BODY. PT PRESENTED PHONE TO DR. STEWART AND SEEMS LIKE PT IS SENDING PAGES OF MESSAGES TO HER COUSIN ABOUT GOING TO HEAVEN TO MEET HER FATHER ETC. SHE IS ALLERGIC TO FLAGYL AND UNABLE TO OBTAIN ROS OR HPI DUE TO PT BEING ACUTELY AGGITATED.

Review of the nurse's notes dated 10/24/16 stated, "15:15 Nurse Notes: BH techs to pt's room to have her change into blue scrubs or green gown and to have her belongings removed. Pt refuses to change and release belongings. Pt yelling "Y'all are trying to take away my rights!" Staff assisted pt with removal of clothing and personal belongings and given to security. Pt placed in green gown. Informed pt that blood for labs and urine sample is needed. Pt yells "You not getting it. I will through my pee in your face." Pt refusing to provide urine and blood for labs. Advised pt that if she is unwilling to provide urine sample then an in and out catheter may be used. Pt continues to yell and demanding to leave. Pt with increased agitation and anxiety."

There was no documentation found where patient #45 was given time to adjust to the situation or other de-escalation techniques (SAMA) were used to calm and reassure the patient, before threatening to get blood and urine forcefully. (Satori Alternative to Managing Aggression (SAMA) Program is a safe and least restrictive intervention designed to help manage an individual in crisis until they can regain physical and emotional control. Great emphasis is placed on early verbal intervention.

Review of the patient #45's physician orders revealed the patient was ordered the following medications:

10/24/16 at 15:20 Ativan 2mg IM once. Clinical Indications for Ativan: Agitation.

10/24/16 at 15:20 Haldol 5mg IM once. Indications for Haldol: Disruptive Behavior.

10/24/16 at 15:21 Benadryl 25mg IM once. There was no documentation of clinical indications for the Benadryl.

The medications were ordered immediately after staff threatened the patient.

Further review of Nurses' Notes revealed:

"16:04 Nurse Notes: Pt in bed with eyes closed, resp even/unlabored. Pt no longer with increased agitation/anxiety. Pt no longer yelling at staff. Med effective.

17:20 Labs drawn by ED staff using 23 gauge butterfly from the right hand. Labs sent per order to lab."

Review of the ED chart revealed there was no documentation of a face to face after administering a chemical restraint.


B. Review of patient #44's chart revealed the patient presented to the ED on 11/12/16. Review of the nurses notes dated 11/12/16 stated,

"14:39 Presenting complaint: PT ARRIVED TO ED THROUGH MAIN ENTRANCE, PACING AROUND WAITING AREA LOOKING AROUND, MUMBLING WORDS, PIVOT TECH NOTICED PT HOLDING KNIFE, CUTTING HIMSELF ON HIS WRISTS. PT DROPPED KNIFE IN TRASH CAN, AS WITNESSED BY SECURITY. PT STOPPED BY SECURITY STAFF FROM ENTERING ED DEPARTMENT AT SIDE ENTRANCE. PT WAS SCREAMING " I WANT TO KILL MYSELF, I WANT TO DIE " , FIGHTING STAFF, KICKING, AND SPITTING AT STAFF. SECURITY OFFICERS REQUESTED ASSISTANCE BY STATE TROOPERS WHO WERE ON SITE WITH ANOTHER PT. PT PLACED IN HANDCUFFS BY DPS OFFICER AND TAKEN DIRECTLY INTO ROOM 5. DR. FRAYSER AT BEDSIDE FOR ASSESSMENT MEDICATIONS GIVEN PER DR. FRAYSER ORDERS, PT PLACED ON SAFETY RESTRAINT CHAIR,AND HANDCUFFS IMMEDIATELY REMOVED BY DPS OFFICERS."

Continued review of nurses notes on 11/12/16 at 14:39 revealed "Restraint Order Physician Order for behavior management restraint Type of restraint: Restraint Chair. Patient is agitated by continuing to yell at staff, kick or swing violently, fight against restraints, come out of bed, spit at staff Patient is combative by continuing to yell at staff, kick or swing violently, fight against restraints, come of bed, spit at staff, Patient continues to meet clinical justification for continued restraint use. (SIC)

14:44 Visual check: Patient's physiological and psychological needs addressed and met Patient is agitated by continuing to yell at staff, kick or swing violently, Other MAKING TREATS TO HARM SELF Patient continues to meet clinical justification for continued restraint use."(Sic)

There was no documentation found in the chart that a Code Charlie Brown was initiated as required by the hospital policy before police involvement which lead to the patient placed on handcuffed, the patient was not in police custody. However, in the house supervisor's office a Code Charlie Brown Huddle sheet was found dated 11/12/16 concerning patient #44. The form listed staff members involved but stated no SAMA techniques were used.

Review of the policy and procedure titled Code Charlie Brown stated, "Any employee or contractor may activate code "CHARLIE BROWN" when an individual's (e.g., patient, visitor) behavior escalates beyond the capacity of staff members to manage without assistance.


4. MAIN CAMPUS - The BERT (Behavioral Emergency Response Team) team will respond to all code Charlie Brown activations. The following individuals will respond when available:

a. Mental Health Nurse will function as team leader when present.

b. House Supervisor/Rapid Response will function as team leader in absence of Mental
Health Nurse.

c. Psychiatrist/Designee will evaluate patient and direct plan of care. In the absence of the Psychiatrist/Designee, a telemedicine Psychiatrist consult is available.

d. Security provide support to the team by participating in de-escalation of patient and
containment as needed."

Review of the physician orders revealed patient #44 was ordered Ativan 2 mg IM once and Haldol 10 mg IM once on 11/12/16 at 14:47 (2:47 PM). The Ativan had agitation as the clinical indication. There was no clinical indication documented for the Haldol.

There were no physician's order found for a restraint chair. There was no evidence that de-escalation techniques (SAMA) were used as required by hopital policy.



22676

C. Review of patient #5HD revealed the staff failed to record the machine conductivity of the dialysis machine prior to starting treatment on October 25, 2016.

Interview with Staff #8 on December 13, 2016 at 3:00 p.m. confirmed the above findings.

Based on interview and record review the facility failed to ensure sufficient number of licensed nurses and patient care technicians on 2 of 8 units that were reviewed (Medical/Surgical unit and Pediatrics).

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

Findings include:

Review of the facility's staffing matrix and staffing numbers for the Medical- surgical unit from November 1-15, 2016 revealed the following:

For a patient census of 23-25, the facility required a minimum staffing of 3 patient care technicians (PCT) for the day shift.

Review of staffing numbers from November 3rd, 7th, and the 11th revealed they only had 2 PCT's on day shift on these days with a census of 23-25. The facility was short staffed by 1 PCT.

For a patient census of 20, the facility required a minimum staffing of 5 licensed nurses for the night shift.

Review of staffing numbers for November 2nd revealed there was only 4 licensed nurses. They were short staffed by 1 licensed nurse.



Review of the facility's staffing matrix and staffing numbers for the Pediatrics unit from November 1-15, 2016 revealed the following:

For a patient census of 7-8 the facility required a minimum staffing of 1 patient care technicians for the day shift.

Review of staffing numbers for November 9th ,10th and the 11th revealed they did not have any PCT's on day shift on these days.

For a patient census of 8 the facility required a minimum staffing of 3 licensed nurses for the day shift.

Review of staffing numbers for November 9th and the 11th revealed they had 2 licensed nurses working on day shift on these days for a patient census of 8.

During an interview on 12/15/2016 after 9:30 a.m., Staff #41 confirmed the staffing numbers.

Based on observation, interview and record review the facility failed to ensure patient care plans were accurately developed, current, and included the necessary interdisciplinary staff in 2 of 36 sampled patients (Patient #'s 29 and 31).

This deficient practice had the likelihood to affect all patients.

Findings include:

Review of Emergency Department (ED) notes revealed Patient #29 was a 48 year old male who presented on 12/10/2016 at 8:06 p.m., with diagnoses including cellulitis and diabetes with Hyperglycemia (elevated blood sugar). According to documentation in the nurses notes Patient #29 presented complaining of the "left great toe and second toe having a ulcer on it. State that two days ago it started swelling."

Review of ED notes revealed Patient #29 was assigned an in-patient bed on 12/11/2016 at 1:17a.m and departed from the ED 1:17 a.m.. At 1:34 a.m. Patient #29 was admitted to the Medical Surgical unit.

Review of the nursing assessment on the unit dated 12/11/2016 at 2:00 a.m. revealed Patient #29 had an open wound to the left foot. The left foot was larger and redder with a small amount of foul yellow drainage from between the toes ... Patient #29 had a diabetic left foot wound between the 1st and 2nd toes with a white blister to distal 1st toe.

Patient #29 has had several toes amputated; 2 on left foot and 1 on right foot ....

Underneath the Integumentary Plan, nursing documented they were going to place a wound care consult to examine the left foot between the toes wound ....There was documentation that the appropriate treatment for the wounds would be ordered.

Review of physician orders revealed the following:

12/11/2016 at 1:08 a.m,"Sequential Compression Device CONT"

12/11/2016 at 3:18 p.m., "Apply dressing DAILY"

12/12/2016 at 11:45 a.m.,"Therahoney to Wound bed as DIRE ..."

The physician orders were incomplete.

Review of Patient #29's record revealed no treatment record to show what treatment nursing was providing.The only documentation that could be found was in the nurses notes. The following was found:

12/11/2016 at 6:13 a.m. a wound care consult was placed.

12/11/2016 at 5:10 p.m. the doctor was in to see the patient and new wound care orders were received.

12/11/2016 at 7:06 p.m. ... "I have placed a dressing to cover and protect the lt ft." ...

12/12/2016 at 6:20 a.m., .. "The Lt ft dressing is CDI." ...

12/12/2016 at 8:14 p.m., ..."ambulatory with surgical shoe and dressing is intact that Dr ....put on. He changed the order from unna boot to medihoney, wrapped with kerlix" ..

12/13/2016 at 5:35 a.m, ..." foot rewrapped" ...

12/13/2016 at 9:49 a.m., ...." Late note from 12/12. Informed S300 charge nurse that the hospital does not carry Unna Boot dressings. She informed the MD and he ordered Therahoney instead for the dressing."

Review of the nurses notes revealed no complete documentation of the treatment that was being provided.

During an observation on 12/13/2016 after 3:00 p.m., Patient #29 received a wound treatment to ulcers on his left foot. Staff #63 donned gloves and cut a soiled dressing off Patient #29's foot. The scissors that were used to cut the soiled dressing off the foot were not sanitized before being used to cut the clean dressing (Unna Boot). The piece of clean dressing (Unna boot) was applied to the toes only and then the foot was wrapped with a dry Kerlex dressing. Staff #63 placed her hand into her uniform pocket for a pen to date the dressing without first removing her gloves and sanitizing her hands. Patient #29 asked if the dressing wound dry on his foot and Staff #63 informed him it wound not. Staff #63 reported not really knowing how to apply the Unna boot.

Review of the instructions on the box the dressing came out of revealed the following:

"Curity Unna Boot with Calamine

Directions

Begin bandaging at the base of the toes, without pressure, keeping foot and leg at right angle.

Continue bandaging beyond ankle, doubling back to ensure molding to contours of the leg.

Complete bandaging to just below the knee and apply an adhesive elastic bandage to secure the Unna Boot.

Re-apply as needed."

Review of Drugs.com revealed the following about Unna boots:

"An Unna boot is a compression dressing made by wrapping layers of gauze around your leg and foot. It is often used to protect an ulcer or open wound. The compression of the dressing helps improve blood flow in your lower leg. Compression also helps decrease swelling and pain. You may need to wear the boot for a few weeks or until your wound heals.
How is an Unna boot applied?

The boot is applied by a healthcare provider.

· You will need to elevate your leg above your heart for about 20 minutes before the boot is applied. This will help decrease swelling in your lower leg.

· Your wound will be covered with a layer of gauze that contains petroleum jelly.

· Your healthcare provider will wrap your leg from the base of your toes up to your knee.

The first layer is gauze that has been soaked in medicines and lotions to help your wound heal. One or 2 layers of dry gauze will then be applied. Your leg may also be wrapped in an elastic bandage.

· The boot will become stiff as it dries. The boot will feel tight at first and begin to loosen slightly as you walk.

· Your Unna boot will be changed at least once every 7 days. Your wound will be cleaned and measured to make sure it is healing with each boot change."


The nurse did not follow the directions on how to apply the dressing and the physician's orders did not specify how to treat the wounds.

Review of a policy named "Documentation" dated 03/13/2013 revealed the following:

5. The orders must be written clearly, legibly, and completely and improper written or illegible orders shall not be carried out until fully understood by the nurse.

Staff #55 confirmed the missing documentation in the chart.


Review of ED nurses notes revealed Patient #31 was a 62 year old male who presented on 12/08/2016 at 5:41 p.m., with diagnoses which included septic shock, acute renal failure and myocardial infarction.

Review of a physician's history and physical dated 12/08/2016 revealed Patient #31 had a Stage III sacral decubitus ulcer (pressure sore).

According to ED nurses notes dated 12/09/2016 at 3:22 a.m.,Patient #31's skin temperature warm, excoriation and redness was noted to left gluteal maximum (buttock). At 7:40 a.m. Patient #31 was admitted into the Intensive care unit.

Review of nurse's notes revealed the following:

On 12/09/2016 at 9:00 a.m. revealed Patient #31's skin was very dry with a bloody area on lower back/buttock area. Patient #31's daughter states she knows he has breakdown from home..

Nursing made referrals for case manager, wound care consultant and the dietitian.

On 12/09/2016 at 9:00 p.m., Patient #31 had a wound to the right buttock area, wound care on case, ulcer to the left heel ...

On 12/11/2016 Patient #31 was made NPO (nothing by mouth) for a swallow study.

On 12/12/2016 there was documentation of Patient #31 receiving first time hemodialysis. There was also documentation of Patient #31 failing the swallow study and a recommendation being made for enteral feedings.

Review of physician orders revealed the first documentation for a request for a dietary assessment on this high risk patient was on 12/13/2016. The first documentation of a dietary assessment by the dietitian was on 12/13/2016 (5 days after admission).

During an interview on 12/14/2106 after 12:00 p.m.., Staff #55 confirmed that nursing made a recommendation on 12/09/2016., but there was no documentation of a response to it.

During an interview on 12/14/2016 after 12:30 p.m., Staff #71 (Dietitian) revealed they did not receive the nursing referral from 12/09/2016. Staff #68 reported they try to see the patients 48 hours after the referral unless they are intubated and then it would be 24 hours.


Review of a facility policy named "Assessment, Reassessment, and Care Planning" dated 06/24/2016 revealed the following:

"C. Nutritional and Functional Screening:

Inpatients should be screened within 24 hours to determine whether or not nutritional or rehabilitation services are necessary. Nutritional services (Registered Dietitians) screens by a variety of methods, however nursing services supplements this screening via the assessment process.

V. Assessments and reassessments by other disciplines should lead to an initial and updated plan of care or treatment:

1. Nutritional Services:

a. Patients at high nutritional risk and other patients with a physician's order for nutritional assessment should have an assessment completed by a registered dietitian within the third calendar day following the date of identification/order."

Based on interview and record review the facility failed to ensure blood transfusions were administered timely and transfusion information was documented per facility policy in 2 of 36 sampled patients (Patient #'s 30 and 32).

This deficient practice had the likelihood to affect all patients who received blood in the facility.

Findings include:

Review of the record of Patient #30 revealed he was an 83 year old male who presented to the Emergency department (ED) on 12/12/2016 at 5:42 p.m., with diagnoses including pneumonia, urinary tract infection and altered mental status. Review of the ED notes revealed the following documentation:

"HE'S HAD GENERALIZED WEAKNESS TODAY & HIS DR IS CONCERNED THAT HE MAY NEED A BLOOD TRANSFUSION."

Review of lab results dated 12/12/2016 at 6:26 p.m., revealed the following:

Red blood count was low at 3.9 with reference ranges being 4.27-5.49;

Hemoglobin was low at 8.3 with reference ranges being 12.9-16.1;

Hematocrit was low at 27.7 with reference ranges being 37.7-46.5.

Review of physician orders dated 12/12/2016 at 7:12 p.m., revealed the following:

TYPE AND SCREEN Stat (immediately).

LEUKOREDUCED RBCS (LRBC) Stat.

According to nurses notes at 7:18 p.m. a Type and Screen was sent.

Review of lab results dated 12/13/2016 at 5:34 a.m. the next day, revealed Patient #30's blood count had dropped lower and was as follows:

Red blood count was low at 2.48 with reference ranges being 4.27-5.49;

Hemoglobin was low at 6.4 with reference ranges being 12.9-16.1;

Hematocrit was low at 21.4 with reference ranges being 37.7-46.5.

Review of physician orders from the next day 12/13/2016 at 5:54 a.m. revealed an order for LEUKOREDUCED RBCS (LRBC) Stat (cancelled). At 5:55 a.m. the order was to transfuse TRANSFUSE LRBC (leukoreduced red blood cells) Routine.

Review of a lab collection note dated 12/13/2016 at 6:42 a.m., revealed nursing was notified that "REQUESTED PRODUCTS ARE READY."

Review of a lab collection note dated 12/13/2016 at 9:24 a.m. (over 2.5 hours later) revealed nursing was renotified that "REQUESTED PRODUCTS ARE READY."

Review of the facility transfusion records revealed the blood was started on 12/13/2016 at 10:00 a.m., over 3 hours after the lab results were first called to the unit.





Review of the record of Patient #32 revealed he was a 69 year old male admitted into the facility on 11/25/2016 with a diagnoses of chest pain.

Review of a transfusion record revealed Patient #32 received a unit of blood on 12/06/2016. The area where nursing was to document who administered the blood revealed no name documented. There was only one set of vital signs documented on the form. Anesthesia records, a cell saver document and perfusion records had to be searched to find the required documentation.

Staff failed to complete the facility transfusion record.

Staff #55 confirmed the information was missing in the records.

Review of a facility policy named "Blood Products Transfusion" and dated 07/29/2016 revealed the following:

"8. Documentation:

a. Accurately complete blood product transfusion record in the patient's chart including:

i. Transfusion start and end date/time.

ii. Volume of blood product administered.

iii. Site of administration.

iv. Vital Signs per protocol."

Based on record review and interview, the facility failed to ensure that 1 (#68) of 1 staff member did not alter previous content that was entered into the patient's record.


A review of the log titled, "HLD Log" revealed Patient #40, #41, and #42 were placed on the HLD log twice with all the identical information of date, time, and scope number. On the first page, the 3 patients were listed plus two more patients. On the next page, (in date order) Patient #40, #41, and #42 were listed again, but the bottom two listings were scope #532 and #142. The scopes were listed as washed, but not used on a patient.


Staff #41 was asked why Patient #40, #41, and #42 were listed twice on the HLD log. Staff #41 stated, "I don't know, but I will find out." Later during the survey, Staff #41 came back with the HLD log and the HLD log had been rewritten by Staff #68 from 12/05/2016 through 12/09/2016. Staff #41 was asked why the log information was rewritten. Staff #41 stated, Staff #68 was trying to put the log information in chronological order.


An interview with Staff #41 on 12/13/2016 at approximately 2:00 PM confirmed the HLD Log had been rewritten.

Based on record review and interview, the surgeon and anesthesia provider failed to time, date, and sign the facility's Disclosure and Consent form on 4 (#15, #20, #25, and #55) of 13 surgical records reviewed. Also, the facility failed to follow their own policy on Informed Consent.


A review of Patient #15's record revealed the Disclosure and Consent Anesthesia and /or Perioperative Pain management (Analgesia) form did not have the time entered by the anesthesia provider to determine if the anesthesia risk had been discussed with the patient prior to the surgical procedure.


A review of Patient #20's record revealed the Disclosure and Consent Medical and Surgical Procedures form did not have the time entered by the surgeon to determine if the reasonable risks and alternatives associated the surgical procedure had been discussed with the patient prior to the surgical procedure.


Staff #39 on 12/14/2016 at 9:00 AM confirmed Patient #15 and #20 information was missing.


A review of Patient #25's record revealed the Disclosure and Consent Anesthesia and /or Perioperative Pain management (Analgesia) form was signed off by the patient on 12/13/2016 and timed at 6:30 AM. The consent was witnessed by a nursing staff member, but there was no documentation of a signature of the treating licensed practitioner nor a date or time.


Staff #55 confirmed Patient #25 information was missing.


There was no documented evidence to know if the patient had been provided with information reagrding reasonable risks and alternatives associated with the surgical procedure and the risk of general anesthesia prior to surgery.


A review of the facility's policy titled, "Informed Consent" revealed the following:


"Policy

It is the policy of Good Shepherd Medical Center that the patient be given the opportunity to give an "informed consent" prior to the performance of complex procedures that place the patient at risk, including diagnostic or therapeutic procedures.


Guidelines

Informed consent is the process by which the patient's physician or other appropriate licensed independent practitioner provides the patient with information regarding high-risk procedure(s) or treatment(s) planned, so that an informed decision by the patient can be made. Informed consent is necessary for complex procedures, not for simple and common procedures (i.e. the procedure is known to carry a low associated risk)
1. Complex (list A) and simple (list B) procedures are understood to align with the Texas Administrative Code Title 25, Part 7, Chapter 601


A. Written Verification

Written verification of the informed consent should be on the patient's chart prior to initiation of the above stated procedures. The preferred method of written verification of informed consent is the hospital's approved consent form, however annotation in the medical record of the informed consent process and the patient's understanding of, and agreement to, the procedure are acceptable, and determined to be equivalent to the patient's written acknowledgement of informed consent, if a consent form is not available.


B. Information Provided

Information provided to the patient is consistent with information from List A of the Texas Administrative Code which includes, but may not be limited to the risks, drawbacks, complications, and expected benefits or effects of the procedure, treatment, and/or anesthesia; any alternatives to the procedure and their risks and benefits; the likelihood of success; potential problems related to recuperation; possible results of non-treatment.


C. Obtaining Informed Consent

It is the treating physician's responsibility to provide the patient with information and obtain informed consent.


D. Documentation of Informed Consent

1) The hospital's approved informed consent form is completed and/or

2) An annotation in the medical record that a discussion was held with the patient including the risks and benefits of the procedure and informed consent was obtained."


An interview with Staff #39 and #45 on 12/14/2016 at 9:00 AM confirmed the above findings and the facility's policy was not followed.

Based on observation, record review, and interview, the facility's infection control program failed to ensure:

A. 1.) that the cold disinfectant solution was monitored and the disinfecting procedures were followed according to the manufacturer's guidelines and the hospital's policy. There were six (6) patients that had procedures performed with Transesophageal echocardiogram (TEE) scopes that had been disinfected with expired Cidex solution. Also, eleven (11) of the TEE scopes were disinfected after being used on patients with the expired Cidex solution.

2.) Further review revealed the facility failed to provide a sanitary environment for Non-Invasive Cardiology area, Holding area, Radiology, and off site Emergency Room departments.

During a tour of the Non-Invasive Cardiology, Radiology, Emergency, and Surgical Departments on 12/13/2016 from 11:30 AM through 3:30 PM the following infection control issues were observed:

Non-Invasive Cardiology:

Definition of TEE Scope:

The non-invasive department uses a TEE scopes. Transesophageal echocardiogram is a special type of echocardiogram (ultrasound of the heart). This test uses a special echocardiography transducer (ultrasound camera) that is inserted through the patient's mouth, through the back of the throat, and into the esophagus.

Findings:

Non-Invasive Cardiology Solution Testing Log Sheet For: Cidex OPA:

A review of the log titled, "HLD LOG" from 09/13/2016 through 12/09/2016 revealed the following:

The gallon of Cidex solution was opened and used for the first time on 09/13/2016. The gallon of Cidex should have been discarded on 11/27/2016 (the 75th day) in accordance with the manufacturer's instructions. The hospital policy requires that "On day 75, unused solution in open bottle AND "Working Solution" in bin or tube must be discarded." The Cidex solution was used until 12/08/2016.

There were 6 patients that had TEE procedures performed with improperly disinfected scopes due to the use of expired Cidex solution. Also, there were 11 scopes disinfected with expired Cidex solution.


A review of the log titled, "HLD Log" revealed that the scopes disinfected with the expired Cidex solution were used on the following patients:

Patient #37 had a TEE procedure on 12/01/2016 after scope #532 was disinfected with the expired solution.

Patient #38 had a TEE procedure on 12/01/2016 after scope #330 was disinfected with the expired solution.

Patient #39 had a TEE procedure on 12/03/2016 after scope #330 was disinfected with the expired solution.

Patient #40 had a TEE procedure on 12/06/2016 after scope #330 was disinfected with the expired solution.

Patient #41 had a TEE procedure on 12/05/2016 after scope #756 was disinfected with the expired solution.

Patient #42 had a TEE procedure on 12/06/2016 after scope #580 was disinfected with the expired solution.

Further review of the log titled, "HLD Log" revealed there were 11 scopes disinfected after patient use with the expired Cidex solution. The Cidex solution expired on 11/27/2016.

Scope #532 disinfected 11/29/2016

Scope #142 disinfected 11/29/2016

Scope #532 disinfected 11/29/2016

Scope #330 disinfected 12/01/2016

Scope #532 disinfected 12/01/2016

Scope #756 disinfected 12/02/2016

Scope #756 disinfected 12/02/2016

Scope #330 disinfected 12/03/2016

Scope #756 disinfected 12/05/2016

Scope #580 disinfected 12/06/2016

Scope #330 disinfected 12/06/2016

A review of the manufacture guidelines for Cidex OPA Ortho-Phthalaldehyde Solution high level disinfectant for semi-critical medical devices revealed the following:

"Indications for Use: CIDEX OPA Solution is a high level disinfectant for reprocessing heat sensitive semi-critical medical devices, for which sterilization is not suitable, and when used according to the Directions for Use.


C. Special Instructions for Transesophageal Echocardiography (TEE) probe reprocessing: As with all devices, carefully follow all probe manufacturer recommendations such as use of a sterile protective sheath when performing TEE. Soaking for a minimum of 12 minutes in CIDEX OPA Solution is required for high level disinfection (HLD). Excessive soaking of the probes (e.g., longer than an hour) during HLD and/or not rinsing three times with a fresh quantity of water each time as described in Part B, may result in residual CIDEX OPA Solution remaining on the device, the use of which may cause staining, irritation or chemical burns of the mouth, throat, esophagus, and stomach.


D. Reusage for Disinfection: CIDEX OPA Solution has demonstrated efficacy in the presence of organic soil contamination and microbiological burden during reuse. The ortho-phthalaldehyde concentration of CIDEX OPA Solution during its use-life must be verified by the CIDEX OPA Solution Test Strips prior to each use, to determine CIDEX OPA Ortho-Phthalaldehyde Solution INSTRUCTIONS FOR USE that the MEC of 0.3% is present. CIDEX OPA Solution may be used and reused within the limitations indicated above for up to a maximum of 14 days. CIDEX OPA Solution must be discarded after 14 days, even if the CIDEX OPA Solution Test Strip indicates a concentration above the MEC. (Minimum effective concentration).


1. MONITORING OF GERMICIDE: During reuse, it is recommended that the CIDEX OPA Solution be tested with CIDEX OPA Solution Test Strips prior to each use. This is to ensure that the Minimum Effective Concentration (MEC) of ortho-phthalaldehyde is present.
During the usage of CIDEX OPA Solution as a high level disinfectant, it is recommended that a thermometer and timer be utilized to ensure that the optimum conditions are met. Discard solution if precipitation occurs.


POST-PROCESSING HANDLING AND STORAGE OF REUSABLE DEVICES: Disinfected reusable devices are either to be immediately used, or stored in a manner to minimize recontamination. Refer to the reusable device manufacturer's labeling for additional storage and/or handling instructions.


STORAGE CONDITIONS AND EXPIRATION DATE


1. CIDEX OPA Solution should be stored in its original sealed container at controlled room temperature 15-30°C (59 - 86°F) in a well-ventilated, low-traffic area.

2. Once opened, the unused portion of the solution may be stored in the original container for up to 75 days until used.

3. The expiration date of the CIDEX OPA Solution is found on the immediate container."



A review of the facility's policy titled, "High Level Disinfection" dated July 26, 2016 revealed the following:


"Policy


It is the policy of Good Shepherd Longview/Marshall to perform care, cleaning and high-level disinfection of medical devices in accordance with infection prevention, applicable professional standards, manufacturer's recommendations and regulatory requirements.


Procedure

Care, cleaning and HLD (high-level disinfection) will be performed by competent personnel.

This procedure uses the following definitions:

Scopes/Probes are defined as reusable medical devices that are inserted into the body for viewing or monitoring and may be flexible, rigid and with or without lumens.

Examples include: bronchoscopes, endoscopes, laryngoscope blades, ENT scopes, vaginal, ultrasound and TEE probes.

Cleaning is the physical removal of organic and inorganic material (blood and body fluids) High-level disinfection or HLD eliminates all forms of microbial life with the exception of certain bacterial spores and is the accepted standard of care for scopes/probes (semi critical devices) that make contact with skin or mucous membranes and enter unsterile areas of the body Always follow manufacturer's instructions.

Cidex OPA solution does not require activation or dilution.

Dating:

*One gallon bottle-check manufacturer's printed expiration date on bottle.

*Date (label) for 75 days upon opening first time.

* OPA solution (Working Solution) may be reused per manufacturer's instructions (maximum of 14 days). Working solution indicates solution has been poured from the bottle and is working or in use.

*On day 75, unused solution in open bottle AND "Working Solution" in bin or tube must be discarded.

* Follow hospitals safety requirements for proper use of chemicals. Only use approved products as outlined.

*Adhere to hospital recommendations on hand hygiene and the use of PPE or personal protective equipment.

*Gloves should be changed and hands sanitized or washed when moving from soiled to clean activity.

*OPA does not have an odor and won't irritate eyes or nasal passages, but it is a chemical and stains grey with skin contact

*Eyewash stations/logs are required.

*Reprocessing by HLD is performed in designated locations only, in disinfection soaking station (GUS unit), bin or in an AER (automated endoscopic reprocessor)

*Transport used scopes/probes to the reprocessing area in a biohazard bin/bag and in a manner that avoids cross contamination"


An interview with Staff #44 on 12/13/2016 at 9:45 AM confirmed the cold disinfectant was to be tested daily and once the gallon container was opened the gallon was only good for 75 days. Staff #44 confirmed that the solution was opened on 09/13/2016 and used through 11/27/2016.

An interview with Staff #41, #44, #45, and #68 on 12/13/2016 at approximately 9:45 AM confirmed the manufacturer guidelines and facility's policy were not being followed for the use of cold disinfectant.


During the interviews, Staff #41 the Director of the Non Invasive Cardiology Department, the staff had not realized that they had used the solution beyond the 75th day.


During an interview on 12/13/2016, Staff #41 (Director of the Non Invasive Cardiology) and Staff #76 (Infection Control) confirmed the infection control issues found on the High level Disinfection log during the survey had not been addressed through the infection control program. The Director and Staff working in the Non-Invasive Cardiology department and the Infection Control Staff member were not aware that the manufacturer guidelines and the hospital's policy and procedure had not been followed. Training and education had been provided and a new High level Disinfection policy had been put into place, staff failed to follow the hospital policy.


A further review of the log titled, "HLD Log" revealed Patient #40, #41, and #42 were placed on the HLD log twice with all the identical information of date, time and scope number. On the first page, the 3 patients were listed plus two more patients. On the next page, (in date order) Patient #40, #41, and #42 were listed again, but the bottom two listings were scope #532 and #142. The scopes were listed as washed, but not used on a patient.


Staff #41 was asked why Patient #40, #41, and #42 were listed twice on the HLD log. Staff #41 stated, "I don't know, but I will find out." Later during the survey Staff #41 came back with the HLD log and the HLD log had been rewritten by Staff #68 from 12/05/2016 through 12/09/2016. Staff #41 was asked why the log information was rewritten. Staff #41 stated, Staff #68 was trying to put the log information in chronological order.


An interview with Staff #41 on 12/13/2016 at approximately 2:00 PM confirmed the HLD Log had been rewritten by Staff #68.



Holding Area:

In the clean utility room in the holding area, observed a drain leak under the sink. There was large rusty stained area approximately 2 X 2 feet in size. Also, there was grayish circular stain approximately 6 X 8 cm in size under sink. The bottom cabinet that was in the clean utility room was packed with card board boxes, decorations, and a manual labeled "Surgery Consent Manual".

"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).


In two different holding bays, the vinyl chairs had torn areas in the seats with the foam showing and could not be cleaned properly; which caused the likelihood of an infection control risk to patient and family members.

During the tour of the holding area, surveyor opened a supply drawer and observed a dried brown substance along the edge of the drawer.

An interview with Staff #39 and #45 on 12/13/2016 at 12:00 PM confirmed the above findings.

Radiology Department:

There were two vaginal probes observed hanging on the wall with open clear plastic baggies covering them. Plastic baggies prevent air flow and any moisture on the vaginal probe covered with a plastic baggie will cause mold or bacteria to grow causing a risk of infection for a patient receiving a vaginal ultrasound procedure according to the CDC standard guidelines.

The tile was chipped on the flooring beneath the fire extinguisher on the main hallway of the radiology department. This was an infection control issue as the floor could not be properly sanitized.

An interview with Staff #45 on 12/13/2016 at 12:00 PM confirmed the above findings.


Emergency Room X 2 off Site:

There were vaginal probes observed hanging with open clear plastic baggies covering them. Plastic baggies prevent air flow and any moisture on the vaginal probe covered with a plastic baggie will cause mold or bacteria to grow causing a risk of infection for a patient receiving a vaginal ultrasound procedure according to the CDC standard guidelines. In Emergency room A and B, Vaginal probes were observed with plastic baggies hanging over them.

An interview with Staff #13 and #16 on 12/13/2016 during the tour of the emergency rooms confirmed the above findings.




22676

B. the staff conducted appropriate infection control measures, to prevent the spread of infections in the dialysis unit. Citing 4 (#35, #37, #46, and #47) of 5 (#35, #37, #38 #46, and #47) staff observed.

These deficient practices have the likelihood to cause harm to all patients receiving care in the dialysis unit.

Findings:

The facility policy: 7-03-09 (1.) "Hands will be washed upon entering the hospital/facility, prior to gloving, after removal of gloves, between patients, after contamination with blood or other infectious material, after patient and contaminated machine contact, between patients, before touching clean area such as counter tops, supply carts, or medication carts, and at the close of the business day prior to going home."

Observation in the dialysis unit on December 12, 2016 staff # 35 was observed at 11:30 a.m. charting on the paper medical record with the same gloves on that she had used to provide patient care.

Staff #47 was observed on December 14, 2016 at 8:50 a.m. connecting a catheter patient. Staff #47 opened the syringes and then made the final connection without removing her gloves, cleaning hands, and putting on new gloves. Staff # 37 was then observed turning off the patient lights with the same gloves on.

Staff #37 was observed on December 14, 2016 at 08:45 a.m. connecting a patient for dialysis. Staff #37 was then seen going across the room to the linen cart, opening the blue drape and obtaining a blanket with the same gloves on that was used to connect the patient.

Staff #46 was observed on December 14, 2016 at 8:55 a.m. examining a patient using a stethoscope and them checking the patient's extremities. Staff #47 took off her gloves and impervious gown. Staff #47 then placed the stethoscope around her neck and put her hands on her hips without washing her hand or using hand sanitizer. Staff # 47 also failed to disinfect her stethoscope before putting it around her neck and and leaving the unit.

Interview with Staff #8 on December 12, 2016 at 11:30 and December 14, 2016 at 9:00 a.m. confirmed these were not appropriate infections control techniques and that the staff failed to follow the facility's policy.



10135

C. the staff used appropriate infection control procedures in storing medications, preparing medications, storage of medical supplies, cleansing patient rooms, storage of housekeeping supplies and during skin treatments. This deficient practice was found in 4 of 4 areas (Pharmacy, Pediatric unit, Labor and delivery unit and Medical/Surgical unit).

During an observation on 12/12/2016 after 10:00 a.m. the following was found:

Pharmacy

A bottle of antibiotic had dry spills on the outside of the bottle.

Bottles of medication were covered with dried spills and were stored in a cabinet.

An open jar of Lantiseptic skin protectant was found in a cabinet with other medications without an open date.

An open tube of the skin protectant Zinc Oxide ointment did not have an open date.

Two open bottles of the compounding solution ORA-Sweet and ORA-Plus were stored in a cabinet and did not have an open date on them.

Review of a sign in the pharmacy revealed the following:

ALL BULK ORAL SUSPENSIONS ARE GOOD UNTIL THE MANUFACTURER'S EXPIRATION DATE UNTIL UNIT DOSED. "OPENED" DATE SHOULD BE IDENTIFIED ON ALL BOTTLES. PLEASE TRIPLE CHECK FOR OPEN BOTTLES AND DO NOT OPEN MORE THAN 1 BULK BOTTLE AT A TIME."

A medication refrigerator was found in the pharmacy with the inside vents covered in dust.

The floor in the narcotic room had a buildup of dirt and dust at the baseboards and behind the equipment.

The inside of the refrigerator in the narcotic room was covered with spills.

Plastic medication bins inside the Pyxis in the narcotic room had a build-up of dust in them and the medication had dust build-up.

Shipping boxes containing such things as intravenous solutions and sterile water were stored at the back of the pharmacy in an area which was just outside of the sterile intravenous compounding area. Bags of intravenous fluids had been removed from inside of the boxes. The fluids were placed on the shelves and touching the outside of the shipping boxes. There were boxes of antibiotics which had been removed from the shipping boxes and stored directly underneath other shipping boxes. Vials of sodium chloride injectable concentrate was stored on the shelf and the plastic covering they were wrapped in was partially removed.


Boxes of immuglobulin were stored directly behind the shipping boxes and stored on a bottom shelf which had no protective splash guard. This medication is used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a weakened immune system.

One of the shelves which contained shipping boxes of supplies was soiled with dried spills.

"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 #66 confirmed the observation.

During an observation on 12/13/2016 after 9:00 a.m. the following was found:

Labor and Delivery unit:

There was a biohazard container which had used sharps in it. The outside of the sharps container was soiled and it was attached to a baby's crib in the clean supply room.

A housekeeping closet was found unlocked. The floor in the room had soiled linen, bottles of cleaning solutions, paper towels, and clean towels stored on the floor. On the other side of room was a hopper used to discard mop water. The cleaning chemical dispenser was located on a wall directly over the hopper. The plastic tubing connected to the cleaning chemicals dispenser was lying on the floor. The floor contained a build of dirt, debris and gloves.

Staff #55 and 59 confirmed the observation.

Medical/Surgical unit:

During an observation on 12/13/2016 after 3:00 p.m., Patient #29 received a wound treatment to ulcers on his left foot. Staff #63 donned gloves and cut a soiled dressing off Patient #29's foot. The scissors that were used to cut the soiled dressing off the foot were not sanitized before being used to cut the clean dressing. The clean dressing was applied and then the foot was wrapped with a dry Kerlex dressing. Staff #63 reached into her uniform pocket for a pen to date the dressing without first removing her gloves and sanitizing her hands.




28659


D. proper food storage in the walk-in freezer and proper and secure disposition of biohazard sharps containers.

Dietary Department

On 12/12/2016 at 11:00 a.m., a tour of the dietary department was conducted. The walk in freezer was observed with an empty cooking pot on the floor, a gallon container with a frozen red content without a lid, a bag of frozen meat patties and an open box of ready-made pie crust with one pie crust exposed to the air.

The dietary manager (staff #17) who gave the tour, observed and confirmed these findings.

Environmental Services

On 12/13/2016 in the morning a large capacity rolling bin was observed on the outside loading dock. The lid of the bin was open exposing biohazard sharps containers that were stacked above the top of the bin. The sharps containers were awaiting destruction. The bin was unattended.

An interview with the Environmental Services Director, staff #70, who gave the tour confirmed the bin should be locked and was likely left on the dock awaiting space in the locked biohazard closet. The biohazard sharps containers were an infection control risk, if the contents were accessed for personal use or accidental exposure occurred while unattended.

Based on record review and interview, the surgeon failed to document changes in the patients' medical condition on the History and Physical Update note on 2 (#13 and #15) of 12 surgical records reviewed. Also, the facility failed to follow their own policy on History and Physical update note.

A review of Patient #13's record revealed that the surgeon failed to mark if there were any changes in the patient's medical conditions prior to surgery on the History and Physical Update note dated 10/17/2016.

A review of Patient #15's record revealed the History and Physical was dictated on 10/14/2016 by a resident physician. There was no documented update to the History and Physical by the surgeon to determine if there were any changes to the patient's medical condition prior to the surgical procedure that was performed on 10/17/2016. Also, the surgical procedure EGD (Esophagogastroduodenoscopy) took 2 minutes to perform. The case started at 11:34 AM and ended at 11:36 and included a gastric biopsy.

There was no way to determine if the patient's medical condition had changed prior to surgery according to the history and physical update note.


A review of the facility's policy titled, "History and Physical Examination Policy" revealed the following:

"POLICY:

It is the responsibility of the Medical Staff to assure that a medical history and appropriate physical examination (H&P) is performed on patients being admitted for inpatient care, as well as prior to operative and complex invasive procedures, or procedures requiring anesthesia services in either an inpatient or outpatient setting.

Patients requiring an H&P will receive a full H&P, an abbreviated H&P, or an update note as set forth in these rules and regulations.

Update Note:

An update note is defined as a statement entered into the patient's medical record that the H&P was reviewed, the patient was examined, and that;

1. There are no significant changes to the findings contained in the H&P since the time it was performed, or

2. There are significant changes and such changes are subsequently documented in the patient's medical record.


The update note must be performed by someone who has the privileges to perform an
H&P.


The update note must be documented on or appended to the H&P. For patients undergoing outpatient surgical or complex invasive procedures, the performance of a pre-anesthesia I sedation assessment that includes a pertinent history and physical examination may be considered an update note to the H&P provided the assessment was performed on the day of the surgery or the procedure.


The requirement as to which type of H&P must be performed, and associated time frames are noted in the following table:


Outpatient Surgical Procedure:

A full or abbreviated H&P is required. The H&P must be completed no more than 30 days prior to surgery or on the day of surgery prior to the start of the procedure.

If the H&P was performed within 30 days prior to surgery, an update note must be entered into the record on the day of surgery prior to the start of the procedure."


An interview with Staff #39 and #45 on 12/14/2016 at 9:00 AM confirmed the above findings and that the facility's policy was not followed.

Based on record review and interview, the surgeon and anesthesia provider failed to time, date, and sign the facility's Disclosure and Consent form on 3 (#15, #20, and #25) of 13 surgical records reviewed. Also, the facility failed to follow their own policy on Informed Consent.

A review of Patient #15's record revealed the Disclosure and Consent Anesthesia and /or Perioperative Pain management (Analgesia) form did not have the time entered by the anesthesia provider to determine if the anesthesia risk had been discussed with the patient prior to the surgical procedure.

A review of Patient #20's record revealed the Disclosure and Consent Medical and Surgical Procedures form did not have the time entered by the surgeon to determine if the reasonable risks and alternatives associated the surgical procedure had been discussed with the patient prior to the surgical procedure.

Staff #39 on 12/14/2016 at 9:00 AM confirmed Patient #15 and #20 information was missing.

A review of Patient #25's record revealed the Disclosure and Consent Anesthesia and /or Perioperative Pain management (Analgesia) form was signed off by the patient on 12/13/2016 and timed at 6:30 AM. The consent was witnessed by a nursing staff member, but there was no documentation of a signature of the treating licensed practitioner nor a date or time.

Staff #55 confirmed Patient #25 information was missing.

There was no documented evidence to know if the patient had been provided with the reasonable risks and alternatives associated with the surgical procedure and the risk of general anesthesia prior to surgery.

A review of the facility's policy titled, "Informed Consent" revealed the following:

"Policy

It is the policy of Good Shepherd Medical Center that the patient be given the opportunity to give an "informed consent" prior to the performance of complex procedures that place the patient at risk, including diagnostic or therapeutic procedures.


Guidelines

Informed consent is the process by which the patient's physician or other appropriate licensed independent practitioner provides the patient with information regarding high-risk procedure(s) or treatment(s) planned, so that an informed decision by the patient can be made. Informed consent is necessary for complex procedures, not for simple and common procedures (i.e. the procedure is known to carry a low associated risk)
1. Complex (list A) and simple (list B) procedures are understood to align with the Texas Administrative Code Title 25, Part 7, Chapter 601


A. Written Verification

Written verification of the informed consent should be on the patient's chart prior to initiation of the above stated procedures. The preferred method of written verification of informed consent is the hospital's approved consent form, however annotation in the medical record of the informed consent process and the patient's understanding of, and agreement to, the procedure are acceptable, and determined to be equivalent to the patient's written acknowledgement of informed consent, if a consent form is not available.


B. Information Provided

Information provided to the patient is consistent with information from List A of the Texas Administrative Code which includes, but may not be limited to the risks, drawbacks, complications, and expected benefits or effects of the procedure, treatment, and/or anesthesia; any alternatives to the procedure and their risks and benefits; the likelihood of success; potential problems related to recuperation; possible results of non-treatment.


C. Obtaining Informed Consent

It is the treating physician's responsibility to provide the patient with information and obtain informed consent.


D. Documentation of Informed Consent

1) The hospital's approved informed consent form is completed and/or

2) An annotation in the medical record that a discussion was held with the patient including the risks and benefits of the procedure and informed consent was obtained."


An interview with Staff #39 and #45 on 12/14/2016 at 9:00 AM confirmed the above findings and the facility's policy was not followed.

Based on record review and interview, the facility failed to ensure the patient's record had an operative report that was dated and timed on the chart immediately following the surgery on 6 (#11, 12, 13, 14, 16, and 19) of 12 (#11-22) patient's records.

A review of Patient #11's record revealed the patient had a Laparoscopic Cholecystectomy on 11/23/2016. There was no documented date and time of the surgeon's signature to know when the operative report was completed.


A review of Patient #12's record revealed the patient had a Laparoscopic Right Colon Resection on 11/23/2016. There was no documented date or time of the surgeon's signature to know when the operative report was completed.


A review of Patient #13's record revealed the patient had a Left Shoulder Arthroscopy on 10/17/2016. There was no documented date or time of the surgeon's signature to know when the operative report was completed.


A review of Patient #14's record revealed the patient had a Robotic Assisted Hysterectomy on 10/17/2016. There was no documented time of the surgeon's signature to know when the operative report was completed.


A review of Patient #16's record revealed the patient had a Right Inguinal Hernia Repair on 10/27/2016. There was no documented date or time of the surgeon's signature to know when the operative report was completed.


A review of Patient #19's record revealed the patient had a surgical procedure (handwriting of the procedure was not legible) on 11/9/2016. There was no documented time of the surgeon's signature to know when the operative report was completed.


An interview with Staff #39 and #45 on 12/14/2016 at 9:00 AM confirmed the above findings.

Based on record review and interview, the anesthesia provider failed to enter the time on the Pre Anesthesia Evaluation Assessment form on 5 (#13, 14, 15, 19, and #22) of 12 surgical records reviewed. There was no documented evidence to know if the patient had been evaluated for anesthesia risks prior to the surgical procedure.


A review of Patient #13's record revealed the Pre Anesthesia Evaluation Assessment form did not have the time entered by the anesthesia provider.


A review of Patient #14's record revealed the Pre Anesthesia Evaluation Assessment form did not have the time entered by the anesthesia provider.


A review of Patient #15's record revealed the Pre Anesthesia Evaluation Assessment form did not have the time entered by the anesthesia provider.


A review of Patient #19's record revealed the Pre Anesthesia Evaluation Assessment form did not have the time entered by the anesthesia provider.


A review of Patient #22's record revealed the Pre Anesthesia Evaluation Assessment form did not have the time entered by the anesthesia provider.



An interview with Staff #39 and #45 on 12/14/2016 at 9:00 AM confirmed the above findings.

Based on record review and interview, the anesthesia provider failed to enter the time and sign the Post-operative Anesthesia Evaluation Note on 4 (#14, 15, 18, and #19) of 12 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 policy.


A review of Patient #14's record revealed the Post-Operative Anesthesia Evaluation Note did not have the time entered by the anesthesia provider.


A review of Patient #15's record revealed the Post-Operative Anesthesia Evaluation Note was signed by the anesthesia provider on 11/07/2016; twenty-one days after the surgery was performed. The surgical procedure was performed on 10/17/2016. The post anesthesia evaluation was not performed within 48 hours timeframe of the surgical procedure.


A review of Patient #18's record revealed the Post-Operative Anesthesia Evaluation Note was signed by the anesthesia provider on 11/11/2016; nine days after the surgery was performed. The surgical procedure was performed on 11/02/2016. The post anesthesia evaluation was not performed within 48 hours timeframe of the surgical procedure.


A review of Patient #19's record revealed the Post-Operative Anesthesia Evaluation Note 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 policy titled, "Provisions of Anesthesia Services" revealed the following:


"Post-Anesthesia Evaluation

A post-anesthesia evaluation should be completed and documented no later than 48 hours after surgery or a procedure requiring anesthesia services. The calculation of the 48 hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation should be completed and documented by any practitioner who is qualified to administer anesthesia as noted in this section of the policy.

The evaluation may not begin until the patient is sufficiently recovered from the acute administration of the anesthesia so as to participate in the evaluation, (e.g. answer questions appropriately, perform simple tasks, etc.)"


An interview with Staff #39 and #45 on 12/14/2016 at 9:00 AM confirmed the above findings and that the facility's policy was not followed.