QA Investigation Results

Pennsylvania Department of Health
NEW PARIS RURAL HEALTH CLINIC
Health Inspection Results
NEW PARIS RURAL HEALTH CLINIC
Health Inspection Results For:


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Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey on 1/4-5/2024 and completed offsite on 1/19/2024, New Paris Rural Health Clinic 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 1/4-5/2024 and completed offsite 1/19/2024, New Paris Rural Health Clinic 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:




491.4 STANDARD
COMPLIANCE WITH FED., STATE & LOCAL LAWS

Name - Component - 00
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 upon review of policy, CDC (Center for Disease Control) guidelines, personnel files (PF) and staff (EMP) interview it was determined that the facility failed to ensure proper Tuberculosis screenings for the clinic personnel, and for one (1) of three (3) personnel files reviewed. (PF3)

Findings included:

Review of the agency policy was conducted on 1/19/2023 at approximately 3:00 PM which revealed, " Infection Control Policy ...Policy Purpose: The purposes or this policy are to clearly outline the procedures which shall be taken to protect patients and employees from infections and communicable diseases ...4. Communicable Diseases: a. The Clinic shall ensure that all employees have been or shall be appropriately screened for communicable diseases as required by federal state or local law. b. The Clinic shall report incidents of communicable diseases as required by federal, state, or local law ... "

Review of the agency policy was conducted on 1/18/2023 at approximately 1:00 PM which revealed, "TB Screening and Testing of Health Care Personnel Updated August 30, 2022 ...Baseline TB Screening and Testing All U.S. health care personnel should be screened for TB upon hire (i.e., preplacement). TB screening is a process that includes: A baseline individual TB risk assessment , TB symptom evaluation, A TB test (e.g., TB blood test or a TB skin test), and Additional evaluation for TB disease as needed ...*Baseline (preplacement) screening and testing, in addition to the IGRA (interferon-gamma release assay) or TST, shall include a symptom screen questionnaire and an individual TB risk assessment. Serial screening and testing not routinely recommended. Annual TB education is recommended. (CDC/MMWR/May 17, 2019/Vol. 68/No. 19) ... "

During an interview on 1/4/2024 at approximately 12:30 PM, (EMP1) confirmed only initial testing is completed and no annual screenings have been conducted with staff.

A review of PF3 on 1/5/2024 at approximately 12:02 PM revealed date of hire 9/11/2023. Documentation provided confirmed initial TST was administered on 7/20/2022 results could not be confirmed from documentation. The second TST was administered on 8/8/2022 results could not be confirmed from documentation. No documentation was available to confirm initial TB screening was confirmed as negative. No documentation was provided to confirm screening was conducted since 8/8/2022.

An exit interview with the administrator physician, physician, and clinic administrator on 1/5/2024 at approximately 1:45 PM confirmed the above findings.













Plan of Correction:

Plan of correction:
This standard shall be evidenced by ensuring that compliance is demonstrated for J0011. Corrective actions shall include:
1.Educating the RHC staff on the requirements for following the CDC guidelines for initial TB testing and subsequent annual testing for all employees;
2.Ensuring that all employee files contain proof of initial TB testing and annual screenings using the CDC Screening form;
3.Using an HR file checklist tool to ensure that all new employees are screened appropriately and that documentation is on file;
4.Monitoring the HR files periodically

Procedure for Implementing Plan:
1.Multiple training sessions will be conducted from 2/12/2024 – 2/23/2024 to retrain the staff on the standard;
2.Necessary actions were taken to ensure that initial TB screening results and subsequent TB screenings are documented in the HR files. The CDC Screening Tool was placed into use;
3.An HR checklist was also implemented to facilitate in assembling and documenting a complete file for each employee; and
4.The Clinic Administrator shall periodically monitor the HR files to randomly audit the files for completeness.

Plan Completion Date:
All correction actions be completed by 03/15/2024.

Monitoring Procedure Ensuring Plan is Effective:
As previously stated, the clinic shall use the CDC recommended TB screening practices and use the TB screening form for annual screening of all employees and staff. Also, a HR checklist shall be implemented to ensure that the files are complete and updated. Furthermore, the Clinic Administrator shall randomly audit the HR files throughout the year to ensure the completeness of the files and to ensure that J0011 is evidenced as far as compliance with federal, state and local regulations around TB screening.
Title of Staff Responsible for Implementing:
Clinic Administrator

Patient Care Impact:
A review of the patient care files and the employee records did not indicate any adverse patient care impact due to this deficiency. No corrective actions are needed to resolve or report this finding.

Evidence Documents:
The following evidence documents are attached or can be made available to the state agency.
- TB Screening Packet
- HR File Checklist
- Proof of staff training
- Proof of individual TB test results upon request if they can be securely sent to protect PHI.



491.6(b)(2) STANDARD
PHYSICAL PLANT AND ENVIRONMENT

Name - Component - 00
The clinic . . . has a preventive maintenance program to ensure that:

491.6(b)(2) Drugs and biologicals are appropriately stored; and

Observations:


Based upon review of agency policy, observation tour (OBV), and staff (EMP) interview it was determined that the facility failed to ensure proper disposal of expired medication for one (1) of one (1) OBV conducted (OBV1).

Findings included:

Review of the agency policy was conducted on 1/19/2023 at approximately 3:00 PM which revealed, Storage Handling & Administration of Drugs, Biologicals, and Pharmaceuticals ...Policy Purpose: The purpose of this policy is to outline the procedures related to the storage and handling of drugs, biological and pharmaceuticals ...1. General Storage and Handling Guidelines ...c. The clinic shall designate authorized clinical staff to monitor, handle, and administer drugs and biologicals ...n. All Scheduled drugs shall be accounted for when purchased, received, stocked, administered or disposed. O. All drugs and biologicals shall be inventoried for expiration dates (beyond use dates) on a monthly basis by a designated staff member, usually a member of the nursing staff or medical assistant. p. All medications shall be labeled with an open and discard date when applicable. q. Any expired, deteriorated, or adulterated drugs shall be stored separately to prevent use and shall be discarded following the appropriate method as set forth by state and federal laws, regulations, and guidelines..."

OBV1 Rural Health Clinic Tour was conducted on 1/4/2024 at approximately 12:40 PM which revealed the following:

The following medication was expired:
"diphenhydramine Hydrochloride Injection, USP 500mg/10mL (50 mg/mL) For Intravenous or Intramuscular Use HIGH POTENCY...EXP NOV 2023..."

The following medication vial was opened, and no date or staff initials were located on the vial denoting vial is labeled with an open and discard date when applicable.
"Cyanocobalamin injection, USP 10,000 mcg/mL 10 mL MULTIPLE DOSE VIAL...(expiration date) 03/2025."

An exit interview with the administrator physician, physician, and clinic administrator on 1/5/2024 at approximately 1:45 PM confirmed the above findings.











Plan of Correction:

Plan of Correction: The standard shall be evidenced by demonstrating compliance with J0043. Corrective actions shall include:
1.The expired drugs shall be immediately removed from use and appropriately discarded;
2.Training the RHC staff and providers on the standard J0043. The education shall also include retraining on Policy 220 and the processes for correctly labeling MDV.;
3.A designated member of the clinical staff shall be assigned the duty of conducting inventory control checks. These checks shall be done on a weekly basis until there is 100% compliance for 4 consecutive weeks or 20 days. Thereafter, the regular monthly checks will be implemented.

Procedure for Implementing Plan:
1.Immediately discarding the expired drugs and supplies on 01/05/2024;
2.Multiple sessions will be conducted from 2/12/2024 – 2/23/2024 to train staff on J0043, Policy 220 and the processes for labeling MDV;
3.Weekly inventory checks by the designated clinical member began on 02/02/2024;
4.Random environmental rounds will be implemented on 2/08/2024.

Plan Completion Date:
All corrective actions shall be completed on or before 03/15/2024.

Monitoring Procedure Ensuring Plan is Effective:
1.The clinic Administrator shall conduct random environmental rounds to spot check the expiration and beyond use dates of drugs and supplies.

Title of Staff Responsible for Implementing:
Clinic Administrator

Patient Care Impact:
A review of the patient care files and the employee records did not indicate any adverse patient care impact due to this deficiency. No corrective actions are needed to resolve or report this finding.

Evidence Documents: The following documents can be submitted to demonstrate compliance; Proof of education and training on J0043
- Policy 220
- Inventory control checklist to be used for weekly checks




491.9(c)(3) STANDARD
PROVISION OF SERVICES

Name - Component - 00
491.9(c) Direct services

(3) Emergency. The clinic . . . provides medical emergency procedures as a first response to common life-threatening injuries and acute illness and has available the drugs and biologicals commonly used in life saving procedures, such as analgesics, anesthetics (local), antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids

Observations:


Based on review of policy and procedure, observation tour (OBV) and staff (EMP) interviews the clinic failed to ensure emergency supplies were available for use as a first response to common life-threatening injuries and acute illnesses for one (1) of one (1) observation made. (OBV1).

Findings include:

Review of the agency policy was conducted on 1/19/2023 at approximately 3:00 PM which revealed, "Emergency Care and Treatment...Policy Statement: The clinic complies with the RHC requirement to be able to provide medical emergency procedures as a first response to common life-threatening injuries and acute illnesses ...c) Other medical supplies and equipment that has been determined necessary for providing emergency care within the scope and training of the providers...3) Life-Threatening Medical Emergencies: The clinic shall provide the following medical care to patients with life-threatening emergencies ...b) If the patient presents to the clinic with serious or life-threatening condition: (1) The staff shall call 911 or arrange for emergency transport of the patient to the Emergency Department at the closest hospital. (2) The staff shall attend to the patient and provide emergency medical care within the scope of training of the clinical staff until the patient can be transported..."

OBV1 Rural Health Clinic Tour was conducted on 1/4/2024 at approximately 12:40 PM which revealed the following: The surveyor request to be shown the equipment and supplies available to be used in an emergency. The clinic did not possess airway suction equipment. EMP3 confirmed no suction equipment was available for use at the clinic.

An exit interview with the administrator physician, physician, and clinic administrator on 1/5/2024 at approximately 1:45 PM confirmed the above findings.













Plan of Correction:

Plan of Correction:
This standard shall be evidenced by demonstrating compliance with the standard J 0136. Corrective actions shall include the following:
1.Educating the RHC staff on the requirements of J 0136;
2. Suction Equipment shall be purchased as part of this plan of correction.

Procedure for Implementing Plan:
The corrective actions were implemented accordingly:
1.Multiple training sessions will be conducted from 2/12/2024 – 2/23/2024. The staff will be trained on the requirements of J 0136;

Plan Completion Date:
All corrective actions shall be completed on or before 03/15/2024.

Monitoring Procedure Ensuring Plan is Effective:
1.The Clinic Administrator shall conduct random environmental audits to ensure that the drugs and supplies required to comply with J 0136 are maintained and part of the inventory control processes.

Title of Staff Responsible for Implementing:
Clinic Administrator

Patient Care Impact A review of the patient care files and the employee records did not indicate any adverse patient care impact due to this deficiency. No corrective actions are needed to resolve or report this finding.

Evidence Documents:
The following documents can be submitted to demonstrate compliance;
Proof of training
Invoice for supplies if mandated