Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed 9/10/25, Meadville Community Health Center was found not to be in compliance with the requirements of 42 CFR, Part 491.12, Subpart A, Conditions for Certification: Rural Health Clinics - Emergency Preparedness.
Plan of Correction:
491.12(b)(1) STANDARD
Policies for Evac. and Primary/Alt. Comm.
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§403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2)
[(b) Policies and procedures. The [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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:]
[(3) or (1), (2), (6)] Safe evacuation from the [facility], which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
*[For RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):]
Safe evacuation from the [RNHCI or ASC or REHs] which includes the following:
(i) Consideration of care needs of evacuees.
(ii) Staff responsibilities.
(iii) Transportation.
(iv) Identification of evacuation location(s).
(v) Primary and alternate means of communication with external sources of assistance.
* [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):]
Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients.
* [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients.
Observations:
Based on facility observations (OBS) and staff (EMP) interview, the facility failed to ensure safety checks were documented and completed related to fire extinguisher tank fill levels being sufficient in case of an emergency for four (4) of four (4) observations. (OBS 1-4)
Findings included:
OBS 1 on 9/9/25 at approximately 10:50 am: fire extinguisher located on the "yellow" side of the facility, by exam room #12; last documented facility check occurred 6/25.
OBS 2 on 9/9/25 at approximately 10:55 am: fire extinguisher located on the "yellow" side of the facility, by exam room #10; last documented facility check occurred 6/25
OBS 3 on 9/9/25 at approximately 11:05 am: fire extinguisher located on the "yellow" side fo facility, by exam room #7; last documented facility check occurred 6/25
OBS 4 on 9/9/25 at approximately 12:10 pm: fire extinguisher located on the "green" side of the facility, administrative assistant "check-in" office; last documented facility check occurred 6/25
Interview with facility manager and medical practice manager on 9/9/25 at approximately 3:45 p.m. confirmed findings. Email, received on 9/10/25 at approximately 11:30 am, from medicatl practice manager stating "Facility Engineering does not currently have a policy/procedure in place for the extinguishers." A facility representative will be responsible for them moving forward.
Plan of Correction:The property manager within the facilities engineering department will validate the punching of the inspection tag and the inspectors record sheet for six months to ensure that maintenance, inspection, and testing is completed.
A Portable Fire Extinguisher Inspection, Maintenance, and Testing Policy has been established. RHC clinic staff will verify monthly that the maintenance department has completed the required inspections.
Subject: Portable Fire Extinguisher Inspection, Maintenance, and Testing
Purpose: To define the requirements for inspection, maintenance and testing of all portable fire extinguishers in all MMC occupied locations.
Standard: NFPA 10
Policy: This policy applies to all buildings under the control of the Meadville Medical Center (MMC). MMC Facility Engineering Department is responsible for the inspection, maintenance and testing of all portable fire extinguishers in MMC occupied facilities.
Procedure:
1.Selection and Installation:
- Extinguishers must be of the type required for the class of fire anticipated in the area.
- Extinguishers removed from service will be replaced with an extinguisher that meets or exceeds code requirements.
- Maximum travel distance to extinguishers must not exceed 75 feet in any direction or 50 feet where flammable liquids are present.
- All extinguishers will be located so they are readily available when needed.
- Cabinets housing fire extinguishers must not be locked except where malicious use of the extinguisher is anticipated. Cabinets locked for this reason must include means of emergency access.
- Extinguishers must be installed as follow.
- Extinguishers less than or equal to 40 pounds in weight must be installed so that the top of the extinguisher is not more than five feet (60 inches) above the floor.
- Extinguishers more than 40 pounds (except wheeled type) must be installed so the top of the extinguisher is not more than three- and one-half feet (42 inches) above the floor.
- In no instance will the bottom of the extinguisher be less than 4 inches above the floor.
2.Maintenance, Testing and Inspection:
- The record shall consist of punching the inspection tag and in the inspector's record sheet.
- Extinguishers must be subjected to "annual certifications" not more than one year apart. The extinguisher's seal (color or year) shall indicate completion of the annual certification.
- Annual certifications shall be conducted by a qualified third-party entity.
- Certification shall include:
- Checking the extinguisher's internal components.
- Ensuring that it is fully charged and this it will discharge properly in cased of an emergency.
- Refilling or replacing the extinguisher if necessary.
- Extinguishers must be subjected to "monthly inspections" not more than 30 days apart.
- Inspections shall be performed by Facility Engineering personnel or other qualified third-party entity identified by the Facility Engineering department to perform such inspections.
- Inspections shall include:
- The pressure gauge is within the recommended range.
- The pin is intact, and the tamper seal is unbroken.
- There are not visible signs of physical damage or corrosion.
- The fire extinguisher is in its designated location and accessible.
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed 9/10/25, Meadville Community Health Center was found not to be in compliance with the requirements of 42 CFR, Part 405, Subpart X and 42 CFR, Part 491.1 - 491.12, Subpart A, Conditions for Certification: Rural Health Clinics.
Plan of Correction:
491.8(a)(5) and (6) STANDARD
STAFFING AND STAFF RESPONSIBILITIES
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491.8(a) Staffing.
(5) The staff is sufficient to provide the services essential to the operation of the clinic . . .
(6) A physician, nurse practitioner, physician assistant, certified nurse-midwife, clinical social worker, clinical psychologist, marriage and family therapist, or a mental health counselor is available to furnish patient care services at all times the clinic . . . operates. . . .
Observations:
Based on review of personnel files (PF), facility policy and interview with staff (EMP), the facility failed to provide sufficient documentation and failed to follow facility policy and procedure regarding staff qualifications/testing/training to provide first responder type emergency services to individuals in the clinic that could possibly experience a medical emergency.
Findings included:
Review of facility policy and procedure on 9/10/25 at approximately 9:30 am revealed: "HUMAN RESOURCES POLICY HR-215... SUBJECT: CARDIOPULMONARY RESUSCITATION TRAINING FOR STAFF (CPR). ... POLICY: All Meadville Medical Center (MMC) staff that deliver direct patient care have a current CPR card. Staff who deliver "direct patient care" are defined as those whose functions and responsibilities are predominantly for or with the patients..."
Review of PF's on 9/9/25 from approximately 2:10 pm to 3:10 pm and on 9/10/25 from approximately 10:00 am to 11:00 am revealed:
PF#1 CPR basic life support (BLS) last updated: 1/20/23 recommended renewal date 1/31/25
PF#3 CPR basic life support (BLS) last updated: 4/11/23 recommended renewal date 4/30/25
Interview with clinic manager and medical practice manager on 9/9/25 at approximately 3:30 p.m., and email confirmation from medical practice manager received on 9/10/25 at approximately 11:30 am confirmed the above findings. "Both employees were actively practicing and seeing patients at the facility after the cards expired."
Plan of Correction:To ensure compliance with Human Resources Policy HR-215 regarding Cardiopulmonary Resuscitation (CPR) Training for Staff, all providers will be enrolled in the RQI program and are required to complete the training on a quarterly basis.
The Organization Development Department will monitor compliance. Any staff members found to be out of compliance may be removed from the schedule and will not be permitted to work until the training is completed.
PF#1 - enrolled in RQI and completed.
PF#3 - enrolled in RQI and will complete prior to returning to work from maternity leave.
If an employee's CPR certification expires during FMLA or maternity leave, they will be required to complete the RQI training prior to returning to work.
491.9(b)(3)(iii) STANDARD
PROVISION OF SERVICES
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491.9(b) Patient care policies.
(3) The policies include:
(iii) Rules for the storage, handling, and administration of drugs and biologicals.
Observations:
Based on review of policies/procedures, observations and interview with the clinic administrator the clinic failed to ensure the disposal of expired drugs and/or medical supplies for one (1) of one (1) observations made. OBS #1.
Findings include:
Review of policy and procedure "TITLE: 3.2 n MULTI-DOSE VIALS AND SINGLE-DOSE CONTAINERS... To establish handling procedure for multiple dose vials and singgle dose parenteral containers. ... DEFINITIONS AND TERMS: ... Expiration date reflects the shelf life of a product when stored according to FDA-approved labeling in its original unopened container... POLICY: Multiple Dose Vials... If a multi-dose vial is used for more than one patient, the vial is not kept or accessed in the immediate patient treatment area (eg., operating and procedure rooms, anethesia, and procedure carts, patient rooms or bays). If a mulit-dose vial enters the immediate patient area, it is dedicated to that patient only or discarded after use. ... Beyond Use Date (BUD) of Multi-dose vials... The beyond use date (BUD) for an opened or entered (i.e. needle punctured) multiple dose vial with antimicrobial perservatives is 28 days..."
OBS #1 conducted 9/9/25 between approximately 10:15 am through 12:45 pm revealed the following:
Seven (7) - size eight (8) Polyisoprene Underglove Surgical Gloves; Lot# 2208084705; Expiration date: 8/25/25
17 Size nine (9) Polyisoprene Underglove Surgical Gloves; Lot# 2208007205; Expiration date: 8/2/25
Five (5) size seven and one half (7 1/2) Polyisoprene Underglove Surgical Gloves; Lot# 2207036705; Expiration date: 7/12/25
Two (2) #10 safety scalpel; Lot# 52756408; Expiration date: 8-3-25
Two (2) unlabeled bottles with nozzle spouts filled with unknow liquid - not labeled
Six (6) Povidin-Iodine Single-Use Swabstick; Lot#12400365; Expiration date: 8/2025
Two (2) opened multi-dose vials of Lidocaine HCL 1% 200mg/20ml; Lot#LN5355; no BUD on open multi-dose vial; vials not stored in facility dedicated medication room; vials were observed in a locked cupboard within Exam room #15.
Interview with facility manager and medical practice manager on 9/9/25 at approximately 10:40 am and then again at approximately 3:15 pm confirmed the above findings.
Plan of Correction:The Practice Manager at Meadville Community Health Center will validate the implemented checklist and spot check supplies and vials for expiration dates for six months to ensure the POC remedy is maintained.
Procedure Created: TAH RHC - 201 Multi-Dose Vial Use and Storage. All staff were educated on and reviewed the procedure on 9/15/2025.
Additionally, staff were instructed on the process for checking expired items. A monthly rotation will be implemented, assigning staff to inspect all areas for expired medications.
PROCEDURE TAH RHC-200
SUBJECT: Multi-Dose Vial Use and Storage
PURPOSE: To establish standardized guidelines for the safe handling, labeling, and storage of multi-dose medication vials in order to prevent contamination, maintain medication integrity, and comply with manufacturer and regulatory requirements.
Procedure: For Meadville Rural Health Centers (RHC) Requires all trained staff to follow the manufacturer's instructions regarding the use and storage of multi-dose vials. This ensures patient safety and compliance with best practices for medication administration.
PROCEDURE:
1. All multi-dose vials must be used and stored strictly according to the instructions provided in the manufacturer's insert, including specified beyond-use dates and storage temperatures.
2. Once a multi-dose vial is opened, staff must clearly label the vial with the expiry date and their initials. Vials must be discarded once they reach their expiration date, disposal date, or recall, even if medication remains.
3. Opened multi dose vials must be discarded within 28 days unless manufacturer specifies a different time frame
4. Any multi-dose vial that is found opened and not labeled with a date of first use must be immediately discarded.
491.10(a)(3)(i)-(iv) STANDARD
PATIENT HEALTH RECORDS
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491.10(a) Records system.
(3) For each patient receiving health care services, the clinic . . .. maintains a record that includes, as applicable:
(i) Identification and social data, evidence of consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient;
(ii) Reports of physical examinations, diagnostic and laboratory test results, and consultative findings;
(iii) All physician's orders, reports of treatments and medications, and other pertinent information necessary to monitor the patient's progress;
(iv) Signatures of the physician or other health care professional.
Observations:
Based on review of Clinical records (CR), facility policy and procedure and interview with clinic manager, the clinic failed to ensure a consent form was completed by the patient/patient representative prior to services being rendered for three (3) of 20 records reviewed. (CR#1, #3 and #13).
Findings include:
Review of facility policy: "... PROCEDURE TAH RHC-500... SUBJECT: PATIENT REGISTRATION... 1. Upon having the patient sign in at the reception desk, the office specialist will verify all demographic information, insurance and all related required fields to complete registration. Patients are required to sign Authorization at each visit upon check in. ..."
A review of patient medical records completed 9/9/25 between approximately 1:30 pm - 2:45 pm revealed the following:
CR#1, service date: 9/2/25 did not contain a signed consent form for services prior to those services being rendered.
CR#3, service date: 8/18/25 did not contain a signed consent form for services prior to those services being rendered.
CR#13, service date: 8/12/25 did not contain a signed consent form for services prior to those services being rendered.
Interview with the clinic manager and medical practice manager completed 9/9/25 at approximately 3:30 pm confirmed the above findings.
Plan of Correction:The Practice Manager at Meadville Community Health Center will audit three charts per month for six months to ensure that authorization is obtained on a yearly basis. If it is found that authorization was not obtained appropriately, the office specialist will be verbally counseled and progress through the disciplinary process if repeated authorization issues are found.
On September 16, 2025, staff were educated on the updated policy and procedure for obtaining Authorization/Consent. Policy TAH RHC - 500 was revised to require annual authorization rather than authorization at each visit.
PROCEDURE TAH RHC-500
SUBJECT: PATIENT REGISTRATION
PURPOSE: To ensure staff obtains required documentation from a patient at time of registration.
PROCEDURE: The following are procedures for the office specialist to follow for patient registration.
1. Upon having the patient sign in at the reception desk, the office specialist will verify all demographic information, insurance and all related required fields to complete registration. Patients are required to sign Authorization at least annually upon check in.
2. The office specialist will obtain all of the patient's insurance card(s) and scan into the practice management software. This procedure shall occur for all patients at least annually or upon insurance change.
3. Co-pay and/or self-pay amounts will be collected at check in. Receipt is given to all patients after co-pay/self-pay is collected.
4. The office specialist will obtain the patient's driver's license or valid ID, if over 18 years of age and will scan into the practice management software.
5. When the provider is finished providing treatment to the patient, provider will give the patient the encounter form if applicable, which the patient shall give to the checkout office specialist before leaving the health center. If applicable, the office specialist shall compute the charges for self-pay patients and collect the appropriate amount from the patient.
6. If patient is unable to pay at the time of service, a financial application is given to the patient to fill out and return.
7. If the provider indicates on the encounter form the patient is to return for follow-up, the appointment should be scheduled at check out. The patient will be given an appointment card with the date and time of their next appointment.
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