QA Investigation Results

Pennsylvania Department of Health
CORNERSTONE COORDINATED HEALTH CARE LLC
Health Inspection Results
CORNERSTONE COORDINATED HEALTH CARE LLC
Health Inspection Results For:


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Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey conducted on September 13, 2018 through September 14, 2018, Cornerstone Coordinated Health Care Llc was identified to have the following standard level deficiencies that were determined to be in substantial 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:




491.12(a)(1)-(2) STANDARD
Plan Based on All Hazards Risk Assessment

Name - Component - 00
403.748(a)(1)-(2), 416.54(a)(1)-(2), 418.113(a)(1)-(2), 441.184(a)(1)-(2), 460.84(a)(1)-(2), 482.15(a)(1)-(2), 483.73(a)(1)-(2), 483.475(a)(1)-(2), 484.102(a)(1)-(2), 485.68(a)(1)-(2), 485.625(a)(1)-(2), 485.727(a)(1)-(2), 485.920(a)(1)-(2), 486.360(a)(1)-(2), 491.12(a)(1)-(2), 494.62(a)(1)-(2)

[(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:]

(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.*

(2) Include strategies for addressing emergency events identified by the risk assessment.

* [For Hospices at 418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care.

*[For LTC facilities at 483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents.
(2) Include strategies for addressing emergency events identified by the risk assessment.

*[For ICF/IIDs at 483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:

(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients.
(2) Include strategies for addressing emergency events identified by the risk assessment.

Observations:


Based upon review of the facility's emergency preparedness plan and an interview with the Office Manager, it was determined the facility failed to ensure the emergency preparedness plan to be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.

Findings include:

Review of facility emergency preparedness plan on 9/13/2018 at approximately 1:00 PM did not include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.

An interview with the Office Manager on 9/14/2018 at approximately 12:30 PM confirmed the above finding.







Plan of Correction:

Cornerstone will develop an emergency preparedness plan utilizing the facility-based and community-based all-hazards Pennsylvania Public Health Risk Assessment tool. The plan will be reviewed and updated annually. The plan will include strategies for addressing each emergency event identified by the risk assessment. The Medical Director and Office Manager will be responsible for developing a plan and reviewing / updating annually. The facility will maintain documentation of risk assessment and policy on site. The risk assessment and policy will be ready to review. The corrective action will be completed by: November 9, 2018.


491.12(d)(1) STANDARD
EP Training Program

Name - Component - 00
403.748(d)(1), 416.54(d)(1), 418.113(d)(1), 441.184(d)(1), 460.84(d)(1), 482.15(d)(1), 483.73(d)(1), 483.475(d)(1), 484.102(d)(1), 485.68(d)(1), 485.625(d)(1), 485.727(d)(1), 485.920(d)(1), 486.360(d)(1), 491.12(d)(1).

*[For RNCHIs at 403.748, ASCs at 416.54, Hospitals at 482.15, ICF/IIDs at 483.475, HHAs at 484.102, "Organizations" under 485.727, OPOs at 486.360, RHC/FQHCs at 491.12:]
(1) Training program. The [facility] must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Maintain documentation of all emergency preparedness training.
(iv) Demonstrate staff knowledge of emergency procedures.
(v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures.

*[For Hospices at 418.113(d):] (1) Training. The hospice must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles.
(ii) Demonstrate staff knowledge of emergency procedures.
(iii) Provide emergency preparedness training at least every 2 years.
(iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others.
(v) Maintain documentation of all emergency preparedness training.
(vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and
procedures.

*[For PRTFs at 441.184(d):] (1) Training program. The PRTF must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) After initial training, provide emergency preparedness training every 2 years.
(iii) Demonstrate staff knowledge of emergency procedures.
(iv) Maintain documentation of all emergency preparedness training.
(v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures.

*[For PACE at 460.84(d):] (1) The PACE organization must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency.
(iv) Maintain documentation of all training.
(v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures.

*[For LTC Facilities at 483.73(d):] (1) Training Program. The LTC facility must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of all emergency preparedness training.
(iv) Demonstrate staff knowledge of emergency procedures.

*[For CORFs at 485.68(d):](1) Training. The CORF must do all of the following:
(i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment.
(v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures.

*[For CAHs at 485.625(d):] (1) Training program. The CAH must do all of the following:
(i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures.

*[For CMHCs at 485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years.

Observations:


Based upon personnel file review and an interview with the Office Manager, it was determined the facility failed to ensure initial training in facility emergency preparedness policies and procedures to all new and existing staff for eleven (11) out of eleven (11) personnel files (PF) reviewed (PF#1 - PF#11).

Findings include:

PF#1-PF#11 were reviewed on 9/14/2018 from 10:00 AM-11:30 AM and revealed no documentation of training in facility emergency preparedness policies and procedures.

An interview with the Office Manager on 9/14/2018 at approximately 12:30 PM confirmed the above finding.





Plan of Correction:

Cornerstone will conduct an initial training on emergency preparedness for all new and existing staff. The training will educate employees on policies and procedures of the emergency events identified by the risk assessment tool. The Office Manager will utilize an online CMS tool to perform the training. The training will be conducted annually and documented with the emergency preparedness plan. The training will be signed off by each individual employee and kept with the emergency preparedness plan and also in the employee's personnel file. The training and plan will address how the facility will meet the needs of the patients in the event of an emergency and an analysis of the providers ability to continue providing care and services during an emergency. The corrective action will be completed by: November 9, 2018.


Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey conducted on September 13, 2018 through September 14, 2018, Cornerstone Coordinated Health Care Llc was identified 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:




491.6(b)(2) STANDARD
MAINTENANCE

Name - Component - 00
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#3, Observation#4, and Observation#5).
Findings include:
Review of Policy " Drugs and Biologicals " on 9/14/2018 at approximately 11:45 AM 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 #3: On 9/13/18 at approximately 10:15 AM, review of Sample Medication and Wound Care cabinets at the " Charting Area " revealed the following:
One (1) Suture Removal Kit expiration date of 5/2017
Four (4) pairs of Triflex Sterile Latex Powdered Surgical Gloves Size 7.5 expiration date 5/2017
One (1) Flexible Caustic Applicator 6-inch expiration date 5/2018
One (1) bottle Swan 91% Isopropyl Alcohol expiration 10/2017
One (1) box Steristrip expiration date 7/2018
Two (2) boxes Skin Gel protective dressing wipes expiration date 3/2018
Gebauers Ethyl Chloride Steam Spray Expiration Date 8/2018
Two (2) Excision and Drainage packs expiration 1/2017
Two (2) Ethilon Suture packs expiration 7/2017
Nine (9) packs Albuterol Sulfate Inhalation Solution expiration date 9/2017
Two (2) vials Sterile Diluent expiration date 9/10/2018
Five (5) packs DuoNeb Inhalation Solution expiration 5/2017
Observation #4: On 9/13/2018 at approximately 10:30 AM in the Laboratory Room, revealed Four (4) Dark green top tubes with the expiration date of 7/31/2018.
Observation #5: On 9/13/2018 at approximately 10:45 AM in medication room, review of the medication fridge revealed the following:
Three (3) vials Rotavirus Vaccine with expiration date 5/2018
Four (4) vials Influenza Vaccine Flu Zone Pediatric Dose expiration date 6/30/2018
One (1) box Florajen Probiotic Dietary Supplement expiration date 6/2018
Four (4) boxes Soliqua 100/33 prefilled Insulin

An interview with the Office Manager on 9/14/2018 at approximately 12:30 PM confirmed the above findings.







Plan of Correction:

Cornerstone will conduct a monthly check on pharmaceuticals performed by Medical Assistant #1. The check will be documented and kept on site. Any expired pharmaceuticals will be disposed of properly. The office manager will also sign off on check list to ensure Medical Assistant has been performing monthly checks. All pharmaceuticals will be labeled with an open date and will be stored with the closest expiration date in the front of supply. The corrective action will be completed by: November 9, 2018


491.6(b)(3) STANDARD
MAINTENANCE

Name - Component - 00
The premises are clean and orderly.



Observations:


Based upon observation, policy and procedure review, and interview with the Office Manager, it was determined the facility failed to ensure the patient waiting room carpet to be clean and free from stains (Observation #1).

Findings include:

Review of policy " General Description" on 9/14/2018 at approximately 12:00 PM states "Cleanliness...the premises are clean and orderly."

Observation #1: On 9/13/2018 at approximately 10:00 AM the patient waiting room carpet was observed to have two (2) large dark stains between the reception window and the patient entrance door into the clinic.

An interview with the Office Manager on 9/14/2018 at approximately 12:30 PM confirmed the above finding.







Plan of Correction:

The facility will rent a carpet cleaner to remove two large dark stains in the waiting room near the reception window. If the stains are not removable, the facility will replace the carpet with a type of flooring that can be easily cleaned. The cleaning staff will be responsible for renting the carpet cleaner and shampooing carpets on a quarterly schedule or as needed to keep carpets clean from any stains. The corrective action will be completed by: November 9, 2018.


491.9(c)(3) STANDARD
DIRECT SERVICES - EMERGENCY

Name - Component - 00
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 upon observation, policy and procedure review, and an interview with the Chief Medical Director, it was determined the facility failed to ensure an anticonvulsant drug to be available on the premises (Observation #2).

Findings include:

Review of policy "Medical Emergency Care" on 9/13/2018 states ...4. The following drugs and biologicals commonly used in life-saving procedures are at the Rural Health Clinic for use at the discretion of the midlevel practitioner by or an R.N. in such life threatening emergencies..c. Ativan IM...."

Observation #2: On 9/13/2018 at approximately 10:30 PM, review of the facility's Emergency Medication box, Medication refrigerators and Medication Cabinets, revealed no Ativan IM or any other anticonvulsant drug on the premises.

An interview with the facility Chief Medical Director on 9/13/2018 confirmed the above findings, stating he has been unable to obtain injectable Ativan from pharmacies, but did order injectable Dilantin (anticonvulsant) on 9/13/2018.







Plan of Correction:

The facility replaced the emergency medication that was missing. The facility was missing an anticonvulsant due to the pharmacy not being able to get Ativan IM. The Medical Director advised the Office Manager to order Dilantin. Dilantin was ordered on 9/13/18 from Moore Medical and was received 9/24/18. The drug received was Dilantin 250 mg/ 5 ml. Lot # 048349 Expiration date: 04/2020 Manufacturer: West-Ward. The policy for the emergency kit will now list dilantin as the anticonvulsant drug, not Ativan. The corrective action will be completed by: November 9, 2018


491.11(c)(2) STANDARD
PURPOSE OF EVALUATION

Name - Component - 00
The established policies were followed; and



Observations:


Based upon Job Description review, personnel file review, and an interview with the Office Manager, it was determined the facility failed to ensure CPR certification for three (3) out of five (5) personnel files which required the certification per job description (PF#1, PF#2, and PF#9,) and Medical Assistant certification/training program according to facility established job description for two (2) out of three (3) medical assistant personnel files reviewed (PF#8 and PF#9).

Findings include:

Review of facility "Policy and Procedure" Binder revealed the last review date of 12/14/2017. Included in the "Policy and Procedure" Binder were the following job descriptions:
"Medical Assistant.....Education: Completion of a Medical Assistant Training Program...Certification: Certification of Medical Assistant training and CPR Certification..."
"Clinic Manager....Certification : CPR Certification."

Review of PF#1 (Office Manager) (Date of hire (DOH) 4/26/2013) on 9/14/2018 at approximately 10:00 AM revealed no documention of CPR certification.

Review of PF#2 (Medical Assistant) (DOH 1/31/2014: ) on 9/14/2018 at approximately 10:10 AM revealed no documentation of CPR certification.

Review of PF#8 (Medical Assistant) (DOH 5/10/2018: ) on 9/14/2018 at approximately 10:40 AM revealed no documentation of certification of Medical Assistant training.

Review of PF#9 (Medical Assistant) (DOH 3/03/2017: ) on 9/14/2018 at approximately 10:50 AM revealed no documentation of certification of Medical Assistant training or CPR certification.

An interview with the Office Manager on 9/14/2018 at approximately 12:30 PM confirmed the above findings.






Plan of Correction:

Review of PF #1 : The employee was notified of expired CPR Training. The office will contact a certified BLS instructor and hold a training in office for all employees who need to be certified. Office Manager will be responsible for making sure employees stay updated on certifications. The corrective action will be completed by: November 9, 2018.
Review of PF #2: The employee was notified of expired CPR Training. The office will contact a certified BLS instructor and hold a training in office for all employees who need to be certified. Office Manager will be responsible for making sure employees stay updated on certifications. The corrective action will be completed by: November 9, 2018.
Review of PF #8: Office Manager will get a copy of employee's Medical Assistant certification training and make sure that a current copy of trainings are on file. Office Manager will obtain a copy from McCann School of Business and Technology and a copy will be put into employee's file. The corrective action will be completed by: November 9, 2018.
Review of PF #9: Office Manager advised employee that we do not have a copy of his/her Medical Assistant Certification. Employee contacted McCann School of Business and Technology and obtained a copy. A copy was put into the employee's file. Office Manager will also make sure this employee receives proper CPR training and has an updated certification on file. Office Manager will also be responsible for making sure employees stay updated on certifications. The corrective action will be completed by: November 9, 2018.

Personnel files will be organized and color coded by categories such as: office forms, certifications/licenses, clearances, insurance forms, immunizations/tb testing, insurances and special requests. All files will include labels and check off lists indicating when items will expire and when they are due. Files will be audited by the office manager quarterly to ensure all items are current. Signed documentation will be kept on site of when files have been audited.