Fmc Shenandoah Valley

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 42725 Based on document review and interview, it was determined the facility failed to evaluate and update the emergency preparedness plan annually as directed by facility policy. Findings: Review of facility document, Guidelines for Emergency Preparedness, in the section titled, “Community Based Drill”, it partly reads: “... The Governing Body will: Review and update the Facility Specific Disaster Safety Plan initially and annually...”. In the section titled ,”Corporate Disaster Committee”, it reads: “The Corporate Disaster Committee will review and update disaster policies/procedures annually. The Governing Body at each facility will review the disaster policies annually”. A review of the facility’s emergency preparedness plan did not reveal a date of when the last evaluation and update occurred. EMP6 assisted with the review of the plan but was unaware of when the plan had last been evaluated. The governing body meeting minutes reviewed did not contain an entry indicating the emergency preparedness plan had been evaluated and updated.”

“Development of EP Policies and Procedures CFR(s): §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: 42725 Based on document review and interview, it was determined the facility failed to evaluate and update the emergency preparedness policies and procedures annually as directed by facility policy. Findings: Review of facility document, Guidelines for Emergency Preparedness, in the section titled “Corporate Disaster Committee”, it reads: “The Corporate Disaster Committee will review and update disaster policies/procedures annually. The Governing Body at each facility will review the disaster policies annually”. A review of the facility’s emergency preparedness plan did not reveal a date of when the last evaluation and update occurred for the policies and procedures. EMP6 assisted with the review of the plan but was unaware of when the policies and procedures had last been evaluated. The governing body meeting minutes reviewed did not contain an entry indicating the emergency preparedness policies and procedures were evaluated and updated.”

“Dialysis Emergency Equipment CFR(s): §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. This Standard is not met as evidenced by: 42725 Based on observation and document review, it was determined the facility failed to remove expired medications and supplies from the emergency cart and failed to ensure the emergency cart and evacuation box were locked. Findings: Review of facility document “Emergency Medications, Equipment and Supplies”, under the section “Emergency Cart”, it partly reads: “... The emergency cart must be: Locked when not in use; Checked monthly or after use for contents, 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...”. Under the section “Emergency Evacuation Box”, it partly reads: “An emergency evacuation box must: ... Be locked when not in use...”. The policy was published 7/7/2025. On August 18, 2025, the state agency (SA) reviewed the contents of the facility’s emergency cart and evacuation box. Both, the cart and box, were found unlocked. The following medications and supplies were discovered: One (1) set of adult automated external defibrillator (AED) pads - expired 6/24/25 Two (2) vials of solu-medrol 125mg/2mL - expired 07/2025 One (1) vial of adrenalin 1mg/1mL - expired 01/25 Three (3) vials of adrenalin 1mg/1mL - expired 06/25 Eight (8) adult standard nasal cannula tubing - five (5) expired 11/21/24 and three (3) expired 5/19/24 Seven (7) bags of sodium chloride 1.9% - expired 08/24 Six (6) “C” batteries - use by “Mar 2025” One (1) 17G fistula needle - expired 5/31/25 Two (2) vials of heparin 30,000U/30mL - expired 5/1/25 The SA informed employee (EMP) 1 of the expired medications, expired supplies, and finding both, the cart and box, unlocked at the time of the review. EMP1 acknowledged that any expired medications or supplies should be discarded and both, the cart and box, should be locked when not in use.”

“Development of Communication Plan CFR(s): §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This Standard is not met as evidenced by: 42725 Based on document review and interview, it was determined the facility failed to evaluate and update the communication plan as directed by facility policy. Findings: Review of facility document, Guidelines for Emergency Preparedness, in the section titled, “Community Based Drill”, it partly reads: “... The Governing Body will: Review and update the Facility Specific Disaster Safety Plan initially and annually...”. In the section titled ,”Corporate Disaster Committee”, it reads: “The Corporate Disaster Committee will review and update disaster policies/procedures annually. The Governing Body at each facility will review the disaster policies annually”. A review of the facility’s emergency preparedness plan, which includes a communication plan, did not reveal a date of when the last evaluation and update occurred. EMP6 assisted with the review of the plan but was unaware of when the plan had last been evaluated. The governing body meeting minutes reviewed did not contain an entry indicating the emergency preparedness plan, to include the communication plan, had been evaluated and updated.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 42725 Based on document review and interview, it was determined the facility failed to evaluate and update the training, testing, and orientation program within the plan as directed by facility policy. Findings: Review of facility document, Guidelines for Emergency Preparedness, in the section titled ,”Corporate Disaster Committee”, it reads: “The Corporate Disaster Committee will review and update disaster policies/procedures annually. The Governing Body at each facility will review the disaster policies annually”. A review of the facility’s emergency preparedness plan, which includes training, testing, and orientation, did not reveal a date of when the last evaluation and update occurred. EMP6 assisted with the review of the plan but was unaware of when the plan had last been evaluated. The governing body meeting minutes reviewed did not contain an entry indicating the emergency preparedness plan, to include training, testing, and orientation, had been evaluated and updated.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 42725 Based on three (3) infection control observations and document review, it was determined the facility failed to clean and disinfect non-disposable equipment prior to returning the equipment to the clean area. Findings: Review of facility document, Cleaning and Disinfecting the Dialysis Station, under the heading “General Cleaning” reads, in part: “The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis station... must be disinfected ... before being removed from the dialysis station”. During observations on August 20, 2025 from approximately 10:00 AM to 11:15 AM, the SA observed the following: EMP8 and EMP11 use a hoyer lift to assist in moving a patient from a wheelchair to the recliner. After using the lift, EMP11 returned it to the clean area without cleaning or disinfecting it. After using a stethoscope to assess a patient, EMP11 put the stethoscope around their neck. EMP11 then left that station and laid the stethoscope down on the counter. After another patient entered the treatment floor, the stethoscope was picked back up for use. The SA did not observe any cleaning or disinfection of the stethoscope between uses.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 42725 Based on observations and document review, it was determined the facility staff failed to follow facility policy and procedure for cleaning and disinfection of the dialysis station for three (3) of four (4) observations. Findings: Review of facility document, Cleaning and Disinfecting the Dialysis Station, under the heading “Procedure”, it partly reads: “... 3. Use a cloth wetted with 1:100 bleach solution or EPA-approved disinfectant to clean and disinfect the dialysis stations (chair/bed, tables, machine, ...) 4. Clean all surfaces... 5. ... While wiping, remember to wipe all surfaces of the machine...”. During the treatment floor observations on August 19, 2025 at 1:20 PM, EMP16 was observed cleaning a dialysis station. The prime waste container was not removed for cleaning and disinfection. EMP16 did not wipe underneath the side trays of the chair. On August 20, 2025 between 9:30 AM and 10:30 AM, the SA observed EMP8 cleaning a station. EMP8 did not remove the prime waste container for cleaning and disinfecting. The area underneath both side trays on chair were not wiped. EMP7 was observed cleaning a dialysis station. EMP7 did not wipe underneath the side trays of the chair and did not remove the prime waste container for cleaning and disinfection.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [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 This Standard is not met as evidenced by: 42725 Based on observation and document review, it was determined the facility failed to ensure expired medications were removed from the treatment area, medication vials were properly labeled upon opening, and opened vials were discarded according to the specified timeframe. Findings: Review of facility document, Medication Preparation and Administration, under the heading “Labeling Vials”, it reads: “When preparing medications, if the vial is not used immediately in it’s entirety, the nurse or PCT (Patient Care Technician) (If allowed by state regulations) must place the date and time the medication was opened on the medication label with their initials. Note: To ensure all open vials are properly marked, the nurse must never walk away from an opened multi-dose vial without writing the date and time the vial was opened. Label any open multi-dose vial that is not used immediately and store vial accordingly...”. Under the heading “Monitoring Expired Medications”, it partly reads: “Expiration dates for all stored medications are to be monitored on a monthly bases. Expired medications are to be discarded... Any open vials must be discarded 28 days after opening or per manufacturer’s expiration date...”. A review of the medication storage and preparation area on August 18, 2025, revealed the following: One (1) bottle of nitroglycerin 0.4mg tablets - expired 7/2025 Two (2) vials of solu-medrol 125mg/2mL - expired 7/2025 One (1) tube of glutose 15g oral gel - expired 6/2025 Twenty-five (25) vials of tazicef (ceftazidime) 1g/vial - expired 8/1/25 Three (3) bottles of calcitriol 0.25mcg tablets - expired 5/25 One (1) tube of gentamicin sulfate cream 0.1% - expired 1/25 Seven (7) syringes of Flublock age 65 and older - expired 4/2025 One (1) multi-dose vial of tuberculin - opened on 4/15/25 One (1) multi-dose vial of heparin 30,000U/30mL - opened with no date or time label”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 42725 Based on observations, interview and document review, it was determined the facility staff failed to aseptically conduct exit site care for two (2) of two (2) patients with a central venous catheter site. Findings: Review of facility document, Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer, under the heading “Preparing the Catheter: Dressing Change”, it partly reads: “... the catheter exit site care and dressing replacement must be completed prior to accessing the bloodstream...”. On August 20, 2025 between 10:30 AM and 11:15 AM, the SA observed CVC exit site care on two patients. EMP8 cleansed the area around the CVC exit site with antiseptic for the first patient. While the site was drying, the patient’s clothing moved and was partly laying on the cleansed area. EMP8 did not recleanse the area before applying a new dressing. EMP9 provided CVC exit site care on the second patient. After the exit site was cleansed, the patient’s clothing moved and touched the cleansed area. The exit site was not recleansed prior to applying a new dressing. The SA requested a facility document outlining the procedure for providing CVC exit site care. The aforementioned document was provided. EMP1 confirmed that a patient’s clothing should be secured and out of the way so there is no risk of it touching an exposed, cleansed CVC exit site.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 42725 Based on document review and interview, it was determined the facility failed to obtain pre-treatment assessment data, namely a standing blood pressure, for two (2) of four (4) records sampled (MR1 and MR4). Findings: Review of facility document, Patient Assessment and Monitoring, under the heading “Pre-Treatment”, it partly reads: “Follow the steps below for obtaining pre-treatment assessment data: ... Blood Pressure. Record blood pressure. Verify: Systolic blood pressures greater than 180 mm/Hg and / or diastolic blood pressures greater than 100 mm/Hg. Systolic blood pressures less than or equal to 100 mm/Hg systolic during treatment...”. Review of facility document, Nursing Supervision and Delegation, under the heading “Guidelines for PCT/LPN/LVN/RN: When to Refer a Patient to the Team Leader/Charge Nurse for Further Assessment: ... Blood Pressure. A systolic blood pressure greater than 180 mm/Hg and / or diastolic blood pressure greater than 100 mm/Hg at any time before, during, or after the treatment...”. MR1 8/6/2025, 8/8/25, 8/11/25, 8/15/25, and 8/18/25 - The pre-treatment nursing evaluation indicated the patient arrived ambulatory. Under the pre-dialysis vitals and evaluation section of the flowsheets, there was no standing blood pressure documented. There was documentation to indicate why a pre-treatment blood pressure reading was not obtained. MR4 8/6/25, 8/8/25, 8/13/25, and 8/18/25 - The pre-treatment nursing evaluation indicated the patient arrived ambulatory. Under the pre-dialysis vitals and evaluation section of the flowsheets, there was no standing blood pressure documented. There was documentation to indicate why a pre-treatment blood pressure reading was not obtained. Interview on August 20, 2025 at 12:15 PM, EMP1 indicated that when the patients get to their station and get settled, “sometimes they don’t want to stand back up” for a blood pressure reading. EMP1 acknowledged that a standing blood pressure reading should be obtained prior to the initiation of treatment. If a reading cannot be obtained, there should be a reason documented.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 42725 Based on document review and interview, it was determined the facility failed to follow the dialysis prescription for two (2) of four (4) records sampled (MR1 and MR4). Findings: Review of facility document, Patient Assessment and Monitoring, under the heading “During Treatment”, it partly reads: “... Machine Parameters and Extracorporeal Circuit. Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered...”. The document was published 05/01/2023. MR1 The prescribed blood flow rate (BFR) is 350 and the dialysate flow rate (DFR) is autoflow 1.5 which equates to 525. The duration of treatment is 2 hours and 30 minutes. 8/6/2025 - The DFR ran at 600 for the duration of treatment. 8/8/2025 - The BFR ran at 300 and the DFR ran at 500 for the duration of treatment. 8/11/2025 - The BFR ran at 375 and the DFR ran at 600 for approximately 1 hour and 19 minutes of the treatment. 8/13/2025 - The BFR ranged from 325 to 375 and the DFR ranged from 500 to 800 during the treatment. 8/15/2025 - The BFR ranged from 265 to 350 and the DFR ran at 500 for approximately 1 hour and 28 minutes. 8/18/2025 - The BFR ranged from 300 to 350 and the DFR ran from 500 to 600 during the treatment. There was no documentation indicating the reason for the variance. MR4 The prescribed BFR is 350 and DFR is autoflow 2.0 which equates to 700. The duration of treatment is 4 hours. 8/18/2025 - The BFR ran at 250 and the DFR ran at 500 for the duration of the treatment. There was no documentation indicating the reason for the variance. Interview on August 20, 2025 at 12:15 PM, EMP1 indicated if there is a variance in the prescribed flow rate (blood and/or dialysate) during treatment, a reason should be documented.”