The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

PARIS REGIONAL MEDICAL CENTER 865 DESHONG DR PARIS, TX 75460 Oct. 16, 2019
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on document review and interview, the facility failed to protect the patient's right to make informed decisions on their care for 1 (Patient #1) of 14 patients records reviewed. The facility failed to ensure that patients or their representatives were provided with the risks and benefits as related to their procedures.

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


Findings include:


Patient #1


Patient #1 is an [AGE]-year-old male admitted on [DATE] with a right humerus fracture.

A review of Patient #1's medical record revealed an order was written on 4/24/2019 at 12:45 PM for a Peripheral Inserted Central Catheter (PICC). The order was as follows:
" ...Obtain patient consent for Peripheral Inserted Central Catheter (PICC). Insert PICC: PICC Nurse or Interventional Radiology ..."

A review of the informed consent for Patient #1 to have a PICC line placed revealed the PICC line qualified nurse was not listed on the consent. Further review revealed Staff #21 listed her name where the patients name should have been listed.

A review of the policy titled, Informed Consent with a revision date of 7/2017 revealed:

" ...GUIDELINE:

1. Before a patient or a legally authorized representative gives consent to any medical treatment requiring informed consent, the physician must disclose information to the patient, or the legally authorized representative, the risks, benefits, and alternatives involved in such medical treatment to make an informed decision.

A review of the policy titled, CENTRAL VENOUS CATHETER AND PERIPHERALLY INSERTED CENTRAL CATHETER INSERTION AND MANAGEMENT with a revision date of 10-2016 revealed:


4.0 PERIPHERALLY INSERTED CENTRAL CATHETER (PICC):
OVERVIEW:

Prior to inserting a PICC, it is important that clinicians understand and perform certain preparation steps. These steps include evaluating the patient, his/hers medical history, and his/her vascular condition; educating the patient about the medical care and treatment; obtaining a physician's order and informed consent; complying with requirements for a maximal sterile barrier to mitigate the risks for infection; and verifying through a "time-out" that the correct data is on file and the procedure is still the appropriate thing to do ..."

An interview was conducted on 10/15/2019 with Staff #1 after 9:30 AM. Staff #1 was asked why the consent form for the PICC Insertion was not completed correctly and missing the PICC nurses name for insertions. Staff #1 stated, "I don't really know, and Staff #21 is not one of our PICC line insertion nurses."

An interview was conducted with Staff #11 on 10/16/2019 at 2:15 PM. Staff #21 was asked if she completed her own informed consents for her PICC line insertions. Staff #21 stated, "Yes, I usually do but sometimes the nurses on the floor will do them if they have time and I am very busy." Staff #21 was asked how sure was that the correct information was given to the patients regarding the risks and benefits of the procedure. Staff #21 replied, "The risks and benefits are listed on the consent and I assume they go over them with the patient." Staff #21 was asked if she was sure the risks and benefits were discussed by the nurse on every consent. Staff #21 stated, "No." Staff # 21 was asked if she was sure the risks and benefits were properly discussed with Patient #1 before the procedure and if she was listed as the nurse inserting the PICC line. Staff #21 stated, "I'm sure the risks and benefits were discussed with the patient and I should be listed on the consent." Staff #21 was informed she was not listed as the RN that would be inserting the PICC line and therefore she inserted the PICC line without a valid consent from the Patient #1.



Staff #1 and #21 confirmed the above findings.
VIOLATION: PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT Tag No: A0145
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on document review and interview the facility failed to ensure patients were free from neglect (a form of abuse) in 2 (Patient #1 and #2) of 14 patients reviewed.


The facility failed to:

A. ensure physicians provided clear documentation of what their plans for treatment were for patients presenting with complaints of severe arm pain. There was no clear documentation in the medical record to determine if the patient received thorough assessments and treatment by the Emergency Department (ED) physicians.

B. ensure nursing staff treated severe pain in a timely manner and ensure nursing staff documented follow-up pain assessments after administration of pain medication.

C. ensure discharge instructions were given to family and skilled nursing facility to ensure proper care was received for a fractured humerus.


D. ensure staff followed doctors orders for new consults in a timely manner.



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


Findings include:


Patient #1


On 10/15/2019 a review of Patient #1's medical record with Staff #1 revealed the following:


A. Patient #1 is a [AGE] year old male arrived the emergency room by ambulance on 4/15/2019 at 11:52 AM with a stated complaint of "right shoulder and right arm pain". Initial nursing assessment at 11:56 AM by Staff #6 revealed vital signs of blood pressure 124/87, pulse 58, respirations 17, temperature 97.2, oxygen saturation of 97%. Pulse is regular and in normal sinus rhythm, oriented x 3 and confused, bruising to right ear, right side of face, and to right arm with swelling. Patient #1 had fallen at home prior to arriving to the emergency room . Staff #4's assessment at 11:59 revealed right arm pain to be a 6 on a 0-10 pain scale, 10 being severe with right arm tenderness. Staff #4 ordered a cat scan of the cervical spine, cat scan of the chest, chest x-ray, lab work, IV with normal saline and Lopressor (a medication used to lower blood pressure and heart rate). Further review of the medical record showed no x-ray was ordered for the right arm during the emergency room visit and no pain medication was given for a pain intensity scale of 6. Staff # 4 admitted Patient #1 at 3:27 PM to the hospital with a diagnosis of [DIAGNOSES REDACTED]


B. A review of the history and physical dated 4/15/2019 by Staff #9 revealed Patient #1 had some ecchymosis and a hematoma to his right arm. A consult would be ordered for Nephrology, Cardiology, Physical Therapy and Social Work. Physical exam by Staff #9 revealed, " ...Right arm examination has ecchymosis, swelling, [DIAGNOSES REDACTED], it looks like has multiple falls there ..."
Physical Therapy (PT) note dated 4/16/2019 at 11:01 by Staff #18 revealed Patient #1 stated a pain level of 8 on a numerical pain scale of 0-10, 10 being severe, in the right arm. There was no documented staff interventions for pain control in the medical record. Further review of the medical record revealed the next pain assessment and intervention documented was greater than 4 hours later at 3:09 PM. At 3:09 PM Patient #1 complained of pain in the right shoulder to be a 9 on a numeric pain scale of 0-10. Patient #1 was treated with 50mg of Tramadol and reassessed at 4:36 PM with a decrease in pain to a 2 on a numeric pain scale of 0-10. At 9:23 PM Patient #1 complained of pain in the right shoulder to be a 5 on a numeric pain scale. Patient #1 was given 50mg of Tramadol and reassessed at 10:23 PM with a decrease in pain to a 3 on numeric pain scale of 0-10. On 4/17/2019 at 6:39 AM Patient #1 complained of pain in the right shoulder to be a 5 on a numeric pain scale. Tramadol 50mg was given. Patient #1 was reassessed at 7:39 AM and pain level was documented as "acceptable". The PT note dated 4/17/2019 at 10:46 by Staff #17 revealed Patient #1 complained of right shoulder pain to be an 8 on a numeric pain scale of 0-10. No interventions or medications for pain control were documented by staff. At 12:37 PM Patient #1 complained of pain in the right shoulder to be a 6 on a numeric pain scale. Patient #1 was given 50mg of Tramadol at 12:37 PM and reassessed at 1:37 PM and pain level was documented as "effective". PT's note dated 4/18/2019 at 10:59 AM by Staff #17 revealed Patient #1 complained of pain in the right shoulder to be a 6 on a numeric pain scale of 0 -10. No interventions were documented for the treatment of the pain.

An interview was conducted on 10/15/2019 at 10:15 AM with Staff #1. Staff #1 was asked why was there a delay in treating the pain. Staff #1 replied, "There was no order for any pain medications until 2:46 PM and the order was acknowledged by the nurse at 2:53 PM and medication was given at 3:09 PM."

A review of the policy titled, Pain Management with a revision date of 7-2018 revealed the following:
" ...GUIDELINES:
2.0 Pain Assessment and Reassessment
2.1 A measure of pain intensity and a measure of pain relief as reported by the patient should be assessed by and documented as follows:
2.1.1 Upon admission
2.1.2 After any pain-producing event
2.1.3 With each new report of pain
2.1.4 Routinely at regularly department specific intervals (at least each shift)
2.1.5 After each pain management intervention once sufficient time has elapsed for the
the treatment to reach peak effects.

3.0 These assessments are documented on the physical assessment/reassessment, admission database, pain assessment, and pain reassessment following interventions in the electronic health record.

4.1 For the purposes of classification, mild pain will be considered a rating of 1-4, moderate
Pain a rating of 5-7, and severe pain a rating of 8-10.

11.0 Patient/Family Education

11.2 Upon discharge, patient instructions will be provided specific to pain management while at home, if applicable. These will include, but not be limited to, non-pharmacological interventions, prescriptions for analgesics, potential side effects, and the importance of reporting any inadequate pain relief and side effects to the physician as soon as possible.


On 4/18/2019 a discharge order was written by Staff #16 at 9:47 AM. Further review of the medical record revealed a right shoulder x-ray was ordered at 9:52 AM on 4/18/2019 by Staff #16. Results of the Shoulder x-ray dated 4/18/2019 revealed " ...Mildly displaced fracture through the shaft of the right humerus just below the intramedullary orthopedic hardware with approximately 1.5 cm lateral displacement of the distal fracture fragment and 1 cm overriding of the fracture fragments ..."

A review of the discharge summary dated 4/18/2019 by Staff #16 revealed, " ...the right shoulder x-ray demonstrated a midshaft humerus fracture with 75% displacement. Given the patients advanced age in poor overall health I discussed this case with Dr. Green on call orthopedics and he recommended placing the patient in his swelling and see him next week for a possible fracture orthosis ..."



C. A review of the discharge instructions was as follows:

" ...Discharge instructions:
New Medications:
Dilitiazem 120mg po QAM
Metoprolol 25mf Tab PO BIDWC

Discharge Activity: Resume activities as Tolerated, Sling to right arm/shoulder, Activities per Physical Therapy

Post Hospital Care
Follow up Referrals:
Cardiology
Internal Medicine

Discharge Plan
Discharge Disposition: Skilled Nursing Facility

Discharge Diagnosis
6. right humerus midshaft fracture present on admission ..."

A review of the discharge instructions did not reveal any instructions to follow up with an orthopedic for further evaluation or care and treatment of a fractured humerus.

Staff #1 was asked to provide documentation the patient was placed in a sling or immobilizer upon discharge. Staff #1 stated, "I do not see any documentation where the patient had one placed on him before he was discharged ." Staff #1 was then asked to provide documentation the skilled nursing facility was notified of the right arm fracture. No further documentation was provided for review.


Patient was discharged to a skilled nursing facility on 4/18/2019 at 16:50 PM.


Staff #1 confirmed the above findings.




Patient #1 was transferred back to the emergency room on [DATE] at 3:05 PM by the skilled nursing facility with a chief complaint of arm pain and arm seeping.

A review of the emergency room record revealed significant bruising and swelling that begins at the right shoulder and extends distally into the right forearm. An x-ray of the right humerus was completed on 4/21/2019 and results were as follows, "Right mid diaphyseal humeral fracture at the intramedullary rod site." MRSA (a drug resistant bacteria infection) labs were ordered at 4:55 PM. MRSA resulted as positive at 5:45 PM. An order was written by Staff #20 at 5:56 PM to admit Patient #1 to the hospital and consult orthopedics for evaluation and treatment of right arm fracture.

A review of the consult by the orthopedist revealed an orthopedic surgeon was consulted by phone on 4/18/2019 before discharge and the decision was made for the patient to follow up in a week in the office. A review of the discharge instructions on 4/18/2019 did not reveal any follow up appointments for orthopedics.

A review of the consult by orthopedics revealed Patient #1 was scheduled for an open reduction internal fixation of the right humerus with plate, screws, and cables for periprosthetic fracture on 4/23/2019. Patient underwent surgery for a fractured humerus on 4/23/2019.

Patient #1 was discharged to a Skilled Nursing Facility on 4/26/2019 at 3:35 PM.


Staff #1 confirmed the above findings.





Patient #2

A review of the medical record for Patient #2 on 10/14/2019 after 10:00 AM revealed the following:

Patient #2 is a [AGE]-year-old female admitted to the facility on [DATE] with a diagnosis of [DIAGNOSES REDACTED][DIAGNOSES REDACTED] with a vulvectomy in 2009, radiation cystitis after radiation treatment of Cervical cancer. She was operated on in August 2019 for a sacrum coccygectomy and excision of a peri coccygeal mass. Further review revealed on 10/03/2019 a non-emergent orthopedic consult was written at 7:45 PM. On 10/06/2019 at 12:11 PM the orthopedist on call, Staff #22, was contacted. Staff #22 informed the staff Patient #2 was an established patient of Staff #24's and he would text him but asked for ICU to officially notify him in the AM of the consult. Staff #23 evaluated Patient #2 at 1:30 PM on 10/6/2019 but no documented consult was found in the medical record. This was 3 days after the orthopedic consult order had been written. On 10/07/2019 Staff #24 consulted on Patient #2 at 7:02 AM. This was 4 days after the order was written for the orthopedic consult.


A review of the Medical Staff Rules and Regulations, revised and approved April 4, 2016, does not limit the time a consulted physician has to consult on a patient.


An interview was conducted on 10/16/2019 with Staff #25 after 9:30 AM. Staff #25 was asked what process was followed to notify physicians of a consult. Staff #25 stated, "The unit secretary informs the doctor they have a consult. They don't call them late if it is not an emergent consult, but they will call them the following morning." Staff #25 was asked why the consulting physician was not notified for 3 days on Patient #2. Staff #25 replied, "The unit secretary called in sick and I stepped in to help and it just got missed." Staff #25 was asked if there was a protocol on how the Unit Secretary was notified. Staff #25 replied, "No there isn't. She goes through the charts every morning to see if any consults were written overnight and calls the consulted physician at that time."

An interview was conducted with Staff #14 on 10/16/2019 after 11:00 AM. Staff #14 was asked to explain the process on how the physicians are contacted for a consult. Staff #14 replied, "We call them when we see the order or if the nurse informs us that there is an order. We don't call them late if it is not an emergency and we will just call them the next morning. Once we call them we place a pink sticker on the chart with the date and time contacted." Staff #14 was then asked how the nurses notified her of a consult. Staff #14 stated. "They will leave a note or just tell me in person."


Staff #1 confirmed the above findings.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on document review and interview, the facility failed to ensure surgical services were performed in a safe manner. The facility failed to ensure that there was documentation in the surgical chart that ensured timeouts were completed prior to the surgical procedure and follow their own policy regarding surgical time-outs in 3 (Patient #2, #7, and #8) of 14 records reviewed.



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


Findings include:


Patient #2

A review of Patient #2's medical record revealed the following:

Patient #2 was admitted on [DATE] for a surgical procedure. Further review of the surgical record revealed Patient #2 was taken to the Operating room at 3:55 PM, Procedure start time was 4:20 PM, Procedure stop time was 5:24 PM and the time the patient left the Operating room was 5:29. The documented time in the electronic health record for surgical "time-out" by Staff #26 was 4:31. This is 11 minutes after the start of the procedure. A review of the anesthesia record revealed a surgical "time-out" was completed at 4:18 PM. A review of the document titled, "MEDICAL AND SURGICAL PROCEDURES CONSENT AND DISCLOSURE, TIME OUT DOCUMENTATION (Documentation is not required in this section for areas with electronic documentation) revealed Staff # 26 documented a "time-out" on 8/19/2016 at 4:20 PM. There is no consistent documentation on the surgical time-out verification.


Patient #7

A review of Patient #7's medical record revealed the following:

Patient #7 was admitted on [DATE] for a surgical procedure. Further review of the surgical record revealed Patient #7 was taken to the Operating room at 12:41 PM, Procedure start time was 12:41 PM, Procedure stop time was 1:23 PM and the time the patient left the Operating room was 1:27 PM. The documented time in the electronic health record for surgical "time-out" by Staff #27 was 12:47 PM. This is 6 minutes after the start of the procedure. A review of the anesthesia record revealed no surgical "time-out" was documented by anesthesia staff. A review of the document titled, "MEDICAL AND SURGICAL PROCEDURES CONSENT AND DISCLOSURE, TIME OUT DOCUMENTATION (Documentation is not required in this section for areas with electronic documentation) revealed no documented "time-out by Staff #27.


Patient #8

A review of Patient #8's medical record revealed the following:

Patient #8 was admitted on [DATE] for a surgical procedure. Further review of the surgical record revealed Patient #8 was taken to the Operating room at 1:16 PM, Procedure start time was 1:40 PM, Procedure stop time was 3:12 PM and the time the patient left the Operating room was 3:23 PM. The documented time in the electronic health record for surgical "time-out" by Staff #28 was 1:43 PM. This is 3 minutes after the start of the procedure. A review of the anesthesia record revealed no surgical "time-out" was documented by anesthesia staff. A review of the document titled, "MEDICAL AND SURGICAL PROCEDURES CONSENT AND DISCLOSURE, TIME OUT DOCUMENTATION (Documentation is not required in this section for areas with electronic documentation) revealed no documented "time-out by Staff #28.


A review of the policy titled, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery" with a review date of 4/2018 was as follows:

" ...PURPOSE:

For the Prevention of performing wrong person, wrong site, wrong procedure, surgery or
Invasive procedure(s).

GUIDELINE:

To provide a comprehensive approach for confirming:

1.0 the proposed procedure
2.0 the patient's identity
3.0 the correct surgical site for the proposed procedure to include, but not limited to a choice
of right, left, bilateral, multiple structures; ie fingers, toes, lesions, or multiple levels; ie spinal
procedures.
4.0 the correct patient
5.0 Any required blood products, implants, devices, and/or special equipment required for the
procedure.

PROCEDURES:

4.0 TIME OUT UP.01.03.01

4.1 Purpose: To conduct a final verification of the correct patient, procedure, site, and as
Applicable, implants.
4.2 Process: During the timeout, all activities are suspended to allow active communication
Among all members of the surgical/procedure team, consistently initiated by a designated member of the team, conducted in a "fail-safe" mode, (ie: the procedure is not started until any questions or concerns are resolved).
4.2.1 After all activities are suspended to allow active communication among all members of the team, conduct a final verification of the patient, procedural agreement, side and site, patient position and the availability of correct implants and necessary special equipment will occur immediately before starting the procedure or making the incision.
4.2.2 This must be conducted in the location where the procedure/surgery is to occur.
4.2.3 Time out must be documented ..."


An interview was conducted with Staff #10 on 10/16/2019 after 11:00 AM. Staff #10 was asked what the procedure was the Operating Room Nurses followed for their surgical time-out verification. Staff #10 stated, "We do the time-out after the patient is prepped and draped." Staff #10 was asked if she was aware that the documented time-out times for surgical procedures was documented after the start of the procedure and on some surgical records the documentation was inconsistent. Staff #10 stated, "That is just going be a documentation error. I'll have to look more into that."


Staff #1 confirmed the above findings.