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Based on the systemic nature of the standard level deficiencies and the nature and severity of the unsafe care of Patient #3, the facility failed to comply with the Conditions of Participation for patient rights.

The findings were:

§482.13(a)(1) Tag A-0117

Based on interview and document review, it was determined the hospital failed to inform three (3) of three (3) emergency department (ED) patients of their rights (Patients #1, 2, and 9).

§482.13(a)(2) Tag A-0118

Based on interview and document review, it was determined the hospital failed to inform three (3) of three (3) emergency department (ED) patients of the process for filing a grievance (Patients #1, 2, and 9).

§482.13(b)(2) Tag A-0131

Based on interview and document review, it was determined the facility failed to provide the patient's representative with the necessary information to make an informed decision in one (1) out of twenty-one (21) patients sampled (Patient #3).

§482.13(c)(2) Tag A-0144

Based on interview and document review, it was determined the facility failed to deliver care in a safe setting for one (1) out of twenty-one (21) patients sampled (Patient #3).

Based on observations, interviews, and document review it was determined the facility's failed to verify readiness of emergency equipment needed for Medical Surgical Emergency Team (MSET) response for two (2) of two (2) emergency/MSET carts located on Telemetry.

§482.13(e)(4) Tag A-0166

Based on observation, interview and document review it was determined facility staff failed to develop or modify patients' plan of care after utilization of restraints for five (5) of five (5) patients included in the survey sample. (Patients #7, #8, #10, #14, and #17)

Based on interview and document review, it was determined the hospital failed to inform three (3) of three (3) emergency department (ED) patients of their rights (Patients #1, 2, and 9).

The findings include:

1.
a. On August 22, 2018 at 1:14 p.m., surveyors spoke with Patient #1, an ED patient. Patient #1 advised a family member transported her/him to the hospital after closing her/his finger in a car door. When asked if the patient received a packet containing information on patient rights and responsibilities or how to file a grievance the patient replied in the negative. When asked if a staff member from the facility spoke to the patient about her/his rights and responsibilities or the grievance process again the patient answered in the negative. The patient asked her/his family member and two other persons who accompanied them to the ED if anyone handed them paperwork detailing the information above and they replied in the negative. Patient #1 did advise that she/he could "figure out how to file a complaint if needed" by conducting an Internet search.

b. On August 23, 2018 at 9:18 a.m., surveyors examined the electronic medical record for Patient #1 with Staff Member #10. The review of that record revealed a document titled "Authorization for Claims, Payment, and Reviews - Inpatient" signed by Patient #1 on August 22, 2018 at 12:43 p.m. The signing of the document occurred prior to the interview outlined above. Paragraph #9 of the document states in part "Patient Rights and Advance Directives - Hospital patients have specific rights and responsibilities and a list is provided in the Patient Information Handbook and brochure provided to you..."As advised by Patient #1, she/he did not receive the handbook as outlined in the signed document.

2.
a. On August 23, 2018 at 8:36 a.m., surveyors spoke to Patient #2, an ED patient. Patient #2 advised he/she arrived at the hospital by Uber around 7:00 a.m. after experiencing abdominal pain and anxiety. Patient #2 advised he/she did not remember seeing signage near the entrance that addressed patient right and responsibilities or the grievance process. Patient #2 did advise that he/she was "very upset and not feeling well" and does not recall what paperwork he/she may have signed. When asked if Patient #2 received paperwork that addressed patient rights and responsibilities or grievance procedures, Patient #2 advised any paperwork given to her/him "[I] would put it in [my] bag." Patient #2 looked in her/his bag for paperwork related to the hospital and advised she/he did not see anything. Upon inquiry by surveyors, Patient #2 advised the staff did not speak to her/him about patient rights and responsibilities or the grievance process.

b. On August 23, 2018 at 9:33 a.m., surveyors examined the electronic medical record for Patient #2 with Staff Member #10. The review of that record revealed a document titled "Authorization for Claims, Payment, and Reviews - Inpatient" signed by Patient #2 on August 23, 2018 at 6:31 a.m. The signing of the document occurred prior to the interview outlined above. Paragraph #9 of the document states in part "Patient Rights and Advance Directives - Hospital patients have specific rights and responsibilities and a list is provided in the Patient Information Handbook and brochure provided to you..."As advised by Patient #2 she/he did not receive the handbook as outlined in the signed document.

3.
a. On August 23, 2018 at 3:49 p.m., surveyors spoke to Patient #9, an ED patient. Patient #9 advised her/his family members have used this hospital in the past and were "well treated." For this reason, she/he came to the facility today for her/his medical issue. Patient #9 advised that "no paperwork [was] handed" to her/him by the facility and she/he had the option of having a receipt for payment emailed. Patient #9 further advised she/he did not notice any signage that addressed patient rights and responsibilities or the grievance process nor did a staff member discuss those things with her/him.

b. On August 24, 2018 at 12:08 p.m., Surveyors examined the electronic medical record for Patient #9 with Staff Member #36. The review of that record revealed a document titled "Authorization for Claims, Payment, and Reviews - Inpatient" signed by Patient #9 on August 23, 2018 at 1:29 p.m. The signing of the document occurred prior to the interview outlined above. Paragraph #9 of the document states in part "Patient Rights and Advance Directives - Hospital patients have specific rights and responsibilities and a list is provided in the Patient Information Handbook and brochure provided to you..."As advised by Patient #9 she/he did not receive the handbook as outlined in the signed document.

4. a. On August 22, 2018 at 1:05 p.m., surveyors spoke to Staff Member #37 from registration. Staff Member #37 advised a folder which contains information on patient rights and responsibilities and information on filing a grievance is handed to the patient but "nothing is documented or checked-off" in the medical record to indicate receipt.

b. On August 22, 2018 at 1:21 p.m., surveyors asked Staff Member #7 and Staff Member #9 how it is know that a patient received the required notification of rights and responsibilities and information on filing a grievance if the patient denies being given the "folder." Staff Member #9 advised they did not know but could "see if something was printed out for them during discharge" or if notification is contained in the electronic medical record.

5. A review of the facility's policy titled "Patient Rights and Responsibilities" states in part:

"B. Hospital Responsibilities
The Inova hospitals shall use all reasonable efforts to ensure that patients are aware of their rights and can exercise their rights effectively...

Each Inova Hospital will:
1. Provide to each patient or his/her representative a summary of the rights set forth in this policy."

Based on interview and document review, it was determined the hospital failed to inform three (3) of three (3) emergency department (ED) patients of the process for filing a grievance (Patients #1, 2, and 9).

The findings include:

1.
a. On August 22, 2018 at 1:14 p.m., surveyors spoke with Patient #1, an ED patient. Patient #1 advised a family member transported her/him to the hospital after closing her/his finger in a car door. When asked if the patient received a packet containing information on patient rights and responsibilities or how to file a grievance the patient replied in the negative. When asked if a staff member from the facility spoke to the patient about her/his rights and responsibilities or the grievance process again the patient answered in the negative. The patient asked her/his family member and two other persons who accompanied them to the ED if anyone handed them paperwork detailing the information above and they replied in the negative. Patient #1 did advise that she/he could "figure out how to file a complaint if needed" by conducting an Internet search.

b. On August 23, 2018 at 9:18 a.m., surveyors examined the electronic medical record for Patient #1 with Staff Member #10. The review of that record revealed a document titled "Authorization for Claims, Payment, and Reviews - Inpatient" signed by Patient #1 on August 22, 2018 at 12:43 p.m. The signing of the document occurred prior to the interview outlined above. Paragraph #9 of the document states in part "Patient Rights and Advance Directives - Hospital patients have specific rights and responsibilities and a list is provided in the Patient Information Handbook and brochure provided to you..."As advised by Patient #1 she/he did not receive the handbook as outlined in the signed document.

2.
a. On August 23, 2018 at 8:36 a.m., surveyors spoke to Patient #2, an ED patient. Patient #2 advised he/she arrived at the hospital by Uber around 7:00 a.m. this morning after experiencing abdominal pain and anxiety. Patient #2 advised he/she did not remember seeing signage near the entrance that addressed patient right and responsibilities or the grievance process. Patient #2 did advise that he/she was "very upset and not feeling well" and does not recall what paperwork he/she may have signed. When asked if Patient #2 received paperwork that addressed patient rights and responsibilities or grievance procedures, Patient #2 advised any paperwork given to her/him "[I] would put it in [my] bag." Patient #2 looked in her/his bag for paperwork related to the hospital and advised she/he did not see anything. Upon inquiry by surveyors, Patient #2 advised the staff did not speak to her/him about patient rights and responsibilities or the grievance process.

b. On August 23, 2018 at 9:33 a.m., surveyors examined the electronic medical record for Patient #2 with Staff Member #10. The review of that record revealed a document titled "Authorization for Claims, Payment, and Reviews - Inpatient" signed by Patient #2 on August 23, 2018 at 6:31 a.m. The signing of the document occurred prior to the interview outlined above. Paragraph #9 of the document states in part "Patient Rights and Advance Directives - Hospital patients have specific rights and responsibilities and a list is provided in the Patient Information Handbook and brochure provided to you..."As advised by Patient #2 she/he did not receive the handbook as outlined in the signed document.

3.
a. On August 23, 2018 at 3:49 p.m., surveyors spoke to Patient #9, an ED patient. Patient #9 advised her/his family members have used this hospital in the past and were "well treated." For this reason, she/he came to the facility today for her/his medical issue. Patient #9 advised that "no paperwork [was] handed" to her/him by the facility and she/he had the option of having a receipt for payment emailed. Patient #9 further advised she/he did not notice any signage that addressed patient rights and responsibilities or the grievance process nor did a staff member discuss those things with her/him.

b. On August 24, 2018 at 12:08 p.m., Surveyors examined the electronic medical record for Patient #9 with Staff Member #36. The review of that record revealed a document titled "Authorization for Claims, Payment, and Reviews - Inpatient" signed by Patient #9 on August 23, 2018 at 1:29 p.m. The signing of the document occurred prior to the interview outlined above. Paragraph #9 of the document states in part "Patient Rights and Advance Directives - Hospital patients have specific rights and responsibilities and a list is provided in the Patient Information Handbook and brochure provided to you..."As advised by Patient #9 she/he did not receive the handbook as outlined in the signed document.

4. a. On August 22, 2018 at 1:05 p.m., surveyors spoke to Staff Member #37 from registration. Staff Member #37 advised a folder which contains information on patient rights and responsibilities and information on filing a grievance is handed to the patient but "nothing is documented or checked-off" in the medical record to indicate receipt.

b. On August 22, 2018 at 1:21 p.m., surveyors asked Staff Member #7 and Staff Member #9 how it is know that a patient received the required notification of rights and responsibilities and information on filing a grievance if the patient denies being given the "folder." Staff Member #9 advised they did not know but could "see if something was printed out for them during discharge" or if notification is contained in the electronic medical record.

5. A review of the facility's policy titled "Patient Complaint / Grievance Process in the Hospital" states in part:

"Patients will be informed of the process for addressing complaints/grievances through printed materials and verbal communication with hospital staff."

Based on interview and document review, it was determined the facility failed to provide the patient's representative with the necessary information to make an informed decision in one (1) out of twenty-one (21) patients sampled (Patient #3).

The findings include:

From August 22, 2018 through August 24, 2018, surveyors reviewed the electronic medical record for Patient #3 with two staff members, Staff Member #10 and Staff Member #37. A review of the medical record did not reveal a note or any documentation the facility contacted Interviewee #2 about Patient #3's altered mental status or the administration of Haldol and Benadryl for agitation. That review revealed the following (All quotes from the electronic medical record are transcribed as written except for redacted portions to protect identities).

According to the electronic medical record, Patient #3 (99 years of age at the time) arrived at the facility's emergency department (ED) on February 7, 2018 at 10:58 a.m. via EMS with a chief complaint of shortness of breath. The ED listed the diagnosis as "acute respiratory failure, unspecified whether hypoxia or hypercapnia" and admitted the patient to the ICU on February 7, 2018 at 4:05 p.m. After treatment in the ICU for approximately twenty-five (25) hours, the facility transferred the patient to the telemetry unit on February 8, 2018 at 5:15 p.m.

On February 10, 2018 at 1:54 a.m., Staff Member #22 entered two orders into the electronic medical record with Staff Member #13 as the ordering provider. The first order was for the administration of haloperidol lactate (Haldol) 2 mg IV and the second order was for the administration of diphenhydramine (Benadryl) 6.25 mg IV. Staff Member #22 completed the order per the medical record with the administration of the prescribed drugs on February 10, 2018 at 2:04 a.m. and 2:03 a.m. respectively.

At 4:28 a.m. on February 10, 2018, Staff Member #22 made the following note in Patient #3's plan of care:

"Patient was increasingly confused and agitated during the evening. Situation was escalated to charge RN. Sitter currently present at bedside for patient's safety. Agitation got worse around 0200. MD informed. IV haldol and IV benadryl ordered and administered. Patient was placed on 2L NC for ease of breathing d/t SOB during agitation- spO2 was 85-88% on RA; spO2 is 97% on 2L NC. Patient is incontinent; briefs are on patient to prevent dressings on BLE from getting wet. High fall precautions in placed. Hourly rounding ongoing."

The next update to the medical record occurred three (3) and a half hours later at 10:00 a.m. on February 10, 2018. The nursing note entered by Staff Member #23 stated:

"MD updated patient is lethargic, responds to voice but does not open eyes, grunts. Afebrile, BP = 148/81, HR 71 afib controlled on tele, SPO2 at 97% with 2L NC. Blood glucose 90. Patient received dose of haldol and benadryl last night. MD aware. Kept warm and comfortable."

At 2:10 p.m. on February 10, 2018, Staff Member #23 noted the following in the electronic medical record:

"Notified MD patient's daughter requesting to see patient. Patient not opening [redacted] eyes, less lethargic than this AM, reaches for blankets and moving [redacted] arms and legs. Strong grip. Verbalizes discomfort when being changed. Patient seen and evaluated by [redacted, Staff Member #14]."

On August 27, 2018 at 10:30 a.m., Surveyors spoke with Interviewee #2 via telephone. Surveyors learned that on the evening of February 9, 2018 until approximately 9:30 p.m., Interviewee #2 visited Patient #3 in the hospital. At no time during the visit did Patient #3 exhibit signs of an altered mental stats. Interviewee #2 further advised the following morning on February 10, 2018 she/he attempted to contact Patient #3 in her/his hospital room with no answer. Interviewee #2 figured Patient #3 might be out of the room for medical testing. Upon returning to the hospital at approximately 1:30 p.m. on the afternoon of February 10, 2018, Interviewee #2 advised the following found the patient unresponsive and demanded the nurse summon Patient #3's physician to the room.

On August 24, 2018 at 9:22 a.m., surveyors spoke with Staff Member #22, the nurse who cared for Patient #3 the night of February 9, 2018 and the early morning of February 10, 2018. Staff Member #22 is also the nurse who administered the Haldol and Benadryl on the orders of Staff Member #13. Staff Member #22 advised she/he cared for Patient #3 the night prior (February 8, 2018 and morning of February 9, 2018) with no problems noted and did meet Interviewee #2. Staff Member #22 advised the patient maintained a normal mental status that evening (February 8, 2018 and morning of February 9, 2018). Staff Member #22 advised the "agitation" began around 8:00 p.m. to 9:00 p.m. on February 9, 2018. The bed alarm for patient #3 continued to go off so Staff Member #22 starting sitting with the patient and then other nursing staff members rotated through. Later in the evening, Staff Member #22 advised she/he "escalated to the charge RN" and requested a "sitter" for the patient. Staff Member #22 believes at one point two sitters were in the patient's room and the patient attempted to get out of bed and strike the sitters. After the patient's oxygen saturation decreased into the 80s, Staff Member #22 contacted the overnight hospitalist. After the administration of Haldol and Benadryl, Staff Member #22 advised Patient #3 became more controllable but did not go to sleep until around 6:00 a.m. Staff Member #22 advised she/he did not call Interviewee #2 because she/he "didn't think it was necessary to call the [redacted, Interviewee #2] at 2 a.m. because we gave Haldol."

On August 24, 2018 at 8:53 a.m., surveyors spoke with the nurse who cared for the patient during the day on February 10, 2018 prior to transfer to another facility. Staff Member #23 advised they did discuss the patient during the safety huddle in the morning where she/he learned of the patient's agitation the night prior and the administration of Haldol and Benadryl. Staff Member #23 advised she/he did not care for the patient the day prior (February 9, 2018) but did remember the patient and recalls the patient being alert. As outlined in the nursing note entered into the electronic medical record at 10:00 a.m. on February 10, 2018, Staff Member #23 advised she/he notified the physician, Staff Member #14, that the patient is "lethargic, responds to voice but does not open eyes, grunts." Staff Member #23 stated Staff Member #14 advised she/he "would come see patient during rounds." In the afternoon on February 10, 2018, Staff Member #23 advised Interviewee #2 arrived and she/he expected a "negative reaction." Based on this, Staff Member #23 contacted the charge nurse and Staff Member #14 and said, "they need to stay close to the unit." Staff Member #23 did remember Interviewee #2 placing water in her/his hands and throwing the water on the patient's face in an attempt to rouse Patient #3.

On August 24, 2018 at 11:15 a.m., surveyors spoke with the Chief Medical Officer (CMO) Staff Member #2. During that interview, surveyors asked the CMO if the facility should have notified the medical power attorney of Patient #3's updated condition and the treatment provided. The CMO stated "[I'm] not sure if a notification to family is definitely necessary. Mostly based on the late hour."

On August 24, 2018 at 11:01 a.m., surveyors spoke with Interviewee #1, the admitting physician at the receiving facility. Surveyors learned Interviewee #1 has treated Patient #3 for many years. Interviewee #1 further advised Interviewee #2 is the medical power of attorney for the patient, and when asked if the facility should have notified her/him of Patient #3's change in mental status or the administration of Haldol/Benadryl, Interviewee #1 responded, "No question they should have called [redacted, Interviewee #2]." Interviewee #1 further explained the facility could have called Interviewee #2 so she/he could return to the hospital and sit with the patient, or at a minimum let Interviewee #2 know Patient #3 was sedated. Interviewee #1 further advised Patient #3's altered mental status lasted for about twenty-four (24) hours with no other medical reason identified for the altered mental status outside of the Haldol and Benadryl administration.

A review of the facility's policy Titled "Disclosure / Communication of Outcomes and Adverse Events to Patients and Families" states in part:

"Expected outcomes
Physicians are responsible for sharing information with their patients and/or the patient's designated decision maker regarding outcomes of diagnostic tests, treatments, procedures, and surgeries in an accurate, timely, and comprehensive manner."

1. Based on interview and document review, it was determined the facility failed to deliver care in a safe setting for one (1) out of twenty-one (21) patients sampled (Patient #3)

2. Based on observations, interviews, and document review it was determined the facility's failed to verify readiness of emergency equipment needed for Medical Surgical Emergency Team (MSET) response for two (2) of two (2) emergency/MSET carts located on Telemetry.

The findings include:

1. From August 22, 2018 through August 24, 2018, surveyors reviewed the electronic medical record for Patient #3 with two staff members, Staff Member #10 and Staff Member #37. That review revealed the following (All quotes from the electronic medical record are transcribed as written except for redacted portions to protect identities).

According to the electronic medical record, Patient #3 (99 years of age at the time) arrived at the facility's emergency department (ED) on February 7, 2018 at 10:58 a.m. via EMS with a chief complaint of shortness of breath. The ED listed the diagnosis as "acute respiratory failure, unspecified whether hypoxia or hypercapnia" and admitted the patient to the ICU on February 7, 2018 at 4:05 p.m. After treatment in the ICU for approximately twenty-five (25) hours, the facility transferred the patient to the telemetry unit on February 8, 2018 at 5:15 p.m.

On February 10, 2018 at 1:54 a.m., Staff Member #22 entered two orders into the electronic medical record with Staff Member #13 as the ordering provider. The first order was for the administration of haloperidol lactate (Haldol) 2 mg IV and the second order was for the administration of diphenhydramine (Benadryl) 6.25 mg IV. Staff Member #22 completed the order per the medical record with the administration of the prescribed drugs on February 10, 2018 at 2:04 a.m. and 2:03 a.m. respectively. Neither order contained a note or any other form of documentation that addressed the reason for the order and the administration.

The next entry into the electronic medical record did not occur until over two (2) hours later at 4:21 a.m. on February 10, 2018. In that entry, made by Staff Member #22, it documents a cognition assessment reported to be completed the evening prior at 8:00 p.m. on February 9, 2018. The entry assessed the cognition of Patient #3 as "Impulsive; Poor safety awareness; Poor attention/concentration; Poor judgement; Unable to follow commands."

Approximately seven (7) minutes later at 4:28 a.m. on February 10, 2018, Staff Member #22 made the following note in Patient #3's plan of care:

"Patient was increasingly confused and agitated during the evening. Situation was escalated to charge RN. Sitter currently present at bedside for patient's safety. Agitation got worse around 0200. MD informed. IV haldol and IV benadryl ordered and administered. Patient was placed on 2L NC for ease of breathing d/t SOB during agitation- spO2 was 85-88% on RA; spO2 is 97% on 2L NC. Patient is incontinent; briefs are on patient to prevent dressings on BLE from getting wet. High fall precautions in placed. Hourly rounding ongoing. "

At 10:00 a.m. on February 10, 2018. A nursing note entered by Staff Member #23 stated:

"MD updated patient is lethargic, responds to voice but does not open eyes, grunts. Afebrile, BP = 148/81, HR 71 afib controlled on tele, SPO2 at 97% with 2L NC. Blood glucose 90. Patient received dose of haldol and benadryl last night. MD aware. Kept warm and comfortable."

At 2:10 p.m. on February 10, 2018, staff entered the first note into the medical record of an in-person physician assessment conducted after the administration of Haldol and Benadryl (twelve (12) hours after the administration). The note was entered by the nursing staff (Staff Member #23) and advised the following:

"Notified MD patient's daughter requesting to see patient. Patient not opening [redacted] eyes, less lethargic than this AM, reaches for blankets and moving [redacted] arms and legs. Strong grip. Verbalizes discomfort when being changed.

Patient seen and evaluated by [redacted, Staff Member #14]."

Staff Member #14 is not the physician who ordered the Haldol and Benadryl, and this is the first documentation of an assessment by a physician since that administration twelve (12) hours earlier.

In an additional nursing note at 6:20 p.m. on February 10, 2018, Staff Member #23 advised:

"Patient transferred to stretcher, patient still lethargic but able to respond to commands compared to this morning, still no eye opening. Family member made aware. Report given and transfer packet given to PTS. Tele removed. Incontinence care done. Mepilex placed on sacrum and hydraguard. Heart failure booklet given to family member. All other needs attended."

The first documentation by a physician concerning an in-person assessment of Patient #3 after the administration of Haldol and Benadryl is a discharge summary signed at 5:12 p.m. February 10, 2018 by Staff Member #14. This documented assessment is approximately fifteen (15) hours after the administration of Haldol and Benadryl, and nearly thirty-two (32) hours after the last documented in-person assessment conducted by a physician (Staff Member #14) on February 9, 2018 at 9:13 a.m. The discharge summary contained the following notes in part:

"Overnight on 2/9, the patient became agitated and was given haldol 2 IV and Benadryl 6.5 mg IV. [Redacted, Patient #3] was altered and drowsy on 2/10 which is presumed to be from the benadryl and haldol. Patient's [redacted, Interviewee #2] requested transfer to [redacted]. [Redacted, interviewee #1] was contacted and transfer initiated. Patient stable for transfer...

Time spent examining patient, discussing with patient/family regarding hospital course, chart review, reconciling medications and discharge planning: 60 minutes."

It should be noted, surveyors did not locate any medical documentation completed by Staff Member #13 (The physician who order the Haldol and Benadryl) regarding Patient #3 on February 9, 2018 or February 10, 2018 outside of electronically signing the orders for Haldol and Benadryl. Additionally, those orders only contained the drug type, dose, route, etc., and did not include a note for context or reasoning. During a review of the medical record on August 24, 2018 at 1:17 p.m. with Staff Member #36, surveyors asked if a note or any other documentation exists that Staff Member #13 assessed Patient #3 or followed up on the patient via telephone after the administration of Haldol and Benadryl. Staff Member #36 advised "nothing I'm seeing." Staff Member #36 further advised the only physician documentation after midnight February 10, 2018 was an infectious disease consult and the discharge summary prepared by Staff Member #14 signed at 5:12 p.m. February 10, 2018.

On August 27, 2018 at 10:30 a.m., Surveyors spoke with Interviewee #2 via telephone and reviewed a written statement. Surveyors learned that on the evening of February 9, 2018 until approximately 9:30 p.m., Interviewee #2 visited Patient #3 in the hospital. Interviewee #2 advised:

"Throughout the time I was there and until the point in time that I left, my [redacted, Patient #3] was doing well, was alert, oriented and in full communication with me. You must understand that, despite [redacted, Patient #3] age [99 years old], [redacted, Patient #3] mental acuity has always been very sharp, and [redacted, Patient #3] communication skills is exceptional. "

Interviewee #2 further advised the following morning on February 10, 2018 she/he attempted to contact Patient #3 in her/his hospital room with no answer. Interviewee #2 figured Patient #3 might be out of the room for medical testing.

Concerning her/his arrival at the hospital at approximately 1:30 p.m. on the afternoon of February 10, 2018, Interviewee #2 advised the following:

"Upon my arrival, at approximately, 1:30 PM, I was stunned to discover a sitter, named [redacted, Staff Member #38], at the bedside. I immediately observed my [redacted, Patient #3] was unresponsive. I called out to my [redacted, Patient #3] - no response. I shook [redacted, Patient #3] - no response. I pinched [redacted, Patient #3] - no response. I went to the bathroom and turned the water on to get it very cold and cupped cold water in my hands and went to the bedside and threw the cold water in my [redacted, Patient #3] face - no response! I repeated this four (4) times - no response! I was shocked, as I had never seen my [redacted, Patient #3] like this. "

After speaking with the nurse for Patient #3 (Staff Member #23), Interviewee #2 instructed the nurse to "summon the physician to the room..." Interviewee #2 advised that as the medical power of attorney for Patient #3, the facility did not contact her/him to provide an update on Patient #3's condition or the medication administered the night prior. Interviewee #2 learned of these events upon returning to the hospital that afternoon.

On August 24, 2018 at 9:22 a.m., surveyors spoke with Staff Member #22, the nurse who cared for Patient #3 the night of February 9, 2018 and the early morning of February 10, 2018. Staff Member #22 is also the nurse who administered the Haldol and Benadryl on the orders of Staff Member #13. Staff Member #22 advised she/he cared for Patient #3 the night prior (February 8, 2018 and morning of February 9, 2018) with no problems noted and did meet Interviewee #2. Staff Member #22 advised the patient maintained a normal mental status that evening (February 8, 2018 and morning of February 9, 2018). Staff Member #22 advised the "agitation" began around 8:00 p.m. to 9:00 p.m. on February 9, 2018. The bed alarm for patient #3 continued to go off so Staff Member #22 starting sitting with the patient and then other nursing staff members rotated through. Later in the evening, Staff Member #22 advised she/he "escalated to the charge RN" and requested a "sitter" for the patient. Staff Member #22 believes at one point two sitters were in the patient's room and the patient would attempt to get out of bed and strike the sitters. After the patient's oxygen saturation decreased into the 80s, Staff Member #22 contacted the overnight hospitalist. Staff Member #22 advised Staff Member #13 did not see the patient in-person and she/he spoke to the physician over the telephone. During the telephone conversation, Staff Member #22 "saw [the] order [for Haldol and Benadryl] and questioned the doctor." When surveyors asked Staff Member #22 why she/he questioned the order, Staff Member #22 advised "It was because the age of patient and combined with Benadryl." During the telephone discussion, Staff Member #13 advised Staff Member #22 that Benadryl reduces extrapyramidal effects. After the administration of the medication, Staff Member #22 advised Patient #3 became more controllable but did not go to sleep until around 6:00 a.m. Staff Member #22 advised later in the morning Staff Member #13 "did come down to the floor and spoke to [redacted, Staff member #22]." Staff Member #13 looked into Patient #3's room but did not go inside.

On August 24, 2018 at 8:53 a.m., surveyors spoke with the nurse who cared for the patient during the day on February 10, 2018 prior to transfer to another facility. Staff Member #23 advised they did discuss the patient during the safety huddle in the morning where she/he learned of the patient's agitation the night prior and the administration of Haldol and Benadryl. Staff Member #23 advised she/he did not care for the patient the day prior (February 8, 2018) but did remember the patient and recalled the patient being alert. As outlined in the nursing note entered into the electronic medical record at 10:00 a.m. on February 10, 2018, Staff Member #23 advised she/he notified the physician, Staff Member #14, that the patient is "lethargic, responds to voice but does not open eyes, grunts." Staff Member #23 stated Staff Member #14 advised she/he "would come see patient during rounds." In the afternoon on February 10, 2018, Staff Member #23 advised Interviewee #2 arrived and she/he expected a "negative reaction." Based on this, Staff Member #23 contacted the charge nurse and Staff Member #14 and said, "they need to stay close to the unit." Staff Member #23 did remember Interviewee #2 placing water in her/his hands and throwing the water on the patient's face in an attempt to rouse her/him. Surveyors asked Staff Member #23 if she/he would question the orders for Haldol and Benadryl as prescribed the night prior. Staff Member #23 advised she/he would question the "Haldol dose but would question it because of combined with Benadryl." When surveyors asked about the patient's age (99 years old), Staff Member #23 stated "yes I would question based on the patient's age."

On August 24, 2018 at 11:01 a.m., surveyors spoke with Interviewee #1, the admitting physician at the receiving facility. Surveyors learned Interviewee #1 has treated Patient #3 for many years. Interviewee #1 advised she/he did receive regular updates about Patient #3 from the sending facility and found the treatment in the ICU to be adequate. Interviewee #1 further advised, "odd combination Haldol - Benadryl because [it] can make someone agitated" and they "kind of over treated [redacted, Patient #3]." Concerning the specific medication dosing, Interviewee #1 advised 2 mg of Haldol usually lasts for 2 hours, but with a patient who is 99 years old it could last twelve (12) hours. The response to the medication based on the patient's age (Patient #3 99 years old) can be "very unusual." Interviewee #1 further advised she/he would have started at a lower Haldol dose and "crescendo up" and further she/he is a "little disappointed that any physician did not assess [redacted, patient #3] that evening." Interviewee #1 further advised Patient #3's altered mental status lasted for about twenty-four (24) hours with no other medical reason identified for the altered mental status outside of the Haldol and Benadryl administration.

On August 24, 2018 at 11:15 a.m., surveyors spoke with the Chief Medical Officer (CMO) Staff Member #2. Staff Member #2 advised the dosing range for Haldol is 2 mg to 5 mg and the Benadryl dose ordered was a "very small dose of Benadryl." Staff Member #2 further explained, "was it the inappropriate dose [of Haldol]? No, it was on the low end. Was it intended for the patient to sleep for 6 to 8 hours? No, then it was the wrong dose." Staff Member #2 explained the initial dosing decision was appropriate but in hindsight, the response to the medication after administration would indicate incorrect dosing. Staff Member #2 further advised only one (1) hospitalist works at night, and in the early morning of February 10, 2018, Staff Member #13 was involved in a rapid response event. When asked if the appropriate thing to do would be an in-person assessment of the patient after the administration of the medication, Staff Member #2 advised "I think it's an appropriate thing to do" although she/he reiterated it was not a requirement. Staff Member #2 did advise that Staff Member #43 (Chief Hospitalist) counseled Staff Member #13 regarding this event because Staff Member #43 is Staff Member #13's supervisor. When asked how the facility would ensure something like this would not happen again, Staff Member #2 responded "[redacted, Staff Member #43] speaking with the hospitalist would ensure [the] process would change."

On August 23, 2018 at 4:39 p.m., surveyors provided a written list of persons they would like to interview regarding this event to Staff Member #4. On August 24, 2018 at 1:09 p.m., Staff Member #4 advised Staff Member #13 and Staff Member #14 are contracted hospitalists. Additionally, the malpractice insurance provider for the hospitalist group advised Staff Member #4 that surveyors would need to arrange interviews through that third party.

Surveyors reviewed the contract between the facility and the hospitalist group that employs Staff Member #13 and #14. That contract states in part:

"Group Physicians are responsible for the evaluation of all patients as requested by a nurse or attending physician...

Services to be provided include, but are not limited to, the following:...
Assessment of deterioration of patient's condition...
Assessment and intervention of any sudden or unexpected patient condition...

Group Physicians are responsible for appropriate medical record documentation, including orders. Telephone orders are discouraged."

Additionally, a review of the "Patient Care Partnership" provided to patients states in part:

"While in the facility, you have the right to:...

Receive care in a safe setting..."



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2. On August 22, 2018 from 1:15 p.m. through 2:44 p.m., the surveyor with two (2) staff members performed an initial tour of inpatient units for observations and patient/staff interviews. The surveyor along with Staff Members #28, and #29 entered the Telemetry Unit at approximately 1:27 p.m. on August 22, 2018. On August 22, 2018 at 1:30 p.m., the surveyor interviewed Staff Member #26, a Telemetry Registered Nurse (RN) along with Staff Member #27, the Clinical Director for the Telemetry Unit. Staff Member #26 discussed provisions for patient rights and nursing services. Staff Member #26 reported the unit had two (2) emergency carts for utilization by rapid response team/MSET.

Staff Members #26, #28, and #29 with the surveyor reviewed of the "Daily MSET (Medical Surgical Emergency Team) Cart/Defibrillator Check - All Except NICU (Neonatal Intensive Care Unit)" forms for the designated "Telemetry North" cart.
The review revealed the "Daily MSET Cart/Defibrillator Check - All Except NICU" form for the "Telemetry North" cart failed to have a "Signature of RN Checking Equipment" on the following dates:
August 1, 8, and 9, 2018;
July 10, 13, 18, 19, 26, and 27, 2018;
June 27, 2018 and incomplete documentation of the time June for 11 and 14, 2018;
May 17 and 20, 2018;
April 1 and 26, 2018; and
March 1, 5, and 6, 2018.

"Daily MSET Cart/Defibrillator Check - All Except NICU" form read in part "Signature indicates verification of the following: Signature forms present [Sic]. Medication or intubation tray has not expired. Cart lock is intact, red lock number is identical to that on the signature sheet. Combo pads on top of cart. Portable O2 (oxygen) tank and regulator present. O2 tank full (at least 2,000 psi [pounds per square inch]). MSET Documentation forms present (CPR/Emergency Event Note sheet, MSET Critique, and EKG mounting paper [Sic]. Capnography unit and tubing present. Assess battery life [of Capnography unit]. Portable suction: assure unit is plugged in. Unplug, turn unit on, and test suction strength using regulator ..."

[Capnography is used for monitoring of the concentration or partial pressure of carbon dioxide (CO 2) in the respiratory gases.]

Staff Member #26 explained it was the responsibility of the night shift charge nurse to perform the cart checks within the first hour of the shift. Staff Member #26 in the present of Staff Members #28 and #29 verified the failed opportunities for a RN to ensure the MSET cart was ready for an emergency situation. The surveyor requested to review the "Daily MSET Cart/Defibrillator Check - All Except NICU" forms for the Telemetry unit's second emergency (MSET) Cart.

Staff Members #26, #27, #28, and #29 with the surveyor reviewed of the "Daily MSET Cart/Defibrillator Check - All Except NICU" forms for the designated either Telemetry Central or Front cart.
The review revealed the "Daily MSET Cart/Defibrillator Check - All Except NICU" forms for the Telemetry Central or Front cart failed to have a "Signature of RN checking Equipment" on the following dates:
August 1, 8, and 9, 2018;
July 13, 18, 19, 26, and 27, 2018 with incomplete documentation regarding the time on July 10, 2018;
June 20 and 27, 2018;
May 20, 23, and 24, 2018;
April 3, 18 and 26, 2018; and
March 1, 7, and 8, 2018.

Staff Member #26 verified the findings. Staff Member #26 reviewed the "Daily MSET Cart/Defibrillator Check - All Except NICU" forms with the surveyor for both emergency/MSET carts and acknowledged the missed checks revealed on certain dates the unit did not have a verified "as ready" emergency/MSET cart.

The surveyor inquired whether the Telemetry Unit had already discovered the lack of documentation and if a quality project/activity had been initiated, Staff Member #26 stated, "No." The surveyor inquired regarding the follow-up process for ensuring the MSET/emergency carts were checked and ready. Staff Member #26 stated, "It would be communicated from night charge nurse to night charge nurse." The surveyor asked if the Telemetry unit had documentation or some form of communication regarding the failure to ensure the readiness of MSET/emergency carts had been addressed between night shift charge nurses. Staff Member #27 reported the night shift charge nurses had a standard work product sheet to follow; the surveyor requested a copy to review. Staff Member #26 reported he/she would check for additional communication between night shift charge nurses that addressed "coaching" regarding the gaps in ensuring the MSET cart was verified as ready for an emergency.

Review of the "Standard Work Document" specific for the unit indicated the "Charge Nurse Responsibilities" included "20. Night CRN [Charge Registered Nurse] completes MSET cart (s) check ... MSET Checklist ..."


Review of the facility's policy titled "MSET Adult and Pediatric" provided the documented expectations for the cart utilized during emergencies. The policy read in part: "I. Policy This document outlines the procedure for initiation, implementing, and documenting emergency clinical services provided by the MSET response team. This policy also describes emergency equipment availability, maintenance and readiness procedures ... III. Applies to All Departments ... IV. Procedure ... 3. All MSET carts and Airway carts will be routinely checked by designated staff in the area it is housed. a) Documentation of routine MSET cart and defibrillator checks will be kept on the MSET cart or in a designated area ... 7. After the MSET it is the responsibility of the RN where the MSET occurred to notify Material Management to replace adult or pediatric cart ... c) On arrival, the new adult or pediatric cart is to be checked by a RN using the same procedure as daily checking. The RN will sign the Adult MSET Cart Expiration Dates and Lock Signature Form verifying readiness of the new cart ..."

On August 24, 2018 at approximately 1:00 p.m. Staff Member #6 reported the Telemetry unit did not have further documentation. The surveyors did not receive additional information prior to exit on August 27, 2018.

Based on observation, interview and document review it was determined facility staff failed to develop or modify patients' plan of care after utilization of restraints for five (5) of five (5) patients included in the survey sample. (Patients #7, #8, #10, #14, and #17)

The findings included:

An observation conducted on August 22, 2018 at 1:01 p.m. within the facility's intensive care unit revealed nursing staff in the process of admitting a patient. Staff Member #24 reported the patient underwent an endoscopic procedure. The observations revealed the patient was in bilateral soft wrist restraints. The patient was included in the survey sample and designated Patient #10. An observation conducted on August 24, 2018 approximately 9:00 a.m., revealed Patient #10 continued to have bilateral soft wrist restraints in place.

A review of Patient #10's electronic medical record (EMR), on August 24, 2018 with Staff Member #36, indicated the patient was admitted to the facility on August 15, 2018 for gastric and cardiac concerns. After the endoscopic procedure on August 22, 2018, Patient #10 was transferred to the facility's intensive care unit in bilateral soft wrist restraints. During the review of Patient #10's EMR, Staff Member #36 verified the EMR did not include a plan of care related to restraints.

Patient #14 was placed in the survey sample related to the receipt of blood transfusions. During the EMR review on August 23, 2018 at 1:24 p.m. with Staff Member #32, the documentation included restraint orders and monitoring. The documentation indicated Patient #14 had been placed in restraints from 2:02 a.m. through 4:37 p.m. on March 03, 2018. Staff Member #32 verified Patient #14's EMR did not have a plan of care that reflected the use of restraints.

An interview was conducted on August 23, 2018 at approximately 2:40 p.m. with Staff Members #9 and #32 regarding the location of the restraint plan of care in the patient's EMR. Staff Member #32 reported he/she would inquire. At approximately 3:00 p.m. on August 23, 2018, Staff Member #9 presented a print-out of Patient #14's electronic restraint flowsheet. Staff Member #9 reported the patient's flowsheet for monitoring the restraints functioned as the patient's plan of care. The surveyor requested the facility's policy, which identified the electronic restraint monitoring flowsheet as the restraint plan of care.

An end of the day second request was made on August 23, 2018 at 4:38 p.m., for the facility's policy for care planning restraints.

Patient #17 was added to the survey sample related to being is soft non-violent restraints prior to death. Review of Patient #17's EMR was conducted on August 24, 2018 at 10:20 with Staff Member #32. The review indicated Patient #17 had been admitted to the facility on March 30, 2018 after an outside of the hospital cardiac arrest. Patient #17 was intubated related to multiple episodes of cardiopulmonary resuscitation. Patient #17 was placed in bilateral restraints at 00:00 a.m. (Midnight) March 31, 2018. The physician determined Patient #17's diagnoses included Anoxic Brain Injury (thirty (30) minutes without oxygen] and Acute Respiratory Failure. After the family and medical staff documented discussion of Patient #17's prognosis the decision was made to list the patient as a do not resuscitate and the bilateral soft wrist restraints were removed later on March 31, 2018. Staff Member #32 verified Patient #17's EMR did not contain a plan of care for restraints and the safety plan of care did not have modifications to include restraints.


Patient #7 was added to the survey sample related to being is soft non-violent restraints prior to death. Staff Member #10 reviewed Patient #7's EMR on August 23, 2018 with the surveyor. Patient #7's admission date was documented as January 18, 2018. Patient #7 was in non-violent soft restraints from January 19, 2018 until his/her death on January 20, 2018. Staff Member #10 verified Patient #7's EMR did not have a plan of care that reflected the use of restraints.


Patient #8 was added to the survey sample related to being is soft non-violent restraints prior to death. Staff Member #10 reviewed Patient #8's EMR on August 23, 2018 with the surveyor. Patient #7's admission date was documented as February 23, 2018. Patient #8 was in non-violent soft restraints from March 03, 2018 until his/her death on March 05, 2018. Staff Member #10 verified Patient #8's EMR did not have a plan of care that reflected the use of restraints.

During the end of the day interview conducted on August 24, 2018 at 2:58 p.m., the surveyor made a third request for the facility's policy related to identifying the restraint monitoring flowsheet as the patient's plan of care. The surveyor reviewed the regulatory language related to use of restraint must be in accordance with a written modification to the patient's plan of care. As well as the facility's restraint policy that documented the need for a plan of care or modification of the patient's plan of care to include the use of restraints. Staff Member #9 explained the EMR system did not provide a drop down for restraints. Staff Members #5 and #9 verified there was not a specific plan of care for restraints. Staff Members #5 and #9 verified the facility did not have a policy that identified the restraint monitoring flowsheets as the patient's restraint plan of care.

The facility did not supply additional information or documentation prior to exit on August 28, 2018.

Review of the facility's policy titled: "Restraints and Restraint Alternatives" indicated the documentation needed for non-violent and violent restraints. "B. Documentation 1. The following must be documented in the EHR [Electronic Health Record] ... g. plan of care and any modifications ..."

Based on interview and document review, it was determined the facility failed to administer blood products in accordance with facility policies and procedures for three (3) out of five (5) patients included in the survey sample (Patients #4, 6 and 12)

The findings included:

1. Patient #12 was added to the survey samples related to being on a list of patients that received a blood transfusion. Staff Member #32 and the surveyor reviewed Patient #12's electronic medical record (EMR). Patient #12 has a diagnosis of "Chronic Anemia" and receives multiple blood transfusions monthly. The review revealed Patient #12 received eight (8) units of blood products between July 12, 2018 and July 30, 2018. Patient #12's EMR documented the patient received twelve (12) units of blood products from August 8, 2018 to August 20, 2018.

The surveyor request to review Patient #12's consent for blood transfusions. Staff Member #32 reported a consent for blood transfusion was good for 180-days as long as the reason or the requested blood product did not change. The surveyor conducted a review of Patient #12's scanned media. Patient #12 had five (5) "Informed Consent Form Blood / Blood Product Transfusions" forms. Two (2) incomplete "Informed Consent Form Blood / Blood Product Transfusions" forms where found. The "Informed Consent Form Blood / Blood Product Transfusions" dated "1/3/2018" did not list the treating condition for blood transfusion. The "Informed Consent Form Blood / Blood Product Transfusions" dated "1/29/2018" did not list the treating condition for blood transfusion. Staff Member #32 reported the treating physician and /or the nurse should have document the patient's condition that required the need for the blood transfusion.

Staff Member #32 and the surveyor reviewed Patient #12's transfusion dates beginning in January 2018 to determine which consents had been utilized. The review revealed multiple utilizations of the incomplete consents. The January 29, 2018 "Informed Consent Form Blood / Blood Product Transfusions" was used to administer blood products on: March 31, 2018, May 22, 2018; June 14, 2018; June 27, 2018; July 12, 18, 25, 29, and 30, 2018; August 8, 9, 15, 16, and 20, 2018. The January 3, 2018 "Informed Consent Form Blood / Blood Product Transfusions" was used to administer blood products on that date.

Staff Member #32 confirmed the incomplete January 29, 2019 "Informed Consent Form Blood / Blood Product Transfusions" had been utilized for Patient #12's inpatient stay for shortness of breath August 8 to 10 , 2018, which included the patient receiving five (5) units of blood product. Staff Member #32 confirmed the January 29, 2018 "Informed Consent Form Blood / Blood Product Transfusions" had been utilized for multiple inpatient admissions for blood transfusions. Staff Member #32 confirmed nursing staff administered blood products without a verified consent for blood products.

2. On August 23, 2018 at 11:11 a.m., surveyors reviewed the electronic medical record for Patient #4 with Staff Member #10. During that review, surveyors learned that Patient #4 received a blood transfusion at the facility on August 15, 2018. Upon examination of the blood transfusion flow sheet, surveyors discovered the transfusion began at 10:30 a.m. with vitals recorded prior to the start at 10:23 a.m. The second round of complete vitals did not occur based on the flowsheet until twenty-one (21) minutes after the blood transfusion began. Additionally, the electronic medical record for Patient #4 contained two blood transfusion consent forms with the first form dated July 24, 2018 and the second form dated July 27, 2018. Neither form contained an entry in the section labeled, "An order has been placed by your physician for you to receive a blood product transfusion as needed to treat:". The form dated July 27, 2018 does not have a box checked indicating whether the patient or designated decision maker consents or does not consent to the blood transfusion. Lastly, the form dated July 27, 2018 does not contain a witness signature as outlined by the form ("Patient or Designated Decision Maker signature MUST be witnessed") or a signature for the physician ("I declare that I have personally explained the above information to the patient or the patient's designated decision maker"). On August 23, 2018 at 11:44, surveyors reviewed the information outlined above with Staff Member #10 who agreed with surveyors understanding of the record.

3. On August 23, 2018 at 3:07. surveyors reviewed the electronic medical record for Patient #6 with Staff Member #10. During that review, surveyors learned that Patient #6 received a blood transfusion at the facility on August 10, 2018. Upon examination of the blood transfusion consent contained in the medical record, surveyors noticed the form did not contain an entry in the section labeled "An order has been placed by your physician for you to receive a blood product transfusion as needed to treat:" When surveyors pointed-out the blank section, Staff Member #10 replied the "[the patient] had a low H&H to begin with."

4. Review of the facility's policy titled "Transfusion / Infusion of Blood Components" was conducted with Staff Member #32. The review indicated the "Informed Consent Form Blood / Blood Product Transfusions" was "valid for 180 days for the same admission or outpatient course of treatment ... A single informed consent may cover multiple transfusions over the course of an inpatient admission ... if they are part of a single course of treatment and the consent is in the electronic health care (EHR) or available on the unit ... A single informed consent may cover multiple transfusions over the course of outpatient treatment if they are part of a single course of treatment and the consent is in the electronic health care (EHR) or available on the unit ... "

An additionally review of the policy by surveyors revealed:
"A new blood consent must be obtained if the reason for the blood has changed from the original consent...
Vital Signs should be documented pre-transfusion, 15 minutes after start of transfusion and hourly until completed."