QA Investigation Results

Pennsylvania Department of Health
ELLWOOD CITY MEDICAL CENTER
Health Inspection Results
ELLWOOD CITY MEDICAL CENTER
Health Inspection Results For:


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Initial Comments:

This report is the result of an unannounced complaint investigation (JAC19C010A) conducted on November 27, 2019-December 11, 2019, at Ellwood City Medical Center with additional employee confirmations on December 16, 2019. Final review of the findings was completed on January 6, 2020. It was determined the facility was not in compliance with the requirements of 42 CFR, Title 42, Part 482-Conditions of Participation for Hospitals.

An Immediate Jeopardy was called at 2:10 PM on November 27, 2019, when it was identified that the facility was not providing Radiology Services, specifically CT and MRI Services, presenting safety concerns for Inpatients and patients seeking treatment within the Emergency Department.

The Immediate Jeopardy was abated at 5:00 PM on November 27, 2019, when the facility placed a ban on the Emergency Department and Inpatient Services, until adequate services could be provided.








Plan of Correction:




482.1 CONDITION
Basis and Scope

Name - Component - 00
482.1 Basis and scope.

(a) Statutory basis. (1) Section 1861(e) of the [Social Security] Act provides that-

(i) Hospitals participating in Medicare must meet certain specified requirements; and

(ii) The Secretary may impose additional requirements if they are found necessary in the interest of the health and safety of the individuals who are furnished services in hospitals.
. . .

(b) Scope. Except as provided in subpart A of part 488 of this chapter, the provisions of this part serve as the basis of survey activities for the purpose of determining whether a hospital qualifies for a provider agreement under Medicare and Medicaid.

Observations:

Based on review of facility documentation and employee interview (EMP), it was determined that the facility failed to meet the specified requirements for Medicare when the facility reported an average daily census of 0.91 between December 4, 2018, and December 3, 2019.

Findings include:

Review on December 3, 2019, at 1:15 PM of the facility's census report December 4, 2018, to December 3, 2019, revealed a total of 332 admission days.

Review on December 11, 2019, at 10:00 AM of the facility's census report for December 10, 2018, to December 10, 2019, revealed a total of 348 admission days.

Interview with EMP3 on December 3, 2019, at 1:22 PM revealed a spreadsheet for the average length of stay of 3.8. At 1:42 PM EMP3 stated they spoke with EMP2 who confirmed the what was provided was from the last survey, April 2019. EMP2 had manually calculated it. EMP3 re-calculated the data. EMP3's calculations showed an average daily census of 0.91.

An Immediate Jeopardy was called at 2:10 PM on November 27, 2019, when it was identified that the facility was not providing Radiology Services, specifically CT and MRI Services, presenting safety concerns for Inpatients and patients seeking treatment within the Emergency Department.

At 5:00 PM on November 27, 2019, the facility placed signage noting a ban on providing Emergency Department services and Inpatient Services. The one remaining Emergency Department patient was transferred. There were zero inpatients at that time. The Immediate Jeopardy was abated at 5:00 PM on November 27, 2019.

Cross Reference:
(482.26 Tag A-0528) The information reviewed during the survey provided evidence the facility failed to provide radiology services for 16 of 27 medical records reviewed.

(482.26(b)(2) Tag A-0537) The information reviewed during the survey provided evidence the facility failed ensure the required preventative maintenance was completed on the computerized tomography (CT scanner) and magnetic resonance imaging (MRI) machines in the facility's Radiology Department.




Plan of Correction:

An approved Plan of Correction is not on file.


482.12(d) STANDARD
INSTITUTIONAL PLAN AND BUDGET

Name - Component - 00
The institution must have an overall institutional plan that meets the following conditions:
(1) The plan must include an annual operating budget that is prepared according to generally accepted accounting principles.
(2) The budget must include all anticipated income and expenses. This provision does not require that the budget identify item by item the components of each anticipated income or expense.
(3) The plan must provide for capital expenditures for at least a 3-year period, including the year in which the operating budget specified in paragraph (d)(2) of this section is applicable.
(4) The plan must include and identify in detail the objective of, and the anticipated sources of financing for, each anticipated capital expenditure in excess of $600,000 (or a lesser amount that is established, in accordance with section 1122(g)(1) of the Act, by the State in which the hospital is located) that relates to any of the following:
(i) Acquisition of land;
(ii) Improvement of land, buildings, and equipment; or
(iii) The replacement, modernization, and expansion of buildings and equipment.


Observations:

Based on employee interview (EMP), it was determined that the facility failed to provide an institutional plan to include an annual operating budget prepared according to generally accepted accounting principles; all anticipated income expenses; capital expenditures for at least a 3-year period including the year in which the operating budget was applicable; the anticipated sources of financing for each anticipated capital expenditure in excess of $600,000, or a lesser amount that is established in accordance with section 1122(g)(1) of the Act, by the State in which the hospital is located, that relates to acquisition of land, improvement of land, buildings, and equipment, or the replacement, modernization, and expansion of buildings and equipment.

Findings include:

Interview on December 3, 2019, at 10:02 AM with EMP6 revealed the facility did not have an annual operating budget. EMP6 could not provide a date the last time the budget was completed. EMP6 was unsure if the facility had an operating budget for the last fiscal year or if the operating budget had been reviewed.




Plan of Correction:

An approved Plan of Correction is not on file.


482.12(d)(5) STANDARD
INSTITUTIONAL PLAN AND BUDGET

Name - Component - 00
The plan must be submitted for review to the planning agency designated in accordance with section 1122(b) of the Act, or if an agency is not designated, to the appropriate health planning agency in the State. (See part 100 of this title.)


Observations:

Based on employee interview (EMP), it was determined the facility failed to submit an institutional plan for review to the planning agency designated in accordance with section 1122(b).

Findings include:

Interview on December 3, 2019, at 10:02 AM with EMP6 revealed there was not a current institutional plan with an annual operating budget. EMP6 did not know the last time the budget was completed or if there was one for the last fiscal year. EMP6 did not know if the operating budget was submitted for review by the designated planning agency. EMP6 noted if there were an operating budget it would have been approved by EMP1.






Plan of Correction:

An approved Plan of Correction is not on file.


482.12(d)(6) STANDARD
INSTITUTIONAL PLAN AND BUDGET

Name - Component - 00
The plan must be reviewed and updated annually.


Observations:

Based on employee interview (EMP), it was determined the facility failed to ensure the Institutional Plan was reviewed an updated annually.

Findings include:

Interview on December 3, 2019, at 10:02 AM with EMP6 revealed the facility did not have a current institutional plan with an annual operating budget. EMP6 did not know the last time a budget was completed, if the facility had one for the last fiscal year, or the last time an annual budget was reviewed.










Plan of Correction:

An approved Plan of Correction is not on file.


482.12(d)(7) STANDARD
INSTITUTIONAL PLAN AND BUDGET

Name - Component - 00
The plan must be prepared-
o Under the direction of the governing body; and
o By a committee consisting of representatives of the governing body, the administrative staff, and the medical staff of the institution.


Observations:

Based on employee interview (EMP), it was determined that the facility failed to ensure that the Institutional Plan was prepared under the direction of the governing body and by a committee consisting of representatives of the Governing Body, the administrative staff, and the medical staff of the institution.

Findings include:

Interview on December 3, 2019, at 10:02 AM with EMP6 revealed the facility did not have a current institutional plan with an annual operating budget that was prepared under the direction of the governing body and by a committee consisting of representatives of the governing body, the administrative staff and the medical staff of the institution. EMP6 did not know the last time a budget was completed, if the facility had one for the last fiscal year, or the last time an annual budget was reviewed.





Plan of Correction:

An approved Plan of Correction is not on file.


482.22(a)(1) STANDARD
MEDICAL STAFF PERIODIC APPRAISALS

Name - Component - 00
The medical staff must periodically conduct appraisals of its members.


Observations:

Based on review of facility documents and credential files (CF), as well as employee interviews (EMP), it was determined the facility failed to ensure the medical staff periodically conducted appraisals for 12 of 17 members (CF1, CF2, CF3, CF4, CF5, CF6, CF7, CF8, CF9, CF10, CF11 and CF12).

Findings Include:

Review on November 27, 2019, at 11:00 AM of the "Ellwood City Medical Center Medical Staff Bylaws and Rules & Regulations," dated December 5, 2018, revealed, "... 1.2 The Medical Staff shall actively participate in the following activities related to the clinical aspects of patient care and safety: a. Participate as requested in all Peer Review activities; ..."

Review on November 27, 2019, at 9:59 AM-10:24 AM of CF1, CF2, CF3, CF4, CF5, CF6, CF7 and CF8 revealed no documentation of peer review. EMP14 confirmed there was no documentation of peer review in these credential files at the time of observation.

Review on December 2, 2019, at 1:20 PM-1:49 PM of CF9, CF10, CF11 and CF12 revealed no documentation of peer review. EMP14 confirmed there was no documentation of peer review in these credential files at the time of observation.

Interview on December 2, 2019, at 1:00 PM with EMP14 revealed OTH1 did not require specifics on peer review or education. EMP14 stated the facility had to do it on their own.

Interview on December 16, 2019, at 12:59 PM with EMP14 revealed they were unaware of a separate policy for peer review. EMP14 confirmed peer review was to be completed as per the bylaws and rules and regulations with Ellwood City Medical Center and OTH2.




Plan of Correction:

An approved Plan of Correction is not on file.


482.24(c)(1) STANDARD
MEDICAL RECORD SERVICES

Name - Component - 00
All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures.


Observations:

Based on review of facility documents, medical records (MR), and employee interviews (EMP), it was determined the facility failed to ensure the medical records were complete for transfer information and/or disposition of the patient for 24 of 27 Emergency Department (ED) medical records reviewed (MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR14, MR15, MR16, MR17, MR18, MR19, MR20, MR21, MR22, MR24, MR26, and MR27).

Findings include:

Review on November 26, 2019 at 2:06 PM of the facility document "Transfer of Patient from Emergency Department to Another Hospital or Health Care Facility," revision dated June 2015, revealed "... After stabilization, a safe and efficient transfer of the patient to another hospital or health care facility will be provided. ..."

Review on November 27, 2019 at 2:20 PM of the "Transfer of Patient to Another Acute Care Facility," review/revised September 2017, revealed "... The patient being transported to another acute care facility will be transported by the appropriate mode of transportation (ambulance or aeromedical), and accompanied by the appropriate level of professional caregiver (EMT, Paramedic and/or Registered Nurse), as requested by the physician, to provide ongoing continuity of care until the patient is delivered to the receiving facility. ... Procedure: ... 3. ... The physician must explain the risks and benefits of the transfer to the patient and/or the person acting on behalf of the patient and consent is then obtained. ..."

Emergency Department medical records were reviewed on November 25, 2019, beginning at 12:30 PM, November 26, 2019, beginning at 9:45 AM and November 27, 2019, beginning at 2:30 PM with the following findings:

1. The ED medical records each contained the facility's Consent to Transfer form. The form contained a section "Physician Recommended Transfer." This section provided an area for documentation of the ED Physician's name, the receiving facility's name, the accepting physician's name and/or the risks and benefits of the transfer.

For MR3, MR6, MR8, MR9, MR10, MR12, MR16, MR17, MR22, MR24, MR26, and MR27, the section "Physician Recommended Transfer was incomplete. The required information was not documented elsewhere in these patients' medical records.

2. MR2 and MR11 were transferred from the facility's ED to another health care facility. There were no physician transfer orders in MR2 and MR11.

EMP2 confirmed via email on November 27, 2019 at 10:50 AM that there were no transfer orders for MR2 and MR11.

3. For MR1, MR2, MR4, MR5, MR7, MR8, MR9, MR10, MR11, MR12, MR14, MR15, MR16, MR19, MR20, MR21, and MR22, the risks and benefits of transfer were documented as:
Benefits: CT Scan Risks: Travel
Benefits: CT availability Risks: travel
Benefits: Specialty Care Risks: travel
Benefits: Higher level of care ... Risks: MVA
Benefits: Higher level of care Risks: MVA
Benefits: further evaluation Risks: travel
Benefits: CT Scan Risks: MVA
Benefits: Specialty care Risks: traffic
Benefits: higher level of care Risks: travel
Benefits: Specialized Care Risks: Travel
Benefits: Ortho Specialty Risks: travel
Benefits: higher level of care personal vehicle Risks: travel.

4. MR1, MR2, MR12, MR14, MR16, MR17, MR21, MR22, MR24, MR26, and MR27 revealed these patients were transferred to another acute care facility via private vehicle. There was no documentation to support transfer via private vehicle.

5. Review of MR18 revealed the patient presented ambulatory to the facility's ED. The patient's chief complaint was right eye double vision. The ED triage assessment documented the chief complaint as double vision right eye, requesting STAT [immediate] magnetic resonance imaging (MRI). There was no documentation of an assessment of the patient, vital signs or testing. Not seen in ED was handwritten on every page.

Review of the facility's ED Central Log revealed MR18 was placed in Trauma Room 1 at the time of arrival to the facility.

Cross Reference:
482.26 Condition of Participation Radiologic Services
482.26(b)(2) Periodic Equipment Maintenance (Radiology)






Plan of Correction:

An approved Plan of Correction is not on file.


482.26 CONDITION
RADIOLOGIC SERVICES

Name - Component - 00
The hospital must maintain, or have available, diagnostic radiological services. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications.

Observations:

Based on review of facility documents, medical records (MR), and employee interview (EMP), it was determined the facility failed to provide radiology services for 16 of 27 medical records reviewed (MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR10, MR11, MR12, MR16, MR18, MR20, MR24, and MR26).

Findings include:

Review on December 3, 2019, at 12:02 PM of the facility's "Policy 300.439, Imaging Equipment Care and Service," revised May 2019, revealed "Purpose: To ensure that all Imaging equipment is of the highest possible quality proper Preventative Maintenance and Quality Control measures shall be in place. ..."

Review on November 27, 2019, at 10:30 AM of the "Ellwood City Medical Center Medical Staff Bylaws and Rules & Regulations," dated December 5, 2018, revealed, "... Section 1. Responsibilities of Medical Staff 1.1 All physician members are expected to participate in providing a safe care environment for all patients at all times and adhere to all hospital policies and procedures ..."

1. Review of MR1-MR12 was completed on November 25, 2019, at 12:30 PM-2:30 PM; and on November 26, 2019, at 9:45 AM-12:00 PM. Reviews of MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR10, MR11, and MR12 revealed the patients were transferred to other facilities for computerized tomography (CT) scanning.

2. Review of MR13-MR27 was completed on November 27, 2019, at 2:30 PM and 3:30 PM. Reviews of MR20, MR24, and MR26 revealed the patients were transferred to other facilities for CT scanning.

3. Review of MR16 revealed the patient was transferred to another facility for Doppler services that were not available at the facility, due to that department being closed for the day.

4. Review of MR18 revealed the patient was not evaluated due to the facility not having magnetic resonance imaging (MRI) availability.

An Immediate Jeopardy was called at 2:10 PM on November 27, 2019, when it was identified that the facility was not providing Radiology Services, specifically CT and MRI Services, presenting safety concerns for Inpatients and patients seeking treatment within the Emergency Department.

The Immediate Jeopardy was abated at 5:00 PM on November 27, 2019, when the facility placed a ban on the Emergency Department and Inpatient Services, until adequate services could be provided.


Cross Reference:
482.26(b)(2) Periodic Equipment Maintenance (Radiology)
482.55 Condition of Participation Emergency Services





Plan of Correction:

An approved Plan of Correction is not on file.


482.26(b)(2) STANDARD
PERIODIC EQUIPMENT MAINTENANCE

Name - Component - 00
Periodic inspection of equipment must be made and hazards identified must be promptly corrected.

Observations:

Based on review of facility documentation and employee interview (EMP), it was determined the facility failed to ensure the required preventative maintenance was completed on the computerized tomography (CT scanner) and magnetic resonance imaging (MRI) machines in the facility's Radiology Department.

An Immediate Jeopardy was called at 2:10 PM on November 27, 2019, when it was identified the facility was not performing the required preventative maintenance and was not providing computerized tomography and magnetic resonance imaging services.

Findings include:

Review on December 3, 2019, at 12:02 PM of the facility's "Policy 300.439, Imaging Equipment Care and Service," revised May 2019, revealed "Purpose: To ensure that all Imaging equipment is of the highest possible quality proper Preventative Maintenance and Quality Control measures shall be in place ... Procedure for Routine Preventative Maintenance: Periodic equipment inspections (PMs) shall be performed by engineers to ensure equipment is running properly. Routine maintenance is part of the service contract purchased at the time of equipment purchase. These will be performed based on each vendors' recommendations. ..."

Review on November 27, 2019, at 10:30 AM of the "Ellwood City Medical Center Medical Staff Bylaws and Rules & Regulations," dated December 5, 2018, revealed, "... Section 1. Responsibilities of Medical Staff 1.1 All physician members are expected to participate in providing a safe care environment for all patients at all times and adhere to all hospital policies and procedures ..."

Review on December 2, 2019, at 11:14 AM of a spreadsheet titled "Monthly Equipment Preventative Maintenance, Radiology," dated November 21, 2019, revealed the quarterly preventative maintenance (PM) for the Philips Cat Scan was completed August 14, 2019. The next quarterly PM was due November 2019. The monthly inspection was documented as out of service. The quarterly PM for the MRI was completed August 14, 2019. The next quarterly PM was due November 2019. The monthly inspection was document as due. There was handwritten documentation that the service was due for PM on the CT and MRI.

Interview on December 2, 2019, at 11:15 AM with EMP4 confirmed the PMs that were to be completed in November for the CT and MRI were not completed.

Interview on December 2, 2019, at 11:30 AM with EMP3 revealed the facility continued to use the MRI on patients without the preventative maintenance which was due as of November 31, 2019.

Review on December 10, 2019, at 12:07 PM of the facility's "Radiology Log," dated December 10, 2019, revealed MR45 had an MRI completed on December 2, 2019. The Radiology Log revealed hand-written documentation which noted two MRIs were completed on December 10, 2019, and one was scheduled for December 11, 2019.

Review on December 10, 2019, at 12:30 PM of a facility spreadsheet titled "Monthly Equipment Preventative Maintenance Radiology," dated December 10, 2019, revealed the quarterly PM for the Phillips Cat Scan was completed August 14, 2019. The next PM was due November 2019. The monthly inspection was documented as broke. The quarterly PM for the MRI was completed August 14, 2019. The next quarterly PM was due November 2019. The monthly inspection was documented as not done. There was hand written documentation which noted the Phillips CAT Scan was out of service since November 11, 2019.

Review on December 10, 2019, at 1:15 PM of MR45 revealed an MRI was completed with and without gadolinium contrast on December 2, 2019.

Cross Reference:
482.26 Condition of Participation Radiologic Services
482.55 Condition of Participation Emergency Services





Plan of Correction:

An approved Plan of Correction is not on file.


482.55 CONDITION
EMERGENCY SERVICES

Name - Component - 00
The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice.


Observations:

Based on the systemic nature of the standard-level deficiencies, the facility staff failed to substantially comply with the Condition for Emergency Services. The following standards were cited and show a systemic nature of non-compliance directly impacting the Emergency Department.

Findings include:

(482.12(d) Tag A-0073) The information reviewed during the survey provided evidence the facility failed to provide an institutional plan to include an annual operating budget.

(482.24(c)(1) Tag A-0450) The information reviewed during the survey provided evidence
the facility failed to ensure the medical records were complete for transfer information and/or disposition of the patient for 24 of 27 Emergency Department (ED) patients.

(482.26 Tag A-0528) The information reviewed during the survey provided evidence the facility failed to provide radiology services for 16 of 27 medical records reviewed.

(482.26(b)(2) Tag A-0537) The information reviewed during the survey provided evidence the facility failed ensure the required preventative maintenance was completed on the computerized tomography (CT scanner) and magnetic resonance imaging (MRI) machines in the facility's Radiology Department.

An Immediate Jeopardy was called at 2:10 PM on November 27, 2019, when it was identified that the facility was not providing Radiology Services, specifically CT and MRI Services, presenting safety concerns for Inpatients and patients seeking treatment within the Emergency Department.

The Immediate Jeopardy was abated at 5:00 PM on November 27, 2019, when the facility placed a ban on the Emergency Department and Inpatient Services, until adequate services could be provided.





Plan of Correction:

An approved Plan of Correction is not on file.