Initial Comments:
An onsite follow up and relicensure survey completed on September 26, 2024, found that A&M Healthcare Agency Llc had not corrected the following deficiencies cited under requirements of 28 PA Code, Part IV, Health Facilities, Subpart G, Chapter 601. The deficiencies were cited as a result of an unannounced complaint investigation survey completed on October 26, 2023, an onsite follow up and State re-licensure survey completed March 13, 2024, and an onsite follow up survey completed on June 11, 2024.
Plan of Correction:
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 policy and clinical records, and Administrator interview, it was determined that the Administrator failed to organize and direct the agency's ongoing functions and maintain a liaison among the governing body, group of professional personnel and the staff. Specifically, the administrator failed to provide training and proof of competencies, ensure physician orders were obtained, ensure the initial assessment, nursing visit records and discharge summaries were completed, and report an event within 24 hours of discovery that seriously compromised quality assurance and patient safety.
Findings include:
Review of agency Policy "Administrative Responsibilities" on 9/26/24, At 10:05 a.m. indicated the Administrator has the overall authority and responsibility for the operation and administrative function of the agency.
1. The agency failed to provide training and proof of competencies related to related to peripherally inserted central catheters and intravenous medications. Cross reference 1007: Personnel Policies - 601.21(f).
2. The agency failed to obtain and follow physician orders. Cross Reference 1020 Conformance with Physician Orders - 601.31(d).
3. The agency failed to ensure the initial assessment and nursing visit records were completed by the Registered Nurse (RN). Cross Reference 1023 Duties of the Registered Nurse - 601.32(b)
4. The agency failed to demonstrate the presence of a discharge summary. Cross Reference 1035 Maintenance and Content of Record - 601.35(a)
5. The agency failed to report an event within 24 hours of discovery that seriously compromised quality assurance and patient safety. Ch. 51 009 Notifications - 51.3(g)(1-14)
Plan of Correction:1. Training related to peripherally inserted central catheters and intravenous medications is scheduled for 10/24/24 to all RNS. Training will be signed and dated by each individual RN on staff. Annual nursing training will be implemented by administrator.
2. As of October 3rd, 2024, all doctor's order were submitted and signed. Administrator will ensure that all orders patients order from hospital upon discharge is submitted to the physician's office within 24 hours of receipt. Quarterly audits will be completed during plan of care.
3. Nursing notes are to be submitted weekly by each nurse. Administrator will audit nursing notes every 90 days.
4. As of October 3rd, 2024, all discharges relating to death or patient request were submitted to physician office. When a patient dies, a discharge is required to be submitted to the physician's office and documented within 24 hours. Patient files will be audited within 7 days of death and file charts will be closed upon completion.
Upon hospitalization, the agency is required to submit notification to the physician's office and documented within 24 hours. Start date will be 11/1/2024
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 review of employee files (EF), clinical records (CR) and staff (EMP) interviews, the agency failed to provide training and determine proof of competency related to peripherally inserted central catheters and intravenous medications for two of three personal file reviews (EF2 and EF3).
Findings include:
Review of agency Policy "Home IntraVenous (IV - medication administered into the vein) therapy and first dose drug procedure" on 9/26/24, At 10:05 a.m. indicated Intravenous therapy shall be provided by a qualified licensed nurse having knowledge and documented competency to interpret and implement written orders. The IV may be initiated by a Registered Nurse ... who has demonstrated technical competence through an approved training program which includes 1. potential injection sites 2) expected action of therapy 3) potential side effects 4) infection control practices sterile techniques 5. emergency action 6. return demonstration of accessing a vein appropriately.
Review of employee files (EF) on 9/25/26, at 10:06 a.m. revealed the following:
EF2 RN hired 1/4/18, did not contain training to determine proof of competency related to Peripherally Inserted Central Catheter (PICC - long thin flexible tube inserted through veins in the arm to a large vein in the chest, one use is for long term antibiotics) and IV medications.
EF3 RN hired 10/16/19, did not contain training to determine proof of competency related to PICC's and IV medications.
Review of CR1's clinical record on 9/25/24 at 1:45 p.m. Nursing Visit Record dated 9/10/24, and 9/11/24, indicated EF2 Registered Nurse administered IV Rocephin (antibiotic administered into vein to treat infections) into CR1' right arm peripherally inserted central catheters.
During an interview on 9/26/24, at 11:40 a.m. the EMP1 the Administrator EMP2 the Vice President confirmed the above information that CR1 was readmitted to their service from the hospital they were aware she needed IV Rocephin administered through a PICC line, and they had no employees trained or determined to be competent for IV administration.
Plan of Correction:1. Training related to peripherally inserted central catheters and intravenous medications is scheduled for 10/24/24 to all RNS. Training will be signed and dated by each individual RN on staff.
Trainings will be scheduled annually by administrator.
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 review of agency policy and discharge clinical records and staff (EMP) interview, the agency failed to obtain and follow physician orders for one (1) of seven (7) clinical records reviewed (CR1).
Findings include
Review of agency Policy on 9/26/24, At 10:05 a.m. revealed:
Policy: CLN.005 "Physician Communication and Receiving Orders", 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. Procedure: 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.
Policy: CLN.024 "Medication Administration", It shall be policy of this agency that nurses follow acceptable standards of practice when administering medications. Procedure: The patient's physician must order administration of medication...Medication administration will be documented in the medical record...physician will be notified on any medications not administered...General Guidelines: During the admission process and throughout the course of care the nurse will view all current medications the patient is taking...all of which must be verified with the physician.
Review of CR1's clinical record on 9/25/24, at 1:45 p.m. Home Health Certification and Plan of Care Start of Care date was 9/18/18, certification review period was 7/21/24 to 9/21/24, indicated skilled nursing would perform wound care one hour every Tuesday, Thursday, Saturday and Sunday, and did not contain a documented counter signature by the physician.
Review of CR1's discharge clinical record on 9/25/24 at 1:45 p.m. Nursing Visit Record dated 9/10/24, and 9/11/24, indicated EMP3 Registered Nurse administered intravenous Rocephin (antibiotic administered into vein to treat infections) into CR1' right arm peripherally inserted central catheters (PICC - long thin flexible tube inserted through veins in the arm to a large vein in your chest, one use is for long term antibiotics).
Review of CR1's discharge clinical record on 9/26/24 at 12:37 p.m. revealed it contained hospital documents with a print date 9/5/24, at 12:44 and a prescription dated 9/8/24, for home infusion, Ceftriaxone 2 grams in 20 milliliter sterile water for injection slow intravenous push over at least four minutes daily as directed .... Dose 2 gram daily till 10/2.
Further review of CR1's documents revealed a Final Report section that indicated labs to be completed weekly are:
Complete Blood Count with differential (test to measure number of red and white blood cells)
Platelets (help to clot blood, test determines if platelet count is normal)
BUN, (Blood Urea Nitrogen is a waste by product in blood, tests kidney function)
Creatinine, ( waste product from muscles, tests kidney function)
Lytes (measure electrolytes in blood)
AST, (aspartate aminotransferase a liver enzyme, tests liver function)
ALT, (alanine transaminase a liver enzyme tests liver function)
total bilirubin, (byproduct of red blood cell breakdown and tests liver function)
T Bili, D Bili and I Bili (Total, Direct and Indirect Bilibubin levels a by product of blood breakdown and test for liver function)
Alkaline Phosphate, (blood or liver enzyme, tests liver function).
Additional Discharge Information indicated to pull PICC line at the end of therapy: Remove PICC line when ordered by Medical Doctor ... PICC line care per protocol.
During an interview on 9/26/24, at 11:40 a.m. the EMP1 the Administrator EMP2 the Vice President confirmed that CR1 returned to home on Thursday 9/5/24, their nurse EMP3 first saw CR1 on Saturday 9/7/24, and Administered CR1's Ceftriaxone, that they have no nurses notes documenting that visit and have no documentation indicating that they had contacted CR1's physician for Ceftriaxone orders, or any clarification of the above information in the hospital documents. That they shared CR1 with another home care that sees CR1 on Monday, Wednesday and Friday, but they have no contact with that agency to coordinate care with, and CR1 was discharged to the hospital where she remains as of 9/18/24.
Plan of Correction:As of October 3rd, 2024, based on audits completed on all patients by administrator, all doctor's order were submitted and signed.
Hospital order for CR1 was faxed to physician on 9/25/2024. Agency received signed physician's order on 9/26/2024.
Administrator will ensure that all patients order from hospital upon discharge is submitted to the physician's office within 24 hours of receipt.
All DC paperwork is faxed directly to office. Administrative staff is responsible for submitting DC paperwork to Administrator. Administrator is responsible for reviewing DC hospital documents for proper orders and admit readmits. Administrator will not accept hospital DC until all DC paperwork has been reviewed and signed. Patient files will be audited every 90 days by Administrator.
Nursing notes are to be submitted weekly by each nurse. Administrator will audit nursing notes every 90 days.
Upon hospitalization, the agency is required to submit notification to the physician's office and documented within 24 hours. Corrective action date is 11/1/2024.
601.32(b) REQUIREMENT
DUTIES OF THE REGISTERED NURSE
Name - Component - 00
601.32(b) Duties of the Registered
Nurse. The registered nurse:
(i) makes the initial evaluation
visit,
(ii) regularly reevaluates the
patient's nursing needs,
(iii) initiates the plan of treatment
and necessary revisions,
(iv) provides those services
requiring substantial specialized
nursing skill,
(v) initiates appropriate
preventive and rehabilitative nursing
procedures,
(vi) prepares clinical and progress
notes,
(vii) coordinates services, and
(viii) informs the physician and other
personnel of changes in the patient's
condition and needs, counsels the
patient and family in meeting nursing
and related needs, participates in
inservice programs, and supervises and
teaches other nursing personnel.
Observations:
Based on review of a job description and discharge clinical records and staff (EMP) interview, the agency failed to ensure the initial assessment and nursing visit records were completed by the Registered Nurse (RN) for one of seven clinical records reviewed (CR1).
Findings Include:
Review of EMP3's Job Description "Registered Nurse" on 9/26/24 at 10:20 a.m. revealed the RN is responsible for the delivery of patient care services through coordination, implementation, and supervision of patients. The registered nurse must follows the POC (plan of care) and supervises staff delivering the care. The Registered nurse participates in quality improvement activities within the agency promoting overall compliance with State and Federal guidelines and professional standards of practice...Duties and Responsibilities ... Establish the patient individualized treatment and medical record baseline.. Collaborate with physicians and other agency staff and other contract services to coordinate and implement the plan of care. Re-evaluate the patient plan of care at least every 60 days and when there is change in the patient condition, after a hospital stay,, and at the time of discharge.
Review of facility policy "Physician Communication and Receiving orders on 9/26/24, at 10:30 a.m. indicated it shall be the policy of this agency to establish clearly defined procedures for contacting a patients physician, receiving orders and documenting all communication verbal and written. Communication with the physician is required in the following cases: upon admission, recertification or discharge. A Change in the patient's Condition.
Review of CR1's discharge clinical record on 9/25/24, at 1:45 p.m. revealed the following:
CR1's Home Health Certification and Plan of Care Start of Care date was 9/18/18 certification review period was 7/21/24 to 9/21/24, indicated skilled nursing would perform wound care one hour every Tuesday, Thursday, Saturday and Sunday, and did not contain a documented counter signature by the physician. Further review revealed it failed to contain documentation of nurses visit notes for 9/7/24 and 9/8/24.
CR1's Incident Report Dated 8/18/24, Completed by RN EMP3 with signature of EMP1 Administrator indicated Type of Incident: "old gauze found in right ischium" Description of Incident: ... While checking wounds a new area of breakdown noted to area in fold on top of leg. A gauze pad noted in wound. Gauze very moist and greenish in color with foul odor. Interventions to Prevent Reoccurrence: Incident happened with (the others agencies) nurse. Form does contain documentation of contact with physician, or that CR1 was sent out the hospital.
CR1's Nursing Visit Record Dated 8/18/24, at 10:00 a.m. indicated EMP3 found a the above wound and did not contain documentation of contact with the physician, or that CR1 was sent out to the hospital.
CR1's Nursing Visit Record dated 9/10/24, and 9/11/24, indicated EMP3 Registered Nurse administered IV Rocephin (antibiotic administered into vein to treat infections) into CR1' right arm peripherally inserted central catheters (PICC - long thin flexible tube inserted through veins in the arm to a large vein in your chest, one use is for long term antibiotics).
Further review of CR1's documents revealed a Final Report section that indicated labs to be completed weekly are:
Complete Blood Count with differential (test to measure number of red and white blood cells)
Platelets (help to clot blood, test determines if platelet count is normal)
BUN, (Blood Urea Nitrogen is a waste by product in blood, tests kidney function)
Creatinine, ( waste product from muscles, tests kidney function)
Lytes (measure electrolytes in blood)
AST, (aspartate aminotransferase a liver enzyme, tests liver function)
ALT, (alanine transaminase a liver enzyme tests liver function) total bilirubin, (byproduct of red blood cell breakdown and tests liver function)
T Bili, D Bili and I Bili (Total, Direct and Indirect Bilibubin levels a by product of blood breakdown and test for liver function)
Alkaline Phosphate, (blood or liver enzyme, tests liver function).
Additional Discharge Information indicated to pull PICC line at the end of therapy: Remove PICC line when ordered by Medical Doctor ... PICC line care per protocol.
During an interview on 9/26/24, at 11:40 a.m. the EMP1 the Administrator EMP2 the Vice President confirmed the above information and verbally stated CR1's was sent out to the hospital on 8/18/24, and that CR1 returned to home on Thursday 9/5/24, that they do not have nurses notes for the 9/7/24 and 9/824 nurses visits.. That they and EMP3 RN, did not notify or collaborate with the physician upon a change in the patient's condition, discharge or readmission
Plan of Correction:As of October 3rd, 2024, all doctor's order has been submitted and signed. Administrator will ensure that all patient orders from hospital upon discharge is submitted to the physician's office within 24 hours of receipt. Services will not be resumed until physician order is received.
Nursing notes are to be submitted weekly by each nurse. Administrator will audit nursing notes and physician orders every 90 days.
Upon hospitalization, the agency is required to submit notification to the physician's office and documented within 24 hours.
Administrator will implement annual training on completing initial assessment and visit records. Initial assessment/intake of patient will be audited by administrator within 7 days. Administrator is responsible for contacting physician re change in condition, discharge and readmission.
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 review of discharged clinical records and staff (EMP) interview the agency failed to demonstrate the presence of a discharge summary for two of three discharged records reviewed (CR1 and CR2) .
Findings include:
Review of CR1's discharged clinical record on 9/25/24 at 1:45 p.m. Revealed Start of Care date was 9/18/18 to 9/18/24. There was no evidence of a discharge summary in the clinical record.
Review of CR2's on 9/26/24 at 11:01 a.m. revealed start of care date was 7/29/22, to 6/3/24. There was no evidence of a discharge summary in the clinical record.
During an interview on 9/26/24, at 11:40 a.m. the EMP1 the Administrator EMP2 the Vice President confirmed the above findings.
Plan of Correction: As of October 3rd, 2024, all discharges relating to death or patient request were submitted to physician office including CR1 and CR2. When a patient dies, a discharge is required to be submitted to the physician's office and documented within 24 hours.
Administrator is responsible to maintain patient's medical records. Once office is notified of patient's death. Administrator must be informed and submit discharge documentation due to death to physician's office.
VP, client care coordination & RNS has been trained to inform administrator of patient's death within 24 hours of notification 10 9/27/2024. Administrator is responsible for submitting discharge to physician's office. Discharges will be reviewed in quarterly meetings.
Initial Comments:
Based on an onsite follow up and relicensure survey completed on September 26, 2024, A&M Healthcare Agency Llc, was found not to be in compliance with the following requirements of 28 Pa. Code, Health Facilities, Part IV, Chapter 51, Subpart A.
Plan of Correction:
51.3 (g)(1-14) LICENSURE
NOTIFICATION
Name - Component - 00
51.3 Notification
(g) For purposes of subsections (e)
and (f), events which seriously
compromise quality assurance and
patient safety include, but not
limited to the following:
(1) Deaths due to injuries, suicide
or unusual circumstances.
(2) Deaths due to malnutrition,
dehydration or sepsis.
(3) Deaths or serious injuries due
to a medication error.
(4) Elopements.
(5) Transfers to a hospital as a
result of injuries or accidents.
(6) Complaints of patient abuse,
whether or not confirmed by the
facility.
(7) Rape.
(8) Surgery performed on the wrong
patient or on the wrong body part.
(9) Hemolytic transfusion reaction.
(10) Infant abduction or infant
discharged to the wrong family.
(11) Significant disruption of
services due to disaster such as fire,
storm, flood or other occurrence.
(12) Notification of termination of
any services vital to continued safe
operation of the facility or the
health and safety of its patients and
personnel, including, but not limited
to, the anticipated or actual
termination of electric, gas, steam
heat, water, sewer and local exchange
of telephone service.
(13) Unlicensed practice of a
regulated profession.
(14) Receipt of a strike notice.
Observations:
Based on a review of the electronic reporting system (ERS), discharged clinical records, and an staff (EMP) interview, the agency failed to report an event within 24 hours of discovery that seriously compromised quality assurance and patient safety for one (1) of seven (7) records reviewed
Findings include:
The ERS Manual states on the "Event Reporting System- Facility Login...28 PA Code 51.3 Notification Confidential Information...All facilities are required to submit notification of events as defined in 28 Pa Code Chapter 51 to the Department of Health within 24 hours of occurrence or discovery. The Electronic Event Reporting System is the mechanism the Department will use to meet this regulatory requirement."
Review of the Department of Health Event Reporting System on 9/23/24, at 9:00 a.m., from 7/20/23 to 9/23/24, revealed the agency has not reported an event in the ERS system.
CR1's Incident Report Dated 8/18/24, Completed by RN EMP3 with signatures of EMP1 and the Administrator indicated Type of Incident: "old gauze found in right ischium" Description of Incident: ... While checking wounds a new area of breakdown noted to area in fold on top of leg. A gauze pad noted in wound. Gauze very moist and greenish in color with foul odor. Interventions to Prevent Reoccurrence: Incident happened with the others agencies nurse.
During an interview on 9/26/24, at 11:40 a.m. the EMP1 the Administrator EMP2 the Vice President confirmed the above information and verbally stated CR1's was sent out to the hospital on 8/18/24. That they share this patient with another agency that agency sees CR1 on Monday, Wednesday and Friday, and the reports indicates it happened with the other agencies nurse that they never contacted this agency to clarify their findings, and no incidents have been reported.
Plan of Correction:Upon discovery of a Critical Incident, the agency must report Critical Incidents in the Enterprise Incident Management system within 48 hours. Critical Incident report is included in annual training
Critical Incident must also be reported in the electronic reporting system, to the service coordinator as well as the physician's office with 48 hours. VP is responsible for submitting critical incident report.
Start date will be October 1, 2024. Annual staff trainings with all staff including Registered Nurse, administrative staff, and personal care attendants will be implemented. All incidents for both agencies will be reviewed in quarterly meetings with discharges.
As of November 15, 2024, a communication log will be placed in the home when there are multiple agencies providing care with the contact information for supervisors and administrators for each provider. This will enable better communication between providers.
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