Initial Comments:Based on the findings of an unannounced, onsite Medicare recertification survey conducted March 12 through March 14, 2024, Associated Family Home Care, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.
Plan of Correction:
484.60(e)(1) ELEMENT
Visit schedule
Name - Component - 00
Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA.
Observations:
Based on review of agency policies/procedures, documentation and clinical records, and based on interview with the supervising registered nurse (RN-Employee #8) and the administrator (Employee #9), the agency failed to ensure written instructions regarding the visit frequency were provided to five (5) of five (5) patients for whom a home visit was conducted. (Patients #1, #2, #3, #4 and #5)
Findings include:
On March 14, 2024 at approximately 3:40 PM, review of the agency policy titled "Patient Rights and Responsibilities" revealed the following under "Rights of the Patient":
Participated in, be informed about...(v) The frequency of visits...
On March 14, 2023 at approximately 3:42 PM, review of the agency policy titled "Patient Care Planning Policy" revealed the following: The 485 (Home Health Certification and Plan of Care) will be designed to meet patient's medical needs based on physician orders and patient's participation in their care.
Patient #1: On March 14, 2024 at approximately 9:28 AM, review of the clinical record revealed skilled nursing (SN) services are to be provided one (1) time a week for one (1) week, followed by three (3) times a week for one (1) week then one (1) time a week for eight (8) weeks as ordered on the "Home Health Certification and Plan of Care" for the initial certification period of February 17 through April 16, 2024. Review of verbal order documentation revealed the SN visit frequency was increased to three (3) times a week.
Review of the initial physical therapy (PT) evaluation note revealed PT services are to be provided two (2) time a week for four (4) weeks effective 02/20/2024.
Review of the initial occupational therapy (OT) evaluation note revealed OT services are to be provided two (2) times a week for four (4) weeks effective 02/20/2024. Review of the OT re-evaluation note revealed OT services were to continue two (2) times a week for four (4) weeks effective 03/11/2024.
During a home visit conducted on March 13, 2024 at approximately 9:00 AM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the SN, PT and OT visit frequency.
Patient #2: On March 14, 2024 at approximately 10:13 AM, review of the clinical record revealed SN services are to be provided one (1) time a week for one (1) week, followed by two (2) times a week for one (1) week then one (1) time a week for seven (7) weeks as ordered on the "Home Health Certification and Plan of Care" for the initial certification period of February 2 through April 1, 2024.
Review of the initial PT evaluation note revealed PT services are to be provided two (2) time a week for four (4) weeks effective 02/07/2024. Review of the PT re-evaluation note revealed PT services were to continue two (2) times a week for four (4) weeks effective 03/04/2024.
Review of the initial OT evaluation note revealed OT services are to be provided two (2) times a week for four (4) weeks effective 02/07/2024. Review of the OT re-evaluation note revealed OT services were to continue two (2) times a week for four (4) weeks effective 03/04/2024.
During a home visit conducted on March 13, 2024 at approximately 9:50 AM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the SN, PT and OT visit frequency.
Patient #3: On March 14, 2024 at approximately 10:41 AM, review of the clinical record revealed SN services are to be provided one (1) time a week for one (1) week for nine (9) weeks as ordered on the "Home Health Certification and Plan of Care" for the recertification period of January 27 through March 26, 2024.
During a home visit conducted on March 13, 2024 at approximately 10:50 AM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the SN, visit frequency.
Patient #4: On March 14, 2024 at approximately 10:57 AM, review of the clinical record revealed SN services are to be provided one (1) time a week for one (1) week, followed by two (2) times a week for one (1) week then one (1) time a week for seven (7) weeks as ordered on the "Home Health Certification and Plan of Care" for the initial certification period of February 28 through April 27, 2024.
Review of the initial OT evaluation note revealed OT services are to be provided two (2) times a week for four (4) weeks effective 03/04/2024.
Review of verbal order documentation dated 03/04/3034 revealed home health aide (HHA) services are to be provided two (2) time a week for eight (8) weeks.
During a home visit conducted on March 13, 2024 at approximately 12:00 PM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the SN , OT and HHA visit frequency.
Patient #5: On March 14, 2024 at approximately 11:18 AM, review of the clinical record revealed SN services are to be provided two (2) times a week for one (1) week followed by one (1) time a week for eight (8) weeks as ordered on the "Home Health Certification and Plan of Care" for the initial certification period of March 4 through May 2, 2024.
During a home visit conducted on March 13, 2024 at approximately 1:00 PM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the SN visit frequency.
During interview conducted on March 14, 2024 at approximately 4:00 PM, the supervising RN (Employee #8) and the administrator (Employee #9) confirmed written instructions regarding the above referenced visit frequencies had not been provided to the above identified patients.
Plan of Correction: The Supervising R.N. will be responsible with ensuring visit schedule, including frequency of visits by HHA personnel, are provided to patient. Once generated, patient 485, which includes visit schedule, will be provided to patient by HHA personnel and kept in admission packet. Any further changes to visit schedule will be documented on sheet titled "Vital signs and updated information" in patient admission packet. To ensure patients have been provided visit schedule, The Supervising R.N. will call randomly chosen patients via phone for confirmation that visit schedule was provided. Admission packets will be reviewed during in home employee annual evaluations by Supervising R.N to ensure visit schedule has been provided and updated as needed.
484.60(e)(2) ELEMENT
Patient medication schedule/instructions
Name - Component - 00
Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA.
Observations:
Based on review of agency policies/procedures, documentation and clinical records, and based on interview with the supervising registered nurse (RN-Employee #8) and the administrator (Employee #9), the agency failed to ensure written instructions regarding the medication schedule and instructions were provided to four (4) of five (5) patients for whom a home visit was conducted. (Patients #1, #2, #4 and #5)
Findings include:
On March 14, 2023 at approximately 3:42 PM, review of the agency policy titled "Patient Care Planning Policy" revealed the following: The 485 (Home Health Certification and Plan of Care) will be designed to meet patient's medical needs based on physician orders and patient's participation in their care,
Patient #1: On March 14, 2024 at approximately 9:28 AM, review of the clinical record revealed a total of four (4) medication orders were included on the "Home Health Certification and Plan of Care" for the initial certification period of February 17 through April 16, 2024.
During a home visit conducted on March 13, 2024 at approximately 9:00 AM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the medication schedule and instructions for the medications ordered on the initial "Home Health Certification and Plan of Care".
Patient #2: On March 14, 2024 at approximately 10:13 AM, review of the clinical record revealed a total of 21 medication orders were included on the "Home Health Certification and Plan of Care" for the initial certification period of February 2 through April 1, 2024.
During a home visit conducted on March 13, 2024 at approximately 9:50 AM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the medication schedule and instructions for the medications ordered on the initial "Home Health Certification and Plan of Care".
Patient #4: On March 14, 2024 at approximately 10:57 AM, review of the clinical record revealed a total of 18 medication orders were included on the "Home Health Certification and Plan of Care" for the initial certification period of February 28 through April 27, 2024.
During a home visit conducted on March 13, 2024 at approximately 12:00 PM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the medication schedule and instructions for the medications ordered on the initial "Home Health Certification and Plan of Care".
Patient #5: On March 14, 2024 at approximately 11:18 AM, review of the clinical record revealed a total of 18 medication orders were included on the "Home Health Certification and Plan of Care" for the initial certification period of March 4 through May 2, 2024.
During a home visit conducted on March 13, 2024 at approximately 1:00 PM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the medication schedule and instructions for the medications ordered on the initial "Home Health Certification and Plan of Care".
During interview conducted on March 14, 2024 at approximately 4:00 PM, the supervising RN (Employee #8) and the administrator (Employee #9) confirmed written instructions regarding medication schedule and instructions had not been provided to the above identified patients.
Plan of Correction:The Supervising R.N. will be responsible with ensuring patient medication schedule/instructions, including medication name, dosage and frequency, are provided to patient. Once generated, patient 485, which includes medication schedule/instructions, will be provided to patient by HHA personnel and kept in admission packet. Any further changes to medication schedule/instructions will be documented on sheet titled "Vital signs and updated information" in patient admission packet. To ensure patients have been provided medication schedule/instructions, The Supervising R.N. will call randomly chosen patients via phone for confirmation that medication schedule/instructions was provided. Admission packets will be reviewed during in home employee annual evaluations by Supervising R.N to ensure medication schedule/instructions have been provided and updated as needed.
484.60(e)(3) ELEMENT
Treatments and therapy services
Name - Component - 00
Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services.
Observations:
Based on review of agency policies/procedures, documentation and clinical records, home visit observation and based on interview with agency staff (Employee #1), the supervising registered nurse (RN-Employee #8) and the administrator (Employee #9), the agency failed to ensure written instructions regarding the type of treatments to be provided by skilled nursing (SN) were provided to three (3) of three (3) patients for whom the "Home Health Certification and Plan of Care" and/or interim physician orders included wound care orders. (Patients #1, #2 and #3)
Findings include:
On March 14, 2024 at approximately 3:40 PM, review of the agency policy titled "Patient Rights and Responsibilities" revealed the following under "Rights of the Patient":
Participated in, be informed about...(ii) The care to be furnished...
On March 14, 2023 at approximately 3:42 PM, review of the agency policy titled "Patient Care Planning Policy" revealed the following: The 485 (Home Health Certification and Plan of Care) will be designed to meet patient's medical needs based on physician orders and patient's participation in their care.
Patient #1: On March 14, 2024 at approximately 9:28 AM, review of the clinical record revealed the following wound care orders were obtained on 03/06/2024: Bilateral (both) buttocks to be cleansed with soap and water or normal saline solution (NSS), skip prep (protectant) to surrounding skin, apply Silvasorb gel (wound treatment) to bed of wounds, cover with Optifoam dressing; skilled nursing to change three (3) times a week and as needed.
Review of SN visit note documentation revealed wound assessment and care were performed/provided during the SN visits performed on 03/06, 03/08 and 03/11/2024.
During a home visit conducted on March 13, 2024 at approximately 9:00 AM, an interview conducted with the licensed practical nurse (Employee #1) revealed written instructions regarding wound care are provided if a caregiver is available to perform wound care. The LPN reported that a caregiver was not available to provide wound care for patient #1. Review of the agency's admission folder failed to reveal written instructions had been provided to the patient regarding the wound care orders obtained on 03/06/3034.
Patient #2: On March 14, 2024 at approximately 10:13 AM, review of the clinical record revealed the following wound care orders were obtained on 02/21/2024: Bilateral lower extremities: Cleanse with soap and water, pat dry, apply Silvadene (wound treatment) and ace bandages.
Review of SN visit note documentation revealed wound assessment and care were performed/provided during the SN visits performed on 02/27, 03/04 and 03/11/2024.
During a home visit conducted on March 13, 2024 at approximately 9:50 AM, review of the agency's admission folder failed to reveal written instructions had been provided to the patient regarding the wound care orders obtained on 02/21/2024.
Patient #3: On March 14, 2024 at approximately 10:41 AM, review of the clinical record revealed the following wound care orders were included on the "Home Health Certification and Plan of Care" for the recertification period of January 27 through March 26, 2024: Left and right abdominal wounds to be cleansed with NSS, then acetic acid wet to dry dressing to abdominal dehiscence (wound/incision edges which have reopened), apply acetic acid above area of wound dehiscence, cover with dry sterile dressing and secure with tape twice a day. Skin prep to skin surrounding wounds.
During a home visit conducted on March 13, 2024 at approximately 10:50 AM, the RN (Employee #3) provided wound care to the abdominal wounds, Review of the agency's admission folder failed to reveal written instructions had been provided to the patient regarding the wound care orders included on the "Home Health Certification and Plan of Care".
During interview conducted on March 14, 2024 at approximately 4:00 PM, the supervising RN (Employee #8) and the administrator (Employee #9) confirmed written instructions regarding the above referenced wound care orders had not been provided to the above identified patients.
Plan of Correction:The Supervising R.N. will be responsible with ensuring written instructions regarding the type of treatments by HHA personnel, are provided to patient. Once generated, patient 485, which includes written instructions regarding the type of treatments, will be provided to patient by HHA personnel and kept in admission packet. Any further changes to type of treatments will be documented on sheet titled "Vital signs and updated information" in patient admission packet. To ensure patients have been provided written instructions regarding the type of treatments, The Supervising R.N. will call randomly chosen patients via phone for confirmation that written instructions regarding the type of treatments was provided. Admission packets will be reviewed during in home employee annual evaluations by Supervising R.N to ensure written instructions regarding the type of treatments have been provided and updated as needed.
484.105(b)(1)(iv) ELEMENT
Ensure that HHA employs qualified personnel
Name - Component - 00
(iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies.
Observations:
Based on the review of agency policies/procedures, clinical records, personnel files and a Nursing2024 publication, and based on interview with the supervising registered nurse (RN-Employee #8) and the administrator (Employee #9), the agency failed to ensure documentation was maintained in the personnel file which provided evidence three (3) of three (3) registered nurses (RN) completed a demonstration to determine competency for maintenance and care of tunneled central venous catheters (CVC-intravenous line which can be inserted into a vein in the chest) and/or maintenance and care and/or removal of peripherally inserted central catheters (PICC-intravenous line which is inserted into a vein in the arm.). (Employees #3, #10 and #11)
Findings include:
On March 14, 2024 at approximately 3:41 PM, review of the agency policy titled "Staff Selection, Competency, and Qualifications Policy" revealed the following under guidelines: 8. All individuals will demonstrate competency for any technology required in the care/services of clients by the completion of proficiency checklists.
On March 14, 2024 at approximately 3:44 PM, review of the agency policy titled "Staff Credentialing/Certification Policy revealed the following:
General Statement: It is the policy of this agency to identify guidelines for staff requirements pertaining to those staff members providing high tech therapies in the home setting...
PICC Certification...2. Competency will be measured during the orientation period by experienced staff members or prior to being scheduled to perform skill alone.
On March 12, 2024 at approximately 3:50 PM, review of the "Nursing2024" article titled "How to Remove a PICC with Ease" (https://journals.lww.com/nursing/citation/2002/05000/how_to_remove_a_picc_with_ease.27.aspx) revealed the following: Inspect the PICC...measure its length...
During interview conducted on March 14, 2024 at approximately 3:02 PM, the supervising RN (Employee #8) confirmed the external length of the PICC line is to be measured with each PICC line dressing change.
Patient #8: On March 14, 2024 at approximately 12"35 PM, review of the clinical record revealed the registered nurse (RN-Employee #10) identified the right chest central venous catheter (CVC) intravenous (IV) line as a PICC line (IV line which is inserted into a vein in the arm) as evidenced by the documentation included on "Home Health Certification and Plan of Care" for the initial certification period of 02/02/2024 through 04/01/2024, the start of care SN note dated 02/02/2024 and the SN note dated 02/05/2024.
Review of SN note documentation revealed the RN (Employee #10) provided site care to the right chest CVC on 02/05, 02/08, 02/15 and 02/22/2024.
Patient #10 (Discharge): On March 14, 2024 at approximately 1:56 PM, review of the clinical record revealed the following was documented related to the right arm PICC line:
-On 12/04, 12/06 and 12/11/2023, the RN (Employee #10) performed PICC line dressing change but the RN failed to assess the external length of the PICC line. On during the first SN visit on 12/26/2023 and during the SN visit on 01/02/2024, the RN (Employee #11) performed PICC line dressing change but the RN failed to assess the external length of the PICC line.
-On 12/18/2023, the RN (Employee #11) documented the external length of the PICC line was five (5) centimeters (cm). On 12/26/2023, a second SN visit was performed due to PICC line complications. During the second SN visit on 12/26/2023, the RN (Employee #3) documented the external length of the PICC line was 1.0 cm.
-On 01/08/2024, the RN (Employee #10) discontinued (removed) the PICC line but there was no documentation the PICC length was measured after removal.
Between March 13, 2024 at approximately 1:47 PM and March 14, 2024 at approximately 3:12 PM, review of personnel file documentation revealed the following:
Employee #3: The date of hire of the RN was 04/29/2014. Review of the "Infusion Skills Checklist" and the "Nursing Skills Proficiency Checklist" forms dated 04/29/2014 failed to reveal that a competency demonstration was completed for PICC line maintenance and care.
Employee #10: The date of hire of the RN was 11/06/2017. Review of the "Infusion Skills Checklist" and the "Nursing Skills Proficiency Checklist" forms dated 11/07/2017 failed to reveal that a competency demonstration was completed for CVC and PICC line maintenance and care nor PICC line removal.
Employee #11: The date of hire of the RN was 11/17/2015. Review of the "Infusion Skills Checklist" and the "Nursing Skills Proficiency Checklist" forms dated 11/17/2025 failed to reveal that a competency demonstration was completed for PICC line maintenance and care.
During interview conducted on March 14, 2024 at approximately 4:00 PM, the supervising RN (Employee #8) and the administrator (Employee #9) confirmed there was no documentation in the personnel files prior to 03/14/2024 which provided evidence that the above referenced RN"s had completed a competency demonstration for maintenance and care of PICC land/or CVC lines.
Plan of Correction:The Supervising R.N. will ensure documentation is maintained in the personnel file to provide evidence of registered nurses completing a demonstration to determine competency for maintenance and care of CVC and PICC lines. The Supervising R.N. will complete competency demonstration for maintenance and care of CVC and PICC lines. Once Supervising R.N. completes competency demonstration for maintenance and care of CVC and PICC lines, all agency RNs who participate in direct patient care will complete competency demonstration for maintenance and care of CVC and PICC lines with competency checklist placed in each individual personnel file. Agency policy on PICC and CVC dressing change will be revised. PICC and CVC dressing change competency checklist will be revised. The Supervising R.N. will re-evaluate competency for maintenance and care of CVC and PICC lines on a yearly basis in conjunction with annual employee evaluation via clinical setting and/or classroom setting. Human Resources will ensure competency documentation is maintained in personnel files.
Initial Comments:Based on the findings of an unannounced, onsite Medicare recertification survey conducted March 12 through March 14, 2024, Associated Family Home Care, Inc. was found not to be in compliance with the following requirement of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.
Plan of Correction:
484.102(d)(2) STANDARD
EP Testing Requirements
Name - Component - 00
§416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2).
*[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]:
(2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following:
(i) Participate in a full-scale exercise that is community-based every 2 years; or
(A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or
(B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed.
*[For Hospices at 418.113(d):]
(2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following:
(i) Participate in a full-scale exercise that is community based every 2 years; or
(A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or
(B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or
(B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed.
*[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):]
(2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or
(B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed.
*[For PACE at §460.84(d):]
(2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or
(B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed.
*[For LTC Facilities at §483.73(d):]
(2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise.
(B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed.
*[For ICF/IIDs at §483.475(d)]:
(2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or.
(B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed.
*[For HHAs at §484.102]
(d)(2) Testing. The HHA must conduct exercises to test the emergency plan at
least annually. The HHA must do the following:
(i) Participate in a full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or.
(B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed.
*[For OPOs at §486.360]
(d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following:
(i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event.
(ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed.
*[ RNCHIs at §403.748]:
(d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following:
(i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed.
Observations:
Based on a review of the agency policies and procedures and documentation, and based on interview with the administrator (Employee #9), the agency failed to ensure emergency preparedness exercises were conducted for three (3) of three (3) years beginning 2021. (2021, 2022 and 2023)
Findings Include:
On March 12, 2024 at approximately 12:35 PM, review of the "All Hazard Emergency Preparedness Policy" revealed the following under "Drills": Agency staff will participate in an annual desktop drill to determine the effectiveness and efficiency of the current policy and any forms developed for use in a disaster.
On March 12, 2024 at approximately 11:44 AM, review of Governing Body meeting minutes dated 12/15/2023 revealed the category of emergency preparedness.
On March 13, 2024 at approximately 8:20 AM, review of PA DOH ERS report documentation revealed the agency's emergency preparedness plan was activated in March 2020 due to COVID-19.
On March 12, 2024 at approximately 12:35 PM, review of the emergency preparedness binder failed to reveal that an emergency preparedness exercise (full-scale community-based, facility-based functional, mock disaster drill or tabletop exercise) had been conducted in 2021, 2022 or 2023.
During interview conducted on March 14, 2024 at approximately 4:00 PM, the administrator confirmed emergency preparedness exercises were not conducted in 2021, 2022 nor 2023.
Plan of Correction:The Administrator will ensure that the facility will test the emergency plan annually and monitor plan for compliance. The facility will conduct a full-scale community-based exercise every 2 years or a facility-based functional exercise if a community-based exercise is not available. The facility will conduct an additional tabletop or workshop exercise opposite the year of the full-scale community-based or facility-based functional exercise. The Administrator will re-evaluate the emergency plan on an annual basis to determine the effectiveness and efficiency of the current plan for emergency preparedness.
Initial Comments:Based on the findings of an unannounced, onsite state re-licensure survey conducted March 12 through March 14, 2024, Associated Family Home Care, Inc. was found not to be in compliance with the following requirements of 28 PA Code, Part IV, Health Facilities, Subpart G. Chapter 601.
Plan of Correction:
601.21(c) REQUIREMENT
GOVERNING BODY
Name - Component - 00
601.21(c) Governing Body. A governing
body (or designated persons so
functioning) assumes full legal
authority and responsibility for the
operation of the agency. The
governing body appoints: (i) a
qualified administrator, (ii) arranges
for professional service, (iii) adopts
and periodically reviews written
bylaws or an acceptable equivalent,
and (iv) oversees the management and
fiscal affairs of the agency. The
name and address of each officer,
director, and owner are disclosed to
the State agency with changes reported
promptly.
Observations:
Based on a review of the agency policies and procedures and documentation, and based on interview with the administrator (Employee #9), the governing body failed to ensure emergency preparedness exercises were conducted for three (3) of three (3) years beginning 2021. (2021, 2022 and 2023)
Findings Include:
On March 12, 2024 at approximately 12:35 PM, review of the "All Hazard Emergency Preparedness Policy" revealed the following under "Drills": Agency staff will participate in an annual desktop drill to determine the effectiveness and efficiency of the current policy and any forms developed for use in a disaster.
On March 12, 2024 at approximately 11:44 AM, review of Governing Body meeting minutes dated 12/15/2023 revealed the category of emergency preparedness.
On March 13, 2024 at approximately 8:20 AM, review of PA DOH ERS report documentation revealed the agency's emergency preparedness plan was activated in March 2020 due to COVID-19.
On March 12, 2024 at approximately 12:35 PM, review of the emergency preparedness binder failed to reveal that an emergency preparedness exercise (full-scale community-based, facility-based functional, mock disaster drill or tabletop exercise) had been conducted in 2021, 2022 or 2023.
During interview conducted on March 14, 2024 at approximately 4:00 PM, the administrator confirmed emergency preparedness exercises were not conducted in 2021, 2022 nor 2023.
Plan of Correction:The Administrator will ensure that the facility will test the emergency plan annually and monitor plan for compliance. The facility will conduct a full-scale community-based exercise every 2 years or a facility-based functional exercise if a community-based exercise is not available. The facility will conduct an additional tabletop or workshop exercise opposite the year of the full-scale community-based or facility-based functional exercise. The Administrator will re-evaluate the emergency plan on an annual basis to determine the effectiveness and efficiency of the current plan for emergency preparedness.
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 review of agency policies/procedures, documentation and clinical records, and based on interview with agency staff (Employee #1), the supervising registered nurse (RN-Employee #8) and the administrator (Employee #9), the agency failed to ensure written instructions regarding the visit frequency, the medication schedule and instructions and/or wound care orders were provided to five (5) of five (5) patients for whom a home visit was conducted. (Patients #1, #2, #3, #4 and #5)
Findings include:
On March 14, 2024 at approximately 3:40 PM, review of the agency policy titled "Patient Rights and Responsibilities" revealed the following under "Rights of the Patient":
Participated in, be informed about...(v) The frequency of visits......(ii) The care to be furnished...
On March 14, 2023 at approximately 3:42 PM, review of the agency policy titled "Patient Care Planning Policy" revealed the following: The 485 (Home Health Certification and Plan of Care) will be designed to meet patient's medical needs based on physician orders and patient's participation in their care.
Patient #1: On March 14, 2024 at approximately 9:28 AM, review of the clinical record revealed skilled nursing (SN) services are to be provided one (1) time a week for one (1) week, followed by three (3) times a week for one (1) week then one (1) time a week for eight (8) weeks and that a total of four (4) medication orders are included on the "Home Health Certification and Plan of Care" for the initial certification period of February 17 through April 16, 2024. Review of verbal order documentation revealed the SN visit frequency was increased to three (3) times a week.
Review of the initial physical therapy (PT) evaluation note revealed PT services are to be provided two (2) time a week for four (4) weeks effective 02/20/2024.
Review of the initial occupational therapy (OT) evaluation note revealed OT services are to be provided two (2) times a week for four (4) weeks effective 02/20/2024. Review of the OT re-evaluation note revealed OT services were to continue two (2) times a week for four (4) weeks effective 03/11/2024.
Review of verbal order documentation revealed the following wound care orders were obtained on 03/06/2024: Bilateral (both) buttocks to be cleansed with soap and water or normal saline solution (NSS), skip prep (protectant) to surrounding skin, apply Silvasorb gel (wound treatment) to bed of wounds, cover with Optifoam dressing; skilled nursing to change three (3) times a week and as needed.
Review of SN visit note documentation revealed wound assessment and care were performed/provided during the SN visits performed on 03/06, 03/08 and 03/11/2024.
During a home visit conducted on March 13, 2024 at approximately 9:00 AM, an interview conducted with the licensed practical nurse (Employee #1) revealed written instructions regarding wound care are provided if a caregiver is available to perform wound care. The LPN reported that a caregiver was not available to provide wound care for patient #1. review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the SN, PT and OT visit frequency, the medication schedule and instructions nor the wound care orders obtained on 03/06/2024.
Patient #2: On March 14, 2024 at approximately 10:13 AM, review of the clinical record revealed SN services are to be provided one (1) time a week for one (1) week, followed by two (2) times a week for one (1) week then one (1) time a week for seven (7) weeks and that a total of 21 medication orders are included on the "Home Health Certification and Plan of Care" for the initial certification period of February 2 through April 1, 2024.
Review of the initial PT evaluation note revealed PT services are to be provided two (2) time a week for four (4) weeks effective 02/07/2024. Review of the PT re-evaluation note revealed PT services were to continue two (2) times a week for four (4) weeks effective 03/04/2024.
Review of the initial OT evaluation note revealed OT services are to be provided two (2) times a week for four (4) weeks effective 02/07/2024. Review of the OT re-evaluation note revealed OT services were to continue two (2) times a week for four (4) weeks effective 03/04/2024.
Review of verbal order documentation revealed the following wound care orders were obtained on 02/21/2024: Bilateral lower extremities: Cleanse with soap and water, pat dry, apply Silvadene (wound treatment) and ace bandages.
Review of SN visit note documentation revealed wound assessment and care were performed/provided during the SN visits performed on 02/27, 03/04 and 03/11/2024.
During a home visit conducted on March 13, 2024 at approximately 9:50 AM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the SN, PT and OT visit frequency, the medication schedule and instructions nor the wound care orders obtained on 02/21/2024.
Patient #3: On March 14, 2024 at approximately 10:41 AM, review of the clinical record revealed SN services are to be provided one (1) time a week for one (1) week for nine (9) weeks and that the following wound care orders are included on the "Home Health Certification and Plan of Care" for the recertification period of January 27 through March 26, 2024: Left and right abdominal wounds to be cleansed with NSS, then acetic acid wet to dry dressing to abdominal dehiscence (wound/incision edges which have reopened), apply acetic acid above area of wound dehiscence, cover with dry sterile dressing and secure with tape twice a day. Skin prep to skin surrounding wounds.
During a home visit conducted on March 13, 2024 at approximately 10:50 AM, the RN (Employee #3) provided wound care to the abdominal wounds,
During a home visit conducted on March 13, 2024 at approximately 10:50 AM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the SN visit frequency nor the wound care orders included on the "Home Health Certification and Plan of Care".
Patient #4: On March 14, 2024 at approximately 10:57 AM, review of the clinical record revealed SN services are to be provided one (1) time a week for one (1) week, followed by two (2) times a week for one (1) week then one (1) time a week for seven (7) weeks and that a total of 18 medication orders are included on the "Home Health Certification and Plan of Care" for the initial certification period of February 28 through April 27, 2024.
Review of the initial OT evaluation note revealed OT services are to be provided two (2) times a week for four (4) weeks effective 03/04/2024.
Review of verbal order documentation dated 03/04/3034 revealed home health aide (HHA) services are to be provided two (2) time a week for eight (8) weeks.
During a home visit conducted on March 13, 2024 at approximately 12:00 PM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the SN , OT and HHA visit frequency nor the medication schedule and instructions.
Patient #5: On March 14, 2024 at approximately 11:18 AM, review of the clinical record revealed SN services are to be provided two (2) times a week for one (1) week followed by one (1) time a week for eight (8) weeks and that a total of 18 medication orders are included on the "Home Health Certification and Plan of Care" for the initial certification period of March 4 through May 2, 2024.
During a home visit conducted on March 13, 2024 at approximately 1:00 PM, review of the agency's admission folder failed to reveal written instructions were provided to the patient regarding the SN visit frequency nor the medication schedule and instructions.
During interview conducted on March 14, 2024 at approximately 4:00 PM, the supervising RN (Employee #8) and the administrator (Employee #9) confirmed written instructions regarding the above referenced visit frequencies, the medication schedule and instructions and wound care orders had not been provided to the above identified patients,
Plan of Correction:The Supervising R.N. will be responsible with ensuring written instructions regarding the visit frequency, the medication schedule and instructions and/or wound care orders, are provided to patient. Once generated, patient 485, which includes written instructions regarding the visit frequency, the medication schedule and instructions and/or wound care orders, will be provided to patient by HHA personnel and kept in admission packet. Any further changes to written instructions regarding the visit frequency, the medication schedule and instructions and/or wound care orders will be documented on sheet titled "Vital signs and updated information" in patient admission packet. To ensure patients have been provided written instructions regarding the visit frequency, the medication schedule and instructions and/or wound care orders, The Supervising R.N. will call randomly chosen patients via phone for confirmation that written instructions regarding the visit frequency, the medication schedule and instructions and/or wound care orders was provided. Admission packets will be reviewed during in home employee annual evaluations by Supervising R.N to ensure written instructions regarding the visit frequency, the medication schedule and instructions and/or wound care orders have been provided and updated as needed.
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 the review of agency policies/procedures, clinical records, personnel files and a Nursing2024 publication, and based on interview with the supervising registered nurse (RN-Employee #8) and the administrator (Employee #9), the agency failed to ensure documentation was maintained in the personnel file which provided evidence three (3) of three (3) registered nurses (RN) completed a demonstration to determine competency for maintenance and care of tunneled central venous catheters (CVC-intravenous line which can be inserted into a vein in the chest) and/or maintenance and care and/or removal of peripherally inserted central catheters (PICC-intravenous line which is inserted into a vein in the arm.). (Employees #3, #10 and #11)
Findings include:
On March 14, 2024 at approximately 3:41 PM, review of the agency policy titled "Staff Selection, Competency, and Qualifications Policy" revealed the following under guidelines: 8. All individuals will demonstrate competency for any technology required in the care/services of clients by the completion of proficiency checklists.
On March 14, 2024 at approximately 3:44 PM, review of the agency policy titled "Staff Credentialing/Certification Policy revealed the following:
General Statement: It is the policy of this agency to identify guidelines for staff requirements pertaining to those staff members providing high tech therapies in the home setting...
PICC Certification...2. Competency will be measured during the orientation period by experienced staff members or prior to being scheduled to perform skill alone.
On March 12, 2024 at approximately 3:50 PM, review of the "Nursing2024" article titled "How to Remove a PICC with Ease" (https://journals.lww.com/nursing/citation/2002/05000/how_to_remove_a_picc_with_ease.27.aspx) revealed the following: Inspect the PICC...measure its length...
During interview conducted on March 14, 2024 at approximately 3:02 PM, the supervising RN (Employee #8) confirmed the external length of the PICC line is to be measured with each PICC line dressing change.
Patient #8: On March 14, 2024 at approximately 12"35 PM, review of the clinical record revealed the registered nurse (RN-Employee #10) identified the right chest central venous catheter (CVC) intravenous (IV) line as a PICC line (IV line which is inserted into a vein in the arm) as evidenced by the documentation included on "Home Health Certification and Plan of Care" for the initial certification period of 02/02/2024 through 04/01/2024, the start of care SN note dated 02/02/2024 and the SN note dated 02/05/2024.
Review of SN note documentation revealed the RN (Employee #10) provided site care to the right chest CVC on 02/05, 02/08, 02/15 and 02/22/2024.
Patient #10 (Discharge): On March 14, 2024 at approximately 1:56 PM, review of the clinical record revealed the following was documented related to the right arm PICC line:
-On 12/04, 12/06 and 12/11/2023, the RN (Employee #10) performed PICC line dressing change but the RN failed to assess the external length of the PICC line. On during the first SN visit on 12/26/2023 and during the SN visit on 01/02/2024, the RN (Employee #11) performed PICC line dressing change but the RN failed to assess the external length of the PICC line.
-On 12/18/2023, the RN (Employee #11) documented the external length of the PICC line was five (5) centimeters (cm). On 12/26/2023, a second SN visit was performed due to PICC line complications. During the second SN visit on 12/26/2023, the RN (Employee #3) documented the external length of the PICC line was 1.0 cm.
-On 01/08/2024, the RN (Employee #10) discontinued (removed) the PICC line but there was no documentation the PICC length was measured after removal.
Between March 13, 2024 at approximately 1:47 PM and March 14, 2024 at approximately 3:12 PM, review of personnel file documentation revealed the following:
Employee #3: The date of hire of the RN was 04/29/2014. Review of the "Infusion Skills Checklist" and the "Nursing Skills Proficiency Checklist" forms dated 04/29/2014 failed to reveal that a competency demonstration was completed for PICC line maintenance and care.
Employee #10: The date of hire of the RN was 11/06/2017. Review of the "Infusion Skills Checklist" and the "Nursing Skills Proficiency Checklist" forms dated 11/07/2017 failed to reveal that a competency demonstration was completed for CVC and PICC line maintenance and care nor PICC line removal.
Employee #11: The date of hire of the RN was 11/17/2015. Review of the "Infusion Skills Checklist" and the "Nursing Skills Proficiency Checklist" forms dated 11/17/2025 failed to reveal that a competency demonstration was completed for PICC line maintenance and care.
During interview conducted on March 14, 2024 at approximately 4:00 PM, the supervising RN (Employee #8) and the administrator (Employee #9) confirmed there was no documentation in the personnel files prior to 03/14/2024 which provided evidence that the above referenced RN"s had completed a competency demonstration for maintenance and care of PICC land/or CVC lines.
Plan of Correction:The Supervising R.N. will ensure documentation is maintained in the personnel file to provide evidence of registered nurses completing a demonstration to determine competency for maintenance and care of CVC and PICC lines. The Supervising R.N. will complete competency demonstration for maintenance and care of CVC and PICC lines. Once Supervising R.N. completes competency demonstration for maintenance and care of CVC and PICC lines, all agency RNs who participate in direct patient care will complete competency demonstration for maintenance and care of CVC and PICC lines with competency checklist placed in each individual personnel file. Agency policy on PICC and CVC dressing change will be revised. PICC and CVC dressing change competency checklist will be revised. The Supervising R.N. will re-evaluate competency for maintenance and care of CVC and PICC lines on a yearly basis in conjunction with annual employee evaluation via clinical setting and/or classroom setting. Human Resources will ensure competency documentation is maintained in personnel files.
Initial Comments:
Based on the findings of an unannounced, onsite state re-licensure survey conducted March 12 through March 14, 2024, Associated Family Home Care, Inc. was found to be in compliance with the requirements of 28 Pa. Code, Health and Safety, Part IV, Health Facilities, Subpart A. Chapter 51.
Plan of Correction:
Initial Comments:Based on the findings of an unannounced, onsite state re-licensure survey conducted March 12 through March 14, 2024, Associated Family Home Care, Inc. was found to be in compliance with the requirements of 35 P.S. § 448.809 (b).
Plan of Correction:
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