Initial Comments:
Based upon the findings of an unannounced onsite Medicare recertification survey conducted August 18, 2025 through August 20, 2025, Lewistown Dialysis Center, was found to be in 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.
Plan of Correction:
Initial Comments:
Based upon the findings of an unannounced onsite Medicare recertification survey conducted August 18, 2025 through August 20, 2025, Lewistown Dialysis Center, 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 Suppliers 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 review of facility policy/procedure, observations of hemodialysis (HD) treatment area during patient care and interview with facility administrator (EMP# 1), it was determined the facility failed to ensure staff performed hand hygiene at the appropriate times during ten (10) of ten (10) treatment floor observations (TFO). (TFO #1, TFO #2, TFO #3, TFO #4 , TFO #5, TFO #6, TFO #7, TFO #8, TFO #9 and TFO #10)
Findings Included:
Review of 'INFECTION CONTROL FOR DIALYSIS FACILITIES' policy/procedure on 8/19/25 at approximately 11:00 a.m. revealed, "HAND HYGIENE: 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene...a. upon entering and exiting the patient treatment area...b. prior to gloving and immediately after removal of gloves...after patient and dialysis delivery system contact...f. between patients even if the contact is casual..."
HD Treatment area observation conducted on 8/1825 between approximately 11:00 a.m. and 2:36 p.m., on 8/19/25 between approximately 11:26 a.m. and 12:44 p.m., and on 8/20/25 at 9:48 a.m. revealed the following:
Treatment Floor Observation (TFO) #1: On 8/18/25 at approximately 10:37 a.m. surveyor observed employee# 10 put one glove on, touch dialysis machine at station #19, then walk over and touch the dialysis machine at station #20 and then walk over and touch the dialysis machine #21. Employee failed to change gloves and perform hand hygiene between each dialysis station and prior to touching the dialysis machine at each dialysis station.
TFO #2: On 8/18/25 at approximately 11:40 a.m. surveyor observed employee #10 removed gloves and failed to perform hand hygiene prior to performing additional tasks in the treatment floor.
TFO #3: On 8/18/25 at approximately 11:48 a.m. surveyor observed employee #11 removed gloves and failed to perform hand hygiene prior to performing additional tasks in the treatment floor.
TFO #4: On 8/18/25 at approximately 11:53 a.m. surveyor observed employee #6 put on gloves, removed a sticky note from dialysis machine at station #12, then walk over to remove a sticky note from dialysis machine at station #13 and then walk over to remove a sticky note from dialysis machine at station #14. Employee failed to change gloves and perform hand hygiene between each dialysis station and prior to touching the sticky note on the dialysis machines at each dialysis station.
TFO #5: On 8/18/25 at approximately 12:06 p.m. surveyor observed employee #2 removed gloves and failed to perform hand hygiene prior to performing additional tasks in the treatment floor.
TFO #6: On 8/19/25 at approximately 10:48 a.m. surveyor observed employee #6 removed gloves and failed to perform hand hygiene prior to performing additional tasks in the treatment floor.
TFO #7: On 8/19/25 at approximately 11:03 a.m. surveyor observed employee #16 removed gloves and failed to perform hand hygiene prior to performing additional tasks in the treatment floor.
TFO #8: On 8/19/25 at approximately 11:05 a.m. surveyor observed employee #16 exit the treatment floor without performing hand hygiene.
TFO #9: On 8/19/25 at approximately 11:29 a.m. surveyor observed employee #16 removed gloves and failed to perform hand hygiene prior to performing additional tasks in the treatment floor.
TFO #10: On 8/19/25 at approximately 11:31 a.m. surveyor observed employee #6 removed gloves and failed to perform hand hygiene prior to performing additional tasks in the treatment floor.
An interview with the facility administrator on 8/20/22 at approximately 1: 00 p.m. confirmed the above findings and confirmed the above policy as current.
Plan of Correction:V 0113 The Facility Administrator or designee held mandatory in-service(s) for all clinical teammates starting on 8/27/2025. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with the emphasis on but not limited to: [Hand Hygiene]: 1) All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene... a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves ... d. after patient and dialysis delivery system contact... f. between patients even if the contact is casual. [Disposable Gloves]: 1) Disposable gloves will be worn when caring for the patient or touching the patient's equipment at the dialysis station. 2) Gloves should be changed when ... After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient's dialysis delivery system. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. The Facility Administrator or designee will conduct infection control audits to verify teammates performan hand hygiene with glove wearing and glove changing per policy and procedure: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.30(b)(2) STANDARD IC-ASEPTIC TECHNIQUES FOR IV MEDS Name - Component - 00 [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and
Observations:
Based on review of facility policy/procedure, observations of hemodialysis (HD) treatment area during patient care and interview with facility administrator (EMP# 1), it was determined the facility failed to ensure medications were labeled appropriately for six (6) of six (6) medication observations. (Medication Observation #1, Medication Observation #2, Medication Observation #3, Medication Observation #4, Medication Observation #5 and Medication Observation #6)
Findings Included:
Review of 'PREPARATION AND ADMINISTRATION OF PARENTERAL MEDICATIONS (NON-ESA-NON-PARSABIV' policy/procedure on 8/19/25 at approximately 12:00 P.m. revealed, "Procedure:...16. Label the syringe with the patient's name, name of the prescribed medication, dose, date, time and initials of licensed teammate preparing the dose. Preprinted labels may be used if available..."
HD Treatment area observation conducted on 8/1825 between approximately 11:00 a.m. and 2:36 p.m., on 8/19/25 between approximately 11:26 a.m. and 12:44 p.m., and on 8/20/25 at 9:48 a.m. revealed the following:
Medication Observation #1: For patient #23 the following drawn up medication syringes were observed on the medication section - One (1) 10 mL (milliliter) syringe with Heparin Pork 2,600 units loading dose- the section on the label 'time' was left blank and section 'initials' was left blank. - One (1) 10 mL (milliliter) syringe with Heparin Pork 2,100 units hourly dose- the section on the label 'time' was left blank and section 'initials' was left blank.
Medication Observation #2: For patient #24 the following drawn up medication syringes were observed on the medication section - One (1) 10 mL (milliliter) syringe with Heparin Pork 2,000 units loading dose- the section on the label 'time' was left blank and section 'initials' was left blank. - One (1) 10 mL (milliliter) syringe with Heparin Pork 2,200 units hourly dose- the section on the label 'time' was left blank and section 'initials' was left blank.
Medication Observation #3: For patient #25 the following drawn up medication syringes were observed on the medication section - One (1) 10 mL (milliliter) syringe with Heparin Pork 3,000 units loading dose- the section on the label 'time' was left blank and section 'initials' was left blank. - One (1) 10 mL (milliliter) syringe with Heparin Pork 4,500 units hourly dose- the section on the label 'time' was left blank and section 'initials' was left blank.
Medication Observation #4: For patient #26 the following drawn up medication syringes were observed on the medication section - One (1) 10 mL (milliliter) syringe with Heparin Pork 1,600 units loading dose- the section on the label 'time' was left blank and section 'initials' was left blank. - One (1) 10 mL (milliliter) syringe with Heparin Pork 2,400 units hourly dose- the section on the label 'time' was left blank and section 'initials' was left blank.
Medication Observation #5: For patient #27 the following drawn up medication syringes were observed on the medication section - One (1) 10 mL (milliliter) syringe with Heparin Pork 2,600 units loading dose- the section on the label 'time' was left blank and section 'initials' was left blank.
Medication Observation #6: For patient #8 the following drawn up medication syringes were observed on the medication section - One (1) 10 mL (milliliter) syringe with Heparin Pork 2,600 units loading dose- the section on the label 'time' was left blank and section 'initials' was left blank.
An interview with the facility administrator on 8/20/22 at approximately 1: 00 p.m. confirmed the above findings and confirmed the above policy as current.
Plan of Correction:V 0146 The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 08/27/25. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-06-01 "Medication Policy" with emphasis on but not limited to: 1) Medication preparation should be performed only for the current shift of patients. 2) If medications are prepared and administered immediately, by the same licensed nurse teammate, the medications do not need to be labeled. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of the teammate preparing the medication. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. Manager of Clinical Services (MCS) provided support and education to teammates immediately after the finding. Medication labels were reprinted and labeled properly, including teammate's initials and preparation time per policy. The Facility Administrator or designee will conduct observational audits for medication preparation and administration to verify syringes are properly labeled per policy: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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