Initial Comments:Based on the findings of an unannounced, onsite Medicare complaint investigation survey completed March 16, 2026, FMC Dialysis Services of the Capital Area was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of End-Stage Renal Disease (ESRD) Services. Plan of Correction:
494.30(a)(1) STANDARD IC-WEAR GLOVES/HAND HYGIENE Name - Component - 00 Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.
Observations:
Based on observations (OBS) review of policies/procedures and interview with Facility Administrator and Director of Operations (EMP) the clinic failed to ensure staff performed hand hygiene between each patient encounter and after removing gloves for two (2) of two (2) observations made OBS #1 and OBS #2.
Findings: OBS #1 completed March 16, 2026 at 9:45 AM showed PCT #1 leaving station #2 and walking to the centrally located trash can, removing her gloves and walking to station #1 and donning new gloves without performing hand hygiene. OBS#2 completed March 16, 2026 at 10:15 AM showed PCT #1 escorting a patient to station #17. Once the patient had been seated in the chair the PCT donned a pair of gloves then walked away from the station, removed the gloves to obtain supplies from a central location. PCT #1 returned to station #17 and donned new gloves without performing hand hygiene. Review of policy "Hand Hygiene" completed March 16, 2026 at approximately 12:30 PM revealed: section: Policy, "Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60 - 90 % alcohol content... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water. Before and after direct contact with patients. immediately after removing gloves". Interviews with EMP #1 and EMP #2 completed March 16, 2026 at approximately 2:00 PM confirmed the above findings.
Plan of Correction:FMC DIALYSIS SERVICES OF THE CAPITAL AREA Plan of Correction for Complaint Provider Identification Number: 39-2672 Date of Survey: 3/16/26 V113 IC-Wear gloves/hand hygiene By 4/4/26, 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: Hand Hygiene Emphasis will be placed on: Ensuring all staff performs hand hygiene to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. Performing hand hygiene between donning and doffing of gloves. For ongoing compliance, effective 4/6/26, the CM or designee will conduct daily audits on all shifts to ensure staff adherence to hand hygiene as per policy and procedure for 2 weeks. A POC specific auditing tool will be used for the audits. Once 100% compliance is sustained, the Governing Body will decrease frequency to weekly for 4 weeks then resume regularly scheduled audits based on QAPI calendar. Monitoring will be done through the Clinic audit checklist. The Medical Director will review the results of audits each month at the QAPI Committee meeting monthly. The Clinical Manager 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: 4/30/26
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 reviews of policies/procedures, medical records (MR) and interview with staff (EMP) the clinic failed to ensure staff completed patient safety checks every thirty (30) minutes or more often as needed for four (4) of four (4) records reviewed. MR #1- 4.
Findings:
Review of policy: Patient Assessment and Monitoring completed March 16, 2026 at approximately 12:30 PM revealed: pg.4. section: During Treatment, "Obtain blood pressure and pulse rate every 30 minutes or more as needed by 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 or per state regulations".
Review of medical records completed March 16, 2026 between approximately 11:00 AM and 1:00PM showed:
MR #1, Admit date: 11/19/2025, Estimated Dry Weight (EDW): 73kg (161 lbs.), Dialyzer: FX CorAL 80, Dialysate: 3.0 K (Potassium), 2.5 Ca (Calcium), 1.0 Mg (Magnesium) , 100 Dextrose (Sugar liquid). Every M-W-F for 3 hours and 30 minutes.
On 3/13/26, treatment records showed the staff completed a safety check at 12:30 PM. The next documented check is completed at 1:31 PM. (61 minutes between safety checks).
On 3/6/26, records showed a staff completed a safety check at 12:00 PM, the next check is documented at 1:07 PM. (67 minutes between checks).
On 2/27/26 records showed the staff completed safety check at 10:20 AM, the next check is documented at 11:06 AM. (46 minutes between checks).
MR #2, Admit date: 4/16/2025, EDW: 41kg (90 lb.), Dialyzer: FX CorAL 60, Dialysate: 3.0 K, 2.5 Ca, 1.0 Mg, 100 Dextrose, Every M-W-F for 3hours and 15 minutes.
On 3/9/26, records showed the staff completed a safety check at 3:34 PM, the next check is documented at 5:21 PM. (1hour and 46 minutes between checks).
On 3/2/26, records showed the staff completed safety check at 4:31 PM, the next check is documented at 5:21 PM. (50 minutes between checks).
On 2/26/26, records showed the staff completed safety check at 1:32 PM, the next check is documented at 2:31 PM. (59 minutes between checks).
MR#3, Admit date: 9/8/22, EDW: 55 kg (121 lb.), Dialyzer: FX CorAL 80, Dialysate: 2.0 K, 2.5 Ca, 1.0 Mg, 100 Dextrose, Every T-Th-S for 3hours and 15 minutes.
On 3/10/26, records showed the staff completed safety check at 12:37 PM, the next check is documented at 1:32 PM. (55 minutes between checks).
On 3/5/26, records showed the staff completed safety check at 12:41 PM, the next check is documented at 1:34 PM. (53 minutes between checks).
On 3/3/26, records showed the staff completed safety check at 2:18 PM, the next check is documented at 3:44 PM. ( 1hour and 26 minutes between checks).
MR#4, Admit date: 4/8/25, EDW:160 kg (352 lbs.), Dialyzer: FX CorAL 100, Dialysate: 2.0 K, 2.5 Ca, 1.0 Mg, 100 Dextrose, Every M-W-F for 4 hours.
On 3/13/26, records showed the staff completed safety check at 10:05 AM, the next check is documented at 11:04 AM. (59 minutes between checks).
On 3/11/26, records showed the staff completed safety check at 8:19 AM, the next check is documented at 9:07 AM. (48 minutes between checks).
On 3/6/26, records showed the staff completed safety check at 8:32 AM, the next check is documented at 9:32 AM. (60 minutes between checks).
On 3/2/26, records showed the staff completed safety check at 9:05 AM, the next check is documented at 10:30 AM. ( 1 hour and 25 minutes between checks).
Interviews with EMP #1 and EMP #2 completed March 16, 2026 at approximately 2:00 PM confirmed the above findings.
Plan of Correction:FMC DIALYSIS SERVICES OF THE CAPITAL AREA Plan of Correction for Complaint Provider Identification Number: 39-2672 Date of Survey: 3/16/26 V715 MD resp-Ensure all adhere to P&P By 4/4/26, the Director of Operations (DO) and Clinic Manager (CM) is scheduled to meet with the Medical Director to discuss Medical Director Responsibilities as defined in the Conditions for Coverage. Emphasis will be placed on the Medical Director responsibilities to ensure staff adherence to policy as it relates particularly to the finding of the SOD. The policy to be reviewed with the Medical Director are: Patient Assessment and Monitoring Documentation of the meeting with the Medical Director is on file at the facility. The Medical Director will be informed at the meeting that the CM and/or designee provided re-education to the direct patient care (DPC) staff on the policies. Emphasis was placed on: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes. Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes. For ongoing compliance, effective 4/6/26, the CM or designee will conduct daily audits of 10% of patient treatment sheets utilizing a developed Plan of Correction Auditing tool to ensure adherence to policy and procedure for 2 weeks. When 100% compliance is achieved, audits will continue weekly for 4 weeks. Once compliance is sustained, the Governing Body will then resume regularly scheduled audits based on QAPI calendar. Monitoring will be done through the medical record audit checklist. The Medical Director will review the results of audits each month at the QAPI Committee meeting monthly. The Clinical Manager 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.
|