Initial Comments:
Based on the findings of an unannounced onsite Home Health Agency State Re-Licensure Survey conducted March 11, 2024 and March 12, 2024, SKR Home and Healthcare Solutions, LLC was found not to be in compliance with the requirements of 28 Pa. Code, Part IV, Health Facilities, Subpart G, Chapter 601.
Plan of Correction:
601.3 REQUIREMENT
COMPLIANCE W/ FED, ST, & LOCAL LAWS
Name - Component - 00
601.3 COMPLIANCE WITH FEDERAL,
STATE AND LOCAL LAWS.
The home health agency and its staff
are in compliance with all applicable
Federal, State and Local Laws and
regulations.
Observations:
Based on a review of personnel files (PF), the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard, 29 CFR 1910,1030, and an interview with the administrator and director of nursing, the agency failed to demonstrate the presence of Hepatitis B Vaccination acceptance or declination for six (6) of six (6) PF's reviewed: PF#1, PF#2, PF#3, PF#4, PF#5, and PF#6.
Findings include:
A review of Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Fact Sheet was conducted on March 8, 2024 at approximately 3:30 PM. The fact sheet reads in part, "Hepatitis B virus (HBV) is a pathogenic microorganism that can cause potentially life-threatening disease in humans. HBV infection is transmitted through exposure to blood and other potentially infectious materials (OPIM) as defined in the OSHA Bloodborne Pathogens Standard, 29 CFR 1910.1030. Any workers who have reasonably anticipated contact with blood or OPIM during performance of their jobs are considered to have occupational exposure and to be at risk of being infected. An employer must develop an exposure control plan.... employers must make hepatitis B vaccination available to these workers.... employers must offer the vaccination series to all workers who have occupational exposure. Examples of workers who may have occupational exposure include, but are not limited to, healthcare workers...the vaccine must be offered at no cost to the worker and at a reasonable time and place."
A review of OSHA Bloodborne Pathogens Standard, 29 CFR 1910,1030 was conducted on March 4, 2024 at approximately 3:30 PM. Standard 1910.1030b defines Occupational Exposure as "reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties. Standard 19.10.1030(c)(1)(i) states "each employer having an employee(s) with occupational exposure shall establish a written Exposure Control Plan designed to eliminate or minimize employee exposure." Section 1910.1030(f)(1)(i) states, "the employer shall make available the hepatitis B Vaccine and vaccination series to all employee who have occupational exposure." Section 1910.1030(f)(1)(ii)(A) states, "made available at no cost to the employee." Section 1910.1030(F)(1)(ii)(B) states, "made available to the employee at a reasonable time and place."
A review of personnel files was conducted on 03/11/2024 starting at approximately 12:21 PM, and again on 03/12/2024 starting at approximately 9:30 AM. The date of hire (DOH) is indicated below.
PF#1 DOH 06/24/2020 PF did not contain evidence of Hepatitis B Vaccination acceptance or declination.
PF#2 DOH 11/06/2020 PF did not contain evidence of Hepatitis B Vaccination acceptance or declination.
PF#3 DOH 06/11/2021 PF did not contain evidence of Hepatitis B Vaccination acceptance or declination.
PF#4 DOH 03/27/2023 PF did not contain evidence of Hepatitis B Vaccination acceptance or declination.
PF#5 DOH 09/11/2019 PF did not contain evidence of Hepatitis B Vaccination acceptance or declination.
PF#6 DOH 01/10/2022 PF did not contain evidence of Hepatitis B Vaccination acceptance or declination.
An interview conducted with the director of nursing on March 12, 2024 starting at 11:00 AM confirmed the above findings.
Plan of Correction:Plan of Correction for SKR Home and Healthcare Solutions is to require all applicants (i.e. all nurses, home health aide and all other employees this relates to) for employment or referral as a direct care worker to have a Hepatitis B Vaccine Acceptance/Declination document provided at the start of the hiring process. For each new hire (applicant), SKR will ensure that this is not only included on the onboarding checklist, but also is reviewed with the applicant prior to hire that this is part of the hiring process. This will be monitored and tracked by the Office Coordinator (who does the interviewing process and collects the paperwork from applicants) and then reviewed by the Owner to ensure that the actions are sustained, and compliance is maintained. The form will also be sent to all employees (i.e. all nurses, home health aide and all other employees this relates to) and signed by all current SKR employees. A tracking tool will be created moving forward to ensure this is in place for all hires. SKR will follow the policy in place per the Infection Control/Exposure Plan which includes preventative measures and identifies the positions that would be at risk per state regulations.
(PDC:24). The plan of correction will be fully implemented by May 6, 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 an interview with the administrator and director of nursing, the agency failed to obtain a written plan of treatment established and periodically reviewed by a physician. Three (3) of three (3) clinical records did not meet the requirement: CR#1, CR#2, and CR#3.
Findings include:
A review of the following policies was conducted on March 12, 2024 from 9:00 AM to 9:30 AM:
Admission Policy/Approved Treatment Policy (Policy Number PDC:5) reads in part, "The patient's Medical Professional must order and approve the provision of any services."
Admission Qualifications Policy (Policy Number: AO.017), states in part, "The physician will review the need for and risks of all services and therapies provided before initiation of the services and therapy," and "There is a written plan of treatment reviewed and approved by the physician..."
Physician Communication and Receiving Orders Policy (Policy: CLN.005) states in part, "It shall be the policy of this agency to establish clearly defined procedures for contacting a patient's physician, receiving orders and documenting all communication both written and verbal;" and "All communication with the physician shall be documented in the medical record. Communication with a patient's physician is required in the following cases: upon admission, recertification or discharge."
Patient Plan of Care Policy (Policy Number CLN.010) reads in part, "It shall be the policy of this Agency to develop and implement an individualized plan of care for each patient admitted for service, which is established and periodically reviewed by a physician to insure appropriate application of services to the patient's condition," and "The Plan of Care is to be filed in the patient's chart and is to be accessible to appropriate personnel providing care to the patient."
Medication Administration Policy (Policy: CLN.024) reads in part, "During the admission process and throughout the course of care, the nurse will review all current medications the patient is taking, notations will be made on the medication list of new, changed and discontinued medications (all of which must be verified with the physician)."
Interruption in Services/Missed Visit Policy (Policy Number PDC:35) states in part, "When an interruption occurs due to a missed visit, the following procedure should be followed....contact the patient's attending medical professional to advise of the alteration in visit frequency authorization in the POC (plan of care)."
A review of clinical records (CR) was conducted on March 11, 2024 starting at approximately 9:40 AM. The start of care (SOC) is indicated below.
CR#1 SOC 10/02/2023 CR did not contain a treatment plan reviewed and approved by the attending physician. There was a document in the front of the CR stating skilled nursing one to two visits weekly. There was no duration established nor was there evidence that it was reviewed/approved by the physician. A plan of care (POC), created by the registered nurse on 10/02/2023, was present in the CR, but the POC did not show evidence of physician review/approval. The CR contained a medication profile. The nurses' notes states that the medications were reconciled with the physician's office on 10/03/2023, but there were no written medication orders from the physician.
CR#2 SOC 10/02/2023 CR did not contain a treatment plan reviewed and approved by the attending physician. There was a document in the front of the CR stating skilled nursing one to two visits weekly. There was no duration established nor was there evidence of physician review/approval. A POC, created by the registered nurse on 10/02/2023, was present in the CR, but the POC did not show evidence of physician review/approval. The CR contained a medication profile. The nurses' notes state that the medications were reconciled with the physician's office on 10/03/2023, but there were no written medication orders from the physician.
CR#3 SOC 06/23/2022 CR did not contain a treatment plan reviewed and approved by the attending physician. There was a document in the front of the CR stating skilled nursing Monday through Saturday, 9 AM-5 PM. There was no duration established nor was there evidence of physician review/approval. Documents reviewed in the CR from 12/12/2023 to 02/07/2024 found no evidence of an updated plan of care, written medication orders from the physician or medication review. The CR contained a missed visit (MV) note dated 12/17/2023 stating that the patient would be out of town from 12/20/2023 to 01/01/2024. A second MV note dated 01/29/2024 stated that the patient would be out of town from 02/08/2024 to 02/18/2024. There was no evidence that the physician was informed of either of the missed visits.
An interview conducted with the director of nursing on March 12, 2024 starting at 11:00 AM confirmed the above findings.
Plan of Correction:Plan of Correction for SKR Home and Healthcare Solutions per 601.31 is to require each clinical record, at the start of care, will have a verbal and written plan of treatment developed in consultation with the Director of Nursing, that covers diagnosis, but also include treatments, disciplines and their frequency and duration, medications (Name, dose, route, frequency) that are ordered and signed by the physician.
In addition, this written plan of treatment will be reviewed periodically by the Physician as needed – changes, modifications, or additions. This will be monitored and tracked by the Director of Nursing as needed and then reviewed by the Owner to ensure that the actions are sustained, and compliance is maintained. A tracking tool will be created moving forward to ensure this is in place.
This correction will be implemented by May 6, 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 policy, and an interview with the administrator and director of nursing, the agency failed to demonstrate that the plan of treatment was reviewed by the attending physician and agency personnel at least once every sixty (60) days for three (3) of three (3) CR's reviewed: CR#1 CR#2, and CR#3.
Findings include:
A review of the agency's Admission Qualifications Policy (Policy: AO.017) conducted on March 12, 2024 at 9:15 AM reads in part, "There is a written plan of treatment reviewed and approved by the physician and reviewed at least every (60) days.
A review of clinical records (CR) was conducted on March 11, 2024 starting at approximately 9:40 AM. The start of care (SOC) is indicated below.
CR#1 SOC 10/02/2023 CR did not contain any evidence that the plan of treatment was reviewed by the physician at least every sixty (60) days.
CR#2 SOC 10/02/2023 CR did not contain any evidence that the plan of treatment was reviewed by the physician at least every sixty (60) days.
CR#3 SOC 06/23/2022 CR did not contain any evidence that the plan of treatment was reviewed by the physician at least every sixty (60) days.
An interview conducted with the director of nursing on March 12, 2024 starting at 11:00 AM confirmed the above findings.
Plan of Correction:Plan of Correction for SKR Home and Healthcare Solutions per 601.31 is to require each clinical record have a periodic review of plan of treatment by the attending Physician and agency personnel every 60 days. At the start of care, each clinical record has a verbal and written plan of treatment that is monitored by the Director of Nursing and signed off by the attending Physician. Each record will be reviewed, monitored, and altered based on immediate changes or severity of case, but must be completed every 60 days. This will be monitored and tracked by the Director of Nursing as needed and then reviewed by the Owner to ensure that the actions are sustained, and compliance is maintained. A tracking tool will be created moving forward to ensure this is in place.
This correction will be implemented by May 6, 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 policy and an interview with the director of nursing, the agency failed to demonstrate that all prescription drugs were administered by agency staff in accordance with written orders of the physician for three (3) of three (3) CR's reviewed: CR#1, CR#2, CF#3.
Findings include:
A review of the following policies was conducted on March 12, 2024 from 9:00 AM to 9:30 AM:
Medication Administration Policy (Policy Number CLN.024) states in part, "The medical record will contain a current medication list..."
Admission Qualifications Policy (Policy Number AO.017) reads in part, "The patient is under the care of a licensed physician who will provide orders for services."
CR#1 SOC 10/02/2023 CR contained one (1) undated medication profile. The nurses' note states that the medications were reconciled with the physician's office on 10/03/2023. There were no written medication orders from the physician nor was there any evidence of review and/or updates to the medication profile in the CR. A nurses' note on 12/22/2023 states that the patient had lesions on his/her back that were biopsied, and one area on the patient's back had an infected cyst. The nurses' note further states the following: Cefalexin (antibiotic) 500 milligrams (mg), one (1) capsule to be administered two (2) times per day, and the area to be washed with soap and water, antibiotic ointment applied and a band-aid placed for coverage. There was no evidence of written physician orders to support the addition of the antibiotic or the wound care, and no evidence of an updated medication profile.
CR#2 SOC 10/02/2023 CR contained an undated medication profile. The nurses' note states that the medications were reconciled with the physician's office on 10/03/2023. There were no written medication orders from the physician in the CR. The medication profile was updated on 11/13/2023. Sertraline (used for mental/mood disorders) 50 mg, one (1) tablet at night was added as a new medication. The nurses' note states that the medication was ordered by the patient's psychiatrist. The nurses' note further states that the nurse reported the new medication to the patient's attending physician. However, there is no written order from the physician for the new medication. The medication profile was updated again on 12/16/2023 noting an increase in the dosage of the Sertraline. There was no written order from the physician regarding the dosage change.
CR#3 SOC 06/23/2022 CR did not contain a medication profile. Medication administration records were in the CR. There were no written medication orders from the physician in the CR. On 02/01/2024, the nurses' note states that the physician ordered the patient's "Prednisone (steroid) 5 mg. be taken twice per day in the morning and in the afternoon (instead of the evening)." There was no written order from the physician regarding the time change.
An interview with the director of nursing on March 12, 2024 starting at 11:00 AM confirmed the above findings.
Plan of Correction:Plan of Correction for SKR Home and Healthcare Solutions per 601.31 is to require each clinical record have a Conformance with Physicians Orders for all prescription and non-prescription (over the counter) drugs, devices, medications and treatments. This shall be administered by the agency staff (Director of Nursing or a skilled professional) in accordance with the written orders by the attending Physician. Prescription drugs and devices shall be prescribed by a licensed physician. The licensed nurse who is authorized, shall immediately record and sign oral orders and within 7 days obtain physicians' counter signature. Each record will be reviewed, monitored, and altered based on immediate changes or ineffectiveness/contraindicated of medicines prescribed and promptly report back to Physician for guidance. This will be monitored and tracked by the Director of Nursing as needed and then reviewed by the Owner to ensure that the actions are sustained and compliance is maintained. This will be communicated to all SKR nurses through verbal education from the Director of Nursing.
This correction will be implemented by May 6, 2024.
Initial Comments:
Based on the findings of an unannounced onsite Home Health Agency State Re-Licensure Survey conducted March 11, 2024 and March 12, 2024, SKR Home and Healthcare Solutions, 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 onsite Home Health Agency State Re-Licensure Survey conducted March 11, 2024 and March 12, 2024, SKR Home and Healthcare Solutions, LLC was found to be in compliance with the requirements of 35 P.S. 448.809 (b).
Plan of Correction:
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