Every finding on record at Guardian Health Network Corporation

Emergency Preparedness 42 CFR 484.22 The facility must meet the Condition of Participation for Home Health Agencies. Based on an onsite Recertification Survey and Complaint Investigation Survey (ACTS reference number 104026) conducted at Guardian Health Network, located at 24 Main St. #8, Peabody, MA 01960, on 1/17/24, 1/18/24 and 1/22/24, for Emergency Preparedness it was determined the Agency was not in compliance with these requirements. Deficiencies were cited.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on interview and policy review, the agency failed to ensure that their emergency policies were reviewed at least every two years as required. Findings include: Review of the agency Emergency Preparedness policies and procedures, maintained in the Agency policy and procedure binder, indicated that they were last reviewed in 2018. During an interview on 1/22/24 at 10:00 A.M., the Administrator said that they had reviewed and updated items within the emergency plan such as the risk assessment, patient list, and staff list, but did not review the policies and procedures to ensure they were up to date.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on review of Emergency Preparedness (EP) documentation, review of employee records and interviews, the agency failed to provide initial EP training for 4 of 5 employees (#1, #3, #4 and #5). Finding include: For Employee #1, with a date of hire of 10/23/23, the agency failed to provide initial EP training as required. For Employee #3, with a date of hire of 9/11/23, the agency failed to provide initial EP training as required. For Employee #4, with a date of hire of 10/20/23, the agency failed to provide initial EP training as required. For Employee #5, with a date of hire of 8/25/23, the agency failed to provide initial EP training as required. During an interview with the Administrator on 1/22/24 at 10:00 A.M., he stated the EP training was not provided to the employees.

An onsite Recertification Survey and Complaint Investigation Survey (ACTS reference number 104026) was conducted at Guardian Health Network, located at 24 Main St. #8, Peabody MA 01960, on 1/17/24, 1/18/24 and 1/22/24 to determine compliance with the 42 CFR Part 488 requirements for Home Health Agencies. As a result of this survey, it was determined the Agency was not in compliance with these requirements. §484.45 Condition of participation: Reporting OASIS information was not met. Deficiencies were cited.

Reporting OASIS information CFR(s): 484.45 Condition of participation: HHAs must electronically report all OASIS data collected in accordance with §484.55. This CONDITION is not met as evidenced by: Based on interview and record review the Condition of Participation related to reporting the Outcome and Assessment Information Set (OASIS) was reviewed and found to be out of compliance. Please refer to: G372: The Agency failed to encode and electronically transmit Oasis data within 30 days of assessment. G378: The agency failed to transmit OASIS data for all completed assessments in a format that meets the requirements. G382: The Agency failed to transmit OASIS data using electronic communications software that complies with Federal Information Standard.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on review of Outcome and Assessment Information Set (OASIS) data and interview, the Agency failed to transmit OASIS assessments within 30 days of completion. Findings include: A review of the Center for Medicare and Medicaid Service (CMS) State Report: HHA (Home Health Agency) List - No Successful Production Submissions Report (submission dates 1/1/23 to 12/31/2023) indicated the Agency did not transmit any OASIS data for 2023. During an interview on 1/18/24 at 11:00 A.M., the Administrator said that the agency did not transmit any OASIS data for over a year.

OASIS data transmission format CFR(s): 484.45(c)(1) For all completed assessments, transmit OASIS data in a format that meets the requirements of paragraph (d) of this section. This ELEMENT is not met as evidenced by: Based on review of Outcome and Assessment Information Set (OASIS) data and interview, the Agency failed to transmit OASIS data in a format that meets the requirements. Findings include: A review of the Center for Medicare and Medicaid Service (CMS) State Report: HHA (Home Health Agency) List - No Successful Production Submissions Report (submission dates 1/1/23 to 12/31/2023) indicated the Agency did not transmit any OASIS data for 2023 in the required format. During an interview on 1/18/24 at 11:00 A.M., the Administrator said that the agency did not transmit any OASIS data for over a year.

Transmit data using compliant software CFR(s): 484.45(c)(2) Transmit data using electronic communications software that complies with the Federal Information Processing Standard (FIPS 140-2, issued May 25, 2001) from the HHA or the HHA contractor to the CMS collection site. This ELEMENT is not met as evidenced by: Based on review of Outcome and Assessment Information Set (OASIS) data and interview, the Agency failed to transmit OASIS data using electronic communications software that complies with Federal Information Standard. Findings include: A review of the Center for Medicare and Medicaid Service (CMS) State Report: HHA (Home Health Agency) List - No Successful Production Submissions Report (submission dates 1/1/23 to 12/31/2023) indicated the Agency did not transmit any OASIS data for 2023 using electronic communications software to the Centers for Medicare and Medicaid (CMS) collection site as required. During an interview on 1/18/24 at 11:00 A.M., the Administrator said that the agency did not transmit any OASIS data for over a year.

Mistreatment, neglect or abuse CFR(s): 484.50(e)(1)(i)(B) (i)(B) Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on employee file review and interview, the agency failed to obtain nurse aide registry checks in accordance with state requirements for 5 of 5 employee files (#1, #2, #3, #4, #5 and #6) reviewed. Findings include: The Massachusetts Department of Public Health Regulations at 105 CMR 155.010 (E)(3) requires all home health agencies, homemaker agencies, and hospice programs to contact the registry prior to hiring an individual who will provide direct care to patients or have access to patients or their property to ascertain if there is any sanction, finding or adjudicated finding of patient or resident abuse, neglect, mistreatment or misappropriation of patient or resident property against the prospective employee. On 1/22/24, 5 employee files were reviewed for proper screening prior to employment. Included in the screening were nurse aide registry checks. The results include: 1. Employee #1 was hired as a Registered Nurse on 10/23/23. There was no documentation that a nurse aide registry check was conducted prior to hire. 2. Employee #2 was hired as a Licensed Practical Nurse on 5/25/23. There was no documentation that a nurse aide registry was conducted prior to hire. 3. Employee #3 was hired as a Registered Nurse on 9/11/23. There was no documentation that a nurse aide registry was conducted prior to hire. 4. Employee #4 was hired as a Registered Nurse on 10/20/23. There was no documentation that a nurse aide registry was conducted prior to hire. 5. Employee #5 was hired as a Home Health Aide on 8/25/23. There was no documentation that a nurse aide registry was conducted prior to hire. During an interview on 1/22/24 at 10:30 A.M., the Administrator said that he did not conduct nurse aide registry checks on employees prior to hire as required.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure patient's plans of care were signed by the physician in a timely manner for 5 patients (RR#2, HV#2, HV#3, DC#1and DC#2), out of a total sample of 7 patients. Findings include: 4. For Patient HV#3, for the certification period of 11/17/23 - 1/15/23, the plan of care had not been signed by the physician as required, as of the completion of the survey. 5. For Patient DC #1, for the certification period of 4/12/23 - 6/10/23, the plan of care had not been signed by the physician as required, as of the completion of the survey. During an interview on 1/22/24 at 10:45 A.M., the Administrator said that she was unable to locate any signed plans of care for these patients. 1. For Patient RR#2, the plans of care for the past year (1/12/24, 11/14/23, 9/14/23, 7/17/23, 5/18/23, 3/18/23 and 1/14/23) had not been signed by a physician as required, as of the completion of survey. 2. For Patient HV#2, the plans of care for the past year (1/17/24, 11/9/23, 9/11/23, 7/9/23, 5/14/23, 3/15/23 and 1/13/23) had not been signed by a physician as required, as of the completion of the survey. 3. For DC#2, the plans of care for the year prior to discharge (11/11/22, 9/16/22, 7/18/22, 5/19/22, 3/20/22 and 1/19/22) had not been signed by a physician as required, as of the completion of the survey.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview, policy review and Centers for Disease Control review, the Agency failed to ensure that 1 of 2 staff members (Nurse #1) utilized adequate hand hygiene and glove use while performing blood sugar testing and insulin administration for 1 of 2 applicable home visits observed (HV #1), out of a total of 3 home visits. Findings include: Review of www.cdc.gov, (CDC) Hand Hygiene in Healthcare Settings, reviewed 1/8/21, included the following: Change gloves and perform hand hygiene during patient care if moving from work on a soiled body site to a clean body site on the same patient or if another clinical indication for hand hygiene occurs. Review of the Agency policy, titled, Specific Procedures for Employee and Patient Infection Control Training, Revised March 2018, included the following: Wear gloves for all phlebotomy and fingerstick procedures and during all invasive procedures. Change gloves and wash hands between patients. The policy failed to state CDC guidance to change gloves and perform hand hygiene during patient care if moving from work on a soiled body site to a clean body site on the same patient or another clinical indication for hand hygiene occurs. On 1/18/24 at 9:15 A.M., the surveyors observed Nurse #1 perform a fingerstick and administer insulin to HV#1 during a home visit. Nurse #1 donned gloves and obtained a blood pressure for HV #x, instead of removing his gloves, he used hand sanitizer on his gloves and exited the room to retrieve supplies. He used sanitizer on his gloved hands and wiped down the outside of a storage bag with an antimicrobial wipe. He used hand sanitizer on his hands and a set of keys he used to open a second storage box. He opened the box and removed an insulin pen, lancet device and needles and placed them on a clean barrier. Without changing his gloves, he used an alcohol swab to HV #1's finger and obtained a drop of blood for fingerstick testing. After obtaining the blood sample he used hand sanitizer on his gloves, attached a needle to the insulin pen, used an alcohol pad to disinfect an area on HV #x's abdomen and administered the insulin. He then used an antimicrobial wipe to disinfect the glucometer he had used. He then used hand sanitizer on his stethoscope. He removed his gloves and without performing hand hygiene, put on a new pair of gloves and continued to use the antimicrobial wipe on the blood pressure cuff and place the items in his bag. During an interview on 1/22/24 at 9:45 A.M., Nurse #1 said he was not aware the CDC recommended changing gloves, not using hand sanitizer on gloves.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on interview, record review and policy review, the Agency failed to ensure that discharge and transfer summaries were provided to the health care practitioner responsible for providing care after discharge for 2 of 2 (DC#1 and DC#2) patients that had been discharged, out of a total of 7 sampled patients. Findings include: 2. For Patient DC#1, the agency failed to provide a discharge summary to the health care practitioner who would be providing care after discharge. Patient DC#1 was admitted to the agency on 10/19/21 with a diagnosis of bipolar disorder. Review of the Discharge summary dated 4/28/23 indicated that the Agency discharged Patient DC#2 due to change in insurance. The record failed to indicate that the completed summary had been provided to a health care practitioner responsible for providing care after discharge. During an interview on 1/22/24 at 10:15 A.M., the Administrator said that DC#2 was discharged due to a change in insurance. She said that she notified the referral source and the referral source made arrangements for a new Agency to provide care with no lapse in coverage. She said the Agency provides a discharge summary to the referral source, but not to the new Agency that will be providing care. She was not able to find documentation that the discharge summary had been sent to the referral source. Review of the Agency policy, titled, Transfer/Referral Criteria policy, revised January 2022, included the following: Patients are transferred or referred to alternative care situations when the following conditions exist: * The patient or payer will no longer pay for the services provided by the Agency. * Patient refuses services or elects to be transferred. The receiving facility or health care practitioner who will be responsible for providing care and services to the patient is sent the transfer summary within two business days of a planned discharge. Review of the Agency policy, titled, Discharge Criteria, revised January 2022, included the following: Patient will be discharged from services as follows: * The patients payer will no longer ay for the services provided by the Agency. * Patient refuses services or elects to be discharged. The health care practitioner who will be responsible for providing care and services to the patient is sent the discharge summary within 5 business days. 1, For DC#2, admitted to the Agency in 12/2015 with diagnoses including Diabetes type 2 requiring insulin and Schizoaffective disorder, the Agency failed to provide a discharge summary to the health care practitioner who would be providing care after discharge. Review of the Discharge summary dated 1/1/23 indicated that the Agency discharged DC#2 due to change in insurance. The record failed to indicate that the completed summary had been provided to a health care practitioner responsible for providing care after discharge.