Initial Comments:
Based on the findings of an on site unannounced Medicare recertification survey completed on March 26, 2025, BHS Rural Health Clinic Nb, was found 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:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed March 26, 2025, BHS Rural Health Clinic Nb, was found to have the following standard level deficiencies that were determined to be in substantial compliance with the following 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:
491.5(a)(3)(iii) STANDARD
LOCATION OF CLINIC
Name - Component - 00
Basic requirements
491.5(a)(3) . . . the RHC . . . may be permanent or mobile units.
(iii) Permanent unit in more than one location. If clinic . . . services are furnished at permanent units in more than one location, each unit is independently considered for approval as a rural health clinic . . .
Observations:
Based on clinic policy and procedure, review of manufacturer directions for use (MDFU), direct observations, and staff (EMP) interview, the facility failed to ensure expired medications and supplies were not available for use. Additionally, the clinic failed to follow clinic policy and procedure for the logging and monitoring of sample medications stored in the clinic.
Findings Included:
During a tour of the clinic on March 26, 2025, at approximately 10:00 a.m., the following expired medications were discovered:
-- One (1) open vial of Tuberculin Purified Protein [medication for tuberculosis screening/testing] 1ml; Lot # 3CA26C1 - was void of staff initials and date the vial was opened for use.
Review of MDFU revealed: "...discard open product after 30 days..."
An interview with EMP1 March 26, 2025 at approximately 11:00 a.m. confirmed the above findings and verified all expiration dates.
Plan of Correction:Identify the underlying cause(s) of the identified issue.
-After talking with the clinical staff in the office, the root cause was determined to be time management. Clinical staff stated that this was missed because of being busy and not double checking each other to make sure this was done when the vial was opened.
Propose key measures to solve these issues.
--Having a "do not use after" sticker on the vial prior to opening
-Having a "do not use after" sticker on the box prior to opening
-Sign on the vaccine container that holds the vial stating "Be sure to note the disposal date on the "do not use after" sticker on the vial and the box, the disposal date is 30 days from the date the vial was opened"
Indicate the specific responsibilities each corrective action entails and the relevant parties.
--Having a "do not use after" sticker on the vial
This will be the responsibility of the clinical staff member who initially opens the vial. They will need to mark the disposal date on the sticker.
-Having a "do not use after" sticker on the box
This will be an extra visual reminder to ensure this is not missed. This is also the responsibility of the clinical staff member who initially opens the vial/box.
-Our third visual reminder will be the sign we put on the vial container that holds the vial in the box. We will note that "Be sure to note the disposal date on the "do not use after" sticker on the vial and the box, the disposal date is 30 days from the date the vial was opened"
This will be the 3rd visual reminder to ensure that disposal date is noted. It is again the clinical staff who first opens to make sure this is done.
Indicate the timeline for each corrective measure, including due dates and goals.
--Having a "do not use after" sticker on the vial
The time frame for this started 4/11/2025. We met as a group to come up with the best solution for our office to ensure this will not be missed. The goal is to ensure the date is noted.
-Having a "do not use after" sticker on the box
The time frame for this started 4/11/2025. We met as a group to come up with the best solution for our office to ensure this will not be missed. The goal is to ensure the date is noted.
-Our third visual reminder will be the sign we put on the vial container that holds the vial in the box. We will note that "Be sure to note the disposal date on the "do not use after" sticker on the vial and the box, the disposal date is 30 days from the date the vial was opened"
The time frame for this started 4/11/2025. We met as a group to come up with the best solution for our office to ensure this will not be missed. The goal is to ensure the date is noted.
Indicate the proposed strategies to monitor and measure corrective action progress.
-We are going to track the TB by lot number/expiration date in a log book. We will then have a running log of who received this, when they did, and who administered.
-We are going to add this to the end of the day duties. The clinical staff member who is responsible for checking temperatures will also need to check the TB vial to confirm whether it was opened that day or not. If the vial is not opened, the staff member will not need do anything. If they do find that it has been opened, we will pull the log book to see who may have forgot and reeducate the importance of noting the "do not use after" date.
491.8(b)(3) and (c)(1)(ii) STANDARD
STAFFING AND STAFF RESPONSIBILITIES
Name - Component - 00
491.8(b) Physician responsibilities. The physician performs the following:
(3) Periodically reviews the clinic's . . . patient records . . .
491.8(c) Physician assistant and nurse practitioner responsibilities.
(1) The physician assistant and the nurse practitioner members of the clinic's . . . . staff:
(ii) Participate with a physician in a periodic review of the patients' health records.
Observations:
Based on a review of the Pennsylvania Society of Physician Assistants SBOM (State Board Of Medicine) Regulations, interview with facility manager and review of medical records (MR) the clinic failed to maintain the ensure providers signatures were documented, failed to ensure supervising physician signature(s) obtained certifying review of medical record and failed to specify a maximum interval between record reviews in its policies and procedures insuring that they are completely and accurately documented, for 4(four) of 24 medical records (MR) reviewed.
(MR# 5, #21, #23 and #24)
Findings include:
3-26-25 a review of SBOM at approximately 4:15 pm revealed:
"Title 49. Professional and Vocational Standards
Part I. Department of State Subpart A. Professional and Occupational Affairs Chapter 25. State Board of Osteopathic Medicine
Subchapter C. PHYSICIAN ASSISTANT PROVISIONS,... 25.142. Definitions...Supervision - The opportunity or ability of the physician, or in his absence a substitute supervising physician, to provide or exercise control and direction over the services of physician assistants...
...(iii) Personal and regular-at least weekly-review by the supervising physician of the patient records upon which entries are made by the physician assistant..."
A review of facility policy and procedure manual conducted 3/26/25 at approximately 4:10 pm, the faciliy failed to provide a policy/procedure for surveyor review regarding supervising physician responsibility for patient record reviews, timeframe on which records are to be reviewed and documentation of such reviews to be obtained.
3/26/25 a review of MR #5, at approximately 1:55 pm revealed: Date of Service (DOS): 3/10/25, care provided by Physician Assistant - signature documented by Physician's Assistant and no signature obtained from supervising physician verifying record review.
3/26/25 a review of MR #21, at approximately 3:30 pm revealed: Date of Service (DOS): 1/6/25, care provided by Physician Assistant - signature documented by Physician's Assistant and no signature obtained from supervising physician verifying record review.
3/26/25 a review of MR #23, at approximately 3:45 pm revealed: Date of Service (DOS): 2/5/25, care provided by Physician Assistant - signature documented by Physician's Assistant and no signature obtained from supervising physician verifying record review.
3/26/25 a review of MR #24, at approximately 3:55 pm revealed: Date of Service (DOS): 2/18/25, care provided by Physician Assistant - signature documented by Physician's Assistant and no signature obtained from supervising physician verifying record review.
An interview with the facility manager on March 26, 2025 at approximately 4:30 pm, confirmed the above findings. "I cannot find a policy that states the physician has to review every record that the physician assistant documents for patients."
Plan of Correction:The practice manager will oversee the co-signing of notes from the supervising physician of the PA-C. This will be monitored on a weekly basis.
Every note that the PA-C opens for patients in the New Bethlehem office will need co-signed by the supervising physician. These notes will need co-signed within 7 days from the date of service to be compliant with our policy at the RHC in New Bethlehem.
On 4/11/2025 the physician, practice manager and PA-C met to discuss a solution. As a group we all agreed on the time frame, as well as the fact that 100 percent of the notes will need a co-signature from the supervising physician.
491.10(a)(3)(i)-(iv) STANDARD
PATIENT HEALTH RECORDS
Name - Component - 00
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 medical records (MR) and interview with climnic manager, the clinic failed to ensure a consent form was completed by the patient/patient representative prior to services being rendered for nine (9) of 24 records reviewed. (MR#2, #4, #7, #11, #12, #14, #19, #20 and #21).
Findings include:
A review of patient medical records completed March 26, 2025 between approximately 1:30 pm - 4:00 pm revealed the following:
MR#2, service date: 2/27/25 did not contain a signed consent form for services prior to those services being rendered.
MR#4, service date: 2/27/25 did not contain a signed consent form for services prior to those services being rendered.
MR#7, service date: 3/12/25 did not contain a signed consent form for services prior to those services being rendered.
MR#11, service date: 3/13/25 did not contain a signed consent form for services prior to those services being rendered.
MR#12, service date: 3/14/25 did not contain a signed consent form for services prior to those services being rendered.
MR#14, service date: 3/18/25 did not contain a signed consent form for services prior to those services being rendered.
MR#19, service date: 3/26/25 did not contain a signed consent form for services prior to those services being rendered.
MR#20, service date: 3/26/25 did not contain a signed consent form for services prior to those services being rendered.
MR#21, service date: 1/6/25 did not contain a signed consent form for services prior to those services being rendered.
Interview with the clinic manager completed March 26, 2025 at approximately 4:30 pm confirmed the above findings.
Plan of Correction:Identify the underlying cause(s) of the identified issue.
-We did not have a paper copy of the consent form in our health systems "form fast" program. The only way a patient could sign a consent for treatment is if they checked in on their phone or used the Phreesia tablets we have in office. Often times patients are running late, do not have service or a smart phone, or refuse to check in on tablet/phone.
Propose key measures to solve these issues
-After our tour on 3/26/2025, the Practice Manager created a paper copy of the consent to treatment. This was created, copied and distributed to the front desk staff members. This consent form will need signed by the patient/patient representative yearly and then will need scanned into the patients electronic medical record.
-The front desk staff members have been giving the consent form to each patient who does not have one on file within 365 days of their appointment date. The front desk staff members are able to check last scan date of the consent to treatment via the patient summary in our medical record.
Indicate the specific responsibilities each corrective action entails and the relevant parties.
-When the patient comes to the office to check in, it is the responsibility of the front desk staff member to check to see when they last signed a consent to treatment. If it is older than 364 days from the date of their appointment, the patient will need to sign this.
-The front desk staff member will then check to ensure the consent form is filled out correctly. If it is, they will then scan it into the administrative document section of the patients medical record.
-It is the responsibility of the front desk staff member to monitor when a patient needs to sign this again.
Indicate the timeline for each corrective measure including dates/goals
-After the RHC inspection, we all met as a group to discuss our solution for ensuring each patient has a updated consent form. (3/27/2025)
-The front desk staff members and first made sure there was a paper copy of the consent drafted. We then discussed how often these are needed. Our goal was to begin obtaining the consent forms 4/01/2025.
-We implemented this on 4/01/2025 and out goal is to make sure this is obtained yearly from all patients.
Indicate the proposed strategies to monitor and measure corrective action process.
-The Front desk staff will be responsible for checking each patients summary to see when the consent for treatment was last filed.
-The Front Desk Staff Members will be obtaining if the patient is due/overdue for the consent for treatment.
-The Front Desk Staff Member will be scanning this to the patients medical record.
To monitor, The Practice Managers plan weekly is to pull (10) random patient charts to spot check their administrative documents to ensure the front desk staff members are collecting these from each patient at the time of their appointment.
|