Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on September 8, 2021 through September 10, 2021, Cornerstone Coordinated Health Care Llc was identified to be in compliance with the following requirements of 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 conducted on September 8, 2021 through September 10, 2021, Cornerstone Coordinated Health Care Llc was identified to have the following standard level deficiency that was 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
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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 upon observation, policy and procedure review, and interview with the facility office manager, it was determined that the facility failed to ensure proper Tuberculosis screenings for clinic personnel for five (5) out of ten (10) personnel files reviewed. (PF #2, #5, #8-#10)
Findings include:
Review of Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel: Recommendations from the National Tuberculosis Controllers Association and CDC, 2019 dated May, 17, 2019 revealed: "the 2005 CDC recommendations for testing U.S. health care personnel have been updated and now include 1) TB screening with an individual risk assessment and symptom evaluation at baseline (preplacement); 2) TB testing with an interferon-gamma release assay (IGRA) or a tuberculin skin test (TST) for persons without documented prior TB disease or latent TB infection (LTBI); 3) no routine serial TB testing at any interval after baseline in the absence of a known exposure or ongoing transmission; 4) encouragement of treatment for all health care personnel with untreated LTBI, unless treatment is contraindicated; 5) annual symptom screening for health care personnel with untreated LTBI; and 6) annual TB education of all health care personnel."
Review of Policy " TB Testing Policy " on 9/22/21 at approximately 1:00 PM states " Policy Explanation and Compliance Guidelines: "1. New staff testing: At the time of employment, all new staff, including those with a history of Bacille Calmette-Guerin, a Quantiferon blood test will be drawn. 2. Current staff testing: All staff previously Tuberculosis (TB) skin test negative will submit to periodic retesting as follows: All staff previously tested negative will not require repeat testing unless the staff person is exposed to infectious TB. Tests shall be interpreted according to current Centers for Disease Control (CDC) guidelines. 3. Compliance with this policy: Proof of compliance is a requirement of the annual performance review. Test results will be necessary for recredentialing. Failure to comply with this policy may result in disciplinary action."
Review of Personnel Files (PF) on 9/9/21 between 10:30 AM-11:30 AM revealed:
1. Personnel File (PF) #2: Date of Hire (DOH): 7/8/21: contained no documentation of TB screening upon hire
2. PF #5: DOH: 9/9/19: contained no documentation of TB screening upon hire
3. PF #8: DOH: 5/4/21: contained no documentation of TB screening upon hire
4. PF #9: DOH: 6/1/20: contained no documentation of TB screening upon hire
5. PF #10: DOH: 8/3/20: contained no documentation of TB screening upon hire
An interview with the Office Manager on 9/10/2021 at approximately 2:00 PM confirmed the above findings.
Plan of Correction:Our facility will take the following measures to make sure all compliance with tuberculosis testing/screenings will be complete.
All current employees were given a quantiferon TB test at the time of the exit interview by our phlebotomist and reviewed by our physician and office manager to make sure everyone was properly screened for Tuberculosis.
The following measures will be taken in the future:
At the time of employment, during the initial immunization and screening evaluation, all new staff, including those with a history of Bacille Calmette-Guerin, a quantiferon blood test will be drawn by our phlebotomist. A quantiferon blood test shall be performed and interpreted by a trained healthcare provider on our staff, or any licensed physician. No one may interpret his/her own test. Tests shall be interpreted according to current Centers for Disease Control and Prevention guidelines.
Following the initial evaluation, employees will be asked to take a education course on the CDC website yearly to be up to date with TB screenings. The office manager will perform yearly education at the yearly meeting and documented in a manual.
491.6(b)(2) STANDARD
PHYSICAL PLANT AND ENVIRONMENT
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The clinic . . . has a preventive maintenance program to ensure that:
491.6(b)(2) Drugs and biologicals are appropriately stored; and
Observations:
Based upon observation, policy and procedure review, and interview with the facility office manager, it was determined that the facility failed to ensure proper disposal of expired drugs and biologicals (Observation#1, Observation#2, and Observation#3).
Findings include:
Review of Policy " Drugs and Biologicals " on 9/10/21 at approximately 1:30 PM states " Procedure: Pharmaceuticals will be checked monthly to assure they are not outdated or deteriorated. A monthly check should be conducted to ensure all expired drugs have been removed from the storage area .... All outdated medications will be disposed of (i.e. hazardous waste).
Observation #1: On 9/8/21 at approximately 11:10 AM, review of Exam rooms revealed:
1) Eighteen (18) packets of McKesson Lubricating Jelly with expiration date of 10/19/2020
Observation #2: On 9/8/21 at approximately 2:15 PM, review of the Vaccine storage area revealed:
1) Two (2) boxes of HemoCue Glucose 201 with expiration date of 4/4/2020
Observation #3: On 9/9/21 at approximately 2:55 PM, review of Emergency medical box revealed:
1) One (1) vial of Adrenalin one milligram per millimeter (1mg/ml) with expiration date of 3/30/21
2) Two (2) Terumo Surguard safety hypodermic needle twenty five (25) gauge by five eighth of a inch with expiration date of 4/28/2019
3) Four (4) Terumo U-100 insulin single use syringe with twenty eight (28) gauge by a half (0.5) inch needle with expiration date of 2/21/2019
4) Two (2) Terumo syringe tuberculin with needle twenty six (26) gauge by three eighth of a inch with expiration of 12/28/2017
An interview with the Office Manager on 9/10/2021 at approximately 2:00 PM confirmed the above findings.
Plan of Correction:The plan of correction our facility will be taking to make sure all of expired items will be disposed of is as follows:
Each exam room will consist of a binder, that will need to be signed off on monthly. The binder will state that all expiration dates have been checked and all expired items have been disposed of properly. The binder will consist of two signatures for each month, the Medical Assistant who checked expiration dates and the overseeing Medical Assistant.
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