Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on 9/18/25, Fresenius Medical Care-Sayre was found to have the following standard level deficiency that was determined to be in substantial compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness.
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Plan of Correction:
494.62(b)(9) STANDARD
Dialysis Emergency Equipment
Name - Component - 00
§494.62(b)(9) Condition for Coverage:
[(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. At a minimum, the policies and procedures must address the following:]
(9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available.
Observations:
Based on observations, review of policies and procedures, facility documentation, and staff interview, the facility failed to monitor the emergency cart timely and ensure that emergency supplies were not expired.
Findings include:
Review of the current policy entitled, "Emergency Medications, Equipment and Supplies," revealed that "the medications and supplies ...must be maintained at the facility for emergency use. The emergency cart must be checked monthly or after use for contents, expirations, cleanliness, and proper functioning of all equipment."
Observations of the facility's clinical area on 9/16/25 between approximately 10:00 AM and 11:45 AM revealed that 6 (six) Air life tri-flow 10 French suction catheters located in the emergency cart that expired on 9/5/25.
Review of facility documentation entitled, "Crash Cart Contents," dated July 2024, revealed that staff noted the above suction catheters were to expire on 9/5/25. There was no documentation after July 2024 (14 months prior to the survey) which indicated that staff checked the emergency cart.
Interview conducted with the Facility Administrator on 9/16/25 at approximately 12:00 PM confirmed the above findings.
Plan of Correction:On 10/1/2025, the Director of Operations (DO) verified on 9/16/2025, the 6 Air life tri-flow 10 French suction catheters located
in the emergency cart were discarded.
By 10/11/2025, the Facility Administrator (FA) and/or designee will review citations from the Statement of Deficiencies via a
staff meeting and/or huddles, elicit feedback, and reinforce the expectations and responsibilities of the facility Direct Patient Care
(DPC) staff on the following Policy and Procedure:
Emergency Medications, Equipment and Supplies
Emphasis will be placed on:
The emergency cart must be: checked monthly or after use for contents and expiration dates.
An itemized log must be kept indicating the contents and expiration dates of contents. Items approaching expiration must
be reordered and replaced prior to the actual expiration date.
Complete the monthly check in the approved electronic documentation system.
The in-service attendance forms document this activity and are available for review at the facility. Any employees not in
attendance will be educated on return to the facility.
For ongoing compliance, 10/13/2025, the FA and/or designee will conduct a monthly audit, to ensure all supplies in the
emergency cart are within expiration date and the cart is checked monthly per policy utilizing the Plan of Correction (POC) audit
tool times 3 months. Once compliance is sustained the Governing Body will then resume regularly scheduled clinic audits based
on the QAPI calendar. A summary of the monitoring will be reported in the monthly QAPI meeting to ensure compliance.
The FA is responsible to review, analyze and trend all data and Monitor/Audit results as related to this Plan of Correction prior to
presenting to the QAPI Committee monthly.
The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the
resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.
The FA/ Charge RN along with the QAPI Committee is responsible to provide oversight, review findings, and take actions as appropriate to monitor the continued implementation of the plan of correction. The root cause
analysis process is utilized to develop the Plan of Correction. The Plan of correction is reviewed in QAPI monthly.
The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues
identified by the Statement of Deficiency, is effective and is providing resolution of the issues.
The QAPI and Governing Body minutes, education and monitoring documentation, are available for review at the clinic.
Completion Date: 11/2/25
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on 9/18/25, Fresenius Medical Care-Sayre, was found have the following standard level deficiencies that were determined to be in substantial compliance with the requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT
Name - Component - 00
The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.
Observations:
Based on review of facility policy, observations, and staff interview, the facility failed to ensure supplies were not expired.
Findings include:
Review of the current policy entitled, "Emergency Medications, Equipment and Supplies," revealed that "the medications and supplies ...must be maintained at the facility for emergency use. The emergency cart must be checked monthly or after use for contents, expirations, cleanliness, and proper functioning of all equipment."
Review of the current policy entitled, "Storage of Supplies," revealed that "supplies must be rotated first in-first out to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date."
Observations of the facility''s clinical area during a flash tour on 9/16/25 between approximately 10:00 AM and 11:45 AM revealed the following:
6 (six) Air life tri-flow 10 French suction catheters located in the emergency cart that expired on 9/5/25.
Plan of Correction:On 10/1/2025, the Director of Operations (DO) verified on 9/16/2025, the 6 Air life tri-flow 10 French suction catheters located
in the emergency cart were discarded.
By 10/11/2025, the Facility Administrator (FA) and/or designee will review citations from the Statement of Deficiencies via a
staff meeting and/or huddles, elicit feedback, and reinforce the expectations and responsibilities of the facility Direct Patient Care
(DPC) staff on the following Policy and Procedure:
Emergency Medications, Equipment and Supplies
Storage of Supplies
Emphasis will be placed on:
Supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately
dispose of items that have reached the expiration date which includes but not limited to: 10 French suction catheters.
The in-service attendance forms document this activity and are available for review at the facility. Any employees not in
attendance will be educated on return to the facility.
For ongoing compliance, 10/13/2025, the FA and/or designee will conduct a monthly audit, to ensure all supplies in the
emergency cart are within expiration date per policy utilizing the Plan of Correction (POC) audit tool times 3 months. Once
compliance is sustained the Governing Body will then resume regularly scheduled clinic audits based on the QAPI calendar. A
summary of the monitoring will be reported in the monthly QAPI meeting to ensure compliance.
The FA is responsible to review, analyze and trend all data and Monitor/Audit results as related to this Plan of Correction prior to
presenting to the QAPI Committee monthly.
The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the
resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.
The FA/ Charge RN along with the QAPI Committee is responsible to provide oversight, review findings, and take actions as appropriate to monitor implementation of the plan of correction. The root cause
analysis process is utilized to develop the Plan of Correction. The Plan of correction is reviewed in QAPI monthly.
The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues
identified by the Statement of Deficiency, is effective and is providing resolution of the issues.
The QAPI and Governing Body minutes, education and monitoring documentation, are available for review at the clinic.
Completion Date: 11/2/25
494.80(a)(2) STANDARD
PA-ASSESS B/P, FLUID MANAGEMENT NEEDS
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
Blood pressure, and fluid management needs.
Observations:
Based on a review of Facility Policies, Medical Record reviews (MR) and staff interview it was determined the facility failed to ensure the policy for blood pressure assessment was followed for two (2) of three (3) in center dialysis MR reviewed (MR#1, MR#2).
Findings include:
A review of facility policy Determination of Blood Pressure on 9/17/25 at 3:30 PM states, the purpose of this procedure is to provide guidance for measuring the patient's blood pressure...Policy Incenter patients: Obtain blood pressure readings pre and post-dialysis sitting and standing (if applicable) and every 30 minutes or more during hemodialysis treatments as indicated."
Review of medical records on 9/17/25 from approximately 10:00 AM revealed the following:
MR#1: Admit date 10/24/19:
Treatment flow sheet dated 9/1/25 showed there was no blood pressure assessment from from 10:31 AM until 11:34 AM.
Treatment flow sheet dated 9/3/25 showed there was no blood pressure assessment from from 9:31 AM until 10:31 AM.
Treatment flow sheet dated 9/8/25 showed there was no blood pressure assessment from from 9:04 AM until 9:59 AM.
MR#2: Admit date 11/26/24:
Treatment flow sheet dated 9/11/25 showed there was no blood pressure assessment from from 10:57 AM until 12:38 AM.
Treatment flow sheet dated 9/13/25 showed there was no blood pressure assessment from from 12:31 PM until 1:32 PM.
An interview conducted with nurse manager on 9/17/25 at approximately 12:00 PM confirmed the above findings.
Plan of Correction:By 10/11/2025, the Clinical Manager (CM) and/or designee will review citations from the Statement of Deficiencies via a staff
meeting and/or huddles, elicit feedback, and reinforce the expectations and responsibilities of the facility Direct Patient Care
(DPC) staff on the following Policy and Procedure:
Patient Assessment and Monitoring
Emphasis will be placed on:
During treatment obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes
or per state regulations. Document machine parameters and safety checks every 30 or more often as needed but not to
exceed 45 minutes.
The in-service attendance forms document this activity and are available for review at the facility. Any employees not in
attendance will be educated on return to the facility.
For ongoing compliance, 10/13/2025, the CM and/or designee will conduct daily audits, 6 days a week on a minimum of 3
treatment sheets a day, to ensure the Blood pressure is documented with the safety check and is completed every 30 minutes not
to exceed 45 minutes per policy utilizing the Plan of Correction (POC) audit tool times 2 weeks. Once compliance is sustained
the Governing Body will then decrease the audit to once a week, on a minimum of 10 treatment sheets times 2 weeks,
then resume regularly scheduled clinic audits based on the QAPI calendar. A summary of the monitoring will be reported in the
monthly QAPI meeting to ensure compliance.
The CM is responsible to review, analyze and trend all data and Monitor/Audit results as related to this Plan of Correction prior
to presenting to the QAPI Committee monthly.
The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the
resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.
The FA/ Charge RN along with the QAPI Committee is responsible to provide oversight, review findings, and take actions as appropriate is responsible for monitoring the continued implementation of the plan of corrections. The root cause
analysis process is utilized to develop the Plan of Correction. The Plan of correction is reviewed in QAPI monthly.
The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues
identified by the Statement of Deficiency, is effective and is providing resolution of the issues.
The QAPI and Governing Body minutes, education and monitoring documentation, are available for review at the clinic.
Completion Date: 11/2/25
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based on review of facility policy, observations, and staff interview it was determined the medical director failed to ensure the policy for medication security was followed.
Findings include:
Review of a current facility policy entitled, "Medication Preparation and Administration," revealed that "the following steps must be taken for the (medication) securement: all medications will be kept in a locked cabinet except when in use."
Observation of the facility's clinical area on 9/16/25 between approximately 10:00 AM and 11:45 AM revealed that there were two (2) unlocked cabinets and one (1) unlocked drawer located by the nurse's station contained medications therein.
Observation of the facility's clinical area on 9/17/25 at 3:30 PM revealed that the above noted cabinets and drawer with medications therein continued to be unlocked.
During both observations, patients were in the clinical area and receiving dialysis.
An interview with the administrator on 9/17/25 at approximtely 3:45 PM confimed the above findings.
Plan of Correction:On 10/1/2025, the Facility Administrator (FA) verified all medications have been moved to a locked drawer/cabinet. The FA
verified locks for the medication drawers/cabinets have been installed on 10/1/2025.
By 10/11/2025, the CM and/or designee will review citations from the Statement of Deficiencies via a staff meeting and/or
huddle, elicit feedback, and reinforce the expectations and responsibilities of the facility Direct Patient Care (DPC) staff on the
following Policy and Procedure:
Medication Preparation and Administration
Emphasis will be placed on:
All medications will be kept in a locked cabinet except when in use.
The in-service attendance forms document this activity and are available for review at the facility. Any employees not in
attendance will be educated on return to the facility.
For ongoing compliance, 10/13/2025, the FA and/or designee will conduct daily audits 5 days a week, on a minimum of 2 shifts a
day, to ensure medications are kept secured at all times per policy utilizing the plan of correction (POC) audit tool 2 weeks. Once
compliance is sustained the Governing Body will decrease frequency to once a week times 2 weeks, then resume regularly
scheduled clinic audits based on the QAPI calendar. A summary of the monitoring will be reported in the monthly QAPI meeting
to ensure compliance.
The FA is responsible to review, analyze and trend all data and Monitor/Audit results as related to this Plan of Correction prior to
presenting to the QAPI Committee monthly.
The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the
resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.
The QAPI Committee is responsible to provide oversight, review findings, and take actions as appropriate. The root cause
analysis process is utilized to develop the Plan of Correction. The Plan of correction is reviewed in QAPI monthly.
The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues
identified by the Statement of Deficiency, is effective and is providing resolution of the issues.
The QAPI and Governing Body minutes, education and monitoring documentation, are available for review at the clinic.
Completion Date: 11/2/25
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