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.

CAROLINAS MEDICAL CENTER/BEHAV HEALTH 1000 BLYTHE BLVD CHARLOTTE, NC 28203 Oct. 2, 2020
VIOLATION: PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION Tag No: A0123
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of the hospital policies, review of closed medical records, review of the grievance log and interviews with staff, the facility failed to ensure a written response to a grievance for 1 of 6 grievance files reviewed (Patient #7) and failed to describe the steps taken on behalf of the patient to investigate the grievance and the results of the investigation for 2 of 6 grievance files reviewed (Patient #8 and Patient #1).

The findings include:

Review of the policy titled "Patient Complaint and Grievance Management Policy" with a revision date of 08/2019, revealed "Purpose: This policy sets forth the procedure for appropriately identifying and promptly resolving patient and/or patient representative complaints and grievances...Grievances: Complaints meeting any of the following criteria are considered a grievance and require a written response. 1. A written or verbal complaint that cannot be resolved at the time of the complaints by staff present and requires further investigation and/or related actions for resolution...Process: 1. Grievances are to be resolved within an average of seven (7) calendar days whenever possible. A written notice of the determination regarding the grievance shall be communicated to the patient and will contain: a. The steps taken on behalf of the patient to investigate the grievance. b. The results of the grievance process. c. The name and contact number of the contact person. d. The date of completion. 2. If the designee determines the investigation is not or will not be completed within an average of seven (7) calendar days, the designee must provide a written response to the patient 7-10 calendar days from receipt of the grievance and will contain: a. Acknowledgement of receipt of grievance. b. Documentation of a reasonable timeframe to expect resolution communication from the hospital. c. The name and contact number of the contact person. d. The date of completion...."

a. Review of a closed medical record of Patient #7 revealed a [AGE] year old male admitted on [DATE] for mania episodes (state of elevated arousal) with a history of bipolar disorder (periods of mania and depression) and ADHD (attention deficit hyperactivity disorder). Review of the discharge summary dated 04/05/2020 at 0705 revealed Patient #1 was transferred from a long term care facility for further management of a left lower extremity wound.

Review of a handwritten note dated 04/06/2020 (no time) revealed patient #7's name on the document. Review revealed "I have been told by the staff that I can not be given Juven (protein liquid nutrition) for wound care per my doctors orders to recieve (sic) & take Juven twice a day! It is part of my wound care regiment (sic) and a necassity (sic) in the healing process! I was also forced today 04/06/2020 to use my own wound care belongings to Redress (sic) my wound! nothing (sic) was provided to change my bandas (sic). I said I had to use my own supplies!..."

Interview on 09/30/2020 at 1230 with AS #1 (floor manager) revealed the handwritten note was written by Patient #7 and placed in my mailbox outside of my office door. Interview revealed the handwritten letter was received on 04/07/2020. Interview revealed a letter was not sent to the patient about the grievance. Interview revealed the handwritten letter from the patient should have been viewed as a grievance. Interview revealed the policy was not followed.





b. Closed medical record review on 09/29/2020 to 10/01/2020 revealed Patient # 8 was a 6-year-old female who arrived to the facility on [DATE] for right ear swelling and redness. Review revealed Patient #8 had a complex past medical history of [DIAGNOSES REDACTED]'s windpipe to allow air to enter the lungs) and G-tube (gastrostomy tube-tube inserted through abdomen that delivers nutrition directly to the stomach) dependent. Review revealed Patient #8 was discharged on [DATE] with orders for home health with nursing, respiratory services and enteral services.

Review of the grievance file, on 10/01/2020, revealed the grievance was received on 07/29/2020. Review revealed Patient #8's mother had emailed the palliative care social worker and was upset that the home health orders had not been received by the home health agencies. Review revealed the grievance was investigated by the clinical care manager. Review revealed "... Area of concern Quality of care, Communication, Wait time / Delay in Care..." File review revealed a letter, dated 08/05/2020 that stated "...I would like to thank you for taking the time to share your concern about the coordination of discharge plans for your daughter (Patient #8). Our goal as case managers is to assist in carrying out a safe discharge plan for our patients. Oftentimes, discharge plans are a group effort with many entities involved in providing a safe and smooth discharge. We are truly sorry for any inconvenience you experienced after your most recent discharge. Again, I apologize for a less than excellent experience. Thank you for speaking to me and for your willingness to share your thoughts and concerns. This allows us to be a better organization. If I can be of further assistance, please feel free to call me (Clinical Care Manager Name)..." Letter review did not reveal a description of the steps taken on behalf of the patient to investigate the complaint nor the outcome of the investigation.

Request on 10/02/2020 to interview Clinical Care Manager #1 who wrote the grievance letter revealed she was not available for interview.

Interview on 10/02/2020 at 1000 with the Director of Clinical Care Management, revealed when a grievance was placed, the manager of the department the grievance was referring to would be the one to write the grievance letters. Interview revealed there was a template letter, managers could use for grievance letters or they could write their own letter. Interview revealed for Patient #8 the letter did not indicate the steps taken on behalf of the patient or the results of the grievance process. Interview revealed there was not formal training on how to write a grievance letter that the manager received. Interview revealed the grievance letter was not reviewed prior to being sent out. Interview revealed the grievance letter did not contain the required components according to policy.







c. Review of the open medical record for Patient #1 revealed, the [AGE]-year-old male arrived at the hospital on [DATE] via airlift from an OSH (outside hospital). Review of the H & P (history and physical) signed by MD (medical doctor) #20 on 09/16/2019 at 1915, revealed the chief complaints for Patient #1 included an LV thrombus (blood clot in the left ventricle of the heart), bacteremia (presence of bacteria in the blood) and AMS (altered mental status). Review revealed Patient #1 suffered a previous myocardial infarction (heart attack) and had recurrent cardiovascular accidents (strokes) prior to his arrival at the facility and remained unresponsive, with a tracheostomy (a surgically created hole in the windpipe to assist in breathing) and G-J tube (a soft plastic tube inserted through the stomach into the intestines for food and medication administration).

Review of the grievance file on 10/01/2020, revealed an emailed grievance from Patient #1's family member to the President of the facility on 05/12/2020 at 1152. Review of the grievance revealed an expressed concern about the family's inability to visit Patient #1 (disabled) during the COVID-19 pandemic and several patient care complaints including the failure by staff to turn, bathe and round on Patient #1 on several occasions. File review revealed an emailed response from the President to Patient #1's family member on 05/12/2020 at 1333. Review of the grievance file revealed a final letter to Patient #1's family member dated 05/14/2020, from the Nurse Manager (NM) on Patient #1's unit and stated, "...As you know, the strain of the Covid-19 pandemic as well as stay in place orders in response to mitigate the virus has been stressful on our patients, and our patient's families...We are pleased to increase the frequency of virtual visitation...After our conversation on April 21st...where we discussed the individual concerns, I have had discussions with my care team to provide further coaching on our processes and standards. Should there be any further clinical concerns...please do not hesitate to bring those to my attention..." Review of this final written response revealed the facility failed to include a description of the steps taken to investigate the grievance or the outcome of the investigation.

Interview on 10/02/2020 at 1113 with NM (nurse manager) #4 revealed she spoke to the nurse (RN #15) mentioned in the grievance and was told the allegation of not rounding on Patient #1 for 5-6 hours was not true because she had been in the room to give medications. Interview revealed NM#4 responded by letter to the grievance regarding Patient #1's care, but failed to include all of the required components outlined in facility's policy.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of hospital policies, medical record review, staff interviews and a physician interview, the facility staff failed to notify a physician of a an elevated HR (heart rate) for 1 of 3 patients reviewed with abnormal vital signs (Patient #1) and failed to follow physician orders for ROM (range of motion) for 1 of 2 patients reviewed with contractures (Patient #1).

The findings include:

A. Review on 10/02/2020 of the facility policy titled, "Pulse Assessment", last reviewed on November 15, 2019, revealed "Critical Notes!...RN to notify Provider of abnormal values based on patient's clinical condition and age...Identifying Pulse Patterns...Tachycardia: More than 100 beats /minute..." The facility's policy did not reveal a specific time frame for provider notifications related to abnormal vital signs.

Review of the facility policy titled, "Rapid Response Team and Rounding Nurse", last revised on 02/2018, revealed I. POLICY: The Rapid Response Team (RRT) will be activated to assist with the assessment and treatment of patients with deteriorating clinical conditions. The RRT serves non-ICU adult patients on inpatient units...V. INTERVENTION: A. Activation of the adult RRT is required when an acute change in any of the following criteria are met: 1. Heart rate less than 40 or greater than 130 beats per minute...we encourage our staff to...notify the attending physician ASAP [As soon as possible]."

Review of the open medical record for Patient #1 revealed, the [AGE]-year-old male arrived at the hospital one year ago on 09/16/2019 via airlift from an OSH (outside hospital). Review of the H&P (history and physical) written by MD (medical doctor) #20 on 09/16/2019 at 1915, revealed the chief complaints for Patient #1 included an LV thrombus (blood clot in the left ventricle of the heart), bacteremia (presence of bacteria in the blood) and AMS (altered mental status). Review revealed Patient #1 had a previous myocardial infarction (heart attack) and had recurrent cardiovascular accidents (strokes) prior to his transfer and remained unresponsive, with a tracheostomy (a surgically created hole in the windpipe to assist in breathing) and G-J tube (a soft plastic tube inserted through the stomach into the intestines for food and medication administration). Review of the Vital Signs Flowsheets on 07/28/2020 at 1200 and 08/18/2020 at 0602 revealed Patient #1 had elevated HR's (heart rates) of 139 and 134 respectively. Review of the Physician Notification Flowsheets on 07/28/2020 and 08/18/2020 revealed there were no physician notifications documented.

Interview on 10/01/2020 at 1436 with NM (nurse manager) #4 revealed an expectation for the HCT (healthcare technician) to let the RN (registered nurse) know of any abnormal vitals as soon as possible. NM #4 then stated, "I would expect that if a patient is having significant changes, a physician would be notified within 15-30 minutes, but there is no policy that I am aware of. Heart Rate and Blood Pressure are important and I expect the nurses to call the doctor right away." Interview revealed NM #4 was unsure why the MD was not notified for the two elevated heart rates on 07/28/2020 and 08/18/2020.

Interview on 10/01/2020 at 1554 with RN #18 revealed nurses were supposed to contact the attending with any abnormal vital signs. RN #18 stated , "Ideally we would notify the doctor as it happens, but I'm not sure of any policy though."

Interview on 10/01/2020 at 1632 with MD #18 revealed no knowledge of a specific policy for notifying providers for patient changes, but expected to be notified of abnormal vital signs within 5 minutes or as ordered. MD #18 stated, "We normally get a text, but sometimes a call."

B. Review of the facility policy titled "Pressure Injury Prevention" last revised on 02/21/2020 revealed, "Introduction...Preventive measures include off-loading pressure...and ensuring mobility to relieve pressure...Implementation...Post a repositioning schedule at the patient's bedside...Implement active or passive range-of-motion exercises, as appropriate, to redistribute pressure and promote circulation."

Review of the open medical record for Patient #1 revealed, the [AGE]-year-old male arrived at the hospital on [DATE] via airlift from an OSH (outside hospital). Review of the H&P (history and physical) writtend by MD (medical doctor) #20 on 09/16/2019 at 1915, revealed the chief complaints for Patient #1 included an LV thrombus (blood clot in the left ventricle of the heart), bacteremia (presence of bacteria in the blood) and AMS (altered mental status). Review of a PT Evaluation Form dated 06/13/2020 at 1352 revealed, "[Patient #1] is seen for PT re-evaluation to address ROM [range of motion] and tone deficits. At time of evaluation, pt demonstrates...contractures to B (bilateral) shoulders, ankles, knees, c-spine, knees, and hips...ROM program given to nursing staff to perform 2-3x/day. Record review revealed an order for ROM (range of motion - exercises done to assess, preserve or increase joint and muscle flexibility) tid (3 times daily) written by MD #15 on 06/16/2020 at 1359. Review of nursing flowsheets from 09/01/2020 through 09/30/2020 failed to reveal documentation of ROM being done for Patient #1 on 24 of 30 days.

Interview on 09/30/2020 at 1624 with RN (registered nurse) #19 revealed ROM was typically something done during the day shift but there was a binder in Patient #1's room with a list of exercises and pictures. Interview further revealed that ROM did not appear on the nursing task list and was a possible reason for it not being done every day. RN #19 was not sure why ROM was not done as ordered.

Interview on 10/01/2020 at 1436 with NM (nurse manager) #4 revealed that the order for Patient #1's ROM was written by the physician and did not populate on the task list for some reason. Interview revealed NM #4 was unsure why ROM was not carried out for Patient #1 as ordered.

Interview on 09/30/2020 at 1614 with PT (physical therapy) #1 revealed ROM was protocol for immobile patients due to the high risk for contractures. Interview revealed PT #1 performed the PT re-evaluation for Patient #1 in June 2020. PT #1 further revealed a set of exercises and pictures had been printed out and left in a folder inside Patient #1's chart. PT #1 stated ROM is important and if not done, "contractures will get worse." PT #1 stated a nurse (unknown) on Patient #1's floor called a few days after the PT evaluation to inquire about where the ROM recommendations were located, "So I know they were aware."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, Care Event review, and physician and staff interviews anesthesia staff failed to verify allergies prior to administering a medication for 1 of 7 patients reviewed who underwent a procedure (Patient #8).

The findings include:

Closed medical record review on 09/29/2020 to 10/01/2020 revealed Patient # 8 was a 6-year-old female who arrived to the facility on [DATE] for right ear swelling and redness. Review revealed Patient #8 had a complex past medical history of [DIAGNOSES REDACTED]'s windpipe to allow air to enter the lungs) and G-tube (gastrostomy tube-tube inserted through abdomen that delivers nutrition directly to the stomach) dependent. Review revealed on 07/10/2020 Patient #8 needed a PICC (peripherally inserted central catheter) line placed for antibiotic administration. Review of the pre-operative assessment on 07/10/2020 revealed allergies listed on the pre-operative assessment were: "...Adhesive Bandage [skin irritation] Dilaudid (pain medication) [Itching, Rash] Latex [Rash] Versed (sedative medication) [seizure like, Shaking all over] morphine (pain medication) [hives]..." Review of the "Anesthesia Record" revealed it was a paper document and had Patient #8's allergies written at the top of the form as: "latex, dilaudid, versed, morphine, adhesive." Review revealed Patient #8 was in the procedure room at 1545. Review revealed at 1547 Patient #8 was given Versed 1 mg (milligram). Review revealed the time-out was performed at 1603 and the procedure started at 1609. Patient #8 was transported to the PACU (post anesthesia care unit) at 1640. Review of the post-operative assessment at 1708 revealed Patient #8's vital signs were checked every 5 to 15 minutes in PACU, Patient #8 was recovered from anesthesia and had no anesthetic complications. Review revealed Patient #8 was taken back to the floor at 1743. Review of a nursing note revealed "...RN (Registered Nurse) notified providers of upon patients return from PACU pt. (patient) HR (heart rate) dipping into the 50s w/ low BPs. (blood pressures) Providers came to bedside, bolus given." Review of Patient #8's vital signs at 1747 revealed HR 62 and BP 97/56. Review revealed Patient #8's vital signs were monitored every 3-5 minutes and at 1822 Patient #8's HR was 59 and BP was 84/56. Review of a physician note on 07/10/2020 at 2204 revealed "...Around 6pm patient returned from PICC line procedure and heart rate was fluctuating between 50-70s, family reported patient seemed very off, BP was measured 84/56, patient was given fluid bolus to 98/59..." Review revealed a PERT (pediatric emergency response team) was called on Patient #8 on 07/11/2020 at 0343. Review of a progress note on 07/11/2020 at 0649 revealed "...PERT called at approx. 0340 on 07/11 due to bradycardia. (low heart rate) Concern per bedside nurse that patient's HR had been in 50s sustained for a few minutes and that her hands and feet were cold. Also reported mottling. (blotchy red-purplish marbling of the skin)...Review of work-up overnight included initial assessment at approx. 2000 s/p (status post) PICC line placement this evening. Patient had received Versed, which mother was concerned about considering this was listed as an allergy on her chart due to previous reaction of respiratory depression and decrease in vitals...Attending Addendum...Called to PERT for concerns of bradycardia and increased oxygen need since returning from PICC placement with anesthesia....Mom describes her previous reaction to Versed as a drop in blood pressure, drop in heart rate, and breathing slowly that occurred suddenly after Versed. Suspect she is still having some effects of anesthesia with slower metabolism of the anesthesia causing the lower HR, but reassured with good perfusion, responding well to stimuli and no signs of sepsis. Discussed continued close monitoring and reviewed results of workup with mom and nursing..." Review of a physician progress note on 07/14/2020 revealed "...Mom today was tearful and upset about sedation medications given during PICC line procedure...Mother was very emotional last evening and feels that the patient's sedation from the PICC line including Versed and rocuronium (paralytic medication) led to this...I did apologize for the patient receiving Versed which is a known allergy. We discussed with anesthesia who came into talk to mom. They discussed their thinking and also apologized as well..." Review revealed Patient #8 was discharged on [DATE].

Review of a "Care Event Notification" dated 07/10/2020 revealed "...patient was taken down to ir (interventional radiology) for picc placement, in patients allergies versed is listed. patient was given at some point between ir and pacu 1 mg versed. upon arrival back to unit patient became bradycardic and dropping O2 sats...Severity of Injury: Mild harm..." Review revealed it was entered by RN #21.

Interview on 10/01/2020 with CRNA (Certified Registered Nurse Anesthetist) #6 revealed she recalled Patient #8. Interview revealed CRNA #6 gave Patient #8 1mg of Versed prior to Patient #8's PICC procedure. Interview revealed CRNA #6 had been called to be the CRNA for Patient #8 during her PICC procedure on 07/10/2020. Interview revealed the PICC procedure was done in interventional radiology. Interview revealed the date of the procedure 07/10/2020 was a Friday in the late afternoon and the PICC procedure needed to be done prior to the interventional radiology staff leaving for the day because they had limited weekend hours. Interview revealed CRNA #6 was setting up the anesthesia cart for the PICC procedure in the procedure room and MD #22, the anesthesiologist went to complete the pre-operative assessment on Patient #8. Interview revealed CRNA #6 did not have a chance to look up Patient #8 in the electronic medical record system prior to the procedure. Interview revealed MD #22, Patient #8, Patient #8's mother and grandmother all came into the procedure room with the interventional radiology staff. Interview revealed CRNA #6 and MD #22 did a verbal report of Patient #8 and the plan for anesthesia. Interview revealed Patient #8 had multiple allergies and CRNA #6 recalled MD #22 discussing Patient #8's allergies. Interview revealed CRNA #6 thought that MD #22 gave Patient #8's true allergies not all of her allergies listed in the medical record. Interview revealed Patient #8 and Patient #8's mother were getting upset so CRNA #6 reached over and gave Patient #8 1 mg of Versed to help with the transition of Patient #8's mother leaving the room. Interview revealed giving Versed was a common practice with pediatric patients during the transition of their parents leaving so they did not get so upset. Interview revealed CRNA #6 then went over to the computer in the procedure room that had Patient #8 pulled up and saw Patient #8 had an allergy to Versed listed. Interview revealed CRNA #6 told MD #22 she gave Patient #8 Versed. Interview revealed CRNA #6 and MD #22 continued to monitor Patient #8 throughout the procedure and Patient #8 did not have any reaction of shaking or seizures to the Versed during the procedure. Interview revealed Patient #8 was transported to PACU and CRNA #6 and MD #22 checked on Patient #8 multiple times in PACU and Patient #8 had no complications. Interview revealed Patient #8 stayed in PACU for at least 45 minutes and CRNA #6 felt "comfortable" with the care Patient #8 received. Interview revealed CRNA #6 was aware Patient #8's blood pressure and heart rate had fluctuated on the evening of 07/10/2020 after Patient #8 arrived to the floor from PACU and discussed this with MD #22. Interview revealed Versed had a short half-life and they felt that the Versed would have been out of Patient #8's system before she started having issues on the floor. Interview revealed after the incident there were several debriefings with MD #22 and the anesthesia leadership team. Interview revealed the case was discussed during the anesthesia pediatric focus group meeting that month. Interview revealed CRNA #6 stated she understood she had made an error.

Interview on 09/30/2020 at 1406 with MD #22 revealed he was the anesthesiologist for Patient #8 during her surgery on 07/05/2020 and her PICC procedure on 07/10/2020. Interview revealed MD #22 was on-call on 07/10/2020 and had been called to be the anesthesiologist for Patient #8's PICC procedure. Interview revealed MD #22 had done the pre-operative assessment of Patient #8 in the interventional radiology holding area. Interview revealed MD #22 was familiar with Patient #8 because of a previous surgery and wanted to do mild sedation because of her complex medical history and recent anesthesia on 07/05/2020. Interview revealed MD #22 discussed this with CRNA #6. Interview revealed after he completed the pre-operative assessment MD #22 brought Patient #8, Patient #8's mom and Patient #8's grandma into the procedure room. Interview revealed Patient #8's mom and grandma then left the procedure room. Interview revealed MD #22 connected Patient #8's tracheostomy to the anesthesia gas. Interview revealed everyone stopped for the time-out and the interventional radiology nurse went through Patient #8's allergies. Interview revealed MD #22 turned to CRNA #6 and stated "let's not use Versed", CRNA #6 responded and said she gave a little already for sedation. Interview revealed MD #22 and CRNA #6 monitored Patient #8 throughout the procedure. Interview revealed MD #22 recalled Patient #8's reaction to Versed was unusual and Patient #8 did not have any shaking or seizures during the procedure. Interview revealed Patient #8 was taken to PACU after the procedure and MD #22 checked on Patient #8 multiple times. Interview revealed Patient #8 recovered from anesthesia and met criteria to go back up to the floor. Interview revealed the next day MD #22 heard that Patient #8 had "something happen" after she arrived to the floor that night and Patient #8's mother was upset about Patient #8 receiving Versed. Interview revealed MD #22 spoke with Patient #8's mother about the Versed, apologized that Patient#8 received Versed and agreed it should not have happened because it was on her allergy list. Interview revealed MD #22 stated it was unlikely Versed was the cause of Patient #8's issues upon return to the floor on 07/10/2020 because it had a short half-life. Interview revealed MD #22 discussed the incident with anesthesia leadership, CRNA #6 and presented the incident at the pediatric focus group meeting that month.

Interview on 09/30/2020 at 1524 and on 10/02/2020 at 1012 with the Director of Anesthesia Quality revealed she was aware of the medication error for Patient #8 on 07/10/2020. Interview revealed she became aware of the incident due to a care event being placed. When a care event was placed the Director received an email about the care event. Interview revealed when a care event was placed it went to risk management and the service line it was associated with it. Interview revealed the severity level of a care event would be put in by who was entering the event and by risk management and then would also be classified as a system or human error. Interview revealed the incident was considered mild harm to the patient and a human error.

Interview on 10/01/2020 at 1535 with RN #21 revealed she was the nurse for Patient #8 when she returned from her PICC procedure and she placed the care event in the system. Interview revealed she went into Patient #8's room because her monitor was alarming. Interview revealed Patient #8's heart rate and blood pressure were low and she was "just not acting right." Interview revealed RN #21 looked at Patient #8's medical record and saw she received Versed during her PICC procedure. Interview revealed RN #21 told Patient #8's mom and she stated Patient #8's blood pressure and heart rate were normally low when she got Versed. Interview revealed RN #21 called the provider who came to the bedside and ordered a fluid bolus. Interview revealed Patient #8 started slowly coming back to baseline and Patient #8 was closely monitored. Interview revealed RN #21 had cared for Patient #8 previously and she "metabolized things differently."

NC 709, NC 775, NC 852, NC 879, NC 063, NC 593