Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed December 18, 2025, John E Balmer D.O./Canadohta Lake Health Center was found not to be in compliance with the following requirements of Rural Health Clinics: Conditions for Certification 42 CFR, Part 405, Subpart S - 491.3 through 491.11.
Plan of Correction:
491.4 STANDARD
COMPLIANCE WITH FED., STATE & LOCAL LAWS
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Standard-level Tag
491.4 Compliance with Federal, State and local laws
The rural health clinic . . . and its staff are in compliance with applicable Federal, State and local laws and regulations.
Observations:
Based on review of Centers for Disease Control and Prevention CDC guidance, agency policy, personnel files (PF) and staff (EMP) interview it was determined the agency failed to ensuret each EMP was provided education, screened for and is free of mycobacterium tuberculosis (TB) in accordance with CDC (Center for Disease and Control) guidelines upon hire and at least every twelve (12) months for five (5) of five (5) PFs reviewed who were employed by the agency for at least 12 months (PF1, PF2, PF3 PF4 and PF5).
Finding included:
Review of the Centers for Disease Control and Prevention CDC guidance was conducted on 12/18/2025 at approximately 3:00 PM revealed, "...Clinical Testing Guidance for Tuberculosis: Health Care Personnel...TB screening programs in health care setting, TB screening programs should include anyone working or volunteering in health care settings, including: *Inpatient settings *Outpatient settings...All health care personnel should receive annual TB education. TB education should include: *Information on TB risk factors, *Signs and symptoms of TB disease, and *TB infection control policies and procedures... Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel: Recommendations from the National Tuberculosis Controllers Association and CDC, 2019... Baseline (preplacement) screening and testing, in addition to the IGRA (interferon-gamma release assay) or TST [tuberculin skin testing], shall include a symptom screen questionnaire and an individual TB risk assessment..."
Retrieved from https://www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6819-H.pdf
Interview with facility administrative assistant revealed: "We do not have a policy for review related to TB or infection control."
Review of Personnel files (PF) on 12/17/25 from approximately 11:30 am to 1:45 pm revealed:
PF1; date of hire (DOH) of 8/2/22: No documentation was available to verify initial TB testing or screening was performed upon hire or within previous 12 months of hire and did not contain annual TB education.
PF2; DOH 9/4/24: No documentation was available to verify initial TB testing or screening was performed upon hire or within previous 12 months of hire and did not contain annual TB education.
PF3; DOH 12/3/14: No documentation was available to verify initial TB testing or screening was performed upon hire or within previous 12 months of hire and did not contain annual TB education.
PF4; DOH 3/23/07: No documentation was available to verify initial TB testing or screening was performed upon hire or within previous 12 months of hire and did not contain annual TB education.
PF5; DOH 1/22/07: No documentation was available to verify initial TB testing or screening was performed upon hire or within previous 12 months of hire and did not contain annual TB education.
An exit interview was conducted with the facility assigned point of contact (administrative assistant) confirmed the above findings. "The employees who have been here said that we used to do testing every year, but we don't anymore. No education or screening of employees is provided because of 'low risk' area."
Plan of Correction:491.4 STANDARD
COMPLIANCE WITH FED., STATE & LOCAL LAWS
The (RHC) John E Balmer, D.O./Canadohta will comply with all federal, state, and local laws and regulations. The RHC will develop and maintain a TB/Infection Control Policy and Procedure in accordance with the CDC guidelines. Policy compliance is to insure safety and health care services to the patients of the Rural Health Clinic to maintain highest quality of care.
Newly hired employees will be required to have either the PPD 2-Step injections or the QFT-Gold laboratory analysis. New employees will be oriented to infection control protocols and policy and all employees will be educated on the information yearly.
A draft Infection Control Plan policy and procedure will be prepared for review and approval by the professional advisory group by January 22, 2026. Upon approval staff education will be completed at the staff meeting to be held on January 29, 2026. Following the meeting the policy and procedure will be implemented immediately.
The RHC administrator will ensure that a physician assistant and/or nurse practitioner member(s) in conjunction with the physician participate in the development and periodic review of the clinic's written policies.
The RHC will ensure that the clinic's written policies are reviewed at least annually by a group of professional personnel as required. The group will include one or more physicians, one or more physician assistant and/or nurse practitioner, and a person who is not employed by the clinic.
The RHC will ensure that the annual total program evaluation held each October includes documentation of a review of the health care policies. Documentation of the review will be included in all future evaluations.
The Office Manager or her designee will be responsible for monitoring and continued implementation of the plan of correction.
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),and interview with administrative assistant, the clinic failed to ensure a consent form to treat and diagnose was completed by the patient/patient representative prior to services being rendered for twenty (20) of twenty (20) records reviewed. (CR#1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #17, #18, #19, and #20.
Findings include:
A review of patient medical records completed 12/17/25 between approximately 12:15 pm - 1:30 pm revealed the following:
CR#1, service date(s): 01/02/2025, 02/24/2025, 03/31/2025, 04/14/2025, 07/17/2025, 09/22/2025, 12/09/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#2, service date(s): 05/14/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
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CR#3, service date(s): 04/24/2025, 07/03/2025, 09/25/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#4, service date(s): 08/26/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#5, service date(s): 01/06/2025, 01/20/2025, 03/10/2025, 03/25/2025, 04/22/2025, 05/20/2025, 06/19/2025, 09/16/2025, 10/21/2025, 12/16/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#6, service date(s): 10/02/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#7, service date(s): 03/11/2025, 11/04/2025, 11/21/2025, 12/01/2025, did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#8, service date(s): 11/12/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#9, service date(s): 01/02/2025, 06/09/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#10, service date(s): 04/07/2025did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#11, service date(s): 02/28/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#12, service date(s): 03/07/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#13, service date(s): 04/09/2025, 08/22/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#14, service date(s): 06/04/2025, 06/11/2025, 08/11/2025, did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#15, service date(s): 01/10/2025, 02/07/2025, 04/25/2025, 07/25/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#16, service date(s): 08/08/*2025, 09/05/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#17, service date(s): 03/05/2025, 04/02/2025, 04/30/2025, 05/08/2025, 06/04/2025, 06/25/2025, 7/23/2025, 08/22/2025, 09/24/2025, 10/24/2025, did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#18, service date(s): 10/01/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#19, service date(s): 11/14/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
CR#20, service date(s): 11/21/2025 did not contain a signed consent form to treat and diagnose prior to those services being rendered.
An exit interview was conducted with the administrative assistant on 12/17/2025 at approximately 2:15pm which confirmed the findings.
Plan of Correction:491.10(a)(3)(i)-(iv) STANDARD
PATIENT HEALTH RECORDS:
The (RHC) John E Balmer, D.O./Canadohta will comply with all federal, state, and local laws and regulations. The RHC will develop and maintain a Consent for Care Policy and Procedure to include a Consent for Care form to be maintained in the electronic medical record in the required documentation area. Policy compliance is to ensure that every patient, or a legally authorized representative, gives a written Consent for Care for treatment received in the Rural Health Clinic prior to services being rendered.
The policy and form will be drafted to be in compliance with the appropriate guidelines. The Office Manager or her designee will contact the EMR (MEDENT) to provide assistance in placing the consent for care electronically in the medical record for signing as required in the policy.
A draft Consent for Care policy and procedure will be prepared for review and approval by the professional advisory group by January 22, 2026. Upon approval staff education will be completed at the staff meeting to be held on January 29, 2026. Following the meeting the policy and procedure will be implemented immediately.
The RHC administrator will ensure that a physician assistant and/or nurse practitioner member(s) in conjunction with the physician participate in the development and periodic review of the clinic's written policies.
The RHC will ensure that the clinic's written policies are reviewed at least annually by a group of professional personnel as required. The group will include one or more physicians, one or more physician assistant and/or nurse practitioner, and a person who is not employed by the clinic.
The RHC will ensure that the annual total program evaluation held each October includes documentation of a review of the health care policies. Documentation of the review will be included in all future evaluations.
The Office Manager or her designee will be responsible for monitoring and continued implementation of the plan of correction.
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