Pennsylvania Department of Health
LAKEWOOD REHABILITATION & HEALTHCARE CENTER
Patient Care Inspection Results

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LAKEWOOD REHABILITATION & HEALTHCARE CENTER
Inspection Results For:

There are  125 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.
LAKEWOOD REHABILITATION & HEALTHCARE CENTER - Inspection Results Scope of Citation
Number of Residents Affected
By Deficient Practice
Initial comments:


Based on a revisit and an abbreviated complaint suurvey completed on March 21, 2024, it was determined that Lakewood Rehabilitation and Healthcare Center failed to correct the federal deficiencies cited during the surveys of February 1, 2024, and February 29, 2024, and continued to be out of compliance with the following requirements of 42 CFR Part 483 Subpart B Requirements for Long Term Care and the 28 PA Code Commonwealth of Pennsylvania Long Term Care Licensure Regulations.




 Plan of Correction:


483.45(a)(b)(1)-(3) REQUIREMENT Pharmacy Srvcs/Procedures/Pharmacist/Records:This is a less serious (but not lowest level) deficiency and affects more than a limited number of residents, staff, or occurrences. This deficiency is one that results in minimal discomfort to the resident or has the potential (not yet realized) to negatively affect the resident's ability to achieve his/her highest functional status. This deficiency was not found to be throughout this facility.
483.45 Pharmacy Services
The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in 483.70(g). The facility may permit unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse.

483.45(a) Procedures. A facility must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident.

483.45(b) Service Consultation. The facility must employ or obtain the services of a licensed pharmacist who-

483.45(b)(1) Provides consultation on all aspects of the provision of pharmacy services in the facility.

483.45(b)(2) Establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and

483.45(b)(3) Determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.
Observations:

Based on a review of clinical records and controlled drug records and staff interview, it was determined that the facility failed to implement pharmacy procedures to promote accurate accounting and administration of controlled medications for two of 10 residents sampled (Resident 40 and Resident 76).

Findings include:

A review of the clinical record revealed Resident 40 was admitted to the facility on March 17, 2024, with diagnoses to include alcoholic cirrhosis of the liver, end stage renal disease and acute respiratory failure with hypoxia.

The resident had physician orders dated March 20, 2024, for Oxycodone 5 mg tablet, give 1 tablet by mouth every 6 hours as needed, which may be taken with Benadryl 25 mg by mouth (po) every 6 hours as needed, and discontinued on March 21, 2024. The resident also had physician orders dated March 21, 2024, for Oxycodone 5 mg tablet, give 5 mg by mouth every 4 hours as needed, may take with Benadryl 25 mg by mouth (po) every 6 hours as needed. Hold for sedation.

The physician order did not identify the reason for the administration of the Oxycodone 5 mg tablets prescribed as needed every 6 hours, which may be taken with Benadryl, whereas only asterisk were noted as the reason for drug administration.

A review of the facility's "controlled substance record", accounting for Resident 40's Oxycodone 5 mg tablets, one every six hours prn for moderate pain (not noted on the physician order), revealed that on March 21, 2024, the time a dose was removed, was illegible, and written over numerous times. On the side of the record, "0250, dose given 1, amount remaining 27, signed by Employee 3, Registered Nurse (RN), as identified by the Director of Nursing during the survey ending March 21, 2024.

A review of the resident's March 2024 MAR (Medication administration record) revealed that the resident was experiencing severe pain (10), and was administered the 5 mg Oxycodone, noted for moderate pain on the controlled drug record . The controlled substance record, for the resident's supply of Oxycodone 5 mg, also revealed on March 21, 2024, at time illegible, dose given 1, amount remaining 26, signed by Employee 3, Registered Nurse (RN).

A review of the clinical record revealed Resident 76 was admitted to the facility on August 5, 2021, with diagnoses to include malignant neoplasm of cerebellum, neoplasm of parts of nervous system, and neoplasm related acute, and chronic pain.

Resident 76 had a physician order dated June 19, 2023, for Oxycodone (a narcotic opioid pain medication) 10 milligrams (mg) tablet, give 1 tablet by mouth in the afternoon (1:00 PM), and 1 tablet by mouth at bedtime (9:00 PM) for cancer pain, discontinued on February 8, 2024; orders dated December 26, 2023, for Oxycodone 10 mg tablet every 6 hours, as needed, for breakthrough pain for 14 days, (start date December 27, 2023, end on - duration January 9, 2024); and a physician order dated January 10, 2024, for Oxycodone 10 mg tablet every 6 hours, as needed, for breakthrough pain for 14 days, (start date January 11, 2024, end on - duration January 24, 2024).

Current physician orders dated February 11, 2024, were noted as Oxycodone 10 mg tablet every 4 hours, as needed, for moderate to severe pain, (start date February 11, 2024, end on - duration indefinite).

A review of facility provided document, "controlled substance record", accounting for Resident 76's Oxycodone, stated "Oxycodone 10 mg tablet, take 1 tablet by mouth twice daily, take 1 tablet by mouth every 4 hours, as needed, for severe pain, date filled December 22, 2023."

A review of the controlled substance record, for the Oxycodone 10 mg, revealed on January 4, 2024, at 2204 (10:04 PM), one dose was given, with the amount of tablets remaining 29.

A review of the controlled substance record, for the Oxycodone 10 mg, revealed on January 5, 2024, at 0715 (7:15 AM), dose given 1, amount remaining 28. However, the administration of the controlled drug to the resident was not recorded on the resident's Medication Administration Record (MAR) on that date and time, as signed by Employee 3, Registered Nurse (RN), (as identified by the Director of Nursing).

A review of the controlled substance record, for the Oxycodone 10 mg, revealed on January 5, 2024, at 0715 (7:15 AM), dose given 1, amount remaining 27. However, the administration of the controlled drug to the resident was not recorded on the resident's Medication Administration Record (MAR) on that date and time, and in addition, is a duplicate drug administration with the same date, and time, signed by Employee 3, Registered Nurse (RN), (as identified by the Director of Nursing).

The controlled substance record, for the Oxycodone 10 mg, revealed on January 5, 2024, at 2001 (8:01 PM), dose given 1, amount remaining 25.

The controlled substance record, for the Oxycodone 10 mg, revealed on January 6, 2024, at 0137 (1:37 PM), dose given 1, amount remaining 24, signed by Employee 3, Registered Nurse (RN), (as identified by the Director of Nursing). However, the administration of the controlled drug to the resident was not recorded on the resident's Medication Administration Record (MAR) on that date and time.

The controlled substance record, for the Oxycodone 10 mg, revealed on January 6, 2024, at 0650 (6:50 AM), words written "error not given", initialed, amount remaining was illegible, signed by Employee 3, Registered Nurse (RN), (as identified by the Director of Nursing).

A continued review of the controlled substance record, for the Oxycodone 10 mg, revealed on January 6, 2024, at (blank - no time documented), words written "error not given", amount remaining 22. However, no initial or signature documented.

The controlled substance record, for the Oxycodone 10 mg, revealed on January 8, 2024, at 0600 (6:00 AM), dose given 1, amount remaining 17, signed by Employee 3, Registered Nurse (RN), (as identified by the Director of Nursing). However, the administration of the controlled drug to the resident was not recorded on the resident's Medication Administration Record (MAR) on that date and time.

The controlled substance record, for the Oxycodone 10 mg, revealed on January 9, 2024, at 0600 (6:00 AM), dose given 1, amount remaining 14, signed by Employee 3, Registered Nurse (RN), (as identified by the Director of Nursing). However, the administration of the controlled drug to the resident was not recorded on the resident's Medication Administration Record (MAR) on that date and time.

The controlled substance record, for the Oxycodone 10 mg, revealed on January 10, 2024, at 0730 (7:30 AM), dose given 1, amount remaining 11, signed by Employee 3, Registered Nurse (RN), (as identified by the Director of Nursing). However, the administration of the controlled drug to the resident was not recorded on the resident's Medication Administration Record (MAR) on that date and time.

The controlled substance record, for the Oxycodone 10 mg, revealed on January 10, 2024, at 0110 (1:10 AM), dose given 1, amount remaining 10. However, the administration of the controlled drug to the resident was not recorded on the resident's Medication Administration Record (MAR) on that date and time, and in sequence with the prior drug administration (January 10, 2024, at 0730) is out of sequence.

A further review of the January 2024, MAR, revealed the Oxycodone 10 mg, was administered on January 18, at 0132 (1:32 AM), January 21, at 0042 (12:42 AM), and 0648 (6:48 AM), and January 22, 2024, at 0035 (12:35 AM), and 0648 (6:48 AM). However, at the time the survey ended March 21, 2024, the administration of the controlled drug to the resident was not recorded on the resident's-controlled substance record.

Interview with the DON on March 21, 2024, at approximately 2:00 PM, confirmed the above controlled substance record, and stated that her expectation is that the controlled substance record be documented clearly and accurately documented.


28 Pa. Code 211.19(a)(1)(k) Pharmacy services

28 Pa. Code 211.5 (f) Medical records

28 Pa. Code 211.12 (d)(3)(5) Nursing services






 Plan of Correction - To be completed: 04/16/2024

1. Facility cannot retroactively correct the deficiency cited.
2. The Director of Nursing or designee will conduct an initial audit of current residents that are on narcotic medications to verify documentation of the narcotic administration record is accurate and legible, and administration is documented on the medication administration record.
3. The Director of Nursing or Designee will re-educate licensed nursing staff on the Controlled Substance Policy with the focus on legible documentation, and the process for documenting narcotic medication administration on the medication record and controlled substance record.
4. Director of nursing or designee will conduct audits weekly x 4, then monthly x 2 of current residents on narcotic medications to verify the narcotic administration record is accurate and legible, and administration is documented on the medication administration record. Results of audits will be reported and reviewed by the Quality Assurance Performance Improvement Committee and changes will be made as needed.

483.75(c)(d)(e)(g)(2)(i)(ii) REQUIREMENT QAPI/QAA Improvement Activities:This is a less serious (but not lowest level) deficiency and affects more than a limited number of residents, staff, or occurrences. This deficiency is one that results in minimal discomfort to the resident or has the potential (not yet realized) to negatively affect the resident's ability to achieve his/her highest functional status. This deficiency was not found to be throughout this facility.
483.75(c) Program feedback, data systems and monitoring.
A facility must establish and implement written policies and procedures for feedback, data collections systems, and monitoring, including adverse event monitoring. The policies and procedures must include, at a minimum, the following:

483.75(c)(1) Facility maintenance of effective systems to obtain and use of feedback and input from direct care staff, other staff, residents, and resident representatives, including how such information will be used to identify problems that are high risk, high volume, or problem-prone, and opportunities for improvement.

483.75(c)(2) Facility maintenance of effective systems to identify, collect, and use data and information from all departments, including but not limited to the facility assessment required at 483.70(e) and including how such information will be used to develop and monitor performance indicators.

483.75(c)(3) Facility development, monitoring, and evaluation of performance indicators, including the methodology and frequency for such development, monitoring, and evaluation.

483.75(c)(4) Facility adverse event monitoring, including the methods by which the facility will systematically identify, report, track, investigate, analyze and use data and information relating to adverse events in the facility, including how the facility will use the data to develop activities to prevent adverse events.

483.75(d) Program systematic analysis and systemic action.

483.75(d)(1) The facility must take actions aimed at performance improvement and, after implementing those actions, measure its success, and track performance to ensure that improvements are realized and sustained.

483.75(d)(2) The facility will develop and implement policies addressing:
(i) How they will use a systematic approach to determine underlying causes of problems impacting larger systems;
(ii) How they will develop corrective actions that will be designed to effect change at the systems level to prevent quality of care, quality of life, or safety problems; and
(iii) How the facility will monitor the effectiveness of its performance improvement activities to ensure that improvements are sustained.

483.75(e) Program activities.

483.75(e)(1) The facility must set priorities for its performance improvement activities that focus on high-risk, high-volume, or problem-prone areas; consider the incidence, prevalence, and severity of problems in those areas; and affect health outcomes, resident safety, resident autonomy, resident choice, and quality of care.

483.75(e)(2) Performance improvement activities must track medical errors and adverse resident events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the facility.

483.75(e)(3) As part of their performance improvement activities, the facility must conduct distinct performance improvement projects. The number and frequency of improvement projects conducted by the facility must reflect the scope and complexity of the facility's services and available resources, as reflected in the facility assessment required at 483.70(e). Improvement projects must include at least annually a project that focuses on high risk or problem-prone areas identified through the data collection and analysis described in paragraphs (c) and (d) of this section.

483.75(g) Quality assessment and assurance.

483.75(g)(2) The quality assessment and assurance committee reports to the facility's governing body, or designated person(s) functioning as a governing body regarding its activities, including implementation of the QAPI program required under paragraphs (a) through (e) of this section. The committee must:

(ii) Develop and implement appropriate plans of action to correct identified quality deficiencies;
(iii) Regularly review and analyze data, including data collected under the QAPI program and data resulting from drug regimen reviews, and act on available data to make improvements.
Observations:

Based on a review clinical records, the facility's plan of correction from the surveys ending February 29, 2024, and February 1, 2024, and the outcome of the activities of the facility's quality assurance committee it was determined that the facility failed to develop and implement a quality assurance plan, which was able to identify and correct ongoing quality deficiencies related to fully developing and implementing operational policies and procedures designed to protect residents from unacceptable practices of facility initiated disenrollment of residents from their Medicare health plans, the implementation of pharmacy procedures to promote accurate controlled drug records and administration, the pharmacist's identification of irregularities in residents' drug regimens and respiratory care.

Findings include:


During the survey ending February 29, 2024, deficient facility practice was identified related to the facility's failure to develop policies and procedures in accordance with CMS (Center for Medicare and Medicaid Services) guidance to protect the resident from unacceptable practices of disenrolling residents from the Medicare Health Plans to ensure all risks of disenrolling are fully explained, both verbally and in writing, and that residents are assessed as competent at the time to make informed health care decisions for one resident of five reviewed.

The facility developed a plan of correction that was to be completed by March 19, 2024, that included the following systemic change:

The facility has developed a policy to allow residents or their representatives to request assistance from the facility in changing their health care coverage. Residents requesting assistance from the facility will have their cognitive ability evaluated prior to any change and the responsible party notified if it is determined the resident is not cognitively intact. The NHA, Admissions staff and Business office manager will be educated on this policy.

However, at the time of this current revisit survey ending March 21, 2024, it was determined that the facility failed to fully develop and implement operational policies and procedures designed to protect residents from unacceptable practices of disenrolling residents from their Medicare health plans. The facility had failed to develop an operational policy that addressed all required elements of the CMS guidance for disenrollment to protect resident rights when changing their Medicare health plans. At time of the survey, the facility provided a generic template policy, lacking the facility name, and any operational role specificity for its employees to implement the procedures. The policy included the language from the CMS memo, but was not written in a manner to identify which employees were responsible for each step and procedures to ensure consistent and accurate implementation.

During the survey ending February 29, 2024, it was identified that the facility failed to implement pharmacy procedures for accounting for controlled drugs on one of four medication carts. Continued deficient practice was identified under this same requirement at the time of this revisit survey ending March 21, 2024, whereas the facility failed to implement pharmacy procedures to promote accurate accounting and administration of controlled medications for two of 10 residents sampled (Resident 40 and Resident 76).

During the survey ending February 29, 2024, deficient facility practice was identified related to the failure of the facility's pharmacist to identify irregularities in a resident's drug regimen. Continued deficient practice was identified under this same requirement at the time of this revisit survey ending March 21, 2024, whereas the pharmacist failed to identy irregularities in the drug regimen of Resident CR1.

During the survey ending February 1, 2024, deficient facility practice was identified related to the facility's failure to provide respiratory care, supplemental oxygen, as ordered by the physician. Deficient facility practice under this same quality of care requirement for respiratory care was identified during this revisit survey ending March 21, 2024, whereas observations revealed that the facility failed to ensure that respiratory care, neubulizer treatments, were provided in a sanitary manner for Residents 7 and 29.

The facility's quality assurance monitoring plans designed to ensure solutions were sustained, failed to identify the continuing deficient practice with these quality requirements and prevent recurrence of similar deficient practice as cited during the surveys of February 29, 2024, and February 1, 2024.


Refer F574, F695, F755, F756

28 Pa. Code 211.12 (c)(d)(3) Nursing services

28 Pa. Code 201.18(e)(1) Management.




 Plan of Correction - To be completed: 04/16/2024

1. No resident was identified regarding this deficiency.
2. Residents residing in the facility have the potential to be affected by the identified deficient practice. The Administrator/designee will continue to routinely monitor the plan of correction for compliance and address any needed interventions.
3. The administrator will re-educate the IDT team members on Quality Assurance and Performance Improvement and what metrics will be used to identify areas of opportunity.
4. The Quality Assurance Performance Improvement Committee will audit plan of corrections to ensure compliance with the cited deficiency. The results will be reviewed at the Quality Assurance and Performance Improvement Committee meeting.

483.10(g)(4)(i)-(vi) REQUIREMENT Required Notices and Contact Information:This is a less serious (but not lowest level) deficiency and is isolated to the fewest number of residents, staff, or occurrences. This deficiency is one that results in minimal discomfort to the resident or has the potential (not yet realized) to negatively affect the resident's ability to achieve his/her highest functional status.
483.10(g)(4) The resident has the right to receive notices orally (meaning spoken) and in writing (including Braille) in a format and a language he or she understands, including:
(i) Required notices as specified in this section. The facility must furnish to each resident a written description of legal rights which includes -
(A) A description of the manner of protecting personal funds, under paragraph (f)(10) of this section;
(B) A description of the requirements and procedures for establishing eligibility for Medicaid, including the right to request an assessment of resources under section 1924(c) of the Social Security Act.
(C) A list of names, addresses (mailing and email), and telephone numbers of all pertinent State regulatory and informational agencies, resident advocacy groups such as the State Survey Agency, the State licensure office, the State Long-Term Care Ombudsman program, the protection and advocacy agency, adult protective services where state law provides for jurisdiction in long-term care facilities, the local contact agency for information about returning to the community and the Medicaid Fraud Control Unit; and
(D) A statement that the resident may file a complaint with the State Survey Agency concerning any suspected violation of state or federal nursing facility regulations, including but not limited to resident abuse, neglect, exploitation, misappropriation of resident property in the facility, non-compliance with the advance directives requirements and requests for information regarding returning to the community.
(ii) Information and contact information for State and local advocacy organizations including but not limited to the State Survey Agency, the State Long-Term Care Ombudsman program (established under section 712 of the Older Americans Act of 1965, as amended 2016 (42 U.S.C. 3001 et seq) and the protection and advocacy system (as designated by the state, and as established under the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15001 et seq.)
(iii) Information regarding Medicare and Medicaid eligibility and coverage;
(iv) Contact information for the Aging and Disability Resource Center (established under Section 202(a)(20)(B)(iii) of the Older Americans Act); or other No Wrong Door Program;
(v) Contact information for the Medicaid Fraud Control Unit; and
(vi) Information and contact information for filing grievances or complaints concerning any suspected violation of state or federal nursing facility regulations, including but not limited to resident abuse, neglect, exploitation, misappropriation of resident property in the facility, non-compliance with the advance directives requirements and requests for information regarding returning to the community.
Observations:

Based on a review of guidance issued by the Centers for Medicare and Medicaid Services, select facility policy, and staff interview, it was determined that the facility failed to fully develop and implement operational policies and procedures designed to protect residents from unacceptable practices of disenrolling residents from their Medicare health plans.

Finding include:

During an abbreviated complaint survey conducted at the facility on February 29, 2024, deficient facililty practice was cited related to the facility's practice of initiating changes in residents' Medicare insurance plans, without the resident or their representatives having requested these changes, assessment of the resident's cognitive capabilities for understanding the changes and in the absences of operational policies and procedures consistent with CMS guidance for disenrollment.

The facility's plan of correction for this deficient practice, to be completed by March 19, 2024, revealed that the facility had developed a policy to allow residents or their representatives to request assistance from the facility in changing their health care coverage. Residents requesting assistance from the facility will have their cognitive ability evaluated prior to any change and the responsible party notified if it is determined the resident is not cognitively intact. The NHA, Admissions staff and Business office manager will be educated on this policy.

However, at the time of this revisit survey, the facility had failed to develop an operational policy that addressed all required elements of the CMS guidance for disenrollment to protect resident rights when changing their Medicare health plans. At time of the survey, the facility provided a generic template policy, lacking the facility name, and any operational role specificity for its employees to implement the procedures. The policy included the language from the CMS memo, but was not written in a manner to identify which employees were responsible for each step and procedures to ensure consistent and accurate implementation.

A review of a CMS guidance entitled "Memo to Long Term Care (LTC) Facilities on Medicare Health Plan Enrollment" dated October 2021 revealed that CMS continues to hear reports of the unacceptable practice of nursing facilities or skilled nursing facilities (collectively, long-term care or LTC facilities) disenrolling beneficiaries from Medicare health plans (Medicare Advantage plans with and without Part D, Medicare-Medicaid plans, or Programs of All-Inclusive Care for the Elderly without the beneficiary's or the beneficiary's representative's request, consent, knowledge, and/or complete understanding.

CMS guidance noted that "Only a Medicare beneficiary, the beneficiary's authorized or designated representative, or the party authorized to act on behalf of the beneficiary under state law can request enrollment in or voluntary disenrollment from a Medicare health or drug plan. Changes in a beneficiary's health care coverage generally must be initiated by the beneficiary or their representative. If a beneficiary or their legal representative requests assistance from the LTC facility in changing the beneficiary's health care coverage, the LTC facility should take the following steps to help ensure changes to a beneficiary's health care coverage comply with regulations regarding enrollment/disenrollment and resident rights:

1)Explain orally and in writing the impact to the beneficiary if they change coverage (e.g., to a stand-alone prescription drug plan (PDP) and Original Medicare, or to a different Medicare health plan).
2)Develop written policies and procedures regarding the process of assisting beneficiaries with changing their health care coverage. At a minimum, information should include the circumstances under which the facility can assist a beneficiary with a plan change. The need to obtain a document signed by the beneficiary or representative that acknowledges that the specific information regarding the impact of a change in coverage was provided to them orally and in writing, and that that the beneficiary and/or the representative understand the information. The need to obtain an attestation signed by the facility staff member that assisted with the change in enrollment, attesting that the beneficiary or representative requested the change and that the beneficiary or representative (as applicable) received and understood the minimum required information listed above. In cases where beneficiaries request disenrollment from PACE, LTC facilities that are contracted with PACE organizations should work directly with the PACE organization and the participant's interdisciplinary team to ensure the PACE participant receives the information required under the PACE regulations and to coordinate the transition of care, including as specified in their contract requirements.

If a LTC facility cannot provide documentation of a beneficiary's request to change enrollment, this may suggest that the enrollment action was not initiated by the beneficiary or their legal representative and therefore was not legally valid.

Lastly If the facility has the beneficiary sign documentation regarding their understanding of an enrollment change, CMS will expect to find that the beneficiary's assessed cognitive function also supports an ability to understand this type of information. If CMS becomes aware of enrollment actions that the beneficiary alleges were taken without their request, consent, knowledge, and/or complete understanding, CMS will expect the facility to provide the above noted documentation to support that it appropriately assisted the beneficiary with their choice to change coverage, including that the beneficiary's cognitive function supports such decision-making.

A review of the facility provided facility policy during the revisit survey ending March 21, 2024, entitled "Medicare Health Plan Enrollment Policy and Procedure", revealed that it was a a template for a facility as evidenced by [FACILITY NAME] not included, typed on top of the first page, policy; it is the policy of [FACILITY NAME] (the "Facility"), that all enrollment or disenrollment of the beneficiary in the health care plan or original Medicare Medicaid, shall be accompanied by a minimally sufficient explanation of change of coverage in accordance with applicable state, federal, or local laws, including but not limited to Medicare or Medicaid rights and/or benefits, as well as resident rights.

A review of the "Disenrollment Checklist", dated December 14, 2022, revealed that in order to facilitate a disenrollment for a Medicare managed care plan, several steps are required by CMS. Please make sure that the facility takes the following steps prior to disenrolling a resident.

This checklist included four steps: step 1. Affirmative request is initiated by the resident or the resident's representative (assuming they have legal authority), step 2. Explain orally and in writing the impact to the beneficiary if they change coverage, step 3. Develop written policies and procedures regarding the process of assisting beneficiaries with changing their health care coverage, and step 4. Ensure that the representative possesses the legal authority (standing) to make the necessary decisions. The checklist did not identify the employees responsible for completing each step of this checklist.

The facility policy failed to identify circumstances under which the facility can assist a beneficiary with a plan change, nor provided the attestation forms to ensure that facility staff attest that the change was requested by the resident and or representative, nor was an attestation form that the resident and or representative understood the change.

Interview with the Director of Nursing (DON), on March 21, 2024, at approximately 3:00 PM, failed to provide any additional information at the time the survey ended and that what was provided to the survey team was the facility's policy to fulfill the requirement.

Refer F 867

28 Pa. Code 201.29 (a)(c) Resident rights






 Plan of Correction - To be completed: 04/16/2024

1. The facility has a policy and procedure is updated.
2. Nursing Home Administrator or Designee will conduct an initial audit to validate that any changes made to current residents Medicare Health Plans follow the facilities policy.
3. Nursing Home Administrator of Designee will re-educated Business Office Manager and Social Service Director regarding Medicare Health Plan Enrollment Policy and Procedure.
4. Nursing Home Administrator or Designee will conduct weekly random audits for four weeks and then monthly audits for two months thereafter to validate that current residents who have recently elected to change their Medicare Health Plan is following the facility policy. Results of the audits will be reviewed by the Quality Assurance Performance Improvement Committee and changes will be made as necessary.

483.25 REQUIREMENT Quality of Care:This is a less serious (but not lowest level) deficiency and is isolated to the fewest number of residents, staff, or occurrences. This deficiency is one that results in minimal discomfort to the resident or has the potential (not yet realized) to negatively affect the resident's ability to achieve his/her highest functional status.
483.25 Quality of care
Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents. Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the residents' choices.
Observations:


Based on review of clinical records and interviews with staff, it was determined the facility failed to provide nursing services consistent with professional standards of practice by failing to demonstrate prompt and thorough assessment of a resident displaying signs and symptoms of a change in condition to ensure the resident received timely and necessary treatment for one resident out of 10 sampled (Resident CR1), which resulted in the facility's failure to timely identify signs of digoxin toxicity.


Findings include:

The Pennsylvania Code, Title 49, Professional and Vocational Standards, State Board of Nursing, 21.11 (a)(1)(2)(4) indicates that the registered nurse was to collect complete and ongoing data to determine nursing care needs, analyze the health status of individuals and compare the data with the norm when determining nursing care needs, and carry out nursing care actions that promote, maintain and restore the well-being of individuals.

The Pennsylvania Code, Title 49, Professional and Vocational Standards, State Board of Nursing, 21.145 Functions of the LPN (licensed practical nurse) (a) The LPN is prepared to function as a member of the health-care team by exercising sound judgement based on preparation, knowledge, skills, understandings, and past experiences in nursing situations. The LPN participates in the planning, implementation, and evaluation of nursing care in settings where nursing takes place.

A review of the clinical record revealed that Resident CR1 was admitted to the facility on January 23, 2024, from the hospital with diagnoses of chronic atrial fibrillation (a disease of the heart characterized by irregular and often faster heartbeat), chronic obstructive pulmonary disease and a history of peptic ulcer disease.

An admission Minimum Data Set Assessment (MDS - a federally mandated assessment of a resident's abilities and care needs) of Resident CR1, dated January 29, 2024, revealed that the resident was cognitively intact and required extensive assistance from staff with activities of daily living (bed mobility, dressing, and transfers).

Hospital discharge instructions dated dated January 23, 2024, at 9:56 AM, revealed that "future medications" the resident was to be prescribed at the skilled nursing facility included digoxin (Lanoxin - used to treat a-fib) 125 micrograms (mcg) at bedtime, which staff were to "hold for a heart rate of less than 60 beats per minute and notify \ service if dose is held."

A physician order dated January 23, 2024, at 10:26 PM, was noted for digoxin 125 mcg by mouth in the evening for heart rate. However, this order did not include the any parameters or heart rate monitoring, as noted in the hospital discharge instructions to "hold for a heart rate of less than 60 beats per minute and notify \ service if dose is held."

Following the resident's admission to the skilled nursing facility, there was no physician order to obtain digoxin laboratory levels for monitoring the resident's blood levels of digoxin or to obtain the resident's heart rate in relationship to the resident's daily administration of digoxin.
(Digoxin has a narrow therapeutic window, meaning there is a small margin between the benefit of its effects and toxicity; therefore, monitoring is an important part of its use. Monitoring of serum digoxin is usually carried out after any dose changes, suspected signs and symptoms of toxicity, or changes in therapy).

A review of progress notes entitled "Change in Condition Evaluation" dated March 1, 2024, at 4:28 PM, revealed that Employee 2, RN, Assistant Director of Nursing (ADON) noted that the resident was complaining of chest pain that started in the afternoon, and no vital signs were able to be obtained according to the nursing entry. The RN did not indicate why vital signs, including the resident's heart rate, could not be obtained in the progress note. Nursing staff instead, referenced the resident's vitals obtained earlier that morning, on March 1, 2024, and the day prior on February 29, 2024, and also on February 25, 2025, failing to provide a current assessment of the resident's status and change in condition.

The vital signs that were documented, from these past occassions were blood pressure (BP) 122/74 dated March 1, 2024 at 8:43 AM, heart rate (HR) 76 dated February 29, 2024 at 5:58 PM, respiration rate (RR) 18 dated February 25, 2024 at 1:53 PM, temperature 98 degrees Fahrenheit dated February 25, 2024 at 1:53 PM, pulse oximetry ([SPO2] peripheral oxygen saturation, measures the amount of oxygen bound to hemoglobin in tour red blood cells - normal ranges fall between 92%-100%) 88% on room air (RA) dated March 1, 2024 at 4:29 PM, blood glucose (BG) 128 dated March 1, 2024 at 11:38 AM.

Nursing noted on March 1, 2024, at 4:28 PM that the resident's family was requesting that the resident be seen in the emergency department (ED) for a cardiac evaluation. However, the physician assistant (PA) was aware of this request and present, and noted in progress notes, that the PA did not believe that a transfer to the ER, as the family requested, was warranted.

Nursing documentation dated March 1, 2024, at 4:29 PM noted that the resident's oxygen saturation on March 1, 2024, at 9:12 AM was 95 % on room air, and at 4:29 PM the resident's SPO2 was 88% on room air. The resident's described symptoms reported are "chest pain and tightness." Nursing did not document any further assessment, including the resident's heart rate, or intervention, and noted "unable to determine" or "not applicable" (N/A) in documentation. Nursing noted that it was unknown if this (change in condition) had occurred in the past, the resident had no distress all day, but the resident's family arrived, and the resident complained of chest tightness. Family demanded the resident to be transferred to the ED and the PA was present and aware at 4:18 PM. Nursing noted on March 1, 2024, at 4:34 PM that emergency medical services (EMS) arrived and transported the resident to the ED.

A review of progress notes dated March 1, 2024, at 9:54 PM revealed that the resident was admitted to the hospital for digoxin toxicity (occurs when there is an excessive amount of the medication digoxin in the blood stream).

Hospital documentation dated March 1, 2024, from the ED revealed that the resident presented with nausea, vomiting and dizziness when he tried to ambulate (walk). At 7:30 PM the resident received Digifab (an antidote to treat a life-threatening overdose of digoxin) 120 milligrams (mg) intravenously (IV) for digoxin toxicity a level of 3.0 ng/ml (normal range 0.5-1.1 ng/ml The resident's heart rate was in the 50s (normal HR range is 60-100) in the ED.

On March 6, 2024, at 12:50 PM a surgical note revealed that the resident had a new DDD pacemaker (a type of dual-chamber pacemaker that senses and paces both atrial and ventricular events) implanted surgically.

An interview with the DON on March 21, 2024, at approximately 1:20 PM, she was unable to explain why nursing staff failed to obtain the resident's vital signs when the resident voiced complaints of chest pain. The DON also failed to explain why nursing staff did not timely consult with the physician regarding the initial order for digoxin lacking parameters for heart rate monitoring as noted in the hospital discharge summary.

An interview with Employee 2, RN ADON on March 21, 2024, at approximately 3:18 PM confirmed that the resident's vital signs were not obtained prior to the resident being transferred to the ED. When asked why they were not obtained to fully assess the resident's change in condition, Employee 2 ADON stated that she "just started the paperwork that day, she was not the nurse taking care of the resident." Employee 2 stated that she was the supervisor of the licensed practical nurse (LPN) taking care of this resident, and she documented the "Change of Condition" progress note on March 1, 2024, at 4:28 PM stating "vital signs were unable to be obtained", because EMS was already there to transport the resident to the ED.

An interview with the Nursing Home Administrator (NHA) and DON on March 21, 2024, at approximately 1:00 PM failed to provide evidence that the facility's licensed and professional nursing staff had timely consulted with the physician regarding the resident's digoxin order as it compared to the hospital discharge instructions and failed to demonstrate prompt and thorough assessment of the resident's status in response to a change in condition to ensure timely treatment.

Refer F756

28 Pa. Code 211.12 (c)(d)(1)(3)(5) Nursing services

28 Pa. Code 211.5 (f) Medical records.




 Plan of Correction - To be completed: 04/16/2024

1. Resident CR1 is no longer a resident at the facility.
2. The Director of Nursing or designee will conduct an initial audit of residents that are on digoxin to identify if the MD order was transcribed accurately including any parameters given to follow.
3.The Staff Educator or designee will re-educate licensed nurses transcribing orders from MD accurately including any parameters, medications that require routine blood work monitoring, and identifying residents change in condition with MD notification timely.
4. The Director of Nursing or designee will conduct a random audit new orders to ensure any parameters order have been transcribed, if any necessary blood work is ordered, and change in conditions have been followed up on timely. This audit will be conducted weekly for four weeks and then monthly for two months thereafter. These audits will be reviewed by the Quality Assurance Improvement Committee and changes will be made as needed.

483.25(i) REQUIREMENT Respiratory/Tracheostomy Care and Suctioning:This is a less serious (but not lowest level) deficiency and is isolated to the fewest number of residents, staff, or occurrences. This deficiency is one that results in minimal discomfort to the resident or has the potential (not yet realized) to negatively affect the resident's ability to achieve his/her highest functional status.
483.25(i) Respiratory care, including tracheostomy care and tracheal suctioning.
The facility must ensure that a resident who needs respiratory care, including tracheostomy care and tracheal suctioning, is provided such care, consistent with professional standards of practice, the comprehensive person-centered care plan, the residents' goals and preferences, and 483.65 of this subpart.
Observations:

Based on observation, clinical record review and staff interview it was determined that the facility failed to consistently provide respiratory care in manner to promote safe and optimal functioning for two residents out of 10 sampled (Residents 7, and 29).

Findings included:

A review of Resident 7's clinical record revealed admission to the facility March 25, 2023, with diagnoses to include chronic obstructive pulmonary disease (COPD), acute and chronic respiratory failure with hypoxia and asthma.

A current physician order dated February 14, 2024, was noted for Ipratropium - Albuterol Solution 0.5 - 2.5 (3) mg/3 ml, take 3 ml inhale orally every 6 hours as needed for shortness of breath (SOB) or cough via nebulizer.

An observation conducted on March 21, 2024, at approximately 12:05 PM, revealed Resident 7 in his room. A nebulizer machine and tubing and mask was observed on a metal folding chair. The tubing and mask were in a clear plastic bag, dated February 29, 2024, which was confirmed by Employee 1 (LPN) at the time of the observation.

A review of Resident 29's clinical record revealed that she was admitted to the facility on August 3, 2023, with diagnoses to include chronic obstructive pulmonary disease (COPD) and pneumonia (infection of the air sacs in one or both lungs that can be characterized by severe cough with fever, chills and difficulty breathing).

A current physician order dated March 10, 2024, was noted for Ipratropium - Albuterol Solution 0.5 - 2.5 (3) mg/3 ml, take 3 ml inhale orally every 6 hours as needed via nebulizer for pneumonia and continuous oxygen therapy at three liters per minute via nasal cannula, every shift for pneumonia.

An observation conducted on March 21, 2024, at approximately 11:39 PM, revealed Resident 29 was in her room. A nebulizer machine, tubing and inspiratory valve were on the resident's bedside table. The tubing and valve were placed on the table top, and not covered or dated. The oxygen tubing was also not observed to be dated.

Interview with the Director of Nursing (DON) on March 21, 2024, at approximately 2:00 PM, indicated her expectation is the oxygen equipment is to be kept clean, and that the tubing and bag are to be changed weekly and the above observations were not consistent with that expectation.

Refer F867

28 Pa. Code 211.12 (d)(5) Nursing services





 Plan of Correction - To be completed: 04/16/2024

1. Residents 7 and 29 oxygen and nebulizers are stored and dated properly.

2. The Director of Nursing or designee will complete an initial audit of current residents in the facility who are receiving oxygen and nebulizer treatments to verify that they are stored and dated properly.

3. The Staff Educator or designee will re-educate nursing staff on properly storing and dating Oxygen and Nebulizers.
4. The Director of Nursing or designee will conduct random audits of current residents on oxygen and nebulizers treatments to verify they are stored and dated properly. This will be conducted weekly times four weeks, then monthly times two months thereafter. These audits will be reviewed by the Quality Assurance Improvement Committee and changes will be made as needed.

483.25(k) REQUIREMENT Pain Management:This is a less serious (but not lowest level) deficiency and is isolated to the fewest number of residents, staff, or occurrences. This deficiency is one that results in minimal discomfort to the resident or has the potential (not yet realized) to negatively affect the resident's ability to achieve his/her highest functional status.
483.25(k) Pain Management.
The facility must ensure that pain management is provided to residents who require such services, consistent with professional standards of practice, the comprehensive person-centered care plan, and the residents' goals and preferences.
Observations:

Based on a review of clinical records and resident and staff interview, it was determined that the facility failed to provide person-centered pain management consistent with professional standards of practice for one resident out of ten sampled (Resident 76).

The findings include:

According to the US Department of Health and Human Services, Interagency Task Force, Executive Summary Final Report May 6, 2021, for Pain Management Best Practices the development of an effective pain treatment plan after proper evaluation to establish a diagnosis with measurable outcomes that focus on improvements including quality of life (QOL), improved functionality, and Activities of Daily Living (ADLs). Achieving excellence in acute and chronic pain care depends on the following:

-An emphasis on an individualized patient-centered approach for diagnosis and treatment of pain is essential to establishing a therapeutic alliance between patient and clinician.
-Acute pain can be caused by a variety of different conditions such as trauma, burn, musculoskeletal injury, neural injury, as well as pain due to surgery/procedures in the perioperative period. A multi-modal approach that includes medications, nerve blocks, physical therapy and other modalities should be considered for acute pain conditions.
-A multidisciplinary approach for chronic pain across various disciplines, utilizing one or more treatment modalities, is encouraged when clinically indicated to improve outcomes. These include the following five broad treatment categories.
-Medications: Various classes of medications, including non-opioids and opioids, should be considered for use. The choice of medication should be based on the pain diagnosis, the mechanisms of pain, and related co-morbidities following a thorough history, physical exam, other relevant diagnostic procedures and a risk-benefit assessment that demonstrates the benefits of a medication outweighs the risks. The goal is to limit adverse outcomes while ensuring that patients have access to medication-based treatment that can enable a better quality of life and function. Ensuring safe medication storage and appropriate disposal of excess medications is important to ensure best clinical outcomes and to protect the public health.
-Restorative Therapies including those implemented by physical therapists and occupational therapists (e.g., physiotherapy, therapeutic exercise, and other movement modalities) are valuable components of multidisciplinary, multimodal acute and chronic pain care.
-Interventional Approaches including image-guided and minimally invasive procedures are available as diagnostic and therapeutic treatment modalities for acute, acute on chronic, and chronic pain when clinically indicated. A list of various types of procedures including trigger point injections, radiofrequency ablation, cryoneuroablation, neuromodulation and other procedures are reviewed.
-Behavioral Health Approaches for psychological, cognitive, emotional, behavioral, and social aspects of pain can have a significant impact on treatment outcomes. Patients with pain and behavioral health comorbidities face challenges that can exacerbate painful conditions as well as function, QOL, and ADLs.
-Complementary and Integrative Health, including treatment modalities such as acupuncture, massage, movement therapies (e.g., yoga, tai chi), spirituality, among others, should be considered when clinically indicated.
-Effective multidisciplinary management of the potentially complex aspects of acute and chronic pain should be based

A review of the clinical record revealed Resident 76 was admitted to the facility on August 5, 2021, with diagnoses to include malignant neoplasm of cerebellum, neoplasm of parts of nervous system, and neoplasm related acute, and chronic pain.

An Annual Minimum Data Set assessment (MDS-standardized assessment completed at specific intervals to identify specific resident care needs) dated February 2, 2024, revealed that the resident was cognitively intact with a Brief Interview for Mental Status (BIMS section of the MDS which assesses cognition, a tool to assess the resident's attention, orientation, and ability to register and recall new information, a score of 13-15 equates to being Cognitively Intact) score of 13. The MDS Section J, Pain Management, question J0300, indicated that the resident has had pain and or was hurting within the last 5 days, question J0600 pain intensity, rate pain (0 to 10), 0 being no pain and 10 as the worst pain you can imagine, she responded as a 10, for the most severe pain.

The resident had physician orders for Acetaminophen Tablet 325 mg give 650 mg by mouth every 6 hours as needed for generalized Pain 1-3, Non-Pharmacological Interventions 1. Reposition, 2. Back rub, 3. Music, 4. Warm/cool compress, 5. Diversional activity, 6. Other (progress note). May 30, 2023, discontinued February 8, 2024.

Acetaminophen Tablet 500 mg give 2 tablet by mouth every 6 hours as needed for Moderate pain 4-6 related to malignant neoplasm of cerebellum, neoplasm of unspecified behavior of brain, Non-Pharmacological Interventions 1. Reposition, 2. Back rub, 3. Music, 4. Warm/cool compress, 5. Diversional activity, 6. Other (progress note), order date May 29, 2023, and discontinued February 8, 2024.

Resident 76 had a physician orders dated June 19, 2023, for Oxycodone (a narcotic opioid pain medication) 10 milligrams (mg) tablet, give 1 tablet by mouth in the afternoon (1:00 PM), and 1 tablet by mouth at bedtime (9:00 PM) for cancer pain, discontinued on February 8, 2024.

Resident 76 had a physician orders dated December 26, 2023, for Oxycodone 10 mg tablet every 6 hours, as needed, for breakthrough pain for 14 days, (start date December 27, 2023, end on - duration January 9, 2024). 1. Reposition, 2. Back rub, 3. Music, 4. Warm/cool compress, 5. Diversional activity, 6. Other (progress note).

Resident 76 had a physician order dated January 10, 2024, for Oxycodone 10 mg tablet every 6 hours, as needed, for breakthrough pain for 14 days, (start date January 11, 2024, end on - duration January 24, 2024). 1. Reposition, 2. Back rub, 3. Music, 4. Warm/cool compress, 5. Diversional activity, 6. Other (progress note).

The resident had a physcian order dated February 11, 2024, for Oxycodone 10 mg tablet every 4 hours, as needed, for moderate to severe pain, (start date February 11, 2024, end on - duration indefinite) non-pharmacological interventions 1. Reposition, 2. Back rub, 3. Music, 4. Warm/cool compress, 5. Diversional activity.

Nursing noted on February 6, 2024, at 10:24 PM that the resident was admitted to the hospital with hypotension secondary to neuroblastoma, and returned to the facility on February 11, 2024, at 1:11 PM,

Interview Resident 76 on March 21, 2024, at approximately 10:15 AM revealed that the resident stated that she experiences pain mostly during the awakening hours, in the mid back, rated at an 8 on a scale of 0-10. She further stated, she does not feel the facility is managing her pain well.

During interview with the Director of Nursing (DON) on March 21, 2024, at approximately 1:20 PM, she confirmed that Resident 76 is seen by oncology for cancer treatment. The DON confirmed that prior to the resident's hospital stay on February 6, 2024, through February 11, 2024, the resident had orders for Acetaminophen Tablet 325, mg and 500 mg, as needed, and a straight dose of Oxycodone 10 mg twice daily, and as needed dose, but upon return from the hospital, the resident currently had orders for only for Acetaminophen and Oxycodone on a as needed basis with straight dose.

Interview with the Director of Nursing (DON) on March 21, 2024, at approximately 2:00 PM, confirmed that Resident 76 continued to have pain and that the resident's current pain management regimen was not effective.



28 Pa. Code 211.12 (d)(3)(5) Nursing Services



 Plan of Correction - To be completed: 04/16/2024

1.Resident 76 had a pain evaluation completed. Pain medication was changed to routine dosing.
2.Current residents taking prn narcotic pain medications will have a pain evaluation completed, and residents due for MDS will have section J reviewed for pain. Pain evaluations will be completed and physicians notified as indicated, in order to provide person centered pain
3.The Staff educator or designee will inservice licensed nurses on the Pain management policy with the focus on providing person centered pain management, including resident specific interventions to ensure residents pain management regimen is effective.
4.The DON or designee will conduct weekly audits x 4, then monthly x 2 of residents with MDS due and residents taking frequent narcotic pain medications to verify a pain evaluation has been completed and physician was notified in order to provide a person centered pain management plan.

483.45(c)(1)(2)(4)(5) REQUIREMENT Drug Regimen Review, Report Irregular, Act On:This is a less serious (but not lowest level) deficiency and is isolated to the fewest number of residents, staff, or occurrences. This deficiency is one that results in minimal discomfort to the resident or has the potential (not yet realized) to negatively affect the resident's ability to achieve his/her highest functional status.
483.45(c) Drug Regimen Review.
483.45(c)(1) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist.

483.45(c)(2) This review must include a review of the resident's medical chart.

483.45(c)(4) The pharmacist must report any irregularities to the attending physician and the facility's medical director and director of nursing, and these reports must be acted upon.
(i) Irregularities include, but are not limited to, any drug that meets the criteria set forth in paragraph (d) of this section for an unnecessary drug.
(ii) Any irregularities noted by the pharmacist during this review must be documented on a separate, written report that is sent to the attending physician and the facility's medical director and director of nursing and lists, at a minimum, the resident's name, the relevant drug, and the irregularity the pharmacist identified.
(iii) The attending physician must document in the resident's medical record that the identified irregularity has been reviewed and what, if any, action has been taken to address it. If there is to be no change in the medication, the attending physician should document his or her rationale in the resident's medical record.

483.45(c)(5) The facility must develop and maintain policies and procedures for the monthly drug regimen review that include, but are not limited to, time frames for the different steps in the process and steps the pharmacist must take when he or she identifies an irregularity that requires urgent action to protect the resident.
Observations:


Based on clinical record review and staff interviews, it was determined that the pharmacist failed to identify drug irregularities in the drug regimen of one of 10 sampled residents (Resident CR1).

Findings included:

A review of the clinical record revealed that Resident CR1 was admitted to the facility on January 23, 2024, with diagnoses of chronic atrial fibrillation (a disease of the heart characterized by irregular and often faster heartbeat), chronic obstructive pulmonary disease ([COPD] a disease characterized by persistent respiratory symptoms like progressive breathlessness and cough), and a history of peptic ulcer disease ([PUD] an illness characterized by open sores called ulcers in the stomach).


Hospital discharge instructions dated dated January 23, 2024, at 9:56 AM, revealed that "future medications" the resident was to be prescribed at the skilled nursing facility included digoxin (Lanoxin - used to treat a-fib) 125 micrograms (mcg) at bedtime, which staff were to "hold for a heart rate of less than 60 beats per minute and notify \ service if dose is held."

A physician order dated January 23, 2024, at 10:26 PM, was noted for digoxin 125 mcg by mouth in the evening for heart rate. However, this order did not include the any parameters or heart rate monitoring, as noted in the hospital discharge instructions to "hold for a heart rate of less than 60 beats per minute and notify \ service if dose is held."

Following the resident's admission to the skilled nursing facility, there was no physician order to obtain digoxin laboratory levels for monitoring the resident's blood levels of digoxin or to obtain the resident's heart rate in relationship to the resident's daily administration of digoxin.

A review of a "Medication Regimen Review" dated February 1, 2024, through February 29, 2024, revealed that the pharmacist reviewed Resident CR1's medication regimen and identified no irregularities, including the lack of heart rate monitoring or digoxin blood levels in relationship to the resident's use of digoxin.

An interview with the Director of Nursing (DON) and NHA on March 21, 2024, at approximately 1:20 PM, confirmed that the pharmacist had not identified the lack parameters or heart rate monitoring, or laboratory blood level monitoring for this resident's use of digoxin.

Refer F684

28 Pa. Code 211.9 (k) Pharmacy services.





 Plan of Correction - To be completed: 04/16/2024

1. R CR1 is no longer a resident at facility.
2. DON/Designee will review March 2024 pharmacy recommendations on current residents to ensure drug regimen of each resident was reviewed, pharmacist reviewed resident's medical chart, and pharmacist reported any drug irregularities in the drug regimen of current residents.
3. DON/designee will educate pharmacy consultant on medication regimen reviews policy which will include: medications ordered in excessive doses or without clinical indication; medication regimens that appear inconsistent with the resident's stated preferences; duplicative therapies or omissions of ordered medications; inadequate monitoring for adverse consequences; potentially significant drug-drug or drug-food interactions; potentially significant medication-related adverse consequences or actual signs and symptoms that could represent adverse consequences; incorrect medications, administration times or dosage forms; or other medication errors, including those related to documentation
4. DON/designee will audit pharmacy recommendations monthly to ensure the drug regimen reviews include identified drug irregularities and any irregularities noted by the pharmacist during this review will be documented on a separate, written report that includes the resident's name, the relevant drug, and the irregularity the pharmacist identified.

483.45(g)(h)(1)(2) REQUIREMENT Label/Store Drugs and Biologicals:This is a less serious (but not lowest level) deficiency and is isolated to the fewest number of residents, staff, or occurrences. This deficiency is one that results in minimal discomfort to the resident or has the potential (not yet realized) to negatively affect the resident's ability to achieve his/her highest functional status.
483.45(g) Labeling of Drugs and Biologicals
Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable.

483.45(h) Storage of Drugs and Biologicals

483.45(h)(1) In accordance with State and Federal laws, the facility must store all drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys.

483.45(h)(2) The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.
Observations:

Based on observation, clinical record review, and staff interview, it was determined that the facility failed to ensure that medications were labeled according to accepted labeling requirements for two of 10 residents sampled (Resident 40, and 76).

Findings include:


Labeling for prescription medicines is FDA ' s primary tool for communicating drug information to healthcare professionals, and patients and their caregivers. Labeling for prescription medicines includes:
Prescribing Information (labeling for healthcare professionals);
Carton and container labeling (cartons and containers are outside packaging that contain information about prescription medicines), and; Labeling for patients or caregivers (e.g., Medication Guides, Patient Package Inserts, and Instructions for Use).

A review of the clinical record revealed Resident 40 was admitted to the facility on March 17, 2024, with diagnoses to include alcoholic cirrhosis of the liver, end stage renal disease and acute respiratory failure with hypoxia.

The resident had a physician order dated March 20, 2024, which read "Oxycodone 5 mg tablet, give 1 tablet by mouth every 6 hours as needed for ** May take with Benadryl 25 mg by mouth (po) every 6 hours as needed. Non-pharmacological interventions which was discontinued on March 21, 2024, and a physician order dated March 21, 2024, which read "Oxycodone 5 mg tablet, give 5 mg by mouth every 4 hours as needed for ** May take with Benadryl 25 mg by mouth (po) every 6 hours as needed. Hold for sedation."

The facility's "controlled substance record", accounting for Resident 40's supply of Oxycodone 5 mg read "Oxycodone 5 mg tablet, take 1 tablet by mouth every 6 hours, as needed for moderate pain," which did not match the physician order.

During an interview with the Director of Nursing (DON) on March 21, 2024, at approximately 1:20 PM, she was unable to explain Resident 40's physician orders dated March 21, 2024, for Oxycodone 5 mg tablet, give 5 mg by mouth every 4 hours as needed for **, (as documented in the physician orders). Furthermore, she was unable to provide the documented evidence to support the label on the controlled drug record which included the directions to take as needed for moderate pain.

A review of the clinical record revealed Resident 76 was admitted to the facility on August 5, 2021, with diagnoses to include malignant neoplasm of cerebellum, neoplasm of parts of nervous system, and neoplasm related acute, and chronic pain.

Resident 76 had a physician order dated June 19, 2023, for Oxycodone (a narcotic opioid pain medication) 10 milligrams (mg) tablet, give 1 tablet by mouth in the afternoon (1:00 PM), and 1 tablet by mouth at bedtime (9:00 PM) for cancer pain, discontinued on February 8, 2024; an order dated December 26, 2023, for Oxycodone 10 mg tablet every 6 hours, as needed, for breakthrough pain for 14 days, (start date December 27, 2023, end on - duration January 9, 2024); and a physician order dated January 10, 2024, for Oxycodone 10 mg tablet every 6 hours, as needed, for breakthrough pain for 14 days, (start date January 11, 2024, end on - duration January 24, 2024).

Current physician orders dated February 11, 2024, were noted as Oxycodone 10 mg tablet every 4 hours, as needed, for moderate to severe pain, (start date February 11, 2024, end on - duration indefinite)/

A review of facility provided document, "controlled substance record", accounting for Resident 76's supply of Oxycodone, read " Oxycodone 10 mg tablet, take 1 tablet by mouth twice daily, take 1 tablet by mouth every 4 hours, as needed, for severe pain, date filled December 22, 2023."

During an interview with the DON on March 21, 2024, at approximately 1:20 PM, the DON confirmed that the label on Resident 76's controlled substance record, Oxycodone 10 mg, was incorrect whereas the physician order for the time frame December 26, 2023, through January 24, 2024 was to take 1 tablet by mouth every 6 hours (not 4 hours) as needed.

Interview with the DON, on March 21, 2024, at approximately 2:00 PM, also confirmed that the label on the controlled substance record for Resident 40, oxycodone 5 mg, did not match the current physician order, to "give 5 mg by mouth every 4 hours as needed for **." She also confirmed the physician order for Resident 76's Oxycodone 10 mg, take 1 tablet by mouth every 6 hours was in effect for 28 days (December 26, 2023, through January 24, 2024), and the label on the controlled substance record did not reflect the correct physician order during that time.



28 Pa Code 211.12 (d)(3)(5) Nursing services

28 Pa. Code 211.9 (a)(1)(k) Pharmacy Services



 Plan of Correction - To be completed: 04/16/2024

1.The facility is unable to retroactively correct the cited deficiency.
2. The Director of Nursing or designee will conduct an initial audit of current residents with orders for controlled substances to verify that the order matches the controlled substance record.
3. The Staff Educator or designee will educate licensed nurses on medication labeling. Residents with new orders for controlled substances will be reviewed during clinical meeting to verify the order matches the controlled substance record.
4. The Director of Nursing or designee will conduct random audits of current residents with orders for controlled substances to verify that the order matches the controlled substance record. This will be conducted weekly times four weeks, then monthly times two months thereafter. These audits will be reviewed by the Quality Assurance Improvement Committee and changes will be made as needed.

483.20(f)(5), 483.70(i)(1)-(5) REQUIREMENT Resident Records - Identifiable Information:This is a less serious (but not lowest level) deficiency and is isolated to the fewest number of residents, staff, or occurrences. This deficiency is one that results in minimal discomfort to the resident or has the potential (not yet realized) to negatively affect the resident's ability to achieve his/her highest functional status.
483.20(f)(5) Resident-identifiable information.
(i) A facility may not release information that is resident-identifiable to the public.
(ii) The facility may release information that is resident-identifiable to an agent only in accordance with a contract under which the agent agrees not to use or disclose the information except to the extent the facility itself is permitted to do so.

483.70(i) Medical records.
483.70(i)(1) In accordance with accepted professional standards and practices, the facility must maintain medical records on each resident that are-
(i) Complete;
(ii) Accurately documented;
(iii) Readily accessible; and
(iv) Systematically organized

483.70(i)(2) The facility must keep confidential all information contained in the resident's records,
regardless of the form or storage method of the records, except when release is-
(i) To the individual, or their resident representative where permitted by applicable law;
(ii) Required by Law;
(iii) For treatment, payment, or health care operations, as permitted by and in compliance with 45 CFR 164.506;
(iv) For public health activities, reporting of abuse, neglect, or domestic violence, health oversight activities, judicial and administrative proceedings, law enforcement purposes, organ donation purposes, research purposes, or to coroners, medical examiners, funeral directors, and to avert a serious threat to health or safety as permitted by and in compliance with 45 CFR 164.512.

483.70(i)(3) The facility must safeguard medical record information against loss, destruction, or unauthorized use.

483.70(i)(4) Medical records must be retained for-
(i) The period of time required by State law; or
(ii) Five years from the date of discharge when there is no requirement in State law; or
(iii) For a minor, 3 years after a resident reaches legal age under State law.

483.70(i)(5) The medical record must contain-
(i) Sufficient information to identify the resident;
(ii) A record of the resident's assessments;
(iii) The comprehensive plan of care and services provided;
(iv) The results of any preadmission screening and resident review evaluations and determinations conducted by the State;
(v) Physician's, nurse's, and other licensed professional's progress notes; and
(vi) Laboratory, radiology and other diagnostic services reports as required under 483.50.
Observations:

Based on review of clinical records, facility provided documents, and staff interviews, it was determined that the facility failed to maintain complete clinical records, according to professional standards of nursing practice by failing to document assessment of changes in a residents condition for one of 10 residents sampled (Resident CR1).

Findings include:

According to the American Nurses Association Principles for Nursing Documentation, nurses document their work and outcomes and provide an integrated, real-time method of informing the health care team about the patient status. Timely documentation of the following types of information should be made and maintained in a patient record to support the ability of the health care team to ensure informed decisions and high-quality care in the continuity of patient care: Assessments, Clinical problems, Communications with other health care professionals regarding the patient, Communication with and education of the patient, family, and the patient's designated support person and other third parties.

A review of the clinical record revealed that Resident CR1 was admitted to the facility on January 23, 2024, from the hospital with diagnoses of chronic atrial fibrillation (a disease of the heart characterized by irregular and often faster heartbeat), chronic obstructive pulmonary disease and a history of peptic ulcer disease.

An admission Minimum Data Set Assessment (MDS - a federally mandated assessment of a resident's abilities and care needs) of Resident CR1, dated January 29, 2024, revealed that the resident was cognitively intact and required extensive assistance from staff with activities of daily living (bed mobility, dressing, and transfers).

Hospital discharge instructions dated dated January 23, 2024, at 9:56 AM, revealed that "future medications" the resident was to be prescribed at the skilled nursing facility included digoxin (Lanoxin - used to treat a-fib) 125 micrograms (mcg) at bedtime, which staff were to "hold for a heart rate of less than 60 beats per minute and notify \ service if dose is held."

A physician order dated January 23, 2024, at 10:26 PM, was noted for digoxin 125 mcg by mouth in the evening for heart rate. However, this order did not include the any parameters or heart rate monitoring, as noted in the hospital discharge instructions to "hold for a heart rate of less than 60 beats per minute and notify \ service if dose is held."

Following the resident's admission to the skilled nursing facility, there was no physician order to obtain digoxin laboratory levels for monitoring the resident's blood levels of digoxin or to obtain the resident's heart rate in relationship to the resident's daily administration of digoxin. (Digoxin has a narrow therapeutic window, meaning there is a small margin between the benefit of its effects and toxicity; therefore, monitoring is an important part of its use. Monitoring of serum digoxin is usually carried out after any dose changes, suspected signs and symptoms of toxicity, or changes in therapy).

A review of progress notes entitled "Change in Condition Evaluation" dated March 1, 2024, at 4:28 PM, revealed that Employee 2, RN, Assistant Director of Nursing (ADON) noted that the resident was complaining of chest pain that started in the afternoon, and no vital signs were able to be obtained according to the nursing entry. The RN did not indicate why vital signs, including the resident's heart rate, could not be obtained in the progress note. Nursing staff instead, referenced the resident's vitals obtained earlier that morning, on March 1, 2024, and the day prior on February 29, 2024, and also on February 25, 2025, failing to provide a current assessment of the resident's status and change in condition.

The vital signs that were documented, from these past occassions were blood pressure (BP) 122/74 dated March 1, 2024 at 8:43 AM, heart rate (HR) 76 dated February 29, 2024 at 5:58 PM, respiration rate (RR) 18 dated February 25, 2024 at 1:53 PM, temperature 98 degrees Fahrenheit dated February 25, 2024 at 1:53 PM, pulse oximetry ([SPO2] peripheral oxygen saturation, measures the amount of oxygen bound to hemoglobin in tour red blood cells - normal ranges fall between 92%-100%) 88% on room air (RA) dated March 1, 2024 at 4:29 PM, blood glucose (BG) 128 dated March 1, 2024 at 11:38 AM.

Nursing noted on March 1, 2024, at 4:28 PM that the resident's family was requesting that the resident be seen in the emergency department (ED) for a cardiac evaluation. However, the physician assistant (PA) was aware of this request and present, and noted in progress notes, that the PA did not believe that a transfer to the ER, as the family requested, was warranted.

Nursing documentation dated March 1, 2024, at 4:29 PM noted that the resident's oxygen saturation on March 1, 2024, at 9:12 AM was 95 % on room air, and at 4:29 PM the resident's SPO2 was 88% on room air. The resident's described symptoms reported are "chest pain and tightness."

Nursing did not document any further assessment, including the resident's heart rate, or intervention, and noted "unable to determine" or "not applicable" (N/A) in documentation. Nursing noted that it was unknown if this (change in condition) had occurred in the past, the resident had no distress all day, but the resident's family arrived, and the resident complained of chest tightness. Family demanded the resident to be transferred to the ED and the PA was present and aware at 4:18 PM. Nursing noted on March 1, 2024, at 4:34 PM that emergency medical services (EMS) arrived and transported the resident to the ED.

A review of progress notes dated March 1, 2024, at 9:54 PM revealed that the resident was admitted to the hospital for digoxin toxicity (occurs when there is an excessive amount of the medication digoxin in the blood stream).

Hospital documentation dated March 1, 2024, from the ED revealed that the resident presented with nausea, vomiting and dizziness when he tried to ambulate (walk). At 7:30 PM the resident received Digifab (an antidote to treat a life-threatening overdose of digoxin) 120 milligrams (mg) intravenously (IV) for digoxin toxicity a level of 3.0 ng/ml (normal range 0.5-1.1 ng/ml The resident's heart rate was in the 50s (normal HR range is 60-100) in the ED.
On March 6, 2024, at 12:50 PM a surgical note revealed that the resident had a new DDD pacemaker (a type of dual-chamber pacemaker that senses and paces both atrial and ventricular events) implanted surgically.

During interview with Employee 2, RN ADON on March 21, 2024, at approximately 3:18 PM regarding the absence of a documented nursing assessment of the resident, including vital signs, Employee 2 ADON stated that she "just started the paperwork that day, she was not the nurse taking care of the resident." Employee 2 stated that she was the supervisor of the licensed practical nurse (LPN) taking care of this resident, and she documented the "Change of Condition" progress note on March 1, 2024, at 4:28 PM stating "vital signs were unable to be obtained", because EMS was already there to transport the resident to the ED. The ADON confirmed that the reported reason the resident's vitals were unable to be obtained was not documented in the resident's clinical record.

An interview with the Nursing Home Administrator (NHA) and DON on March 21, 2024, at approximately 1:00 PM confirmed that the facility failed to demonstrate that its licensed and professional nursing staff had accurately and completely documented this resident's change in condition in the resident's clinical record, whereas the record did not contain an accurate representation of the actual experiences of the resident and include enough information to provide a picture of the resident's change in condition, lacking current vital signs, including the resident's heart rate.



28 Pa. Code 211.5 (f) Medical records.

28 Pa. Code 211.12 (c)(d)(1)(5) Nursing services.




 Plan of Correction - To be completed: 04/16/2024

1.Resident CR1 is no longer a resident at the facility.
2. The Director of Nursing or designee will audit the 24-hour report for the past three days to verify all changes in condition have been assessed by a registered nurse and documented. Current residents will be reviewed during clinical meeting to verify an RN completed an assessment and vital signs were obtained for residents with changes in condition.
3. The Director of Nursing or designee will re-educate licensed nurses on the Change In Resident Condition Policy.
4. The Director of Nursing or designee will audit the 24-hour report during clinical meeting weekly for four weeks, monthly for two months thereafter, for resident changes in condition to verify documentation of an assessment was completed. These audits will be reviewed by the Quality Assurance Improvement Committee and changes will be made as needed.


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