QA Investigation Results

Pennsylvania Department of Health
DELIA MARIA HOME CARE AGENCY, LLC
Health Inspection Results
DELIA MARIA HOME CARE AGENCY, LLC
Health Inspection Results For:


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Initial Comments:


Based on the findings of an unannounced on-site follow-up survey and state re-licensure survey conducted on March 4, 2024 through March 6, 2024, and off site March 11, 2024, and March 13, 2024, Delia Maria Home Care Agency, LLC, was found not to be in compliance with the requirements of 28 Pa. Code, Part IV, Health facilities, Subpart G. Chapter 601 and to have not corrected the deficiencies that were cited as a result of a state re-licensure survey completed October 31, 2023 and a follow-up survey completed on January 3, 2024. Nine (9) of twelve (12) deficiencies remain uncorrected.










































Plan of Correction:




601.6 LICENSURE
Definitions.

Name - Component - 00
The following words and terms, when used in this subpart, have the following meanings, unless the context clearly indicates otherwise:


Observations:

Based on a review of clinical records (CR), personnel files (PF) agency documentation, the Department of Health Event Reporting System, Department of Health Facility documentation, and the home care agency regulations, 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries and an interview with the human resources director and director of nursing, the agency failed to provide home health aide services in accordance with the definition of a home health care agency. The agency was providing services for six (6) of sixteen (16) clinical records reviewed under 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries. (CR#6, CR#7, CR#8, CR#11, CR#15, and CR#16). Four (4) of fifteen (15) home health aide PF's do not meet the training requirements as set forth in the Chapter 601 Home Health Agency regulations, 601.35(a): PF#6, PF#13, PF#17, and PF#22. Nine (9) of fifteen (15) home health aide PF's contained language that the agency is providing services to the patient under the consumer direction model that is applicable to 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries. PF#16, PF#17, PF#18, PF#19, PF#20, PF#22, PF#23, PF#24, and PF#25.

Findings include:

A review of the agency's active patient roster conducted on March 4, 2023 at approximately 9:45 AM revealed a total of one-hundred five (105) patients. The agency identified ten (10) patients who were receiving home health agency skilled services. The agency confirmed that the remaining ninety-five (95) consumers were receiving home health aide services only.

A review of the agency's active home health aide roster was conducted on March 4, 2024 at approximately 9:55 AM revealed a total of one hundred twenty-eight (128) home health aides.

A review of the Department of Health facility information on March 4, 2024 at approximately 7:30 AM revealed that the agency had a home care agency (license 25993601) that was closed effective August 31, 2021.

A review of the Pennsylvania Home Care Association's My Learning Center on March 13, 2024 at 4:00 PM found that the twelve (12) video courses equates to a total of 3.75 hours of video training.

A review of the Department of Human Services The Office of Long-Term Living's (OLTL) Home and Community-Based Services (HCBS) website: was conducted on March 13, 2024 at 10:45 AM states: "Consumer direction is an option that is available to you under the OLTL's Home and Community-Based Waiver Services and ACT 150. This option allows you to employ a personal attendant, rather than arranging for a worker through an agency." Consumer direction applies to the home care agency/registry program, 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries.

A review of the home care agency regulations, 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries was conducted on March 11, 2024 at approximately 11:00 AM.

611.55(a) Prior to assigning or referring a direct care worker to provide services to a consumer, the home care agency or home care registry shall ensure that the direct care worker has done one of the following:
(2) Demonstrated competency by passing a competency examination developed by the home care agency or home care registry which meets the requirements of subsection (b)and (c).
(3) Has successfully completed one of the following:
(i) A training program developed by a home care agency, home care registry, or other entity which meets the requirements of subsection (b) and (c).
(ii) A home health aide training program meeting the requirements of 42 C.F.R. 484.36 (relating to the Conditions of Participation; Home Health Aide Services).
(iii) The nurse aid certification and training program sponsored by the Department of Education and located at www.pde.state.pa.us.
(iv) A training program meeting the training standards imposed on the agency or registry by virtue of the agency ' s or registry ' s participation as a provider in a Medicaid waiver or other publicly funded program providing home and community based services to qualifying consumers.
(v) Another program identified by the Department by subsequent publication in the Pennsylvania Bulletin or on the Department ' s website.

611.57(a) (a) The consumer of home care services provided by a home care agency or through a home care registry shall have the following rights: (1) To be involved in the service planning process and to receive services with reasonable accommodation of individual needs and preferences, except where the health and safety of the direct care worker is at risk. (2) To receive at least 10 calendar days advance written notice of the intent of the home care agency or home care registry to terminate services. Less than 10 days advance written notice may be provided in the event the consumer has failed to pay for services, despite notice, and the consumer is more than 14 days in arrears, or if the health and welfare of the direct care worker is at risk.

611.57(b) (b) No individual as a result of the individual's affiliation with a home care agency or home care registry may assume power of attorney or guardianship over a consumer utilizing the services of that home care agency or home care registry. The home care agency or home care registry may not require a consumer to endorse checks over to the home care agency or home care registry.

611.57(c ) (c) Prior to the commencement of services, the home care agency or home care registry shall provide to the consumer, the consumer's legal representative or responsible family member an information packet containing the following information in a form that is easily read and understood: (1) A listing of the available home care services that will be provided to the consumer by the direct care worker and the identity of the direct care worker who will provide the services. (2) The hours when those services will be provided. (3) Fees and total costs for those services on an hourly or weekly basis. (4) Who to contact at the Department for information about licensure requirements for a home care agency or home care registry and for compliance information about a particular home care agency or home care registry. (5) The Department's complaint Hot Line (1-800-254-5164) and the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA). (6) The hiring and competency requirements applicable to direct care workers employed by the home care agency or referred by the home care registry. (7) A disclosure, in a format to be published by the Department in the Pennsylvania Bulletin by February 10, 2010, addressing the employee or independent contractor status of the direct care worker providing services to the consumer, and the resultant respective tax and insurance obligations and other responsibilities of the consumer and the home care agency or home care registry.

A review of thirteen (13) agency Employment Offer Letters conducted on 03/04/2024 at approximately 12:30 PM stated, "...Delia Maria requires that you meet at least one of the following criteria: State Certification as a Nurse's Aide, 80+ hours of Home Health Care Certification, One full year of experience as a HHA in an established agency..."

A review of the job description for a home health aide conducted on 03/04/2024 at approximately 11:00 AM reads in part "Meets one of the following: A home health aide training and competency evaluation program as specified by CMS (Centers for Medicare and Medicaid Services) in the CoP (Conditions of Participation) 484.80 (b) and (c) respectively; or a competency evaluation program that meets CMS specifications; or a nurse aide training and competency evaluation program approved by the state as meeting the requirements of 42 CFR (Code of Federal Regulations) 483.151-154; or the requirements of a state licensure program that meets the provision of CMS Home Health CoP 484.80 (b) and (c)."

A review of clinical records (CR) was conducted on March 4, 2024 starting at approximately 9:15 AM and on March 5, 2024 starting at approximately 9:10 AM. The Start of Care (SOC) and Certification Period (CP) are indicated below.

CR#6 SOC 6/19/2022 revealed that the patient is receiving home health aide services only. The CR did not contain a certification period (CP), plan of treatment, periodic review of the plan of treatment, physician orders, a comprehensive nursing assessment, a home health aide (HHA) care plan, evidence of the RN performing supervisory visits of the home health aide, nor HHA notes documenting care performed. The CR contained the following documentation consistent with 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries: 1. A Hello and Welcome form which reads in part, "Delia Maria Home Care Agency also has the right to terminate services with a 10-day notice to our consumer; As a recipient of PA Waiver program services, you have the right to direct your own care and hire your own attendant; You have been provided with Cost of services to be provided on an hourly basis; PA Department of Health Consumer Notice of Direct Care Worker Status, Consumer Protection Policy PA Code 611.57." 2. The consumer notice of direct care worker status form signed by the patient and the agency on 06/23/2022 and again on 12/14/2023. 3. Language on a form titled Delia Maria Home Care Agency which states in part, "Home care services include assistance with self-administered medications; personal care such as assistance with personal hygiene, dressing and feeding; Homemaking such as assistance with household tasks housekeeping, shopping, meal planning and preparation and transportation; companionship; respite care such as assistance and support provided to the family; other non-skilled services; The licensure regulations at 28 PA Code 611.57 require an HCA or HCR, prior to the commencement of home care services, to provide to the consumer, the consumer's legal representative or responsible family member an information packet containing, among other items, a disclosure in the format to be provided by the department, and individuals who have any questions or would like more information regarding home care agencies, home care registries and/or the HCA/HCR licensure program, contact the Division of Home Health at 717 783-1379." 4. An "Acknowledgement of Receipt of Information" Form containing the following information was signed by the patient and the agency on 06/23/2022: "Delia Maria Home Care Agency has provided a list of home care services available to me and the identity of the direct care worker who will provide the services and the hours when those services will be provided; I acknowledge that I was involved in the service planning process for the services that I will receive through Delia Maria Home Care Agency; I acknowledge that I was made aware of all fees and total costs for those services on an hourly basis; I acknowledge that I was informed who to contact at the Department for information about licensure requirements for a home care registry and for compliance information about a particular home care registry; I acknowledge that I was informed of the department's complaint hot line 1-800-254 5164 and the telephone number of the ombudsman program located with the local area agency on aging; I acknowledge that I was informed about the hiring and competency requirements applicable to direct care workers referred by Delia Maria Home Health Care Agency; I acknowledge that I was informed of my rights to receive at least 10 calendar days' advance written notice of the intent of Delia Maria Home Health Care Agency to terminate services; Less than 10 day's advance written notice may be provided in the event the consumer has failed to pay for services, despite notice, and the consumer is more than 14 days in arrears, or if the health and welfare of the direct care worker is at risk; I acknowledge that I was instructed that no individual as a result of the individuals affiliation with Delia Maria Home Care Agency may assume power of attorney or guardianship over a consumer utilizing the services of Delia Maria Home Care Agency; Delia Maria Home Health Care Agency may not require a consumer to endorse checks over to the home care agency or home care registry (does not apply to private pay consumers)." The agency does not have a Home Care Agency License.

CR#7 SOC 12/06/2022 revealed that the patient is receiving home health aide services only. The CR did not contain a certification period (CP), plan of treatment, periodic review of the plan of treatment, physician orders, a comprehensive nursing assessment, a home health aide (HHA) care plan, evidence of the RN performing supervisory visits of the home health aide, nor HHA notes documenting care performed. The CR contained the following documentation consistent The CR contained the following documentation consistent with 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries: 1. A Hello and Welcome form which reads in part, "Delia Maria Home Care Agency also has the right to terminate services with a 10-day notice to our consumer; As a recipient of PA Waiver program services, you have the right to direct your own care and hire your own attendant; You have been provided with Cost of services to be provided on an hourly basis; PA Department of Health Consumer Notice of Direct Care Worker Status, Consumer Protection Policy PA Code 611.57." 2. The consumer notice of direct care worker status form signed by the patient and the agency on 12/06/2022. 3. Language on a form titled Delia Maria Home Care Agency which states in part, "Home care services include assistance with self-administered medications; personal care such as assistance with personal hygiene, dressing and feeding; Homemaking such as assistance with household tasks housekeeping, shopping, meal planning and preparation and transportation; companionship; respite care such as assistance and support provided to the family; other non-skilled services; The licensure regulations at 28 PA Code 611.57 require an HCA or HCR, prior to the commencement of home care services, to provide to the consumer, the consumer's legal representative or responsible family member an information packet containing, among other items, a disclosure in the format to be provided by the department, and individuals who have any questions or would like more information regarding home care agencies, home care registries and/or the HCA/HCR licensure program, contact the Division of Home Health at 717 783-1379." 4. An "Acknowledgement of Receipt of Information" Form containing the following information was signed by the patient and the agency on 12/06/2022: "Delia Maria Home Care Agency has provided a list of home care services available to me and the identity of the direct care worker who will provide the services and the hours when those services will be provided; I acknowledge that I was involved in the service planning process for the services that I will receive through Delia Maria Home Care Agency; I acknowledge that I was made aware of all fees and total costs for those services on an hourly basis; I acknowledge that I was informed who to contact at the Department for information about licensure requirements for a home care registry and for compliance information about a particular home care registry; I acknowledge that I was informed of the department's complaint hot line 1-800-254 5164 and the telephone number of the ombudsman program located with the local area agency on aging; I acknowledge that I was informed about the hiring and competency requirements applicable to direct care workers referred by Delia Maria Home Health Care Agency; I acknowledge that I was informed of my rights to receive at least 10 calendar days' advance written notice of the intent of Delia Maria Home Health Care Agency to terminate services; Less than 10 day's advance written notice may be provided in the event the consumer has failed to pay for services, despite notice, and the consumer is more than 14 days in arrears, or if the health and welfare of the direct care worker is at risk; I acknowledge that I was instructed that no individual as a result of the individuals affiliation with Delia Maria Home Care Agency may assume power of attorney or guardianship over a consumer utilizing the services of Delia Maria Home Care Agency; Delia Maria Home Health Care Agency may not require a consumer to endorse checks over to the home care agency or home care registry (does not apply to private pay consumers)." The agency does not have a Home Care Agency License.

CR#8 SOC 08/02/2023, CP 08/02/2023 to 10/02/2023 revealed that the patient is receiving home health aide services only. The CR did not contain a current certification period (CP), plan of treatment, periodic review of the plan of treatment, physician orders, a comprehensive nursing assessment, a home health aide (HHA) care plan developed by an RN, evidence of the RN performing supervisory visits of the home health aide, nor HHA notes documenting care performed. The CR contained the following documentation consistent with The CR contained the following documentation consistent with 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries: 1. A Hello and Welcome form which reads in part, "Delia Maria Home Care Agency also has the right to terminate services with a 10-day notice to our consumer; As a recipient of PA Waiver program services, you have the right to direct your own care and hire your own attendant; You have been provided with Cost of services to be provided on an hourly basis; PA Department of Health Consumer Notice of Direct Care Worker Status, Consumer Protection Policy PA Code 611.57." 2. The consumer notice of direct care worker status form which was signed by the patient and the agency on 09/27/2023 and again on 02/09/2024. 3. An "Acknowledgement of Receipt of Information" Form containing the following information was signed by the patient and the agency on 09/27/2023: "Delia Maria Home Care Agency has provided a list of home care services available to me and the identity of the direct care worker who will provide the services and the hours when those services will be provided; I acknowledge that I was involved in the service planning process for the services that I will receive through Delia Maria Home Care Agency; I acknowledge that I was made aware of all fees and total costs for those services on an hourly basis; I acknowledge that I was informed who to contact at the Department for information about licensure requirements for a home care registry and for compliance information about a particular home care registry; I acknowledge that I was informed of the department's complaint hot line 1-800-254 5164 and the telephone number of the ombudsman program located with the local area agency on aging; I acknowledge that I was informed about the hiring and competency requirements applicable to direct care workers referred by Delia Maria Home Health Care Agency; I acknowledge that I was informed of my rights to receive at least 10 calendar days' advance written notice of the intent of Delia Maria Home Health Care Agency to terminate services; Less than 10 day's advance written notice may be provided in the event the consumer has failed to pay for services, despite notice, and the consumer is more than 14 days in arrears, or if the health and welfare of the direct care worker is at risk; I acknowledge that I was instructed that no individual as a result of the individuals affiliation with Delia Maria Home Care Agency may assume power of attorney or guardianship over a consumer utilizing the services of Delia Maria Home Care Agency; Delia Maria Home Health Care Agency may not require a consumer to endorse checks over to the home care agency or home care registry (does not apply to private pay consumers)." The agency does not have a Home Care Agency License.


CR#11 SOC 01/08/2024 revealed the patient is receiving home health aide services only. The CR did not contain a certification period (CP), plan of treatment, periodic review of the plan of treatment, physician orders, a comprehensive nursing assessment, a home health aide (HHA) care plan developed by an RN, evidence of the RN performing supervisory visits of the HHA, or HHA notes documenting care performed. The CR contained a Case Assignment/Confirmation form consistent with Home Care Agency Regulations Chapter 611.57(c): "(1) A listing of the available home care services that will be provided to the consumer by the direct care worker and the identity of the direct care worker who will provide the services; and (2) The hours when those services will be provided " . The CR also contained a Notice of Direct Care Worker Status form which is consistent with Home Care Agency Regulations Chapter 611.57(c)(7). The agency does not have a Home Care Agency License.


CR#15 SOC 02/19/2024 revealed that the patient is receiving home health aide services only. The CR did not contain a certification period (CP), plan of treatment, periodic review of the plan of treatment, physician orders, a comprehensive nursing assessment, a home health aide (HHA) care plan developed by an RN, evidence of the RN performing supervisory visits of the home health aide, nor HHA notes documenting care performed. The CR contained a Notice of Direct Care Worker Status form signed by the consumer on 02/23/2024 which is consistent with The CR contained the following documentation consistent with 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries 611.57(c)(7). The agency does not have a Home Care Agency License.

CR#16 SOC 11/01/2023 revealed that the patient is receiving services from a home health aide only. The CR did not contain a certification period (CP), plan of treatment, periodic review of the plan of treatment, physician orders, a comprehensive nursing assessment, a home health aide (HHA) care plan developed by an RN, evidence of the RN performing supervisory visits of the home health aide, nor HHA notes documenting care performed. The CR contained a Notice of Direct Care Worker Status form which was signed by the consumer and the agency on 12/12/2023 which is consistent with The CR contained the following documentation consistent with 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries 611.57(c)(7). The agency does not have a Home Care Agency License.

Reviewed agency's Policy Number P:3 titled, "Competency Skills Testing: Clinical Staff", effective date 1/2023 on March 6, 2024 at approximately 12:15 PM. Policy states, "...Skills competencies are performed on hire and at least annually, upon worker request and if there is a disciplinary/corrective action or quality of care issue needed for the worker. At least 72 hours is required for home health aide staff upon hire, and 12 hours are to be completed annually. Non-aide staff members are required to complete 60 hours of training (hands-on or written documentation) upon during first two to three months of hire with assigned trainer...3. HHA Skills Competency Testing: The HHA will successfully complete all skills on the competency checklist before services any clients ..."

A review of personnel files (PF) was conducted on March 4, 2024 starting at approximately 10:55 AM, and again on March 13, 2024 starting at approximately 2:15 PM. The date of hire (DOH) is indicated below.

PF#6 DOH 01/14/2022 The date of hire as a Direct Care Worker (DCW) was after the agency ' s home care agency closed effective 08/31/2021. The PF contained the following documentation: An offer of employment letter dated 12/21/2021 stating that the employee's position is a personal care assistant, a Direct Care Worker (DCW) training certificate dated 12/28/2021, an "annual training evaluation" showing that (13) in-house training topics were completed on 12/22/2021, a reading/mathematics exam, a signed home health aide job description dated 12/11/2023, the same "annual training evaluation" topics completed on 12/01/2023, and a training transcript showing that twelve (12) video courses (totaling 3.75 hours), provided by the Pennsylvania Home Care Association, were completed in 2023. The above training documentation meets the requirements under Chapter 611.55. The file did not include evidence that the HHA completed a minimum of sixty (60) hours of training as required in Chapter 601.6.

PF#13 DOH 12/15/2023 (Rehire) contained the following training documentation: Two (2) job descriptions - a personal care assistant (dated 11/07/2023) and a home health aide (dated 01/02/2024) and signed by the employee. The date of hire as a Direct Care Worker (DCW) was after the agency ' s home care agency closed effective 08/31/2021. A Direct Care Worker (DCW) training certificate and skills evaluation for 2023. A training transcript showing that twelve (12) video courses (totaling 3.75 hours) were completed in 2023 provided by the Pennsylvania Home Care Association, and a reading/mathematics exam. The above training documentation meets the requirements under Chapter 611.55. The file did not include evidence that the HHA had completed a minimum of sixty (60) hours of training as required under Chapter 601.6.

PF#16 DOH 01/18/2022 contained evidence of a personal care assistant job description (JD) signed on 01/18/2022. The date of hire as a Direct Care Worker (DCW) was after the agency ' s home care agency closed effective 08/31/2021. A direct care worker training certificate, provided by the Pennsylvania (PA) Department of Human Services, was completed on 01/19/2022. The PF contained a home health aide job description dated 12/2023. The PF contained a document dated 11/11/2022 which stated "(named consumer) has chosen you to be his/her caretaker" consistent with the consumer direction model applicable to 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries.

PF#17 DOH 01/22/2022 (Rehire) contained evidence of a personal care assistant job description (JD) signed on 01/22/2020. The date of rehire as a Direct Care Worker (DCW) was after the agency ' s home care agency closed effective 08/31/2021. A direct care worker training certificate, provided by the Pennsylvania (PA) Department of Human Services, was completed on 03/25/2022. The PF contained evidence that twelve (12) video courses (totaling 3.75 hours), provided by the PA Homecare Association, were completed in 2023. There was no evidence that a total of sixty (60) hours of home health aide training was provided. The PF also contained a document dated 01/22/2020 and 02/07/2024 which stated in part, "(named consumer) has chosen you to be his/her caretaker" consistent with the consumer direction model applicable to 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries.

PF#18 DOH 09/01/2022 contained a document dated 09/01/2022 which stated in part, "(named consumer) has chosen you to be his/her caretaker" consistent with the consumer direction model applicable to 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries.

PF#19 DOH 11/01/2021 contained a document dated 10/20/2021 which stated in part, "(named consumer) has chosen you to be his/her caretaker" consistent with the consumer direction model applicable to 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries.

PF#20 DOH 08/23/2023 (Rehire) contained a document dated 08/23/2023 which stated in part, "(named consumer) has chosen you to be his/her caretaker" consistent with the consumer direction model applicable to 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries.

PF#22 DOH 05/13/2020 PF contained evidence of a personal care assistant job description (JD) signed on 05/13/2020. A direct care worker training certificate, provided by the Pennsylvania (PA) Department of Human Services, was completed 05/13/2020. A 2nd Direct Care Worker training certificate was issued on 03/14/2022. A home health aide JD was added to the PF, date unknown (only the first page of the JD was provided). The PF contained evidence that twelve (12) video courses (totaling 3.75 hours), provided by the PA Homecare Association, were completed in '2023'. There was no evidence that a total of sixty (60) hours of home health aide training was provided. The PF also contained a document dated 12/09/2022 which stated in part, "(named consumer) has chosen you to be his/her caretaker" consistent with the consumer direction model applicable to 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries.

PF#23 DOH 03/13/2023 PF contained a document dated 03/13/2023 which stated in part, "(named consumer) has chosen you to be his/her caretaker" consistent with the consumer direction model applicable to 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries.

PF#24 DOH 09/13/2023 PF contained a document dated 09/13/2023 which stated in part, "(named consumer) has chosen you to be his/her caretaker" consistent with the consumer direction model applicable to 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries.

PF#25 DOH 07/01/2020 PF contained a document dated 11/14/2022 which stated in part, "(named consumer) has chosen you to be his/her caretaker" consistent with the consumer direction model applicable to 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries.

A review of the Pennsylvania Department of Health ' s (DOH) Event Reporting System (ERS), (database agencies use to report incidents/events to the DOH) Event number 979870 dated 01/11/2023, was conducted on March 12, 2024 at approximately 10:30 AM. The report, concerning patient neglect, indicated that "all of participant's aides are consumer choice", and that the agency had made attempts to use agency aides but the patient was not in agreement. The aforementioned event demonstrates that the agency is providing services to the patient under the consumer direction model that is applicable to 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries.

An interview conducted with the human resources director and director of nursing on March 6, 2024 starting at 1:15 PM, and discussion via email with administrator and human resources director on March 13, 2024 confirmed the above findings.













































































Plan of Correction:

For CR#6, CR#7, CR#8, CR#11, CR#15 and CR#16 the patient CP will be clarified and updated in the patient's file, plan of treatment, periodic review of the plan, physicians' orders, a comprehensive nursing assessment, a HHA care plan and evidence of the RN supervisory visits documentation in CR file will be updated to be reflective of PA Code 601. Our new DON began with the agency as of 01/08/24, so our agency has been vigorously conducting home visits, updating documentation and policies has been in consistent communication with all CR physicians.

All other CR files will be in review by the DON to ensure all of the above mentioned will be reflective in other CRs. The agency has communicated its staffing limitations in previous audits; however now that we have a more hands-on skilled staff, and we will ensure that are no error by the next plan of correction date. To reduce reoccurrence the agency will complete three rounds of self-audits over the next several weeks to ensure that no CR record is overlooked, and information properly updated.

For PF#6, PF#13, PF#16, PF#17, PF#18, PF#19, PF#20, PF#22 (the back of the JD is in the file), PF#23, PF#24, PF#25 new hire documentation that reflects PA Code 611 has been left in the file due to agency attempting to re-apply for non-skilled license. However, the job descriptions and new hire documentation that reflects PA Code 601 has been obtained during past two months of home visits and will be placed in all employees' files so as to adhere to all requirements under necessary PA Codes. Required trainings to reflect the 72 hours that the agency requires has been obtained and placed in all PF's.

All other PF were audited and updated new hire documentation and trainings were obtained and placed in employees' files. All PF files will be audited three times by the HR Administrator to ensure no files are missing required documents.

The agency has updated new hire checklists (documents, trainings, orientation, etc.) to prevent reoccurrence and ensure information is obtained at time of hire.

For ERS, our agency will update and adopt the PA Code 601 regulations.

In order to confirm that the plan of correction is effective and sustained and that the correct CR requirements, PF requirements and ERS requirements are met we will obtain needed documentations at SOC (CR), DOH (PF) or date of the incident. The HR Director will oversee the process to ensure its completion. We will conduct quarterly audits to ensure 100% compliance is achieved in two consecutive quarters.

The plan of correction will be fully implemented by May 8, 2024.


601.21(d) REQUIREMENT
ADMINISTRATOR

Name - Component - 00
601.21(d) Administrator. The
qualified administrator, who may also
be the supervising physician or
registered nurse: (i) organizes and
directs the agency's ongoing
functions, (ii) maintains ongoing
liaison among the governing body, the
group of professional personnel, and
the staff, (iii) employs qualified
personnel and ensures adequate staff
education and evaluations, (iv)
ensures the accuracy of public
information materials and activities,
and (v) implements an effective
budgeting and accounting system. A
qualified person is authorized in
writing to act in the absence of the
administrator.

Observations:

Based on a review of agency documents and an interview with the human resources director and director of nursing, the agency ' s administrator failed to organize and direct the agency's ongoing functions.

Findings include:

The administrator failed to ensure a physician or allowed practitioner was involved in reviewing the 2023 annual program evaluation completed 01/11/2024. 601.22(a)

The administraor failed to demonstrate the presence of one or more of the following: orientation at time of hire, criminal background check, and COVID-19 vaccination status. 601.21(f)

The administrator failed to operate the agency in accordance to the definition of a home health agency 601.6

The administrator failed to ensure clinical record reviews were completed for 2023. 601.22(d)

The administrator failed to ensure that personnel practices are supported by appropriate, written personnel policies. 601.21(f)

The administrator failed to ensure clinical records included complete and accurate CMS-485 Home Health Certification and Plan of Care (POC). 601.31(b)

The administrator failed to ensure all clinical records were reviewed every sixty (60) days and/or if a patient's condition changed with physician notification. 601.31(c )

The administrator failed to ensure visit frequencies for skilled services were provided according to physician orders. 601.31(d)

The administrator failed to ensure that home health aide training was completed in accordance with 601.35(a).

The administrator failed to ensure that home health aide services were provided in accordance with 601.35(b) and 601.35(c ).

The administrator failed to maintain the content of the clinical record. 601.36(a)

The administrator failed to follow the agency's plan of correction (POC) dated January 22, 2024 to correct previous deficiencies as a result of a re-licensure survey completed on October 31, 2023 and a follow-up survey completed on January 3, 2024.

An interview conducted with the human resources director and the director of nursing starting at 1:15 PM on March 6, 2024 confirmed the above findings.


















































Plan of Correction:

The agency communicated during the exit interview on 03/06/2024 that administrator completed the GOPP document incorrectly and that the form needed to be updated to reflect that work that was done for the Clinical Reviews. At this time there was no inquiry or communication about the absence of the required practitioner. Administration would have communicated that our NP is involved and available for all quarterly and annual meetings as required. Our NP was in attendance during annual meeting on 01/11/2024.

The agency has obtained signed orientation documents at time of hire, COVID vaccination cards, exemption and exemption documents.

Agency will ensure that adherence to PA Code 601.6 is reflective in all CR and PF files at POC date.

The administrator communicated that CR records for 2023 were completed by DON at time of exit interview on 03/06/2024 however agency failed to properly file all records in the files. CR record reviews are now both in patients' files and in binder for proper review for auditors.

Agency will implement a CR checklist and practice of checking compliance to ensure that two satisfactory file audits reflect compliance to PA Code 601.

In order to confirm that the plan of correction is effective and sustained that the proper quarterly and annual meetings, health screenings and records and clinical reviews are in place; the agency will conduct two rounds of file audits on a quarterly basis by DON (CR files) until 100% compliance is achieved for two consecutive quarters.

The plan of correction will be fully implemented by 05/08/2024.


601.21(f) REQUIREMENT
PERSONNEL POLICIES

Name - Component - 00
601.21(f) Personnel Policies.
Personnel practices and patient care
are supported by appropriate, written
personnel policies. Personnel records
include qualifications, licensure,
performance evaluations, health
examinations, documentation of
orientation provided, and job
descriptions, and are kept current.

Observations:

Based on a review of personnel files (PF), agency's plan of correction for a follow-up survey completed on January 3, 2024, agency policies and procedures, agency employee roster, Philadelphia Department of Health Advisory: Updates to COVID-19 Vaccination and Masking Requirements for Healthcare Workers, and an interview with the human resources director (HR) and director of nursing (DON), the agency failed to demonstrate the presence of one or more of the following: orientation at time of hire, criminal background check, and COVID-19 vaccination status for ten (10) of twenty-five (25) PF's reviewed: PF#11, PF#12, PF#15, CR#16, CR#17, PF#21, PF#22, PF#23, PF#24, and PF#25.


Findings include:

The agency's plan of correction dated January 22, 2024, on March 6, 2024 at 10:00 AM, states in part, "In order to reduce reoccurrence agency has been auditing PF and CR records as of January 15th. Policy and Procedures with regard to training, onboarding, screenings and education will be augmented to include discrepancies from self-audit. Biannual audits will be implemented. HR and DON will be responsible for review. Fully implemented by CA (corrective action) date." The corrective action date was February 28, 2024.

A review of the agency's policy New Hire Orientation contained in the Employee Handbook and conducted on 03/05/2024 at approximately 12:00 PM reads in part, "It is mandatory that all new employees attend the new hire orientation program during time of interview and completion of application. Upon coming in for an interview, the potential employee will be notified that application completion will include orientation and a review of all policies and procedures."

A review of the agency's policy Hiring and Personnel Files (Policy Number P:10) conducted on 03/05/2024 at approximately 11:45 AM reads in part, "Prior to an offer of employment, the Agency will conduct a criminal background history check to determine if that person has a criminal conviction or has committed certain conduct..." and "All applicants require criminal background check from the PA State Police..."

The human resources director (HRD), in an interview held on 03/06/2024 at 1:15 PM, stated that the agency does not require COVID vaccination.

In May 2019, the Centers for Disease Control (CDC) updated its recommendation for TB testing of health care personnel. The CDC guidelines state that all Health Care Workers (HCW) should receive 1) baseline tuberculosis screening upon hire using a two-step tuberculin skin test (TST) or a single blood assay for tuberculosis (TB) to test for infection with tuberculosis; 2) Completion of a tuberculosis symptom questionnaire, and 3) Completion of a tuberculosis risk assessment. After baseline testing for infection with tuberculosis, HCW's should receive TB screening annually. HCW's with a baseline positive or newly positive test for tuberculosis infections should receive one chest radiograph result to exclude tuberculosis disease (CDC Guidelines for Preventing Transmission of Mycobacterium Tuberculosis in Health Care Settings, 2005. Morbidity and Mortality World Report 2005, RR-17) (http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf). *Baseline (preplacement) screening and testing, in addition to the IGRA (interferon-gamma release assay) or TST, shall include a symptom screen questionnaire and an individual TB risk assessment. Serial screening and testing not routinely recommended. Annual TB education is recommended. (CDC/MMWR/May 17, 2019/Vol. 68/No. 19).

A review of the Philadelphia Department of Public Health, Division of Disease Control Health Advisory: Updates to COVID-19 Vaccination and Masking Requirements for Healthcare Workers (HCSW) dated May 10, 2023, conducted on 03/01/2024, reads in part, "The Healthcare Worker Vaccine mandate is still in effect. To be considered in compliance with the HCW COVID-19 Vaccine mandate, an individual must have received at least one of the following: two (2) doses of monovalent vaccine, one (1) dose of bivalent vaccine, one (1) dose of Janssen vaccine. An individual may not simply opt out of vaccination. They must submit for approval of a medical or religious exemption to the Healthcare Institution where the individual works in accordance with the policies established by the institution."

Correspondence with the Philadelphia Department of Public Health on March 7, 2024 at 11:00 AM revealed that Health Advisory titled "Updates to COVID-19 Vaccination and Masking Requirements for Healthcare Workers" from May 10th, 2023 remains in effect and that there have been no additional updates to this guidance.

A review of personnel files (PF) was conducted on March 4, 2024 starting at approximately 10:55 AM, and again on March 13, 2024 starting at approximately 2:15 PM. The date of hire (DOH) is indicated below.

PF#11 DOH 09/13/2021 contained a Pennsylvania Access to Criminal History report dated 03/17/2023, eighteen months after the date of hire.

PF#12 DOH 01/08/2023 did not contain evidence that an orientation program was completed upon hire.

PF#15 DOH 02/19/2024 did not contain evidence that the COVID-19 vaccination was administered or an exemption was provided.

PF#16 DOH 01/18/2022 PF contained a COVID Vaccination Exemption Form, but there was no reason stated for the exemption, nor was there evidence of approval of the exemption by the agency. The form was signed by the employee only.

PF#17 DOH 01/22/2022 PF contained a COVID Vaccination Exemption Form, but there was no reason stated for the exemption, nor was there evidence of approval of the exemption by the agency. The form was signed by the employee only.

PF#21 DOH 05/21/2021 PF contained a COVID Vaccination Exemption Form, but there was no reason stated for the exemption, nor was there evidence of approval of the exemption by the agency. The form was signed by the employee only.
PF#22 DOH 05/13/2020 PF contained a COVID Vaccination Exemption Form, but there was no reason stated for the exemption, nor was there evidence of approval of the exemption by the agency. The form was signed by the employee only.
PF#23 DOH 03/13/2023 PF contained a COVID Vaccination Exemption Form, but there was no evidence of approval of the exemption by the agency. The form was signed by the employee only.
PF#24 DOH 09/13/2023 PF contained a COVID Vaccination Exemption Form, but there was no evidence of approval of the exemption by the agency. The form was signed by the employee only.
PF#25 DOH 07/01/2020 PF did not contain evidence of a tuberculosis symptom screen and TB risk assessment on hire. There is no evidence of COVID vaccination or exemption in the PF.

An interview conducted with the human resources director and the director of nursing starting at 1:15 PM on March 6, 2024 confirmed the above findings.


Repeat deficiency 10/31/23, 1/3/24













































































Plan of Correction:

For PF#11, DOH 09/13/2021 the agency requires all employees criminal background be obtained at the time of hire.

For PF#12, DOH 01/08/2023, evidence of orientation program was obtained and placed in employee's file.

For PF #15, PF#16, PF#17, PF#21, PF #22, PF #23, PF #24 and PF #25 COVID vaccination form approval of exemption, TB screening, TB risk assessment was obtained and placed in employee file.

All other employee files were reviewed and there are 95% satisfactory files.

The agency will update agency's policy and procedures to reflect COVID requirement. Administrator will also ensure that employee new hire checklist will be placed in each employee record to ensure 100% compliance.

The plan of correction will be fully implemented by 05/08/2024.


601.22(a) REQUIREMENT
ANNUAL POLICY REVIEW

Name - Component - 00
601.22(a) Annual Policy Review. A
group of professional personnel, which
includes at least one practicing
physician and one registered nurse,
and with appropriate representation
from other professional disciplines,
establishes and annually reviews the
agency's policies governing scope of
services offered, admission and
discharge policies, medical
supervision and plans of treatment,
emergency scope of services offered,
medical care, clinical records,
personnel qualifications, and program
evaluation.

Observations:

Based on a review of agency documents and correspondence with the administrator, the agency failed to demonstrate that a physician or nurse practitioner was involved in the annual review of the agency's policies, governing scope of services offered, admission and discharge policies, medical supervision and plans of treatment, emergency scope of services offered, medical care, clinical records, personnel qualifications, and/or program evaluation.

Findings include:

A review of the agency's Annual Evaluation was conducted on March 5, 2024 at approximately 2:00 PM and March 11, 2024 at approximately 7:10 AM. The Annual Agency Evaluation for 2023, signed January 11, 2024, did not contain evidence that a physician or nurse practitioner was involved in the annual agency evaluation. The team members listed on the evaluation were: executive director, human resources director, director of nursing, human resources representative, training coordinator, and intake supervisor.

The above findings were reviewed via email with the executive director on March 11, 2024 at approximately 9:40 AM.








































Plan of Correction:

The agency communicated during the exit interview on 03/06/2024 that administrator completed the GOPP document incorrectly and that the form needed to be updated to reflect that work that was done for the Clinical Reviews. At this time there was no inquiry or communication about the absence of the required practitioner. Administration would have communicated that our NP is involved and available for all quarterly and annual meetings as required. Our NP was in attendance during annual meeting on 01/11/2024. This was communicated via email on 03/11/2024.

The agency documentation was not completed correctly at the time of review; however, the agency was not notified of concern until email communications on 03/11/2024, in which we clarified the above information.

Agency will ensure that corrected document and signatures reflective of meeting on 01/11/2024 is obtained and provided to auditors upon return.

To prevent reoccurrence agency will create new meeting template to ensure proper signatures and names are listed.

The plan of correction will be fully implemented by 05/08/2024.


601.22(d) REQUIREMENT
CLINICAL RECORD REVIEW

Name - Component - 00
601.22(d) Clinical Record Review. At
least quarterly, appropriate health
professionals, representing at least
the scope of the program, review a
sample of both active and closed
clinical records to assure that
established policies are followed in
providing services (direct as well as
services under arrangement). There is
a continuing review of clinical
records for each 60-day period that a
patient receives home health services
to determine adequacy of the plan of
treatment and appropriateness of
continuation of care.

Observations:

Based on a review of agency documents, the agency's plan of correction for the relicensure survey completed on October 31, 2023, and an interview with the human resources director and director of nursing, the agency failed to complete quarterly clinical record reviews.

Findings include:

A review of the agency's plan of correction dated November 20, 2023, reviewed on March 6, 2024 at 10:00 AM, states, "For CR#1, CR#2, CR#3, CR#4, and CR#5 clinical record reviews will be completed to ensure that the documentation of findings, the dates that the record review is being conducted, and to notate that the file is in or out of compliance. In order to confirm that the plan of correction is effective and sustained and that correct documentation are obtained the agency will conduct quarterly audits by the HR Director until 100% compliance is achieved for two consecutive quarters. The plan of correction will be fully implemented by December 30, 2023."

The agency's plan of correction dated January 22, 2024, on March 6, 2024 at 10:00 AM, states,"The Clinical Record review is currently being completed by the DON. As of January 15, 2024 CR #1, 2, 3, 4 and 5 are being reviewed to ensure accuracy. The Clinical record review for above-named files as well as all other files will be completed by CA (corrective action) date. Agency staff was ill for the last quarter of 2023. However, we have since hired a new D.O.N. (director of nursing) to assist us in this process. In order to confirm that the plan of correction is effective and sustained and that correct documentation are obtained the agency will conduct biannual audits. The plan of correction will be fully implemented by February 28, 2024."

A review of the agency's 2023 annual program evaluation dated 01/10/2024 conducted on March 6, 2024 at approximately 10:00 AM found that the section titled Clinical Record Review Analysis was blank and contained no data or analysis.

There was no evidence that clinical record reviews were conducted for CR#1, CR#2, CR#3, CR#4, and CR#5 per the agency's plan of correction dated November 20, 2023 with a competion date of December 30, 2023 or January 22, 2024 with a completion date of February 28, 2024.

An interview conducted with the human resources director and the director of nursing starting at 1:15 PM on March 6, 2024 confirmed the above findings.




Repeat deficiency 10/31/23, 1/3/24

























































Plan of Correction:

For CR #1, CR #2, CR #3, CR #4, and CR #5 the administrator communicated that the CR document was not in the file however it was completed and reviewed by the DON. Agency completed its first round of audits as mentioned in POC on 01/22/2024; the second round of audits will be completed by April 4 to ensure accuracy and reduction of errors with CR files. 50% of files will be sampled each audit.

The agency will be reviewing all patient files to ensure that the required documentation is placed in patients file as required. Administrator will create patient file checklist to ensure that errors do not reoccur.

In order to confirm that the plan of correction is effective and sustained and that the proper quarterly and annual meetings and clinical record review are in the file; the agency will conduct two rounds of file audits on a quarterly basis by DON (CR files) until 100% compliance is achieved for two consecutive quarters.

The plan of correction will be fully implemented by 05/08/2024.



601.31(b) REQUIREMENT
PLAN OF TREATMENT

Name - Component - 00
601.31(b) Plan of Treatment. The
plan of treatment developed in
consultation with the agency staff
covers all pertinent diagnoses,
including:
(i) mental status,
(ii) types of services and equipment
required,
(iii) frequency of visits,
(iv) prognosis,
(v) rehabilitation potential,
(vi) functional limitations,
(vii) activities permitted,
(viii) nutritional requirements,
(ix) medications and treatments,
(x) any safety measures to protect
against injury,
(xi) instructions for timely
discharge or referral, and
(xii) any other appropriate items.
(Examples: Laboratory procedures and
any contra-indications or
precautions to be observed).

If a physician refers a patient under
a plan of treatment which cannot be
completed until after an evaluation
visit, the physician is consulted to
approve additions or modifications to
the original plan.

Orders for therapy services include
the specific procedures and modalities
to be used and the amount, frequency,
and duration.
The therapist and other agency
personnel participate in developing
the plan of treatment.

Observations:

Based on a review of clinical records (CR), agency policies and procedures, agency's plan of correction for a follow-up survey completed on January 3, 2024, and an interview with the human resources director and director of nursing, the agency failed to ensure that a plan of treatment was established by a physician for patients receiving home health aide services for six (6) of sixteen (16) CR's reviewed: CR#6, CR#7, CR#8, CR#11, CR#15, and CR#16, and that an accurate medication profile was completed for three (3) of sixteen (16) CR's reviewed: CR#3, CR#9, and CR#10.

Findings include:

A review of the agency's policy Provision of Care Treatment and Services conducted on March 6, 2024 at 10:30 AM reads in part, "Delia Maria Home Health Care agency follows physician or allowed practitioner orders when administering medication or providing care treatment or services;" and "the home health agency promptly alerts the physician(s) or allowed practitioners(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or there is a need to alter the plan of care," and "the patient's individualized plan of care is established, periodically reviewed, and signed by a doctor of medicine...or allowed practitioner."

A review of the agency's policy Medication Management (Policy Number C:41)conducted on March 6, 2024 at 11:00 AM reads in part, "Review and confirm prescribed and OTC (over the counter) medications with the patient to create a medication profile;" and "Amend medication profile to reflect accurate medication schedule."

A review of clinical records (CR) was conducted on March 4, 2024 starting at approximately 9:15 AM and on March 5, 2024 starting at approximately 9:10 AM. The Start of Care (SOC) and Certification Period (CP) are indicated below.

CR#3 SOC 10/17/2023. A discrepancy was discovered on the medication profile when compared to the physician orders on the plan of treatment. The plan of treatment contained orders for Ziprasidone (antipsychotic) two (2) capsules in AM and one (1) capsule in PM (route not documented). The medication profile did not list the Ziprasidone. The agency ' s plan of correction (POC) dated 1/22/2024 states, " For CR #3 SOC 10/17/2023 the plan of treatment was updated to ensure that the medication profile is accurate and physicians updated signatures in in the CR. " Clinical record reviewed on 3/4/2024 at 9:15 AM revealed, the medication profile did not list the Ziprasidone. There were no subsequent physician orders or documentation in the CR indicating the medication was discontinued.

CR#6 SOC 06/19/2022 did not contain evidence of a written plan of treatment by the attending physician, and there were no certification periods established.

CR#7 SOC 12/06/2022 did not contain evidence of a written plan of treatment by the attending physician, and there were no certification periods established.

CR#8 SOC 06/19/2022, CP 08/02/2022 to 10/02/2022 did not contain evidence of a written plan of treatment established by the attending physician, nor any further certification periods after 10/02/2022.

CR#9 SOC 11/16/2023. CP 01/14/2024 - 03/14/2024. A discrepancy was discovered on the medication profile when compared to the physician orders on the plan of treatment. The plan of treatment contained orders for Fluticasone Propionate 50mcg/act suspension (treats allergic and non-allergic nasal symptoms) one (1) spray in each nostril daily. The medication profile did not list the Fluticasone Propionate. There were no subsequent physician orders or documentation in the CR indicating the medication was discontinued.

CR#10 SOC 11/3/2023. CP 01/01/2024 - 03/1/2024 and discharged on 02/14/2024. During the current certification period, the following medications were added to the plan of treatment: Albuterol Sulfate 90mcg inhaler, Alendronate 70mg, Amoxicillin Potassium Clavulanate 875mg/125mg, Diclofenac Sodium 1% gel, Ibuprofen 800mg tablets, Methotrexate Sodium 2.5mg, Prednisone 20mg tablets, and Tizanidine 4mg tablets. There was no evidence that medications were reconciled for the current certification period (01/01/2024 - 03/01/2024). The medication profile was last updated on 11/03/2023, which did not include the above medications.

CR#11 SOC 01/08/2024 did not contain evidence of a written plan of treatment established by the attending physician, and did not contain a CP.

CR#15 SOC 02/19/2024 did not contain evidence of a written plan of treatment by the attending physician, and there was no certification period established.

CR#16 SOC 11/01/2023 did not contain evidence of a written plan of treatment by the attending physician, and there were no certification periods established.

An interview conducted with the human resources director and the director of nursing on March 6, 2024 starting at 1:15 PM confirmed the above findings.



Repeat deficiency 10/31/23, 1/3/24





































































Plan of Correction:

For CR#3 the medication profile will be reviewed and updated to reflect correct updated medications. Nursing staff is in communication with patient's physician and will continue to work to have patient's file updated and updated physician order in CR.

For CR #6 SOC 06/19/2022, CR #7 SOC 12/06/2022, CR #8 SOC 06/19/2022, CR #9, CR #10, CR #11, CR #15, CR #16 agency will ensure that certification period, medication profile, medication reconciliation, and plan of treatment is obtained.

It was communicated up until 10/2023 that agency was in transition and attempting to transition all patient files from non-skilled to skilled. Administration communicated the limitations with hands-on skilled care staff.

The CR files will be reviewed and ensure there are no discrepancies with the patient files.

 
In order to confirm that the plan of correction is effective and sustained and that the treatment plan, medications review, and certification periods are in the file; the agency will conduct two rounds of file audits on a quarterly basis by DON (CR files) until 100% compliance is achieved for two consecutive quarters.

The plan of correction will be fully implemented by 05/08/2024.



601.31(c) REQUIREMENT
PERIODIC REVIEW OF PLAN OF TREATMENT

Name - Component - 00
601.31(c) Periodic Review of Plan of
Treatment. The total plan of
treatment is reviewed by the attending
physician and agency personnel as
often as the severity of the patient's
condition requires, but at least once
every 60 days. Agency professional
staff promptly alert the physician to
any changes that suggest a need to
alter the plan of treatment

Observations:

Based on a review of clinical records (CR), agency's plan of correction for a follow-up survey completed on January 3, 2024, agency policies and procedures, and an interview with the human resources director and director of nursing, the agency failed to conduct a periodic review of clinical records at least every 60 days for nine (9) of sixteen (16) records reviewed: CR#6, CR#7, CR#8, CR#9, CR#10, CR#13, CR#14, CR#16 and CR#17.

Findings include:

The agency's plan of correction dated January 22, 2024, on March 6, 2024 at 10:00 AM, states, "CR#6 SOC on/around 06/23/2022 to ensure that errors do not reoccur the agency will ensure that periodic review of plan treatment is updated at SOC and before the 60-day recertification period and/or that time of discharge. The files moving forward will be reviewed at recertification period. The CR only receives HHA services. Agency will obtain 485 for CR and ensure the documentation is in the file. Clinical notes and any physician notes will be added to CR. For CR#7 SOC 12/06/2022 to ensure that errors do not reoccur the agency will ensure that periodic review of plan treatment is updated at SOC and before the 60-day recertification period and/or that time of discharge. The CR only receives HHA services. Agency will obtain 485 for CR and ensure the documentation is in the file. Clinical notes and any physician notes will be added to CR. All of the listed files SOC care date and period of certification will be clearly notated for auditors to review during next visit. For any files not listed in the CAP the agency is currently completing a self-audit to update all CR. The agency re-read the POC from 01/03/2024 and there is no statement that requests the agency plan for other files that were not audited. However, moving forward our agency will ensure that all CR are audited, SOC dates are obtained, 485 are in the file and progress or regression of patient's health is notated and communicated to the physician. Agency is undergoing a transition for non-skilled files to skilled files; however, we are actively working to transition all files and update all policies as of January 2024. Full implementation will be completed by CA date. In order to confirm that the plan of correction is effective and sustained and that correct documentation are obtained the agency will conduct biannual audits by the HR Director until 100% compliance. In addition to the biannual audits mentioned above the agency will ensure the CR is audited upon admission to ensure accuracy. The plan of correction will be fully implemented by February 28, 2024."

A review of the agency's policy Provision of Care Treatment and Services conducted on March 6, 2024 at 10:30 AM reads in part, "The comprehensive assessment is updated and reviewed (including administration of the Outcome and Assessment Information Set (OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but no less frequently than the following: the last 5 days of every 60 days beginning with the start of care date, unless there is a patient-elected transfer..."

The agency's active patient roster was provided to the surveyors on March 4, 2023 at approximately 9:45 AM. One-hundred five (105) patients were on the roster. The agency was asked to identify and confirm the patients who were receiving home health services (skilled care). The agency identified ten (10) patients who were receiving home health agency services (skilled). The remaining ninety-five (95) patients were receiving home health aide services (non-medical). Seven (7) of the ninety-five (95) home health aide patients began services in 2024.

A review of clinical records (CR) was conducted on March 4, 2024 starting at approximately 9:15 AM and on March 5, 2024 starting at approximately 9:10 AM. The Start of Care (SOC) and Certification Period (CP) are indicated below.

CR#6 SOC 06/19/2022. There was no certification period established. The clinical record revealed that the patient was currently receiving services from a home health aide only. The clinical record did not contain a plan of treatment. There was no evidence of a periodic review of the clinical record.

CR#7 SOC 12/06/2022. There was no certification period established. The clinical record revealed that the patient was currently receiving services from a home health aide only. The clinical record did not contain a plan of treatment. There was no evidence of a periodic review of the clinical record.

CR#8 SOC 08/02/2023, CP 08/02/2023 to 10/02/2023. There are no further certification periods after 10/02/2023. The clinical record revealed that the patient was currently receiving services from a home health aide only. The clinical record did not contain a plan of treatment. The clinical record did not contain physician orders authorizing services for a home health aide. There was no evidence of a periodic review of the clinical record.

CR#9 SOC 11/16/2023. CP 01/14/2024 - 03/14/2024. The clinical record revealed that the patient was receiving skilled nursing services two (2) times per week for sixty (60) days, and physical therapy services two (2) times per week for sixty (60) days. There was no evidence of a periodic review of the clinical record.

CR#10 SOC 11/3/2023. CP 01/01/2024 - 03/1/2024 and discharged on 02/14/2024. The clinical record revealed that the patient was receiving skilled nursing services one (1) to three (3) times per week for sixty (60) days, and physical therapy services one (1) to three (3) times per week for sixty (60) days. There was no evidence of a periodic review of the clinical record.

CR#13 SOC 11/21/2023, CP #2 01/19/2024 to 03/19/2024. The clinical record revealed that the patient was receiving skilled nursing two (2) times per week for sixty (60) days, and physical therapy two (2) times per week for sixty (60) days. There was no evidence of a periodic review of the clinical record.

CR#14 SOC 11/01/2023, CP 12/30/2023 to 02/27/2024, Discharge 02/06/2024. The clinical record revealed that the patient was receiving skilled nursing one (1) to two (2) times per week for sixty (60) days, and physical therapy one (1) to two (2) times per week for sixty (60) days. There was no evidence of a periodic review of the clinical record.

CR#16 SOC 11/01/2023. There was no certification period established. The clinical record revealed that the patient was currently receiving services from a home health aide only. The clinical record did not contain a plan of treatment. There was no evidence of a periodic review of the clinical record.

CR#17 SOC 11/13/2023. CP 01/11/2024 - 03/11/2024. The clinical record revealed that the patient was receiving skilled nursing services two (2) times per week for sixty (60) days, and physical therapy services two (2) times per week for sixty (60) days. There was no evidence of a periodic review of the clinical record.

An interview conducted with the human resources director and the director of nursing on March 6, 2024 starting at 1:15 PM confirmed the above findings.



Repeat deficiency 10/31/23, 1/3/24












































































Plan of Correction:

For CR#6 SOC 06/19/2022, CR #7 SOC 12/06/2022, CR #8 SOC 08/02/2023, CR #9 SOC 11/16/2023, CR#10 SOC 11/3/2023, CR #13 SOC 11/21/2023, CR #14 SOC 11/01/2023, CR#16 SOC 11/01/2023, CR #17 SOC 11/13/2023 the DON will ensure that clinical records that were completed are placed in the CR file.

The agency will implement a checklist and practice of checking compliance to ensure that two satisfactory file checks are obtained prior to the end of the certification period. Agency will ensure the CRs will include Plan of Treatment and documentation of periodic clinical review.

In order to confirm that the plan of correction is effective and sustained and that required evidence is in the files; the agency will conduct two rounds of file audits on a quarterly basis by DON (CR files) until 100% compliance is achieved for two consecutive quarters.

The plan of correction will be fully implemented by 05/08/2024.




601.31(d) REQUIREMENT
CONFORMANCE WITH PHYSICIAN'S ORDERS

Name - Component - 00
601.31(d) Conformance With
Physician's Orders. All prescription
and nonprescription (over-the-counter)
drugs, devices, medications and
treatments, shall be administered by
agency staff in accordance with the
written orders of the physician.
Prescription drugs and devices shall
be prescribed by a licensed physician.
Only licensed pharmacists shall
dispense drugs and devices. Licensed
physicians may dispense drugs and
devices to the patients who are in
their care. The licensed nurse or
other individual, who is authorized by
appropriate statutes and the State
Boards in the Bureau of Professional
and Occupational Affairs, shall
immediately record and sign oral
orders and within 7 days obtain the
physician's counter-signature. Agency
staff shall check all medicines a
patient may be taking to identify
possible ineffective drug therapy or
adverse reactions, significant side
effects, drug allergies, and
contraindicated medication, and shall
promptly report any problems to the
physician.

Observations:


Based on a review of clinical records (CR), agency policies and procedures, agency's plan of correction for the relicensure survey completed 10/31/2023, and an interview with the human resources director and director of nursing, the agency failed to provide care in accordance with physician orders for five (5) of sixteen (16) CR's reviewed: CR#9, CR#10, CR#13, CR#14, and CR#17.

Findings include:

A review of the agency's policy Missed Visits (MV) (Policy Number C:36), conducted on March 6, 2024 at 9:15 AM reads in part, "When a missed visit occurs, a missed visit or new schedule form is completed to clarify/explain why visits have not occurred. it does not apply to a one-time missed visit occurrence when the visit was rescheduled for another day in the same week the visit was to occur; When an interruption occurs due to a missed visit, the following procedure should be followed: complete the missed visit/new schedule form including an explanation why visit did not occur per the POC or must be temporarily halted (i.e. hospitalization) and anticipated length of hold, if known; if agency misses visits or services as required by the plan of care, the agency must notify the responsible physician of the missed visit if there is any potential for clinical impact upon the patient. The physician will determine whether the patient visit may be skipped or additional intervention is required by the agency due to the impact on the patient."

A review of the agency's plan of correction dated 11/20/2023, on March 6, 2024 at 10:00 AM, states, " In accordance with 601.31(d) Conformance with physicians orders our agency will ensure that all prescription and nonprescription (over-the-counter) drugs, devices, medications and treatments will be administered in accordance with the written orders of the physician... " The corrective action date was 12/30/2023.

A review of clinical records (CR) was conducted on March 4, 2024 starting at approximately 9:15 AM and on March 5, 2024 starting at approximately 9:10 AM. The Start of Care (SOC) and Certification Period (CP) are indicated below.

CR#9 SOC 11/16/2023. CP 01/14/2024 - 03/14/2024. The clinical record contained physician orders via Form CMS-485 Home Health Certification and Plan of Care (POC) for the following: Skilled Nursing (SN) two (2) times per week for sixty (60) days, and Physical Therapy (PT) two (2) times per week for sixty (60) days. During the week of 02/12/2024, only one (1) PT visit was conducted. There was no evidence that the second PT visit was conducted. During the weeks of 02/19/2024 and 02/26/2024, there was no evidence that PT services were provided. During the week of 02/26/2024, only one (1) SN visit was conducted. There was no evidence that the second SN visit was conducted. There were no clinical notes, no missed visit notes, nor any indication that the physician was notified of the missed visits.


CR#10 SOC 11/3/2023. CP 01/1/2024 - 03/1/2024 and discharged on 02/14/2024. The clinical record contained physician orders via Form CMS-485 Home Health Certification and Plan of Care (POC) for the following: Skilled Nursing (SN) one (1) to three (3) times per week for sixty (60) days, and Physical Therapy (PT) one (1) to three (3) times per week for sixty (60) days. During the week of 02/05/2024, there was no evidence that SN or PT services were provided. There were no clinical notes, no missed visit notes, nor any indication that the physician was notified of missed PT and SN visits the week of 2/05/2024.

CR#13 SOC 11/21/2023, CP #2 01/19/2024 to 03/19/2024. The CMS 485 Home Health Certification and Plan of Care (POC) contained physician orders for skilled nursing (SN) visits two times per week for 60 days. There was one (1) SN MV the week of 01/22/2024 (on 01/25/2024), and two (2) SN MV the week of 02/12/2024 (on 02/13/2024 and 02/15/2024). There was no evidence that the physician was notified of the MV. The 'physician notified' section of the above three MV forms was blank.


CR#14 SOC 11/02/2023, CP 12/30/2023 to 02/27/2024, The POC contained orders for skilled nursing visits one (1) to two (2) times per week for 60 days. A notation on a Physician Authorization Form reads, "this is nurse for patient CR#3. I am writing to inform 'his' primary physician that 'he' missed skilled nursing visits from 12/15/23 to 01/3/24 due to 'her' not feeling well. The patient was seen 1/3/24 and is feeling better...." The communication form was dated 01/03/24. The form did not contain evidence that it was sent to the physician or that the physician was notified of the MV from 12/15/2023 to 01/03/2024.

CR#17 SOC 11/13/2023. CP 01/11/2024 - 03/11/2024. The clinical record contained physician orders via Form CMS-485 Home Health Certification and Plan of Care (POC) for the following: Skilled Nursing (SN) two (2) to three (3) times per week for sixty (60) days, and Physical Therapy (PT) two (2) to three (3) times per week for sixty (60) days. During the week of 01/08/2024, only one (1) SN and PT visit was conducted. There was no evidence that the second SN and PT visits were conducted. During the week of 01/22/2024, there was no evidence that the second SN visit was conducted. During the week of 02/05/2024, only one (1) PT visit was conducted. There was no evidence that the second PT visit was conducted. During the weeks of 02/19/2024 and 02/26/2024, there was no evidence that SN and PT services were provided. There were no clinical notes, no missed visit notes, nor any indication that the physician was notified of the missed visits.

An interview with the human resources director and the director of nursing conducted on March 6, 2024 starting at 1:15 PM confirmed that clinical records not previously reviewed (CR#9, CR#10, CR#13, CR#14, and CR#17) demonstrate that the deficiency was not corrected.



Repeat deficiency 10/31/23

































































Plan of Correction:

For CR #9 SOC 11/16/2023, CR #10 SOC 11/3/2023, CR #13 SOC 11/21/2023, CR #14 SOC 11/02/2023, and CR #17 SOC 11/13/2023 the file will be updated to reflect any clinical notes missed visit notes and indications that the physician is notified of patients care/changes.

The agency will implement a checklist and practice of checking compliance to ensure that two satisfactory file checks are obtained prior to the end of the certification period.

In order to confirm that the plan of correction is effective and sustained and that required evidence is in the files; the agency will conduct two rounds of file audits on a quarterly basis by DON (CR files) until 100% compliance is achieved for two consecutive quarters.

The plan of correction will be fully implemented by 05/08/2024.



601.35(a) REQUIREMENT
SELECTION OF AIDES

Name - Component - 00
601.35(a) Selection of Aides. Home
health aides are selected on the basis
of such factors as sympathetic
attitude toward the care of the sick,
ability to read, write, and carry out
directions, and maturity and ability
to deal effectively with the demands
of the job. Aides are carefully
trained in assisting patients to
achieve maximum self-reliance,
principles of nutrition and meal
preparation, the aging process and
emotional problems of illness,
maintaining a clean, healthful, and
pleasant environment, changes in
patient's condition that should be
reported, work of the agency and the
health team, ethics and
confidentiality, and recordkeeping.

Home Health Aid Training. All home
health aides have completed a minimum
of 60 hours of classroom instruction
prior to or during the first 3 months
of employment.

They are closely supervised to assure
their competence in providing care.



Observations:

Based on a review of personnel files (PF), agency's job description for a home health aide, the agency's plan of correction from a re-licensure survey completed October 31, 2023, and an interview with the human resources director and director of nursing, the agency failed to demonstrate that sixty (60) hours of classroom instruction, at minimum, were provided to home health aides (HHA) nor follow the criteria listed in the home health aide job description for 80+ training hours for four (4) of fifteen (15) HHA files reviewed: PF#6, PF#13, PF#17, and PF#22.

Findings include:

A review of agency's 72 video course initial training course transcript on 04/04/2024 at approximately 11:30 AM included HHA training for assisting patients to achieve maximum self-reliance, principles of nutrition and meal preparation, the aging process and emotional problems of illness, maintain a clean, healthful, and pleasant environment, changes in patient's condition that should be reported, ethics and confidentiality, and recordkeeping, transferring people the right way.

A review of agency's criteria for home health aide conducted on 03/04/2024 at approximately 12:30 AM stated, "...Delia Maria requires that you meet at least one of the following criteria: State Certification as a Nurse's Aide, 80+ hours of Home Health Care Certification, One full year of experience as a HHA in an established agency..."

A review of the job description for a home health aide conducted on 03/04/2024 at approximately 11:00 AM reads in part "Meets one of the following: A home health aide training and competency evaluation program as specified by CMS (Centers for Medicare and Medicaid Services) in the CoP (Conditions of Participation) 484.80 (b) and (c) respectively; or a competency evaluation program that meets CMS specifications; or a nurse aide training and competency evaluation program approved by the state as meeting the requirements of 42 CFR (Code of Federal Regulations) 483.151-154; or the requirements of a state licensure program that meets the provision of CMS Home Health CoP 484.80 (b) and (c)."

A review of home health aide (HHA) personnel files conducted on 03/04/2024 at 10:55 AM found that there are two different initial training course transcripts intended to meet the sixty (60) hour training requirement upon hire. One transcript consists of seventy-two (72) videos, while the second transcript consists of twelve (12) videos. The training courses are provided by the Pennsylvania Homecare Association.

The human resources director (HRD), in an interview on 03/06/2024 at 1:15 PM, stated that upon hire, instead of the seventy-two (72) video courses, that are provided from the PA Homecare Association, to English-speaking HHA's, twelve (12) video courses, from the PA Homecare Association, are provided to Spanish-speaking HHA's, and that the twelve (12) video courses along with generalized training to include 'mpox' training, a mathematics and reading comprehension test, and a general orientation consisting of fourteen (14) topics, meet the sixty (60) hour training requirement. However, the total course hours associated with the twelve (12) video courses was not provided by nor able to be verified from the agency.

A review of the agency's 12 video courses transcript on 04/04/2024 at approximately 11:30 AM, which are provided by the Pennsylvania (PA) Homecare Association, and the corresponding courses listed on the PA Homecare Associations' My Learning Center website, conducted on 03/13/2024 at approximately 4:00 PM, found the following courses and course completion times: Activities to Keep Your Consumer Engaged (9 minutes, 57 seconds), Bathroom Blues (11 minutes, 7 seconds), How to Protect Against Infection (10 minutes, 43 seconds), Assistive Devices to Help Seniors/People with Disabilities (18 minutes, 32 seconds), Caregiver First Aid (16 minutes, 31 seconds), Recognizing Signs of Heat Stroke, Exhaustion & Hypothermia (12 minutes, 57 seconds), Consumer Choice & Independent Living Philosophy (15 minutes, 35 seconds), Understanding Hospice Care (20 minutes, 24 seconds), Maintaining Boundaries with a Consumer (17 minutes, 24 seconds), Professionalism (21 minutes, 34 seconds), Understanding Family Dynamics (18 minutes, 38 seconds), and Understanding PA's Homecare Agency & Registry Licensure (15 minutes, 11 seconds). Total time: 3 hours, 45 minutes).

A review of the agency's plan of correction dated January 22, 2024, on March 6, 2024 at 10:00 AM, states, "PF#6 DOH 01/14/2022 the PF has 72 training videos, reading and comprehension testing in the PF. This equates to 80 hours of HHA training. The administrator will ensure that all required classroom instruction hours (sixty hours) are properly outlined to be easily identified by auditors. HR Director will ensure that PF training hours (60 hours) are clearly notated upon auditors next visit. Agency will update the documentation to reflect the number of required hours are notated upon hire. In order to confirm that the plan of correction is effective and sustained and that correct documentation are obtained the agency will conduct biannual audits by the HR Director until 100% compliance is achieved. In addition to the above audits, the agency will ensure file is audited upon hired to ensure accuracy and reduce reoccurrence. The plan of correction will be fully implemented by February 28, 2024."

Reviewed agency's Policy Number P:3 titled, "Competency Skills Testing: Clinical Staff " , effective date 1/2023 on March 6, 2024 at approximately 12:15 PM. Policy states, " ...Skills competencies are performed on hire and at least annually, upon worker request and if there is a disciplinary/corrective action or quality of care issue needed for the worker. At least 72 hours is required for home health aide staff upon hire, and 12 hours are to be completed annually. Non-aide staff members are required to complete 60 hours of training (hands-on or written documentation) upon during first two to three months of hire with assigned trainer ...3. HHA Skills Competency Testing: The HHA will successfully complete all skills on the competency checklist before services any clients ... "

A review of personnel files (PF) was conducted on March 4, 2024 starting at approximately 10:55 AM, and March 13, 2024 starting at approximately 2:15 PM. The date of hire (DOH) is indicated below.

PF#6 DOH 01/14/2022 contained a home health aide job description signed by the employee on 12/11/2023. A training transcript in the CR revealed that twelve (12) video courses (totaling 3.75 hours), provided by the PA Homecare Association, were completed in "2023." The 72 video courses dated "2022," also provided by the PA Home Care Association, showed zero (0) percent completion. There was no evidence to confirm that the home health aide completed a total of sixty (60) hours of classroom training, at minimum.

PF#13 DOH 12/15/2023 contained a training transcript showing that twelve (12) video courses were completed in 2023 (totaling 3.75 hours), provided by the Pennsylvania Home Care Association. There was no evidence to confirm that the home health aide completed a total of sixty (60) hours of classroom training, at minimum.

PF#17 DOH 01/22/2022. PF contained a training transcript showing that twelve (12) video courses (totaling 3.75 hours), provided by the PA Homecare Association, were completed in 2023. There was no evidence to confirm that the home health aide completed a total of sixty (60) hours of classroom training, at minimum.

PF#22 DOH 05/13/2020 PF contained a personal care assistant job description (JD) signed on 05/13/2020. A direct care worker training certificate, provided by the Pennsylvania (PA) Department of Human Services, was completed 05/13/2020. A 2nd Direct Care Worker training certificate was issued on 03/14/2022. A home health aide JD was added to the PF, date unknown (only the first page of the JD was provided). The CR contained evidence that twelve (12) video courses (totaling 3.75 hours), provided by the PA Homecare Association, were completed in "2023". There was no evidence that a total of sixty (60) hours of home health aide training was provided, at minimum.

An interview conducted with the human resources director and director of nursing on March 6, 2024 starting at 1:15 PM, and discussion via email with administrator and human resources director on March 13, 2024 confirmed the above findings.

Repeat deficiency 10/31/23, 1/3/24





































































Plan of Correction:

For PF #6 DOH 01/14/2022, PF #13 DOH 12/15/2023, PF #17 DOH 01/22/2022, PF #22 DOH 05/13/2020 (JD was obtained prior to transition from 611 requirements to 601 requirements); agency has obtained additional required hours of training in accordance with CMS specifications and standards. Updated trainings were placed in employee's file.

The agency will implement a checklist and practice of checking compliance with job descriptions, trainings and onboarding practices; to ensure that two satisfactory file checks are obtained prior to the end of the certification period.

In order to confirm that the plan of correction is effective and sustained and that required evidence is in the files; the agency will conduct two rounds of file audits on a quarterly basis by HR Director until 100% compliance is achieved for two consecutive quarters.

The plan of correction will be fully implemented by 05/08/2024.



601.35(b) REQUIREMENT
ASSNMNT & DUTIES OF HOME HEALTH AIDE

Name - Component - 00
601.35(b) Assignment and Duties of
the Home Health Aide. The home health
aide is assigned to a particular
patient by a registered nurse. Written
instructions for patient care are
prepared by a registered nurse or
therapist as appropriate. Duties
include:
(i) the performance of simple
procedures as an extension of therapy
services,
(ii) personal care,
(iii) ambulation and exercise,
(iv) household services essential to
health care at home,
(v) assistance with medications
that are ordinarily self-administered,
(vi) reporting changes in the
patient's conditions and needs, and
(vii) completing appropriate
records.

Observations:


Based on a review of clinical records (CR), the agency's active patient roster, agency policies and procedures, job description for a registered nurse, the agency's plan of correction for a follow-up survey completed on January 3, 2024, and an interview with the human resources director and the director of nursing, the agency failed to assure that home health aides were assigned to patients by a registered nurse and that a registered nurse prepared instructions for patient care for the home health aide. Six (6) of sixteen (16) CR's reviewed did not meet the requirement: CR#6, CR#7, CR#8, CR#11, CR#15, and CR#16.

Findings include:

A review of the agency's plan of correction dated January 22, 2024, on March 6, 2024 at 10:00 AM, states, "CR#6 SOC on/around 06/23/2022 the Start of care date has been updated and will be placed in CR file. The agency will ensure that a RN will review and assign files. At time of audit, it was communicated that agency lost interim as of 11/2023 and has since hired new DON to assist with completion of CR. AS of 01/2024 the DON has developed HHA POC and placed in file. CR#7 SOC 12/06/2022 The agency will ensure that a RN will review and assign files. At time of audit, it was communicated that agency lost interim as of 11/2023 and has since hired new DON to assist with completion of Clinical Record Review. AS of 01/2024 the DON has developed HHA POC and placed in file. For CR#8 SOC on/around 09/27/2023; exact start date was obtained and placed in CR. The agency will ensure that a RN will review and assign files. At time of audit, it was communicated that agency lost interim as of 11/2023 and has since hired new DON to assist with completion of Clinical Record Review. As of 01/2024 the DON has developed HHA POC and placed in file. Agency is currently reviewing all files to ensure accuracy and to ensure there are no issues moving forward. Any issues from self-audit will be updated in agency's policy and procedures. File audit review will be completed upon admission of patient as well as during biannual audit. Upon next auditors visit DON will ensure that all SOC dates are clearly notated in the CR. In order to confirm that the plan of correction is effective and sustained and that correct documentation are obtained the agency will conduct biannual audits by the HR Director until 100% compliance is achieved. The plan of correction will be fully implemented by February 28, 2024."

A review of the registered nurse job description conducted on March 6, 2024 at 9:30 AM reads in part, "Develops and implements the HHA (home health aide) plan of care when HHA services are ordered. Revises and signs this care plan the beginning of each certification period."

A review of the agency's patient roster took place on March 4, 2024 at approximately 12:10 PM. The list contained ninety-five (95) patients who were receiving unskilled services only from a home health aide.

A review of the agency's policy Provision of Care Treatment and Services conducted on March 6, 2024 at 10:30 AM reads in part, "the registered nurse or other appropriate skilled professional who is responsible for supervision of the home health aide, prepares written patient care instructions that specify the duties of the home health aide."

A review of clinical records (CR) was conducted on March 4, 2024 starting at approximately 9:15 AM and on March 5, 2024 starting at approximately 9:10 AM. The Start of Care (SOC) and Certification Period (CP) are indicated below.

CR#6 SOC 06/19/2022, CP unknown. The record did not contain evidence that a registered nurse (RN) assigned the home health aide (HHA) to this patient, nor was there evidence that the RN developed a home health aide plan of care for a patient who was receiving home health aide services.

CR#7 SOC 12/06/2022, CP unknown. The record did not contain evidence that a registered nurse (RN) assigned the home health aide (HHA) to this patient, nor was there evidence that the RN developed a home health aide plan of care for a patient who was receiving home health aide services.

CR#8 SOC 08/02/2023, CP 08/02/2023 to 10/02/2023. There are no further certification periods after 10/02/2023. The record did not contain evidence that a registered nurse (RN) assigned the home health aide (HHA) to this patient, nor was there evidence that the RN developed a home health aide plan of care for a patient who was receiving home health aide services.

CR#11 SOC 02/08/2024, CP unknown. The record did not contain evidence that a registered nurse (RN) assigned the home health aide (HHA) to this patient, nor was there evidence that the RN developed a home health aide plan of care for a patient who was receiving home health aide services.

CR#15 SOC 02/19/2024, CP unknown. The record did not contain evidence that a registered nurse (RN) assigned the home health aide (HHA) to this patient, nor was there evidence that the RN developed a home health aide plan of care for a patient who was receiving home health aide services.

CR#16 SOC 11/01/2023, CP unknown. The record did not contain evidence that a registered nurse (RN) assigned the home health aide (HHA) to this patient, nor was there evidence that the RN developed a home health aide plan of care for a patient who was receiving home health aide services.

An interview conducted with the human resources director and director of nursing on March 6, 2024 starting at 1:15 PM confirmed the above findings.


Repeat deficiency 10/31/23, 1/3/24






























































Plan of Correction:

For CR #6 SOC 06/19/2022, CR #7 SOC 12/06/2022, CR #8 SOC 08/02/2023, CR #11 SOC 02/08/2024, CR #15 SOC 02/19/2024, CR #16 SOC 11/01/2023 administration will ensure that CP periods are specified and the RN documentation to show evidence that assignment of HHA to any patient's case is updated and will be placed in all patient's file.

In order to confirm that the plan of correction is effective and sustained and that required evidence is in the files; the agency will conduct two rounds of file audits on a quarterly basis by the DON and HR Director until 100% compliance is achieved for two consecutive quarters.

The plan of correction will be fully implemented by 05/08/2024.



601.35(c) REQUIREMENT
SUPERVISION

Name - Component - 00
601.35(c) Supervision. The
registered nurse, or appropriate
professional staff member, if other
services are provided, makes a
supervisory visit to the patient's
residence at least every 2 weeks,
either when the aide is present to
observe and assist, or when the aide
is absent to assess the relationships
and determine whether goals are being
met.

Observations:


Based on a review of clinical records (CR), agency's plan of correction for a follow-up survey completed on January 3, 2024, job description for a registered nurse, active patient roster, and an interview with the human resources director and director of nursing, the agency failed to assure that a registered nurse makes a supervisory visit to the patient's residence at least every 2 weeks to assess the relationships and determine whether goals are being met for patients receiving home health aide services. Six (6) of sixteen (16) CR's reviewed did not meet the requirement: CR#6, CR#7, CR#8, CR#11, CR#15, and CR#16.

Findings include:

A review of the agency's plan of correction dated January 22, 2024, on March 6, 2024 at 10:00 AM, states, "For CR#6 SOC on/around 06/23/2022 The SOC was updated and notated on CR. The agency will ensure that a RN will perform supervised visits are conducted within 2 weeks to assess the relationship and determine whether goals are being met. The RN review and assign files and signature will be in the CR file. For CR#7 SOC 12/06/2022. The agency will ensure that a RN will perform supervised visits are conducted within 2 weeks to assess the relationship and determine whether goals are being met. The RN review and assign files and signature will be in the CR file. For CR#8 SOC on/around 09/27/2022 The SOC was updated and notated on CR. The agency will ensure that a RN will perform supervised visits are conducted within 2 weeks to assess the relationship and determine whether goals are being met. The RN review and assign files and signature will be in the CR file. All maintenance of records documentation will be clearly notated upon auditors next visit. An RN will conduct Home Health Aide supervisory visits every two (2) weeks for the clinical records reviewed (CR6, CR7, and CR8) as well as all other patient files under agency's care. In order to confirm that the plan of correction is effective and sustained and that correct documentation are obtained the agency will conduct biannual audits by the HR Director until 100% compliance is achieved. Agency will reduce reoccurrence by ensuring that RN review files upon admission on then monthly to ensure accuracy, conducting audit review upon hire as well as during biannual audit. The agency is undergoing a self-audit and errors or discrepancies notated during review will be updated in agency's policy and procedures. The plan of correction will be fully implemented by February 28, 2024.

A review of the registered nurse job description conducted on March 6, 2024 at 9:30 AM reads in part, "Supervises HHA (home health aide), as assigned, in accordance with state/federal requirements and documents the supervision."

A review of the agency's patient roster took place on March 4, 2024 at approximately 12:10 PM. The list contained ninety-six (96) patients who were receiving unskilled services only from a home health aide.

A review of clinical records (CR) was conducted on March 3, 2024 starting at approximately 9:15 AM and on March 4, 2024 starting at approximately 9:10 AM. The Start of Care (SOC) is indicated below.

CR#6 SOC 06/19/2022, Certification Period (CP) unknown. The record did not contain evidence that any supervisory visits were being conducted by a registered nurse at least every 2 weeks for a patient receiving home health aide services. There was one "Supervisory Visit of Skilled Care Staff Form" contained in the CR which was completed 12/14/2023 and signed by the Intake Supervisor who is not a registered nurse.

CR#7 SOC 12/06/2022, CP unknown. The record did not contain evidence that any supervisory visits were being conducted by a registered nurse at least every 2 weeks for a patient receiving home health aide services. There was one "Supervisory Visit of Skilled Care Staff Form" contained in the CR which was completed 02/02/2024 and signed by the Intake Supervisor who is not a registered nurse.

CR#8 SOC 08/02/2023, CP 08/02/2023 to 10/02/2023. There are no certification periods after 10/02/2023 The record did not contain evidence that any supervisory visits were being conducted by a registered nurse at least every 2 weeks for a patient receiving home health aide services. There was one "Supervisory Visit of Skilled Care Staff Form" contained in the CR which did not contain a completion date nor a signature of who conducted the supervision.

CR#11 SOC 01/08/2024, CP unknown. The clinical record indicated that an RN supervisory visit was conducted on 01/31/2024, which is twenty-three (23) days after SOC. There was no indication that additional supervisory visits were conducted thereafter.

CR#15 SOC 02/19/2024, CP unknown. The record did not contain evidence that any supervisory visits were being conducted by a registered nurse at least every 2 weeks for a patient receiving home health aide services. There was one "Supervisory Visit of Skilled Care Staff Form" contained in the CR which was blank.

CR#16 SOC 11/01/2023, CP unknown. The record did not contain evidence that any supervisory visits were being conducted by a registered nurse at least every 2 weeks for a patient receiving home health aide services. There was one "Supervisory Visit of Skilled Care Staff Form" contained in the CR which was blank.

An interview conducted with the human resources director and director of nursing on March 6, 2024 starting at 1:15 PM confirmed the above findings.



Repeat deficiency 10/31/23, 1/3/24
















































Plan of Correction:

For CR #6 SOC 06/19/2022, CR #7 SOC 12/06/2022, CR #8 SOC 08/02/2023, CR #11 SOC 01/08/2024, CR #15 SOC 02/19/2024, CR #16 SOC 11/01/2023 the CP, supervisory visits are properly signed by RN, dated, and placed in correct files. Agency will ensure administrator/RN will complete the supervisory visits and they are conducted every 14 days for patients receiving HHA services.

Agency will review all other files to ensure that checklist is effective.

In order to confirm that the plan of correction is effective and sustained and that required evidence is in the files; the agency will conduct two rounds of file audits on a quarterly basis by the DON and HR Director until 100% compliance is achieved for two consecutive quarters.

The plan of correction will be fully implemented by 05/08/2024.




601.36(a) REQUIREMENT
MAINTENANCE AND CONTENT OF RECORD

Name - Component - 00
601.36(a) Maintenance and Content of
Record. A clinical record is
maintained in accordance with accepted
professional standards and contains:
(i) pertinent past and current
findings,
(ii) plan of treatment,
(iii) appropriate identifying
information,
(iv) name of physician,
(v) drug, dietary, treatment and
activity orders,
(vi) signed and dated clinical
progress notes (clinical notes are
written the day service is rendered
and incorporated no less often than
weekly),
(vii) copies of summary reports sent
to the physician, and
(viii) a discharge summary.

Observations:

Based on a review of clinical records (CR), agency policies and procedures, agency's plan of correction for a follow-up survey completed on January 3, 2024, and an interview with the human resources director, and director of nursing, the agency failed to maintain a clinical record containing pertinent past and current findings, plan of treatment, appropriate identifying information, name of physician, drug, dietary treatment and activity orders, signed and dated clinical progress notes, copies of summary reports sent to the physician, a discharge summary (if applicable), and informed consent for treatment and services. Nine (9) of sixteen (16) records reviewed did not meet the requirement: CR#1, CR#4, CR#6, CR#7, CR#8, CR#11, CR#12, CR#15, and CR#16.

Findings include:

A review of the agency's plan of correction dated January 24, 2024, on March 6, 2024 at 10:00 AM, states, "For CR#1 SOC 09/26/2023 the agency reviewed file and informed consent for skilled care services was obtained from patient. Documentation is obtained from patient upon admission. The agency will ensure file is highlighted upon auditors return to ensure documentation is reviewed. For CR#4 SOC 10/02/2023 the agency reviewed file and informed consent for skilled care services was obtained from patient. Documentation is obtained from patient upon admission. The agency will ensure file is highlighted upon auditors return to ensure documentation is reviewed. For CR#6 on/around 06/23/2022. The exact SOC has been obtained. The agency reviewed file and informed consent for skilled care services was obtained from patient. Patient has file has been updated to reflect the requirements of the skilled care license. It was communicated to auditors that the agency DON stopped 11/2023. New DON as since began employment and all files are currently being updated. CR#7 SOC on/around 12/06/2022. The agency reviewed file and informed consent for skilled care services was obtained from patient. Patient has file has been updated to reflect the requirements of the skilled care license. It was communicated to auditors that the agency DON stopped 11/2023. New DON as since began employment and all files are currently being updated. CR#8 SOC on/around 09/27/2023. The SOC date was obtained and notated in CR. The agency reviewed file and informed consent for skilled care services was obtained from patient. Patient has file has been updated to reflect the requirements of the skilled care license. It was communicated to auditors that the agency DON stopped 11/2023. New DON as since began employment and all files are currently being updated. In order to confirm that the plan of correction is effective and sustained and that correct documentation are obtained the agency will conduct biannual audits by the HR Director until 100% compliance is achieved. To reduce reoccurrence all CR will be audited upon admission to ensure accuracy, in addition to biannual audits. Agency is currently completing self-audit. Any discrepancies will be notated and updated in agency's policies and procedures. The plan of correction will be fully implemented by February 28, 2024.

A review of the agency's policy Provision of Care Treatment and Services conducted on March 6, 2024 at 10:30 AM reads in part, "the patient's individualized plan of care is established, periodically reviewed, and signed by a physician or allowed practitioner...The individualized plan of care specifies the care and services necessary to meet the needs identified in the comprehensive assessment and addresses the following: all pertinent diagnosis, mental, psychosocial and cognitive status, types of services, supplies, and equipment required, the frequency and duration of visits, the patient's prognosis, the patient's potential for rehabilitation, the patient's functional limitations, the patient's permitted activities, the patient's nutritional requirements, all medications and treatments, safety measures to protect against injury, measurable outcomes and goals, patient and caregiver education, identification of disciplines involved in providing care, any other relevant items, including additions, revisions, and deletions that the home health agency, physician or allowed practitioner may choose....the initial assessment visit must be held within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician's ordered start of care date....Delia Maria Home Health Care will complete the comprehensive assessment within time frames that meet the patient's needs, but no later than five calendar days after the start of care...the comprehensive assessment is updated and revised as frequently as the patient's condition warrants due to a major decline or improvement, but no less frequently that the following: the last 5 days of every 60 days beginning with the start of care date...the individualized plan of care must be reviewed and revised by the physician or allowed practitioner responsible for the home health plan of care and the home health agency as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care."

A review of the Department of Health facility information on March 4, 2024 at approximately 7:30 AM revealed that the agency had a home care agency license that was closed effective August 31, 2021.

A review of clinical records (CR) was conducted on March 3, 2024 starting at approximately 9:15 AM and on March 4, 2024 starting at approximately 9:10 AM. The Start of Care (SOC) is indicated below.

CR#1 SOC 09/26/2023. There was no informed consent contained in the clinical record for a patient who was receiving skilled nursing (SN) and physical therapy (PT) services. The agency ' s plan of correction (POC) dated 1/22/2024 states, " For CR #1 SOC 09/26/2023 the agency will ensure compliance with 601.36(a) Maintenance and content of record. For patients receiving PT and/or RN services the agency has obtained the informed consent and the documentation with signature and the information is in the CR."

CR#4 SOC 10/2/2023. There was no informed consent contained in the clinical record for a patient who was receiving skilled nursing (SN) and physical therapy (PT) services. The agency ' s plan of correction (POC) dated 1/22/2024 states, " For CR #4 SOC 10/02/2023 the agency will ensure compliance with 601.36(a) Maintenance and content of record. For patients receiving PT and/or RN services the agency has obtained the informed consent and the documentation with signature and the information is in the CR."

CR#6 SOC 06/19/2022 was receiving services from a home health aide only. The CR contained a CMS 485 Home Health Certification and Plan of Care (POC) which was blank except for demographic information. The CR did not contain a certification period (CP), plan of treatment, periodic review of the plan of treatment, physician orders, a comprehensive nursing assessment, a home health aide (HHA) care plan, evidence of the RN performing supervisory visits of the home health aide, nor HHA notes documenting care performed. The CR contained the following documentation consistent with 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries: 1. A Hello and Welcome form which reads in part, "Delia Maria Home Care Agency also has the right to terminate services with a 10-day notice to our consumer; As a recipient of PA Waiver program services, you have the right to direct your own care and hire your own attendant; You have been provided with Cost of services to be provided on an hourly basis; PA Department of Health Consumer Notice of Direct Care Worker Status, Consumer Protection Policy PA Code 611.57." 2. The consumer notice of direct care worker status form signed by the patient and the agency on 06/23/2022 and again on 12/14/2023. 3. Language on a form titled Delia Maria Home Care Agency which states in part, "Home care services include assistance with self-administered medications; personal care such as assistance with personal hygiene, dressing and feeding; Homemaking such as assistance with household tasks housekeeping, shopping, meal planning and preparation and transportation; companionship; respite care such as assistance and support provided to the family; other non-skilled services; The licensure regulations at 28 PA Code 611.57 require an HCA or HCR, prior to the commencement of home care services, to provide to the consumer, the consumer's legal representative or responsible family member an information packet containing, among other items, a disclosure in the format to be provided by the department, and individuals who have any questions or would like more information regarding home care agencies, home care registries and/or the HCA/HCR licensure program, contact the Division of Home Health at 717 783-1379." 4. An "Acknowledgement of Receipt of Information" Form containing the following information was signed by the patient and the agency on 06/23/2022: "Delia Maria Home Care Agency has provided a list of home care services available to me and the identity of the direct care worker who will provide the services and the hours when those services will be provided; I acknowledge that I was involved in the service planning process for the services that I will receive through Delia Maria Home Care Agency; I acknowledge that I was made aware of all fees and total costs for those services on an hourly basis; I acknowledge that I was informed who to contact at the Department for information about licensure requirements for a home care registry and for compliance information about a particular home care registry; I acknowledge that I was informed of the department's complaint hot line 1-800-254 5164 and the telephone number of the ombudsman program located with the local area agency on aging; I acknowledge that I was informed about the hiring and competency requirements applicable to direct care workers referred by Delia Maria Home Health Care Agency; I acknowledge that I was informed of my rights to receive at least 10 calendar days' advance written notice of the intent of Delia Maria Home Health Care Agency to terminate services; Less than 10 day's advance written notice may be provided in the event the consumer has failed to pay for services, despite notice, and the consumer is more than 14 days in arrears, or if the health and welfare of the direct care worker is at risk; I acknowledge that I was instructed that no individual as a result of the individuals affiliation with Delia Maria Home Care Agency may assume power of attorney or guardianship over a consumer utilizing the services of Delia Maria Home Care Agency; Delia Maria Home Health Care Agency may not require a consumer to endorse checks over to the home care agency or home care registry (does not apply to private pay consumers)." The agency does not have a home care (non-medical) license.

CR#7 SOC 12/06/2022 was receiving services from a home health aide only. The CR did not contain a certification period (CP), plan of treatment, periodic review of the plan of treatment, physician orders, a comprehensive nursing assessment, a home health aide (HHA) care plan, evidence of the RN performing supervisory visits of the home health aide, nor HHA notes documenting care performed. The CR contained the following documentation consistent with 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries: 1. A Hello and Welcome form which reads in part, "Delia Maria Home Care Agency also has the right to terminate services with a 10-day notice to our consumer; As a recipient of PA Waiver program services, you have the right to direct your own care and hire your own attendant; You have been provided with Cost of services to be provided on an hourly basis; PA Department of Health Consumer Notice of Direct Care Worker Status, Consumer Protection Policy PA Code 611.57." 2. The consumer notice of direct care worker status form signed by the patient and the agency on 06/23/2022 and again on 12/14/2023. 3. Language on a form titled Delia Maria Home Care Agency which states in part, "Home care services include assistance with self-administered medications; personal care such as assistance with personal hygiene, dressing and feeding; Homemaking such as assistance with household tasks housekeeping, shopping, meal planning and preparation and transportation; companionship; respite care such as assistance and support provided to the family; other non-skilled services; The licensure regulations at 28 PA Code 611.57 require an HCA or HCR, prior to the commencement of home care services, to provide to the consumer, the consumer's legal representative or responsible family member an information packet containing, among other items, a disclosure in the format to be provided by the department, and individuals who have any questions or would like more information regarding home care agencies, home care registries and/or the HCA/HCR licensure program, contact the Division of Home Health at 717 783-1379." 4. An "Acknowledgement of Receipt of Information" Form containing the following information was signed by the patient and the agency on 06/23/2022: "Delia Maria Home Care Agency has provided a list of home care services available to me and the identity of the direct care worker who will provide the services and the hours when those services will be provided; I acknowledge that I was involved in the service planning process for the services that I will receive through Delia Maria Home Care Agency; I acknowledge that I was made aware of all fees and total costs for those services on an hourly basis; I acknowledge that I was informed who to contact at the Department for information about licensure requirements for a home care registry and for compliance information about a particular home care registry; I acknowledge that I was informed of the department's complaint hot line 1-800-254 5164 and the telephone number of the ombudsman program located with the local area agency on aging; I acknowledge that I was informed about the hiring and competency requirements applicable to direct care workers referred by Delia Maria Home Health Care Agency; I acknowledge that I was informed of my rights to receive at least 10 calendar days' advance written notice of the intent of Delia Maria Home Health Care Agency to terminate services; Less than 10 day's advance written notice may be provided in the event the consumer has failed to pay for services, despite notice, and the consumer is more than 14 days in arrears, or if the health and welfare of the direct care worker is at risk; I acknowledge that I was instructed that no individual as a result of the individuals affiliation with Delia Maria Home Care Agency may assume power of attorney or guardianship over a consumer utilizing the services of Delia Maria Home Care Agency; Delia Maria Home Health Care Agency may not require a consumer to endorse checks over to the home care agency or home care registry (does not apply to private pay consumers)." The agency does not have a home care (non-medical) license.

CR#8 SOC 08/02/2023, CP 08/02/2023 to 10/02/2023 was receiving services from a home health aide only. There were two Plans of Treatment in the file. One Plan of Treatment (POT) noted a SOC date of 08/02/2023 and a CP 08/02/2023 to 10/02/2023. The CR did not contain a current certification period (CP), plan of treatment, periodic review of the plan of treatment, physician orders, a comprehensive nursing assessment, a home health aide (HHA) care plan, evidence of the RN performing supervisory visits of the home health aide, nor HHA notes documenting care performed. The second POT (POT #2) contained in the file had the same SOC date of 08/02/2023 but the certification period was blank. POT #2 was signed by the physician on 01/24/2024, but there were no physician orders for disciplines or treatments to be provided. There was no evidence of medication reconciliation. The Medication Profile contained in the CR did not contain a listing of medications (section is blank). The medication profile was signed by the patient on the "clinician signature" line on both the first and third pages of the medication profile. The CR contained the following documentation consistent with 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries: 1. A Hello and Welcome form which reads in part, "Delia Maria Home Care Agency also has the right to terminate services with a 10-day notice to our consumer; As a recipient of PA Waiver program services, you have the right to direct your own care and hire your own attendant; You have been provided with Cost of services to be provided on an hourly basis; PA Department of Health Consumer Notice of Direct Care Worker Status, Consumer Protection Policy PA Code 611.57." 2. The consumer notice of direct care worker status form which was signed by the patient and the agency on 09/27/2023 and again on 02/09/2024. 3. An "Acknowledgement of Receipt of Information" Form containing the following information was signed by the patient and the agency on 09/27/2023: "Delia Maria Home Care Agency has provided a list of home care services available to me and the identity of the direct care worker who will provide the services and the hours when those services will be provided; I acknowledge that I was involved in the service planning process for the services that I will receive through Delia Maria Home Care Agency; I acknowledge that I was made aware of all fees and total costs for those services on an hourly basis; I acknowledge that I was informed who to contact at the Department for information about licensure requirements for a home care registry and for compliance information about a particular home care registry; I acknowledge that I was informed of the department's complaint hot line 1-800-254 5164 and the telephone number of the ombudsman program located with the local area agency on aging; I acknowledge that I was informed about the hiring and competency requirements applicable to direct care workers referred by Delia Maria Home Health Care Agency; I acknowledge that I was informed of my rights to receive at least 10 calendar days' advance written notice of the intent of Delia Maria Home Health Care Agency to terminate services; Less than 10 day's advance written notice may be provided in the event the consumer has failed to pay for services, despite notice, and the consumer is more than 14 days in arrears, or if the health and welfare of the direct care worker is at risk; I acknowledge that I was instructed that no individual as a result of the individuals affiliation with Delia Maria Home Care Agency may assume power of attorney or guardianship over a consumer utilizing the services of Delia Maria Home Care Agency; Delia Maria Home Health Care Agency may not require a consumer to endorse checks over to the home care agency or home care registry (does not apply to private pay consumers)." The agency does not have a home care (non-medical) license.

CR#11 SOC 01/08/2024 was receiving services from a home health aide only. The CR did not contain a certification period (CP), plan of treatment, periodic review of the plan of treatment, physician orders, a comprehensive nursing assessment, a home health aide (HHA) care plan, evidence of the RN performing supervisory visits of the home health aide, nor HHA notes documenting care performed. The CR contained the following documentation consistent with Home Care Agency Regulations Chapter 611.57(c): "(1) A listing of the available home care services that will be provided to the consumer by the direct care worker and the identity of the direct care worker who will provide the services; (2) The hours when those services will be provided; and (7) A disclosure...addressing the employee or independent contractor status of the direct care worker providing services to the consumer...". The agency does not have a home care (non-medical) license.

CR#12 SOC 02/16/2024, CP 02/16/2024 to 04/15/2024. The POT contained orders for physical therapy one (1) to two (2) times per week for 6 weeks. There were no PT visit notes found in the CR. The POC also contained a list of twenty-two (22) medications The medication profile, signed by the physical therapist on 02/1/2024, was blank. There were no medications listed on the medication profile nor evidence of medication reconciliation.

CR#15 SOC 02/19/2024 was receiving services from a home health aide only. The CR did not contain a certification period (CP), plan of treatment, periodic review of the plan of treatment, physician orders, a comprehensive nursing assessment, a home health aide (HHA) care plan, evidence of the RN performing supervisory visits of the home health aide, nor HHA notes documenting care performed. The CR contained a Notice of Direct Care Worker Status form signed by the consumer on 02/23/2024 which is consistent with 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries 611.57(c)(7). The agency does not have a home care (non-medical) license.

CR#16 SOC 11/01/2023 was receiving services from a home health aide only. The CR did not contain a certification period (CP), plan of treatment, periodic review of the plan of treatment, physician orders, a comprehensive nursing assessment, a home health aide (HHA) care plan, evidence of the RN performing supervisory visits of the home health aide, nor HHA notes documenting care performed. The CR contained a Notice of Direct Care Worker Status form signed by the consumer on 02/23/2024 which is consistent with 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries 611.57(c)(7). The agency does not have a home care (non-medical) license.

An interview conducted with the human resources director and director of nursing on March 6, 2024 starting at 1:15 PM confirmed the above findings.



Repeat deficiency 10/31/23, 1/3/24



















































Plan of Correction:

For CR #1 SOC 09/26/2023 the informed consent was in patients file and may have been overlooked by auditors. Agency will ensure that we better identify the document at the expiration of the plan of care.

CR #4 SOC 10/2/2023, CR #6 06/19/2022, CR #7 SOC 12/06/2022, CR #8 SOC 08/02/2023, CR #11 SOC 01/08/2024, CR #12 SOC 02/16/2024, CR #15 SOC 02/19/2024, CR #16 SOC 11/01/2023 the CP, plan of treatment, physicians' orders and a comprehensive nursing assessment, HHA care plan, and supervisory visit documentation will be completed and placed in patient's file.

Agency will review all other files to ensure that checklist is effective.

In order to confirm that the plan of correction is effective and sustained and that required evidence is in the files; the agency will conduct two rounds of file audits on a quarterly basis by the DON and HR Director until 100% compliance is achieved for two consecutive quarters.

The plan of correction will be fully implemented by 05/08/2024.



Initial Comments:


Based on the findings of an unannounced on-site follow-up survey and state re-licensure survey conducted on March 4, 2024 through March 6, 2024, and off site March 11, 2024, and March 13, 2024, Delia Maria Home Care Agency, LLC, was found to be in compliance with the requirements of 28 Pa. Code, Health Facilities, Part IV, Chapter 51, Subpart A.
















Plan of Correction:




Initial Comments:


Based on the findings of an unannounced on-site follow-up survey and state re-licensure survey conducted on March 4, 2024 through March 6, 2024, and off site March 11, 2024, and March 13, 2024, Delia Maria Home Care Agency, LLC, was found to be in compliance with the requirements of 35 P.S. 448.809 (b).














Plan of Correction: