Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed July 14, 2022, Three Oaks Hospice Pittsburgh was found to be in compliance with the requirements of 42 CFR, Part 418.113, Subpart D, Conditions of Participation: Hospice Care - Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification and state licensure survey completed July 14, 2022, Three Oaks Hospice Pittsburgh was found not to be in compliance with the following requirements of 42 CFR, Part 418, Subparts A, C, and D, Conditions of Participation: Hospice Care.
Plan of Correction:
418.52 STANDARD
PATIENTS' RIGHTS
Name - Component - 00
The patient has the right to be informed of his or her rights, and the hospice must protect and promote the exercise of these rights.
Observations:
Based on review of "OUT-OF-HOSPITAL DO-NOT-RESUSCITATE ORDER[s]," agency admission packet, clinical records (CR), and staff (EMP) interview, the agency failed to protect and promote the rights of the patient. The agency failed to obtain physician signatures and DNR orders for four (4) of five (5) patients whose clinical records contained out-of-hospital DNR (do not resuscitate) forms (CR1, CR7, CR10, & CR11).
Findings included:
Review of agency admission packet on July 11, 2022, at 10 a.m. showed, "ADVANCE DIRECTIVES ... III. The agency staff will inquire whether the patient has an advance directive at the time of the initial assessment. ... A. If an advance directive is in place, the Agency staff will request a copy of the patient's medical record, and the medical record will be 'flagged' or identified appropriately. ... PENNSYLVANIA: OUT-OF-HOSPITAL DO-NOT RESUSCITATE ('OOH-DNR') ORDER ... PURPOSE I. To ensure adherence to the patient's right to have resuscitative and life-sustaining procedures withheld in any out of hospital setting POLICY I. Agency will not initiate resuscitation measures on patients who have implemented and completed a(n) ... 'OOH-DNR' ... PROCEDURE ... A. A patient who is competent and who is an adult may execute a written ... 'OOH-DRN' order ... the declarant must sign the order ... The attending physician must sign the order."
Review of the "OUT-OF-HOSPITAL DO-NOT-RESUSCITATE ORDER" document contained in CR1, CR7, CR10, and CR11 showed, "2A. Attending physician Statement: I, the undersigned, state that I am the attending physician of the patient named above. The above-named patient, or the patient's surrogate or other person by virtue of that person's legal relationship to the patient, has requested this order, and I have made a determination that this patient is eligible for an order and satisfies one of the following: (1) the patient has an end-stage medical condition; (2) the patient is in a terminal condition; (3) the patient is permanently unconscious and has a living will directing that no cardiopulmonary resuscitation be provided to the patient in the event of the patient's cardiac or respiratory arrest; or (4) the patient is permanently unconscious and has a living will authorizing the surrogate or other person named below to request an out-of-hospital do-not-resuscitate order for the patient. I direct any and all emergency medical services personnel, commencing on the date of my signature below, to withhold cardiopulmonary resuscitation, (cardiac compression, invasive airway techniques, artificial ventilation, defibrillation and other related procedures) from the patient in the event of the patient's respiratory or cardiac arrest. If the patient is not yet in cardiac or respiratory arrest, I further direct such personnel to provide to the patient other medical interventions, such as intravenous fluids, oxygen or other therapies necessary to provide comfort, care or to alleviate pain, unless directed otherwise by the patient or the emergency medical services provider's authorized medical command physician."
Review of CR1 on July 12, 2022, at 8 a.m. showed an initial physician ordered plan of care from 6/10/2022 to 9/7/2022. The patient elected her hospice benefit on 6/10/2022 and signed the out of hospital DNR form the same day indicating that she wished to be a DNR. The out of hospital DNR form was not signed by the patient's attending physician.
Review of CR7 on July 12, 2022, at 12:35 p.m. showed an initial physician ordered plan of care from 6/8/2022 to 9/5/2022. The patient's spouse elected the hospice benefit for the patient on 6/8/2022 and signed the out of hospital DNR form the same day. The out of hospital DNR form was not signed by the patient's attending physician. During a home visit on July 13, 2022, at 9:55 a.m. an interview with the patient's wife confirmed DNR status, "We don't want that [resuscitation]." Review of the patient's admission packet contained in the home showed an unsigned copy of the out of hospital DNR form."
Review of CR10 on July 12, 2022, at 2:50 a.m. showed an initial physician ordered plan of care from 6/6/2022 to 9/3/2022. The patient's wife elected the hospice benefit on 6/6/2022 and signed the out of hospital DNR form the same day. The out of hospital DNR form was not signed by the patient's attending physician.
Review of CR11 July 12, 2022, at 3:15 p.m. showed an initial physician ordered plan of care from 5/27/2022 to 8/24/2022. The patient elected his hospice benefit on 5/27/2022 and signed the out of hospital DNR form the same day. The patient was discharged from hospice on 6/20/2022. The out of hospital DNR form was not signed by the patient's attending physician.
Another review of the above records with EMP1 on July 14, 2022, at 11 a.m. confirmed above findings.
Plan of Correction:This plan of correction constitutes our written allegation of compliance for the deficiencies cited. However, submission of this plan of correction is not an admission that a deficiency exists or that one was correctly cited. This plan of correction is submitted to comply with state and federal laws.
- Executive Director or designee will educate the interdisciplinary team on Advance Directives Policy RI.1, Patient Rights Policy RI.2, and DNR policy RI.3.
- Executive Director or designee will educate the interdisciplinary team on 'Out of Hospital DNR' (OOH-DNR) and the process for obtaining 'OOH-DNR.' Executive Director of designee will educate interdisciplinary team on process of entering the physician signed OOH-DNR into the medical record as well as placing signed copy in the home of the patient.
- Executive Director or designee will audit 100% of active records and identify any patient with an 'OOH-DNR.' Executive Director will verify that the physician has signed the document. The document will then be uploaded into the patient's medical record and copy taken to patient's home. This audit will be performed until 100% completion is obtained.
- Executive Director or designee will audit 100% of admissions until 100% sustained compliance for 2 months to ensure the OOH-DNR is contained in the patient's medical record
- Once 100% sustained compliance achieved, the agency QAPI audits performed monthly will include auditing for the OOHDNR in a minimum of 10% patient records
- If compliance falls below 100%, a performance improvement plan will be initiated with the personnel involved.
418.104(a)(6) STANDARD
CONTENT
Name - Component - 00
[Each patient's record must include the following:]
(6) Any advance directives as described in §418.52(a)(2).
Observations:
Based on review of agency policy and procedure, a clinical record (CR) and staff (EMP) interview the agency failed to ensure one (1) of (1) patient whose hospice benefit was elected by the power of attorney (POA) contained advance directives (CR1), and for one (1) of five (5) patients who utilized the out-of-hospital DNR (do not resuscitate) form (CR2).
Findings included:
Advance directives as described by The hospice must comply with the requirements of subpart I of part 489 of this chapter regarding advance directives.
According to subpart I part 489 of this chapter regarding advance directives, "489.100 Definition. For purposes of this part, advance directive means a written instruction, such as a living will or durable power of attorney for health care, recognized under State law (whether statutory or as recognized by the courts of the State), relating to the provision of health care when the individual is incapacitated."
Review of agency policy and procedure was conducted on July 13, 2022, at 9:15 a.m.
"MEDICAL RECORD CONTENT IM.6 ... PURPOSE To ensure each medical record contains complete correct information ... POLICY I. The agency will initiate and maintain an individual and accurate medical record containing past and current information for each patient accepted for care. The medical record will be in compliance with all federal and state laws and regulations. ... PROCEDURE I. Each medical record will contain the following: ... F. Advance directives (if any) ... H. Documentation of care provided will include: ... 12. Information and/or documents regarding advance directives, the power of attorney and or healthcare power of attorney as applicable."
"ADVANCE DIRECTIVES RI.1 ... PURPOSE I. To ensure that adult patients and their legal representatives are informed of patient rights under federal and state law to make and direct decisions concerning medical care; including the right to accept or refuse medical or surgical treatment and the right to formulate advance directives such as a 'Living Will', 'Medical Power of Attorney', and 'Do-Not Resuscitate' (DNR). ... III. ... A. If an advance directive is in place, Agency staff will request a copy for the patient's medical record and the medical record will be 'flagged' appropriately."
Review of CR1 on July 12, 2022, at 8 a.m. showed a hospice plan of care from 6/10/2022 to 9/7/2022. The patient's POA (son) elected the hospice benefit for the patient on 6/10/2022 because the patient was "cognitively impaired, unable to follow directions."
Another review of CR1 was conducted on 7/13/2022 at 1:54 p.m. with EMP1 and he/she confirmed the clinical record did not contain a copy of the power of attorney.
Review of CR2 on July 13, 2022, at 8:30 a.m. showed an initial physician ordered plan of care from 5/16/2022 to 8/13/2022. The patient elected her hospice benefit on 5/16/2022. The clinical record only contained one page of the out of hospital DNR form and was missing the signature page. Another review of CR2 with EMP1 on 7/14/2022 at 11 a.m. confirmed patient wished to be a DNR but the physician signature page was missing, "Not seeing second page."
Plan of Correction:- Executive Director or designee will educate the interdisciplinary team on Advance Directives Policy RI.1 as well as the process for identifying a Power of Attorney (POA) and entering the POA paperwork into the medical record.
- Executive Director or designee will audit 100% of active records and identify any patient with a POA. If so, the POA paperwork will be obtained and uploaded into the patient's medical record until 100% completion is obtained.
- Executive director or designee will audit 100% of admissions until 100% sustained compliance for 2 months to ensure the POA paperwork is contained in the patient's medical record
- Once 100% sustained compliance achieved, the agency QAPI audits performed monthly will include auditing for the OOHDNR in a minimum of 10% patient records.
- If compliance falls below 100%, a performance improvement plan will be initiated with the personnel involved.
418.116 STANDARD
FEDERAL, STATE, LOCAL LAWS & REGULATIONS
Name - Component - 00
The hospice and its staff must operate and furnish services in compliance with all applicable Federal, State, and local laws and regulations related to the health and safety of patients. If State or local law provides for licensing of hospices, the hospice must be licensed.
Observations:
Based on review of the do-not-resuscitate (DNR) act and its DNR form, agency admission packet, the Department's event reporting system (ERS), ERS manual, a Department message board posting, clinical records (CR), and observation during home visits and staff (EMP) interview, the agency failed to comply with the do-not-resuscitate act. More specifically, the agency failed to ensure the patient's do-not-resuscitate (DNR) orders were reviewed and ordered by the patient's attending physician for four (4) of five (5) clinical records reviewed who did not reside in a facility (CR1, CR7, CR10, & CR11).
The agency failed to report a health department reportable diseases in accordance with requirements of PA Code, Title 28, Health and Safety, Part IV, Health Facilities, Subpart A, Chapter 51. The agency failed to submit a Covid-19 positive test result for one (1) of one (1) patient (CR12).
Findings included:
Act of Jun. 19, 2002, P.L. 409, No. 59 Cl. 20, "Amending Title 20 (Decedents, Estates and Fiduciaries) of the Pennsylvania Consolidated Statutes, further providing for advance directives for health care, for definitions and for emergency medical services; and providing for out-of-hospital nonresuscitation. ... Section 3. Title 20 is amended by adding a chapter to read: CHAPTER 54A OUT-OF-HOSPITAL NONRESUSCITATION Sec. ... 54A01. Short title of chapter. This chapter shall be known and may be cited as the Do-Not-Resuscitate Act. 54A02. Legislative findings and intent. (1) Although cardiopulmonary resuscitation has saved the lives of individuals about to experience sudden, unexpected death, present medical data indicates that cardiopulmonary resuscitation rarely leads to prolonged survival in individuals with terminal illnesses in whom death is expected. (2) In many circumstances, the performance of cardiopulmonary resuscitation may cause infliction of unwanted and unnecessary pain and suffering. (3) Existing emergency medical services protocols may require emergency medical services personnel to proceed to cardiopulmonary resuscitation when an individual is found in a cardiac or respiratory arrest even if the individual has completed a living will or advance directive indicating that the individual does not wish to receive cardiopulmonary resuscitation. (4) The administration of cardiopulmonary resuscitation by emergency medical services personnel to an individual with an out-of-hospital do-not-resuscitate order offends the dignity of the individual and conflicts with standards of accepted medical practice. (5) This chapter provides clear direction to emergency medical services personnel and other health care providers in regard to the performance of cardiopulmonary resuscitation. ... 54A03. Definitions. 'Attending physician.' The physician who has primary responsibility for the treatment and care of the patient. ... 'Order.' An out-of-hospital do-not-resuscitate order. ... 'Out-of-hospital do-not-resuscitate order.' An order in the standard format set forth in section 54A04 (relating to orders, bracelets and necklaces), supplied by the department and issued by the attending physician, directing emergency medical services providers to withhold cardiopulmonary resuscitation from the patient in the event of respiratory or cardiac arrest. ... b) Absence of order, bracelet or necklace.--The absence of an order, bracelet or necklace by a patient shall not give rise to any presumption as to the intent of the patient to consent to or to refuse the initiation. ... 54A10. Emergency medical services. ... (c) Uncertainty regarding validity or applicability of order, bracelet or necklace.-- (1) Emergency medical services providers who in good faith are uncertain about the validity or applicability of an order, bracelet or necklace shall render care in accordance with their level of certification." Retrieved from https://www.legis.state.pa.us/WU01/LI/LI/US/HTM/2002/0/0059..HTM
Review of agency admission packet on July 11, 2022, at 10 a.m. showed, "ADVANCE DIRECTIVES ... III. The agency staff will inquire whether the patient has an advance directive at the time of the initial assessment. ... A. If an advance directive is in place, the Agency staff will request a copy of the patient's medical record, and the medical record will be 'flagged' or identified appropriately. ... PENNSYLVANIA: OUT-OF-HOSPITAL DO-NOT RESUSCITATE ('OOH-DNR') ORDER ... PURPOSE I. To ensure adherence to the patient's right to have resuscitative and life-sustaining procedures withheld in any out of hospital setting POLICY I. Agency will not initiate resuscitation measures on patients who have implemented and completed a(n) ... 'OOH-DNR' ... PROCEDURE ... A. A patient who is competent and who is an adult may execute a written ... 'OOH-DRN' order ... the declarant must sign the order ... The attending physician must sign the order."
Review of the "OUT-OF-HOSPITAL DO-NOT-RESUSCITATE ORDER" document contained in CR1, CR7, CR10, and CR11 showed, "2A. Attending physician Statement: I, the undersigned, state that I am the attending physician of the patient named above. The above-named patient, or the patient's surrogate or other person by virtue of that person's legal relationship to the patient, has requested this order, and I have made a determination that this patient is eligible for an order and satisfies one of the following: (1) the patient has an end-stage medical condition; (2) the patient is in a terminal condition; (3) the patient is permanently unconscious and has a living will directing that no cardiopulmonary resuscitation be provided to the patient in the event of the patient's cardiac or respiratory arrest; or (4) the patient is permanently unconscious and has a living will authorizing the surrogate or other person named below to request an out-of-hospital do-not-resuscitate order for the patient. I direct any and all emergency medical services personnel, commencing on the date of my signature below, to withhold cardiopulmonary resuscitation, (cardiac compression, invasive airway techniques, artificial ventilation, defibrillation and other related procedures) from the patient in the event of the patient's respiratory or cardiac arrest. If the patient is not yet in cardiac or respiratory arrest, I further direct such personnel to provide to the patient other medical interventions, such as intravenous fluids, oxygen or other therapies necessary to provide comfort, care or to alleviate pain, unless directed otherwise by the patient or the emergency medical services provider's authorized medical command physician."
Review of CR1 on July 12, 2022, at 8 a.m. showed an initial physician ordered plan of care from 6/10/2022 to 9/7/2022. The patient elected her hospice benefit on 6/10/2022 and signed the out of hospital DNR form the same day indicating that she wished to be a DNR. The out of hospital DNR form was not signed by the patient's attending physician.
Review of CR7 on July 12, 2022, at 12:35 p.m. showed an initial physician ordered plan of care from 6/8/2022 to 9/5/2022. The patient's spouse elected the hospice benefit for the patient on 6/8/2022 and signed the out of hospital DNR form the same day. The out of hospital DNR form was not signed by the patient's attending physician. During a home visit on July 13, 2022, at 9:55 a.m. an interview with the patient's wife confirmed DNR status, "We don't want that [resuscitation]." Review of the patient's admission packet contained in the home showed an unsigned copy of the out of hospital DNR form."
Review of CR10 on July 12, 2022, at 2:50 a.m. showed an initial physician ordered plan of care from 6/6/2022 to 9/3/2022. The patient's wife elected the hospice benefit on 6/6/2022 and signed the out of hospital DNR form the same day. The out of hospital DNR form was not signed by the patient's attending physician.
Review of CR11 July 12, 2022, at 3:15 p.m. showed an initial physician ordered plan of care from 5/27/2022 to 8/24/2022. The patient elected his hospice benefit on 5/27/2022 and signed the out of hospital DNR form the same day. The patient was discharged from hospice on 6/20/2022. The out of hospital DNR form was not signed by the patient's attending physician.
Another review of the above records with EMP1 on July 14, 2022, at 11 a.m. confirmed above findings.
Per Chapter 51, 51.3 Notification (f) If a health care facility is aware of a situation or the occurrence of an event at the facility which could seriously compromise quality assurance or patient safety, the facility shall immediately notify the Department in writing. The notification shall include sufficient detail and information to alert the Department as to the reason for its occurrence and the steps which the health care facility shall take to rectify the situation.
Per the Department's message board posting from March 24, 2021, "All COVID events are to be reported to ERS by the facilities, within 24 hours of the facility becoming aware of the diagnosis."
Per the Department's ERS Manual, "PA Department of Health (PA-DOH) Event Notification Internet Site Overview - Facilities ... Purpose: To provide a system to enter events per 28 PA Code - 51.3 that is readily available to all appropriate PA-DOH facilities, a simple process to insure consistent data entry and submission, and a source for quick and meaningful feedback on event notification submissions. All facilities are required to submit notification of events as defined in 28 Pa Code Chapter 51 to the Department of Health within 24 hours of occurrence or discovery. The Electronic Event Reporting System is the mechanism the Department will use to meet this regulatory requirement. ... The following is a list of all Categories that should be submitted: ... Health Department Reportable Diseases."
Review of agency documentation on July 13, 2022, at 9:43 a.m. showed CR12 was admitted to hospice from 6/30-7/11/2022. The patient tested positive for Covid-19 on 6/30/2022.
Review of ERS was conducted on July 13, 2022, at 1:47 p.m. The time frame reviewed was from 6/30-7/13/2022 and showed there were no reports submitted. Interview with EMP1 at time of ERS review confirmed above findings and that he/she did not submit CR12's Covid-19 positive test result.
Plan of Correction:- Executive Director or designee will educate the interdisciplinary team identifying reportable events as well as on the process for reporting reportable events to the State of Pennsylvania, 28 PA Code 51.3.
- Executive Director initiated a separate column for reportable events on the daily stand-up report to ensure all events are identified for reporting into the Event Reporting System (ERS).
- Executive Director or designee will audit 100% of active employee and patient records and identify any event that should have been reported over the next 30 days.
- Administrator or designee will audit 100% of admissions until 100% sustained compliance for 2 months to ensure all reportable events are reported in the ERS system within 24 hours.
- Once 100% sustained compliance achieved, the agency QAPI audits performed monthly will include auditing for State reportable events in a minimum of 10% patient records.
- If compliance falls below 100%, a performance improvement plan will be initiated with the personnel involved.
- The results of these audits will be reported to the agency QAPI committee on a quarterly basis
Initial Comments:
Based on the findings of an onsite unannounced state license survey completed July 14, 2022, Three Oaks Hospice Pittsburgh was found not to be in compliance with the following requirements of PA Code, Title 28, Health and Safety, Part IV, Health Facilities, Subpart A, Chapter 51.
Plan of Correction:
51.3 (f) LICENSURE
NOTIFICATION
Name - Component - 00
51.3 Notification
(f) If a health care facility is
aware of a situation or the occurrence
of an event at the facility which
could seriously compromise quality
assurance or patient safety, the
facility shall immediately notify the
Department in writing.
The notification shall include
sufficient detail and information to
alert the Department as to the reason
for its occurrence and the steps which
the health care facility shall take to
rectify the situation.
Observations:
Based on review of the Department's event reporting system (ERS) and message board postings, ERS manual, agency documentation, and staff (EMP) interview, the agency failed to report incidents that could seriously compromise quality assurance or patient safety. More specifically, the agency failed to submit a Covid-19 positive test result for one (1) of one (1) patient (CR12).
Findings included:
Per the Department's message board posting from March 24, 2021, "All COVID events are to be reported to ERS by the facilities, within 24 hours of the facility becoming aware of the diagnosis."
Per the Department's ERS Manual, "PA Department of Health (PA-DOH) Event Notification Internet Site Overview - Facilities ... Purpose: To provide a system to enter events per 28 PA Code - 51.3 that is readily available to all appropriate PA-DOH facilities, a simple process to insure consistent data entry and submission, and a source for quick and meaningful feedback on event notification submissions. All facilities are required to submit notification of events as defined in 28 Pa Code Chapter 51 to the Department of Health within 24 hours of occurrence or discovery. The Electronic Event Reporting System is the mechanism the Department will use to meet this regulatory requirement. ... The following is a list of all Categories that should be submitted: ... Health Department Reportable Diseases."
Review of agency documentation on July 13, 2022, at 9:43 a.m. showed CR12 was admitted to hospice from 6/30-7/11/2022. The patient tested positive for Covid-19 on 6/30/2022.
Review of ERS was conducted on July 13, 2022, at 1:47 p.m. The time frame reviewed was from 6/30-7/13/2022 and showed there were no reports submitted. Interview with EMP1 at time of ERS review confirmed above findings and that he/she did not submit CR12's Covid-19 positive test result.
Plan of Correction:- Executive Director or designee will educate the interdisciplinary team identifying reportable events as well as on the process for reporting reportable events to the State of Pennsylvania, 28 PA Code 51.3.
- Executive Director initiated a separate column for reportable events on the daily stand-up report to ensure all events are identified for reporting into the Event Reporting System (ERS).
- Executive Director or designee will audit 100% of active employee and patient records and identify any event that should have been reported over the next 30 days.
- Administrator or designee will audit 100% of admissions until 100% sustained compliance for 2 months to ensure all reportable events are reported in the ERS system within 24 hours.
- Once 100% sustained compliance achieved, the agency QAPI audits performed monthly will include auditing for State reportable events in a minimum of 10% patient records.
- If compliance falls below 100%, a performance improvement plan will be initiated with the personnel involved.
- The results of these audits will be reported to the agency QAPI committee on a quarterly basis
Initial Comments:
Based on the findings of an onsite unannounced state license survey completed July 14, 2022, Three Oaks Hospice Pittsburgh was found to be in compliance with the requirement of 35 P.S. 448.809 (b).
Plan of Correction:
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