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Based upon observation and interview, the facility failed to ensure the safe administration of psychoactive medication for the management of violent behavior in 1 (#30) out of 13 (patients #16 and #28 - #40) patients reviewed. Patient #30 reported he was "allergic" to Benzodiazepines (psychoactive medication given for treatment of anxiety and agitation) and they made him violent. Ativan (Psychoactive medication) was given x2 with adverse effects.


This deficient practice had the likelihood of causing harm to all patients in the facility.



A review of patient #30's record revealed the following information:

Patient #30 was a 38 year old male, who arrived to the facility's Emergency Department (ED) on 10/30/16 @ 1448 via Emergency Medical Services (EMS). The Sulphur Springs Police Department (SSPD) was called to the scene by the patient's family for reported "agitation and strange behavior". Pt was reported to be agitated, diaphoretic (sweating), and speaking rapidly upon arrival to ED.

Review of the RN notes in the Emergency department revealed:

1455 - "PT (patient) STATES THAT HE IS ALLERGIC TO BENZOS (benzodiazepines) BECAUSE THEY MAKE HIM VIOLENT. PT REFUSING BENZOS AT THIS TIME.

1501 - "ATIVAN 2MG (milligram) IM (intramuscular) ORDERED. PT CONTINUES TO REFUSE BENZOS."

1747 - "DR (staff #40) TO BEDSIDE. ATIVAN 1 MG GIVEN BY DR. (staff #40). PT REMAINS COMBATIVE AND YELLING."

Staff #40 administered the Ativan (benzodiazepine) after the patient had informed staff he was "allergic" to benzodiazepines and stated they made him violent. The physician's note listedthat the Patient #30 was allergic to "benzos." The physician's order for Ativan did not contain any indications for the drug to be given.

1800 - "PT YELLING, KICKING, SCREAMING, SPITTING, CURRENTLY 4 OFFICERS AT BEDSIDE ATTEMPTING TO KEEP PATIENT FROM HURTING SELF OR OTHERS, PT ATTEMPTING TO CRAWL OVER RAILS AT THIS TIME, OFFICERS AT SIDE ASSISTING PATIENT BACK TO STRETCHER FOR SAFETY. PT DIAPHORETIC, SPORADIC MOVEMENT NOTED DURING ENTIRE STAY IN ED. DR (staff #40) ADMIN (administered) 1 MG ATIVAN IV AT THIS TIME, PT TOLERATED WELL. VSS (vital signs stable)".

Staff #40 administered a 2nd dose of Ativan (benzodiazepine) after the patient had informed staff he was "allergic" to benzodiazepines and stated they made him violent. The physician's note listed "benzos" as the patient's allergy. The physician's order for Ativan did not contain any indications for the drug to be given.

1822 - "GEODON (antipsychotic drug) 10 MG GIVEN IN THE L (left) HIP. GIVEN BY DR. (staff #40) ....SSPD AT BEDSIDE AT THIS TIME, CURRENTLY TAKING 5 OFFICERS TO KEEP PATIENT FROM HARMING HIMSELF OR OTHERS, PATIENT YELLING, SCREAMING, CUSSING, KICKING, SPITTING, HANDCUFFS IN PLACE, PATIENT ATTEMPTING TO CRAWL OVER SIDE RAIL OF STRETCHER. DR (staff #40) AT BEDSIDE, ADMIN (administered) GEODON AS STATED."

The physician's order for Geodon did not contain any indications for the drug to be given on the date it was given. There was a late entry documented by the physician dated 12/11/16, that stated, "Geodon given for severe agitation, suspect bipolar psychosis". The documentation was done 42 days after the medication was ordered and administered.

1855 - "PT HOB (head of bed) FLAT. SNORING AND SATS (oxygen saturation) 87%. O2 (oxygen) at 2 L (liters) PLACED AND HOB ELEVATED. SATS UP TO 92%.".

The patient was sedated with Ativan 2 mg IV and Geodon 10 mg IM in a period of 37 minutes. 18 minutes later, the patient was flushed, diaphoretic, and not following commands. 33 minutes after the Geodon was administered, the patient's oxygen saturation dropped to a critical level.


1920 - "PT'S BP HAS BEEN DROPPING, NOW 79/45. DR (staff #40) and DR (staff #41) TO ROOM FOR EVAL (evaluation). PT PLACED IN TRENDELENBURG (head of bed tilted down with foot of bed tilted up to assist with rise in blood pressure). PULSES AND STRONG AND PALPABLE IN RADIAL AND PEDAL PULSES. PT DOES RESPOND AND STIR AND SLIGHTLY OPEN EYES AND MUMBLE WHEN TOUCHED. SKIN DRY AND MUCH LESS FLUSHED."

Forty (40) minutes after the last dose of sedation was administered, the patient's blood pressure dropped to a critical level. The side effects of benzodiazeine includes central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, paradoxical reactions, dysarthia, and lethargy. In more serious cases, symptoms may include ataxia, hypotonia, hypotension, cardiovascular depression, hypnotic state, coma, and death.

1923 - "BP IMPROVED AND WDL (within defined limits). HEAD REPOSITIONED AS PT DOES SNORE AND SATS ARE 91% IF CHIN IS DROPPED."

1940 - "BP IN WDL OUT OF TRENDELENBURG. PT CONTINUES TO RESPOND WHEN TOUCHED, BY MUMBLING OR MOVING."

1945 - "BP STABLE, SATS HOLDING AT 96%, HR 102. NO LONGER ONE ON ONE WITH PT. SSPD OFFICER REMAINS AT BEDSIDE. WILL CONTINUE TO MONITOR AND CHECK ON PT OFTEN, PT VIEWED ON TELEMONITOR AT LVN STATION. SSPD STILL HAVE HAND CUFFS ON AND SOFT LEG RESTRAINTS THAT THEY PLACED AND VOICE THEIR DESIRE TO KEEP THEM ON."

2035 - "PT MUMBLING, TURNED OVER ONTO SIDE. O2 CANNULA OFF OF NOSE AND AROUND PT'S NECK AFTER HE TURNED. O2 CANNULA TAKEN OFF. HOB LOWERED AS IT APPEARS MORE COMFORTABLE FOR PT ON HIS SIDE. WILL CONTINUE TO MONITOR."


0130 - "DR (staff #41) RE EVAL DONE AND IS GOING TO DC (discharge) PT."

The patient was sedated with Ativan 2 mg IV (in 2 separate doses of 1 mg) and Geodon 10 mg IM in a period of 37 minutes. 18 minutes later, the patient was flushed, diaphoretic, and not following commands. 33 minutes after the last dose of sedation was administered, the patient's oxygen saturation dropped to a critical level. 40 minutes after the last dose of sedation was administered, the patient's blood pressure dropped to a critical level.









29191

Based upon record review and interview, the facility failed to follow their own policy for restraints and ensure the restraints were ordered by a physician, the least restrictive method of restraint was used, the patients were assessed and monitored while in restraints, and ensure the patients were released from restraints once the unsafe situation ended in 2 (#37, #38) of 13 (patients #16 and #28 - #40) patient records reviewed.

This deficient practice had the likelihood of harm to all patients receiving services in the facility.


A review of the medical record for patient #37 revealed the following information:

Patient #37 was a 19 year old male, who presented after ingesting salicylates. Patient reported that several years ago he tried to hang himself with his belt. Patient reported he had smoked some marijuana, drank some whiskey and took 60 pills of aspirin and came to the hospital.

Review of the RN notes in the Emergency department revealed:

"11/12/16 - 1907 Pt to room 15 via w/c w/ uncle at side. Pt tearful upon entering room, uncle attempting to get pt out of w/c and take pt's jacket off, pt appearing to become upset, This nurse asked pt's uncle to stop so pt could get out of w/c on own, pt becoming more aggressive, attempting to push w/c out of room, pt crying, yelling "You don't know what the fuck I've been thru" , pt's uncle grabbed pt in a head lock and pt fell out of w/c with uncle falling onto pt, pt was screaming, pt and uncle wrestling on ER floor, pt laid on back w/ uncle laying on top of pt holding pt down, SSPD notified of need for assistance.

This practice is not in compliance with the regulatory requirement that hospitals must maintain adequate number of staff to meet the needs of patients.

1912 - Pt and uncle stood up and pt walked back into room and laid on stretcher. 1918 - SSPD at bedside.

1925 - XXX RN and myself and two SSPD officers in room. Pt agreed to walk with us to Room 17. When he got out of the room he bolted, running and SSPD officers gave chase and had to take the pt down in the hallway near registration. Pt was put in cuffs. Pt yelling and laughing and jumped up when allowed and walked with the officers to Room 17.

Unless a patient is in police custody, application of handcuffs is not permissible under the regulation.

1930 - SSPD and staff trying to calm pt but he reared off the stretcher and tried to jump off. Soft restraints applied for his safety. Soft restraints applied to lower limbs, handcuffs were placed by SSPD and remain in place. "

Review of physician's hand written ED orders revealed the following orders: "11/12/16 - 1930 Soft restraints, Haldol 10 mg IM".

Review of the electronic physician's order revealed the following orders: "11/12/16 - 2009 Soft wrist restraints-bilateral, Soft ankle restraints-bilateral, Physical Hold for Calming/Protection, Seclusion, Haldol 10 mg. "

The patient never had soft wrist restraint applied due to the handcuffs being applied. The patient was not in the custody of the SSPD, so the handcuffs were inappropriate in the care setting because a less restrictive intervention had been ordered. The restraint orders did not state the criteria for release. The order for the Haldol did not have the reason for being given and there was no documentation in the nurses notes that the Haldol had been given.

Further review of the ED record revealed the following:

2332-Soft leg restraints removed. Pt. verbalized understanding and relates that he will remain calm and will not run away again .... "

Documentation revealed patient was calm and cooperative and officer removed handcuffs. Continued documentation revealed patient was cooperative and even fell asleep. However, the ankle restraints were not removed until 3 hours later.

A review of patient #38's record revealed the following information:

Patient #38 was a 22 year old male, who presented to the ED with EMS on 11/25/16 at 1625. Per EMS the patient reported he took 2 gms (grams) of Meth (methamphetamines) po (by mouth) and approximately 20 Xanax (benzodiazepine used to treat anxiety) prior to being arrested.

Review of the RN notes in the Emergency department revealed:

11/25/16 1625 - "pt speech slurred, garbled, groans. Pt does not follow commands. Pt w/ridged extremities, bouncing body, arms and legs on stretcher. Pt placed on monitor. ST (sinus tachycardia) at 128 noted w/ elevated T wave. Pt speaks loudly 'don't shock me' ....Left wrist hand cuffed to stretcher side rail on arrival to ER 17 per officer Pruitt. Pt is in SSPD custody per Officer Pruitt ...."

1631 - "LAB NOTIFIED OF LAB DRAW ORDERED BY MD."

1632 - "PT IS SUPINE IN BED AND IS MALIING (sic) BODY SHAKE BY TENSING UP HIS BODY AND MOVING HIS SHOULDERS UP AND DOWN AS WELL AS HIS LEGS. PT STATES HE TOOK 2 GRAMS OF METH AND 20 XANEX (sic). MD HAS ORDERED LAB DRAWS FOR DIAGNOSIS. PT IS HANDCUFFED TO BED AND POLICE IS IN HALLWAY."

1636 - "LAB HERE TO DRAW BLOOD"

1655 - "URINAL HELD AT PENIS TO URINATE AND PT. STATE HE CAN'T URINATE. PT. TRIED FOR 15 MINUTES TO USE URINAL TO NO AVAIL. IN AND OUT CATHETER TO OBTAIN UA (urine sample) MD'S ORDERS. PT. IS HOLLERING AND SCREAMING. TWO OTHER NURSES AND ALL THREE POLICE IN HOLDING PT. HE IS KICKING AND CONTINUES TO SCREAM AFTER PROCEDURE COMPLETED. PT. AWAITS LAB RESULTS AND FURTHER MD ORDERS"

According to the facility's own policy, a forced hold on a patient to give medications or treatment is recognized as a physical restraint. The physical restraint was done without a physician's order.

1705 - "HALDOL (antipsychotic) 5 MG GIVEN IM ...BENADRYL 50 MG GIVEN IM AS ORDERED."

The physician's order for Haldol did not contain any indications for the drug to be given. There was no documentation the patient was continuously monitored every 15 minutes for the psychological and psychological effect of the restraint/seclusion on the patient. There was no documentation of a face-to-face observation by staff members.

11/26/16 0042 - "DR (staff #41) TO BEDSIDE FOR RE-EVAL."

0054 - "PT MEDICALLY CLEARED, DR (staff #41) WRITES ON DC PAPERWORK FOR ..., SSPD OFFICER. FOLLOW UP INSTRUCTIONS GIVEN. ALL QUESTIONS ADDRESSED AND ANSWERED. PT. AND/OR FAMILY VERBALIZED UNDERSTANDING OF DISCHARGE INSTRUCTIONS. PT DISCHARGED TO HOME WITH D/C INSTRUCTIONS."

0058 - "PT AMBULATES OUT OF THE ER WITH 2 SSPD OFFICERS WITH STEADY GAIT."


A review of the facility's policy titled, "Restraint and Seclusion", revealed the following information:

"I. POLICY

Restraint or seclusion is only used to ensure the immediate physical safety of the patient, a staff member, or others and is provided in a safe manner.

Attachment A


Examples of Physical Restraint ...


Device: Holding to give medications or treatments
Not Restraint: Voluntary
Restraint: Forced


An interview was conducted on 1/12/16 at 0845, with the ED Director (staff #11) and the future Interim ED Director (staff #38) in the ED Director's office. Staff #11 was informed the subject of the interview would be physical and chemical restraints. Staff #11 quickly responded, "Oh, we don't do chemical restraints anymore." Staff #11 stated the ED had taken Geodon off of their pharmacy formulary and Haldol and Ativan were their "drugs of choice" when needed for patients with violent behavior. When Staff #11 was asked about the SSPD being used in the ED to assist with violent patients/families, she agreed that the SSPD did assist the ED with violent patients and had handcuffed patients that were combative to staff and others. When asked if the PD handcuffed the patients to the stretcher rails, she stated they did not ever handcuff patients to the bed or rails. The facility had hired security on nights and weekends only, so the SSPD assisted the ED frequently.

Based upon record review, the facility failed to ensure a face to face evaluation was conducted within one hour after the initiation of restraints for 1 (#37) out of 13 (patients #16 and #28 - #40) patient records reviewed.


A review of the medical record for patient #37 revealed the following information:

Patient #37 was a 19 year old male, who presented after ingesting salicylates. Patient reported that several years ago he tried to hang himself with his belt. Patient reported he had smoked some marijuana, drank some whiskey and took 60 pills of aspirin and came to the hospital.

Review of the RN notes in the Emergency department revealed:

"11/12/16 - 1907 Pt to room 15 via w/c w/ uncle at side. Pt tearful upon entering room, uncle attempting to get pt out of w/c and take pt's jacket off, pt appearing to become upset, This nurse asked pt's uncle to stop so pt could get out of w/c on own, pt becoming more aggressive, attempting to push w/c out of room, pt crying, yelling "You don 't know what the fuck I ' ve been thru," pt 's uncle grabbed pt in a head lock and pt fell out of w/c with uncle falling onto pt, pt was screaming, pt and uncle wrestling on ER floor, pt laid on back w/ uncle laying on top of pt holding pt down, SSPD notified of need for assistance.

This practice is contrary to the regulatory requirement that hospitals mus have adequate number of staff to meet the needs of patients.

1912 - Pt and uncle stood up and pt walked back into room and laid on stretcher. 1918 - SSPD at bedside.

1925 - XXX RN and myself and two SSPD officers in room. Pt agreed to walk with us to Room 17. When he got out of the room he bolted, running and SSPD officers gave chase and had to take the pt down in the hallway near registration. Pt was put in cuffs. Pt yelling and laughing and jumped up when allowed and walked with the officers to Room 17.

Unless a patient is in police custody, application of handcuffs is not permissible under the regulation.

1930 - SSPD and staff trying to calm pt but he reared off the stretcher and tried to jump off. Soft restraints applied for his safety. Soft restraints applied to lower limbs, handcuffs were placed by SSPD and remain in place."

Review of physician's hand written ED orders revealed the following orders: "11/12/16 - 1930 Soft restraints, Haldol 10 mg IM "

Review of the electronic physician's order revealed the following orders: "11/12/16 - 2009 Soft wrist restraints-bilateral, Soft ankle restraints-bilateral, Physical Hold for Calming/Protection, Seclusion, Haldol 10 mg. "

The patient never had soft wrist restraint applied due to the handcuffs being applied. The patient was not under arrest and was not in the custody of the SSPD so the handcuffs were inappropriate in the care setting because a less restrictive intervention had been ordered. The restraint orders did not state the criteria for release. The order for the Haldol did not have the reason for being given and there was no documentation in the nurses notes that the Haldol had been given. There was no documentation of a face-to-face evaluation within one hour of the initiation of restraints.

Further review of the ED record revealed the following:

"11/12/16 - 2032-Pt calm and cooperative. Pt relates that he will be cooperative and will not try to run again. Officer at bedside. Officer removes handcuffs. Pt. is alert and oriented x4.

2332-Soft leg restraints removed. Pt. verbalized understanding and relates that he will remain calm and will not run away again .... "

Documentation revealed patient was calm and cooperative and officer removed handcuffs. Continued documentation revealed patient was cooperative and even fell asleep. However, the ankle restraints were not removed until 3 hours later.


A review of the facility's policy titled, "Restraint and Seclusion", revealed the following information:

"I. POLICY

Restraint or seclusion is only used to ensure the immediate physical safety of the patient, a staff member, or others and is provided in a safe manner....

I. Assessment and Monitoring of Restraint/Seclusion

1. Restraint used for the management of violent behavior:

One-hour face-to-face Assessment: A responsible licensed independent
practitioner, qualified registered nurse or physician's assistant shall perform a
face-to-face assessment of the patient's physical and psychological status
within 1 hour of the initiation of restraint or seclusion. Registered nurses or
physician assistants who perform such assessment shall be trained and have
demonstrated competence in the management of violent behavior as specified
in Attachment B of this policy.

Based on interview and record review, the facility failed to ensure a timely analysis and reporting of quality assurance data that was being collected from the timeframe of April 2016 to December 2016.

Findings include:

Review of facility's "Quality Reporting Schedule" dated 2016 and 2017 revealed the following:

April -June 2016 was the designated 2nd quarter;

July - September 2016 was the designated 3rd quarter;

October - December 2016 was the designated 4th quarter;

and January -March 2017 was the designated 1st quarter.


Review of the 2nd quarter information which ended June 2016 revealed 2 months later in September 2016 wound care, radiology, laboratory, outpatient services, inpatient rehabilitation, rehabilitation services and infection prevention and control were scheduled to report their information to quality.

Review of the 3nd quarter information which ended September 2016 revealed 2 months later in December 2016 wound care, radiology, laboratory, outpatient services, inpatient rehabilitation, rehabilitation services and infection prevention and control were scheduled to report their information to quality.

Review of the 4th quarter information which ended December 2016 revealed 2 months later in March 2017 wound care, radiology, laboratory, outpatient services, inpatient rehabilitation, rehabilitation services and infection prevention and control were scheduled to report their information to quality.

During an interview on 01/10/2017 after 8:40 a.m., Staff #'s 5 and 13 reported staff were sending their quality information to them on a monthly basis, but were making their verbal report of that information to quality on a quarterly basis. Staff #5 reported during the monthly quality meetings they were going through all of the information in general. During the monthly meetings they were just to provide general information and for questions to be asked. Different departments had a scheduled date of when they verbally presented their information to the quality committee.

Physician #26 reported he took the quality information to the Governing Board on a quarterly basis.

Staff #5 and Physician #26 confirmed the reporting schedule was behind.

Based on interview and record review, the facility failed to ensure 2 of 8 credentialing files were completely examined by the medical staff for physician's providing telemedicine (Physician #'s 20 and 21).

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

Findings include:

Review of physician credentialing files revealed the following:

Physician #20 completed a credentialing application on 04/16/2016 and completed a "CLINICAL PRIVILEGE DELINEATION-INTERNAL MEDICINE" form which was signed off by the Medical executive committee on 08/09/2016. There was a category for telemedicine on the form which was not checked.

Physician #21 completed a credentialing application on 06/01/2015 and completed a "CLINICAL PRIVILEGE DELINEATION-INTERNAL MEDICINE" form which was signed off by the Medical executive committee on 07/14/2015. There was a category for telemedicine on the form which was not checked.

Review of the credentialing files revealed both physicians were sent letters of appointments without having a completed delineation of privileges request.

During an interview on 01/10/2017 after 3:00 p.m., Physician #22 reported Physician #'s 20 and 21 were included in physicians who provided telemedicine service for the hospital.

During an interview on 01/11/2017 after 10:30 a.m., Staff #26 confirmed Physician #'s 20 and 21 failed to complete the delineation forms.

Review of the facility's 2016 "MEDICAL STAFF BYLAWS" revealed the following:

"6.6 Telemedicine
Practitioners providing only telemedicine services to the hospital from a distant site will be appointed to the medical staff, but must be granted privileges at this hospital. Practitioners providing official reading of images,tracings, or specimens through a telemedicine mechanism must:

a. Must be granted clinical privileges that include these services ...

c. Requests for telemedicine privileges will be processed through the established procedure for reviewing and granting privileges. Information included in the completed practitioner application for telemedicine privileges shall be collected in the usual manner."

Based on interview and record review, the facility failed to ensure assessments and plans were accurately developed on Emergency Department (ED) patients. This deficient practice was found in 2 of 50 sampled patients (Patient #'s 24 and 25).

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

Findings include:

Review of Emergency Department (ED) records revealed Patient #24 was a 67 year old male who presented to the ED on 01/01/2017 at 11:01 a.m.. Patient #24 had complaints of sudden onset of being dizzy, stumbling, and trouble using his right hand.

Review of the ED nursing triage assessment at 11:07 a.m. revealed Patient #24 complained of right sided weakness, episodes of expressive aphasia (difficulty speaking). Patient #24 was categorized with an Emergency Severity Index score of 2 (Urgent).

Underneath the Neurovascular assessment the documented neuro findings listed that were outside of the defined limits was "left sided weakness/left sided facial drooping/difficulty talking/since 0700 headache since 0300."

Underneath the Eyes, Ears, Nose and Throat Assessment there was a selection made indicating everything was within the defined limits.

Underneath the Musculoskeletal/Functional Assessment revealed documentation there was "left side weakness."

Review of the ED physician's assessment at 11:09 a.m.. revealed Patient #24 had right sided weakness, right facial dropping and acute cerebral vascular accident.

Review of ED nurses notes at 12:44 p.m.,revealed Patient #24 was medicated for a stroke. "Patient swallowed asa (Aspirin) but having difficulty swallowing the water. Dr ...made aware. Pt NPO at this time."

Review of the "ED Assessment- Adult" key which explained what could be selected by nursing for each body system revealed the following:

"Ears, Nose Throat WDL?__Yes If yes, skip to next section)____No-describe all findings outside of defined limits (WDL=Eyes clear, no drainage.Ears non-tender, no drainage. Nose septum symmetrical, nares patent, no drainage. No difficulty swallowing. Trachae midline.)"

There was a place for nursing to assess the swallowing capabilites on the assessment, but it was not assessed by nursing. Nursing also gave a conflicting assessment of which side of the body was affected by the stroke.

Staff #27 confirmed the missing assessment and the conflicting information that was documented.

Review of an ED record revealed Patient #25 was a 7 month old female who presented to the ED on 01/03/2017 at 1:36 p.m..

Review of the ED triage assessment at 2:00 p.m. revealed the chief complaint was "DECREASED URINARY OUTPUT AND CONSTIPATED "

Underneath the pain assessment nursing documented "PT CRIES WHEN DIAPER CHANGED. ABD TOUCH. PT QUIET WHEN NOT BEING TOUCHED."

Underneath the gastrointestinal assessment there was documentation indicating the patient was not within defined limits. The findings documented listed outside the defined limit was "G BUTTON NOTED" (gastrostomy button used as avenue for nutrition and medication administration). Nursing failed to complete this category with the other symptoms that were mentioned under the pain section.

Underneath the genitourinary/reproductive assessment there was documentation indicating the patient was within defined limits. Nursing staff failed to list the problems with Patient #25's urinary status in this section.

Staff #27 confirmed the missing assessment.

Based on document review and interview, the facility failed to follow its policy for documentation of blood transfusion in 1 (#10) of 3 (#9, #10 and #11) patients medical records reviewed for blood transfusions.


Findings include:


On 1/11/2017 three (3) blood transfusion recipients medical records were reviewed (Patients #9, #10 and #11).


Patient #10 received four (4) units of blood.


Unit #1 began 12/26/2016 at 11:00 a.m.. Complete vital signs were recorded as taken at 15 minutes into the transfusion. Complete vitals signs were taken again 1 hour into the transfusion. A blood pressure only was taken at the beginning of the second hour. Complete vitals signs were taken at the completion of the blood transfusion. The blood transfusion was completed at 1:15 p.m.. The time required for the first transfusion was 2 hours and 15 minutes.


Unit #2 began 12/26/2016 at 2:15 p.m.. Complete vital signs were taken at 15 minutes into the transfusion and each hour until completion was documented at 4:55 p.m.. The time required for this transfusion was 2 hours and 40 minutes.


Unit #3 began 12/28/2016 at 12:00 p.m.. Complete vital signs were documented at 15 minutes into the transfusion and each hour until the transfusion was complete. The transfusion was completed at 3:00 p.m..


Unit #4 began on 12/28/2016 at 4:45p.m.. Complete vital signs were documented at 15 minutes into the transfusion. Complete vital signs were documented at the beginning of the first hour. The time was documented for the second hour but no vital signs were recorded. The completion of the transfusion was not recorded.


Further investigation of the medical record indicated patient #10 was transferred to a higher level of care. A review of the Memorandum of Transfer (MOT) indicated the consent for transfer was dated and timed for 12/28/2016 at 1040 a.m.. The transporting Emergency Medical Service was contacted at 12/28/2016 at 3:20 p.m.. Unit #4 began at 4:45 p.m. on 12/28/2016.


Further investigation of the medical record for patient #10 failed to indicate a resolution of the fourth blood transfusion. Vital signs were not recorded and the Post transfusion assessment was not documented. The staff failed to include the disposition of the patient at the completion of the fourth unit of blood that was transfused.


The above medical record review was facilitated by staff #33 who confirmed the final blood transfusion record was incomplete.


On 1/12/2017 in the morning, a review of the Policy, "Blood Transfusion and Procedure for Transfusion Reaction Guidelines" was conducted. The policy, at item "L", indicated "Vital signs are be taken prior to the start of transfusion, at 15 minutes, hourly during remainder of transfusion and upon completion. Documentation of sequential vital signs using the Blood Transfusion Record intervention.


Note: With each unit of blood product, the assessment and vital signs sequence begins again."


The policy at item "O", indicated "Discontinuation of Blood after Transfusion:

1. Flush blood tubing with normal saline.

2. Resume previously ordered IV (intravenous) fluids or maintain saline lock.

3. Verify all fields are complete on Blood Transfusion Record.

4. If reactions noted, state so in the Record.

5. Document volume and type

6. If patient is to be discharged post transfusion, provide the patient /family with post transfusion care, symptoms to watch for and actions to take if symptoms arise at discharge."

Based on observation, record review, and interview, the infection control officer failed to develop a system that ensured the hospital was a clean and sanitary environment in six of the hospital departments (Cath Lab, GI Lab, Laboratory, Emergency Room, Pharmacy, and Dietary.)


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


Findings include:


During a tour of the facility from January 9-12, 2017, with staff members assisting the surveyors, the following infection control issues were observed in the following departments of the hospital:


Cath Lab Department:


In the Pyxis medication system on the bottom shelf observed dead bugs and dust particles.


On the Crash cart found two (2) expired protective intravenous safety IV catheter 18 gauge. Expiration date was 07/2016.


There was visible dust particles on the bottom shelf of the crash cart.


An interview with Staff #31 and #39 on 01/09/2017 at 1:30 PM confirmed the above findings during the tour of the Cath Lab.



Gastro Intestinal Lab Department:


During the tour of the GI lab observed multiple rust spots on the GI cart that stores the reprocessing machine that it used for the endoscopy procedures performed on patients. Rust spots on metal cannot be sanitized.


An interview with Staff #31 and #32 on 01/11/2017 at 11:30 AM confirmed the above findings during the tour of the GI Lab.



35515



Laboratory Department:


A tour of the facility's lab areas was conducted on 1/9/2017. The lab's blood product storage refrigerator observation revealed the following findings:


The outer areas of the 5 metal pull out drawers were visibly dirty and had multiple yellowed and dirty labels taped to the drawers. One of the labels was partially detached from the drawer.


A drawer that contained multiple units of packed red blood cells (PRBC), was visibly dirty and contained unidentifiable debris.


A drawer that contained multiple units of PRBCs, was visibly dirty, with rust colored stains. The back of the drawer contained a torn and dirty book and a piece of white tape stuck to the bottom of the drawer that appeared to contain blood stains.


The bottom drawer contained multiple items including 2 red plastic blood tube holding rack that were visibly covered with dust. One of the racks held blood tubes containing blood. The surface of the drawer was visibly dirty and contained multiple areas of what appeared to be mold.


An interview was conducted with the facility's Lab Director, staff #35, during the tour. Staff #35 confirmed all of the above observations. A policy related to the cleaning of the blood product storage refrigerator was requested from staff #35. Staff #35 stated there was no written policy or procedure related to the cleaning of the refrigerator.


An interview was conducted with the facility's Infection Control nurses, staff #33 and #34. Both confirmed there was no written policy or procedure related to the cleaning of the blood product storage refrigerator. Both staff #33 and #34, stated they had performed environmental rounds in the Lab Department but, had not observed the inside of the refrigerator and were unaware of its condition.









10135


Emergency Department:

During an observation on 01/09/2017 after 1:40 p.m., a central venous catheter kit with an expiration date of 12/2015 was found stored on a crash cart.

Review of the January 2017" CRASH CART DOCUMENTATION FORM" revealed supplies were checked from 01/01/2017-01/09/2017 and staff indicated all supplies were current.

Staff #11 confirmed the observation.


Pharmacy Department:

During an observation on 01/11/2017 after 9:10 a.m. the following was found in the pharmacy;

The baseboards in the room were found to have a build-up of dust and dirt.

The tile flooring had indentations and the tile had broken areas throughout the room. The subfloor underneath could be seen. There was no way the tiles could be properly sanitized.

Bags of intravenous fluids were stored in plastic bins on the shelves which were not covered. The inside of the plastic bins were soiled with spills and dust.

Bags of intravenous fluids and scrub pads were stored on a shelf in the ante-room outside of the sterile compounding area. Two bottles of cleansing solution that was being used to clean the room was stored on the shelf with the supplies.

A plastic spray bottle had a label taped on it that identified the solution in the bottle as being Isopropyl alcohol. There was no documentation on the bottle of when the solution was poured in it nor was there an expiration date on the solution.


Review of the January 2017 "IV Room Personnel Documentation of Quality Assurance for IV Room Maintenance" revealed the following was documented:

According to documentation on the form the room temperature should be less than 70 degrees. On 01/01, 01/02, and 01/11/2017 the temperature was documented as being 70 or above. There was no documentation on the form of when the temperature came back into range on these days.


According to documentation on the form the buffer room air pressure should be greater than 0.02. There was documentation that the air pressure was less than 0.02 from 01/01-11/2017.

According to documentation on the form, the humidity should be between 35-65 percent. On 01/06-08/2017 the humidity was out of range of less than 35 percent. There was no documentation on the form to indicate if the humidity came back into range on these three days.

Staff #'s 14 and corporate staff #'s 16 and 17 confirmed the observations.


28659


Dietary Department:


On 01/09/2017 at 1:30 PM, during the tour of the dietary department, clean pans were observed stacked one upon the other. The first column held 8 deep pans. All 8 of the deep pans were observed wet inside and water was dripping off the outside, the second column was 8 smaller pans. All 8 pans were wet on the inside and dripping water off the outside, the third column was 14 small pans. The top 5 pans were wet on the inside and dripping water off the outside.


This observation was confirmed by the Dietary Director, who gave the tour. She confirmed the pans should have been hand dried or stacked on their sides to allow air drying to avoid accumulation of water inside the surface of the pan which would come in contact with food.


Moisture trapped inside cooking utensils that are stored, increased the risk of bacterial contamination of food prepared for both patient and staff population.

Based on record review and interview, the surgeon failed to complete a History and Physical examination form for the patient having a surgical procedure for 1 (#45) of 11(#3, #41, #42, #43, #44, #45, #46, #47, #48, #49, and #50) surgical charts reviewed. Also, the facility failed to follow their own Medical Staff Rules and Regulations on History and Physical examination note.

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

Findings include:

A review of Patient #45's record revealed that the surgeon failed to document and complete the history and physical information for the patient's medical conditions prior to surgery on the History and Physical form dated 01/10/2017. There was no documented height, weight, allergies, family history, digestive cancer, surgical history, past medical history, sedation risks, current medications, and/or anesthesia plan. The facility form that was to be used for endoscopy case indicated that all the following listed above was to be addressed on the facility's form.

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

"Medical Staff Rules and Regulations:

E. MEDICAL RECORDS

The attending practitioner shall be responsible for the preparation of a complete and legible medical record for each patient. Its contents shall be pertinent and current.

1. Content

This record shall include identification data; complaint; personal history; family history; history of present illness; physical examinations; system review, provisional diagnosis; special reports such as consultations, clinical laboratory and radiology services, and others; medical or surgical treatment; operative reports; pathological findings; progress notes; final diagnosis; condition on discharge; summary or discharge note (clinical resume); and autopsy report when performed.

2. History and Physical Examination

History and physical examinations shall be completed as described in and required by the Medical Staff Bylaws and as noted in Sections D.4 and D.5 above. In addition to the general guidelines for history and physicals as outlined in the Medical Staff Bylaws, for patients (observation or admitted) with emotional or behavioral disorders physicians should include at least the following elements as applicable:

a. A history of mental, emotional, behavioral and substance use problem(s), their co-occurrence and treatment.

b. Current mental, emotional, and behavioral functioning, including a mental status examination.

c. Maladaptive or problem behaviors.

d. A psychosocial assessment...

3. History and Physical Examination Prior to Invasive Procedure

History and physical examinations shall be completed as described in the Medical Staff Bylaws. Pre-operative history and physicals should be dictated 24 hours prior to the time of scheduled surgeries or procedures requiring anesthesia services in order to allow reasonable transcription time. In cases where a complete history and physical is not present in the medical record, the clinical supervisor will request the admitting physician, or if unavailable, the surgeon to record a pertinent handwritten history and physical in the medical record prior to the induction of anesthesia.

A history and physical must be performed within thirty (30) days of admission. If a history and physical is performed within 30 days of admission, a History and Physical Addendum Note or dictated summary of review of history and physical with new or changed assessed findings will be required. If history and physical is older than thirty (30) days, a new examination and history and physical is required.
All non-MD and non-DO staff members must have a primary care H&P for patients.

(NOTE: Podiatric patients with an ASA Class I or II may be admitted by podiatrists who shall perform and dictate an appropriate history and physical. Patients with an ASA Class III will require a family Practice consultation with the assessment and dictation of the History and Physical performed by the Family Practice physician.)

4. History and Physical for Outpatient Services

The history and physical will minimally consist of a chief complaint, brief history, including current medications and allergies and a system-specific physical to include a respiratory and cardiac examination, diagnosis/problem list with initial plan of care."


An interview with Staff #30 and #31 on 01/11/2017 at 2:00 PM confirmed the above findings and that the facility's Medical Staff Rules and Regulations on History and Physical were not followed.

Based on record review and interview, the surgeon failed to time and date the Disclosure and Consent form prior to the surgical procedure for 6 (#3, #43, 46, #48, #49, and #50) of 11 (#3, #41, #42, #43, #44, #45, #46, #47, #48, #49, and #50) surgical records reviewed. Also, the facility failed to follow their own policy on Informed Consent.

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

Findings include:

A review of Patient #3's record revealed the Disclosure and Consent Medical and Surgical Procedures form was dated and timed the day before the surgery on 01/09/2017; therefore, there was no way to determine if the surgeon had seen the patient prior to the surgical procedure on 01/10/2017.

A review of Patient #43's record revealed the Disclosure and Consent Medical and Surgical Procedures form was dated and timed the day before the surgery on 01/09/2017; therefore, there was no way to determine if the surgeon had seen the patient prior to the surgical procedure on 01/10/2017.

A review of Patient #46'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 with the surgical procedure had been discussed with the patient prior to the surgical procedure.

A review of Patient #48'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 with the surgical procedure had been discussed with the patient prior to the surgical procedure. The consent form was dated 10/24/2016 without a time; however, the surgery date was not until 11/04/2016.


A review of Patient #49'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 with the surgical procedure had been discussed with the patient prior to the surgical procedure. The consent form was dated 09/29/2016 without a time; however, the surgery date was not until 10/21/2016.

A review of Patient #50'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 with the surgical procedure had been discussed with the patient prior to the surgical procedure. The consent form was dated 11/28/2016 without a time; however, the surgery date was not until 12/01/2016.

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

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

"Policy

It is the policy of Hopkins County Memorial Hospital that the patient be given the opportunity to give an "informed consent" prior to the performance of procedures that place the patient at risk, including diagnostic or therapeutic procedures.

II. Guideline:

A. Process of Informed Consent
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)

B. Written Verification

Written verification of the informed consent must 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.

C. Information Provided

Information provided to the patient 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.

D. Obtaining Informed Consent

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

E. 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.

F. Duration of Informed Consent

1) Informed consent remains in effect until the patient revokes the consent

2) Circumstances have changed which affect the nature of the risks of the procedure, and/or the alternatives to the procedure for which information was provided and consent was received."



An interview with Staff #28 and #31 on 01/11/2017 at 2:00 PM confirmed the above findings and the facility's policy was not followed.